দেশ: নেদারল্যান্ডস
ভাষা: ডাচ
সূত্র: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ANIDULAFUNGINE 0-WATER, FRUCTOSE VRIJ
Sigillata Limited Block A, 15 Castleforbes Square, Sheriff Street DUBLIN 1 (IERLAND)
J02AX06
ANIDULAFUNGINE 0-WATER, FRUCTOSE FREE
Poeder voor concentraat voor oplossing voor infusie
NATRIUMHYDROXIDE (E 524) ; POLYSORBAAT 80 (E 433) ; SACCHAROSE ; WIJNSTEENZUUR, (L (+) Vorm) (E 334) ; ZOUTZUUR (E 507),
Intraveneus gebruik
Anidulafungin
Hulpstoffen: NATRIUMHYDROXIDE (E 524); POLYSORBAAT 80 (E 433); SACCHAROSE; WIJNSTEENZUUR, (L (+) Vorm) (E 334); ZOUTZUUR (E 507);
2018-05-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ORRAKRUTT 100 MG, POEDER VOOR CONCENTRAAT VOOR OPLOSSING VOOR INTRAVENEUZE INFUSIE Anidulafungin 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, pharmacist or nurse. - If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Orrakrutt is and what it is used for 2. What you need to know before you or your child use Orrakrutt 3. How to use Orrakrutt 4. Possible side effects 5. How to store Orrakrutt 6. Contents of the pack and other information 1. WHAT ORRAKRUTT IS AND WHAT IT IS USED FOR Orrakrutt 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_ . Orrakrutt belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections. Orrakrutt prevents normal development of fungal cell walls. In the presence of Orrakrutt, 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 USE ORRAKRUTT DO NOT USE ORRAKRUTT: - 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 using Orrakrutt. Your doctor may decide to monitor you - for liver function more closely if you develop liver problems during your treatment. - if you are given anaesthetics during your treatment with Orrakrutt. - for signs of an al সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT Orrakrutt 100 mg, poeder voor concentraat voor oplossing voor intraveneuze infusie 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. 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, free of visible evidence of contamination 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 Orrakrutt 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. _Patients with renal and hepatic impairment_ No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Orrakrutt can be given without regard to the timing of haemodialysis (see section 5.2). _Other special populations_ No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2). _ _ _ _ _Paediatric p সম্পূর্ণ নথি পড়ুন