Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Cilastatin sodium 530.7mg equivalent to 500 mg cilastatin; Imipenem monohydrate 530.1mg equivalent to 500 mg imipenem
Douglas Pharmaceuticals Limited
Cilastatin sodium 530.7 mg (equivalent to 500 mg cilastatin)
500mg/500mg
Powder for injection
Active: Cilastatin sodium 530.7mg equivalent to 500 mg cilastatin Imipenem monohydrate 530.1mg equivalent to 500 mg imipenem Excipient: Sodium bicarbonate
Bottle, glass, Type 1 clear, 10 x 100mL infusion bottle, with bromobutyl rubber plug, PP filp-off seal, 1 L
Prescription
Prescription
Sun Pharmaceutical Industries Ltd
Indicated for the treatment of the following infections due to susceptible organisms: · Intra-abdominal infections · Lower respiratory tract infections · Gynaecological infections · Septicaemia · Genitourinary tract infections · Bone and joint infections · Skin and soft tissue infections · Endocarditis Indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by faecal flora or flora originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, ephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to imipenem and cilastatin combination. Imipenem and cilastatin combination has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime and ceftriaxone. Similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment imipenem and cilastatin. IMIPENEM+CILASTATIN RBX is not indicated for the treatment of meningitis.
Package - Contents - Shelf Life: Bottle, glass, Type 1 clear, 100mL infusion bottle, with bromobutyl rubber plug and PP filp-off seal - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, Type 1 clear, 100mL infusion bottle, with bromobutyl rubber plug, PP filp-off seal - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type 1 clear 30mL vial, chlorobutyl rubber plug, PP flip-off lid - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type 1 clear, chlorobutyl rubber plug, 22mL vial with transfer set - 1 dose units - 24 months from date of manufacture stored at or below 25°C
2011-06-07
IMIPENEM+CILASTATIN RBX ® _imipenem/cilastatin sodium _ 500 mg/500 mg Powder for Solution for Infusion WHAT IS IN THIS LEAFLET This leaflet answers some common questions about IMIPENEM+CILASTATIN RBX. 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 IMIPENEM+CILASTATIN RBX against the benefits he or she expects 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 IMIPENEM+CILASTATIN RBX IS USED FOR IMIPENEM+CILASTATIN RBX is an antibiotic which is used to treat serious infections caused by bacteria (germs). These infections may occur in many different parts of the body. IMIPENEM+CILASTATIN RBX is sometimes given in addition to other antibiotics. IMIPENEM+CILASTATIN RBX works by killing the bacteria causing the infection. BEFORE YOU ARE GIVEN IMIPENEM+CILASTATIN RBX WHEN YOU MUST NOT BE GIVEN IT Do not use IMIPENEM+CILASTATIN RBX if you have an allergy to the active ingredients imipenem/cilastatin sodium or any of the ingredients listed at the end of this leaflet. BEFORE YOU ARE GIVEN IT Your doctor must know about all of the following before you are given IMIPENEM+CILASTATIN RBX, if you have or have had: • any allergies to other antibiotics, in particular, penicillins and cephalosporins • allergies to any other substances, such as foods, preservatives, or dyes If you have any of these allergies you may be allergic to IMIPENEM+CILA Read the complete document
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME IMIPENEM+CILASTATIN RBX 500 mg/500 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each container contains 530.1 mg of imipenem monohydrate (equivalent to 500 mg imipenem) and 530.7 mg of cilastatin sodium (equivalent to 500 mg cilastatin). EXCIPIENT(S) WITH KNOWN EFFECT Each container contains sodium bicarbonate (equivalent to 37.5 mg (1.6 mEq) sodium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Imipenem is a light tan to white, nonhygroscopic, ultraviolet light-sensitive, crystalline compound which is sparingly soluble in water, and slightly soluble in methanol. Cilastatin is an off-white to yellowish-white, hygroscopic, amorphous compound which is very soluble in water or methanol. IMIPENEM+CILASTATIN RBX for intravenous use is supplied as a white to pale yellow sterile powder. The reconstituted solution is clear (however variations in colour from colourless to yellow do not affect the potency of the product). IMIPENEM+CILASTATIN RBX for intramuscular use is not available in New Zealand. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The activity of IMIPENEM+CILASTATIN RBX against an unusually broad spectrum of pathogens makes it particularly useful in the treatment of polymicrobic mixed aerobic/anaerobic infections as well as initial therapy prior to the identification of the causative organisms. IMIPENEM+CILASTATIN RBX is indicated for the treatment of the following infections due to susceptible organisms: • Intra-abdominal infections • Lower respiratory tract infections • Gynaecological infections • Septicaemia • Genitourinary tract infections 2 | P a g e • Bone and joint infections • Skin and soft tissue infections • Endocarditis IMIPENEM+CILASTATIN RBX is indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by faecal flora or flora originatin Read the complete document