METROGYL 400 metronidazole 400mg tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

metronidazole, Quantity: 400 mg

Tilgjengelig fra:

Alphapharm Pty Ltd

Legemiddelform:

Tablet, uncoated

Sammensetning:

Excipient Ingredients: quinoline yellow aluminium lake; lactose monohydrate; magnesium stearate; disodium edetate; sodium starch glycollate; Guar Gum; colloidal anhydrous silica; ethylcellulose

Administreringsrute:

Oral

Enheter i pakken:

21

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Metronidazole is indicated in the oral treatment of: 1. Urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male. The male consort of females suffering from urogenital trichomoniasis should be treated concurrently. 2. Bacterial vaginosis. 3. All forms of amoebiasis (intestinal and extra-intestinal disease). 4. Giardiasis. 5. Acute ulcerative gingivitis. 6. Anaerobic infections including: septicaemia, bacteraemia, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and postoperative wound infections, in which the pathogens have been identified as Bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. Metronidazole may be used prophylactically to prevent infection by anaerobic organisms of the surgical site following appendicectomy, colonic surgery, vaginal hysterectomy, abdominal surgery in the presence of anaerobes in the peritoneal cavity and s

Produkt oppsummering:

Visual Identification: 12.5 mm, normal convex, pale yellow tablet debossed MZ/400 on one side and G on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

1991-09-20

Informasjon til brukeren

METROGYL
®
M
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O
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING METROGYL?
METROGYL contains the active ingredient metronidazole. METROGYL is
used to used to treat certain infections caused by bacteria
and other organisms in different parts of the body. It is also used to
prevent or treat certain infections that may occur during surgery.
For more information, see Section 1. Why am I using METROGYL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METROGYL?
Do not use if you have ever had an allergic reaction to METROGYL or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
METROGYL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with METROGYL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE METROGYL?
Follow the instructions provided and use METROGYL until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use METROGYL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METROGYL?
THINGS YOU
SHOULD DO
•
Tell your doctor straight away if the symptoms of your infection do
not improve or become worse, if you
become pregnant or if you are about to start taking any new medicines.
•
Stop taking this medicine and tell your doctor straight away if you
have irrational thoughts, hallucinations,
feeling confused or feeling depressed, including thoughts of self-harm
or suicide.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking METROGYL if you feel better. If you do not complete
the full course prescribed by
your doctor, all of the bacteria/organisms causing your infection may
not be kille

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
METROGYL
®
_Metronidazole _
1
NAME OF THE MEDICINE
Metronidazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each METROGYL 200 and METROGYL 400 contains the active ingredient
metronidazole 200 mg and
metronidazole 400 mg respectively.
Excipients with known effect: sulfites, galactose and sugars as
lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
METROGYL 200 (Metronidazole) 200 mg: 11 mm white normal convex tablet
marked MZ/200 on one side, G
on the reverse.
METROGYL 400 (Metronidazole) 400 mg: 12.5 mm yellow normal convex
tablet marked MZ/400 on one side,
G on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole is indicated in the oral treatment of:
1.
Urogenital trichomoniasis in the female (trichomonal vaginitis) and in
the male. The male consort of
females suffering from urogenital trichomoniasis should be treated
concurrently.
2.
Bacterial vaginosis.
3.
All forms of amoebiasis (intestinal and extra-intestinal disease).
4.
Giardiasis.
5.
Acute ulcerative gingivitis.
6.
Anaerobic
infections
including:
septicaemia,
bacteraemia,
brain
abscess,
necrotising
pneumonia,
osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and
postoperative wound infections, in
which the pathogens have been identified as Bacteroides fragilis and
other species of bacteroides, and
other species such as fusobacteria, eubacteria, clostridia and
anaerobic streptococci.
Metronidazole may be used prophylactically to prevent infection by
anaerobic organisms of the surgical site
following appendicectomy, colonic surgery, vaginal hysterectomy,
abdominal surgery in the presence of
anaerobes in the peritoneal cavity and surgery performed in the
presence of anaerobic septicaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Summarised in
TABLE 1
below.
A maximum of 4 g should not be exceeded during 24 hour period.
METROGYL
®
– PRODUCT INFORMATION
2
2
ORAL
The tablets should be swallowed, without chewing, with half a glass of
water. Tre