Metronidazole Nycomed tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

metronidazole

Disponibil de la:

Takeda Pharma A/S

Codul ATC:

P01AB01

INN (nume internaţional):

metronidazole

Dozare:

500mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(20) in glass container

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-05-29

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
FOR METRONIDAZOLE NYCOMED FILM-COATED TABLETS 500MG
1.
NAME OF THE PRODUCT
Metronidazole Nycomed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
Active substance
Metronidazole 500 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White oval film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Inflammatory infections caused by microorganisms susceptible to
metronidazole: Protozoal
infections: extraintestinal amebiasis, including amebic liver abscess,
intestinal amebiasis (amebic
dysentery), trichomoniasis.
Infections caused by Bacteroides spp. (including B. fragilis, B.
distasonis, B. ovatus, B.
thetaiotaomicron, B. vulgates), bone and joint infections, infections
of the central nervous system
(CNS), including meningitis, brain abscess, infective endocarditis,
pneumonia, empyema and
pulmonary abscess, sepsis.
Infections caused by Clostridium spp., Peptococcus niger,
Peptostreptococcus spp.: intraabdominal
infections (peritonitis, liver abscess), pelvic infections
(endometritis, tubo-ovarian abscess, vaginal
vault infection).
Antibiotic-associated pseudomembranous colitis.
Gastritis or duodenal ulcer associated with Helicobacter pylori (as
combination therapy).
Crohn's disease.
Prevention of postoperative complications (especially interventions on
colon, pararectal surgery,
appendectomy, gynecological surgery).
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Metronidazole should be used orally, before or after the meal. The
drug product should be taken
with sufficient amount of water.
In intestinal amebiasis Metronidazole Nycomed is used for 7 days 1500
mg per day divided into
three doses. In acute amebic dysentery the daily dose for adults is
1500 - 3000 mg divided into
three doses. For children 6 - 15 years old the daily dose is 35 - 50
mg/kg divided into 2-3 doses.
In liver abscess and other extraintestinal forms of amebiasis the
maximum daily exposure is 1500 -
3000 mg divided into 3 d