Document: Oxytocin Grindeks solution for injection and infusion ENG PL change

• Oxytocin Grindeks solution for injection and infusion PL
• Oxytocin Grindeks solution for injection and infusion ENG PL

---

Package leaflet: Information for the user

Oxytocin Grindeks 8.3 microgram/ml solution for injection and infusion (Injection and Infusion)

Oxytocin Grindeks 16.7 microgram/ml solution for injection and infusion (Injection and Infusion)

Oxytocin

Read all of this leaflet carefully before you start using 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 or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

What is in this leaflet

1. What Oxytocin Grindeks is and what it is used for

2. What you need to know before you receive Oxytocin Grindeks

3. How to use Oxytocin Grindeks

4. Possible side effects

5. How to store Oxytocin Grindeks

6. Contents of the pack and other information

1. What Oxytocin Grindeks is and what it is used for

Oxytocin Grindekscontains oxytocin. Oxytocin is a hormone that contracts the smooth muscles in the womb.

Oxytocin Grindeks is used:

• to start or help contractions during childbirth (labour);

• during caesarean section;

• to prevent and control bleeding after delivery of your baby;

• to help in the management of a miscarriage.

2. What you need to know before you receive Oxytocin Grindeks

You must not receive Oxytocin Grindeks

• if you are allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);

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

• where there are obstructions that may prevent delivery;

• where contractions of the womb are unusually strong.

If any of the above applies to you, or if you are not sure, talk to your doctor before you receive Oxytocin Grindeks.

Warnings and precautions

Oxytocin Grindeks should only be administered by a healthcare professional in a hospital setting.

Talk to your doctor or nurse before you receive Oxytocin Grindeks if:

• you have had a previous caesarean section;

• 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 Grindeks);

• you have raised blood pressure or heart problems;

• you are more than 35 years old;

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

• you have had complications during your pregnancy (such as diabetes, high blood pressure, lack of thyroid hormone);

• you are more than 40 weeks pregnant.

When Oxytocin Grindeks is given to start or help contraction during 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 Grindeks should not be used for prolonged periods if:

Oxytocin Grindeks 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.

Oxytocin Grindeks may rarely cause blood clotting, bleeding and anaemia.

High doses 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.

Oxytocin Grindeks must not be given simultaneously with oxytocin‑containing nasal spray.

Children

Oxytocin Grindeks is not intended for use in children or adolescents.

Other medicines and Oxytocin Grindeks

Tell your doctor if you are using, have recently used or might use any other medicines.

The following medicines may interfere with Oxytocin Grindeks:

• prostaglandins (used to start labour or to treat stomach ulcers) and similar medicines as the effects of both medicines may be increased;

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

• medicines known to cause heart rhythm disturbances called ‘long QT syndrome’;

Oxytocin Grindeks with food and drink

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

Pregnancy and breast-feeding

Oxytocin Grindeks can start labour – it should only be used in pregnancy under medical supervision.

Oxytocin Grindeks will not harm your newborn baby when breast-feeding.

Driving and using machines

Oxytocin Grindeks can induce labour, therefore caution should be exercised when driving or operating machines.

3. How to use Oxytocin Grindeks

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

Oxytocin Grindeks is usually diluted before use and given as an intravenous infusion (drip) into one of your veins. To prepare intravenous infusion your doctor may use half of a dose of Oxytocin Grindeks 16.7 microgram/ml solution for injection and infusion.

The usual dose is different in the following circumstances:

To start or help contractions during labour

0.2 ml Oxygrindeks 8.3 microgram/ml per 100 ml 5.5 % dextrose solution or physiological sodium chloride solution will be administered as drip infusion into your vein.

The rate of infusion will start at 2‑8 drops per minute (0.1‑0.4 ml per minute). This may be gradually increased to a maximum rate of 40 drops per minute (2 ml per minute). The infusion rate can often be reduced once the contractions reach an adequate level.

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

If your contractions do not reach the adequate level after 1 ml Oxytocin Grindeks 8.3 microgram/ml, the attempt to start labour should be stopped and then repeated the following day.

Caesarean section

The dose is 1 ml Oxytocin Grindeks 8.3 microgram/ml given as drip infusion (1.0 ml diluted in physiological sodium chloride solution) or preferably by means of a variable-speed infusion pump over 5 minutesinto your vein after delivery of your baby.

Treatment of bleeding after delivery

0.6-2.0 ml Oxytocin Grindeks 8.3 microgram/ml may be given into vein. 1.0 ml Oxytocin Grindeks 8.3 microgram/ml (1.0 ml diluted in physiological sodium chloride solution) given as drip infusion or preferably by means of a variable-speed infusion pump over 5 minutes into your vein.

Miscarriage/Abortion

The dose is 1 ml Oxytocin Grindeks 8.3 microgram/ml given as drip infusion (1.0 ml diluted in physiological sodium chloride solution) or preferably by means of a variable-speed infusion pump over 5 minutes into your vein.

During surgery a maximal infusion rate is applied, i.e. about 300 drops/min (15 ml/min). After the surgery the drop rate is reduced to about 120 drops/min (6 ml/min).

Patients with liver or kidney impairment

Patients with impaired liver and kidney function may require dose reduction or longer intervals between doses.

Older people

There are no indications for use of Oxytocin Grindeks in elderlypatients.

If you receive more Oxytocin Grindeks 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 medicines or the empty packet to the doctor.

An overdose of Oxytocin Grindeks could cause:

• harm to your baby;

• very strong contractions of your womb;

• damage to your womb which could include tearing;

• water retention, blood vessels spasm, high blood pressure.

If you miss a dose of Oxytocin Grindeks

As a doctor is giving you this medicine, you are unlikely to miss a dose. If you have any worries, talk to your doctor.

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

If the treatment with Oxytocin Grindeks is stopped

Once labour is progressing, Oxytocin Grindeks infusion may be gradually withdrawn.

There is no information regarding undesirable effects.

4. Possible side effects

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

The frequency of side effects is following:

Common(may affect more than 1 in 100 patients):

• Fast heartbeat

• Slow heartbeat

• Nausea

• Vomiting

Uncommon(may affect more than 1 in 1 000 patients):

Rare (may affect more than 1 in 10 000 patients):

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

• An irregular heartbeat

• Laryngeal oedema

In rare circumstances abnormal blood clotting may occur.

Prolonged venous administration or rapid infusion may cause side effects.

Rapid vein injection at doses more than 3.34 micrograms may result in acute short-lasting low blood pressure accompanied with flushing and fast heartbeat.

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

Läkemedelsverket

Box 26

751 03 Uppsala

Webbplats:www.lakemedelsverket.se

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

5. How to store Oxytocin Grindeks

Do not store above 25 °C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton.The expiry date refers to the last day of that month.

Do not use any pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Oxytocin Grindeks contains

- The active substance is oxytocin.

1 ml of solution contains 8.3 microgram oxytocin (5 IU).

1 ml of solution contains 16.7 microgram oxytocin (10 IU).

- The other ingredients are chlorobutanol hemihydrate, acetic acid (pH-adjustment), water for injections.

What Oxytocin Grindeks looks like and contents of the pack

Colourless, clear liquid with characteristic odour.

1 ml transparent glass ampoules. Pack size: 10 ampoules.

Marketing Authorisation Holder and Manufacturer

AS GRINDEKS.

Krustpils iela 53, Rīga, LV‑1057, Latvia

Tel: + 371 67083205

Fax: + 371 67083505

e-mail: grindeks@grindeks.lv

This leaflet was last revised in 2015-06-23