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PABAL 100 MICROGRAMS IN 1ML OF SOLUTION FOR INJECTION

Active substance(s): CARBETOCIN / CARBETOCIN

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Package leaflet: Information for the patient

Package leaflet: Information for the patient

Reading
direction



Solution for injection
Carbetocin

100 micrograms/ml solution for injection
Carbetocin

Reading
direction



100 m

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information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor, midwife or nurse.



If you get any side effects, tell your doctor, midwife or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

1.
2.
3.

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If you get any side effects, tell your doctor, midwife
or nurse. This includes any possible side effects not listed
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See section 4.
What Pabal is and what it is used for
What you need to know before you are treated with Pabal

What
is in this leaflet
How Pabal is given to you

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4.
1

Possible side effects

5. How PABAL is stored
What Pabal is and what it is used for
6. Contents of the pack and other information
Pabal is used to treat women who have just had a baby by caesarean section.
In some women, after a caesarean, the womb (uterus) doesn’t contract (shrink)
quickly enough. This makes it more likely that they’ll bleed more than normal. Pabal
makes the womb contract and so reduces the risk of bleeding.
The active ingredient in Pabal is carbetocin. It is similar to a substance called
oxytocin, which is naturally produced by the body to make the womb contract
during childbirth.

2

What you need to know before you are treated with Pabal
Pabal must not be given until after the baby has been delivered.
Before giving Pabal, your doctor needs to know about any medical conditions you
may have. You should also tell your doctor about any new symptoms that develop
while you are being treated with Pabal.

2 What you need to know before you are treated
with PABAL

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Pabal must not be used
• if you are allergic to carbetocin or any of the ingredients of Pabal
(see Section 6)
• if you have any disease of the liver or kidneys
• if you have pre-eclampsia (high blood pressure in pregnancy) or eclampsia
(toxaemia of pregnancy)
• if you have any serious heart disease
• if you have epilepsy
• if you ever have had an allergic reaction to oxytocin (sometimes given as a drip
or injection during or after labour)
If any of these apply to you, tell your doctor.

R

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Doctors need to take special care when using Pabal
• if you get migraines
• if you have asthma
• if you have problems with your heart or your circulation (such as high blood
pressure)
• if you have any other medical condition
If any of these apply to you, tell your doctor.

N

Children: Not relevant

T

Other medicines and Pabal
Tell your doctor if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.
Pregnancy and breast-feeding
Pabal must not be used during pregnancy, but may be given after delivery by
Caesarean section.

Children: Not relevant

Small amounts of carbetocin have been shown to pass from the nursing mother’s
blood into the breast milk, but it is assumed to be degraded in the infant’s bowels.

Other medicines and PABAL

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3

How Pabal is given to you
Pabal is given as an injection into one of your veins, immediately after your baby has
been delivered by caesarean section under an epidural or spinal anaesthetic. The
dose is one vial (100 micrograms).
If someone is given too much Pabal
If you are accidently given too much Pabal, your womb may contract strongly
enough to become damaged or to bleed heavily. You may also suffer drowsiness,
listlessness and headache, caused by water building up in your body. You will be
treated with other medication, and possibly surgery.

4

Possible side effects
Reading
direction

Reading
direction

Like all medicines, Pabal can have side effects, but not everybody gets them.

The most common side effects may affect at least 10 of every 100 women treated
with Pabal. They include:
• nausea
• pain in the stomach
• itching
• flushing (red skin)
• feeling warm
• low blood pressure
• heachaches
• shakiness

8mm

8mm

Fiber direction

Other side effects, which may affect between 1 and 10 of every 100 women, include:
• vomitting
• dizziness
• pain in the back or chest
• a metallic taste in the mouth
• anaemia
• breathlessness
• chills
Infrequently some women might experience rapid heartbeat or sweating.
Pabal may cause a build up of water in the body which can lead to drowsiness,
listlessness and headache.
Reporting of side effects
If you get any side effects, talk to your doctor, midwife or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
(see below). By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom: Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971; Fax: +353 6762517;
Website: www.hpra.ie; E-mail: medsafety@hpra.ie

5

How Pabal is stored
Pabal vials are stored in the outer carton in order to protect from light. Store below
30ºC. Do not freeze.
Only clear solutions practically free from particles should be used.
Pabal must not be used after the expiry date printed on the carton and vial.
Pabal should be kept out of sight and reach of children.

6

Contents of the pack and other information
What Pabal contains
The active substance is carbetocin. Each millilitre contains 100 micrograms of
carbecotin. The other ingredients are L-methionine, succinic acid, mannitol, sodium
hydroxide and water for injections.
What Pabal looks like and contents of the pack

F

Pabal is clear colourless solution for injection, ready for intravenous injection,
supplied in packs of five vials of 1ml.

R

Pabal should be used only in well equipped specialist obstetrics units.

O

Marketing Authorisation Holder
UK marketing authorisation holder - PL 03194/0058
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Draton, UB7 7PS,
UK.

N

Irish product authorisation holder - PA 1009/21/1
Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park,
Citywest Road, Dublin 24.
Manfacturer
Ferring GmbH, Wittland 11, D-24109 Kiel, Germany.

T

This medical product is authorised in other Member Stated of the EEA under
the following names: Pabal / DURATOCIN / DURATOBAL
This leaflet was last revised in April 2016.

Pabal, FERRING and the FERRING Logo are trademarks of Ferring B.V.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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