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DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION

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About the medicine

How to use DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for theuser

DURATOBAL 100 micrograms/ml solution for injection

Carbetocin

Read all of this leaflet carefully before you start usingthis medicine, because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What DURATOBAL is and what it is used for
  2. What you need to know before you use DURATOBAL
  3. How to use DURATOBAL
  4. Possible side effects
  5. Storage of DURATOBAL
  6. Contents of the pack and further information

1. What DURATOBAL is and what it is used for

The active substance of DURATOBAL is carbetocin. It is similar to a substance called oxytocin, which is produced naturally by the body to contract the uterus during childbirth.

DURATOBAL is used in the treatment of women who have just given birth.

In some women, after childbirth, the uterus (womb) does not contract quickly enough. This makes it more likely that they will bleed more than usual. DURATOBAL makes the uterus contract and thus reduces the risk of bleeding.

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Doctor consultation

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2. What you need to know before you use DURATOBAL

DURATOBAL should not be used until after the baby has been delivered.

Before using DURATOBAL, your doctor should know about any diseases you may have. You should tell your doctor about any new symptoms that develop while you are being treated with DURATOBAL.

Do not use DURATOBAL:

  • if you are pregnant
  • if you are in labor and the baby has not yet been delivered
  • to induce labor
  • if you are allergic to carbetocin or any of the other components of this medicine (listed in section 6)
  • if you are allergic to oxytocin (whether administered by drip or 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 convulsions, loss of consciousness)

If you experience any of these symptoms, consult your doctor, midwife, or nurse.

Warnings and precautions

Tell your doctor, midwife, or nurse before receiving DURATOBAL

  • if you have migraines (recurring headaches)
  • if you have asthma (respiratory disorder with recurring episodes of difficulty breathing, wheezing, and coughing)
  • if you have pre-eclampsia (high blood pressure during pregnancy) or eclampsia (toxemia of pregnancy - intense agitation, involuntary movements)
  • if you have heart or circulation problems (such as high blood pressure)
  • if you have any other disease

If you experience any of these symptoms, consult your doctor, midwife, or nurse.

DURATOBAL may cause water retention in the body, which can cause drowsiness, apathy, and headache.

Children and adolescents

Not relevant in children under 12 years.

Experience with adolescents is limited.

Using DURATOBAL with other medicines

Tell your doctor, midwife, or nurse if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

DURATOBAL should not be used during pregnancy and childbirth until the baby has been delivered.

It has been seen that small amounts of carbetocin pass from the blood of breastfeeding mothers into breast milk, but it is assumed to be degraded in the infant's intestine. Breastfeeding does not need to be restricted after using DURATOBAL.

3. How to use DURATOBAL

DURATOBAL is administered by injection into one of your veins or into one of your muscles, immediately after the delivery of your baby. The dose is one vial (100 micrograms).

If you use more DURATOBAL than you should:

If you have accidentally used more DURATOBAL than you should, you may experience uterine hyperactivity with strong contractions that can lead to uterine rupture or postpartum hemorrhage. You may also experience drowsiness, apathy, and headache caused by fluid retention. You should be treated with other medication and possible surgery.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When DURATOBAL is administered into one of your veins after acesarean

Very common: may affect more than 1 in 10 women

  • nausea
  • stomach pain
  • pruritus (itching)
  • flushing (red skin)
  • feeling of warmth
  • low blood pressure
  • headache
  • tremors

Common: may affect up to 1 in 10 women

  • vomiting
  • dizziness
  • back or chest pain
  • metallic taste in the mouth
  • anemia (reduced red blood cells)
  • shortness of breath
  • chills
  • general pain

Unknown: frequency cannot be estimated from the available data

  • Accelerated heart rate, slow heart rate that can cause 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 may be expected with carbetocin:

Irregular heartbeats, chest pain, fainting or palpitations that may indicate that the heart is not beating correctly.

Occasionally, some women may experience sweating.

When DURATOBAL is administered into one of your muscles after a vaginal delivery

Uncommon: may affect up to 1 in 100 women

  • nausea
  • stomach pain
  • vomiting
  • low blood pressure
  • anemia
  • 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)
  • shortness of breath
  • tremors
  • difficulty urinating

Unknown: frequency cannot be estimated from the 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 may be expected with carbetocin:

Slow heart rate, irregular heartbeats, chest pain, fainting or palpitations that may indicate that the heart is not beating correctly.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side 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 which is stated on the carton or vial after EXP. The expiry date is the last day of the month shown.

The vials of DURATOBAL are stored in the original package 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 further information

Composition of DURATOBAL:

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 injection.

Appearance of DURATOBAL and contents of the pack.

Duratobal is a clear and colorless solution for injection, prepared for intravenous and intramuscular injection, and provided in packs of five 1 milliliter vials.

DURATOBAL should only be used in specialized obstetric units that are well equipped.

Marketing Authorization Holder:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas 3, 1º

Madrid 28040

Spain

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Manufacturer:

FERRING GMBH

Wittland 11, D-24109 Kiel

Germany

This medicine is authorized in other EEA Member States under the following names:

PABAL/ DURATOCIN.

This text was approved in June 2023

Online doctors for DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION

Discuss questions about DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Lisa Drigo

Paediatrics 34 years exp.

Dr Lisa Drigo is an experienced paediatrician based in Italy with over 30 years of clinical practice. She graduated from Università Cattolica del Sacro Cuore in Rome and has spent decades working within the Italian healthcare system, supporting children and families with both acute care and long-term prevention.

She is well familiar with Italian paediatric standards, including local vaccination schedules, preventive check-ups, growth monitoring, and everyday medical issues faced by families living in Italy. This makes her consultations especially valuable for parents who want guidance that aligns with local medical practice.

Her primary focus is paediatrics, with additional support in family medicine when a child’s health needs to be assessed in a broader family or preventive context.

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Dr Drigo communicates in a clear, calm, and reassuring way, helping parents understand what is happening and what steps to take next. Online consultations allow families to receive reliable paediatric guidance aligned with Italian medical practice, without unnecessary stress or waiting.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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General internal medicine and preventive care:
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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Frequently Asked Questions

Is a prescription required for DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION?
DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION?
The active ingredient in DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION is carbetocin. This information helps identify medicines with the same composition but different brand names.
Who manufactures DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION?
DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION is manufactured by Ferring S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to DURATOBAL 100 micrograms/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (carbetocin) include CARBETOCINA GP-PHARM 100 micrograms Injectable Solution in Pre-filled Syringe, OXITOCIN KABI 10 IU/ML INJECTABLE SOLUTION AND PERFUSION SOLUTION, SYNTOCINON 10 IU/mL Injectable Solution and Perfusion Solution. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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