Patient Leaflet Updated 06-Jul-2021 | EVER Valinject GmbH / Kent Pharma UK Ltd
OXYTOCIN 5 IU & 10 IU Solution for Injection
PATIENT INFORMATION LEAFLET
OXYTOCIN 5 IU
OXYTOCIN 10 IU
Solution for Injection
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Oxytocin 5 IU and Oxytocin 10 IU solutions for injection are and what they are used for
2. Before you take Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
3. How to take Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
4. Possible side effects
5. Storing your Oxytocin 5 IU and Oxytocin 10 IU solutions for injection
6. Contents of the pack and other information
1. WHAT OXYTOCIN 5 IU SOLUTION FOR INJECTION OR OXYTOCIN 10 IU SOLUTION FOR INJECTION ARE AND WHAT THEY ARE USED FOR.
Each Oxytocin ampoule contains oxytocin EP, 5 IU (International Units) or 10 IU in 1 ml solution, equivalent to 8.5 micrograms or 17 micrograms respectively. Oxytocin is a drug that belongs to the group of medicines called oxytocins and it is identical with oxytocin, a hormone released by the pituitary gland, which has an effect on the muscles of the uterus (womb). Oxytocin is used to help the muscles of the womb contract.
Oxytocin may be used to induce labour, or to stimulate labour where the contractions are not adequate, or after delivery of the baby where there may be weak or absent contraction of the uterus or to prevent or treat uterine bleeding. It may also be used during caesarean section or as additional therapy for the management of miscarriage.
2. BEFORE YOU TAKE OXYTOCIN 5 IU SOLUTION FOR INJECTION OR OXYTOCIN 10 IU SOLUTION FOR INJECTION
Do not take Oxytocin:
Oxytocin will not be used for a prolonged period if:
Special care with Oxytocin will be taken:
Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Oxytocin:
Each ampoule contains 2.9 mg (0.13 mmol) of sodium.
The active substance in might cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Please tell your doctor if you know you are allergic to latex.
3. TREATMENT WITH OXYTOCIN
Oxytocin should only be given under medical supervision and in a hospital.
The dose used will vary depending on the reason for its use.
If you receive more Oxytocin than you should or if you miss a dose:
As this medicine will be given to you by a healthcare professional in hospital, it is very unlikely that an overdose or missed dose will happen.
If you have any further questions on the use of this product, ask your doctor or midwife.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxytocin can cause side effects, although not everybody gets them.
Rare side effects (more than 1 in 10,000 patients) of Oxytocin include:
Very rarely, if high doses of Oxytocin are given with large volumes of fluids through a drip the condition of water intoxication may occur.
Symptoms may include:
Exceptionally, side effects of Oxytocin include: skin rashes and anaphylactoid reactions, hypotension, or anaphylactic shock.
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or midwife.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OXYTOCIN
The hospital pharmacy will store this medicine in a refrigerator at 2°C to 8°C. It may be stored at 25°C for 6 months, but then discarded.
Keep Oxytocin out of the reach and sight of children.
The pharmacy will not use OXYTOCIN after the expiry date that is stated on the label.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Oxytocin contains:
The active substance is oxytocin.
The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid, glacial and water for injection.
What Oxytocin looks like and contents of the pack:
Your medicinal product comes in a clear glass 1 ml ampoule. Boxes of 5, 10, 50 or 100 ampoules.
Marketing Authorisation Holder:
This leaflet was last updated in September 2015.
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