Land: Nieuw-Zeeland
Taal: Engels
Bron: Medsafe (Medicines Safety Authority)
Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL)
Pfizer New Zealand Limited
Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL)
1,200,000 U/2.3 mL
Suspension for injection
Active: Benzathine benzylpenicillin tetrahydrate 442 mg/mL (1,200,000U/2.3mL) Excipient: Carmellose sodium Lecithin Methyl hydroxybenzoate Povidone Propyl hydroxybenzoate Sodium citrate dihydrate Water for injection
Cartridge, glass, 2 mL
Prescription
Prescription
Sandoz GmbH
Intramuscular benzathine benzylpenicillin is indicated in the treatment of infections due to penicillin-sensitive micro-organisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular benzathine benzylpenicillin: · Streptococcal infections (Group A - without bacteraemia). Mild-to-moderate infections of the upper respiratory tract (eg., pharyngitis). · Venereal infections - Syphilis, yaws, bejel and pinta.
Package - Contents - Shelf Life: Syringe, glass, Pre-filled 2.3 mL in cardboard carton - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 2 months not refrigerated stored at or below 30°C. Do not return to refrigerated storage.
1996-03-20
New Zealand Consumer Medicine Information BICILLIN L-A ® 1 BICILLIN® L-A _benzathine benzylpenicillin tetrahydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Bicillin L-A. 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 receiving Bicillin L- A against the benefits they expect it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT RECEIVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT BICILLIN L-A IS USED FOR Bicillin L-A is used to treat infections in different parts of the body caused by bacteria. Bicillin L- A is also used to prevent certain infections such as rheumatic fever. Bicillin L-A will not work against infections caused by viruses such as colds or flu. Bicillin belongs to the group of penicillin antibiotics. It works by killing bacteria or preventing their growth. This particular type of Bicillin is called Bicillin L-A because it is long-acting. It is supplied in a syringe for once-only use. Your doctor may have prescribed Bicillin L-A for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BICILLIN L-A HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN BICILLIN L-A _WHEN YOU MUST NOT BE GIVEN _ _IT: _ DO NOT HAVE BICILLIN L-A IF YOU HAVE AN ALLERGY TO: • any medicine containing benzathine benzylpenicillin • any of the ingredients listed at the end of this leaflet • any other similar medicines such as other penicillin antibiotics • cephalosporins. You may have an increased chance of being allergic to Bicillin L-A if you are allergic to cephalosporins. If you are not sure, check with your pharmacist. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongu Lees het volledige document
Version: pfdbicii10122 Superseded: pfdbicii11120 Page 1 of 11 NEW ZEALAND DATA SHEET 1. PRODUCT NAME BICILLIN L-A ® Benzathine Benzylpenicillin 1,200,000 Units/2.3 mL suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BICILLIN L-A contains benzathine benzylpenicillin (the benzathine salt of benzylpenicillin) in aqueous suspension 1,200,000 Units/2.3 mL pre-filled syringe, containing benzathine benzylpenicillin tetrahydrate 1016.6 mg/2.3 mL. EXCIPIENT(S) WITH KNOWN EFFECT • Methyl hydroxybenzoate • Propyl hydroxybenzoate. BICILLIN L-A contains approximately 0.11 mEq of sodium per 600,000 units of benzylpenicillin (approximately 2.59 mg of sodium per 600,000 units of benzylpenicillin). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Suspension for injection pre-filled syringe with needle. BICILLIN L-A in the disposable pre-filled syringe formulation is a viscous and opaque white suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intramuscular benzathine benzylpenicillin is indicated in the treatment of infections due to penicillin-sensitive micro-organisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular benzathine benzylpenicillin: Streptococcal infections (Group A - without bacteraemia). Mild-to-moderate infections of the upper respiratory tract (e.g. pharyngitis). Venereal infections - Syphilis, yaws, bejel and pinta. Version: pfdbicii10122 Superseded: pfdbicii11120 Page 2 of 11 Medical conditions in which benzathine benzylpenicillin therapy is indicated as prophylaxis: Rheumatic fever and/or chorea - Prophylaxis with benzathine benzylpenicillin has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease Lees het volledige document