Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Micafungin 50mg
Seqirus (NZ) Ltd
Micafungin 50 mg
50 mg
Powder for injection
Active: Micafungin 50mg Excipient: Citric acid Lactose Nitrogen Sodium hydroxide
Prescription
Astellas Pharma Tech Co Limited
Treatment of invasive candidiasis in children & adults Treatment of oesophageal candidiasis in adults, adolescents NLT 16 yrs of age, and elderly patients for whom intravenous therapy is appropriate Prophylaxis of Candida infection in children and adult patients undergoing allogenic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count below 500 cells per microliter) for 10 or more days
Package - Contents - Shelf Life: Vial, glass, 1 x - 50 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light - Vial, glass, 10 x - 500 mg - 3 years from date of manufacture stored at or below 25°C 48 hours reconstituted stored at or below 25°C 96 hours diluted stored at or below 25°C protect from light
2013-11-14
Mycamine MYCAMINE _ _ _Micafungin (as sodium)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Mycamine. 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 having Mycamine against the benefits they expect it will 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 MYCAMINE IS USED FOR This medicine is used to treat: _ _ • adults, adolescents and children who have a serious fungal infection called invasive candidiasis (an infection caused by a yeast called _Candida_ that has penetrated the body) • adults and adolescents ≥ 16 years of age who have a fungal infection in the food pipe (oesophagus) where treatment into a vein is appropriate • adults, adolescents and children who are at risk of developing a _Candida_ (yeast) infection while undergoing a certain type of stem cell transplant or if you are expected to have white blood cell counts below a certain level. This medicine belongs to a group of medicines called echinocandins which are used to treat infections caused by fungal or yeast cells called Candida. It works by interfering with the production of a part of the fungal cell wall making the fungus unable to live and grow. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason . BEFORE YOU ARE GIVEN MYCAMINE _WHEN YOU MUST NOT HAVE IT _ DO NOT HAVE MYCAMINE IF YOU HAVE AN ALLERGY TO: • any medicine containing micafungin • any of the ingredients listed at the end of this leaflet • any other medicines belonging to the echinocandin group. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or ot Read the complete document
1 DATA SHEET MYCAMINE ® 50 MG AND 100 MG POWDER FOR INJECTION 1. NAME OF THE MEDICINE MYCAMINE ® 50 mg powder for injection MYCAMINE ® 100 mg powder for injection _Active ingredient: _ micafungin (as sodium) _Chemical structure: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Chemical name: _ Sodium 5-[(1 _S_ ,2 _S_ )-2-[(3 _S_ ,6 _S_ ,9 _S_ ,11 _R_ ,15 _S_ ,18 _S_ ,20 _R_ ,21 _R_ ,24 _S_ ,25 _S_ ,26 _S_ )-3- [( _R_ )-2-carbamoyl-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[( _R_ )-1- hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[4-[5-(4-pentyloxyphenyl)- isoxazol-3-yl]benzoylamino]-1,4,7,13,16,22-hexaazatricyclo-[22.3.0.0 9,13 ]heptacos-6-yl]-1,2- dihydroxyethyl]-2-hydroxyphenyl sulfate. _ _ _Molecular formula: _ C 56 H 70 N 9 NaO 23 S _CAS registry number: _ 208538-73-2 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MYCAMINE is a sterile, white, powder for injection containing the active ingredient micafungin as the sodium salt. Micafungin sodium is a light sensitive, hygroscopic, amorphous, white powder that is freely soluble in water, isotonic sodium chloride solution, _N,N_ - dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and _n_ -hexane. H N O O O NH O N N O NH HN O CH 3 OH SO 3 Na O OH NH H OH H HO H H 2 N O OH H H H OH H H OH HO H 3 C H N O O H 3 C O HO H H H H H H 2 MYCAMINE must be diluted with either sodium chloride 0.9% or glucose 5% solution prior to use (see DOSAGE AND ADMINISTRATION). 3. PHARMACEUTICAL FORM MYCAMINE 50 mg is a white-coloured powder for injection, containing 50.86 mg micafungin sodium, corresponding to 50 mg micafungin. MYCAMINE 100 mg is a white-coloured powder for injection, containing 101.73 mg micafungin sodium, corresponding to 100 mg micafungin. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION MYCAMINE is indicated for: Treatment of invasive candidiasis in children and adults Treatment of oesophageal candidiasis in adults, adolescents ≥ 16 years Read the complete document