Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Clarithromycin 500mg
Max Health Limited
Clarithromycin 500 mg
500 mg
Powder for infusion concentrate
Active: Clarithromycin 500mg Excipient: Lactobionic acid
Prescription
Ind-Swift Laboratories Limited
Clarithromycin intravenous infusion is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in the following conditions: · upper respiratory tract infections · lower respiratory tract infections · skin and soft tissue infections
Package - Contents - Shelf Life: Vial, glass, Type I clear glass - 1 dose units - 48 months from date of manufacture stored at or below 30°C 24 hours reconstituted (not refrigerated) stored at or below 25°C protect from light. Reconstituted with sterile water for injection. 48 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Reconstituted with sterile water for injection. 6 hours diluted stored at or below 25°C protect from light. In final infusion solution 48 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. In final infusion solution
2013-12-11
Page 1 of 22 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg of clarithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Infusion, powder for concentrate. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Clarithromycin I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in the following conditions: • Upper respiratory tract infections. • Lower respiratory tract infections (see section 4.4 and 5.1 regarding Sensitivity testing). • Skin and soft tissue infections (see section 4.4 and 5.1 regarding Sensitivity testing). Consideration should be given to official guidance on the appropriate use of antibacterial agents. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE The recommended dosage of clarithromycin I.V. in adults 18 years of age or older is 1 gram daily, divided into 2 equal doses, each infused, after further dilution with an appropriate I.V. diluent, over a 60-minute time period. At the present time, there are no data supporting intravenous use of clarithromycin in children. Clarithromycin should not be given as a bolus or an intramuscular injection. Intravenous therapy may be limited for up to 2 to 5 days in the very ill patient and should be changed to oral therapy whenever possible as determined by the physician. _DOSAGE IN PATIENTS WITH MYCOBACTERIAL INFECTIONS _ Although there currently is no data regarding use of clarithromycin I.V. in immunocompromised patients, data are available regarding the use of oral clarithromycin in HIV-infected patients. In disseminated or localized infections (_M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. _ _kansasii_), the recommended treatment, in adults, is 1000 mg/day in two divided doses. Page 2 of 22 _SPECIAL POPULATIONS _ RENAL IMPAIRMENT In patients with renal impairment who have creatinine clearance less than 30 mL/min, the dosag Lugege kogu dokumenti