PABAL 100 MICROGRAMS IN 1ML OF SOLUTION FOR INJECTION
Active substance: CARBETOCIN
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In some women, after a caesarean, the womb (uterus) doesnt contract (shrink) quickly enough. This makes it more likely that theyll 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 Before you are treated with PABAL
PABAL must not be given until after the baby has been delivered. Before giving you 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.
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.
Read all of this leaflet carefully before you are given an injection of PABAL. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, midwife or nurse. If you have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor, midwife or nurse.
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.
In this leaflet
1 2 3 4 5 6 What PABAL is and what it is used for Before you are treated with PABAL How PABAL is given to you Possible side effects How PABAL is stored Further information
Taking other medicines
Tell your doctor if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.
1 What PABAL is and what it is used for
PABAL is used to treat women who have just had a baby by caesarean section.
Pregnancy and breast-feeding
PABAL must not be used during pregnancy, but may be given after delivery by Caesarean section.
Small amounts of carbotocin have been shown to pass from the nursings mother's blood into the breast milk, but it is assumed to be degraded in the infant's bowels.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, midwife, or nurse.
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 ampoule (100 micrograms).
5 How PABAL is stored
PABAL ampoules are stored in the outer carton in order to protect from light. Store in a refrigerator (2C-8C). Do not freeze. PABAL must not be used after the expiry date printed on the carton and ampoule. PABAL should be kept out of reach and sight of children.
If someone is given too much PABAL
If you are accidentally 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.
6 Further information
What PABAL contains:
The active substance is carbetocin. Each millilitre contains 100 micrograms of carbetocin. The other ingredients are sodium chloride, glacial acetic acid, water for injections. Pabal contains less than 1 mmol sodium chloride (23mg) per dose, so it is essentially 'sodium-free'. What PABAL looks like and contents of the pack: Pabal is clear colourless solution for injection, ready for intravenous injection, supplied in packs of five 1ml ampoules. PABAL should be used only in well equipped specialist obstetrics units. UK marketing authorisation holder Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton UB7 7PS (UK). Irish product authorisation holder Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24. Manufacturer Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. This medicinal product is authorised in other Member States of the EEA under the following names: DURATOCIN / DURATOBAL.
PABAL 100 micrograms /ml solution for injection PL 03194/0058 PA 1009/21/1 This leaflet was last revised in October 2011. PABAL is a registered trademark.
4 Possible side effects
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 headaches shakiness Other side effects , which may affect between 1 and 10 of every 100 women, include: vomiting 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.
2 Before you are treated with PABAL
PABAL must not be given until after the baby has been delivered. Before giving you 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.
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.
Read all of this leaflet carefully before you are given an injection of PABAL. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, midwife or nurse. If you have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor, midwife or nurse.
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.
In this leaflet
1 2 3 4 5 6 What PABAL is and what it is used for Before you are treated with PABAL How PABAL is given to you Possible side effects How PABAL is stored Further information
Taking other medicines
Tell your doctor if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.
1 What PABAL is and what it is used for
PABAL is used to treat women who have just had a baby by caesarean section.
Pregnancy and breast-feeding
PABAL must not be used during pregnancy, but may be given after delivery by Caesarean section.
Small amounts of carbotocin have been shown to pass from the nursings mother's blood into the breast milk, but it is assumed to be degraded in the infant's bowels.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, midwife, or nurse.
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 ampoule (100 micrograms).
5 How PABAL is stored
PABAL ampoules are stored in the outer carton in order to protect from light. Store in a refrigerator (2C-8C). Do not freeze. PABAL must not be used after the expiry date printed on the carton and ampoule. PABAL should be kept out of reach and sight of children.
If someone is given too much PABAL
If you are accidentally 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.
6 Further information
What PABAL contains:
The active substance is carbetocin. Each millilitre contains 100 micrograms of carbetocin. The other ingredients are sodium chloride, glacial acetic acid, water for injections. Pabal contains less than 1 mmol sodium chloride (23mg) per dose, so it is essentially 'sodium-free'. What PABAL looks like and contents of the pack: Pabal is clear colourless solution for injection, ready for intravenous injection, supplied in packs of five 1ml ampoules. PABAL should be used only in well equipped specialist obstetrics units. UK marketing authorisation holder Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton UB7 7PS (UK). Irish product authorisation holder Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24. Manufacturer Ferring GmbH, Wittland 11, D-24109 Kiel, Germany. This medicinal product is authorised in other Member States of the EEA under the following names: DURATOCIN / DURATOBAL.
PABAL 100 micrograms /ml solution for injection PL 03194/0058 PA 1009/21/1 This leaflet was last revised in October 2011. PABAL is a registered trademark.
4 Possible side effects
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 headaches shakiness Other side effects , which may affect between 1 and 10 of every 100 women, include: vomiting 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.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
