Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AMIKACIN SULFATE
Bristol-Myers Squibb (Holdings) Limited
J01GB06
AMIKACIN SULFATE
100 mg/2ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Other aminoglycosides
Authorised
1976-07-15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AMIKIN INJECTION 100 MG/2ML AMIKACIN (AS AMIKACIN SULFATE) PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - PLEASE KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SIGNS OF ILLNESS ARE THE SAME AS YOURS. IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET What is in this leaflet1. What AMIKIN is and what it is used for 2. What you need to know before you are given AMIKIN 3. How AMIKIN is given 4. Possible side effects 5. How to store your medicine 6. Contents of the pack and other information 1. WHAT AMIKIN IS AND WHAT IT IS USED FOR The name of this medicine is AMIKIN. Each 2mL vial contains 100 mg amikacin sulfate as the active ingredient. Amikacin is an antibiotic and belongs to the group of medicines called aminoglycosides. AMIKIN is used to treat serious infections caused by certain bacteria. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIKIN DO NOT USE AMIKIN IF: • You are allergic (hypersensitive) to any of the ingredients in AMIKIN or other antibiotics. If any of the above affects you, or you are unsure if they do, tell your doctor who will be able to advise you. YOU MUST TELL YOUR DOCTOR IF: • You have any kidney problems • You have any hearing problems or other problems with your ears • You have any muscular disorders such as myasthenia gravis or Parkinson's Disease . AMIKIN is not recommended to be given by injection read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amikin Injection 100 mg/2 ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains amikacin sulfate equivalent to amikacin activity 100 mg (100,000 international units) in 2 mL (50 mg/mL). Excipients with known effect: Each vial contains 3 mg of sodium. Each vial contains 2.64 mg sodium metabisulfite (E223). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of infections due to gram negative organisms sensitive to the anti-infective. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For most infections the intramuscular route is preferred, but in life-threatening infections, or in patients in whom intramuscular injection is not feasible the intravenous route may be used. Intramuscular and intravenous administration At the recommended dosage level, uncomplicated infections due to sensitive organisms should respond to therapy within 24 to 48 hours. If clinical response does not occur within three to five days consideration should be given to alternative therapy. The patient’s pretreatment body weight should be obtained for calculation of correct dosage. The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy. Whenever possible, amikacin concentrations in serum should be measured to assure adequate, but not excessive levels. It is desira read_full_document