VIATOCINON oxytocin 5 IU/1 mL injection ampoule

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Download Bijsluiter (PIL)
01-12-2017
Download Productkenmerken (SPC)
17-08-2019

Werkstoffen:

oxytocin, Quantity: 5 IU

Beschikbaar vanaf:

Viatris Pty Ltd

INN (Algemene Internationale Benaming):

Oxytocin

farmaceutische vorm:

Injection, solution

Samenstelling:

Excipient Ingredients: glacial acetic acid; sodium acetate trihydrate; water for injections; sodium hydroxide

Toedieningsweg:

Intravenous Infusion, Intramuscular

Eenheden in pakket:

5, 10

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

Oxytocin is indicated for the induction of labour; inadequate uterine effort; management of third stage of labour; post-partum haemorrhage.

Product samenvatting:

Visual Identification: Clear, colourless solution in clear glass ampoule; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Registered

Autorisatie datum:

2011-03-11

Bijsluiter

                                OXYTOCIN ASPEN INJECTION- Consumer Medicine Information
Page 1 of 2
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OXYTOCIN ASPEN
INJECTION.
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.
All medicines have risks and benefits.
Your doctor has more information
about this medicine than is contained in
this leaflet. Also, your doctor has had
the benefit of taking a full and detailed
history from you and is in the best
position to make an expert judgement
to meet your individual needs.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT OXYTOCIN
ASPEN INJECTION IS
USED FOR
OXYTOCIN ASPEN INJECTION can
be used to bring on (induce) labour. It
can also be used during and
immediately after delivery to help the
birth and to prevent or treat excessive
bleeding.
OXYTOCIN ASPEN INJECTION is a
man-made chemical that is identical to
a natural hormone called oxytocin. It
works by stimulating the muscles of the
uterus (womb) to produce rhythmic
contractions.
OXYTOCIN ASPEN INJECTION is
not suitable in all situations - for
example, if the baby or placenta are in
the wrong position or if you have had a
previous Caesarian section or other
surgery involving the uterus. Your
doctor can give you more information
on the suitability of this medicine in
your particular case.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY OXYTOCIN
ASPEN INJECTION HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is only available with a
doctor's prescription. It is not addictive.
BEFORE YOU ARE GIVEN IT
TELL YOUR DOCTOR IF YOU HAVE ANY OF
THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED ANY OF THESE
CONDITIONS.
It is very important that yo
                                
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Productkenmerken

                                OXYTOCIN ASPEN INJECTION – Product Information
Page 1 of 9
PRODUCT INFORMATION
_OXYTOCIN ASPEN INJECTION _
NAME OF THE DRUG:
OXYTOCIN
_Structural Formula _
CAS No. 50-56-6
DESCRIPTION:
The active substance in OXYTOCIN ASPEN INJECTION is a synthetic
nonapeptide identical with oxytocin
(AAN), a hormone released by the posterior lobe of the pituitary gland
of mammals.
The hormone is prepared synthetically to avoid possible contamination
with vasopressin (ADH) and other
small polypeptides with biologic activity.
Oxytocin
Aspen
Injection
is
a
sterile,
clear,
colourless
aqueous
solution
of
synthetic
oxytocin,
for
intravenous infusion or intramuscular injection.
Excipients are sodium acetate, glacial acetic acid and water for
injections.
PHARMACOLOGY:
PHARMACODYNAMICS
Oxytocin stimulates the smooth muscle of the uterus, producing
rhythmic contractions, particularly
towards the end of pregnancy, during labour, after delivery and in the
puerperium, that is, at times when
the number of specific oxytocins receptors in the myometrium is
increased. When given by low-dose
intravenous infusion, oxytocin injection elicits rhythmic uterine
contractions that are indistinguishable in
frequency, force and duration from those observed during natural
labour. At higher infusion doses, or
when given by a single injection, the drug is capable of causing
sustained tetanic uterine contractions.
Upon discontinuation of the infusion or following a substantial
reduction in the infusion rate (e.g. in the
event of over stimulation), uterine activity declines rapidly but may
continue at an adequate lower level.
Oxytocin also causes contraction of the myo-epithelial cells
surrounding the mammary alveoli. It
therefore facilitates lactation in women experiencing difficulty in
breast feeding. Synthetic oxytocin has
only very slight pressor and anti-diuretic activity due to the absence
of vasopressin.
Another pharmacological effect observed with high doses of Oxytocin,
particularly when administered by
rapid intravenous bolus injection, has a trans
                                
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