CARBETOCIN INTERPHARMA Carbetocin 100 microgram/1 mL Solution for IV injection in pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbetocin, Quantity: 100 microgram

Available from:

Interpharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: glacial acetic acid; water for injections; sodium chloride

Administration route:

Intravenous

Units in package:

Each pack size contains 5 pre-filled syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Colourless transparent and particles free solution in colourless glass syringe.; Container Type: Syringe; 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

Authorization status:

Registered

Authorization date:

2019-06-27

Patient Information leaflet

CARBOTECIN WOCKHARDT CMI V2.0
14 May 2020
CARBETOCIN WOCKHARDT
INJECTION
_Carbetocin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
CARBETOCIN
WOCKHARDT.
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
CARBETOCIN
WOCKHARDT
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
CARBETOCIN
WOCKHARDT
IS USED FOR
CARBETOCIN
WOCKHARDT
contains
carbetocin, a substance
which is an oxytocic agent
and causes the womb (uterus)
to contract.
CARBETOCIN
WOCKHARDT
is used to
minimise post-delivery
bleeding in women who have
delivered their baby by
elective caesarean section
under local anaesthetic
around the spinal cord
(epidural).
_HOW IT WORKS _
In some women, following
delivery by caesarean section,
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 why this
medicine has been
prescribed for you.
Your doctor may have
prescribed it for another
reason.
CARBETOCIN
WOCKHARDT
is
available only with a
doctor's prescription. It is
not addictive.
BEFORE YOU ARE
GIVEN
CARBETOCIN
WOCKHARDT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
CARBETOCIN
WOCKHARDT
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.

Summary of Product characteristics

1
CARBETOCIN WOCKHARDT V2.0 May 2020
AUSTRALIAN
PRODUCT
INFORMATION–
CARBETOCIN
WOCKHARDT
(CARBETOCIN) INJECTION
1
NAME OF THE MEDICINE
Carbetocin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARBETOCIN WOCKHARDT contains carbetocin 100 micrograms/mL.
Carbetocin 100 micrograms/mL is a solution for injection which is
packaged in 1 mL clear and
colourless Type I glass pre‐filled syringes.
For the full list of excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
Solution for IV injection or infusion
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CARBETOCIN WOCKHARDT is indicated for the prevention of uterine atony
and excessive bleeding
following delivery of the infant by caesarean section or vaginal
delivery.
CARBETOCIN WOCKHARDT must be administered after delivery of the
infant.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PRODUCT IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY RESIDUE.
CARBETOCIN WOCKHARDT 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
CARBETOCIN
WOCKHARDT 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
CARBETOCIN WOCKHARDT (carbetocin
injection) should be administered intravenously as a bolus injection,
slowly over 1 minute after
delivery of the infant. CARBETOCIN WOCKHARDT can be administered
either before or after delivery
of the placenta.
_Vaginal Delivery_: A single dose of 100 micrograms (1 mL) of
CARBETOCIN WOCKHARDT (carbetocin
injection) should be administered after delivery of the infant for the
active management of the third
stage of labour intravenously as