Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
imipenem, Quantity: 500 mg; cilastatin, Quantity: 500 mg
Merck Sharp & Dohme (Australia) Pty Ltd
Injection, powder for
Excipient Ingredients: sodium bicarbonate
Intravenous
1 vial of powder - 500mg:500mg
Medicine Registered
(S4) Prescription Only Medicine
PRIMAXIN is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below: 1. Lower respiratory tract infections. 2 Intra-abdominal infections. 3. Gynaecological infections. 4. Bacterial septicaemia. 5. Bone and joint infections. 6. Skin and skin structure infections. 7. Endocarditis. 8. Polymicrobial infections. PRIMAXIN is indicated for polymicrobial infections including those in which S. pneumoniae (pneumonia, septicaemia), Group A beta-haemolytic streptococcus (skin and skin structure), or non-penicillinase-producing S. aureus is one of the causative organisms. However monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penicillin G. Efficacy against polymicrobial infection in the immunocompromised host has not yet been established. Although clinical improvement has been observed in patients with cystic fibrosis, chronic pulmonary disease, and lower respiratory tract infections cau
Visual Identification: White powder; Container Type: Vial; Container Temperature: Store below 25 degrees Celsius
Registered
1991-07-22
PRIMAXIN ® _Imipenem/Cilastatin sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PRIMAXIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using PRIMAXIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT PRIMAXIN IS USED FOR PRIMAXIN is an antibiotic which is used to treat serious infections caused by bacteria. These infections may occur in many different parts of the body. PRIMAXIN is sometimes given in addition to other antibiotics. PRIMAXIN works by killing the bacteria causing the infection. BEFORE YOU ARE GIVEN PRIMAXIN _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE PRIMAXIN IF YOU HAVE AN ALLERGY TO PRIMAXIN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR IF: 1. YOU ARE PREGNANT OR ARE BREAST- FEEDING Your doctor will discuss the possible risks and benefits of using PRIMAXIN during pregnancy and breast-feeding. PRIMAXIN passes into breast milk and may be passed on to the baby. 2. YOU HAVE ANY MEDICAL CONDITIONS, ESPECIALLY THE FOLLOWING: • colitis or any other gastrointestinal disease • any central nervous system disorders, such as localised tremors, or seizures (fits) • kidney or urinary problems • bowel problems 3. YOU HAVE ANY ALLERGIES TO OTHER ANTIBIOTICS, IN PARTICULAR, PENICILLINS AND CEPHALOSPORINS If you are allergic to any of these, you may be allergic to PRIMAXIN. 4. IF YOU HAVE ANY ALLERGIES TO ANY OTHER MEDICINES OR ANY OTHER SUBSTANCES, SUCH AS FOODS, PRESERVATIVES OR DYES. IF YOU HAVE NOT TOLD YOUR DOCTOR ABOUT ANY OF THE ABOVE, TELL THEM BEFORE YOU ARE GIVEN PRIMAXIN. PRIMAXIN SHOULD NOT BE USED IN CHILDREN UNDER 3 MONTHS OF AGE OR CHILDREN WITH KIDNEY PROBLEMS. _TAKING OTHER Lugege kogu dokumenti
Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION PRIMAXIN ® (IMIPENEM AND CILASTATIN SODIUM) POWDER FOR INJECTION 1 NAME OF THE MEDICINE Imipenem and cilastatin sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PRIMAXIN (Imipenem-Cilastatin Sodium) is a formulation of imipenem, a thienamycin antibiotic, and cilastatin sodium, the inhibitor of the renal dipeptidase, dehydropeptidase l, with sodium bicarbonate added as a buffer. PRIMAXIN is a potent broad spectrum antibacterial agent for intravenous administration. PRIMAXIN is supplied as Imipenem 500 mg and cilastatin sodium equivalent to cilastatin 500 mg. Excipient with known effect: PRIMAXIN contains 37.5 mg of sodium (1.6mEq). For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PRIMAXIN is supplied as a sterile powder mixture in a vial. PRIMAXIN is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed. (See SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION, COMPATIBILITY AND STABILITY.) Solutions of PRIMAXIN range from colourless to yellow. Variations of colour within this range do not affect the potency of the product. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMAXIN is indicated for the treatment of serious infections caused by susceptible strains of micro-organisms in the diseases listed below: 1. Lower respiratory tract infections. 2. Intra-abdominal infections. 3. Gynaecological infections. 4. Bacterial septicaemia. 5. Bone and joint infections. 6. Skin and skin structure infections. 7. Endocarditis. Page 2 of 16 8. Polymicrobial infections. PRIMAXIN is indicated for polymicrobial infections including those in which _S. pneumoniae_ (pneumonia, septicaemia), Group A beta-haemolytic streptococcus (skin and skin structure), or non-penicillinase-producing _ S. aureus_ is one of the causative organisms. However, monobacterial infections due to these organisms are usually treated with narrower spectrum antibiotics, such as penic Lugege kogu dokumenti