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Duratocin Injection vial

Carbetocin
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Duratocin Injection vial. It does not contain all the information that is known about Duratocin Injection vial. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, 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 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.
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.
You must not be given Duratocin if you are suffering from serious heart disease.
Duratocin should not be given to children.
Safety and effectiveness in children have not been established.
Duratocin must not be given after the expiry date printed on the vials and outer packaging.
Duratocin must not be given if packaging is torn or shows signs of tampering.
If you not sure whether you should be given Duratocin, talk to your doctor.

Before you are given it

Tell your doctor if you have high blood pressure or any heart problems.
Your doctor may want to take extra precautions.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
severe heart disease
high blood pressure
liver or kidney problems
problems with blood clotting
disease of a gland
gestational diabetes (diabetes that starts during pregnancy)
epilepsy
migraine
asthma.
If you have not told your doctor about any of the above, tell him/her before you have Duratocin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

How Duratocin is given

Duratocin is a medicine that is used only in hospital and should only be administered by qualified staff.
Duratocin will be given to you by injection into one of your veins immediately after the delivery of your baby.

How much you will be given

Duratocin will be given as a single dose of 100 micrograms (1 mL) into a vein by injection, slowly over one minute.

Side effects

Tell your doctor or nurse immediately if you do not feel well after you have been given Duratocin.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Tell your doctor or nurse if you notice any of the following and they worry you:
nausea (feeling sick) or vomiting
stomach pain
itching
flushing or feeling of warmth
feeling light headed, dizzy or faint
headache
tremor.
These are the more common side effects of Duratocin. Mostly these are mild and short-lived.
Tell your doctor or nurse immediately if you notice any of the following:
back pain
dizziness
metallic taste
signs of anaemia, such as tiredness, being short of breath and looking pale
sweating
chest pain
fast heart beat
shortness of breath
chills
nervousness, feeling anxious.
All of these side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor or nurse if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor to answer any questions you may have.

After using Duratocin

Storage

Duratocin is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Duratocin:
Keep it where children cannot reach it.
Keep Duratocin in the original container until it is time for it to be given.
Keep vial in a place where the temperature stays below 30°C.
If you take your medicine out of the original container, it will not keep well.

Product description

What it looks like

Duratocin is a clear colourless solution in a 1 mL clear glass vial.

Ingredients

Duratocin contains 100 micrograms of carbetocin as the active ingredient.
It also contains:
methionine
succinic acid
mannitol
sodium hydroxide
water for injections.
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Duratocin is supplied in Australia by:
Ferring Pharmaceuticals Pty Ltd
Suite 2, Level 1, Building 1
20 Bridge Street
Pymble NSW 2073
Australia
 
Australian Registration Number:
AUST R 233671 - Duratocin carbetocin 100 microgram/1 mL injection vial
 
This leaflet was prepared in January 2015
 
DOCS#11524-v7A