Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
mebendazole
Arpimed LLC
P02CA01
mebendazole
100mg
tablets
(10/1x10/) in blister
Prescription
Registered
2023-11-25
SUMMARY PRODUCT CHARACTERISTIC (SPC) MEBENDAZOLE TABLETS 1. NAME OF THE MEDICINAL PRODUCT 1.1 TRADE NAME – Mebendazole 1.2 INTERNATIONAL NON-PROPERTY NAME – Mebendazole 2. CUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE INGREDIENT:_ Mebendazole Each 100 mg tablet contains 100 mg mebendazole. Each 500 mg tablet contains 500 mg mebendazole. _For a full list of excipients, see section 6.1._ _ _ 3. PHARMACEUTICAL FORM MEBENDAZOLE 100 MG TABLETS are white or almost white, round, biconvex and scored in half on one side. MEBENDAZOLE 500 MG TABLETS are white with a yellowish tint, round, flat and with bevel edge of two sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _MEBENDAZOLE 100 MG TABLETS_:_ _ For the treatment of patients 2 years of age and older of _ Trichuris trichuria _ (whipworm), _Enterobius _ _vermicularis _ (pinworm or threadworm), _Ascaris _ _lumbricoides _ (roundworm), _Ancylostoma duodenale _ (common hookworm), _ Necator americanus _ (American hookworm) in_ _single or mixed gastrointestinal infestations._ _ There is no evidence that Mebendazole 100 mg tablets are effective in the treatment of cysticercosis. _MEBENDAZOLE 500 MG TABLETS: _ Mebendazole is an anthelmintic indicated for the treatment of patients 2 years of age and older with gastrointestinal infections caused by: _Ascaris lumbricoides _(roundworm) _Trichuris trichiura _(whipworm) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _MEBENDAZOLE 100 MG TABLETS_:_ _ Adults and children over 2 years: For the control of trichuriasis, ascariasis and hookworm infections, one Mebendazole 100 mg tablet twice a day for three consecutive days. For the control of enterobiasis a single tablet is administered. It is highly recommended that a second tablet is taken after two weeks, if reinfection is suspected. Tablets may be chewed or swallowed whole. Crush the tablet before giving it to a young child. Always supervise a child while they are taking this medicine. _MEBENDAZOLE 500 MG TABLETS: _ The recommended dosage in patients 2 years of age a Baca dokumen lengkap