ACI-JEL THERAPEUTIC VAGINAL JELLY

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

ACETIC ACID

Dostopno od:

Janssen-Cilag Ltd

Odmerek:

0.93865%w/ %w/w

Farmacevtska oblika:

Vaginal Gel

Datum dovoljenje:

1994-04-01

Lastnosti izdelka

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aci-Jel Therapeutic Vaginal Jelly
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The gel contains 0.9386 % w/w Glacial Acetic Acid in
a buffered formulation (as described in the application).
For excipients, see section 6.1
3 PHARMACEUTICAL FORM
Vaginal gel.
White mobile gel of characteristic odour.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
To restore and maintain vaginal acidity, to reduce recurrence and
severity of trichomonas infection or in the 
management of non-specific vaginitis or cervicitis. 
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Route of Administration
Vaginal use
Recommended Dose
One applicatorful intravaginally once or twice daily for up to 2
weeks or as prescribed.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
If there is no improvement or the condition is aggravated,
consult the doctor.
Do not use in conjunction with barrier methods of contraception.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 21/10/2005_
_CRN 2015877_
_page number: 1_
4.6 PREGNANCY AND LACTATION
For glacial acetic acid no clinical data on exposed
pregnancies are available.
Animal studies do
not indicate direct or indirect harmful effects with
respect to pregnancy, embryonal/foetal 
development, parturition or postnatal development (see section
5.3).
Caution should be exercised when prescribing to pregnant women.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Rarely, local irritation and inflammation.
4.9 OVERDOSE
Aci-Jel Therapeutic Vaginal Jelly is intended
for intravaginal use. If accidental ingestion occurs, an
approp