Document: Oxygrindeks solution for injection and infusion ENG PL change

• Oxygrindeks solution for injection and infusion PL
• Oxygrindeks solution for injection and infusion ENG PL

---

Package leaflet: Information for the user

Oxygrindeks 8.3 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, pharmacist 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 Oxygrindeks is and what it is used for

2. What you need to know before you receive Oxygrindeks

3. How Oxygrindeks is given to you

4. Possible side effects

5. How to store Oxygrindeks

6. Contents of the pack and other information

1. What Oxygrindeks is and what it is used for

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

Oxygrindeks is used:

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

• to help in the management of a miscarriage;

• to control bleeding after delivery of your baby.

2. What you need to know before you receive Oxygrindeks

You must not receive Oxygrindeks:

• if you are allergic to oxytocin or any of the 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;

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

Warnings and precautions

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

Talk to your doctor or nurse before you receive Oxygrindeks 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 Oxygrindeks);

• you have raised blood pressure or heart problems;

• you are more than 35 years old;

• you have kidney problems, as Oxygrindeks 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 Oxygrindeks 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.

Oxygrindeks 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);

Oxygrindeks 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.

Oxygrindeks 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.

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

Children and adolescents

Oxygrindeks is not intended for use in children or adolescents.

Other medicines and Oxygrindeks

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

The following medicines may interfere with Oxygrindeks:

• 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, halothane, as their use with Oxygrindeks may cause problems with your heartbeat;

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

Oxygrindeks with food and drink

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

Pregnancy and breast-feeding

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

Oxygrindeks will not harm your newborn baby when breast-feeding.

Driving and using machines

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

3. How Oxygrindeks is given to you

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

Oxygrindeks 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

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 Oxygrindeks.

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

Caesarean section

The dose is 1 ml Oxygrindeks 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 after delivery of your baby.

Miscarriage/Abortion

The dose is 1 ml Oxygrindeks 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).

Treatment of bleeding after delivery

0.6-2.0 ml Oxygrindeks 8.3 microgram/ml may be given into vein. 1.0 ml Oxygrindeks 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.

Patients with liver or kidney impairment

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

Older people

Oxygrindeks is not intended for use in elderly patients.

If you receive more Oxygrindeks 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 Oxygrindeks 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 Oxygrindeks

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

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

If the treatment with Oxygrindeks is stopped

Once labour is progressing, Oxygrindeks infusion may be gradually withdrawn.

There is no information regarding undesirable effects.

4. Possible side effects

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

The frequency of side effects is following:

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

• Headache

• 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 and lightheadedness, feeling faint, nausea, cold and clammy skin or a fast or weak pulse

• An irregular heartbeat

• Laryngeal oedema

• Skin rashes, hives

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:

[To be completed nationally]

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

5. How to store Oxygrindeks

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 after EXP.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. 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 Oxygrindeks contains

- The active substance is oxytocin.

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

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

What Oxygrindeks 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 medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Oxygrindeks8,3 mikrogram/ml injektions/infusionsvätska, lösning

Hungary: Oxygrindeks 8,3 microgramm/ml oldatos injekció vagy infúzió

Slovakia: Oxygrindeks 8,3 mikrogramov/ml injekčný a infúzny roztok

This leaflet was last revised in 2015-06-24