Land: Sydafrika
Sprog: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Ranbaxy Pharmaceutical (Pty) Ltd û Roodepoort
See ingredients
INJECTION
EACH VIAL CONTAINS CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mgIMIPENEM 500,0 mg
Registered
2010-04-06
APPLICANT/PHCR: Ranbaxy Pharmaceuticals (Pty) Ltd PRODUCT PROPRIETARY NAME: CILAPEN 500 DOSAGE FORM AND STRENGTH: Powder for injection; Each bottle contains Imipenem 500 mg and Cilastatin sodium equivalent to Cilastatin 500 mg DATE OF AMENDMENT: June 2021 Page 1 of 8 1.5.5 PROPOSED PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 CILAPEN 500 POWDER FOR INJECTION Imipenen and Cilastatin Sugar free Contains sodium: 36,14 mg per bottle READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE CILAPEN 500 • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. WHAT IS IN THE LEAFLET 1. What CILAPEN 500 is and what it is used for 2. What you need to know before you take CILAPEN 500 3. How to take CILAPEN 500 4. Possible side effects 5. How to store CILAPEN 500 6. Contents of the pack and other information 1. WHAT CILAPEN 500 IS AND WHAT IT IS USED FOR APPLICANT/PHCR: Ranbaxy Pharmaceuticals (Pty) Ltd PRODUCT PROPRIETARY NAME: CILAPEN 500 DOSAGE FORM AND STRENGTH: Powder for injection; Each bottle contains Imipenem 500 mg and Cilastatin sodium equivalent to Cilastatin 500 mg DATE OF AMENDMENT: June 2021 Page 2 of 8 CILAPEN 500 belongs to a group of medicines called thienamycins. It kills a wide range of bacteria (germs) that cause infections in various parts of the body. CILAPEN 500 is used for the treatment of several bacterial infections, except meningitis. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE CILAPEN 500 YOU SHOULD NOT RECEIVE CILAPEN 500: • if you have had an allergic reaction to imipenem and cilastatin or similar antibiotics (including penicillin or cephalosporin) or to any of the ingredients (listed in section 6). (An allergic reaction may include rash, itching, swelling of face/lips/tongue/hands/feet or breathing difficulties.) • if you are pregnant or planning to become pregnant or breastfeeding. • if you are suffering from meningitis (which is inflammation of the membranes surrounding the brain and Læs hele dokumentet
APPLICANT/PHCR: Ranbaxy Pharmaceuticals (Pty) Ltd PRODUCT PROPRIETARY NAME: CILAPEN 500 DOSAGE FORM AND STRENGTH: Powder for injection; Each bottle contains Imipenem 500 mg and Cilastatin sodium equivalent to Cilastatin 500 mg DATE OF AMENDMENT: June 2021 Page 1 of 27 1.5.5 PROPOSED PROFESSIONAL INFORMATION SCHEDULING STATUS S4 1. NAME OF THE MEDICINE CILAPEN 500 Powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains imipenem (sterile) equivalent to anhydrous imipenem 500 mg and cilastatin sodium (sterile) equivalent to cilastatin 500 mg. Sugar free Contains sodium: 36,14 mg per bottle For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for injection White to pale yellow powder filled in 100 ml moulded clear glass infusion bottle sealed with rubber plug and flip off seal. After reconstitution a clear, pale yellow to yellow coloured solution is formed. 4. CLINICAL PARTICULARS APPLICANT/PHCR: Ranbaxy Pharmaceuticals (Pty) Ltd PRODUCT PROPRIETARY NAME: CILAPEN 500 DOSAGE FORM AND STRENGTH: Powder for injection; Each bottle contains Imipenem 500 mg and Cilastatin sodium equivalent to Cilastatin 500 mg DATE OF AMENDMENT: June 2021 Page 2 of 27 4.1 THERAPEUTIC INDICATIONS CILAPEN 500 is indicated for the treatment of the following infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: INTRA-ABDOMINAL INFECTIONS _Enterococcus _ _faecal _ _is, _ _Staphylococcus _ _aureus _ _(penicillinase-producing _ _strains)*, _ _Staphylococcus epidermidis, Citrobacter species, Enterobacter species, Escherichia coli, _ _Klebsiella _ _species, _ _Morganella _ _morganii*, _ _Proteus _ _species, _ _Pseudomonus _ _aeruginosa, _ _Bifidobacterium species, Clostridium species, Eubacterium species, Peptococcus species, _ _Peptostreptococcus species, Propionibacterium species*, Bacteroides species including B. _ _fragilis, Fusobacterium species. _ _ _ LOWER RESPIRATORY TRACT INFECTIONS _Staphylococcus aureus (penicillinase-producing strains Læs hele dokumentet