8.3 micrograms/ml concentrate for solution for injection and infusion
oxytocin
What Oxytocin Pilum is and what it is used for
Oxytocin Pilum contains oxytocin. Oxytocin is a hormone that causes contractions in the smooth muscles of the uterus.
Oxytocin is used:
- to initiate labor, in case of mild pain
- in case of miscarriage, abortion
- to reduce and control postpartum hemorrhage
- by cesarean section.
Oxytocin contained in Oxytocin Pilum may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oxytocin Pilum
Do not use Oxytocin Pilum
- if you are allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6).
- if your doctor/midwife considers that it is not appropriate for you to start or increase the contractions in the uterus, eg:
- when there are obstacles that can stop the birth
- when labor or vaginal delivery is inappropriate
- when the contractions of the uterus are unusually strong
- when your child may be deprived of oxygen.
If this applies to you, or if you feel unsure, talk to your doctor or midwife before giving Oxytocin Pilum.
Warnings and cautions
Before treatment with Oxytocin Pilum Talk to your doctor or midwife about:
- you have previously had a cesarean section or other operation on the uterus
- you are older than 35 years
- you have mild or moderate hypertension or disorders of heart function (eg long QT syndrome or symptoms)
- you are taking medicines with known effects to prolong QT time (see section “Other medicines and Oxytocin Pilum”).
Oxytocin Pilum should not be used for any length of time if:
- your pain does not increase despite the treatment
- you have preeclampsia (high blood pressure, protein in urine, and edema )
- you have serious problems with your heart and blood circulation.
If any of the above applies to you, or if you are not sure, talk to your doctor or midwife before taking Oxytocin Pilum.
Latex allergy
The active substance in Oxytocin Pilum may cause a severe allergic reaction ( anaphylaxis ) in patients with latex allergy. Tell your doctor if you know you are allergic to latex.
Other medicines and Oxytocin Pilum
You must tell your doctor or midwife if you are taking or have recently taken any of the following medicines as these may affect Oxytocin Pilum:
- prostaglandins (used to initiate labor or to treat stomach ulcers ) as the effect may increase for both of these medicines
- anesthetics (for anesthesia during surgery) eg cyclopropane or halothane, as these together with Oxytocin Pilum, can cause a drop in blood pressure and problems with heart rhythm
- spinal anesthesia (used as pain relief during childbirth).
- nasal sprays containing oxytocin should not be used concomitantly.
Oxytocin Pilum with drink
You may be told to drink as little as possible.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Oxytocin Pilum can start labor pains, and should only be used under medical supervision during pregnancy.
Oxytocin Pilum does not harm your newborn baby while you are breastfeeding.
Driving and using machines
The drug should be used during childbirth and then the patient should not drive or use machines.
How to use Oxytocin Pilum
Your doctor or midwife will decide when and how you should be treated with Oxytocin Pilum. Oxytocin Pilum is usually diluted before being given as an intravenous drip into a vein.
Dose one varies depending on what it is used for. Your doctor or midwife will prescribe a dose that can be changed if necessary depending on the effect of the medicine.
To initiate labor, in case of mild pain
Infusion one begins at a slow pace. The infusion rate is increased until the pains are sufficient. Thereafter, the infusion rate can often be reduced.
Your pain and your baby’s heartbeat will be closely monitored during the time you receive Oxytocin Pilum.
If the pain has not become effective enough after giving an ampoule, the test is stopped and possibly repeated the next day.
Abortion
During an abortion, an intravenous infusion is given at a faster rate.
Cesarean section
An ampoule is given as an intravenous infusion after the baby is born.
If you use more Oxytocin Pilum than you should
An overdose can cause severe contractions of the uterus,
As this medicine is given in a hospital, it is unlikely that you will get an overdose. If this medicine is given to someone by mistake, contact a doctor or hospital. Show the doctor any leftover medicine or the empty package.
If you stop using Oxytocin Pilum
As soon as the pain starts, Oxytocin Pilum should be discontinued gradually.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
- nausea and vomiting
- headache
- fast or slow heartbeat
Uncommon side effects (may affect up to 1 in 100 people)
Water poisoning, can cause headaches and nausea
Rare side effects (may affect up to 1 in 1,000 people)
- redness and hives
- severe allergic reaction with dizziness, feeling faint, weakness, difficulty breathing. Swelling of the larynx.
- irregular heartbeat
- blood clot after the baby is born.
If high doses of Oxytocin Pilum are given at the same time as large amounts of liquid with a drip, water poisoning may occur. Symptoms that may occur:
- headache
- nausea and vomiting
- too low levels of certain electrolytes in the blood (eg sodium or potassium )
- cramps, spasm is
How to store Oxytocin Pilum
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C. Do not freeze.
Before dilution: Each ampoule is for single use only and should be used immediately after opening. Unused solutions should be discarded.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is oxytocin. 1 ml solution contains 8.3 micrograms of oxytocin.
- Other ingredients are Chlorobutanol hemihydrate, acetic acid ( pH adjuster), water for injections.
What the medicine looks like and the contents of the pack
A colorless solution in a clear 1 ml glass ampoule.
Pack size: 10 ampoules.
Marketing Authorisation Holder
Pilum Pharma A / S, Energivej 15, 5260 Odense S, Denmark
Local representative
Orifarm Generics AB, Box 56048, 102 17 Stockholm, info@orifarm.com
Manufacturer
JSC Grindeks,
53 Krustpils St. Riga, LV-53 Latvia