Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Anidulafungin
Fresenius Kabi Deutschland GmbH
J02AX; J02AX06
Anidulafungin
100 milligram(s)
Powder for concentrate for solution for infusion
Other antimycotics for systemic use; anidulafungin
Not marketed
2020-07-24
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or pharmacist or nurse. - If you or your child get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Anidulafungin is and what it is used for 2. What you need to know before you or your child are given Anidulafungin 3. How Anidulafungin is given 4. Possible side effects 5. How to store Anidulafungin 6. Contents of the pack and other information 1. WHAT ANIDULAFUNGIN IS AND WHAT IT IS USED FOR This medicine contains the active substance anidulafungin and is prescribed in adults and in paediatric patients aged 1 month to less than 18 years to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by fungal cells (yeasts) called Candida . Anidulafungin belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections. Anidulafungin prevents normal development of fungal cell walls. In the presence of Anidulafungin , fungal cells have incomplete or defective cell walls, making them fragile or unable to grow. 2. WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE GIVEN ANIDULAFUNGIN YOU MUST NOT BE GIVEN ANIDULAFUNGIN - if you are allergic to anidulafungin, other echinocandins (e.g.caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before being given Anidulafungin . Your doctor may decide to monitor you: - for liver function more closely if you develop liver problems during your treatment; - for signs of an allergic reaction such as itching, wheezing, blotchy skin, - if you are given anaesthetics during your treatment with Anidulafungi Прочитать полный документ
Health⋅Products⋅Regulatory⋅Authority 04⋅August⋅2021 CRN00C58J Page⋅1⋅of⋅12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anidulafungin⋅Fresenius⋅Kabi⋅100⋅mg⋅powder⋅for⋅concentrate⋅for⋅solution⋅for⋅infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each⋅vial⋅contains⋅100⋅mg⋅anidulafungin. The⋅reconstituted⋅solution⋅contains⋅3.33⋅mg/mL⋅anidulafungin⋅and⋅the⋅diluted⋅solution⋅contains⋅0.77⋅mg/mL⋅anidulafungin. Excipient with known effect:⋅Fructose⋅100⋅mg⋅per⋅vial For⋅the⋅full⋅list⋅of⋅excipients,⋅see⋅section⋅6.1. 3 PHARMACEUTICAL FORM Powder⋅for⋅concentrate⋅for⋅solution⋅for⋅infusion. White⋅to⋅off-white⋅powder. The⋅reconstituted⋅solution⋅has⋅a⋅pH⋅of⋅3.5⋅to⋅5.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment⋅of⋅invasive⋅candidiasis⋅in⋅adults⋅and⋅paediatric⋅patients⋅aged⋅1⋅month⋅to⋅<⋅18⋅years⋅(see⋅sections⋅4.4⋅and⋅5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment⋅with⋅Anidulafungin⋅Fresenius⋅Kabi⋅should⋅be⋅initiated⋅by⋅a⋅physician⋅experienced⋅in⋅the⋅management⋅of⋅invasive⋅ fungal⋅infections. Posology Specimens⋅for⋅fungal⋅culture⋅should⋅be⋅obtained⋅prior⋅to⋅therapy.⋅Therapy⋅may⋅be⋅initiated⋅before⋅culture⋅results⋅are⋅known⋅ and⋅can⋅be⋅adjusted⋅accordingly⋅once⋅they⋅are⋅available. _Adult population (dosing and treatment duration)_ A⋅single⋅200⋅mg⋅loading⋅dose⋅should⋅be⋅administered⋅on⋅Day⋅1,⋅followed⋅by⋅100⋅mg⋅daily⋅thereafter.⋅Duration⋅of⋅treatment⋅ should⋅be⋅based⋅on⋅the⋅patient's⋅clinical⋅response. In⋅general,⋅antifungal⋅therapy⋅should⋅continue⋅for⋅at⋅least⋅14⋅days⋅after⋅the⋅last⋅positive⋅culture. There⋅are⋅insufficient⋅data⋅to⋅support⋅the⋅100⋅mg⋅dose⋅for⋅longer⋅than⋅35⋅days⋅of⋅treatment. _ _ _Pati Прочитать полный документ