Land: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
diazepam
KRKA d.d.
N05BA01
diazepam
5mg/ml
solution for i/v and i/m injection
(10/2x5/) ampoules 2ml, in blister
Prescription
Registered
2017-05-23
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PI_Text007931_1 – Updated: Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Apaurin solution for i. v. and i.m. injection 5 mg/ ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2 ml of solution (1 ampoule) contains 10 mg diazepam. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection: clear, slightly yellow or greenish yellow, s olution with a smell of ethanol, practically free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ANXIETY Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. For the parenteral route, Apaurin is indicated for the treatment of moderate to severe cases of agitation, anxiety and tension. As a pre-operative drug it is indicated for basal sedation in anxious or tense patients, induction of anaesthesia and sedation prior to diagnostic, surgical and endoscopic procedures (cardiac catheterisation). ALCOHOL WITHDRAWAL In patients with alcohol withdrawal it can be used for relieving excitation, panic, tremor and hallucinations (delirium tremens). ANTICONVULSANT THERAPY Acute treatment of status epilepticus, severe convulsions, tetanus and preeclampsia or eclampsia. In this case possible risk for the fetus as compared to the therapeutic benefit for the mother should be considered. MUSCLE SPASM It is a good adjunctive drug in the treatment of muscle spasms due to local trauma (lesion, inflammation). It can also be used to combat spasticity caused by the diseases of spinal and supraspinal interneurons, such as cerebral palsy and paraplegia, as well as athetosis and generalized muscular rigidity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apaurin injections can be administered intravenously or intramuscularrly. Dosage should be adjusted individually, depending on the severity of symptoms, age and condition of the patient. In acute conditions, the dose may be repeated after 1 hour but the usual dosing interval is 4 hours. Lower doses CONFIDENTIAL Apaurin 5 mg Lestu allt skjalið