OXYTOCIN 10 IU/ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Oxytocin 10 lU/ml Concentrate for Solution for Infusion

Read all ofthis leaflet carefully before you start using thismedicine because it contains important information for you.

• Keep this leaflet. You may need to read it again
• Ifyou haveanyfurther­questions,asky­ourdoctor, midwife orpharmacist
• If you getany side effects,talktoyour doctor, midwife or pharmacist.This includes any possible side effects not listed inthis leaflet. See section 4.

What is in this leaflet

1. What Oxytocin is and what it is used for

2. What you need to know before you receive Oxytocin

• 3. How Oxytocin is given to you

4. Possible side effects

5. How to store Oxytocin

• 6. Contents ofthe pack and other 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 isused:

• To start or help contractions during childbirth (labour)
• To help in the managementofa miscarriage
• To prevent and control bleeding after delivery ofyour baby
• Duringacaesare­ansection

2. what you need to know before you receive oxytocin

Donot take Oxytocin:

• Ifyou are allergic to oxytocin orto any ofthe other ingredients ofthis medicine (listedinsection6)
• Ifyourdoctor thinks that to start or increase contractions ofthe womb would be unsuitablefory­ou,forexample:

• – where contractions ofthe wombare unusually strong

• – where there are obstructions that may prevent delivery

• – where your baby may be short of oxygen

• where labourorvaginal delivery is notadvisable,fo­rexample:

• – ifyour baby’s head istoo largeto fitthroughyour pelvis

• – ifyour babyiswrongly positioned inthe birth canal

• – ifthe placenta lies near or over the neck ofyour womb

• – ifyour baby lacks oxygen due to blood vessels running across the neck ofyour womb

• – ifthe placenta separates from the womb before the baby is born

• – ifthere are one or more loops of umbilical cord betweenthe baby and the neck ofthe womb, either before or after yourwaters break

• – ifyourwomb isover-extendedand more likelytotear,fo­rexample ifyouare carrying more than one baby or have too much water (amniotic fluid) in your womb

• – ifyou have had five or more pregnancies in the past or ifyourwomb is scarred by previous caesarean section or othersurgery

• ifyou have been given medicines called prostaglandins (used to bring on labour ortreat 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-eclampsia (high blood pressure, protein inthe urine and swelling)
• you have severe problems with your heart or blood circulation.

Warnings and precautions

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 low blood pressure, a sudden brief sensation of heat (often over the entire body), and an increased heart rate.

Before you receive Oxytocintell your doctor or midwife:

• ifyouare prone to chest pain due to pre-existing heart and/or circulation problems
• ifyou have a known irregular heart beat (‘long QTsyndrome’) or related symptoms, or are taking medicines known to cause the syndrome (see section ‘Other medicines and Oxytocin’)
• ifyou have had a previous caesarean section
• ifyouare morethan 35 years old
• ifyou have raised blood pressure or heart problems

Method ofadministrationfor each indication: Induction or enhancement oflabour

Oxytocin should not be startedfor 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 beadded 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 4milliunits/minute (2 to8drops/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 10milliunits/minute (20 drops/minute), and the recommended maximum rate is 20milliunits/minute (40 drops/minute). In the

• ifyour womb was contracting strongly but has now begun to contract less strongly
• ifyou have been told by a doctor or midwife that normal delivery may be difficult for you due tothe small size ofyour pelvis
• ifyou have kidney problems, as Oxytocin cancause water retention
• ifyou have had complications during your pregnancy
• ifyouare morethan 40weeks pregnant

When Oxytocin is givento induceand enhance labour, the infusion rate should be set to maintain a contraction pattern similarto normal labourand adjustedto individual response. Too high doses may cause very strong continuous contractions and possibly tearing ofthe womb,with serious complications for you and your baby.

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

High dosesofOxytocin mayforceamnio­ticfluidfromy­ourwomb intoyourblood. This is known asamnioticfluid embolism.

Large doses of Oxytocin over a long period oftime, 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 oftheaboveapplies to you,orifyouarenot sure,speakto your doctor or midwife before you receive Oxytocin.

Latex allergy

The active substance in Oxytocin might cause a severe allergic reaction (anaphylaxis) in patientswith latexallergy.Please tellyourdocto­rifyouknowyou­areallergicto la­tex.

Other medicines and Oxytocin

Tell yourdoctor or midwife ifyou are taking or have recently taken any ofthe following medicinesasthey may interferewith Oxytocin:

• Prostaglandins (used to start labour or to treat stomach ulcers)and similar drugs as the effects of both drugs may be increased
• medicines that can cause an irregular heartbeat, as Oxytocin may increase this effect
• Anaesthetics which you breathe in (e.g. to put you to sleep during surgery, such as halothane, cyclopropane, sevoflurane or desflurane) as these may weaken yourcontractions, or cause problems with your heartbeat
• anaesthetic medicinesfor local or regional pain relief, in particular an epidural for pain reliefduring labour. Oxytocin may increasethe blood vessel narrowing effect ofthese medicines and cause an increase in blood pressure.

Please tell yourdoctor or midwife ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Oxytocin with food and drink

You may betoldto keeptheamount offluidsyoudrin­ktoaminimum.

Pregnancy and breast-feeding

Based on wide experience of use and the nature ofthis medicine, it is not expected that Oxytocinwould be a risk toyourbabywhen used correctly. Oxytocin may be found in small amounts in breast milk but is not expected to have harmful effects because it is quickly inactivated by your baby’s digestive system.

Driving and using machines

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

Oxytocin contains sodium

This medicine contains lessthan 1mmol sodium (lessthan23mg perampoule), i.e. it isessentially sodiumfree.

• 3. How Oxytocin is given to you

Yourdoctor or midwife will decide when and how to treat you with Oxytocin. If you thinkthat the effect ofOxytocin istoo strong or too weak, tell yourdoctor or midwife. While youare receiving Oxytocin, both you and your baby will be closely monitored.

Oxytocin is diluted before use and given asan intravenous infusion (drip) into one ofyourveins.

The usual dose canvaryduetot­hefollowing circumstances:

To start or help contractions during labour

The rate of infusion will start at2to8 drops per minute. This may be gradually increasedtoamaximum rate of40drops per minute. The infusion rate canoften be reduced once the contractions reach an adequate level, about 3–4 contractions every 10 minutes.

Ifyourcontractions do not reach the adequate level after5 IUthe attemptto start labour should be stopped and then repeated the following day.

unusual event that higher rates are required, as may occur in the management of foetaldeath in utero or for induction of labour atan 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 smallervolumes­thanthose given by drip infusion, the concentration suitable for infusion withinthe recommended dosage range must be calculated according to the specifications ofthe 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

Miscarriage

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

Caesarean section

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

Prevention ofbleeding after delivery

The dose is 5 IU by infusion into a vein after delivery ofthe 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 to20IUofoxytocin.

Elderly (65 years and over)

There is no information on use in elderly patients. Oxytocin is not intended for use intheelderly.

Children and adolescents

There is no informationon use in children (2–11years) oradolescents (12–17years). Oxytocin is not intended for use in children oradolescents.

Patientswith kidneydisease

There is no information on use in patients with kidney disease.

However, you should tellyour doctor ifyou suffer from kidney problems (see section 2‘Warningsand precautions’)

Patientswith liver disease

There is no information on use in patients with liver disease.

What to do ifyou receive more Oxytocin than you should

As this medicine is given to you in hospital, it is very unlikely that you will receivean overdose. Ifanyoneacciden­tallytakesthis medicine,tellthe hospital accidentand 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 ofyourwomb
• Damagetoyourwom­bwhichcould includetearing
• The placenta to come away from your womb
• Amniotic fluid (the fluid around the baby) to enteryour bloodstream
• Harmtoyour baby

Ifyou forget to take Oxytocin

As a doctor or midwife is giving you this medicine, youare unlikely to miss a dose. Ifyou haveany furtherquestions on the use ofthis medicine, askyour doctor or midwife.

4. possible side effects

Likeall medicines, Oxytocin can cause side effects,although not everyone getsthem. Yourdoctor may consider it necessarytotreatthe side effects ofOxytocin with other medicines.

Some side effects could be serious. If any ofthe following occur, tell your doctor straight away:

The following side effect may affect between 1and10 in every 10,000 patients:

• a severeallergic (anaphylactic/a­naphylactoid) reactionwith difficultyin breathing, dizziness and lightheadedness, feeling faint, nausea, cold and clammy skin or a fast orweak pulse
• swelling oftheface, lips,tongue,throat, and/orextremities (possiblesignsof angioedema)

Commonside effects (upto 1 in 10 patients) ofOxytocin include:

• Feelingorbeingsick
• Headache
• Fastorslowheartbeat

Uncommon side effects (upto 1in100 patients) ofOxytocin include:

• Anirregularhe­artbeat

Rare side effects (up to 1 in 1,000 patients) ofOxytocin include:

• Skin rashes

Other side effects

Effects inthe mother:

• haemorrhage (bleeding)
• chest pain (angina)
• irregularheartbeat
• excessive or continuous contractions
• tearingofthewomb
• fluid retention (water intoxication). Symptoms may include headache, anorexia (loss ofappetite), feeling or being sick, stomach pain, sluggishness, drowsiness, unconsciousness, low levels ofcertain chemicals in the blood (e.g. sodium or potassium), fits

induce labour be ceased; it may be repeated on the following day, starting again from a rate of 1 to 4 milliunits/mi­nute.

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 ofpostpartum 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

• lowbloodsaltlevels
• sudden fluid overload in the lungs
• sudden brief sensation of heat often over the whole body
• abnormal clotting, bleedingand anaemia
• spasm ofthe muscles ofthe womb

Effects in the baby:

Excessive contractions may cause low blood salt levels, shortage ofoxygen, suffocationan­d death.

Reporting ofside effects

Ifyou get any side effects, talkto yourdoctor, pharmacist or midwife. This includes any possible side effects not listed in this leaflet.You can also report side effects directlyviathe national reporting systems listed below:

United Kingdom:

YellowCard Scheme

Website: orsearchforMHRA­YellowCard inthe Google Play or Apple App Store

Ireland:

HPRA Pharmacovigilance, EarlsfortTerrace, IRL-Dublin 2;Tel:+353 1 6764971; Fax:

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

Malta:

ADRReporting,Web­site:

• 5. Howto store Oxytocin

6. contents of the packand other information

What Oxytocin contains

The active substance is oxytocin.

Eachampoule contains 10 IU (International Units).

The other ingredients are sodium acetate trihydrate, sodium hydroxide, glacial acetic acidandwater.

What Oxytocin looks like and contents ofthe 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 often orfiveampoules. Not all packs sizes may be marketed.To listen to or request a copyofthis leaflet in Braille, large print or audio please call,free ofcharge: 08001985000(UKOnly)

Please be ready to give the following:

PRODUCTNAME	REFERENCE NUMBER
Oxytocin 10 IU/mgSolutionfor Infusion	29831/0625

This is a service provided bythe Royal National Institute ofBlind People.

Forthe RepublicofIreland orMalta please call +441978 661 261

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in UK and Ireland:Wockhardt UK Ltd, Ash Road North,Wrexham, LL13 9UF,UK.

Marketing Authorisation Holder in Malta: Pinewood Laboratories Ltd., Ballymacarbry,Clon­mel, Co. Tipperary, Ireland

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

The information in this leafletapplies only to Oxytocin. Ifyou haveany questions or you are not sureaboutanything, askyour doctor, midwife or a pharmacist.

This leaflet was last revised in 07/2019

TwOCKHARDT

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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 ofpostpartum 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 thesame apparatus as blood or plasma, because the peptidelinkagesare rapidlyinactivated by oxytocin-inactivatingen­zymes. 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 thenbe discarded.

107137/9 ^WOCKHARDT