Tractocile
7.5 mg/ml solution for injection
atosiban
Read all of this leaflet carefully before you start using this medicine
- This leaflet contains practical information on TRACTOCILE.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, midwife or pharmacist.
- TRACTOCILE is a medicinal product to be used in hospital and should only be administered under supervision of experienced hospital personnel.
In this leaflet:
- 1. What TRACTOCILE is and what it is used for
- 2. Before you use TRACTOCILE
- 3. How to use TRACTOCILE
- 4. Possible side effects
- 5. Storing TRACTOCILE
- 6. Further information
TRACTOCILE 7.5 mg/ml, solution for injection
atosiban
The active substance is atosiban.
The other ingredients are mannitol, hydrochloric acid and water for injections.
Marketing Authorisation Holder and Manufacturer
What Tractocile Is And What It Is Used For
Each vial of TRACTOCILE 7.5 mg/ml, solution for injection, contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Atosiban blocks the ability of the natural hormone oxytocin to cause the uterus (womb) to contract. TRACTOCILE can be used to decrease the frequency and intensity of uterine contractions in pregnant women in order to delay a premature birth.
Before You Use Tractocile
Do not use TRACTOCILE:
- if your pregnancy is less than 24 weeks or more than 33 weeks
- if you have premature rupture of the membranes after 30 weeks of pregnancy
- if the fetus is growing insufficiently and has an abnormal fetal heart rate
- if you experience uterine bleeding that requires immediate delivery
- if you have severe pre-eclampsia (high blood pressure, fluid retention and/or protein in the urine) or eclampsia (convulsions associated with pre-eclampsia) requiring delivery
- if the fetus has died
- if you have a suspected infection of the uterus
- if the placenta is covering the birth canal
- if the placenta is detaching
- if you or the fetus have conditions in which continuation of pregnancy are regarded undesirable or hazardous
- if you are allergic to atosiban or any of the other ingredients of TRACTOCILE
Take special care wilh TRACTOCILE:
- if premature rupture of your membranes cannot be excluded
- if you have kidney or liver problems
- if the placenta is not in a normal position
- if you have a multiple pregnancy or a pregnancy between 24 and 27 weeks
- if contractions recur, treatment with TRACTOCILE can be repeated up to three more times
- if the fetus is small tor the time of pregnancy
- during treatment with TRACTOCILE, your contractions and the fetal heart rate may be monitored
- after your baby has been delivered, TRACTOCILE may theoretically reduce the ability of the uterus to contract. This may cause bleeding.
Using other medicines:
Please tell your doctor, midwife or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
How To Use Tractocile
TRACTOCILE is a medicine that is used only in hospital and should only be administered by qualified staff.
Before using TRACTOCILE, the solution should be examined to ensure it is clear and free from particles.
TRACTOCILE 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 dose of 18 mg/hour is given for 3 hours.
- A continuous infusion at a dose of 6 mg/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 TRACTOCILE can be used should contractions recur. It is recommended that no more than three re-treatments should be used during a pregnancy.
Preparation of the intravenous infusion
The intravenous infusion is prepared by diluting TRACTOCILE 7.5 mg/ml, concentrate for solution for infusion in 0.9% w/v sodium chloride solution, 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 TRACTOCILE 7.5 mg/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.
TRACTOCILE should not be mixed with other medicinal products in the infusion bag.
Possible Side Effects
Like all medicines, TRACTOCILE can have side effects. The observed side effects for the mother were generally of a mild severity. There are no known side effects on the fetus or newborn baby.
For the mother the most commonly reported side effects are nausea, headache, dizziness, hot flushes, vomiting, rapid heart beat, low blood pressure, injection site reaction and high blood sugar.
Uncommon side effects include fever, insomnia, itching and rash. Rare side effects include a reduction in the ability of the uterus to contract after your baby has been delivered, which may cause bleeding. Allergic reaction has been rarely reported.
If you notice these or any other side effects not mentioned in this leaflet, please inform your doctor, midwife or pharmacist.
Storing Tractocile
Keep out of the reach and sight of children.
Store in a refrigerator (2°C- 8°C).
Store in the original package.
Do not use after the expiry date stated on the label.
Do not use TRACTOCILE it you notice particulate matter and discoloration prior to administration.
Once the vial has been opened, the product must be used immediately.
Further Information
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved on 31 January 2005.
48 13 01
No comments:
Post a Comment