Warning

Laboratorios ERN, S.A. informs that some of the contents of this website are addressed exclusively to healthcare professionals, authorized for prescribing or dispensing of drugs. Specialized knowledge is required for proper interpretation.

VITULIA SUEROS FISIOLOGICOS

Sueros Vitulia

Suero Fisiológico Vitulia:

Cloruro Sódico.
Estéril y apirógeno.
Solución isotónica para perfusión.

Existen también otros sueros Vitulia de venta hospitalaria como son:

– Suero Glucosado Vitulia 5%.
– Suero Glucosado Vitulia 10%.
– Suero Glucosado Vitulia 20%.
– Suero Glucosalino Vitulia.
– Suero Ringer Lactato Vitulia.

    Suero Fisiológico Vitulia


    Jar with 100 ml.

    N.C. 999789.2


    Jar with 250 ml.

    N.C. 999790.8


    Jar with 500 ml.

    N.C. 999791.5


    Jar with 1.000 ml.

    N.C. 999792.2


    Financed by the S.N.S.

    Suero Fisiológico Vitulia


    20 jars with 50 ml.

    N.C. 645382.7


    20 jars with 100 ml.

    N.C. 642918.1


    20 jars with 250 ml.

    N.C. 621540.1


    10 jars with 500 ml.

    N.C. 615088.7


    10 jars with 1.000 ml.

    N.C. 609057.2

    Suero Glucosado Vitulia


    20 jars with 100 ml Suero Glucosado Vitulia 5%

    N.C: 645374.2


    10 jars with 500 ml Suero Glucosado Vitulia 5%

    N.C. 614834.1


    10jars with 1.000 ml Suero Glucosado Vitulia 5%

    N.C.609065.7


    10 jars with 500 ml Suero Glucosado Vitulia 10%

    N.C. 615013.9


    10jars with 500 ml Suero Glucosado Vitulia 20%

    N.C. 615062.7


    Suero Glucosalino Vitulia


    10 jars with 500 ml.

    C.N. 615237.9

    Suero Ringer Lactato Vitulia


    10 jars with 500 ml.

    C.N. 614925.6

HOW TO USE Suero Fisiológico Vitulia

Follow the administration instructions for Suero Fisiológico Vitulia  given by your doctor exactly. Consult your doctor or pharmacist if you have doubts.

 

The standard dose is up to 40ml per kg of body weight.

 

The velocity of perfusion recommended is of some 5ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

 

Your doctor will decide the dose and frequency with which the solution is administered, it will depend on your age, weight and clinical situation.

 

A greater quantity of solution must be administered and at a higher speed in those patients who manifest a deficit of plasma volume (hypovolemic shock).

HOW TO USE Suero Glucosado Vitulia

Suero Glucosado Vitulia 5%

 

Follow the administration instructions for Suero Glucosado Vitulia 5% indicated by your doctor exactly.

 

The maximum daily dose is 40 ml per kg of body weight.

 

The recommended speed of administration is some 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

 

Suero Glucosado Vitulia 10%

 

Follow the administration instructions for Suero Glucosado Vitulia 10% indicated by your doctor exactly.

 

The maximum daily dose is 20 ml per kg of body weight.

 

The recommended speed of administration is some 2.5 ml per kg of body weight per hour, which corresponds to 0.25 g per kg of body weight per minute.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

 

 

 

Suero Glucosado Vitulia 20%

 

Follow the administration instructions for Suero Glucosado Vitulia 20% indicated by your doctor exactly.

 

The dose will be established according to medical criteria. In general 250-1500ml per day is recommended, 20-40 drops per minute. 100 drops per minute must not be exceeded.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

 

 

ORIENTATIVE DOSAGE REGIME OF Suero Glucosalino VITULIA

Intravenous injection drop by drop at a rhythm of 40-80 drops per minute.

 

The total dose for an adult will oscillate, according to medical criteria, between 500 ml and 3000 ml in 24 hours. In children, doses will be proportionately smaller.

HOW TO USE SUERO RINGER LACTATO VITULIA

Suero Ringer Lactato Vitulia is presented in the form of a solution to be administered intravenously.

 

Suero Ringer Lactato Vitulia will be used in a hospital by the corresponding health staff.

 

Your doctor will indicate the duration of your treatment with Suero Ringer Lactato Vitulia.

 

The dose can be varied according to medical criteria.

 

The quantity of solution necessary to restore the normal volume of blood is 3-4 times the volume of blood lost.

 

Recommended daily dose:

 

-Adults: between 500 and 3000 ml per day.

 

-Children:

 

-          up to 10kg weight: 100 ml per kg weight and day. Between 10 and 20 kg weight: 1000 ml + 50 additional ml per kg over 10kg, per day

-          above 20 kg weight: 1500 ml + 20 additional ml per kg over 20 kg weight, per day.

 

The speed of perfusion must be adjusted to the clinical needs of the patient, according to his/her age, weight, clinical condition, the balance of fluids and electrolytes and the acid-base equilibrium.

 

When the solution is used as a vehicle for the administration of other medicines, the dose and speed of perfusion will be defined by the nature and dosage regime of the prescribed medicine.

 MEDICATION GUIDE

Suero Fisiológico Vitulia 0.9% solution for perfusion

Sodium chloride

 

Read the whole of this medication guide in detail, because it contains information that will be important to you.

 

This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Suero Fisiológico Vitulia with care to obtain the best results.

 

-Keep this leflet; you may need to read it again.

-If you have any doubts, consult your doctor or pharmacists.

 

This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

 

 In this medication guide:

 

1. What are Suero Fisiológico Vitulia and what are they used for?

2. Before using Suero Fisiológico Vitulia

3. How to use Suero Fisiológico Vitulia

4. Possible adverse effects

5. Storage of Suero Fisiológico Vitulia

1. WHAT IS Suero Fisiológico Vitulia AND WHAT IS IT USED FOR?

Suero Fisiológico Vitulia belongs to the intravenous group of medicines.

 

Suero Fisiológico Vitulia is used to replenish water and sodium and chloride salts that can be low as a consequence of different alterations or disorders. It is also used as a transport solution for other compatible medicines.

2. BEFORE USING Suero Fisiológico Vitulia

Do not use Suero Fisiológico Vitulia

 

 -          If you are allergic to (hypersensitive) the principal component of Suero Fisiológico Vitulia.

 

If you present:

 

-          Excess water in the body (hyperhydration), excess sodium (hypernatremia) or chloride (hyperchloremia).

-          Acidosis (a lower pH than the normal range).

-          Oedematous states in patients with cardiac, hepatic or renal alterations or serious hypertension.

 

In the same way it should not be administered to patients with low sodium levels (hypokalemia) above all in those with cardiovascular sicknesses.

 

Be especially careful with Suero Fisiológico Vitulia

 

If you have disorders where a restriction on the consumption of sodium is indicated, such as cardiac insufficiency, generalised retention of liquids oedema, retention of liquid in the lungs, (lung oedema), hypertension (high blood pressure), hypertension during pregnancy (eclampsia), serious kidney insufficiency.

 

Salt in serum needs to be checked regularly as does the water balance and the acid-base equilibrium.

 

In prolonged therapies and in patients with an acid-base disequilibrium, cardiac, hepatic and/or renal alterations, or if you are being treated with corticoids or the adrenocorticotropic hormone frequent checks on the electrolytes in the blood need to be done.

 

In the case that your suffer a case of hypertonic dehydration (loss of water with an excess of salts) a high perfusion speed needs to be avoided as it can provoke an increase in the plasma’s osmolarity (concentration of salts in the plasma), and specifically, an increase in the concentration of sodium in the plasma (the quantity of sodium in the blood).

 

In preterm infants and those breast feeding the administration of sodium chloride must only be done after determining the levels of sodium in the serum.

 

Use of other medicines

 

Inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those acquired without prescription.

 

The administration of sodium chloride accelerated the renal excretion of lithium, leading to its reduced therapeutic effectiveness.

 

It must be administered with care to those being treated with corticoids or the adrenocorticotropic hormone as they can retain water and sodium.

 

Before mixing with other medicines the compatibility tables must be checked, the pH born in mind and the ions controlled.

Pregnancy and while breast feeding

Consult your doctor or pharmacist before using any medicine.

 

Suero Fisiológico Vitulia can be used when indicated during pregnancy and when breast feeding.

 

Until now there is no relevant epidemiological data and so it is recommended that if used it be used with precaution.

 

 

 

Driving and the use of machines

This is not appropriate in the context of treatment with this medicine.

3. HOW TO USE Suero Fisiológico Vitulia

Follow the administration instructions for Suero Fisiológico Vitulia  given by your doctor exactly. Consult your doctor or pharmacist if you have doubts.

 

The standard dose is up to 40ml per kg of body weight.

 

The velocity of perfusion recommended is of some 5ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

 

Your doctor will decide the dose and frequency with which the solution is administered, it will depend on your age, weight and clinical situation.

 

A greater quantity of solution must be administered and at a higher speed in those patients who manifest a deficit of plasma volume (hypovolemic shock).

 

If you use more Suero Fisiológico Vitulia than you should

 

 It is very unlikely that this will happen as your doctor will determine your daily doses. However, if you did receive an overdose, it could provoke an excess concentration of sodium in the blood, chloride and electrolytes in general or have an excess of hydration and related manifestations like metabolic acidosis (inferior blood pH to normal), overcharging of the heart and the formation of oedemas. In such a case, the perfusion must be interrupted, and diuretic medicines administered in order to eliminate the excess liquid, as well as a check on the electrolytes in the blood and the acid-base equilibrium.

 

If you are not checked in to hospital go to the nearest one or consult the Toxicology Information Service. Telephone: 915620420, indicating the medicine and the amount ingested.

 

If you have any doubt about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

As with all medicines,  Suero Fisiológico Vitulia can produce side effects, though not everyone suffers them.

 

If large quantities of the solution are administered, the levels of sodium and chloride in the plasma may increase.

 

If it is administered continuously in the same perfusion location it can produce pain, fever, infections and phlebitis which extends from the point of injection, extravasation and hypervolaemia.

 

If it is used as a vehicle for the administration of other drugs, the nature of the other drugs administered will determine the probability of other side effects.

 

In the case of side effects the perfusion must be interrupted.

 

If you consider any of the side effects you suffer to be serious, or if you notice any other side effect not mentioned in this medication guide, inform your doctor or pharmacist.

5. CONSERVATION OF Suero Fisiológico Vitulia

Keep out of reach and sight of children.

 

It does not require special conditions for its conservation.

 

Do not use Suero Fisiológico Vitulia after the expiry date which appears on the container. The expiry date is the last day of the month indicated.

 

Do not use Suero Fisiológico Vitulia if it is cloudy or shows sedimentation (presence of particles at the bottom of the container) or if the container shows signs of deterioration.

 

Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

6. ADDITIONAL INFORMATION

Composition of Suero Fisiológico Vitulia

 

 

 

The principal component is:

Principal component            Per 100ml

Sodium chloride                         0.9g

 

Electrolytes                    mmol/l  mEq/l

 

Sodium                                 154          154

Chlorides                              154          154

Theoretical osmolarity         308 mOsm/l

Acidity (up to pH 7.4)          <0.3 mmol/l

pH                                                 4.5-7.0

 

The other components are: water for injections.

 

Product appearance and container contents

 

 Suero Fisiológico Vitulia is a solution for perfusion, transparent and colourless, which is presented in plastic jars (Ecoflac Plus®) of 50, 100, 250, 500 and 1000 ml (it is possible that not all sizes are commercialised).

 

Clinical box:

 

20 50 ml jars

20 100 ml jars

20 250 ml jars

10 500 ml jars

10 1000 ml jars

 

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A.

Pedro IV, 499

08020 Barcelona, España

 

This medication guide was revised in June 2011.

 

-------------------------------------------------------------------------------------------

 

This information is for doctors and health professionals only:

 

Single use containers. Dispose of any remaining content not used after finishing the perfusion.

 

The solution must only be used if the seal is not damaged and the solution is clear.

 

Use the sterile administration set for its administration.

 

Detailed and updated information about this product is available on the webpage of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

 

 

USER INFORMATION MEDICATION GUIDE

Suero Glucosado Vitulia Solution for perfusion

Glucose

 

Read the whole of this medicaton guidein detail, because it contains information that will be important to you.

 

This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Suero Glucosado Vitulia with care to obtain the best results.

 

-Keep this leflet; you may need to read it again.

-If you have any doubts, consult your doctor or pharmacists.

 

This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

 

 

 

In this medication guide:

 

1. What are Suero Glucosado Vitulia and what are they used for?

2. Before using Suero Glucosado Vitulia

3. How to use Suero Glucosado Vitulia

4. Possible adverse effects

5. Storage of Suero Glucosado Vitulia

1. WHAT IS Suero Glucosida Vitulia AND WHAT IS IT USED FOR?

Suero Glucosada Vitulia is a solution for perfusion (which is administered intravenously via a dropper) with a low concentration of glucose which is used:

 

-          for the treatment of water loss (hypertonic dehydration) through vomiting, diarrhoea

-          as an energy source in parenteral nutrition when the ingestion of food orally is limited

-          alterations of the metabolism of carbohydrates (glucose deficit or hypoglycaemia, coma due to an excess of insulin, hepatic coma, vomiting)

-          as a vehicle and diluter of other medicines or solutions with electrolytes (substances with an electric charge such as sodium, potassium and chlorides).

2. BEFORE TAKING Suero Glucosado Vitulia

Do not use Suero Glucosado Vitulia

 

 -if you are allergic (hypersensitive) to its principal components or any of the other components of Suero Glucosado Vitulia.

 

If you have:

 

-          oedema due to an accumulation of liquid in tissues

-          high quantities of glucose in the blood (hyperglycemia)

-          a lack of potassium (hypokalemia)

-          hyperlactacydemia (accumulation of lactic acid in the blood)

-          an important alteration to your tolerance to glucose

-          excess water (hyper hydration)

-          hyptonic dehydration (greater loss of salts than of water)

-          in the first 24 hours following cranial trauma.

 

Be especially careful with Suero Glucosado Vitulia

 

 Inform your doctor if you suffer from:

 

-          diabetes mellitus, it can be used if first you start the adequate treatment with insulin

-          kidney insufficiency (deficient working of the kidney)

-          intracranial hypertension

-          sharp ischemic attacks (decrease or absence of circulation of blood in the arteries)

-          alterations of the acid-base equilibrium (blood acidity disorders)

-          malnutrition with a deficiency of vitamin B1 (essential for the glucose metabolism).

 

 

 

You must not be administered Suero Glucosado Vitulia with the same delivery set (equiptment used to administer medication directly to the blood), neither at the same time, nor before, nor after a blood transfusion as incompatibilities may arise.

 

The level of sugar in your blood must be regularly checked, as must the level of electrolytes and the water level.

 

Potassium may be administered in conjunction with Suero Glucosado Vitulia in order to avoid hypokalemia (low potassium levels in the blood) which can appear during parenteral alimentation.

 

If administered continuously and at the same point of perfusion, thrombophlebitis may be produced (inflammation of the veins).

 

Elderly patients will be monitored particularly carefully as the functioning of the liver and/or kidney may be affected.

 

Do not administer via intramuscular.

 

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medication, including those acquired without prescription.

 

It is important to inform your doctor if you use any of the following medicines:

 

-          Insulin or oral antidiabetics (biguanides, sulphonylureas), used in the treatment of diabetes: these medicines diminish the effect of the glucose.

-          Corticosteroids, used in the treatment of inflammation, allergy: due to the risk of an increase in the level of glucose in the blood, or due to the capacity of these drugs to retain sodium and water.

-          Digitalic glucosides (dygoxina), used for cardiac insufficiency (the heart does not pump sufficient blood): If the intravenous administration of glucose coincides with treatment with digitalic glucosides (dygoxina) the risk of intoxication resulting from these medicines exists.

 

In any case, the doctor must check the compatibility of medicines added.

 

Pregnancy and when breast feeding

Consult your doctor or pharmacist before using any medicine.

 

In the case of pregnancy, your doctor will decide the suitability of using 5%glucose solution, as it must be used with precaution in this case. The administration of gluose via injection during pregnancy can increase the levels of glucose and insulin as well as the acidic components in the foetus’s blood.

 

There is no evidence that glucose at 5% can provoke adverse effects on the newborn when breast feeding. Even so, it is recommended to use it with precaution during this period.

 

Driving and using machines

There are no indications that the Suero Glucosado Vitulia 5% solution can affect the capacity to drive or use machines.

3. HOW TO USE Suero Glucosado Vitulia

Suero Glucosado Vitulia 5%

 

Follow the administration instructions for Suero Glucosado Vitulia 5% indicated by your doctor exactly.

 

The maximum daily dose is 40 ml per kg of body weight.

 

The recommended speed of administration is some 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

 

Suero Glucosado Vitulia 10%

 

Follow the administration instructions for Suero Glucosado Vitulia 10% indicated by your doctor exactly.

 

The maximum daily dose is 20 ml per kg of body weight.

 

The recommended speed of administration is some 2.5 ml per kg of body weight per hour, which corresponds to 0.25 g per kg of body weight per minute.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

 

 

 

Suero Glucosado Vitulia 20%

 

Follow the administration instructions for Suero Glucosado Vitulia 20% indicated by your doctor exactly.

 

The dose will be established according to medical criteria. In general 250-1500ml per day is recommended, 20-40 drops per minute. 100 drops per minute must not be exceeded.

 

With children the speed of perfusion depends on the age and weight of the child and, generally, 10 – 18 mg of glucose per kg of body weight per minute must not be exceeded.

 

Your doctor will decide the dose and frequency with which the solution will be administered, this will depend on your age, weight and clinical situation.

If you use more Suero Glucosado Vitulia than you should

 

It is unlikely that this happens as your doctor will determine your daily dose. However, if you receive an overdose, this could provoke:

 

-          an excess of hydration

-          a disequilibrium of the levels of salt and acidic basic substances of the organism

-          an increase in the concentration of sugar in the blood (hyperglycemia) and glucose in urine (glucosuria).

 

If this should happen, the perfusion must be interrupted immediately, and depending on the gravity of the situation, electrolytes, diuretic medication or insulin administered.

 

If you have any other doubt about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

As with all medicines, Suero Glucosado Vitulia can produce side effects, although not everyone suffers them.

 

It can produce hyperglucemia, glucosuria or alterations to the equilibrium of fluids and electrolytes if it is administered too fast, or if the volume of fluid is excessive, or in cases of metabolic insufficiency.

 

A localised reaction at the point of injection may be produced.

 

If it is used as a vehicle for the administration of other medicines, the nature of the medicines added will determine the probability of other adverse reactions.

 

Your doctor will assess the convenience or not of suspending the medication.

 

If you consider any of the side effects you suffer to be serious, or if you appreciate any side effect not mentioned in this medication guide, inform your doctor or pharmacist.

5. CONSERVATION OF Suero Glucosado Vitulia

Keep out of reach and sight of children.

 

It does not require special conditions for its conservation.

 

Do not use Suero Glucosado Vitulia after the expiry date which appears on the container. The expiry date is the last day of the month indicated.

 

Do not use Suero Glucosado Vitulia if it is cloudy or shows sedimentation (presence of particles at the bottom of the container) or if the container shows signs of deterioration.

 

Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

6. ADDITIONAL INFORMATION

Composition of Suero Glucosado Vitulia 5%

The principal component is: Glucose. 100 ml of the product contains 5 g of glucose.

Theoretical osmolarity: 278 mOsm/l

Calories: 200 cal/L

Approximate pH: 4.5

The other components are: water for injectable products.

 

Composition of Suero Glucosado Vitulia 10%

The principal component is: Glucose. 100 ml of the product contains 10 g of glucose.

Theoretical osmolarity: 555 mOsm/L

Calories: 400 cal/L

pH: 4.5

The other components are: water for injectable products.

 

Composition of Suero Glucoasado Vitulia 20%

The principal component is: Glucose. 100ml of the product contains 20 g of glucose.

Theoretical osmolarity: 1110 mOsm/L

Calories: 800 cal/L

Approximate pH: 4-4.5

The other components are: water for injectable products.

 

 

 

Product appearance and container contents:

 

Suero Glucosado Vitulia 5% is a solution for perfusion which is presented, prepared in plastic jars of 100,500,1000 ml.

Suero Glucosado Vitulia 10% is a solution for perfusion which is presented, prepared in plastic jars of 500 ml.

Suero Glucosado Vitulia 20% is a solution for perfusion which is presented, prepared in plastic jars of 500 ml.

 

 

 

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A.

Pedro IV, 499

08020 Barcelona, España

 

Responsable for fabrication.

LABORATORIOS ERN, S.A.

Pedro IV, 499

08020 Barcelona, España

 

This information leaflet was approved in March 2011.

 

-------------------------------------------------------------------------------------------

 

This information is for doctors and health professionals only:

 

Single use containers. Dispose of any remaining content not used after finishing the perfusion.

 

The solution must only be used if the seal is not damaged and the solution is clear.

 

Use the sterile administration set for its administration.

 

The elimination of any unused medicine and all the materials which have been in contact with it shall be done according to local regulations.

 

Detailed and updated information about this product is available on the webpage of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

 

 

MEDICATION GUIDE

SUERO GLUCOSALINO VITULIA (ISOTONIC)

 

 

 

COMPOSITION

Anhydrous glucose......................3.6g

Sodium chloride...........................0.3g

Water for injection c.s.p...............100ml

Electrolyte concentration: Na+ : 51 mEq/l; Cl -:51 mEq/l

Osmolarity: 303 mOsm/l

Calories: 144 cal/l

Approximate pH: 5.0

 INDICATIONS

Dehydration accompanied by saline loss.

 

States of acidosis: uremic coma, diabetic coma (with the administration of insulin).

 

States of weak alkalosis.

 

Sharp abdomen syndrome: peritonitis, colic hepatic, intestinal intussusceptions, mesenteric thrombosis.

 

Acetonemic vomiting.

 

As a vehicle for the administration of other medicines along with a light energy contribution.

ORIENTATIVE DOSAGE REGIME

Intravenous injection drop by drop at a rhythm of 40-80 drops per minute.

 

The total dose for an adult will oscillate, according to medical criteria, between 500 ml and 3000 ml in 24 hours. In children, doses will be proportionately smaller.

REGULATIONS FOR ITS CORRECT USE

It will be administered intravenously using a sterile administration set and apyrogen.

 

 

 

DISPOSE OF ANY SERUM WHICH PRESENTS A CLOUDY APPEARANCE, AN UNAMBIGUOUS SIGN THAT BREAKAGES HAVE BEEN PRODUCED, WITH THE CONSEQUENT LOSS OF STERILITY.

COUNTERINDICATIONS

Uncompensated heart conditions, nephrosis, acute nephritis, cirrhosis, high blood pressure, oedemas, hypotonic dehydration, Addison’s illness, as well as with patients treated for a long time with corticosteroids and ACTH.

PRECAUTIONS

The state of hydration, plasmatic circulation and osmolarity must be monitored in order to avoid a hypotonic haemodilution.

INCOMPATIBILITIES

None known.

INTERACTIONS

Neither erythromycin, dibasic calcium edentate nor disodium histamine can be incorporated with SUERO GLUCOSALINO VITULIA.

SIDE EFFECTS

No side effects after a correct administration of SUERO GLUCOSALINO VITULIA are known.

 INTOXICATION AND ITS TREATMENT

Its excessive administration can lead to a cardiac overload and the formation of oedemas, in this case the administration will be interrupted and a symptomatic treatment applied.

 

In the case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone (91)5620420.

PRESENTATION

Container with 500 ml of solution.

 

WITH PRESCRIPTION

 

MEDICINES MUST BE KEPT OUT OF SIGHT AND REACH OF CHILDREN.

 

LABORATORIOS ERN, S.A.

CALLE PEDRO IV, 499 –08020 BARCELONA

 

 

MEDICATION GUIDE

SUERO RINGER LACTATO VITULIA solution for perfusion

Sodium lactate, Sodium chloride, Potassium chloride, Dehydrated calcium chloride

 

 

 

Read the whole of this medication guide in detail, because it contains information that will be important to you.

 

This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Suero Ringer Lactato Vitulia with care to obtain the best results.

 

-Keep this leaflet; you may need to read it again.

-If you have any doubts, consult your doctor or pharmacists.

 

This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

 

 In this medication guide:

1. What are Suero Ringer Lactato Vitulia and what are they used for?

2. Before using Suero Ringer Lactato Vitulia

3. How to use Suero Ringer Lactato Vitulia

4. Possible adverse effects

5. Storage of Suero Ringer Lactato Vitulia

 1. WHAT IS SUERO RINGER LACTATO VITULIA AND WHAT IS IT USED FOR?

Suero Ringer Lactato Vitulia is a solution for perfusion which belongs to the therapeutic group called Intravenous solutions which affect the electrolyte balance- Electrolytes.

 

Suero Ringer Lactato Vitulia is presented in glass jars of 500 millilitres (ml) and 1000 ml.

 

Suero Ringer Lactato Vitulia is indicated in the following situations:

 

-          Hydroelectric replenishment of extracellular fluid, such as in states of dehydration with a loss of electrolytes or in surgical interventions.

-          Short term replenishment of plasmatic volume in states of hypovolemic shock (haemorrhages, burns and other problems which provoke a loss of circulatory volume) or hypotension (decreased blood pressure).

-          States of light or moderate metabolic acidosis (except lactic acidosis).

2. BEFORE USING SUERO RINGER LACTATO VITULIA

Monitoring the hydroelectric balance is recommended.

 

Do not use Suero Ringer Lactato Vitulia

 

-          if you are allergic (hypersensitive) to sodium lactate, sodium chloride, dehydrated calcium chloride or any of the other components of Suero Ringer Lactato Vitulia

-          extracellular hyperhydration or hypervolemia (excess of fluids in the body)

-          renal insufficiency with oliguria or anuria (kidney failure with a decrease or absence of urine)

-          uncompensated cardiac failure

-          if your blood contains a high level of potassium, sodium, calcium or chlorides

-          metabolic alkalosis

-          serious metabolic alkalosis

-          lactic acidosis

-          serious hepatocellular insufficiency (failure in the functioning of the liver) or deteriorated lactate metaboloism

-          general oedema (excessive accumulation of liquids) or ascetic cirrhosis.

 

Do not use this medication in any of the previous circumstances.

 

Be especially careful with Suero Ringer Lactato Vitulia

 

-          If the kidneys, heart and /or lungs do not function correctly. In these cases the administration of large quantities of this solution must be done under strict clinical control.

-          It is recommended that, during the administration of this solution the patient’s clinical condition be regularly monitored, as well as regular analyses of the blood and urine (electrolytes in the blood and urine, acid-base equilibrium, hematocrit). If there is a risk of hyperkalaemia (high levels of potassium in the blood) regular checks of the level of potassium in the blood must be realised.

 

If you have any of the following illnesses, this medicine will be administered with special care, and it is probable that additional tests be done to determine whether you can receive this medication:

 

-          Due to the presence of sodium: If you have high blood pressure (hypertension), cardiac failure, oedema in the lungs or in ankles, feet and legs, preeclampsia (an illness which can appear during pregnancy or post-partum which leads to increased blood pressure), aldosteronism (an illness associated with an increase in the secretion of the aldosterone hormone) or deteriorated renal function, or other conditions associated with the retention of sodium.

-          Due to the presence of potassium: If you suffer from cardiac illnesses or other problems which can provoke an increase in the amount of potassium in the blood, such as adrenocortical or renal insufficiency, acute dehydration, or massive destruction of tissue, as happens with severe burns.

-          Due to the presence of calcium: If you have a deteriorated renal function or if you have or have had kidney stones produced by an accumulation of calcium, or illnesses associated with elevated concentrations of vitamin D like sarcoidosis.

-          Due to the presence of lactate ions: If Ringer Lactato solution is administered in large quantities it can produce metabolic alkalosis.

-          If you have serious potassium deficiency. Even though Ringer Lactato solution has a similar concentration of potassium similar to that of plasma, this is insufficient to produce a beneficial effect in these situations.

-          If the liver does not function correctly, Ringer Lactato solution may not have effect as the lactate metabolism may be deteriorated.

-          Ringer Lactato solution must be administered with precaution if you are at risk of suffering cerebral oedema or intracranial hypertension.

-          If you are being treated with corticoids, the adrenocorticotrophic hormone or digitalic medicines, the administration of Ringer Lactato solution must be done with precaution (see section Use of other medicines).

 

Special care must be taken with elderly patients, as they may have renal, hepatic and/or cardiac function affected.

 

Continuous administration at the same point of injection must be avoided due to the risk of thrombophlebitis.

 

Use of other medicines

 

Inform your doctor or pharmacist if you are taking or have recently taken other medication, including those acquired without prescription.

 

Certain medicines can interact with Suero Ringer Lactato Vitulia. In this case it may be necessary to change the dose or interrupt the treatment with some of these medicines.

 

Generally, the administration of Ringer Lactato in conjunction with any medicine which presents or can present toxicity at renal level must be avoided, as it can cause retention of liquids and electrolytes.

 

It is important that you inform your doctor if you use any of the following medicines, as these can interact with some of the electrolytes present in Ringer Lactato solution:

 

-          Corticoids/steroids or the adrenocorticotrophic hormone.

-          Lithium carbonate.

-          Potassium sparing diuretics (amiloride, espironolactone, triamterene) on their own or in association.

-          Angiotensin converting enzyme inhibitors (IECA) (captopril, enalapril) or antagonists of the angiotensin II receptors (candesartan, telmisartan, eprosartran, irbesartan, losartan, valsartan).

-          Tacrolimus and cyclosporine (medicines with toxicity at renal level).

-          Cardiotonic digitalic glucoses (dygoxine, metyldygoxine).

-          Thiazide diuretics (hydroclorothiazide, altizide, mebutizide, bendroflumethiazide) or vitamin D.

-          Medicines with acidic character like salicylates and/or barbiturates.

-          Alkaline medicines like the sympathomimetics (ephedrine, pseudoephedrine0 and/or stimulants (amphetamine, dexamphetamine).

 

Pregnancy and while breast feeding

 

Consult your doctor or pharmacist before using any medicine.

 

If Ringer Lactato solution is administered correctly and monitored, no adverse effects should occur during the pregnancy nor during the breast feeding period.

 

During pregnancy and when breast feeding, the use of Ringer Lactato solution as a vehicle for the administration of other drugs must be considered depending on the nature of these.

 

Driving and using machines

No indications exist to show that Suero Ringer Lactato Vitulia can affect the capacity to drive or use machines.

3. HOW TO USE SUERO RINGER LACTATO VITULIA

Suero Ringer Lactato Vitulia is presented in the form of a solution to be administered intravenously.

 

Suero Ringer Lactato Vitulia will be used in a hospital by the corresponding health staff.

 

Your doctor will indicate the duration of your treatment with Suero Ringer Lactato Vitulia.

 

The dose can be varied according to medical criteria.

 

The quantity of solution necessary to restore the normal volume of blood is 3-4 times the volume of blood lost.

 

Recommended daily dose:

 

-Adults: between 500 and 3000 ml per day.

 

-Children:

 

-          up to 10kg weight: 100 ml per kg weight and day. Between 10 and 20 kg weight: 1000 ml + 50 additional ml per kg over 10kg, per day

-          above 20 kg weight: 1500 ml + 20 additional ml per kg over 20 kg weight, per day.

 

The speed of perfusion must be adjusted to the clinical needs of the patient, according to his/her age, weight, clinical condition, the balance of fluids and electrolytes and the acid-base equilibrium.

 

When the solution is used as a vehicle for the administration of other medicines, the dose and speed of perfusion will be defined by the nature and dosage regime of the prescribed medicine.

 

If you are administered more Suero Ringer Lactato Vitulia than you should be

 

In the case of overdose or overly rapid administration, the following symptoms can appear:

 

-          hyperhydration (oedema, hypervolemia), disorders in the electrolyte balance and/or the induction of a metabolic alkalosis, particularly in patients with a deteriorated renal function. In those cases, the administration will be decreased or stopped and symptomatic treatment will be started. If the renal function is compromised, dialysis may be necessary

-          an overload of water and sodium with risk of oedema, particularly when there is a defective renal excretion of sodium.

 

The excessive administration of potassium salts can lead to the development of hyperkalaemia (an increase in potassium in the blood) especially in patients with a deteriorated renal function. Symptoms include, a tingling sensation, drowsiness, a burning feeling in hands and feet, muscular weakness, paralysis, cardiac arrhythmias, cardiac blockage, cardiac arrest and mental confusion.

 

The excessive administration of calcium salts can lead to hypercalcaemia (an increase in calcium in the blood). Symptoms of hypercalcaemia can include, anorexia, nausea, vomiting, constipation, abdominal pain, mental alteration, polydipsia (excessive thirst), polyuria (excessive volume of urine), kidney stones and, in serious cases, cardiac arrhythmias and coma, as well as tast for calcium, peripheral heating and vasodilatation. Asymptomatic light hypercalalaemia is habitually resolved by interrupting the administration of calcium and other contributing medicines such as vitamin D. If the hypercalaemia is serious, urgent treatment is required (like diuretic cycles, haemodialysis, calcitonin, bisphophonates, trisodium edentate).

 

The excessive administration of sodium lactate can lead to hypokalemia (decrease in the amount of potassium in the blood) and metabolic alkalosis (alkalinity of the blood). Symptoms can include a change of character, tiredness, respiratory insufficiency, muscular weakness and an irregular heartbeat. An increase in muscular toning, muscular spasms and tetany (neuromuscular hyperexcitability) can develop, particularly in hypocalcaemic patients. Treatment of metabolic alkalosis associated with an overdose of bicarbonate principally consists in the appropriate correction of the equilibrium between fluids and electrolytes.

 

When the overdose is related to the medicine added to the perfused solution, the signs and symptoms of the over perfusion can be related to the nature of the medicine added. In case of accidental overdose, the treatment must be interrupted and the patient observed in case the symptoms associated with the administered medication appear. If necessary, take the appropriate symptomatic and support measures which are necessary.

 

In the case of overdose or accidental ingestion consult the Toxicology Information Service. Telephone: 915620420.

 

If you have any other doubt about the use of this medicine, ask your doctor or pharmacist.

 4. POSSIBLE SIDE EFFECTS

 As with all  medicines, Suero Ringer Lactato Vitulia can produce side effects, although not everyone suffers them.

 

The most commonly described side effects are hyperhydration (oedemas) and electrolyte alterations (principally after the administration of a large quantity of Ringer Lactato solution), as well as allergic reactions.

 

Possible side effects are:

 

-          Electrolyte alterations.

-          Vein thrombosis (clotting), phlebitis (inflammation of the vein) (associated with intravenous administration).

-          Nasal congestion, coughing, sneezing, respiratory difficulty during the solution’s administration, chest pain with alterations of the cardiac rhythm.

-          Allergic reactions such as hives, skin rashes, reddening of the skin, itching, swelling, accumulation of liquid in the tissues.

-          Hyperhydration (oedemas).

-          Fever, infection  at the point of injection, localised reactions or pain (associated with intravenous administration).

 

When Ringer Lactato solution is used as vehicle for the administration of other medicines, the side effects may e related to the other medicines added to the solution.

 

If side effects appear, the perfusion must e interrupted.

 

If you consider any of the side effects you suffer to e serious or if you appreciate any other side effect not mentioned in this medication guide, inform your doctor or pharmacist.

 5. CONSERVATION OF SUERO RINGER LACTATO VITULIA

 Keep out of sight and reach of children.

 

Do not use Suero Ringer Lactato Vitulia after the expiry date which appears on the container after CAD. The date of expiry is the last day of the month indicated.

 

It does not require special conditions for conservation. Once open, the solution must be used immediately.

 

Do not use Suero Ringer Lactato Vitulia if you observe that the solution is not transparent, contains precipitates or lumps.

 

Medicines must not be thrown into the drains nor into the rubbish. Ask your pharmacist how to dispose of the containers and unneeded medicines. This way you will help protect the environment.

6. ADDITIONAL INFORMATION

 Composition of Suero Ringer Lactato Vitulia

 

-          The principal components are: sodium lactate, sodium chloride, potassium chloride, dehydrated calcium chloride. Per 100 ml: 600mg sodium chloride, 312mg sodium lactate, 40mg potassium chloride, 27mg dehydrated calcium chloride.

-          The other components are: water for injections.

 

 

 

Electrolyte composition: Chloride 111.7 mEq/l, lactate 27.8 mEq/l, sodium 130.5 mEq/l, potassium 5.4 mEq/l and calcium 3.7 mEq/l.

Osmolarity: 277 mOsm/l.

Approximate pH: 6.0

 

Product appearance and container contents

 

Suero Ringer Lactato Vitulia is presented in the form of a solution for intravenous perfusion.

 

Suero Ringer Lactato Vitulia is a transparent, colourless solution, with no visible particles, sterile and pyrogen-free. It is presented in low density polyethylene jars and polyethylene capsules with an elastomer membrane of 500 and 1000 ml.

 

It is possible that only some sizes are commercialised.

 

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A.

Pedro IV, 499

08020 Barcelona, España

 

Laboratorios ERN, S.A.

C/ Perú, 228.

08020 Barcelona. España.

 

This information leflet was revised in May 2010.

 

----------------------------------------------------------------------------------------------------------------

 

This information is for doctors and health professionals.

 

Suero Ringer Lactato itulia is administered by perfusion.

 

The contents of each jar of Suero Ringer Lactato Vitulia are for only one perfusion. Once open, the solution must be administered immediately and any unused must be disposed of.

 

The solution must be transparent and not contain precipitates. Do not administer if this is not the case.

 

To administer the medicine, and in the case of addition of other medicines, the maximum asepsis must be maintained. From a microbiological perspective, when the solution is used as a vehicle for other medicines, it must be used immediately unless the dilution has been realised in adequately controlled aspeptic conditions. If not used immediately, the conditions and periods of conservation during its use are responsibility of the user.

 

You are recommended to check compatibility tables before adding medicines to Ringer Lactato solution, or its simultaneous administration with other medicines. We recommend you check the added medicines information leaflets, as well as checking if they are soluble and stable in an aqueous solution with the pH of Ringer Lactato solution (pH 5.0-7.0).

 

When medication compatible with Suero Ringer Lactato Vitulia is added the solution must be administered immediately.

 

 

 

Ringer Lactato must not be used for medicines that contain ions capable of producing the formation of insoluble calcium salts.

 

We recommend not mixing or simultaneously administering with the same perfusion set, Ringer Lactato solution with total blood, or with blood components, conserved with an anti coagulant containing citrate (like CPD), as the calcium ions present in the solution can exceed the chelating capacity of the citrate, leading to the formation of clots. These clots could perfuse directly to the circulation and provoke an embolism.

 

 

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