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Combined product

Drug form and composition

Syrup. 5 milliliters syrup contains 2.5 mg Galantamine hydrobromide; 7.5 mg Thiamine hydrochloride; 3 mg Riboflavin sodium phosphate; 5 mg Pyridoxine hydrochloride; 25 mg Nicotinamide; 25 mg Calcium pantothenate.

Indications

Poliomyelitis (following the febrile stage) for reduction and elimination of the residual symptoms; neuritis; myopathy; myasthenia gravis; progressive muscular dystrophy; cerebral paralysis in children; birth paralysis; nycturia; residual paresis following cerebral hemorrhage; some forms of impotence; mild and moderate Alzheimer’s disease.

Dosage and administration

The preparation is taken 1 hour after nutrition in following dosage: children 1-2 years - 2.5 ml, 2 times daily; 3-5 years - 5 ml, 2 times daily; 6-9 years - 5 ml, 3 times daily; 10-14 years - 5 ml, 4 times daily; adults and children older than 14 years - 10 ml, 3 times daily. Advisable duration of the treatment is 50-60 days.

Contraindications

The preparation is contraindicated in hypersensitivity to any of its components; bronchial asthma; angina pectoris; bradycardia; heart failure; epilepsy; hyperkinesis; during the first trimester of the pregnancy and lactation.

Special warnings and precautions

Nivabex syrup should be used with care in patients treated with depolarizing myorelaxants, as a danger of intensifying of the neuromuscular block exists. In persons with liver diseases total daily dose of nicotinamide should be determined (high doses lead to exhausting of the choline stores). In patients with ulcer disease total daily amount of the ingested vitamin B6 should be controlled, as a risk of hyperacidity exists.

Drug interactions

Nivabex, due to galantamine, antagonize the action of following substances: morphine and its analogs; atropine and homatropine; ganglion-blocking agents; nondepolarizing myorelaxants. Penicillin is an antagonist of vitamin B6, whereas vitamin B12 potentiates the allergenicity of vitamin B1. Chlorpromazine increases the urine excretion of riboflavin (vitamin B2).

Adverse reactions

The side effects are due mainly to Galantamine and include hypersalivation, nausea, vomiting, sweating. In rare cases intolerance to thiamine (vitamin B1) may appear, manifesting with anxiety, irritability, tremor, and headache.

Pharmacological mechanisms

Nivabex combines pharmacology effects of its ingredients. Nivalin belongs to the group of reversible inhibitors of the cholinesterase. It facilitates the neural impulse conduction in cholinergic synapses of the central and vegetative neural systems and in neuro-muscular synapses. Nivalin increases the tone and peristalsis of the smooth muscles of the gastrointestinal tract, urinary tract and biliary tract. Vitamin B1 participates in decarboxylation of the pyruvate and α-ketoglutarate. In high dose it possesses an anticholineterase action. Riboflavin (vitamin B2) is included in the prosthetic group of several oxydative enzimes and participates in the carbohydrate, protein, and fat metabolism; improves the cell respiration. It plays an important role in the normal functioning of the eye, mucosal membranes, and skin, influence favorably the nervous system function. Vitamin B6 participates in synthesis of the biogenic monoamines, as well as in metabolism of tryptophan and histamine. It is necessary substance for the normal functioning of the central and peripheral nervous systems, skin and digestive system. Nicotinic acid (vitamin PP) and its amide are part of co-hydrase enzymes, which participate in the carbohydrate metabolism and contribute to normal functioning of the gastrointestinal tract, skin and nervous system. Pantotenate (vitamin B5) and its calcium salt are ingredients of the Co-enzyme A. Pantotenate participates in carbohydrate metabolism. Nivabex improves functional capabilities of the central and peripheral nervous systems and the metabolism in the organism, including the metabolism in the nervous system.

Supplied

Vials, containing 125 ml syrup.

Expiry

2 years.