NIVALIN 10 mg. 1 ml. 10 ampoules
Galantamine hydrobromide 1 mg; 10 mg;
Neurology - traumatic injury of the central nervous system, symptoms of cerebral palsy, spinal cord (myelitis, polio, polio form of tick-borne encephalitis) mononeuritis, polyneuritis, polyneuropathy, poliradikulonevriti with-meter Guillain-Barre syndrome, idiopathic facial paralysis , myopathies and enuresis nocturna.
Anesthesia and surgery - to eliminate the effect of non-depolarising neuromuscular blockers in the treatment of postoperative paresis of the intestine and the bladder.
Physiotherapy - applied iontophoretic in neurological diseases of the peripheral nervous system.
Toxicology - poisoning by anticholinergic drugs, morphine and its analogs.
Radiology - to facilitate the functional diagnosis of the gastro - intestinal tract and gall bladder.
Route of administration: parenteral / subcutaneous, intramuscular, intravenous /
The dosage and duration of treatment with Nivalin must be determined by the physician according to the condition of the patient. The treatment starts with the smallest effective dose and gradually increase. The maximum single dose in adults is 10 mg subcutaneously and maximum daily dose 20 mg. Higher daily doses are recommended to be divided into two doses.
In children it is administered subcutaneously in daily doses of the following: 1 to 2 years. - 0,25 - 1,0 mg of 3 to 5 years. - 0,50 - 5,0 mg of 6 to 8 years. - 0,75 - 7,5 mg of 9 to 11 years. - 1,0 - 10,0 mg 12 to 15 years old. - 1,25 - 12,5 mg over 15 years - 12,5 - 20,0 mg
The duration of treatment is dependent on the characteristics and severity of the disease.
* Hypersensitivity to any component of the product, bronchial asthma, bradycardia, AV-block, angina, severe heart failure, epilepsy, hyperkinesia, severe renal or hepatic insufficiency
When treating patients with mild renal insufficiency application of Nivalin should be done carefully and in lower dosages tailored to creatinine clearance.
Treatment with galantamine can lead to loss of body weight.
The product should be used with caution in patients with difficulty in urination or after a recent surgery of the prostate gland, as well as operations with general anesthesia.
Upon occurrence of undesirable effects in the application of Nivalin is necessary to reduce the daily dose or treatment can be discontinued for 2-3 days, and then to continue with lower doses.
Nivalin should be used with caution in patients suffering from chronic obstructive pulmonary disease or ulcer disease because of the possibility of strengthening the complaints.
* Drug Interactions
Nivalin antagonizes the effect of morphine and its analogs with respect to their inhibitory effect on the respiratory center. Between Nivalin and M-cholinolytics (atropine, homatropine) ganglioblokerite (benzoheksoniy, pentamin, pahikarpin), non-depolarizing muscle relaxants (tubocurarine etc.), Quinine and novokainamid exist antagonistic interactions. Aminoglycoside antibiotics (gentamicin, amikacin) may reduce the therapeutic effect of Nivalin in myasthenia gravis. The effect of depolarizing neuromuscular blocking agents (Suxamethonium) can be extended by concomitant use of Nivalin.
Medicinal products that inhibit the enzyme CYP2D6 (quinidine, paroxetine, fluoxetine) and CYP3A4 (ketoconazole, Retrovir, erythromycin) can affect the metabolism of galantamine and increase its plasma concentration.
* Pregnancy and lactation Nivalin should not be used during pregnancy and also during lactation. * Adverse reactions They can be muscarinic and nicotinic. When applying higher doses and individual sensitivity more common side effects are nausea, vomiting, diarrhea, abdominal pain, increased salivation, sweating, anorexia, fatigue, dizziness, headache, drowsiness and weight loss. Less commonly observed adverse reactions were: insomnia, rhinitis, bradycardia, impaired vision and urinary tract infection.
* Formulation and packaging
Ampoules 1 mg / 1 ml; 2,5 mg / 1 ml; 5 mg / 1 ml; 10 mg / 1 ml in ten pieces in a blister pack. One or ten blister packs are placed in boxes.