国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
amikacin
Hospira Australia Pty Ltd
Amikacin
Registered
HOSPIRA™ AMIKACIN INJECTION _ _ _ _ Amikacin _(am-I-KAY-sin)_ CONSUMER MEDICINE INFORMATION _Date of Dispensing _ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Hospira™ Amikacin Injection. 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 being given Hospira™ Amikacin Injection against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT HOSPIRA™ AMIKACIN INJECTION IS USED FOR Amikacin is an antibiotic that belongs to a group of medicines called aminoglycosides (pronounced a-my-noe- GLY-koe-sides). It is used to treat serious bacterial infections. Amikacin works by killing bacteria or preventing their growth. Your doctor may have prescribed amikacin for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMIKACIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN HOSPIRA™ AMIKACIN INJECTION _ _ _WHEN YOU MUST NOT BE _ _GIVEN IT _ You must not be given Hospira™ Amikacin Injection if you have an allergy to amikacin or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN HOSPIRA™ AMIKACIN INJECTION IF YOU HAVE EXPERIENCED SERIOUS REACTIONS (SUCH AS HEARING LOSS OR KIDNEY PROBLEMS) TO AMIKACIN, GENTAMICIN, TOBRAMYCIN, OR NEOMYCIN IN THE PAST. YOU MUST NOT BE GIVEN HOSPIRA™ AMIKACIN INJECTION IF YOU HAVE MYASTHENIA GRAVIS, A CONDITION IN WHICH THE MUSCLES BECOME WEAK AND TIRE EASILY. YOU MUST 完全なドキュメントを読む
Product Information - Australia Version 1.0 Page 1 HOSPIRA™ AMIKACIN INJECTION NAME OF THE MEDICINE Amikacin sulfate The structural formula is shown below. Molecular formula: C 22 H 43 N 5 O 13. 2H 2 SO 4 Molecular weight: 781.8 CAS Registry No: 39831-55-5 DESCRIPTION Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. It is described chemically as 6- _O_ -(3-Amino-3-deoxy-α-D-glucopyranosyl)-4- _O_ -(6-amino-6- deoxy-α-D-glucopyranosyl)-1- _N_ -[(2 _S_ )-4-amino-2-hydroxybutanoyl]-2-deoxy-D-streptamine sulfate. Amikacin sulfate is a white crystalline powder. It is freely soluble in water and practically insoluble in alcohol and acetone. 1.3 g of amikacin sulfate is approximately equivalent to 1 g of amikacin. Hospira™ Amikacin Injection is a sterile clear, colourless solution of amikacin sulfate, sodium citrate and sodium metabisulfite in water for injections. Each mL contains amikacin sulfate equivalent to amikacin activity 250 mg (250,000 IU). Hospira™ Amikacin Injection is available in 500 mg/2 mL strength. No antimicrobial preservative is added to the formulation. This product is for single use in one patient only. Discard any residue. Product Information - Australia Version 1.0 Page 2 PHARMACOLOGY MICROBIOLOGY Amikacin is active, _in vitro_ , against the following organisms: Gram-negative MIC microgram/mL _Pseudomonas species_ 1.6 - 12.5 _Proteus species (indole-positive and indole negative)_ 1.6 - 3.1 _Klebsiella pneumoniae_ 1.6 - 3.1 _Enterobacter cloacae_ 1.6 - 3.1 _Serratia species_ 0.8 - 3.1 _Acinetobacter_ no information available _Providencia stuartii_ 3.1 _Citrobacter freundii_ 1 - 8 _Escherichia coli_ 1.6 - 3.1 Gram-positive _Staphylococcus species_ 0.4 - 5.0 (penicillinase and nonpenicillinase producing, including methicillin resistant strains) Amikacin’s structure has been altered to reduce the possible route of enzymatic deactivation, thus reducing bacterial resistance. Many strains of Gram-negative organisms resistant to gentamicin and tobramycin have shown t 完全なドキュメントを読む