Country: Malta
Language: English
Source: Medicines Authority
BENZYLPENICILLIN POTASSIUM
Ibigen S.r.L Via Fossignano, 2, 04011 Aprilia (LT), Italy
J01CE01
BENZYLPENICILLIN POTASSIUM 1250 mg
POWDER FOR SOLUTION FOR INFUSION OR INJECTION
BENZYLPENICILLIN POTASSIUM 1250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2016-11-22
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER Benzylpenicillin Potassium 625 mg powder for solution for injection or infusion Benzylpenicillin Potassium 1250 mg powder for solution for injection or infusion Benzylpenicillin Potassium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any side-effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Benzylpenicillin Potassium is and what it is used for 2. What you need to know before you use Benzylpenicillin Potassium 3. How to use Benzylpenicillin Potassium 4. Possible side effects 5. How to store Benzylpenicillin Potassium 6. Contents of the pack and other information 1. WHAT BENZYLPENICILLIN POTASSIUM IS AND WHAT IT IS USED FOR This medicine contains benzylpenicillin potassium, which is one of a group of medicines known as penicillins (‘antibiotics’). Antibiotics are used to kill the bacteria (germs) which cause infections. Benzylpenicillin Potassium is used to treat INFECTIONS OF THE EAR, NOSE, THROAT, CHEST, HEART, BONES AND SKIN. Benzylpenicillin Potassium is also used for the prevention of infection in newborn babies. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENZYLPENICILLIN POTASSIUM DO NOT USE BENZYLPENICILLIN POTASSIUM IF YOU: are allergic to benzylpenicillin potassium, any other antibiotics (in particular other penicillins, cephalosporins or beta-lactams). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Benzylpenicillin Potassium: if you suffer from other allergies, especially an allergy to medicines if you are pregnant, breast-feeding or think you could be pregnant if you have kidney problems if you have liver problems if you have any heart problems if you are diabetic O Read the complete document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benzylpenicillin Potassium 1250 mg powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1250 mg of Benzylpenicillin Potassium, equivalent to 1120 mg of benzylpenicillin (2 mega units) Each vial of Benzylpenicillin Potassium 1250 mg contains 3.35 mmol (131 mg) of potassium. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion White crystalline, water-soluble sterile powder for injection, very soluble in water, practically insoluble in fatty oils and in liquid paraffin. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benzylpenicillin Potassium is indicated for the treatment of the following infections (see section 4.4 and 5.1): • Skin and soft tissue infections • Infections of the ear, nose and throat • Community acquired pneumonia • Acute exacerbation of chronic bronchitis • Acute and chronic osteomyelitis • Sub-acute bacterial endocarditis • Meningitis • Brain abscess It is also used for the prevention of neonatal group B streptococcal infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosages apply to both intramuscular and intravenous injection. Alternate sites should be used for repeated injections. _ _ Page 2 of 11 _Adults _ 625 to 3,750 mg (1 to 6 mega units) daily, divided into 4 to 6 doses, depending on the indication. Higher doses (up to 15 g/day (24 mega units) in divided doses) may be given in serious infections such as adult meningitis by the intravenous route. In bacterial endocarditis, 7.5 to 12.5 g (12 to 20 mega units) or more may be given daily in divided doses by the intravenous route, often by infusion. Doses up to 45 g (72 mega units) per day may be necessary for patients with rapidly spreading gas gangrene. High doses should be administered by intravenous injection or infusion, with intravenous doses in e Read the complete document