Syntocinon 10 IU/ml Concentrate for solution for infusion

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

OXYTOCIN

Beszerezhető a:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-kód:

H01BB02

INN (nemzetközi neve):

OXYTOCIN 10 IU/ml

Gyógyszerészeti forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Összetétel:

OXYTOCIN 10 IU/ml

Recept típusa:

POM

Terápiás terület:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Engedélyezési státusz:

Authorised

Engedély dátuma:

2006-01-18

Betegtájékoztató

PATIENT INFORMATION LEAFLET
®
SYNTOCINON
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 take Syntocinon
3.
How to take Syntocinon
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 TAKE SYNTOCINON
DO NOT TAKE 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 the neck
of your womb
-
if the placenta separates from the wom

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
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 minutes and
increments of not more
than 1-2 milliunits/minute, until a contraction pattern similar to
that of normal