Metroniz 200 Oral tablet 200 mg

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Metronidazole

제공처:

Neomedic Limited, UNITED KINGDOM

ATC 코드:

Anti-protozoals: nitroimidazole derivatives

INN (국제 이름):

Metronidazole

복용량:

200 mg

약제 형태:

Oral tablet

Manufactured by:

Globela Pharma Pvt. Limited, INDIA

제품 요약:

Physical description: METRONIZ 200, Metronidazole Tablet BP 200 mg available as a Pink colored film coated round biconvex tablets; Local technical representative: Salama Pharmaceuticals Limited (9410)

승인 상태:

Registered/Compliant

승인 날짜:

2022-07-19

제품 특성 요약

1.
NAME OF THE MEDICINAL PRODUCT
1.1
PRODUCT NAME
BRAND NAME: METRONIZ 200
GENERIC NAME: Metronidazole Tablet BP 200 mg
1.2
DOSAGE STRENGTH
Each Film Coated Tablet Contains
Metronidazole BP.............200 mg
Excipients................................q.s.
Color: Ponceau 4 R
1.3
DOSAGE FORM
Oral solid dosage form (Film Coated Tablet)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Metronidazole 200 mg and excipients
Sodium Methyl Paraben as preservatives and Ponceau 4R as colorant
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
METRONIZ 200, Metronidazole Tablet BP 200 mg available as a Pink
colored film coated
round biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole Tablets 200mg is indicated in the prophylaxis and
treatment of infections in
which anaerobic bacteria have been identified or are suspected to be
the cause.
Metronidazole
Tablets
200mg
is
active
against
a
wide
range
of
pathogenic
micro-
organisms, notably species of _Bacteroides, Fusobacteria, Clostridia,
Eubacteria, _anaerobic
cocci and _Gardnerella vaginalis._
It
is
also
active
against
_Trichomonas _
_vaginalis _
and
other
species
of
trichomonads, _Entamoeba histolytica_, _Giardia lamblia_, _Balantidium
coli _and the causative
organisms of acute ulcerative gingivitis.
Metronidazole Tablets 200mg is indicated in the oral treatment of:
The prevention of post-operative infections due to anaerobic bacteria,
particularly species
of _Bacteroides _and anaerobic streptococci.
The
treatment
of
septicaemia,
bacteraemia,
peritonitis,
brain
abscess,
necrotising
pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic
cellulitis and post-
operative wound infections from which pathogenic anaerobes have been
isolated.
Urogenital trichomoniasis in the female (trichomonal vaginitis) and in
the male. The male
consort of females suffering from urogenital trichomoniasis should be
treated concurrently.
Bacterial vaginosis (also known as non-specific vaginitis, anaerobic
vagin