METRONIDE 400 metronidazole 400 mg tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

metronidazole, Quantity: 400 mg

Διαθέσιμο από:

Sanofi-Aventis Australia Pty Ltd

INN (Διεθνής Όνομα):

Metronidazole

Φαρμακοτεχνική μορφή:

Tablet, uncoated

Σύνθεση:

Excipient Ingredients: magnesium stearate; povidone; hypromellose; calcium hydrogen phosphate; maize starch; purified talc; macrogol 400

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

5 x 400mg tablets, 21 x 400mg tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Anaerobic Infections: Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. Metronide has been used successfully in septicaemia; bacteraemia; brain abscess; necrotising pneumonia; osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis; postoperative wound infections. Note: Metronidazole is inactive against aerobic and facultative anaerobic bacteria. Other Indications: Oral treatment of urogenital trichomoniasis in the female (trichomonal vaginitis) and in the male, and for the treatment of bacterial vaginosis. The male consort of females suffering from urogenital trichomoniasis should be treated concurrently; all forms of amoebiasis (intestinal and extraintestinal disease and that of symptomless cyst passers); giardiasis; acute ulcerative gingivitis.

Περίληψη προϊόντος:

Visual Identification: Round, white to off-white biconvex tablet, one side impressed with 'MTZ400' and breakline on reverse; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2009-06-22

Φύλλο οδηγιών χρήσης

METRONIDE
® 200 AND METRONIDE
® 400
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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 METRONIDE?
Metronide contains the active ingredient metronidazole. Metronide is
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 Metronide? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METRONIDE?
Do not use if you have ever had an allergic reaction to Metronide 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
Metronide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metronide 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 METRONIDE?
Follow the instructions provided and use Metronide until your doctor
tells you to stop.
More instructions can be found in Section 4. How do I use Metronide?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METRONIDE?
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 your tablets if you feel better. If you do not
complete the full course prescribed by your
doctor, all of the bacteria/organisms cau

Αρχείο Π.Χ.Π.

metronide-ccdsv17-piv20-24mar22
1
AUSTRALIAN PRODUCT INFORMATION – METRONIDE® 200 &
METRONIDE® 400 (METRONIDAZOLE) TABLET
1
NAME OF THE MEDICINE
metronidazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronide 200 and Metronide 400 tablets contain 200 mg and 400 mg
metronidazole
respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
200 mg tablets: Round, white to off-white, one face impressed with
‘MTZ 200’ and a breakline
on the other.
400 mg tablets: Round, white to off-white, one face impressed with
‘MTZ 400’ and a breakline
on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ANAEROBIC INFECTIONS
Treatment of infections in which anaerobic bacteria have been
identified or are suspected as
pathogens, particularly
_Bacteroides fragilis_
and other species of bacteroides, and other species
such as fusobacteria, eubacteria, clostridia and anaerobic
streptococci. Metronide has been
used successfully in septicaemia; bacteraemia; brain abscess;
necrotising pneumonia;
osteomyelitis; puerperal sepsis; pelvic abscess; pelvic cellulitis;
postoperative wound
infections.
NOTE:
Metronidazole is inactive against aerobic and facultative anaerobic
bacteria.
OTHER INDICATIONS
Oral treatment of urogenital trichomoniasis in the female (trichomonal
vaginitis) and in the
male, and for the treatment of bacterial vaginosis. The male consort
of females suffering from
urogenital trichomoniasis should be treated concurrently; all forms of
amoebiasis (intestinal
and extraintestinal disease and that of symptomless cyst passers);
giardiasis; acute ulcerative
gingivitis.
metronide-ccdsv17-piv20-24mar22
2
4.2
DOSE AND METHOD OF ADMINISTRATION
A maximum of 4 g should not be exceeded during a 24 hour period.
Dosages should be
decreased in patients with severe hepatic disease; plasma
metronidazole levels should be
monitored.
In elderly patients the pharmacokinetics of metronidazole may be
altered and therefore
monitoring of serum levels may be necessary to adjust the
me