Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
Pfizer Limited
20 Base Milligrams
Pdr+Solv for Soln for Inj
2002-03-08
License 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 m Read the complete document