Syntometrine 500micrograms/1ml solution for injection ampoules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Ergometrine maleate; Oxytocin

Saatavilla:

Alliance Pharmaceuticals Ltd

ATC-koodi:

G02AC01

INN (Kansainvälinen yleisnimi):

Ergometrine maleate; Oxytocin

Annos:

500microgram/1ml ; 5unit/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous; Intramuscular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 07010100; GTIN: 5036631859057

Pakkausseloste

Syntometrine PIL UK 010
PATIENT INFORMATION LEAFLET
SYNTOMETRINE
®
500 MICROGRAMS/5IU SOLUTION FOR INJECTION
ergometrine maleate and oxytocin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, midwife or
pharmacist.
•
If you get any side effects, talk to your doctor, midwife or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Syntometrine is and what it is used for
2. What you need to know before you receive Syntometrine
3. How Syntometrine is given to you
4. Possible side effects
5.
How to store Syntometrine
6.
Contents of the pack and other information
1. WHAT SYNTOMETRINE IS AND WHAT IT IS USED FOR
•
Syntometrine belongs to a group of medicines called oxytocics. This
means it makes
the muscles of the uterus (womb) contract.
Syntometrine is used:
•
to help the delivery of the placenta
•
to prevent or control bleeding after delivery of your baby.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SYNTOMETRINE
YOU MUST NOT RECEIVE SYNTOMETRINE:
•
if you are allergic to oxytocin, ergometrine or any of the other
ingredients of this
medicine (listed in section 6)
•
if you are pregnant or if you are in labour but the baby’s shoulder
still cannot be seen
•
if your womb is not contracting properly
•
if you suffer from severe liver, kidney, heart or circulation problems
•
if you have very high blood pressure
•
if you are suffering from eclampsia or pre-eclampsia (which causes
high blood
pressure, protein in the urine, swelling)
•
if you have a serious infection.
If any of the above applies to you, or if you are not sure, speak to
your doctor or midwife
before you receive Syntometrine.
Syntometrine PIL UK 010
WARNINGS AND PRECAUTIONS
Talk to your doctor or midwife before you receive Syntometrine if:
•
you have raised blood pressure
•
you have liver

Valmisteyhteenveto

OBJECT 1
SYNTOMETRINE AMPOULES
Summary of Product Characteristics Updated 20-Dec-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Syntometrine 500 micrograms/5 IU Solution for Injection
2. Qualitative and quantitative composition
Each 1ml ampoule contains 500 micrograms ergometrine maleate and 5IU
oxytocin.
Excipient with known effect:
Sodium chloride 7.000 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
The solution is clear, colourless, faintly bluish fluorescent.
4. Clinical particulars
4.1 Therapeutic indications
The active management of the third stage of labour (as a means to
promote separation of the placenta and
to reduce blood loss), or routinely, following the birth of the
placenta, to prevent or treat postpartum
haemorrhage.
4.2 Posology and method of administration
Syntometrine should be used under medical supervision only.
_Adults:_
_Active management of third stage of labour: _Intramuscular injection
of 1ml after delivery of the anterior
shoulder, or at the latest, immediately after delivery of the child.
Expulsion of the placenta, which is
normally separated by the first strong uterine contraction, should be
assisted by controlled cord traction.
_Prevention and treatment of postpartum haemorrhage: _Intramuscular
injection of 1ml following
expulsion of the placenta, or when bleeding occurs.
_Special populations_
_Renal impairment / Hepatic impairment _
No studies have been performed in patients with renal or hepatic
impairment. However considering the
metabolic pathway of ergometrine and oxytocin, 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 Syntometri