国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
erythromycin
Hospira Australia Pty Ltd
Erythromycin
Medicine Listed (Export Only)
Listed (Export Only)
1 BENPEN ™ _Benzylpenicillin (as benzylpenicillin sodium) Powder for Injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BENPEN TM . It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking BENPEN TM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet. You may need to read it again. WHAT BENPEN™ IS USED FOR BENPEN TM is an antibiotic used to treat some infections in different parts of the body caused by bacteria. BENPEN TM may also be used to prevent infections before, during and after surgery. BENPEN TM will not work against infections caused by viruses, such as colds or the flu. BENPEN TM is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection. Your doctor may have prescribed BENPEN TM for another reason. Ask your doctor why BENPEN TM has been prescribed for you. This medicine is available only with a doctors prescription. There is no evidence that BENPEN TM is addictive. BEFORE YOU ARE GIVEN BENPEN™ _WHEN YOU MUST NOT BE GIVEN_ _IT_ DO NOT USE BENPEN TM IF: • YOU HAVE AN ALLERGY TO BENPEN TM OR OTHER PENICILLINS. • Some of the symptoms of an allergic reaction may include skin rash, itching and difficult breathing. • YOU HAVE HAD AN ALLERGIC REACTION TO CEPHALOSPORINS. • You may have an increased chance of being allergic to BENPEN TM if you are allergic to cephalosporins. • THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. • THE EXPIRY DATE PRINTED ON THE PACK OR VIAL, HAS PASSED. IF YOU TAKE THIS MEDICINE AFTER THE EXPIRY DATE HAS PASSED, IT MAY NOT WORK. If you are not sure whether you should be given BENPEN TM , talk to your doctor. _BEFORE YOU ARE GIVEN IT_ TELL YOUR DOCTOR 完全なドキュメントを読む
Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – BENPEN BENZYLPENICILLIN (AS BENZYLPENICILLIN SODIUM), POWDER FOR INJECTION 1 NAME OF THE MEDICINE Benzylpenicillin (as benzylpenicillin sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BENPEN (benzylpenicillin sodium) is the sodium salt of (2 _S_ ,5 _R_ ,6 _R_ )-3,3-dimethyl-7-oxo-6- [(phenylacetyl) amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid. BENPEN contains no antiseptic or buffering agent nor are there any excipients. Each 600 mg dose of BENPEN contains 41.4 mg of sodium. 3 PHARMACEUTICAL FORM BENPEN is a fine white to off-white homogenous powder, which is soluble in water. The injection is prepared by the addition of the appropriate volume of Water for Injections to give the desired concentration of benzylpenicillin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections caused by benzylpenicillin sensitive organisms. These include _Streptococcus pyogenes_ and most other Gram-positive organisms. It is also indicated for the treatment of syphilis. BENPEN may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where Streptococci are the likely pathogens. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The initial dose of BENPEN should be sufficient to achieve a bactericidal concentration in the blood as rapidly as possible in order to prevent the emergence of resistant strains. Precise dosage levels cannot be stated. The nature of the infection and the patients’ response to therapy should determine the dose of BENPEN and its frequency of administration. Benzylpenicillin may be given by intramuscular or intravenous injection. Page 2 of 12 The minimum dosage should be: AGE MINIMUM DOSE Adults and Children 10 years 300 mg 6 hourly Children 3 - 10 years 150 to 300 mg 6 hourly Children < 3 years 60 mg 6 hourly Premature babies and neonates 30 to 60 mg 12 hourly A reduc 完全なドキュメントを読む