Hepa-mertz concentrate for preparation of solution for infusion 500mg / ml, 10ml No. 10

• Acute and chronic liver diseases accompanied by hyperammonemia.

• Hepatic encephalopathy incl. as part of the complex therapy of disorders of consciousness (precoma and coma).

• As a corrective additive to parenteral nutrition drugs in patients with protein deficiency.

Intravenously injected up to 4 ampoules per day, dissolving the contents of the ampoules in 500 ml of infusion solution.

In hepatic encephalopathy, depending on the severity of the condition, up to 8 ampoules are administered per day.

The duration of the infusion, the frequency and duration of treatment are determined individually.

The maximum rate of intravenous administration is 5 g per hour.

Do not dissolve more than 6 ampoules in 500 ml of infusion solution!

1 ampoule contains 5 g of L-ornithine-L aspartate, water for injection up to 10 ml.

• Severe renal failure with a creatinine value of more than 3 mg / 100 ml.

• Hypersensitivity to drug components,

• lactation period.

With care: pregnancy.

Trade name Hepa-Merz

International non-proprietary name

ornithine

Dosage form

concentrate for preparation of solution for infusion

Composition

1 ampoule contains 5 g of L-ornithine-L aspartate, water for injection up to 10 ml.

Description

A clear, light yellow solution.

Pharmacotherapeutic group

Hypoazotemic agent ATX code: A05BA

Pharmacological properties

Reduces elevated levels of ammonia in the body, in particular in liver diseases. The action of the drug is associated with its participation in the ornithine cycle of Krebs urea formation (the formation of urea from

ammonia). Promotes the production of insulin and growth hormone. Improves protein metabolism in diseases requiring parenteral nutrition. Pharmacokinetics: Excreted by the kidneys.

Indications for use

• Acute and chronic liver diseases accompanied by hyperammonemia.

• Hepatic encephalopathy incl. as part of the complex therapy of disorders of consciousness (precoma and coma).

• As a corrective additive to parenteral nutrition drugs in patients with protein deficiency.

Contraindications

• Severe renal failure with a creatinine value of more than 3 mg / 100 ml.

• Hypersensitivity to drug components,

• lactation period.

With care: pregnancy.

Method of administration and dosage

Intravenously injected up to 4 ampoules per day, dissolving the contents of the ampoules in 500 ml of infusion solution.

In hepatic encephalopathy, depending on the severity of the condition, up to 8 ampoules are administered per day.

The duration of the infusion, the frequency and duration of treatment are determined individually.

The maximum rate of intravenous administration is 5 g per hour.

Do not dissolve more than 6 ampoules in 500 ml of infusion solution!

Side effect

Allergic reactions, in some cases nausea and vomiting are possible.

Overdose

Symptoms: increased severity of side effects.

Interaction with other medicinal products

Not Described

special instructions

When making a diagnosis of hepatic encephalopathy due to the underlying disease, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

If nausea or vomiting occurs, the rate of administration should be reduced.

Release form

Concentrate for solution for infusion, 500 mg / ml, 10 ml in amber glass ampoules type I, DAB 10 with two colored marking rings and a
white dot. 10 ampoules (2 plastic trays of 5 ampoules) with instructions for use in a cardboard box.

Shelf life

3 years. Do not use after the expiration date.

Storage conditions

At a temperature not higher than 25 ? C. Out of the reach of children.

Conditions of dispensing from pharmacies

On prescription.

Manufacturing company

Merz Pharma GmbH & Co.  vај
D-60318, Germany,
Frankfurt-am-Main.
Claims should be sent to the
address: OOO' Merz Pharma
123242, Moscow,
per. Kapranova, d.Z, bldg. 2