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

Reduces the increased concentration of ammonia in the body, in particular, with liver diseases. The effect of the drug is associated with its participation in the ornithine cycle of urea formation Krebs (formation of urea from ammonia). Ornithine acts as a catalyst for the enzymes carbamoyl phosphate synthetase and ornithine carbamoyl transferase, and is also the basis for the synthesis of urea. In addition, the drug activates the ornithine cycle of urea formation, which also contributes to a decrease in the level of ammonia. Promotes the production of insulin and growth hormone.Improves protein metabolism in diseases requiring parenteral nutrition.

Pharmacokinetics:In vivo forms two active metabolites: aspartate and ornithine, having a short half-life of 0.3-0.4 hours, are excreted by the kidneys through a cycle of urea generation. Minor part asthe partyin unchanged form.

Indications:

- Acute and chronic liver diseases, accompanied by hyperammonemia;

- hepatic encephalopathy, incl. in the complex therapy of mental disorders (precoma and coma);

- as a corrective additive to preparations for parenteral nutrition in patients with protein deficiency.

Contraindications:

- Severe renal insufficiency (serum creatinine> 3 mg / 1 dl);

- hypersensitivity to the components of the drug;

- the period of breastfeeding;

- children's age till 18 years.

Carefully:

Pregnancy and lactation:

During pregnancy, the use of the drug ORNILATEX is possible only under the strict supervision of the doctor taking into account the benefit / risk relationship for the mother and the fetus.

For the duration of treatment, stop breastfeeding.

Dosing and Administration:

Intravenously (intravenously) is drip.Ampoule contents are mixed with 500 ml infusion solution (0.9% sodium chloride solution, 5% dextrose (glucose) solution or Ringer's solution).

Adults

The average therapeutic dose of 20 g of ornithine per day.

When hepatic encephalopathy (depending on the degree of severity of the condition) iv injected up to 40 g of ornithine per day.

It is recommended to dissolve not more than 30 g of ornithine in 500 ml of an infusion solution.

The maximum infusion rate is 5 g of ornithine per hour.

The duration of therapy with the drug is determined in each case individually, based on the pathology and severity of the patient's condition. In severe violations of liver function, strict monitoring of the patient's condition and correction of the rate of drug administration are necessary to prevent the development of nausea and vomiting.

Children

There is no data on the use of the drug in pediatric practice.

Side effects:

Very rarely (less than 0.01%):

- nausea, vomiting;

- allergic reactions.

Overdose:

Symptoms: increased severity of dose-dependent side effects.

Treatment: The drug should be discontinued and symptomatic treatment should be given.

Interaction:

Not found.

ORNILATEX should not be mixed with other medications.For dilution, use only the solutions listed in the instructions.

Special instructions:

When administering the drug in high doses, the urea concentration in blood plasma and urine should be monitored. In severe violations of the liver in accordance with the patient's condition, it is necessary to reduce the rate of administration of the infusion solution in order to prevent nausea or vomiting.

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

ORNILATEX has no influence on the ability to drive a vehicle and potentially dangerous mechanisms.

Form release / dosage:

Concentrate for solution for infusion, 500 mg / ml.

Packaging:

For 10 ml in ampoules of light-protective glass with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional bar code, and alphanumeric coding are additionally applied to the ampoules.By 5 ampoules in a contour cell box made of a polyvinylchloride film and aluminum foil or a polymer film or without a foil and without a film.

1 or 2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 of the year. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002691

Date of registration:31.10.2014 / 15.07.2015

Expiration Date:31.10.2019

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

FarmSirma Soteks, ZAO Russia

Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia

Information update date: & nbsp11.06.2017

Illustrated instructions

Instructions

OrnilaTex® (Ornilatex®)