MELDONIUM-ELLARA 100mg/ml 10amp 5ml (anti-ischemic product)

MELDONIUM-ELLARA  restores the balance between the supply and need of cells for oxygen, eliminates the accumulation of toxic metabolic products in cells, protecting them from damage; also has a tonic effect.

International nonproprietary name: meldonium

Pharmacotherapeutic group: metabolic agent

Ingredients:

ACTIVE SUBSTANCE:

Meldonium dihydrate (trimethylhydrazinium propionate dihydrate, meldonium) - in terms of dihydrate without adsorbed moisture - 100.0 mg - in terms of anhydrous substance - 80.2 mg

EXCIPIENT:

Water for injection - up to 1.0 ml

Pharmacological properties:

PHARMACODYNAMICS

An analogue of gamma-butyrobetaine, suppresses gamma-butyrobetaine hydroxinase, reduces the synthesis of carnitine and the transport of long-chain fatty acids through cell membranes, prevents the accumulation in cells of activated forms of unoxidized fatty acids - derivatives of acylcarnitine and acyl coenzyme A. Under ischemic conditions, it restores the balance of the processes of oxygen delivery and its consumption in cells, prevents disruption of adenosine triphosphate (ATP) transport; At the same time, it activates glycolysis, which occurs without additional oxygen consumption. As a result of a decrease in carnitine concentration, gamma-butyrobetaine, which has vasodilating properties, is intensively synthesized. The mechanism of action determines the variety of its pharmacological effects: increased performance, reduced symptoms of mental and physical stress, activation of tissue and humoral immunity, cardioprotective effect. In case of acute ischemic damage to the myocardium, it slows down the formation of the necrotic zone and shortens the rehabilitation period. In heart failure (HF), it increases myocardial contractility, increases exercise tolerance, and reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral circulation, it improves blood circulation in the ischemic area and promotes the redistribution of blood in favor of the ischemic area. Effective in cases of vascular and dystrophic pathology of the fundus. It also has a tonic effect on the central nervous system (CNS), elimination of functional disorders of the somatic and autonomic nervous systems in patients with chronic alcoholism during the abstinence period.

PHARMACOKINETICS

When administered intravenously, bioavailability is 100%. The maximum concentration of the drug in plasma (Cmax) is achieved immediately after administration. Metabolized in the body to form two main metabolites, which are excreted by the kidneys. The half-life depends on the dose and is 3-6 hours.

Indications for use:

Reduced performance, physical overstrain (including among athletes).

As part of complex therapy:

• coronary heart disease, chronic heart failure, cardialgia due to dishormonal cardiomyopathy;
• cerebrovascular accidents;
• hemophthalmos and retinal hemorrhages, thrombosis of the central retinal vein and its branches, retinopathy;
• alcohol withdrawal syndrome.

Directions for use and doses:

Due to the possible development of an stimulating effect, it is recommended to use the drug in the first half of the day. Parabulbar, intravenous. The method of administration, dose and duration of treatment are determined individually, depending on the indications, severity of the condition, etc.

CARDIOVASCULAR DISEASES 

As part of complex therapy:

- coronary heart disease (myocardial infarction) intravenously in a stream of 0.5 - 1.0 g per day
(5 – 10 ml of Meldonium), applying the entire dose at once or dividing it into 2 injections;

- coronary heart disease (stable angina); chronic heart failure and dyshormonal cardiomyopathy intravenous infusion 0.5 - 1.0 g per day
(5 - 10 ml of the drug Meldonium), using the entire dose at once or dividing it into 2 injections, the course of treatment is 10 - 14 days, followed by a transition to dosage forms for oral administration. The general course of treatment is 4 – 6 weeks.

CEREBROVASCULAR DISORDERS

As part of complex therapy in the acute phase, 0.5 g (5 ml of the drug Meldonium) 1 time per day IV for 10 days, switching to dosage forms for oral administration. The general course of treatment is 4-6 weeks.

For chronic cerebral circulatory failure (dyscirculatory encephalopathy), 0.5 g (5 ml of Meldonium) IV once a day for 10 days, followed by switching to dosage forms for oral administration. The general course of treatment is 4-6 weeks.

Repeated courses (usually 2-3 times a year) are possible after consultation with a doctor.

OPHTHALMOPATHOLOGY (hemophthalmos and retinal hemorrhages of various etiologies, thrombosis of the central retinal vein and its branches, retinopathy of various etiologies (diabetic, hypertensive)).

0.05 g (0.5 ml of Meldonium) parabulbarly for 10 days. It is also used as part of combination therapy.

MENTAL AND PHYSICAL OVERLOAD

0.5 g (5 ml of Meldonium) IV 1 time per day. The course of treatment is 10-14 days. If necessary, treatment is repeated after 2-3 weeks.

CHRONIC ALCOHOLISM

0.5 g (5 ml of Meldonium) IV 2 times a day. The course of treatment is 7-10 days.

Release form:

Solution for parabulbar and intravenous administration 100 mg/ml.

5 ml in neutral glass ampoules.

Contraindications: 

Hypersensitivity to the components of the drug. - Increased intracranial pressure (if venous outflow and intracranial
turnip tumors). - Pregnancy, lactation period. - Age up to 18 years (efficacy and safety have not been established).

Carefully:

For liver and/or kidney diseases.

Use during pregnancy and breastfeeding:

The safety of use in pregnant women has not been studied, therefore, to avoid possible possible adverse effects on the fetus, its use is contraindicated.

Isolation of the drug Meldonium in milk and its effect on health is new born have not been studied, therefore, if necessary, use should be discontinued breast-feeding.

Overdose: 

Symptoms: decreased blood pressure, accompanied by headache, and hicardia, dizziness and general weakness.

Treatment: symptomatic. Meldonium is low-toxic and does not cause unwanted reactions hazardous to health patients.

Interaction with other drugs:

Can be combined with antianginal agents, anticoagulants, antiplatelet agents, antiarrhythmic drugs, diuretics, bronchodilators.
Enhances the effect of cardiac glycosides.
Due to the possible development of moderate tachycardia and arterial hypotension, you should use caution when combined with nitroglycerin, nifedipine, alfa adrenergic blockers, other antihypertensive drugs and peripheral vasodilators tators, since meldonium enhances their effect.

Storage conditions:

Store in a place protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date:

3 years. Do not use after the expiration date stated on the package.

Guaranteed authenticity and quality:

100% Original from  ELLARA LLC (RUSSIAN FEDERATION)

Development and production:

ELLARA  LLC (RUSSIAN FEDERATION)