Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
CEFUROXIME
Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece
J01DC02
CEFUROXIME 750 mg
POWDER FOR SOLUTION FOR INJECTION
CEFUROXIME 750 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2006-11-14
1 PACKAGE INSERT LEAFLET ZETAGAL ® Cefuroxime – Second generation cephalosporin 1. CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT 1.1 NAME ZETAGAL ® 1.2 COMPOSITION ACTIVE INGREDIENT: Cefuroxime Sodium. EXCIPIENTS: Not applicable. 1.3 PHARMACEUTICAL FORM Powder for solution for injection. 1.4 CONTENT IN ACTIVE INGREDIENT ZETAGAL® pd. inj. sol. 250 mg/vial: Cefuroxime Sodium equivalent to 250 mg of Cefuroxime base. ZETAGAL® pd. inj. sol. 750 mg/vial: Cefuroxime Sodium equivalent to 750 mg of Cefuroxime base. ZETAGAL® pd. inj. sol. 1500 mg/vial: Cefuroxime Sodium equivalent to 1500 mg of Cefuroxime base. 1.5 DESCRIPTION- PACKAGE Each carton contains one vial with powder for solution for injection. 1.6. PHARMACOTHERAPEUTIC CLASS Antibiotic (Cephalosporin). 1.7 LICENCE HOLDER ELPEN PHARMACEUTICAL Co., Inc. 95, Marathonos Ave., Pikermi, Attika 19009, Greece Tel: (01) 6039326-9 Fax: (01) 6039300 1.8 MANUFACTURER ELPEN PHARMACEUTICAL Co., Inc. 95, Marathonos Ave., Pikermi, Attika 19009, Greece Tel: (01) 6039326-9 Fax: (01) 6039300 2. INFORMATION YOU SHOULD KNOW ABOUT THE MEDICINE THAT YOUR DOCTOR PRESCRIBED FOR YOU 2.1 GENERAL INFORMATION ZETAGAL® is a second generation semi-synthetic cephalosporin antibiotic. It presents bactericidal activity against a broad range of common pathogens, including beta- lactamase producing strains, and therefore it is effective against a range of strains resistant to ampicillin and amoxycillin. Its bactericidal activity is based on the inhibition of the bacterial cell wall synthesis, by binding its basic proteins. 2.2 INDICATIONS ZETAGAL® is indicated in the treatment of infections caused by susceptible strains as follows: i. Infections (not meningitis) caused by haemophilus influenza resistant to ampicillin. ii. Gonococcal infections due to gonococcus resista Baca dokumen lengkapnya
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT ZETAGAL ® Powder for solution for injection 750MG/vialv 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENT Cefuroxime Sodium- Second generation cephalosporin 2.2 DESCRIPTION- PACKAGE Each carton contains one vial with powder for solution for injection: ZETAGAL® pd. inj. sol. 750 mg/vial: Cefuroxime Sodium equivalent to 750 mg of Cefuroxime base. 3. PHARMACEUTICAL FORM Sterile Powder for solution for injection . 4. CLINICAL PARTICULARS PHARMACOTHERAPEUTIC CLASS Antibiotic (Cephalosporin). 4.1. THERAPEUTIC INDICATIONS GENERAL INFORMATION ZETAGAL® is a second generation semi-synthetic cephalosporin antibiotic. It presents bactericidal activity against a broad range of common pathogens, including beta-lactamase producing strains, and therefore it is effective against a range of strains resistant to ampicillin and amoxycillin. Its bactericidal activity is based on the inhibition of the bacterial cell wall synthesis, by binding its basic proteins. INDICATIONS ZETAGAL® is indicated in the treatment of infections caused by susceptible strains as follows: i. Infections (not meningitis) caused by haemophilus influenza resistant to ampicillin. ii. Gonococcal infections due to gonococcus resistant to penicillin. iii. Nosocomial infections due to strains resistant to 1st generation cephalosporins. (i.e. coccobacter sp, klebsiella sp, proteus sp, enterobacter sp, providencia sp and citrobacter sp.) ZETAGAL® IS INDICATED IN: 1. RESPIRATORY TRACT INFECTIONS such as acute and chronic bronchitis, inflamed bronchectasis, bacterial pneumonia, pulmonary apostema and postoperative pulmonary infections_._ 2. EAR, NOSE AND THROAT INFECTIONS such as sinusitis, tonsillitis, pharyngitis Baca dokumen lengkapnya