Duratobal 100 micrograms/ml solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DURATOBAL 100 micrograms/ml injection solution
Carbetocin
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the package leaflet
- What DURATOBAL is and what it is used for
- What you need to know before using DURATOBAL
- How to use DURATOBAL
- Possible side effects
- How to store DURATOBAL
- Contents of the pack and other information
1. What DURATOBAL is and what it is used for
The active substance in DURATOBAL is carbetocine. It is similar to a substance called oxytocin, which is naturally produced by the body to contract the uterus during childbirth.
DURATOBAL is used for the treatment of women who have just given birth.
In some women, after childbirth, the uterus does not contract quickly enough. This increases the likelihood of excessive bleeding. DURATOBAL causes the uterus to contract, thereby reducing the risk of bleeding.
2. What you need to know before using DURATOBAL
DURATOBAL must not be used until after the child has been delivered.
Before using DURATOBAL, your doctor must be aware of any medical conditions you may have. You must inform your doctor of any new symptoms that develop while you are being treated with DURATOBAL.
Do not use DURATOBAL:
- if you are pregnant
- if you are in labour and the child has not yet been delivered
- to induce labour
- if you are allergic to carbetocin or to any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to oxytocin (whether administered by infusion or by injection during or after childbirth)
- if you have any kidney or liver disease
- if you have any severe coronary disease
- if you have epilepsy (repeated episodes of seizures, loss of consciousness)
If you experience any of these symptoms, consult your doctor, midwife, or nurse.
Warnings and precautions
Inform your doctor, midwife, or nurse before receiving DURATOBAL:
- if you suffer from migraine (recurring headaches)
- if you have asthma (a respiratory disorder with repeated episodes of breathing difficulty, wheezing, and coughing)
- if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (toxemia of pregnancy—severe agitation, involuntary movements)
- if you have heart or circulatory problems (such as high blood pressure)
- if you have any other medical condition
If you experience any of these symptoms, consult your doctor, midwife, or nurse.
DURATOBAL may cause water retention in the body, which can lead to drowsiness, apathy, and headache.
Children and adolescents
Not relevant in children under 12 years of age.
Experience with adolescents is limited.
Use of Duratobal with other medicines
Inform your doctor, midwife, or nurse if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
DURATOBAL must not be used during pregnancy and childbirth until after the child has been delivered.
Small amounts of carbetocin have been shown to pass from the blood of breastfeeding mothers into breast milk; however, it is assumed to be degraded in the infant's intestine. Breastfeeding does not need to be restricted after the use of DURATOBAL.
3. How to use DURATOBAL
DURATOBAL is administered by injection into one of your veins or into one of your muscles, immediately after delivery of your baby. The dose is one vial (100 micrograms).
If you use more DURATOBAL than you should:
If you accidentally use more DURATOBAL than you should, you may experience uterine hyperstimulation with strong contractions, which could lead to uterine rupture or postpartum hemorrhage. You may also experience somnolence, apathy, and headache caused by fluid accumulation. Treatment with other medications and possibly surgery will be required.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
When DURATOBAL is administered into one of your veins after a caesarean section
Very common: may affect more than 1 in 10 women
- nausea
- stomach pain
- pruritus (itching)
- flushing (red skin)
- sensation of warmth
- low blood pressure
- headache
- tremors
Common: up to 1 in 10 women
- vomiting
- dizziness
- back or chest pain
- metallic taste in the mouth
- anaemia (reduction in red blood cells)
- dyspnoea (difficulty breathing)
- chills
- general pain
Not known: frequency cannot be estimated from available data
- Increased heart rate, slow heartbeats that may lead to cardiac arrest (when the heart stops beating)
- Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness)
Side effects observed with similar products that could also be expected with carbetocin:
Irregular heartbeat, chest pain, fainting or palpitations, which may mean that the heart is not beating properly.
Occasionally, some women may experience sweating.
When DURATOBAL is administered into one of your muscles after vaginal delivery
Uncommon: may affect up to 1 in 100 women
- nausea
- stomach pain
- vomiting
- low blood pressure
- anaemia
- headache
- dizziness
- rapid heartbeat
- back or chest pain
- muscle weakness
- chills
- fever
- general pain
Rare: may affect less than 1 in 1,000 women
- flushing (red skin)
- pruritus (itching)
- dyspnoea (difficulty breathing)
- tremors
- difficulty urinating
Not known: frequency cannot be estimated from available data
- Allergic reactions (including severe and sudden allergic reaction with difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, low blood pressure, and loss of consciousness)
Side effects observed with similar products that could also be expected with carbetocin:
Slow heartbeat, irregular heartbeat, chest pain, fainting or palpitations, which may mean that the heart is not beating properly.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of DURATOBAL
Keep this medicine out of the sight and reach of children.
Do not use DURATOBAL after the expiry date stated on the pack or vial after EXP. The expiry date is the last day of the month indicated.
DURATOBAL vials should be kept in the original packaging to protect from light. Store below 30°C. Do not freeze.
The solution should be used immediately after opening the vial.
6. Contents of the pack and other information
Composition of DURATOBAL:
The active substance is carbetocin. Each millilitre contains 100 micrograms of carbetocin.
The other components are: L-methionine, succinic acid, mannitol, sodium hydroxide and water for injection.
Appearance of DURATOBAL and contents of the pack:
Duratobal is a clear, colourless injectable solution intended for intravenous and intramuscular injection, supplied in packs of five 1-millilitre vials.
DURATOBAL should only be used in well-equipped, specialized obstetric units.
Marketing Authorization Holder:
FERRING S.A.U.
C/ del Arquitecto Sánchez Arcas 3, 1º
Madrid 28040
Spain
Manufacturer:
FERRING GMBH
Wittland 11, D-24109 Kiel
Germany
This medicinal product is authorized in other EEA Member States under the following names:
PABAL/ DURATOCIN.
This text was approved in June 2023