Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Praziquantel 600mg
Bayer New Zealand Limited
Praziquantel 600 mg
600 mg
Film coated tablet
Active: Praziquantel 600mg Excipient: Hypromellose Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified water Sodium laurilsulfate Titanium dioxide
Bottle, glass, Type II with PE cap, 8 tablets
Prescription
Prescription
Merck KGaA
Treatment of schistosoma infections due to various types of blood fluke (e.g. Schistosoma haematobium, S. japonicum, S. mekongi or S mansoni).
Package - Contents - Shelf Life: Bottle, glass, - brown, Type II with PE cap - 8 tablets - 48 months from date of manufacture stored at or below 25°C
2011-06-08
BILTRICIDE® CMI VX2.0 1 BILTRICIDE® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING BILTRICIDE? BILTRICIDE contains the active ingredient praziquantel. BILTRICIDE is used for the treatment of schistosomiasis or bilharziasis, which is a chronic parasitic infestation in humans caused by blood flukes (worms). For more information, see Section 1. Why am I using BILTRICIDE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE BILTRICIDE? Do not use if you have ever had an allergic reaction to BILTRICIDE or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use BILTRICIDE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with BILTRICIDE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE BILTRICIDE? • You must take all the BILTRICIDE tablets prescribed by your doctor or pharmacist to kill the type of blood fluke you have. Your doctor will prescribe a dose specifically for you. It is important to take all the tablets your doctor prescribed. • Swallow the tablets with a full glass of water. More instructions can be found in Section 4. How do I use BILTRICIDE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING BILTRICIDE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using BILTRICIDE. • If you are on corticosteroid therapy or if you are about to start taking any new medicine, especially medicines used to treat tuberculosis, leprosy, epilepsy, malaria, stomach acidity, reflux or ulcers, tell your doctor or pharmacist that you are taking BILTRICIDE. THINGS YOU SHOULD NOT DO • Do not stop using t Olvassa el a teljes dokumentumot
BILTRICIDE DS VX2.0, CCDS 08 Page 1 of 8 DATA SHEET 1. BILTRICIDE ® (600 MG FILM COATED TABLET) Biltricide, 600 mg film coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg praziquantel. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM The film-coated tablets are white to pale yellow lacquer-coated oblong shaped tablets with three scores with “Bayer” on one side and "LG" on the reverse. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of schistosoma infections due to various types of blood fluke (eg _Schistosoma _ _haematobium, S.japonicum, S.mekongi, S.mansoni_). 4.2 DOSE AND METHOD OF ADMINISTRATION The doctor must prescribe individual doses for individual cases, according to the diagnosis. _Schistosoma haematobium_ 20 mg/kg body weight _Schistosoma mansoni_ three times a day _Schistosoma japonicum_ at four hourly intervals Schistosoma mekongi for one day. The tablet has 3 score marks, each fragment contains 150 mg active substance, thus allowing a precise dose to be given, corresponding to the patient’s body weight. If 1/4 of a tablet is required, it is convenient to begin by breaking the tablet at one of the outer grooves. The simplest way to break the tablet is to place the thumbnail in the groove. BILTRICIDE DS VX2.0, CCDS 08 Page 2 of 8 TABLE 1: CONVERSION TABLE BODY WEIGHT IN KG 20-25 26-33 34-41 42-48 49-56 57-63 64-70 71-78 79-86 No. of tablets corresponding to 1 x 20 mg/kg ¾ 1 1¼ 1½ 1¾ 2 2¼ 2½ 2¾ Biltricide should be swallowed whole with a little liquid, preferably after meals. 4.2.1 PAEDIATRIC POPULATION See Section 4.4. 4.2.2 HEPATIC IMPAIRMENT See Section 4.4. 4.2.3 RENAL IMPAIRMENT See Section 4.4. 4.3 CONTRAINDICATIONS Known hypersensitivity to praziquantel or any of the excipients. Ocular cysticercosis - parasite destruction within the eye may cause irreparable damage. The concomitant administration of strong inducers of Cytochrome P 450 such as rifampicin must be avoided as therapeutically effective pla Olvassa el a teljes dokumentumot