DURATOCIN carbetocin 100 microgram/mL injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

carbetocin, Quantity: 100 microgram/mL

Tilgjengelig fra:

Ferring Pharmaceuticals Pty Ltd

INN (International Name):

Carbetocin

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: sodium hydroxide; water for injections; succinic acid; methionine; mannitol

Administreringsrute:

Intravenous, Intramuscular

Enheter i pakken:

1 x 5 vials

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

DURATOCIN is indicated for the prevention of uterine atony and excessive bleeding following delivery of the infant by caesarean section or vaginal delivery.,DURATOCIN must be administered after delivery of the infant.

Produkt oppsummering:

Visual Identification: Clear and colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2015-04-17

Informasjon til brukeren

DURATOCIN
® INJECTION
_Carbetocin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Duratocin.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Duratocin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DURATOCIN IS
USED FOR
Duratocin contains carbetocin, a
substance which is an oxytocic agent
and causes the womb (uterus) to
contract.
Duratocin is used to minimise post-
delivery bleeding in women who
have delivered their baby vaginally
or by caesarean section.
_HOW IT WORKS_
In some women, following delivery,
the womb fails to contract quickly
enough which increases the risk of
bleeding. Drugs that act directly on
the womb to make it contract are
used to minimise post-delivery
bleeding and are sometimes called
oxytocic agents because they act in a
similar manner to oxytocin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS MEDICINE.
Your doctor may have prescribed it
for another reason.
Duratocin is available only with a
doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
DURATOCIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DURATOCIN MUST NOT BE GIVEN IF YOU
HAVE AN ALLERGY TO:
•
carbetocin, the active ingredient,
or to any of the ingredients listed
at the end of this leaflet
•
any medicines containing
oxytocin.
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.
YOU MUST NOT BE GIVEN DURATOCIN
DURING PREGNANCY OR ANY TIME
BEFORE DELIVERY OF THE BABY.
Duratocin should only be given after
delivery of your baby.
YOU MUST NOT BE GIVEN DURATOCIN IF
YOU ARE SUFFERING FROM SERIOUS
HEART DISEASE.
DURATOCIN SHOULD

Preparatomtale

1
#15449-v15A
AUSTRALIAN PRODUCT INFORMATION – DURATOCIN (CARBETOCIN)
INJECTION
1
NAME OF THE MEDICINE
Carbetocin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DURATOCIN contains carbetocin 100 micrograms/mL.
Carbetocin is a white, fluffy lyophilized powder, soluble in water,
ethanol, methanol and
acetic acid. Carbetocin is insoluble in ether and petroleum ether.
For the full list of excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DURATOCIN is indicated for the prevention of uterine atony and
excessive bleeding following
delivery of the infant by caesarean section or vaginal delivery.
DURATOCIN must be administered after delivery of the infant.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DURATOCIN should be administered as a single dose only, when delivery
of the infant has been
completed. There are no efficacy or safety data on repeat doses of
DURATOCIN following delivery of
the infant. The use of carbetocin should occur in the context of other
measures to prevent PPH and
associated morbidity, including uterine massage, detection and
correction of coagulopathies (refer
to local clinical guidelines). Other uterotonic agents should be
administered if additional treatment is
required to reduce excessive postpartum bleeding and increase uterine
tone.
_Caesarean Section:_ A single dose of 100 micrograms (1 mL) of
DURATOCIN (carbetocin injection)
should be administered intravenously as a bolus injection, slowly over
1 minute after delivery of
the infant. DURATOCIN can be administered either before or after
delivery of the placenta.
_Vaginal Delivery_: A single dose of 100 micrograms (1 mL) of
DURATOCIN (carbetocin injection)
should be administered after delivery of the infant for the active
management of the third stage of
labour as an intramuscular injection or intravenously as a bolus
injection slowly over 1 minute.
4.3
C
ONTRAINDICATIONS
Because of its long duration of action relative to oxytocin, uterine
contractions produced