ZIDOVAL VAGINAL GEL metronidazole 7.5mg/g gel tube

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

metronidazole, Quantity: 7.5 mg/g

Tilgjengelig fra:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (International Name):

Metronidazole

Legemiddelform:

Gel

Sammensetning:

Excipient Ingredients: carbomer 974P; propylene glycol; sodium hydroxide; disodium edetate; propyl hydroxybenzoate; methyl hydroxybenzoate; purified water

Administreringsrute:

Vaginal

Enheter i pakken:

9 gram, 40 gram

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Zidoval Vaginal Gel 0.75% is indicated in the treatment of symptomatic bacterial vaginosis (formerly referred to as Haemophilus vaginalis vaginitis, Gardnerella vaginalis vaginitis, non-specific vaginitis, Corynebacterium vaginale vaginitis or anaerobic vaginosis). NOTE: For purpose of this indicated, a clincial diagnosis of bacterial vaginosis is usually defined by the presence of at least three of the following four criteria: a) vaginal discharge pH of greater than 4.5, b) a vaginal discharge emitting a "fishy" amine odour when mixed with a 10% KOH solution, c) a vaginal discharge containing clue cells on wet mount microscopy examination, d) a gram stain consistent with a diagnosis of bacterial vaginosis (Lactobacillus morphotype absent of markedly decreased, Gardnerella morphotype predominant flora, white blood cells absent or few, Mobiluncus morphotype may or may not be present). A diagnosis of bacterial vaginosis requires that other pathogens which may be associated with genital infection, such as Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and Neisseria gonorrhoeae, should be ruled out be appropriate laboratory means.

Produkt oppsummering:

Visual Identification: A colourless to straw-coloured transparent, slightly hazy single-phase gel.; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2000-04-18

Informasjon til brukeren

ZIDOVAL
® VAGINAL GEL
_Metronidazole 0.75% w/w_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zidoval Vaginal Gel.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Zidoval
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZIDOVAL IS USED
FOR
Zidoval Vaginal Gel contains an
active ingredient, metronidazole.
Metronidazole is an antibacterial
agent.
Zidoval is used to treat infection of
the vagina (bacterial vaginosis)
caused by certain bacteria. It is not
suitable for all types of vaginal
infections. By applying Zidoval
directly into the vagina,
metronidazole can kill the bacteria at
the site of the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
ZIDOVAL
_WHEN YOU MUST NOT USE IT_
DO NOT USE ZIDOVAL IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
metronidazole
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT GIVE ZIDOVAL TO A CHILD
UNDER THE AGE OF 12 YEARS.
Safety and effectiveness in children
younger than 12 years have not been
established.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING THIS MEDICINE,
TALK TO

Preparatomtale

1
AUSTRALIAN PRODUCT INFORMATION – ZIDOVAL (METRONIDAZOLE)
VAGINAL GEL
1
NAME OF THE MEDICINE
Metronidazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75 %w/w
Each 5 g applicator of vaginal gel contains approximately 37.5 mg of
metronidazole.
Excipients with known effect:
Methyl
hydroxybenzoate 0.08%w/w
Propyl hydroxybenzoate 0.02%w/w.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vaginal gel.
Zidoval Vaginal Gel is a non-sterile gelled, colourless to
straw-coloured transparent, slightly hazy
single-phase purified water solution, containing metronidazole at a
concentration of 7.5 mg/g (0.75
%w/w). The gel is formulated at the normal vaginal pH of 4.0.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Zidoval Vaginal Gel 0.75% is indicated in the treatment of symptomatic
bacterial vaginosis (formerly
referred to as _Haemophilus vaginalis_ vaginitis, _Gardnerella
vaginalis_ vaginitis, non-specific vaginitis,
_Corynebacterium vaginale_ vaginitis or anaerobic vaginosis).
Note: For purposes of this indication, a clinical diagnosis of
bacterial vaginosis is usually defined by
the presence of at least three of the following four criteria:
a) a vaginal discharge pH of greater than 4.5;
b) a vaginal discharge emitting a “fishy” amine odour when mixed
with a 10% KOH solution;
c) a vaginal discharge containing clue cells on wet mount microscopy
examination;
d) a gram stain consistent with a diagnosis of bacterial vaginosis
(_Lactobacillus morphotype_ absent or
markedly decreased, _Gardnerella morphotype_ predominant flora, white
blood cells absent or few,
_Mobiluncus morphotype_ may or may not be present).
2
A diagnosis of bacterial vaginosis requires that other pathogens which
may be associated with
genital infection, such as _Trichomonas vaginalis, Candida albicans,_
_Chlamydia trachomatis and _
_Neisseria gonorrhoeae_, should be ruled out by appropriate laboratory
means.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose is one applicator full