Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml)
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Atosiban acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR
Atosiban sterile concentrate contains atosiban. Atosiban can be used to delay the premature birth of your baby. Atosiban is used in pregnant adult women, from week 24 to week 33 of the pregnancy. Atosiban works by making the contractions in your womb (uterus) less strong. It also makes the contractions happen less often. It does this by blocking the effect of a natural hormone in your body called "oxytocin" which causes your womb (uterus) to contract. 2.
What you need to know before you take it
ATOSIBAN
Do not use Atosiban
- if you are less than 24 weeks pregnant
- if you are more than 33 weeks pregnant
- if your waters have broken (premature rupture of your membranes) and you have completed 30 weeks of your pregnancy or more
- if your unborn baby (foetus) has an abnormal heart rate
- if you have bleeding from your vagina and your doctor wants your unborn baby to be delivered straight away
- if you have something called "severe pre-eclampsia" and your doctor wants your unborn baby to be delivered straight away. Severe pre-eclampsia is when you have very high blood pressure, fluid retention and/or protein in your urine
- if you have something called "eclampsia" which is similar to "severe pre-eclampsia" but you would also have fits (convulsions). This will mean your unborn baby needs to be delivered straight away
- if your unborn baby has died
- if you have or could have an infection of your womb (uterus)
- if your placenta is covering the birth canal 1
• • •
if your placenta is detaching from the wall of your womb if you or your unborn baby have any other conditions where it would be dangerous to continue with your pregnancy if you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Do not use Atosiban if any of the above apply to you. If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban. Warnings and precautions Talk to your doctor, midwife or pharmacist before you are given Atosiban
- if you think your waters might have broken (premature rupture of your membranes)
- if you have kidney or liver problems
- if you are between 24 and 27 weeks pregnant
- if you are pregnant with more than one baby
- if your contractions start again, treatment with Atosiban can be repeated up to three more times
- if your unborn baby is small for the time of your pregnancy
- your womb may be less able to contract after your baby has been born. This may cause bleeding
- if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure. This may increase the risk of lung oedema (accumulation of fluid in the lungs). If any of the above apply to you (or you are not sure), talk to your doctor, midwife or pharmacist before you are given Atosiban. Children and adolescents Atosiban has not been studied in pregnant women less than 18 years old. Other medicines and Atosiban Tell your doctor, midwife or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant and breast-feeding an earlier child, you should stop breast-feeding while you are given Atosiban. 3.
How to take it
Atosiban will be given to you in a hospital by a doctor, nurse or midwife. They will decide how much you need. They will also make sure the solution is clear and free from particles. Atosiban will be given into a vein (intravenously) in three stages:
- The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute
- Then a continuous infusion (drip) will be given at a dose of 18 mg per hour for 3 hours
- Then another continuous infusion (drip) at a dose of 6 mg per hour will be given for up to 45 hours, or until your contractions have stopped. Treatment should last no longer than 48 hours in total. Further treatment with Atosiban can be used if your contractions start again. Treatment with Atosiban can be repeated up to three more times. 2
During treatment with Atosiban, your contractions and your unborn baby's heart rate may be monitored. It is recommended that no more than three re-treatments should be used during a pregnancy. 4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects seen in the mother are generally of a mild severity. There are no known side effects on the unborn or new-born baby. The following side effects may happen with this medicine. Very common (affects more than 1 in 10 people)
- Feeling sick (nausea). Common (affects less than 1 in 10 people)
- Headache
- Feeling dizzy
- Hot flushes
- Being sick (vomiting)
- Fast heartbeat
- Low blood pressure. Signs may include feeling dizzy or light-headed
- A reaction at the site where the injection was given
- High blood sugar. Uncommon (affects less than 1 in 100 people)
- High temperature (fever)
- Difficulty sleeping (insomnia)
- Itching
- Rash. Rare (affects less than 1 in 1,000 people)
- Your womb may be less able to contract after your baby has been born. This may cause bleeding
- Allergic reactions. You may experience shortness of breath or lung oedema (accumulation of fluid in the lungs), particularly if you are pregnant with more than one baby and/or are given medicines that can delay the birth of your baby, such as medicines used for high blood pressure. Reporting of side effects If you get any side effects, talk to your doctor, midwife or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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5.
How to store it
ATOSIBAN
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 label after EXP. The expiry date refers to the last day of that month. Once the vial has been opened, the product must be used immediately. Store in a refrigerator (2°C – 8°C). Store in the original package in order to protect from light. Solution after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 oC. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 oC, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions. Do not use this medicine if you notice particulate matter and discoloration prior to administration. 6.
Contents of the pack and other information
What Atosiban contains The active substance is atosiban. Each vial (5 ml) of Atosiban 37.5 mg/5 ml concentrate for solution for infusion contains 37.5 mg of atosiban (as acetate). Each ml of solution contains 7.5 mg atosiban. The other ingredients are mannitol, hydrochloric acid concentrated and water for injections. What Atosiban looks like and contents of the pack Atosiban 37.5 mg/5 ml concentrate for solution for infusion (sterile concentrate) is a clear, colourless solution without particles. One pack contains one vial containing 5 ml solution. Colourless glass vial, clear, Type I, sealed with grey bromo-butyl rubber stopper type I, and blue flip-off cap. Marketing Authorisation Holder Ibigen S.r.l. Via Fossignano 2 04011 Aprilia (LT) Italy Manufacturer Altan Pharmaceuticals, S.A. Avda. de la Constitución, 198-199 Polígono Industrial Monte Boyal 45950 Casarrubios del Monte (Toledo) Spain This leaflet was last revised in 06/2020 ———————————————————————————————————————–4
The following information is intended for healthcare professionals only (see also section 3): Instructions for use Before using Atosiban, the solution should be examined to ensure it is clear and free from particles. Atosiban is given intravenously in three successive stages. − The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute − A continuous infusion at a rate of 24 ml/hour is given for 3 hours − A continuous infusion at a rate of 8 ml/hour is given for up to 45 hours, or until the contractions of the uterus have subsided. The total duration of the treatment should be no more than 48 hours. Further treatment cycles of Atosiban can be used should contractions recur. It is recommended that no more than three retreatments should be used during a pregnancy. Preparation of the intravenous infusion solution The intravenous infusion is prepared by diluting Atosiban 37.5 mg/5 ml concentrate for solution for infusion in: − sodium chloride 9 mg/ml (0.9%) solution for injection − Ringer's lactate solution or − 5% w/v glucose solution. This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Atosiban 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml. If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation. Atosiban should not be mixed with other medicinal products in the infusion bag. Solution after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 oC. From a microbiological point of view, the product should be used immediately. If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 oC, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.
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Frequently asked questions about Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml)
How do I take Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml)?
Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml) comes as infusion containing 37.5mg / 5ml / 7.5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml)?
The active substance in Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml) is atosiban acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml) without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: atosiban acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Atosiban is indicated to delay imminent pre-term birth in pregnant adult women with:
− regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes
− a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%
− a gestational age from 24 until 33 completed weeks
− a normal foetal heart rate
4.2. Posology and method of administration
Posology
Treatment with Atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.
Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Atosiban therapy should preferably not exceed 330.75 mg of atosiban.
Intravenous therapy using the initial bolus injection of Atosiban 6.75 mg/0.9 ml solution for injection (see Summary of Product Characteristics of this product) should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion. In the case of persistence of uterine contractions during treatment with Atosiban, alternative therapy should be considered.
The following table shows the full posology of the bolus injection followed by the infusion.
Step
Regimen
Infusion rate
Atosiban dose
1
2
3
0.9 ml intravenous bolus injection given over 1 minute
3 hours intravenous loading infusion
Up to 45 hours subsequent intravenous infusion
Not applicable
24 ml/hour (300 µg/min)
8 ml/hour (100 µg/min)
6.75 mg
54 mg
Up to 270 mg
Re-treatment
In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of Atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with Atosiban 37.5 mg/5 ml, concentrate for solution for infusion.
Patients with renal or hepatic impairment
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution.
Paediatric population
The safety and efficacy of Atosiban in pregnant women aged less than 18 years have not been established.
No data are available.
Method of administration
For instructions on preparation of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Atosiban must not be used in the following conditions:
− Gestational age below 24 or over 33 completed weeks
− Premature rupture of the membranes >30 weeks of gestation
− Abnormal foetal heart rate
− Antepartum uterine haemorrhage requiring immediate delivery
− Eclampsia and severe pre-eclampsia requiring delivery
− Intrauterine foetal death
− Suspected intrauterine infection
− Placenta praevia
− Abruptio placenta
− Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous
− Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
When atosiban is used in patients in whom premature rupture of membranes cannot be excluded, the benefits of delaying delivery should be balanced against the potential risk of chorioamnionitis.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Renal impairment is not likely to warrant a dose adjustment, since only a small extent of atosiban is excreted in the urine. In patients with impaired hepatic function, atosiban should be used with caution (see sections 4.2 and 5.2).
There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated. The benefit of atosiban in these subgroups is therefore uncertain.
Re-treatment with Atosiban is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
In case of intrauterine growth retardation, the decision to continue or reinitiate the administration of Atosiban depends on the assessment of fetal maturity.
Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored. However, inadequate uterus contraction postpartum was not observed during the clinical trials.
Multiple pregnancy and medicinal products with tocolytic activity like calcium channel blockers and beta-mimetics are known to be associated with increased risk of pulmonary oedema. Therefore, atosiban should be used with caution in case of multiple pregnancy and/or concomitant administration of other medicinal products with tocolytic activity (see section 4.8).
4.5. Interaction with other medicinal products and other forms of interaction
It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes.
Interaction studies have been performed with labetalol and betamethasone in healthy, female volunteers. No clinically relevant interaction was found between atosiban and bethamethasone or labetalol.
4.6. Fertility, pregnancy and lactation
Pregnancy
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation. If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with Atosiban, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Breastfeeding
In atosiban clinical trials no effects were observed on breast-feeding. Small amounts of atosiban have been shown to pass from plasma into the breast milk of breast-feeding women.
Fertility
Embryo-fetal toxicity studies have not shown toxic effects of atosiban. No studies were performed that covered fertility and early embryonic development (see section 5.3).
4.7. Effects on ability to drive and use machines
Not relevant.
4.8. Undesirable effects
Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials. The observed adverse reactions were generally of a mild severity. The most commonly reported adverse reaction in the mother is nausea (14 %).
For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban. The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
The frequency of adverse reactions listed below is defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA System Organ Class (SOC)
Very common
Common
Uncommon
Rare
Immune system disorders
Allergic reaction
Metabolism and nutrition disorders
Hyperglycaemia
Psychiatric disorder
Insomnia
Nervous system disorders
Headache, Dizziness
Cardiac disorders
Tachycardia
Vascular disorders
Hypotension, Hot flush
Gastrointestinal disorders
Nausea
Vomiting
Skin and subcutaneous tissue disorders
Pruritis, Rash
Reproductive system and breast disorder
Uterine haemorrhage, uterine atony
General disorders and administration site conditions
Injection site reaction
Pyrexia
Post-marketing experience
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and beta-mimetics, and/or in women with multiple pregnancy, have been reported post-marketing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms. There is no known specific treatment in case of an overdose.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- TRACTOCILE 7,5mg/ml prescriptionATOSIBANUM · injection / infusion
- ATOSIBAN EVER PHARMA 37,5 mg/5 ml prescriptionATOSIBANUM · injection / infusion
- ATOSIBAN EVER PHARMA 6,75 mg/0,9 ml prescriptionATOSIBANUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- TractocileAtosibanum · injection / infusion
- Atosiban SUNAtosibanum · injection / infusion
- Atosiban AccordAtosibanum · injection / infusion
- Atosiban EVER PharmaAtosibanum · injection / infusion
- Atosiban MercapharmAtosibanum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Atosiban 37.5mg/5ml concentrate for solution for infusion vials (7.5mg/ml). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.