Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
cefalotin, Quantity: 1 g
Aspen Pharmacare Australia Pty Ltd
Injection, powder for
Excipient Ingredients: sodium bicarbonate
Intramuscular, Intravenous
10 X 1g vials
(S4) Prescription Only Medicine
KEFLIN is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Culture and susceptibility studies should be performed. Therapy may be instituted before results of susceptibility studies are obtained (See notes under Microbiology). Respiratory tract infections caused by S. pneumoniae, staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, Klebsiella, and H. influenzae. Skin and soft-tissue infections, including peritonitis, caused by staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, E. coli, Pr. mirabilis, and Klebsiella. Genito-urinary tract infections caused by E. coli, Pr. mirabilis and Klebsiella. Septicaemia, including endocarditis, caused by S. pneumoniae, staphylococci (penicillinase and non-penicillinase-producing), group A beta-haemolytic streptococci, S. viridans; E. coli, Pr. mirabilis, and Klebsiella. Bone and joint
Visual Identification: A white to off-white crystalline powder; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1991-09-05
KEFLIN ® NEUTRAL _cefalotin sodium_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about KEFLIN Neutral. It does not contain all the available information and does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT KEFLIN NEUTRAL IS USED FOR KEFLIN Neutral contains cefalotin (as cefalotin sodium) as the active ingredient. It belongs to a group of medicines called cephalosporins. KEFLIN Neutral is an antibiotic used to treat serious infections in different parts of the body caused by bacteria. It is also used to prevent possible infections before, during and after surgery. KEFLIN Neutral works by killing the bacteria that are causing the infection. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY KEFLIN NEUTRAL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. This medicine is available only 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 KEFLIN NEUTRAL IF YOU HAVE HAD AN ALLERGIC REACTION TO: • cefalotin • sodium bicarbonate. Signs of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin. YOU MUST NOT BE GIVEN THIS MEDICINE IF YOU HAVE HAD A SERIOUS ALLERGIC REACTION TO ANY OTHER CEPHALOSPORIN ANTIBIOTIC OR PENICILLIN ANTIBIOTIC. If you are allergic to a cephalosporin or a penicillin, you may have an increased chance of being allergic to KEFLIN Neutral. YOU MUST NOT BE GIVEN THIS MEDICINE AFTER THE EXPIRY DATE HAS PASSED OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. IF Izlasiet visu dokumentu
1 PRODUCT INFORMATION KEFLIN ® CEFALOTIN SODIUM FOR INJECTION NEUTRAL DESCRIPTION KEFLIN (cefalotin sodium), Neutral, is a semisynthetic cephalosporin antibiotic for parenteral use. It is the sodium salt of 7-(thiophene-2-acetamido) cephalosporanic acid. Sodium bicarbonate has been added to result in reconstituted solutions having a pH ranging between 6 and 8.5. The total sodium content is approximately 63 mg (2.8 mEq. sodium ion) per g of KEFLIN Neutral. MICROBIOLOGY/PHARMACOLOGY Microbiology - The in-vitro bactericidal action of cefalotin results from inhibition of cell-wall synthesis. In general, cefalotin has higher activity against Gram positive than Gram negative organisms, the latter varying greatly in their sensitivity to the drug. The range of antibiotic concentrations at which bacteria are inhibited may vary substantially according to the isolate, therefore susceptibility testing is highly desirable. KEFLIN is usually active against the following organisms in-vitro: Beta-haemolytic and other streptococci (most strains of enterococci, e.g. _Streptococcus faecalis _are resistant). Staphylococci, including coagulase-positive, coagulase-negative, and penicillinase-producing strains. Methicillin-resistant staphylococci are resistant. _Streptococcus pneumoniae_ _ _ _Haemophilus influenzae_ _ _ _Escherichia coli_ _ _ _Klebsiella_ _ _ _Proteus mirabilis_ NOTE: _Pseudomonas _organisms are resistant to KEFLIN, as are most indole- producing _Proteus _species and motile _Enterobacter _species. Susceptibility Plate Tests - If the Bauer-Kirby-Sherris-Turck method of disc susceptibility testing is used, a disc containing 30 mcg cefalotin should give a zone of over 17 mm when tested against a cefalotin-susceptible bacterial strain, and a zone of over 14 mm with an organism of intermediate susceptibility. 2 Human Pharmacology - KEFLIN is not absorbed significantly following oral administration. It is intended for parenteral administration only. After administration of a 500 mg dose intramuscularly to normal volunteers, Izlasiet visu dokumentu