Mebendazole tablets

Valsts: Armēnija

Valoda: angļu

Klimata pārmaiņas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktīvā sastāvdaļa:

mebendazole

Pieejams no:

Arpimed LLC

ATĶ kods:

P02CA01

SNN (starptautisko nepatentēto nosaukumu):

mebendazole

Deva:

100mg

Zāļu forma:

tablets

Vienības iepakojumā:

(10/1x10/) in blister

Receptes veids:

Prescription

Autorizācija statuss:

Registered

Autorizācija datums:

2018-08-07

Produkta apraksts

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