Syntometrine

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

קנה את זה

הורד עלון מידע (PIL)
15-06-2024
הורד מאפייני מוצר (SPC)
15-06-2024

מרכיב פעיל:

Oxytocin; Ergometrine maleate

זמין מ:

Novartis Pharmaceuticals Australia Pty Ltd

סיווג:

Medicine Registered

עלון מידע

                                SYNTOMETRINE
®
 
_synthetic oxytocin/ergometrine maleate_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Syntometrine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Syntometrine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT SYNTOMETRINE IS
USED FOR
Syntometrine can be used during and
immediately after delivery of a baby
to help the birth and to prevent or
treat excessive bleeding.
Syntometrine works by stimulating
the muscles of the uterus (womb) to
produce rhythmic contractions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SYNTOMETRINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Syntometrine is only available with a
doctor's prescription.
It is not addictive.
BEFORE YOU ARE GIVEN
SYNTOMETRINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN
SYNTOMETRINE IF YOU ARE ALLERGIC TO:
•
oxytocin
•
ergometrine
•
any of the other ingredients listed
at the end of this leaflet.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
IF YOU THINK YOU MAY BE ALLERGIC TO
SYNTOMETRINE, ASK YOUR DOCTOR FOR
ADVI
                                
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מאפייני מוצר

                                 
 
1 
SYNTOMETRINE
®
 
(SYNTHETIC OXYTOCIN/ERGOMETRINE MALEATE) 
 
NAME OF THE MEDICINE 
 
 
Active ingredient  oxytocin 
 
ergometrine maleate 
Chemical name  l-cysteinyl-l-tyrosyl-l-isoleucyl-l-
glutamyl-l-asparaginyl-l-cysteinyl-l-
prolyl-l-leucylglycinamide cyclic 
(1→6)-disulfide 
6aR,9R)-N-[(S)-2-hydroxy-1-
methylethyl]-7-methyl-
4,6,6a,7,8,9-hexahydro-
indolo[4,3-fg]quinoline-9-
carboxamide (Z)-butenedioate 
CAS number  50-56-6 
129-51-1 
Molecular weight  1007 
441.5 
Molecular formula  C
43
H
66
N
12
O
12
S
2
 
C
19
H
23
N
3
O
2
.C
4
H
4
O
4 
 
Chemical structure 
 
 
 
DESCRIPTION 
 
Syntometrine injection is a sterile, clear, colourless solution,
faintly bluish fluorescent, 
containing synthetic oxytocin
5 I.U/mL and ergometrine maleate 0.5 mg/mL.  Syntometrine 
injection also contains maleic acid, sodium chloride, and
water for injections, buffered to pH 
3.2.  
 
PHARMACOLOGY 
 
PHARMACODYNAMIC PROPERTIES 
Pharmacotherapeutic  group: Ergot alkaloids and oxytocin incl.
analogues, in combination; 
ATC code: G02AC. 
 
Syntometrine combines the rapid uterine action of oxytocin,
a nonapeptide hormone released 
by the posterior lobe of the pituitary, with the sustained
uterotonic effect of ergometrine. 
 
 
 
2 
PHARMACOKINETICS 
Following intramuscular administration, the latent period
for the occurrence of the uterine 
response is considerably shorter with Syntometrine (about 2½
min) than with ergometrine 
given alone (about 7 min) whereas the uterotonic effect
of Syntometrine lasts for several 
hours, compared with only ½-1 hour when oxytocin is given alone. 
 
These properties make Syntometrine i.m. suitable for the active management
of the third 
stage of labour (see 'Dosage') and
for the prevention or treatment of postpartum haemorrhage, 
particularly in situations where for any reason
the intravenous administration
                                
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