GLOVAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NONOXINOL 9; RICINOLEIC ACID

Available from:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC code:

G02BB

Pharmaceutical form:

OVULES

Composition:

NONOXINOL 9 140 MG; RICINOLEIC ACID 25 MG

Administration route:

VAGINAL

Prescription type:

Not required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic group:

INTRAVAGINAL CONTRACEPTIVES

Therapeutic indications:

Spermicide for the control of conception.

Authorization date:

2012-12-31

Summary of Product characteristics

GLOVAN 26. 11. 2007 RH
"
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
."
רשואמ ןולע
:
רבמבונ
2007
.
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved.” Date of approval: November 2007.
GLOVAN
VAGINAL OVULES
COMPOSITION
Each vaginal ovule contains:
_Active Ingredient _
_ _Nonoxynol 9 140 mg
Ricinoleic acid 25 mg_ _
_ _
_Other Ingredients _
Witepsol W-35, polysorbate 61, lactic acid.
MECHANISM OF ACTION
Glovan is a topical spermicide. Nonoxynol-9 is responsible for cell
membrane
breakage; it decreases surface tension and kills epithelial cells.
Following insertion
into the vagina, the Glovan ovule dissolves and provides protective
contraceptive
coverage of the vaginal vault. Glovan is not 100% effective in
contraception.
Glovan is used either in conjunction with a vaginal diaphragm or as
the sole
method of contraception.
INDICATIONS
Spermicide contraceptive.
CONTRAINDICATIONS
Known hypersensitivity to either of the components of the preparation.
Vaginal anesthesia, as in spinal cord injuries.
Pregnancy.
WARNINGS
Before using Glovan, pregnancy should be ruled out (see
Contraindications).
Use of Glovan does not preclude the possibility of contraception.
Patients should
be advised to report if a menstrual period is missed.
Vaginal contraceptives containing nonoxynol 9 do not protect against
infection from
HIV (human immunodeficiency virus, the AIDS virus) or other sexually
transmitted
diseases (STDs). Use of vaginal contraceptives containing nonoxynol 9
can increase
vaginal irritation, which may actually increase the possibility of
transmitting the AIDS
virus and other STDs from infected partners.
_Use in Pregnancy and Lactation _
There
is
no
evidence
from
animal
and
human
studies
that
nonoxynol
9
is
teratogenic. Human epidemiological studies have not shown any firm
evidence of
adverse effects on the foetus, however some studies have shown that
nonoxynol 9
may be embryotoxic i