DBL™ Ergometrine

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Ergometrine maleate 0.5 mg/mL

Saatavilla:

Pfizer New Zealand Limited

INN (Kansainvälinen yleisnimi):

Ergometrine maleate 0.5 mg/mL

Annos:

500 mcg/mL

Lääkemuoto:

Solution for injection

Koostumus:

Active: Ergometrine maleate 0.5 mg/mL Excipient: Maleic acid Water for injection

Kpl paketissa:

Ampoule, glass, 5 x 1mL, 5 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Teva Czech Industries s.r.o.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 1mL - 5 mL - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1989-09-22

Valmisteyhteenveto

Version: pfdergoi10620
Superseded: Version 5.0
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL
™
Ergometrine Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL
™
Ergometrine Injection consists of ergometrine maleate BP 500 mcg/ml
and maleic acid
BP in water for injections BP.
3.
PHARMACEUTICAL FORM
DBL
™
Ergometrine Injection is a colourless or slightly yellowish solution
for parenteral use.
It is a Solution for injection.
The pH range of the injection is 2.7 - 3.5.
Ergometrine
maleate
occurs
as
a
white
to
greyish-white
or
faintly
yellow,
odourless,
microcrystalline powder which darkens with age and on exposure to
light. The BP states that
ergometrine maleate is soluble, and the USP that it is sparingly
soluble in water; and slightly
soluble in alcohol; practically insoluble in chloroform and ether.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROPHYLAXIS
Ergometrine is administered after the delivery of the placenta for the
purpose of contracting
the uterus in order to prevent postpartum haemorrhage and postabortion
haemorrhage due to
uterine atony.
TREATMENT
Ergometrine is administered after the delivery of the placenta to
promote involution of the
uterus in order to treat postpartum haemorrhage and postabortion
haemorrhage.
4.2 DOSE AND METHOD OF ADMINISTRATION
Ergometrine may be administered by IM or IV injection. However,
because the risk of severe
adverse effects is increased with IV use of ergometrine, its use via
this route is recommended
only for emergencies such as excessive uterine bleeding or any other
life-threatening situation
(see section 4.4).
_Prophylaxis of postpartum haemorrhage and postabortion haemorrhage_
Version: pfdergoi10620
Superseded: Version 5.0
Page 2 of 12
The immediate postpartum dose of ergometrine maleate is 200 micrograms
administered IM.
The injection should not be given until completion of the delivery is
assured, and until the
possibility of a second twin has been excluded (see section 4.4).
In an emergency situation, 200 micrograms may be injec