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

Patient leaflet - OXYTOCIN 10 IU/ML SOLUTION FOR INFUSION

Oxytocin 10 lU/ml Solution for infusion

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor, midwife or pharmacist.
– If you get any side effects, talk to your doctor, midwife or pharmacist. This includes any possible side effects not listed in this 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. Howto store Oxytocin
6. Contents of the pack and other information

1. what oxytocin is and what it is used for

Oxytocin 10 lU/ml Solution for infusion contains a manufactured form of oxytocin (a natural hormone). It belongs to a group of medicines called oxytocics that makes the muscles of the womb contract.

Oxytocin is used:

to start or help contractions during childbirth (labour);
to help in the management of a miscarriage;
during a caesarean section;
to prevent and control bleeding after delivery of your baby.

2. what you need to know before you receive oxytocin

Oxytocin 10 lU/ml Solution for infusion

Indication

Method of administration

Induction or enhancement of labour

Oxytocin should not be started for 6 hours following administration of vaginal prostaglandins. Oxytocin should be administered as an intravenous (i.v.) drip infusion or, preferably, by means of a variable-speed infusion pump.

For drip infusion it is recommended that 5IU (8.3 micrograms) of Oxytocin be added to 500 ml 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 2 to 8 drops/minute (1 to 4 milliunits/minute). It may be gradually increased at intervals not shorter than 20 minutes and increments of not more than 1 to 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 20 drops/minute (10 milliunits/minute), and the recommended maximum rate is 40 drops/minute (20 milliunits/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 (16.7 micrograms) in 500 ml.

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 (8.3 micrograms), 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 2 to 8 drops/minute (1 to 4 milliunits/minute).

Incomplete, inevitable or missed abortion

5 IU (8.3 micrograms) 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 over5 minutes), if necessary followed by i.v. infusion at a rate of 20 to 40 milliunits/minute.

3. HowOxytocinisgiventoyou

Oxytocin should only be given under medical supervision and in a hospital.

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 usually diluted before use and given as an intravenous infusion (drip) into one of your veins.

The usual dose is different in 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 to 4 contractions every 10 minutes.

If your contractions do not reach the adequate level after 5 III (8.3 micrograms), the attempt to start labour should be stopped and then repeated the following day.

Miscarriage: The dose is 5 III (8.3 micrograms) 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 III (8.3 micrograms) by infusion into a vein immediately after delivery of yourbaby.

Prevention of bleeding after delivery: The dose is 5 III (8.3 micrograms) by infusion into a vein after delivery of the placenta.

Treatment of bleeding after delivery: The dose is 5 III (8.3 micrograms) by infusion into a vein. In some cases this may be followed by a drip containing 5 to 20 III (8.3 to 33.4 micrograms) of oxytocin.

Older people (65 years and over): Oxytocin is not intended for use in elderly.

Patients with kidney disease: There is no information on use in patients with kidney disease. However, you should tell your doctor if you suffer from kidney problems (see section 2).

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

If you receive 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 receives this medicine, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor.

An overdose of Oxytocin could cause:

verystrongcontractionsofyourwomb;
damage to yourwombwhich 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.

If you miss a dose of Oxytocin

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

If you have any further questions on the use of this medicine, askyourdoctor or midwife.

4. possible side effects

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

Common side effects (affects more than 1 in 100 patients)

Headache
Fast or slow heartbeat
Feeling or being sick

Uncommon side effects (affects more than 1 in 1,000 patients)

An irregular heartbeat

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

A severe allergic reaction with difficulty in breathing, dizziness and light-headedness, feeling faint, nausea, cold and clammy skin or a fast or weak pulse
Rash

Otherside effects

Effects in the mother:

Not known (cannot be estimated from the available data)

Chest pain (angina)
Irregular heartbeat (QTc prolongation seen on electrocardiogram)
Low blood pressure
Haemorrhage (bleeding)
Increased uterine tone
Excessiveorcontinuouscontractions
Tearing of the womb
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 fluid overload in the lungs
Sudden brief sensation of heat often over the whole body
Abnormal blood clotting, bleeding and anaemia (disseminated intravascular coagulation)

Effects in the baby:

Not known (cannot be estimated from the available data)

Excessive contractions may cause:

Shortage of oxygen, suffocation and death
Low blood salt levels

Reporting of side effects

If you get any side effects, talk to your doctor or midwife. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

Yellow Card Scheme

Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. HowtostoreOxytocin

6. contents of the pack and other informationwhat oxytocin containsthe active substance is oxytocin.

Each ml of solution contains 10IU (16.7 micrograms) oxytocin.

The other ingredients are: acetic acid, glacial; sodium acetate trihydrate; sodium chloride; sodium hydroxide; water for injections.

What Oxytocin looks like and contents of the pack

Colourless, clear liquid with characteristic odour.

Transparent 1 ml type 1 glass ampoules.

Pack sizes:

5 ampoules

10 ampoules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Intrapharm Laboratories Limited,

The Courtyard Barns, Choke Lane,

Cookham Dean, Maidenhead,

Berks, SL6 6PT, United Kingdom

Manufacturer

AS GRINDEKS.

Krustpi Is iela 53, Riga, LV-1057,

Latvia

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2018

Caesarean section	5 IU (8.3 micrograms) 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 (8.3 micrograms) 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 (8.3 micrograms) 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 (8.3 to 33.4 micrograms) of oxytocin in 500 ml of an electrolyte-containing diluent, run at the rate necessary to control uterine atony.

Paediatric population: There are no indications for use of Oxytocin in children or adolescents.

Older people (65 years and over): There are no i ndications for use of Oxytocin in elderly.

Route of administration: Intravenous infusion.

Incompatibilities: 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.

Excipients: Each 1 ml ampoule contains 2.99 mg (0.13 mmol) sodium. This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml ampoule, i.e. essentially ‚sodium-free‘.

Instructions on preparation and dilution: Oxytocin is compatible with the following infusion fluids: sodium chloride 0.9 %, dextrose 5 %, Ringer's solution, acetated Ringer's solution.

For drip infusion it is recommended that 5 III (8.3 micrograms) of Oxytocin be added to 500 ml 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.

Storage: Store in a refrigerator (2 °C – 8 °C). May be stored up to 30 °C for 3 months, but must then be discarded. Keep the ampoules in the outer carton in order to protect from light.

Storage of diluted product: see ‚Shelf life‘ below.

Shelflife: 4years.

Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C when diluted with the solutions stated in subsection ‚Instructions on preparation and dilution‘ above. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.