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• leaflet MAH GENERIC_PL 29831-0625

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PATIENT INFORMATION LEAFLET

Oxytocin 10 lU/ml Solution for infusion

The information in this leaflet has been divided into the following sections:

1.    What Oxytocin is and what it is used for

2.    Before you take Oxytocin

3.    How Oxytocin is given to you

4.    Possible side effects

5.    How to store Oxytocin

6.    Further information

1. What Oxytocin is and what it is used for

Oxytocin belongs to a group of medicines called oxytocics which make the muscles of the uterus (womb) contract.

Oxytocin is used:

•    To start or help contractions during childbirth (labour)

•    To help in the management of a miscarriage

•    To prevent and control bleeding after delivery of your baby

•    During a caesarean section

2. Before you take Oxytocin

You must not take Oxytocin:

•    If you are allergic (hypersensitive) to oxytocin or to any of the other ingredients of this medicine (see Section 6 - Further Information)

•    If your doctor thinks that to start or increase contractions of the womb would be unsuitable for you, for example:

-    where contractions of the womb are unusually strong

-    where there are obstructions that may prevent delivery

-    where your baby may be short of oxygen

•    Where labour or vaginal delivery is not advisable, for example:

-    if your baby's head is too large to fit through your pelvis

-    if your baby is wrongly positioned in the birth canal

-    if the placenta lies near or over the neck of your womb

-    if your baby lacks oxygen due to blood vessels running across the neck of your womb

-    if the placenta separates from the womb before the baby is born

-    if there are one or more loops of umbilical cord between the baby and the neck of the womb, either before or after your waters break

-    if your womb is over-extended and more likely to tear, for example if you are carrying more than one baby or have too much water (amniotic fluid) in your womb

-    if you have had five or more pregnancies in the past or if your womb is scarred by previous caesarean section or other surgery

•    If you have been given medicines called prostaglandins (used to bring on labour or treat stomach ulcers). Oxytocin should not be used for 6 hours after vaginal prostaglandins as the effects of both medicines may be increased

Oxytocin should not be used for prolonged periods if:

•    your contractions do not increase with the treatment

•    you have a condition known as severe pre-eclamptic toxaemia (high blood pressure, protein in the urine and swelling)

•    you have severe problems with your heart or blood circulation.

If any of the above applies to you, or you are not sure, speak to your doctor or midwife before you receive Oxytocin.

Take special care with Oxytocin

Oxytocin should only be administered by a healthcare professional in a hospital setting. Oxytocin should not be given as rapid injection into a vein as this may cause decreased blood pressure, a sudden brief sensation of heat (often over the entire body), and an increased heart rate.

Before you are given Oxytocin tell your doctor or midwife if:

•    you are prone to chest pain due to pre-existing heart and/or circulation problems

•    you have a known irregular heart beat ('long QT syndrome') or related symptoms, or are taking medicines known to cause the syndrome (see section 'Other medicines and Oxytocin')

•    you have had a previous caesarean section

•    you are more than 35 years old

•    you have raised blood pressure or heart problems

•    your womb was contracting strongly but has now begun to contract less strongly

•    you have been told by a doctor or midwife that normal delivery may be difficult for you due to the small size of your pelvis

•    you have kidney problems, as Oxytocin can cause water retention

•    you have had complications during your pregnancy

•    you are more than 40 weeks pregnant

When Oxytocin is given to induce and enhance labour, the infusion rate should be set to maintain a contraction pattern similar to normal labour and adjusted to individual response. Too high doses may cause very strong continuous contractions and possibly tearing of the womb, with serious complications for you and your baby.

Oxytocin may rarely cause disseminated intravascular coagulation which causes symptoms including abnormal blood clotting, bleeding and anaemia.

High doses of Oxytocin may force amniotic fluid from your womb into your blood.

This is known as amniotic fluid embolism.

Large doses of Oxytocin over a long period of time, whilst drinking or receiving large volumes of fluid may make your stomach feel very full, cause difficulty in breathing and lower salt levels in your blood

If any of the above applies to you, or if you are not sure, speak to your doctor or midwife before you are given Oxytocin.

Taking other medicines

Tell your doctor or midwife if you are taking or have recently taken any of the following medicines as they may interfere with Oxytocin:

•    Prostaglandins (used to start labour or to treat stomach ulcers) as the effects of both drugs may be increased

•    medicines that can cause an irregular heartbeat, as Oxytocin may increase this effect

•    Anaesthetics (used to put you to sleep during surgery) e.g. cyclopropane or halothane, as their use with Oxytocin may cause problems with your heartbeat

•    Epidural (used for pain relief during labour)

Please tell your doctor or midwife if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking with food and drink

You may be told to keep the amount of fluids you drink to a minimum.

Pregnancy and breast-feeding

Based on wide experience of use and the nature of this medicine, it is not expected that Oxytocin would be a risk to your baby when used correctly.

Driving and using machines

Taking Oxytocin can start labour. Women with contractions should not drive or use machines.

Important information about some of the ingredients of Oxytocin

This medicine contains less than 1mmol sodium (less than 23mg per ampoule), i.e. it is essentially sodium free.

Oxytocin 10 IU/ml Solution for Infusion

Method of administration for each indication: Induction or enhancement of labour

Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Oxytocin should be administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump. For drip infusion it is recommended that 5 IU of Oxytocin be added to 500ml of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom infusion of sodium chloride must be avoided, 5% dextrose solution may be used as the diluent.

To ensure even mixing, the bottle or bag must be turned upside down several times before use.

The initial infusion rate should be set at 1 to 4 milliunits/minute (2 to 8 drops/ minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1-2 milliunits/minute, until a contraction pattern similar to that of normal labour is established. In pregnancy near term this can often be achieved with an infusion of less than 10 milliunits/minute (20 drops/minute), and the recommended maximum rate is 20 milliunits/minute (40 drops/minute).

In the unusual event that higher rates are required, as may occur in the management of foetal death in utero or for induction of labour at an earlier stage of pregnancy, when the uterus is less sensitive to oxytocin, it is advisable to use a more concentrated Oxytocin solution, e.g., 10 IU in 500ml.

When using a motor-driven infusion pump which delivers smaller volumes than those given by drip infusion, the concentration suitable for infusion within the recommended dosage range must be calculated according to the specifications of the pump.

The frequency, strength and duration of contractions as well as the foetal heart rate must be carefully monitored throughout the infusion. Once an adequate level of uterine activity is attained, aiming for 3 to 4 contractions every 10 minutes, the infusion rate can often be reduced. In the event of uterine hyperactivity and/or foetal distress, the infusion must be discontinued immediately.

If, in women who are at term or near term, regular contractions are not established after the infusion of a total amount of 5 IU, it is recommended that the attempt to induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/minute.

3. How Oxytocin is given to you

Your doctor or midwife will decide when and how to treat you with Oxytocin.

If you think that the effect of Oxytocin is too strong or too weak, tell your doctor or midwife. While you are receiving Oxytocin, both you and your baby will be closely monitored. Oxytocin is diluted before use and given as an intravenous infusion (drip) into one of your veins.

The usual dose can vary due to the following circumstances:

To start or help contractions during labour

The rate of infusion will start at 2 to 8 drops per minute. This may be gradually increased to a maximum rate of 40 drops per minute. The infusion rate can often be reduced once the contractions reach an adequate level, about 3-4 contractions every 10 minutes.

Your contractions and your baby's heart rate will be carefully monitored while you are receiving Oxytocin.

If your contractions do not reach the adequate level after 5 IU the attempt to start labour should be stopped and then repeated the following day.

Miscarriage

The dose is 5 IU by infusion into a vein. In some cases this may be followed by a drip at 40 to 80 drops per minute.

Caesarean section

The dose is 5 IU by infusion into a vein immediately after delivery of your baby.

Prevention of bleeding after delivery

The dose is 5 IU by infusion into a vein after delivery of the placenta.

Treatment of bleeding after delivery

The dose is 5 IU by infusion into a vein. In some cases this may be followed by a drip containing 5 to 20 IU of oxytocin.

What to do if you take more Oxytocin than you should

As this medicine is given to you in hospital, it is very unlikely that you will receive an overdose. If anyone accidentally takes this medicine, tell the hospital accident and emergency department or a doctor immediately. Show any remaining medicines or the empty packet to the doctor.

An overdose of Oxytocin could cause:

•    Very strong contractions of your womb

•    Damage to your womb which could include tearing

•    The placenta to come away from your womb

•    Amniotic fluid (the fluid around the baby) to enter your bloodstream

•    Harm to your baby

What to do if you miss a dose

As a doctor or midwife is giving you this medicine, you are unlikely to miss a dose.

If you have any worries, tell a doctor or midwife.

If you have any further questions on the use of this product, ask your doctor or midwife.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or contact your nearest hospital straight away if you notice or suspect any of the following symptoms. You may need urgent medical treatment.

•    changes in heartbeat

•    irregular heartbeats

•    a severe allergic reaction causing dizziness, lightheadedness, feeling faint, or difficulty in breathing, nausea, cold and clammy skin or a fast or weak pulse

•    haemorrhage (bleeding)

•    chest pain (angina)

•    tearing of the womb

•    sudden fluid overload of the lungs

•    abnormal clotting, bleeding and anaemia Other side effects of Oxytocin include:

Common side effects (more than 1 in 100 patients) include:

•    Feeling or being sick

•    Headache

•    Fast or slow heartbeat

Rare side effects (more than 1 in 10,000 patients) include:

•    Skin rash

Other side effects

Effects in the mother:

•    excessive or continuous contractions

•    fluid retention (water intoxication). Symptoms may include headache, anorexia (loss of appetite), feeling or being sick, stomach pain, sluggishness, drowsiness, unconsciousness, low levels of certain chemicals in the blood (e.g. sodium or potassium), fits

•    low blood salt levels

•    sudden brief sensation of heat often over the whole body

•    spasm of the muscles of the womb Effects in the baby:

Excessive contractions may cause low blood salt levels, shortage of oxygen, suffocation and death.

If you get any side effects, talk to your doctor or midwife. This includes any possible side effects not listed in this leaflet.

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 national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: http://www.mhra.gov.uk/yellowcard Ireland:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie

5. How to store Oxytocin

Keep out of the sight and reach of children. The hospital pharmacy will store this medicine in a refrigerator between 2°to 8°C and make sure that it is not used after the expiry date on the pack. The expiry date refers to the last day of that month.

May be stored up to 30° C for 3 months, but must then be discarded. Store in the original package in order to protect from light. If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What is Oxytocin?

The active ingredient in this medicine is oxytocin.

The other ingredients are sodium acetate trihydrate, sodium hydroxide, glacial acetic acid and water.

What Oxytocin looks like and the contents of the pack

Oxytocin is a clear, colourless, sterile liquid which comes in a 1ml (millilitre) clear glass ampoule. Oxytocin is a concentrate for solution for infusion and comes in packs of ten or five ampoules. Not all pack sizes may be marketed. Each Oxytocin ampoule contains 10 IU (International Units).

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For the Republic of Ireland please call +44 1978 669272

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder is: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

The manufacturer is: Biologici Italia Laboratories S.R.L, Via F. Serpero 2, 20060 Masate (Milano), Italy.

The information in this leaflet applies only to Oxytocin. If you have any questions or you are not sure about anything, ask your doctor, midwife or a pharmacist.

This leaflet was last revised in April 2016.

Incomplete, inevitable or missed abortion

5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or preferably, by means of a variable- speed infusion pump over 5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

Caesarean section

5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable- speed infusion pump over 5 minutes) immediately after delivery.

Prevention of postpartum uterine haemorrhage The usual dose is 5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable-speed infusion pump over 5 minutes) after delivery of the placenta.

In women given Oxytocin for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.

Treatment of postpartum uterine haemorrhage

5 IU by i.v. infusion (5 IU diluted in physiological electrolyte solution and administered as an i.v. drip infusion or, preferably, by means of a variable- speed infusion pump over 5 minutes), followed in severe cases by i.v. infusion of a solution containing 5 to 20 IU of oxytocin in 500ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Note - Oxytocin should not be infused via the same apparatus as blood or plasma, because the peptide linkages are rapidly inactivated by oxytocin- inactivating enzymes. Oxytocin is incompatible with solutions containing sodium metabisulphite as a stabiliser.

Storage - Store between 2° and 8°C. May be stored up to 30°C for 3 months, but must then be discarded.

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