Aminoven - instructions for use, dose, side effects, contraindications

Amount (g / l)	5%	10%	15%
Active substances:	g	g	g
L-isoleucine	2,50	5,00	5,20
L-leucine	3,70	7,40	8,90
L-lysine acetate	4,655	9,31	15,66
(corresponding to L-leaf)	3,30	6,60	11,10)
L-methionine	2,15	4,30	3,80
L-phenylalanine	2,55	5,10	5,50
L-treonine	2,20	4,40	8,60
L-tryptophan	1,00	2,00	1,60
L-valin	3,10	6,20	5,50
L-arginine	6,00	12,00	20,00
L-cystidine	1,50	3,00	7,30
L-alanine	7,00	14,00	25,00
Glycine	5,50	11,00	18,50
L-proline	5,60	11,20	17,00
L-serine	3,25	6,50	9,60
L-tyrosine	0,20	0,40	0,40
Taurine	0,50	1,00	2,00
Excipients:
Acetic acid ice (for pH correction)	2,2-2,8	4,7-5,7	4,45
Apple acid (for pH correction)	-	-	4,9-6,1
Water for injections	up to 1 liter	up to 1 liter	up to 1 liter
Total concentration of amino acids:	50.0 g / l	100 g / l	150 g / l
Total nitrogen:	8.1 g / l	16.2 g / l	25.7 g / l
Energy value:	840 kJ / l (= 200 kcal / l)	1580 kJ / l (= 400 kcal / l)	2520 kJ / l (= 600 kcal / l)
Titrated acidity:	12 mmol NaOH/ l	22 mmol NaOH/ l	44 mmol NaOH/ l
Theoretical osmolarity:	495 mOsmol / l	990 mOsmol / l	1505 mOsmol / l
pH	5,5-6,3	5,5-6,3	5,5-6,3

Description:

Transparent or slightly opalescent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:Parenteral nutrition - amino acids

ATX: & nbsp

B.05.X.B Amino acids

Pharmacodynamics:

The drug Aminoven is intended for parenteral nutrition of patients with various pathologies with a low, normal or increased protein requirement, when enteral nutrition is ineffective or impossible. The products contained in the preparation are replaceable and irreplaceable L-aMino acids are natural physiological compounds. Like amino acids that come from food and are obtained by splitting proteins, parenterally introduced amino acids enter the pool of free amino acids of the blood plasma and from it into the cells for protein synthesis and into various metabolic pathways.

Pharmacokinetics:

The pharmacokinetic characteristics of amino acids administered intravenously are the same as when administered with food. However, the amino acids of food proteins first enter the portal vein of the liver, and only then into the systemic bloodstream, while the amino acids introduced into the vein enter the systemic circulation directly.

From the intravascular space, amino acids are redistributed into the intercellular fluid and transported into the cells of different tissues.

Concentrations of free amino acids in blood plasma and tissues are regulated by endogenous mechanisms in a narrow range, which depends on the age, nutritional status and clinical state of the patient.

Balanced in composition amino acid solutions, including the preparation Aminovene with their slow administration does not significantly change the physiological pool of amino acids.

Only a small part of the amino acids introduced by infusion is excreted through the kidneys.

Indications:

Complete or partial parenteral nutrition. Amino acid solutions are usually used in combination with a sufficient number of energy sources (glucose, fat emulsions).

Prophylaxis and therapy of protein losses, when oral or enteral nutrition is impossible, is insufficient or contraindicated.

Contraindications:

Violation of the metabolism of amino acids, metabolic acidosis, renal failure in the absence of hemodialysis or hemofiltration, severe hepatic insufficiency, fluid overload, shock, hypoxia, decompensated heart failure.

Aminoven, 5% and 10% infusion solution is not recommended for use in children under 2 years of age. Aminoven 15% infusion solution is not recommended for use in children under the age of 18 due to lack of data on efficacy and safety .

For parenteral nutrition of newborns, infants and children under 2 years of age, use adapted amino acids for children whose composition is specifically designed to meet the metabolic needs of children (Aminoven Infant).

Pregnancy and lactation:

Special studies of the safety of the drug Aminoven in this category of patients have not been conducted. However, clinical experience with the use of similar parenteral solutions of amino acids indicates that there is no risk for pregnant and lactating women. The application is permissible if the expected benefit for the mother exceeds the potential risk to the fetus or the child.

Dosing and Administration:

Intravenously.

The choice of the central or peripheral vein for the administration of the drug Aminovene, a solution for infusions of 5%, depends on the final osmolarity when combined with other solutions.Aminoven, a solution for infusions of 10% and 15%, should be administered only to the central veins. Infusion can be continued for as long as the clinical state of the patient requires, based on the daily requirement for amino acids.

Aminovene, solution for infusions 5%

Adults:

Average daily dose:

16-20 ml of Aminoven, an infusion solution of 5% per kg of body weight (equivalent to 0.8-1.0 g of amino acids per kg of body weight), which corresponds to 1120-1400 ml of the drug for a patient with a body weight of 70 kg.

The maximum daily dose:

20 ml Aminovene, solution for infusion of 5% per kg of body weight (equivalent to 1.0 g of amino acids per kg of body weight), which corresponds to 1400 ml of the drug for a patient with a body weight of 70 kg.

Maximum infusion rate:

2,0 ml of Aminovene, an infusion solution of 5% per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight per hour).

Children:

The maximum daily dose for children from 2 to 5 years - 30 ml of preparation Aminoven, solution for infusions 5% per kg of body weight (equivalent to 1.5 g of amino acids per kg of body weight). For children older than 5 years, the maximum daily dose does not differ from the maximum daily dose for adults.

Maximum injection rate For children over 2 years does not differ from the maximum speed for adults.

Aminoven, solution for infusions 10%

Adults:

Average daily dose:

10-20 ml Aminovene, a solution for infusions of 10% per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight), which corresponds to 700-1400 ml of the drug for a patient with a body weight of 70 kg.

The maximum daily dose:

20 ml of Aminovene, an infusion solution of 10% per kg of body weight (equivalent to 2.0 g of amino acids per kg of body weight), which corresponds to 1400 ml of the drug for a patient with a body weight of 70 kg.

Maximum infusion rate:

1.0 ml of Aminovene, a solution for infusion of 10% per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight per hour).

Children:

The maximum daily dose for children older than 2 years - 10-15 ml of the drug Aminoven, a solution for infusions of 10% per kg of body weight (equivalent to 1.0-1.5 g of amino acids per kg of body weight).

Maximum injection rate For children over 2 years does not differ from the maximum speed for adults.

Aminoven, solution for infusions 15%

Adults

Average daily dose:

6.7-13.3 ml of Aminovene, an infusion solution of 15% per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight), which corresponds to 470-930 ml of the drug for a patient with a body weight of 70 kg.

The maximum daily dose:

13,3 ml of Aminovene, solution for infusion of 15% per kg of body weight (equivalent to 2.0 g of amino acids per kg of body weight), which corresponds to 930 ml of the preparation for a patient with a body weight of 70 kg.

Maximum infusion rate:

0.67 ml of Aminovene, a solution for infusion of 15% per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight per hour).

Children:

It is not recommended to use the drug Aminoven, a solution for infusions of 15% in children under the age of 18 years.

Side effects:

If used correctly, they are not known.

Any infusion into the peripheral vein can cause irritation of the vessel wall and thrombophlebitis.

Overdose:

If the drug is overdosed Aminoven or if the speed of its infusion is exceeded, chills, vomiting, nausea, an increase in the excretion of amino acids through the kidneys can occur.

In case of signs of an overdose, the infusion should be stopped immediately. In the future, its renewal in a reduced dosage is possible.

Side effects that develop with an overdose are usually reversible and disappear when the drug is discontinued.

Too fast infusion can cause the patient to overload the liquid and disturb the electrolyte balance.

There is no specific antidote for overdose.Emergency measures should be of a general supportive nature with special attention to the function of respiratory and cardiovascular systems. It is important to monitor biochemical indicators and appropriate treatment of identified violations.

Interaction:

Currently, the cases of interaction are unknown.

Due to the increased risk of microbiological contamination and incompatibility, amino acid solutions should not be mixed with other medicines not intended for parenteral nutrition.

The drug Aminoven can be mixed with the drug Dipeptivenen, strictly observing the rules of asepsis. Do not add other medicines to the mixture.

Special instructions:

Precautions for use

It is necessary to monitor the concentration of electrolytes, the balance of fluid and kidney function.

In the case of hypokalemia and / or hyponatremia, concomitantly administer sufficient amounts of potassium and / or sodium.

The introduction of any solution of amino acids can provoke an acute deficit of folate, so patients should be administered folic acid daily.

Care should be taken when infusing large volumes of fluid to patients with heart failure.

Any infusion into the peripheral vein can cause irritation of the vessel wall and thrombophlebitis. Therefore, it is recommended that the catheter installation site be inspected daily. If the patient is also prescribed the introduction of fat emulsion, then it should be administered as soon as possible with Aminoven to reduce the risk of phlebitis.

The choice of the location of the catheter (central or peripheral vein) is determined by the final osmolarity of the mixture - for infusion into the peripheral vein the osmolality limit is 800-900 mosmol / l. In addition, the age, clinical condition of the patient and the condition of his peripheral veins should be taken into account.

It is necessary to strictly follow the rules of asepsis, especially when installing a catheter in the central vein.

Instructions for use

Use immediately after opening the vial.

Only for single use.

Use only a transparent solution that does not contain any mechanical inclusions from intact packaging.

The unused remainder of the solution in the vial and the mixture remaining after the infusion should be destroyed.

Special storage conditions after mixing with other components

Aminovene can be mixed in sterile conditions with other parenteral preparations, such as fat emulsions, carbohydrates and electrolytes. Mixtures for parenteral nutrition should be used immediately. In exceptional cases it is possible to store the mixture for not more than 24 hours at a temperature of 2 to 8 ° C with a guarantee of strict aseptic compliance.

Form release / dosage:

Solution for infusion, 5%, 10% and 15%.

Packaging:

For 500 ml in a bottle of colorless glass of hydrolytic class II, sealed with a rubber stopper and coated with an aluminum cap with a plastic cap-control the first opening.

10 vials together with plastic holders or without them in a cardboard box together with instructions for use (for hospitals).

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:For hospitals

Registration number:LS-002152

Date of registration:30.12.2011

Expiration Date:Unlimited

The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany

Manufacturer: & nbsp

FRESENIUS KABI AUSTRIA, GmbH Austria

Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany

Information update date: & nbsp07.08.2017

Illustrated instructions

Instructions

Aminoven (Aminoven)