Infezzol 40 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspsolution for infusions

Composition:

Active substances:

L-alanine 4.00 g

L-arginine 4.55 g

L-aspargic acid 2.00 g

L-glutamic acid 5.00 g

L-gistidine 1.35 g

L-isoleucine 2.10 g

L-leucine 2.75 g

Llysine hydrochloride 2.50 g (corresponding to 2.00 g Llysine)

L-methionine 1.75 g

Lphenylalanine 3.15 g

L-treonine 1.60 g

L-tryptophan 0.50 g

L-valine 2.25 g

Glycine 7.00 g

Xylitol 50.00 g

Sodium acetate trihydrate 3.40 g (corresponding to 2.05 g of sodium acetate)

Potassium chloride 1.86 g

Magnesium chloride hexahydrate 0.51 g (corresponding to 0.24 g of magnesium chloride)

Sodium hydroxide 0.60 g

Excipients:

Water for Injection: 931.00 g

Sodium metabisulphite 0.02 g

Total nitrogen content: Total amino acid content Theoretical osmolarity: Energy value:

Description:

Transparent, almost colorless or with a yellowish tinge of liquid, with a specific odor.

Pharmacotherapeutic group:Parenteral nutrition

ATX: & nbsp

Combined preparations for parenteral nutrition

Pharmacodynamics:

Infezol® 40 is a combined preparation containing L-amino acids, carbohydrates and electrolytes. Amino acids, administered intravenously, serve as links for the synthesis of proteins. Electrolytes are necessary for correcting the water-electrolyte balance. Xylitol is a source of calories, which in the process of carbohydrate metabolism is split at the liver level, while its metabolites enter the processes of glycolysis and gluconeogenesis.

Infezol® 40 is administered intravenously, so its bioavailability is 100%.

Indications:

Parenteral nutrition;
replenishment of fluid loss (with burns, surgeries, bleeding);
prophylaxis and therapy of protein deficiency, which arises as a result of increased need, increased consumption or disruption of protein intake with food, its absorption and excretion.

Contraindications:

Hypersensitivity to sodium disulfite (sodium metabisulphite) and other components of the drug;
severe liver damage;
violation of amino acid metabolism (eg, phenylketonuria);
metabolic acidosis;
acute craniocerebral injury; intoxication with methanol; hyperkalemia;
shock;
hypoxia;
pathologically high level of electrolytes contained in this solution, in blood plasma;
pathological conditions accompanied by presumed or established renal failure of severe severity (creatinine clearance <30 μmol / l);
Decompensated heart failure; acute pulmonary edema;
hyperhydration;
bronchial asthma;
children under 2 years (for children under 2 years there are specific requirements for amino acids).

Carefully:

Pregnancy, lactation.

Pregnancy and lactation:

Use of the drug Infezol® 40 during pregnancy is possible only if the intended benefit of therapy for the mother exceeds the potential risk to the fetus or the baby, which is estimated by the treating doctor, because there is a lack of clinical experience in the use of the drug during pregnancy and lactation.

Dosing and Administration:

The drug is administered intravenously, drip, slowly, with careful monitoring of the patient's condition. Dosage is calculated depending on the clinical condition of the patient and his needs for amino acids, electrolytes and liquids.

Sharp dosing:

Adults:

from 0.6 g to 1.0 g of amino acids (up to 25 ml of the drug Infezol® 40 per kg of body weight per day).

In conditions with prevalence of catabolism:

from 1.3 g to 2.0 g of amino acids (up to 50 ml of the drug Infezol® 40 per kg of body weight per day).

For children from 2 to 18 years:

from 1.0 g to 2.0 g of amino acids (up to 50 ml of the drug Infezol® 40 per kg of body weight per day). With a higher body requirement for liquid and calories, the calculated amount of the preparation of Infezol® 40 can be supplemented by simultaneous or sequential administration of solutions of electrolytes, glucose, etc.

If there is a possibility of partial oral nutrition, the amount of the drug Infezol® 40 delivered parenterally, respectively, decreases by the amount of liquid and calories administered orally.

If the infusion is too rapid, reactions of intolerance, as well as renal losses of amino acids with violation of their balance, are possible.

With renal and hepatic insufficiency, an individual dosage is required. Duration of application until complete transition to enteral or oral nutrition.

Side effects:

Usually, the preparation of Inphezol®40 is well tolerated. When using the drug, side effects are usually not observed. In very rare cases, nausea, vomiting, headache, chills, fever and irritation of the veins can occur, usually with too rapid administration. In isolated cases, allergic reactions may occur.

Overdose:

Symptoms: In case of overdose or too rapid administration of the drug, intolerance reactions in the form of nausea, vomiting, chills and renal losses of amino acids are possible.

Too fast administration or administration of excessive amounts of potassium-containing solutions, particularly with acidosis and kidney failure, can lead to hyperkalemia.The potassium concentration in the serum is> 6.5 mmol / l. Symptoms of hyperkalemia may include: muscle weakness, sensitivity disorders, cardiac disorders (sinus bradycardia, arrhythmia, conduction abnormalities, broadening of the complex QRS up to the blocking of the legs of the bundle of the Guiss, the sharpening of the T wave on the ECG - in patients taking digitalis preparations, the changes in the T wave can be veiled).

Therapy: Immediate cessation of infusion. Osmotic diuresis. In cases that pose a threat to life - dialysis.

Interaction:

Due to the increased risk of microbial contamination and incompatibility, solutions containing amino acids should not be mixed with other drugs. With simultaneous administration of the drug Infezol®40 and thiamine solution (vitamin B₁) there is splitting of thiamine.

Special instructions:

Regular monitoring of the electrolyte content in blood serum, blood glucose concentration, acid-base composition, water balance, total serum protein, renal and hepatic parameters is required. Special care must be taken in patients with heart failure when administeredlarge quantities of liquid. Take care when the serum osmolarity is high.

Due to the sodium disulfite (sodium metabisulphite) contained in the preparation, in particular, asthma patients may experience hypersensitivity reactions manifested by vomiting, diarrhea, intermittent breathing, acute attacks of asthma, impaired consciousness or shock. These reactions in each individual case can proceed very differently and also lead to conditions that pose a threat to life. In addition, the reaction products of sodium disulfite (sodium metabisulphite) with other components of the drug, in particular, with tryptophan, can cause an increase in the activity of hepatic enzymes and bilirubin concentrations.

Effect on the ability to drive transp. cf. and fur:

The drug Infezol®40 does not affect the ability to drive vehicles and control mechanisms.

Form release / dosage:

Solution for infusion.

Packaging:

For 100, 250 or 500 ml of the drug in vials of transparent glass type I, closed with a bromobutyl rubber stopper for piercing and a plastic lid under an aluminum roll, with a plastic holder.

10 bottles along with the instructions for use are placed in a cardboard box (for hospitals).

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dark place.

Do not freeze!

Keep the medicine out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package. Use only clear solutions in intact vials! After opening the vial the drug should be immediately used!

Terms of leave from pharmacies:On prescription

Registration number:П N012478 / 01

Date of registration:05.03.2011 / 10.09.2013

Expiration Date:Unlimited

The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Information update date: & nbsp26.10.2017

Illustrated instructions

Instructions

Infezol® 40 (Infesol® 40)