Syntocinon 10units/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxytocin

Available from:

Viatris UK Healthcare Ltd

ATC code:

H01BB02

INN (International Name):

Oxytocin

Dosage:

10unit/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07010100; GTIN: 5036631859033

Patient Information leaflet

Novartis and Novartis logo
PATIENT INFORMATION LEAFLET
SYNTOCINON
®
5 IU/ML AND 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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.
WHAT IS IN THIS LEAFLET
1. WHAT SYNTOCINON IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SYNTOCINON
3. HOW SYNTOCINON IS GIVEN TO YOU
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SYNTOCINON
6. CONTENTS OF THE PACK AND OTHER INFORMATION
7. INFORMATION FOR THE HEALTH CARE PROFESSIONAL
1. WHAT SYNTOCINON IS AND WHAT IT IS USED FOR
Syntocinon contains a manufactured form of oxytocin (a natural
hormone). It belongs to a group of
medicines called oxytocics that make the muscles of the womb contract.
Syntocinon is used:
•
to start or help contractions during childbirth (labour)
•
to help in the management of a miscarriage
•
to prevent and control bleeding after delivery of your baby
•
during a
caesarean section.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SYNTOCINON
YOU MUST NOT RECEIVE SYNTOCINON:
•
if you are allergic to oxytocin or any of the ingredients of this
medicine (listed in section 6)
•
if your doctor thinks that to start or increase contractions of the
womb would be unsuitable for you, for
example:
-
where contractions of the womb are unusually strong
-
where there are obstructions that may prevent delivery
-
where your baby may be short of oxygen
•
where labour or vaginal delivery is not advisable, for example:
-
if your baby’s head is too large to fit through your pelvis
-
if your baby is wrongly positioned in the birth canal
-
if the placenta lies near or over the neck of your womb
-
if your baby lacks oxygen due to blood vessels running across

Summary of Product characteristics

OBJECT 1
SYNTOCINON 10 IU/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 09-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
Syntocinon
®
10 IU/ml Concentrate for solution for infusion
2. Qualitative and quantitative composition
Oxytocin.
Concentrate for solution for infusion (in 1 mL ampoule) containing 10
IU/mL.
_Excipient(s) with known effect:_
Ethanol 5.000mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
A clear, colourless, sterile solution in 1ml clear glass ampoules.
4. Clinical particulars
4.1 Therapeutic indications
_Antepartum_
• Induction of labour for medical reasons, e.g. in cases of
post-term gestation, premature rupture of the
membranes, pregnancy-induced hypertension (pre-eclampsia)
• Stimulation of labour in hypotonic uterine inertia
• Early stages of pregnancy as adjunctive therapy for the management
of incomplete, inevitable, or
missed abortion.
Postpartum
• During caesarean section, but following delivery of the child
• Prevention and treatment of postpartum uterine atony and
haemorrhage
4.2 Posology and method of administration
_Induction or enhancement of labour:_ Oxytocin should not be started
for 6 hours following administration
of vaginal prostaglandins. Syntocinon should be administered as an
intravenous (i.v.) drip infusion or,
preferably, by means of a variable-speed infusion pump. For drip
infusion it is recommended that 5 IU of
Syntocinon be added to 500ml of a physiological electrolyte solution
(such as sodium chloride 0.9%). For
patients in whom infusion of sodium chloride must be avoided, 5%
dextrose solution may be used as the
diluent (see Section 4.4 “Special warnings and precautions for
use“). To ensure even mixing, the bottle
or bag must be turned upside down several times before use.
The initial infusion rate should be set at 1 to 4 milliunits/minute (2
to 8 drops/minute). It may be
gradually increased at intervals not shorter than 20