What is Atosiban SUN - atosiban used for?
Atosiban SUN is a medicine that contains the active substance atosiban . It is used to delay delivery in adult patients and is found between the 24th and 33rd week of pregnancy, if there are signs of a preterm (premature) birth. These signals include:
- at least four regular contractions every 30 minutes of at least 30 seconds each;
- cervical dilation (of the cervix) of 1-3 cm and disappearance of the cervix (reduction of its thickness) by at least 50%.
Furthermore, the child must have a normal heartbeat. Atosiban SUN is a "generic medicine". This means that Atosiban SUN is similar to a 'reference medicine' already authorized in the European Union (EU) called Tractocile. For more information on generic medicines, see the questions and answers by clicking here.
How is Atosiban SUN - atosiban used?
Atosiban SUN can only be obtained with a prescription. Treatment with Atosiban SUN should be conducted by physicians experienced in the management of preterm labor. Treatment should be started as soon as possible after this diagnosis. Atosiban SUN is available as a solution for injection and as a concentrate for the preparation of a solution for infusion (drip) into a vein. It is given into a vein over a maximum of 48 hours in three phases: an initial injection into a vein (6.75 mg), followed by a high-dose drip (18 mg per hour) over three hours, then by infusion at lower dosage (6 mg per hour) for a maximum duration of 45 hours. In the event that the contractions recur, it is possible to repeat the treatment with Atosiban SUN up to a maximum of three times during the pregnancy.
How does Atosiban SUN - atosiban work?
The active ingredient of Atosiban SUN, atosiban, is an antagonist of the natural hormone oxytocin. This means that atosiban blocks the action of oxytocin. Oxytocin is the hormone responsible for the onset of uterine contractions. By blocking the action of oxytocin, Atosiban SUN prevents uterine contractions and causes uterine relaxation, helping to delay birth.
How has Atosiban SUN - atosiban been studied?
The company presented data taken from the scientific literature. No further studies were necessary as Atosiban SUN is a generic medicine given by infusion or injection and contains the same active substance as the reference medicine, Tractocile.
What are the benefits and risks of Atosiban SUN - atosiban?
Because Atosiban SUN is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Atosiban SUN - atosiban been approved?
The CHMP concluded that, in accordance with EU requirements, Atosiban Sun has been shown to have comparable quality and to be comparable to Tractocile. Therefore, the CHMP considered that, as in the case of Tractocile, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Atosiban SUN.
What measures are being taken to ensure the safe and effective use of Atosiban SUN - atosiban?
A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atosiban SUN, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Atosiban SUN - atosiban
On 31 July 2013, the European Commission issued a marketing authorization for Atosiban SUN, valid throughout the European Union. For more information on Atosiban SUN therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 07-2013.
