FLAGYL TABLET 200 mg

Negara: Singapura

Bahasa: Inggris

Sumber: HSA (Health Sciences Authority)

Beli Sekarang

Selebaran informasi Selebaran informasi (PIL)
22-05-2014
Karakteristik produk Karakteristik produk (SPC)
08-03-2018

Bahan aktif:

METRONIDAZOLE

Tersedia dari:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Kode ATC:

J01XD01

Dosis:

200 mg

Bentuk farmasi:

TABLET, FILM COATED

Komposisi:

METRONIDAZOLE 200 mg

Rute administrasi :

ORAL

Jenis Resep:

Prescription Only

Diproduksi oleh:

Famar Health Care Services Madrid, S.A.U.

Status otorisasi:

ACTIVE

Tanggal Otorisasi:

1988-06-30

Selebaran informasi

                                Flagyl 
®
200mg 
Flagyl 
®
400mg 
         [sanofi 
logo] 
 
_Metronidazole _
Tablets 
1. NAME OF THE MEDICINAL PRODUCT 
Flagyl 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
IN TERMS OF THE ACTIVE INGREDIENT 
Flagyl Tablets 200mg Contain metronidazole BP 200mg 
Flagyl Tablets 400mg Contain metronidazole BP 400mg 
 
3. PHARMACEUTICAL FORM 
Flagyl tablets: 
White to off-white, biconvex, film coated tablets. 
The 200mg tablets are impressed 'FLAGYL 200' on one face, plain
reverse. 
The 400mg tablets are impressed 'FLAGYL 400' on one face, plain
reverse. 
 
4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Flagyl is indicated in the prophylaxis and treatment of infections in
which 
anaerobic bacteria have been identified or are suspected to be the
cause. 
Flagyl 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_, _Entamoeba
histolytica_, _Giardia lamblia_ and 
_Balantidium coli_
. 
_It is indicated in _
1. The prevention of postoperative infections due to anaerobic
bacteria, 
particularly species of bacteroides and anaerobic streptococci. 
2. The treatment of septicaemia, bacteraemia, peritonitis, brain
abscess, 
necrotizing pneumonia, osteomyelitis, puerperal sepsis, pelvic
abscess, pelvic 
cellulitis, and postoperative wound infections from which pathogenic
anaerobes 
have been isolated. 
3. Urogenital trichomoniasis in the female (trichomonal vaginitis)
and in the male. 
4. Bacterial vaginosis (also known as non-specific vaginitis,
anaerobic vaginosis 
or 
Gardnerella vaginitis). 
5. All forms of amoebiasis (intestinal and extra-intestinal disease
and that of 
symptomless cyst passers). 
6. Giardiasis. 
7. Acute ulcerative gingivitis. 
8. Anaerobically-infected leg ulcers and pressure sores. 
9. Acute dental infections (e.g. acute pericoroniti
                                
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Karakteristik produk

                                Flagyl
®
200mg
Flagyl
®
400mg
[sanofi logo]
_Metronidazole _
Tablets
1. NAME OF THE MEDICINAL PRODUCT
Flagyl
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
IN TERMS OF THE ACTIVE INGREDIENT
Flagyl Tablets 200mg Contain metronidazole BP 200mg
Flagyl Tablets 400mg Contain metronidazole BP 400mg
3. PHARMACEUTICAL FORM
Flagyl tablets:
White to off-white, biconvex, film coated tablets.
The 200mg tablets are impressed 'FLAGYL 200' on one face, plain
reverse.
The 400mg tablets are impressed 'FLAGYL 400' on one face, plain
reverse.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flagyl
is
indicated
in
the
prophylaxis
and
treatment
of
infections
in
which
anaerobic bacteria have been identified or are suspected to be the
cause.
Flagyl 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_, _Entamoeba histolytica_,
_Giardia lamblia_ and
_Balantidium coli_.
_It is indicated in _
1.
The
prevention
of
postoperative
infections
due
to
anaerobic
bacteria,
particularly species of bacteroides and anaerobic streptococci.
2.
The
treatment
of
septicaemia,
bacteraemia,
peritonitis,
brain
abscess,
necrotizing pneumonia, osteomyelitis, puerperal sepsis, pelvic
abscess, pelvic
cellulitis, and postoperative wound infections from which pathogenic
anaerobes
have been isolated.
3. Urogenital trichomoniasis in the female (trichomonal vaginitis) and
in the male.
4. Bacterial vaginosis (also known as non-specific vaginitis,
anaerobic vaginosis
or Gardnerella vaginitis).
5. All forms of amoebiasis (intestinal and extra-intestinal disease
and that of
symptomless cyst passers).
6. Giardiasis.
7. Acute ulcerative gingivitis.
8. Anaerobically-infected leg ulcers and pressure sores.
9. Acute dental infections (e.g. acute pericoronitis and acute apical
infections).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral route of administration. All dosages are given in terms of
metron
                                
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