Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
Pfizer Limited
20 Base Milligrams
Pdr+Solv for Soln for Inj
2002-03-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT GEODON 20 mg/ml powder and solvent for solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains ziprasidone mesilate to deliver 20 mg of ziprasidone. After reconstitution, 1ml of solution for injection contains 20 mg ziprasidone. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and Solvent for solution for injection. White to off-white powder Clear colourless solvent 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziprasidone powder and solvent for solution for injection is indicated for the rapid control of agitation in patients with schizophrenia, when oral therapy is not appropriate, for a maximum of 3 consecutive days. Treatment with ziprasidone powder and solvent for solution for injection should be discontinued, and the use of oral ziprasidone should be initiated, as soon as clinically appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intramuscular use only. Intravenous administration must be avoided. Treatment with the intramuscular formulation should only be used in patients, where treatment with an oral formulation is considered to be inappropriate. _Adults_ The recommended dose is 10 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every 2 hours. Some patients may require an initial dose of 20 mg, which can be followed by a further dose of 10 mg after 4 hours. Thereafter, doses of 10 mg may be given every 2 hours up to the maximum daily dose of 40 mg. Intramuscular administration of ziprasidone for more than 3 consecutive days has not been studied. If long-term therapy is indicated, oral ziprasidone hydrochloride capsules, up to 80 mg twice daily, should replace the int Przeczytaj cały dokument