PROSTIN E2 VAGINAL GEL 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DINOPROSTONE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

G02AD02

Pharmaceutical form:

GEL

Composition:

DINOPROSTONE 0.033 %W/W

Administration route:

VAGINAL

Prescription type:

Required

Manufactured by:

PFIZER INC, USA

Therapeutic group:

DINOPROSTONE

Therapeutic area:

DINOPROSTONE

Therapeutic indications:

For labour induction in term and near term pregnant women who have favorable induction features and who have a singleton pregnancy with vertex presentation

Authorization date:

2022-03-31

Summary of Product characteristics

Prostin E2 Vaginal Gel 1 mg and 2 mg LPD CC 170822
Pfleet 2021-0072989
Page 1 of 6
1
NAME OF THE MEDICINAL PRODUCT
Prostin
®
E2 Vaginal Gel 1 mg
Prostin
®
E2 Vaginal Gel 2 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g gel (2.5 ml) contains 1 mg dinoprostone.
Each 3 g gel (2.5 ml) contains 2 mg dinoprostone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gel for intravaginal application.
Semi-translucent viscous gel.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prostin E2 Vaginal Gel is indicated for labor induction in term and
near term pregnant women
who have favorable induction features and who have singleton pregnancy
with a vertex
presentation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Usage is restricted to qualified health care professionals and to
hospitals and clinics with
specialised obstetric units with facilities for continuous monitoring.
The recommended dose should not be exceeded, and the dosing interval
should not be
shortened as this increases the risk of uterine hyperstimulation,
uterine rupture, uterine
haemorrhage, foetal and neonatal death.
For labor induction at or near term, the initial dose of 1 mg of
Prostin E2 Vaginal Gel should
be administered by gentle expulsion of the entire content of the
syringe into the posterior
fornix of the vaginal canal. The patient should remain in supine
position for at least 30
minutes. After 6 hours, a second dose of either 1 or 2 mg of Prostin
E2 Vaginal Gel may be
administered if necessary:
- 2 mg in case of absence of response to initial dose;
- 1 mg to augment an already present response to the initial dose.
SYRINGE ASSEMBLY INSTRUCTIONS:
Prostin E2 Vaginal Gel 1 mg and 2 mg LPD CC 170822
Pfleet 2021-0072989
Page 2 of 6
1.
Remove peel-off seal.
2.
Remove protective end cap (to serve as plunger rod).
3.
Insert protective end cap into the syringe.
4.
Administer syringe content.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
Prostin E2 Vaginal Gel