Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VORICONAZOL 40 mg/ml
Pfizer B.V. Rivium Westlaan 142 2909 LD CAPELLE A/D IJSSEL
J02AC03
VORICONAZOL 40 mg/ml
Poeder voor orale suspensie
CITROENZUUR 0-WATER (E 330) ; MALTODEXTRINE ; NATRIUMBENZOAAT (E 211) ; NATUURLIJK SINAASAPPELSMAAKSTOF 57.458/AP 05.51 Firmenich ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMCITRAAT 2-WATER (E 331) ; XANTHAANGOM (E 415),
Oraal gebruik
Voriconazole
Hulpstoffen: CITROENZUUR 0-WATER (E 330); MALTODEXTRINE; NATRIUMBENZOAAT (E 211); NATUURLIJK SINAASAPPELSMAAKSTOF 57.458/AP 05.51 Firmenich; SACCHAROSE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRINATRIUMCITRAAT 2-WATER (E 331); XANTHAANGOM (E 415);
1900-01-01
VORI PF 2627 EN PIL 40 POS 025 EN track 05Oct2023 1/11 PACKAGE LEAFLET: INFORMATION FOR THE USER VORICONAZOL PFIZER 40 MG/ML POEDER VOOR ORALE SUSPENSIE. voriconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Voriconazole Pfizer is and what it is used for 2. What you need to know before you take Voriconazole Pfizer 3. How to take Voriconazole Pfizer 4. Possible side effects 5. How to store Voriconazole Pfizer 6 Content of the pack and other information 1. WHAT VORICONAZOLE PFIZER IS AND WHAT IT IS USED FOR Voriconazole Pfizer contains the active substance voriconazole. Voriconazole Pfizer is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections. It is used for the treatment of patients (adults and children over the age of 2) with: • invasive aspergillosis (a type of fungal infection due to _Aspergillus sp_ ), • candidaemia (another type of fungal infection due to _Candida sp_ ) in non-neutropenic patients (patients without abnormally low white blood cells count), • serious invasive _Candida sp._ infections when the fungus is resistant to fluconazole (another antifungal medicine), • serious fungal infections caused by _Scedosporium sp._ or _Fusarium sp_ . (two different species of fungi). Voriconazole Pfizer is intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients. This product should only be taken under th Lees het volledige document
VORI PF 2627 EN SmPC 40 POS 025 EN track 05Oct2023 1/35 1. NAME OF THE MEDICINAL PRODUCT Voriconazol Pfizer 40 mg/ml poeder voor orale suspensie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water. Each bottle contains 3 g of voriconazole. Excipients with known effect Each ml of suspension contains 0.54 g sucrose. Each ml of suspension contains 2.40 mg sodium benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension White to off-white powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Voriconazole Pfizer, is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: Treatment of invasive aspergillosis. Treatment of candidaemia in non-neutropenic patients. Treatment of fluconazole-resistant serious invasive _Candida_ infections (including _C. krusei_ ). Treatment of serious fungal infections caused by _Scedosporium_ spp. and _Fusarium_ spp. Voriconazole Pfizer should be administered primarily to patients with progressive, possibly life- threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Electrolyte disturbances such as hypokalaemia, hypomagnesaemia and hypocalcaemia should be monitored and corrected, if necessary, prior to initiation and during voriconazole therapy (see section 4.4). VORI PF 2627 EN SmPC 40 POS 025 EN track 05Oct2023 2/35 Voriconazole Pfizer is also available as 50 mg and 200 mg film-coated tablets and 200 mg powder for solution for infusion. Treatment _ _ _Adults _ Therapy must be initiated with the specified loading dose regimen of either intravenous or oral Voriconazole Pfizer to achieve plasma concentrations on Day 1 that are close to steady state. On the basis of the high oral bioavailability (96%; see section 5.2), switching between intravenous and oral Lees het volledige document