Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
cefazolin, Quantity: 1 g
Aspen Pharmacare Australia Pty Ltd
Injection, powder for
Excipient Ingredients:
Intramuscular, Intravenous
1 X 1g vial, 10 x 1g vials
(S4) Prescription Only Medicine
The treatment of susceptible gram positisve gram negative infections of the respiratory tract, genitourinary tract, bones and joints, bloodstream (including endocarditis and septicaemia), skin and soft tissue. Appropriate culture and sensitivity studies should be performed. INDICATIONS AS AT 26 July 1995: Kefzol is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory tract infections due to S. pneumoniae, Klebsiella species, H. influenzae, Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Kefzol is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Kefzol in the subsequent prevention of rheumatic fever are not available at present. Genitourinary tract infections due to
Visual Identification: A white to off-white lyophilised plug; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-05
KEFZOL CMI- 150410 Page 1 of 3 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Kefzol. It does not contain all the available information and 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 taking Kefzol 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 WITH THE MEDICINE. You may need to read it again. WHAT KEFZOL IS USED FOR Kefzol contains cephazolin (as cephazolin sodium) as the active ingredient. Cephazolin belongs to a group of antibiotics called cephalosporins. Kefzol is used to treat serious infections, caused by bacteria, in different parts of the body. It works by killing the bacteria that are causing your infection, including infections of the: • respiratory tract (throat, tonsils, chest and lungs) • nose • skin and soft tissue • genitourinary tract (kidney and bladder) • bone and joint • blood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY KEFZOL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose . Kefzol is not recommended for use in premature infants and in infants under one month. This medicine is only available with a doctor’s prescription. There is no evidence that it is addictive. BEFORE YOU ARE GIVEN IT _WHEN YOU MUST NOT BE GIVEN IT _ _ _ YOU MUST NOT BE GIVEN KEFZOL IF YOU HAVE A KNOWN ALLERGY TO: • cephazolin • any other cephalosporin antibiotic • or a major allergy to penicillin. Signs of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. YOU MUST NOT BE GIVEN KEFZOL IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. YOU MUST NOT BE GIVEN KEFZOL AFTER THE EXPIRY DATE PRINTED ON THE PACK. IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN THIS MEDICINE, TALK TO YOUR DOCT Les hele dokumentet
KEFZOL PI - (marketed) Page 1 of 9 PRODUCT INFORMATION KEFZOL (cephazolin, as cephazolin sodium) DESCRIPTION Kefzol (cephazolin sodium) is a semisynthetic cephalosporin for parenteral administration. It is the sodium salt of 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)-thio] methyl]-7- [2-(1H-tetrazol-1-yl)acetamido]-3-cephem-4-carboxylic acid. The sodium content is 48.3 mg per g of cephazolin sodium. Cephazolin sodium is a white to off-white crystalline powder with a solubility of ≥ 100mg/mL in water. The structural formula is as follows :- ACTIONS Microbiology -- In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell-wall synthesis. Kefzol is active against the following organisms in vitro: _Staphylococcus aureus _ (penicillin-sensitive and penicillin-resistant). Group A beta-haemolytic streptococci and other strains of streptococci (many strains of enterococci are resistant). _Streptococcus pneumoniae _ _ _ _Klebsiella species_ _Escherichia coli _ _ _ _ _ _Enterobacter aerogenes_ _Proteus mirabilis _ _ _ _ _ _Haemophilus influenzae_ KEFZOL PI - (marketed) Page 2 of 9 Most strains of _Enterobacter cloacae _ and indole-positive _Proteus (Pr. vulgaris, Pr. morganii, _ _Pr. rettgeri) _ are resistant. Methicillin-resistant staphylococci, _Serratia, Pseudomonas, _ _Acinetobacter calcoaceticus _ (formerly _Mima _ and _Herellea _ species) are almost uniformly resistant to cephazolin. Human Pharmacology -- The following table demonstrates the blood levels and duration of cephazolin following intramuscular administration. TABLE 1 SERUM CONCENTRATIONS AFTER INTRAMUSCULAR ADMINISTRATION Serum Concentrations ( µ g/mL) Dose ½ hr 1 hr 2 hr 4 hr 6 hr 8 hr 250 mg 15.5 17.0 13.0 5.1 2.5 500 mg 36.2 36.8 37.9 15.5 6.3 3.0 1 g * 60.1 63.8 54.3 29.3 13.2 7.1 * Average of two studies Clinical pharmacology studies in patients hospitalised with infections indicate that cephazolin produces mean peak serum levels approximately equivalent to those seen in normal volunteers. In a study (usin Les hele dokumentet