Ergometrine 500micrograms/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ergometrine maleate

Available from:

hameln pharma Ltd

ATC code:

G02AB03

INN (International Name):

Ergometrine maleate

Dosage:

500microgram/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 5016386000089

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERGOMETRINE INJECTION
ergometrine maleate
1.
WHAT
ERGOMETRINE
INJECTION
IS
AND
WHAT IT IS USED FOR
Ergometrine Injection is a medicine that causes
contraction of the muscles of the womb and is
used:
• in the active management of the third stage of
labour
• to control bleeding after the birth.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN ERGOMETRINE INJECTION
YOU
MUST
NOT
BE
GIVEN
ERGOMETRINE
INJECTION:
• if you are allergic to ergometrine maleate or any
of the other ingredients in this injection (listed in
section 6)
• if you have severe or very high blood pressure
• if you have heart disease
• if you suffer from severe liver, kidney, heart or
circulation problems
• if
you
are
suffering
from
eclampsia
or
pre-
eclampsia (which causes high blood pressure,
protein in the urine, swelling)
• if your womb is not contracting properly
• if you are pregnant or if you are in labour but the
baby’s shoulder still cannot be seen
• if you have a serious infection
• if you have Raynaud’s disease or phenomenon
(poor circulation which makes the toes and
fingers numb and pale)
WARNINGS AND PRECAUTIONS:
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE BEING GIVEN THE INJECTION:
• if you have raised blood pressure
• if you have liver or kidney problems
• if you have an infection
• if you have any heart problems
• if you are going to have an operation under
general anaesthetic
• if your baby is in a breech position (or any other
abnormal
position)
before
birth,
Ergometrine
Injection will not be given until after your baby
has been born.
• if you have a multiple pregnancy (e.g. twins,
triplets), Ergometrine Injection will not be given
until after the last baby has been born.
If any of the above applies to you, or you are not
sure, speak to your doctor or nurse before you
receive Ergometrine Injection.
OTHER
MEDICINES
AND
ERGOMETRINE
INJECTION:
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any
other medicine

Summary of Product characteristics

OBJECT 1
ERGOMETRINE INJECTION BP 0.05% W/V
Summary of Product Characteristics Updated 08-May-2018 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Ergometrine Injection BP 0.05% w/v.
2. Qualitative and quantitative composition
500 micrograms of Ergometrine in 1ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile Injection.
4. Clinical particulars
4.1 Therapeutic indications
Ergometrine Injection is used in the active management of the third
stage of labour and in the treatment of
post-partum haemorrhage. Ergometrine Injection may be given by
intramuscular or intravenous injection.
4.2 Posology and method of administration
Ergometrine Injection should be used under medical supervision only
_Adults: _
Active Management of the Third Stage of Labour
Ergometrine Injection is administered (often in combination with
synthetic oxytocin 5 units)
intramuscularly as a dose of 500 micrograms following the delivery of
the anterior shoulder of the infant
or at the latest immediately after delivery of the baby.
Prevention and Treatment of Postpartum Haemorrhage
Doses of 200 micrograms to 500 micrograms of Ergometrine are given
intramuscularly, following
expulsion of the placenta or when bleeding occurs. In emergencies,
Ergometrine Injection may be given
intravenously at a dose of 250 micrograms to 500 micrograms.
USE IN SPECIAL POPULATIONS
_Patients with renal impairment or hepatic impairment _
No studies have been performed in patients with renal or hepatic
impairment. However, considering the
metabolic pathway of ergometrine, use is contraindicated in severe
hepatic and renal impairment and
caution is required in mild or moderate hepatic and renal impairment
(see sections 4.3 Contraindications,
4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic
properties).
_Paediatric population _
No data are available.
_Elderly _
Not applicable.
METHOD OF ADMINISTRATION
Intramuscular injection is the recommended route.
Intravenous administration of Ergometrine Injection at a do