Gepatox

GEPATOX

Concentrate for solution for infusion 10 ml in ampoules No.10 .1 ml of the concentrate contains 500 mg of L-ornithine-L-aspartate.

Marketing Authorization UA/12890/01/01

Composition

Active ingredient: L-ornithine-L-aspartate;

1 ml of the concentrate contains 500 mg of L-ornithine-L-aspartate;

Excipients: water for injections.

Pharmaceutical form

Concentrate for solution for infusion.

Pharmacotherapeutical group

Products used to treat hepatic disorders, lipotropic substances. Hepatotrophic products. ATC Code А05В А.

Indications

Treatment of comorbid diseases and complications caused by liver detoxifying function disturbance (for example, liver cirrhosis) with the symptoms of latent or apparent hepatic  encephalopathy, especially at consciousness impairment (pre-coma, coma).

Contraindications

Hypersensitivity to L-ornithine-L-aspartate, inborn ornithine delta-aminotransferase deficiency, severe renal failure (creatinine clearance over 3 mg/100 ml (estimated value)).

Posology and method of administration

Intravenous drop-wise use. Unless otherwise prescribed, the patients may administer up to 4 ampoules (20 g of L-ornithine-L-aspartate) per day.

In case of severe hepatic encephalopathy, which may lead to pre-coma or coma, 8 ampoules (40 g of L-ornithine-L-aspartate) are taken within 24 hours, depending on severity degree.

Before use, the content of the ampoule is added into 500 ml of infusion solution (0.9% of sodium chloride, 5% glucose solution, Ringer solution), but not more than 6 ampoules.

The maximum injection rate of L-ornithine-L-aspartate is 5g/hour which is equivalent to 1 ampoule.

Treatment course is based on patient’s clinical conditions and is prescribed on individual basis.

Instruction for use of  ampule.

Separate one ampoule from the block and shake the contents gently, holding the ampoule by its neck.

Squeeze the ampoule in your hand (the product leakage shall not occur) and remove the cap by rotating it.

Immediately put a syringe in the ampoule through the obtained hole.

Turn the ampoule over and slowly suck the liquid in the syringe.

Put a needle on the syringe.

Adverse reactions

Digestive system: very rare (<1/10000) ― nausea, rare (>1/10000, <1/1000) — vomiting.

These are usually short-term symptoms and do not require discontinue of use. They may disappear depending on dose reduction or injection rate.

Possible allergic reactions.

Overdose

The following reactions may appear when product is overdosed: diarrhea, nausea, vomiting, bloating, stomachache, constipation, erythema, rash, sneezing, lachrymation, increased uric acid level in blood plasma which is manifested through muscle pain.

In case of any overdose symptoms, discontinue the use of the product and obtain medical treatment.

Pregnancy and lactation

No data available   about usage of Gepatox during pregnancy. Therefore, it is not recommended to use the product during the above period.

However, if treatment with Gepatox is deemed to be vital, a correlation between risk and health benefit should be analyzed.

It is not known whether L-ornithine-L-aspartate is able to penetrate into breastmilk. Therefore, it is recommended to avoid the use of Gepatox during lactation.

Children

The data on pediatric use of the product are limited. Therefore, it not recommended to use the product in pediatric practice.

Special warnings

Gepatox, concentrate for infusion solutions, must not be administered in artery.

Precautions for use

In case of severe liver dysfunction, infusion rate is adjusted according to patient’s individual conditions in order to avoid dermal allergic reactions, nausea and vomiting.

Sometimes a slight increase of ureic acid may be observed upon product administration. It is explained by additional injection of the substrate to synthesize urine in the form of ornithine-aspartate compound. This fact must be taken into account while making a decision to prescribe the product in higher doses.

Effects on ability to drive and use machines

When product is used, any work with vehicles or other mechanisms must be avoided.

 

Pharmacological properties

Pharmacodynamics. Effect induced by L-ornithine-L-aspartate is caused by amino-acids, ornithine and aspartate with the help of two key methods of ammonia detoxication:  urine synthesis and glutamine synthesis. Ammonia concentration decrease enables to stabilize acid-alkaline balance and to produce insulin and somatotropic hormone.

Urine synthesis is done in periportal hepatocyte where ornithine activates two elements: ornithine carbamyl transferase and carbamyl phosphate synthetase and it also acts as substrate for substances’ synthesis.

Glutamine synthesis takes place in periportal hepatocytes. In particular, under pathological conditions aspartate and dicarboxylate, including ornithine metabolism products, are absorbed in cells and are used here to bind ammonia in the form of glutamine.

Glutamine is an acid which binds ammonia both under physiological and pathological conditions. Glutamine amino-acid is not only a non-toxic form for ammonia excretion, but it also activates an important urea cycle (intracellular glutamine metabolism).

Under physiological conditions, ornithine and aspartate do not limit substance’s synthesis.

The studies showed that ammonia level decrease during the usage of L-ornithine-L-aspartate is caused by increased glutamine synthesis in relation to branched amino-acids/aromatic amino-acids chain. Such product characteristics are useful for improvement of protein metabolism at diseases which require protein nutrition.

Pharmacokinetics. Both ornithine and aspartate half-life is quite short – 0.3-0.4 hours. Small amounts of product are excreted unchanged with urine.

Main chemical and physical properties

Сlear colorless or yellowish liquid.

Incompatibility

Оскільки даних про дослідження сумісності препарату немає, його не слід змішувати з іншими лікарськими засобами, крім зазначених у розділі «Спосіб застосування та дози». Since there are no data on product’s incompatibility, it should not be used long with other products, unless specified in the section “Posology and method of administration”.

Shelf life

2 years.

Storage conditions

Store in refrigerator (at +2 0С- +8 0С). Do not freeze. Keep the product in its secondary package to protect from light. Keep away from children.

Package

10 ml in ampoules No.10 .

Prescription category

Following the doctor’s prescription.

Feedback

Materials on the medicine

No materials available.

Calculation of dose

Режим дозирования гемаксама индивидуальный, зависит от клинической картины. Вводить внутривенно – капельно, струйно.

Выберите показатель массы тела пациента и получите необходимое количество ампул.

Необходимое количество ампул Гемаксама:


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