Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
CLARITHROMYCIN
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
J01FA09
500 mg/vial
INJECTION, POWDER, FOR SOLUTION
CLARITHROMYCIN 500 mg/vial
INTRAVENOUS
Prescription Only
DELPHARM SAINT REMY
ACTIVE
1997-01-06
I.V. 1. NAME OF THE MEDICINAL PRODUCT Clarithromycin 500 mg, Powder for Intravenous Solution for Injection (IV) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 500 mg of clarithromycin. For the full list of excipients, see PHARMACEUTICAL PARTICULARS, LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM FORMULATION PHARMACEUTICAL FORM Clarithromycin IV White to off-white caked, lyophilized powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in the following conditions: 1. Upper respiratory tract infections 2. Lower respiratory tract infections 3. Skin and soft tissue infections 4. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE AND ADMINISTRATION Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate. Klacid IV should be administered into one of the larger proximal veins as an IV infusion over 60 minutes using a solution concentration of about 2 mg/ml. Clarithromycin should be given as a bolus or an intramuscular injection. ADULTS: The recommended dosage of Klacid IV in adults 18 years of age or older is 1.0 g daily divided into two 500 mg doses, appropriately diluted as described below. PEDIATRIC: There are insufficient data to recommend a dosage regimen for use of the Klacid IV formulation in patients less than 18 years of age (see Pediatric Suspension). ELDERLY: As for adults. _RENAL IMPAIRMENT _ In patients with re Прочетете целия документ
I.V. 1. NAME OF THE MEDICINAL PRODUCT Clarithromycin 500 mg, Powder for Intravenous Solution for Injection (IV)* * This product may be supplied with Water for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 500 mg of clarithromycin. For the full list of excipients, see PHARMACEUTICAL PARTICULARS, List of excipients. 3. PHARMACEUTICAL FORM Formulation Pharmaceutical Form Clarithromycin IV White to off-white caked, lyophilized powder 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Klacid ® I.V. is indicated whenever parenteral therapy is required for treatment of sensitive microorganisms in adults 18 years and older in the following conditions: 1. Upper respiratory tract infections 2. Lower respiratory tract infections (see section 4.4 and 5.1 regarding Sensitivity Testing) 3. Skin and soft tissue infections (see section 4.4 and 5.1 regarding Sensitivity Testing) 4. Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii. Consideration should be given to national official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Dosage and Administration Intravenous therapy may be given for 2 to 5 days and should be changed to oral clarithromycin therapy when appropriate. Klacid ® IV should be administered into one of the larger proximal veins as an IV infusion over 60 minutes using a solution concentration of about 2 mg/ml. Clarithromycin should be given as a bolus or an intramuscular injection. Adults: The recommended dosage of Klacid ® IV in adults 18 years of age or older is 1.0 g daily divided into two 500 mg doses, appropriately diluted as described below. Pediatric: There are insufficient data to recommend a dosage regimen for use of the Klacid ® IV formulation in patients less than 18 years of age (see Pediatric Suspension). Elderly: As for adults. Renal Impairment In patients wi Прочетете целия документ