Gynosporin-1 Vaginal Cream 100

País: Tanzània

Idioma: anglès

Font: Tanzania Medicinces & Medical Devices Authority

ingredients actius:

Clotrimazole

Disponible des:

NabiQasim industries Pvt Ltd, PAKISTAN

Codi ATC:

Other dermatological preparations

Designació comuna internacional (DCI):

Clotrimazole

Dosis:

100

formulario farmacéutico:

Vaginal Cream

Fabricat per:

NABIQASIM INDUSTRIES (PVT) LIMITED, PAKISTAN

Resumen del producto:

Physical description: White colored semisolid cream; Local technical representative: CORE PHARMA LIMITED (1120)

Estat d'Autorització:

Registered/Compliant

Data d'autorització:

2022-04-11

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gynosporin 10% Vaginal Cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gm cream contains:
Clotrimazole……100 mg
_Excipient with known effect: _
Cetyl Alcohol: May cause local skin reactions (e.g contact
dermatitis).
Methyl Paraben and Propyl Paraben: May cause allergic reactions
(possibly delayed).
Benzoic Acid: This medicine contains 1.5 mg benzoic acid in each gm of
cream.
_For full list of Excipients, see section 6.1._
3. PHARMACEUTICAL FORM
Vaginal Cream
Appearance: White colored semisolid cream.
4. CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
It
is
indicated
in
Candida
vaginitis,
vulvitis
and
mixed
vaginal
infections. In case of
Trichomonas, Gynosporin is recommended along with other oral therapy.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
Gynosporin
Vaginal
Cream
10%:
Insert
one
filled
applicator
(5gm
cream)
deeply
intravaginally twice daily for three consecutive days or once daily
for 6 consecutive days
preferably before going to sleep at night.
How to use Gynosporin Vaginal Cream:
First of all, wash your hands and dry
1)
Before use, pierce the tube seal by inverting the cap over the end of
the tube and fix the
applicator on to the mouth threads of tube.
2)
Release cream in the applicator by squeezing the tube gently until
plunger stops. Remove
the applicator from the mouth of tube by unscrewing and replace the
cap on the tube.
3)
Carefully put the applicator as deep as is comfortable into the vagina
(this is
easiest
when
lying
on
your
back
with
your
knees
bent
up).
Holding
the applicator in place,
slowly press the plunger until whole dose of the cream is transferred
into the vagina.
4)
Remove the applicator carefully. Maintain the position for some time
so that the medicine
gets absorbed properly. The applicator may be use again after washing
and drying.
4.3.CONTRAINDICATIONS
Hypersensitivity to clotrimazole or any other excipients listed in
section 6.
4.4.SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Patients should be advised t