Infezzol 100 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspsolution for infusions

Composition:

Active ingredients:
L-isoleucine	5.850 grams
L-leucine	6,240 g
Lysine monoacetate (corresponding to 7,100 g Llysine)	10.020 g
L-methionine	4,680 g
Acetylcysteine (corresponding to 0.500 g L-cysteine)	0.673 g
L-phenylalanine	5,400 grams
Acetyltyrosine (corresponding to 1.620 g L-tyrosine)	2,000 grams
L-treonine	5,000 grams
L-tryptophan	2,000 grams
L-valin	5,000 grams
L-arginine	9.660 g
Ornithine hydrochloride (corresponding to 1,900 g L-ornithine)	2,420 grams
L-cystidine	3,300 g
L-alanine	15,500 grams
L-aspartic acid	1.910 g
L-glutamic acid	5,000 grams
Glycine	7.550 g
L-proline	7,500 grams
L-serine	4,300 g
Apple acid	3,000 grams
Sodium acetate trihydrate	3.456 g
Sodium chloride	0.625 grams
Sodium hydroxide	1.324 g
Potassium chloride	3.355 grams
Calcium chloride dihydrate	0.735 g
Magnesium chloride hexahydrate	1.017 g
Excipient:
Water for injections	921.735 g
Content of total nitrogen	15.6 g
Total amino acid content	100.0 g
Energy value	1700 KJ / 400 kcal
PH value	5,9-6,3
Theoretical osmolality	1145 mOsmol / l

Description:

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

Pharmacotherapeutic group:Parenteral nutrition - amino acids

ATX: & nbsp

Amino acids

Pharmacodynamics:

Amino acids are the components necessary for the synthesis of proteins. Solutions containing amino acids are administered as part of parenteral nutrition along with other components (fats, carbohydrates), electrolytes and liquid.The concentration of free amino acids in the plasma is subject to significant fluctuations, this applies to both individual amino acids and their total concentration. Infezol® 100 is administered intravenously and therefore its bioavailability is 100%.

Pharmacokinetics:

Amino acids are fully used for the synthesis of proteins. Amino acids, which are not required for the synthesis of proteins, do not accumulate as a reserve like fatty acids and glucose. The cleavage of amino acids occurs by deamination of the α-amino group metabolized to urea, which is excreted through the kidneys. The remaining carbon skeleton enters the cycle of citric acid, where it passes into acetyl-CoA, acetoacetyl-CoA and pyruvate. Part of the amino acids (up to 5%) is displayed unchanged.

Indications:

- Parenteral nutrition;

- replenishment of fluid loss;

- prevention and therapy of protein deficiency of various genesis (with burns, surgeries, blood loss, etc.).

Contraindications:

Absolute contraindications:

- acute violation of hemodynamics (including shock);

- acute left ventricular failure;

- total tissue hypoxia;

- children under 2 years;

- craniocerebral trauma;

- intoxication with methanol;

- severe hepatic insufficiency.

Carefully:

With caution, after assessing the relationship between expected benefit and possible risk in the following conditions:

- metabolic disorders of amino acids;

- hyperhydration;

- hyperkalemia;

- hyponatremia;

- acidosis;

- kidney disease;

- chronic heart failure I-IIA degree.

With hepatic and renal insufficiency, an individual dosage is required (selected by a physician under the control of biochemical blood indices).

Pregnancy and lactation:

Applicable in the presence of indications.

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. Begin the infusion with a slower rate of administration and within the first hour bring the rate of administration to the desired value.

Adults:

Daily dose: 10-20 ml / kg body weight ~ 1.0 - 2.0 g amino acids / kg body weight The maximum daily dose: 20 ml / kg body weight ~ 2.0 g amino acids / kg body weight.

Maximum infusion rate: 1 ml / kg body weight: per hour ~ 0.1 g amino acids / kg body weight per hour.

For parenteral nutrition, within the framework of appropriate therapy in adults, the total amount of fluid administered should not exceed 40 ml / kg of body weight per day.

Children:

Data on dosage in children are average and should be determined individually according to age, level of physical development and severity of the disease.

Daily dose for children from 2 to 6 years:

10 ml / kg body weight ~ 1.0 g amino acids / kg body weight.

Daily dose for children from 6 to 14 years:

15 ml / kg body weight ~ 1.5 g amino acids / kg body weight.

Maximum infusion rate:

1 ml / kg body weight per hour ~ 0.1 g amino acids / kg body weight.

The maximum daily dose is calculated on the basis of the daily protein requirement.

The drug is used until the full transition to the enteral method of nutrition.

Side effects:

Usually, Infezol® 100 is well tolerated. When using the drug, side effects are usually not observed. Perhaps the emergence of allergic reactions (hives, anaphylactic reactions). Very rarely there may be increased sweating, nausea, vomiting, chills, tachycardia, usually at too high a rate of administration.

Overdose:

With too rapid intravenous infusion, there may be reactions of intolerance (nausea, vomiting, chills), as well as loss of amino acids through the kidneys.

Overdose can lead to amino acid intoxication, hyperhydration and electrolyte imbalance.

When administering potassium-sparing solutions, too rapid infusion or the administration of excessive amounts can lead to hyperkalemia. The maximum potassium concentration in the serum is> 6.5 mmol / l.

Symptoms of hyperkalemia may include: muscle weakness, impaired sensitivity, disturbance of cardiac rhythm and conduction.

Therapy for overdose:

- decrease in the rate of infusion and, if necessary, interruption of administration;

- appropriate restoration of the electrolyte balance;

- osmotic diuresis;

- in cases that pose a threat to life - dialysis.

Interaction:

Interactions to date are unknown.

Due to the increased risk of microbial contamination and incompatibility, solutions containing amino acids should not be mixed with other drugs.

Special instructions:

It is necessary to control the water balance, ionograms of blood serum, the concentration of glucose in the blood and acid-base composition.

Be careful with increased serum osmolarity!

For complete parenteral nutrition, it is necessary to simultaneously add substances - fats, carbohydrates, electrolytes, vitamins, microelements.

Effect on the ability to drive transp. cf. and fur:It is not known.

Form release / dosage:

Solution for infusion.

Packaging:

For 250 or 500 ml of the preparation in vials of transparent glass type II (Hebr. F.), closed with bromobutyl rubber stopper (Hef.F.) for puncturing and plastic lid under aluminum, with a plastic holder. A label is attached to the vial.

For 10 bottles of 250 ml or 500 ml, along with instructions for use in a cardboard box (for hospitals).

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light.

Keep the medicinal product out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

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 N015159 / 01

Date of registration:05.11.2008 / 18.06.2015

Expiration Date:Unlimited

The owner of the registration certificate:Berlin-Chemie, AGBerlin-Chemie, AG Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp26.10.2017

Illustrated instructions

Instructions

Infezol® 100 (Infesol® 100)