ZIDOVAL 7.5 MGG VAGINAL GEL

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

METRONIDAZOLE

Dostopno od:

MEGAPHARM LTD

Koda artikla:

G01AF01

Farmacevtska oblika:

GEL

Sestava:

METRONIDAZOLE 7.5 MG/G

Pot uporabe:

VAGINAL

Tip zastaranja:

Required

Izdeluje:

MEDA MANUFACTURIN SAS., FRANCE

Terapevtsko območje:

METRONIDAZOLE

Terapevtske indikacije:

Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis (formally called non-specific vaginitis gardnella vaginalis vaginitis or haemophilus vaginitis).

Datum dovoljenje:

2020-05-30

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
THIS MEDICINE IS DISPENSED WITH A
PHYSICIAN’S PRESCRIPTION ONLY
ZIDOVAL 7.5 MG/G VAGINAL GEL
VAGINAL GEL
COMPOSITION:
ACTIVE INGREDIENT: metronidazole 7.5 mg/g
For the list of inactive ingredients and allergens in the
preparation, see section 6, “Additional information”.
1. WHAT IS THIS MEDICINE INTENDED FOR?
ZIDOVAL 7.5 MG/G VAGINAL GEL is indicated for the
treatment of bacterial vaginosis )formally called
nonspecific vaginitis gardnella vaginalis vaginitis
or haemophilus vaginitis(.
THERAPEUTIC GROUP: Antibacterial from the
nitroimidazole group.
2. BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are allergic to the active ingredient
metronidazole or to any of the additional
ingredients that the medicine contains )listed
in section 6, “Additional information”(.
•
You are allergic to any antibacterial substance
belonging to the nitroimidazole group or to
similar antibacterials.
•
You are allergic to parabens )a preservative agent(.
SPECIAL WARNINGS REGARDING THE USE OF THE
MEDICINE:
BEFORE STARTING TREATMENT WITH ZIDOVAL 7.5 MG/G
VAGINAL GEL, TELL YOUR PHYSICIAN IF:
• In the past you have suffered from problems of the
blood system or a disease affecting the blood.
• You have or think you may have vaginal candidiasis:
The symptoms of vaginal candidiasis may become
more noticeable when you use ZIDOVAL 7.5 MG/G
VAGINAL GEL and you may require additional
treatment for dealing with the symptoms.
• You are having your period.
• You are about to have laboratory tests, because
metronidazole may interfere with the results.
• Avoid prolonged and unnecessary use of this
medicine.
As with all vaginal infections, you should avoid
sexual intercourse during the period of infection and
while you are using ZIDOVAL 7.5 MG/G VAGINAL GEL.
CHILDREN AND ADOLESCENTS:
ZIDOVAL 7.5 MG/G VAGINAL GEL is not recommended
for use by girls under the age of 18 because the
efficacy and safety of use by this age gr

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zidoval 7.5 mg/g vaginal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w, 7.5 mg/g
Excipients with known effect:
Methyl parahydroxybenzoate (E218) 0.8 mg/g
Propyl parahydroxybenzoate (E216) 0,2 mg/g
Propylene glycol (E1520) 30.0 mg/g.
For the full list of excipients and allergens, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal gel
A colourless to straw coloured gel
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zidoval 7.5 mg/g vaginal gel is indicated for the treatment of
bacterial vaginosis (formally
called nonspecific vaginitis gardnella vaginalis vaginitis or
haemophilus vaginitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For vaginal administration.
Adults
One application of
Zidoval 7.5 mg/g vaginal gel
inserted into the vagina once daily, at
bedtime, for 5 consecutive days.
Elderly
Bacterial vaginosis is not commonly seen in the elderly population and
consequently clinical assessment in this age group has not been
carried out.
Pediatric population
Not recommended for use in children and adolescents under 18 years
since
safety and efficacy have not been established.
Method of administration
Pierce sealed end of tube and screw open end of applicator tightly
onto tube of
gel. Squeeze tube, filling the applicator with gel. Remove applicator
from tube
and gently insert applicator into vagina as far as it will comfortably
go. Push
the plunger to release the gel. Dispose of applicator as instructed.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1 or to other nitroimidazoles or parabens.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use during menses is not recommended.
Known or previously unrecognised candidiasis may present more
prominent symptoms
during therapy with Zidoval 7.5 mg/g vaginal gel and may require
treatment with
acandicidal agent.
If irritation does occur the patient should be advised to use
metronidazole less frequently or to
stop te