Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Benzatropine mesilate
PHEBRA (SE ASIA) PTE. LTD.
N04AC01
INJECTION, SOLUTION
Benzatropine mesilate 2.0 mg/2ml
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
Phebra Pty Ltd
ACTIVE
2021-06-03
PRODUCT INFORMATION Pack Insert – Benzatropine Injection (AU-NZ-SG) Page 1 of 10 PiINJ187/197 . 03 BENZATROPINE INJECTION (BENZATROPINE MESILATE) 1 NAME OF THE MEDICINE Benzatropine mesilate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzatropine Injection is available as 2 mg in 2 mL vials. Benzatropine Injection contains benzatropine mesilate as the active ingredient. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Benzatropine Injection, 2 mg in 2 mL, clear, colourless, particle free solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Benzatropine Injection is recommended for all forms of parkinsonism - including arteriosclerotic, post-encephalitic, idiopathic, as well as drug-induced extrapyramidal disorders (except tardive dyskinesia). It can be effective at any stage of the disease, even when a patient has become bedridden. Benzatropine Injection often is helpful in patients who have become unresponsive to other agents. Benzatropine Injection is a powerful anticholinergic agent which is mainly effective in relieving tremor and rigidity. Therapy is directed toward control of disturbing symptoms to permit the patient maximum integration of function with minimum discomfort. In non-drug-induced parkinsonism, partial control of symptoms is usually achieved. 4.2 D OSE AND METHOD OF ADMINISTRATION Benzatropine Injection is available as an injection for intravenous and intramuscular use. Each millilitre of the injection contains: Benzatropine mesilate 1.0 mg Sodium chloride 9.0 mg Water for injections q.s 1.0 mL Because Benzatropine Injection is cumulative in action, therapy should be initiated with a small dose which then can be increased gradually at five- or six-day intervals. Increases in dosage should be made in increments of 0.5 mg, to a maximum of 6 mg. PRODUCT INFORMATION BENZATROPINE INJECTION Pack Insert– Benzatropine Injection (AU-SG-NZ) Page 2 of 10 PiINJ187/197 . 03 The injection is especially useful for psychotic patients with acute dystonic rea Lees het volledige document