Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
IVERMECTINE 3 mg/stuk
Galenicum Derma, S.L. CTRA N-1, Km 36 28750 SAN AGUSTÍN DEL GUADALIX (SPANJE)
IVERMECTINE 3 mg/stuk
Tablet
BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD, BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD
Oraal gebruik
2020-11-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IVERGALEN 3 MG, TABLETTEN Ivermectin 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ivergalen is and what it is used for 2. What you need to know before you take Ivergalen 3. How to take Ivergalen 4. Possible side effects 5. How to store Ivergalen 6. Contents of the pack and other information 1. WHAT IVERGALEN IS AND WHAT IT IS USED FOR Ivergalen contains a medicine called ivermectin. This is a type of medicine which is used for infections caused by some parasites. It is used to treat: • an infection in your gut called intestinal strongyloidiasis (anguillulosis). This is caused by a type of round worm called _“_Strongyloides stercoralis”. • an infection of your blood called microfilaraemia due to “lymphatic filariasis”. This is caused by an immature worm called “Wuchereria bancrofti”. Ivergalen does not work against adult worms, only against immature worms. • skin mites (scabies). This is when tiny mites burrow under your skin. This can cause severe itching. Ivergalen should only be taken when your doctor has proven or thinks you have scabies. IVERGALEN WILL NOT STOP YOU FROM GETTING ONE OF THESE INFECTIONS. It does not work against adult worms. Ivergalen should only be taken when your doctor has proven or thinks you have a parasite infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IVERGALEN DO NOT TAKE IVERGALEN - If you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). Sign Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ivergalen 3 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains 3 mg of ivermectin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. The tablets are round, white or almost white, flat chamfered with a diameter of 5.5 mm and thickness of 2.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of gastrointestinal strongyloidiasis (anguillulosis). • Treatment of suspected or diagnosed microfilaraemia in patients with lymphatic filariasis due to _Wuchereria bancrofti_. • Treatment of human sarcoptic scabies. Treatment is justified when the diagnosis of scabies has been established clinically and/or by parasitological examination. Without formal diagnosis treatment is not justified in case of pruritus. Official guidelines should be taken into consideration. Official guidelines will normally include WHO and public health authorities’ guidelines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment of gastrointestinal strongyloidiasis The recommended dosage is one single oral dose of 200 micrograms of ivermectin per kg body weight. For guidance, the dose, as determined by the patient’s weight, is as follows: BODY WEIGHT (KG) DOSE (NUMBER OF 3 MG TABLETS) 15 to 24 one 25 to 35 two 36 to 50 three 51 to 65 four 66 to 79 five ≥ 80 six Treatment of microfilaraemia caused by _Wuchereria bancrofti _ The recommended dosage for mass distribution for the treatment of microfilaraemia caused by _Wuchereria bancrofti _is a single oral dose once every 6 months designed to provide approximately 150 to 200 μg/kg of body weight._ _ 2 In endemic areas where treatment can only be administered once every 12 months, the recommended dosage is 300 to 400 μg/kg of body weight to maintain adequate suppression of microfilaraemia in treated patients. For guidance, the dose, as determined by the patient’s weight, is as follows: BODY WEIGHT (KG) DOSE WHEN GIVEN ONCE EVERY 6 MONTHS (NUM Lees het volledige document