PROSTIN E2 10 MGML

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DINOPROSTONE

Commercializzato da:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Codice ATC:

G02AD02

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

DINOPROSTONE 10 MG/ML

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

PFIZER MANUFACTURING BELGIUM NV/SA

Gruppo terapeutico:

DINOPROSTONE

Area terapeutica:

DINOPROSTONE

Indicazioni terapeutiche:

Therapeutic termination of pregnancy, missed abortion.

Data dell'autorizzazione:

2023-04-30

Scheda tecnica

Prostin E2 10 mg/ml CC 170822
Page 1 of 7 2021-0072989
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Prostin
®
E2 10 mg/ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg Dinoprostone (5 mg per ampoule).
Following dilution in accordance with instructions, each ml of the
resultant solution
for infusion contains 5 micrograms dinoprostone.
Excipient with known effect:
Prostin E2 Sterile Solution 10 mg/ml contains 400 mg anhydrous ethanol
in each 0.5 ml
ampoule which is equivalent to 800 mg/ml (80% w/v).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection
The solution is a clear, colourless, alcoholic sterile solution, for
intravenous
administration after appropriate dilution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapeutic termination of pregnancy, missed abortion.
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 and uterine
haemorrhage.
_ _
Prostin E2 10 mg/ml CC 170822
Page 2 of 7 2021-0072989
_Adults: _
Ampoule contents must be diluted before use and full instructions on
method
of dilution and dosage are given on the package insert which should be
consulted
prior to initiation of therapy. The following is a guide to dosage:
Dilute with normal saline or 5% dextrose according to the package
insert to produce a
5 micrograms/ml solution. The 5 micrograms/ml solution is infused at
2.5
micrograms/minute for 30 minutes and then maintained or increased to 5
micrograms/minute. The rate should be maintained for at least 4 hours
before
increasing further.
_Elderly:_
Not applicable.
_Children:_
Not applicable.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed