100 micrograms/ml solution for injection
carbetocin
What Pabal is and what it is used for
The active substance in Pabal is carbetocin. It is similar to the substance oxytocin which is produced naturally in the body for the uterus to contract during childbirth.
Pabal is used to treat women who have recently given birth. In some women, the uterus does not contract quickly enough after delivery. This can lead to greater bleeding than normal. Pabal causes the uterus to contract and thus reduces the risk of bleeding.
What you need to know before Pabal is given to you
Pabal must not be given until the baby is born.
Before you receive Pabal, your doctor must tell you if you have any disease. You should also tell your doctor if you get any new symptoms after you have been treated with Pabal.
Pabal should not be given
- if you are pregnant
- during childbirth, before the baby is born
- to initiate labor
- if you are allergic to carbetocin or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to oxytocin (sometimes given as a drip or injection during or after childbirth)
- if you have any disease of the liver or kidneys
- if you have a serious heart disease
- if you have epilepsy
If any of these apply to you, tell your doctor, midwife, or nurse.
Warnings and cautions
Talk to your doctor, midwife, or nurse before giving you Pabal
- if you get a migraine
- if you have asthma
- if you have preeclampsia (high blood pressure during pregnancy) or eclampsia (pregnancy poisoning)
- if you have problems with your heart or circulation (such as high blood pressure )
- if you have any other medical conditions
If any of these apply to you, tell your doctor, midwife, or nurse.
Pabal can cause fluid to accumulate in the body, which in turn can cause drowsiness, apathy, and headaches.
Children and young people
Carbetocin is not intended for use in children under 12 years of age.
Experience from use in adolescents is limited.
Other medicines and Pabal
Tell your doctor, midwife, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Do not use Pabal during pregnancy and childbirth until after the baby is born.
Small amounts of carbetocin have been shown to pass from the breastfeeding mother’s blood to breast milk, but they are expected to be broken down in the infant’s gut. Breastfeeding does not need to be restricted after using Pabal.
How Pabal is given to you
Pabal is given as an injection into one of your veins or muscles immediately after your baby is born. Dose one is one vial (100 micrograms).
If you take more Pabal than you should
If you accidentally take too much Pabal, your uterus may contract so severely that it will be damaged or bleed profusely. You may also become drowsy, apathetic, and have headaches due to fluid accumulating in your body. You will be treated with another medicine and possibly surgery.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Pabal is given in a vein after cesarean section
Very common (may affect more than 1 user in 10)
- nausea
- abdominal pain
- itching
- reddening of the skin
- feeling of warmth
- low blood pressure
- headache
- shaking
Common (may affect up to 1 in 10 people)
- vomiting
- dizziness
- back or chest pain
- metallic taste in the mouth
- anemia _ _ _
- respiratory distress
- overindulge
- general pain
Has been reported (occurs in an unknown number of users)
- palpitation
Side effects are seen with similar products that can be expected with carbetocin:
Slow heartbeat, irregular heartbeat, chest pain, fainting, or palpitations, may mean that the heart is not beating properly.
Occasional cases of sweating have been reported.
When Pabal is given into a muscle after vaginal delivery
Uncommon (may affect up to 1 in 100 people)
- nausea
- abdominal pain
- vomiting
- low blood pressure
- anemia _ _ _
- headache
- dizziness
- palpitation
- back or chest pain
- muscle weakness
- overindulge
- fever
- general pain
Rare (may affect up to 1 in 1,000 people)
- reddening of the skin
- itching
- shortness of breath
- shaking
- difficulty urinating
Side effects are seen with similar products that can be expected with carbetocin:
Slow heartbeat, irregular heartbeat, chest pain, fainting, or palpitations, may mean that the heart is not beating properly.
How to store Pabal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.
The vials should be stored in the outer carton. Sensitive to light. Do not store above 30 ° C. Do not freeze.
The solution should be used immediately after opening the vial.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is carbetocin. Each milliliter contains 100 micrograms of carbetocin.
The other ingredients are L-methionine, succinic acid, mannitol, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
Pabal is a clear and colorless, ready-to-use solution for intravenous or intramuscular injection. Pabal is supplied in packs of 5 vials of 1 ml.
Pabal should only be used in well-equipped maternity clinics.
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Tel: +46 40 691 69 00
Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany