ACI-JEL THERAPEUTIC VAGINAL JELLY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
ACETIC ACID
Available from:
Janssen-Cilag Ltd
Dosage:
0.93865%w/ %w/w
Pharmaceutical form:
Vaginal Gel
Authorization date:
1994-04-01
Summary of Product characteristics
License
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
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