Oxytocin grindeks

Patient Information Leaflet

Oxytocin Grindeks, 8.3 micrograms/ml, solution for injection/infusion
Oxytocin Grindeks, 16.7 micrograms/ml, solution for injection/infusion
Oxytocinum
Please read all of this leaflet carefully before 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, please ask your doctor or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the leaflet

1. What Oxytocin Grindeks is and what it is used for
2. What you need to know before using 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

Each ampoule of Oxytocin Grindeks contains 8.3 micrograms of oxytocin (equivalent to 5 IU) or
16.7 micrograms of oxytocin (equivalent to 10 IU) in 1 ml of solution. Oxytocin is a hormone
responsible for contractions of the smooth muscles of the uterus.
Oxytocin Grindeks is used:

• to initiate or augment uterine contractions during labour;
• during caesarean section;
• to prevent and control bleeding after childbirth;
• to assist in management following miscarriage.

2. Important information before using Oxytocin Grindeks

When not to use Oxytocin Grindeks

• if the patient is allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);
• if the doctor considers that initiating or intensifying uterine contractions would be inappropriate for the patient, for example:
  • when there is an obstruction that may prevent vaginal delivery;
  • when uterine contractions are abnormally strong;
  • when the baby may be deprived of oxygen.
• when vaginal delivery is not recommended, for example:
  • if the baby's head is too large to fit through the mother's pelvis;
  • if the baby is abnormally positioned in the birth canal;
  • if the baby is lying close to the cervix or over the cervix (e.g. breech or transverse lie);
  • if the baby is deprived of oxygen due to the umbilical cord lying across the cervix (cord prolapse);
  • in case of premature separation of the placenta from the uterus before the baby is born (placental abruption);
• if one or more loops of the umbilical cord are present between the baby and the cervix, before or after rupture of membranes;
• if the uterus is excessively distended and there is an increased risk of uterine rupture, for example in multiple pregnancy or excessive amniotic fluid (polyhydramnios);
• if the patient has been pregnant five or more times previously or if there is a uterine scar from a previous caesarean section or other uterine surgery.
  • If the patient has received medicines called prostaglandins (used to induce labour or treat stomach ulcers), Oxytocin Grindeks must not be used within 6 hours after administration of prostaglandins vaginally, as this may enhance the effects of both medicines.

Oxytocin Grindeks should not be used for prolonged periods if:

• contractions do not intensify in response to treatment;
• the patient has a condition called severe pre-eclampsia (high blood pressure, protein in urine, and swelling);
• the patient has severe heart or circulatory disorders.

If any of the above conditions apply to the patient or if the patient is uncertain, she should speak with her doctor before receiving Oxytocin Grindeks.

Warnings and precautions

Oxytocin Grindeks must be administered only by trained medical personnel under hospital conditions.

Before receiving Oxytocin Grindeks, discuss with your doctor or nurse if:

• the patient has previously had a caesarean section;
• the patient is prone to chest pain due to pre-existing heart disease and/or circulatory disorders;
• the patient has diagnosed heart rhythm disorders (‘prolonged QT interval syndrome’) or related symptoms, or is taking medicines that cause this syndrome (see section “Oxytocin Grindeks and other medicines”);
• the patient has high blood pressure or heart problems;
• the patient is over 35 years of age;
• the patient has kidney disorders, as Oxytocin Grindeks may cause water retention;
• complications occurred during pregnancy (such as diabetes, high blood pressure, hypothyroidism);
• the pregnancy has lasted beyond 40 weeks.

When administering Oxytocin Grindeks to induce labour or augment uterine contractions, the infusion rate should be adjusted so that contractions resemble those of normal labour and according to individual response. Excessively high doses may cause very strong, continuous contractions and possibly uterine rupture, with serious consequences for both mother and baby.

Oxytocin Grindeks must not be administered by rapid intravenous injection, as this may cause a drop in blood pressure, sudden brief sensation of warmth (often throughout the body), and rapid heartbeat.

Oxytocin Grindeks may rarely cause disseminated intravascular coagulation (DIC), leading to symptoms such as abnormal blood clotting, bleeding, and anaemia.

High doses of Oxytocin Grindeks may allow amniotic fluid to enter the maternal bloodstream. This condition is known as amniotic fluid embolism.

Large doses of Oxytocin Grindeks administered over a prolonged period, together with ingestion or infusion of large amounts of fluids, may cause a feeling of abdominal fullness, difficulty breathing, and low blood sodium levels (hyponatraemia).

Oxytocin Grindeks must not be administered simultaneously with a nasal aerosol containing oxytocin.

If any of the above conditions apply to the patient or if the patient is uncertain, she should speak with her doctor or nurse before receiving Oxytocin Grindeks.

Latex allergy

The active substance in Oxytocin Grindeks may cause a severe allergic reaction (anaphylactic shock) in patients allergic to latex. If the patient knows she is allergic to latex, she should inform her doctor.

Children and adolescents

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

Oxytocin Grindeks and other medicines

Inform your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.

The following medicines may interfere with the action of Oxytocin Grindeks:

• prostaglandins (used to initiate labour or treat stomach ulcers) and similar medicines, as the effects of both medicines may be enhanced;
• anaesthetic agents (used to induce sleep during surgery), e.g. cyclopropane or halothane, as their concomitant use with Oxytocin Grindeks may cause heart rhythm disturbances;
• medicines that cause heart rhythm disorders known as “prolonged QT interval syndrome”;
• local anaesthetics (used to relieve pain during labour). Oxytocin Grindeks may enhance the vasoconstrictive effects of these medicines and cause increased blood pressure.

Oxytocin Grindeks with food and drink

The patient may be advised to minimize fluid intake.

Pregnancy and breastfeeding

Oxytocin Grindeks may initiate labour and should be used during pregnancy only under medical supervision.

Oxytocin Grindeks is present in small amounts in breast milk, but it is not expected to have harmful effects, as it is rapidly inactivated by the infant's digestive system.

Oxytocin Grindeks does not pose a risk to the newborn during breastfeeding.

Driving and using machines

Oxytocin Grindeks may initiate labour; therefore, caution should be exercised when driving or operating machinery.

3. How to use Oxytocin Grindeks

The decision on when and how to administer Oxytocin Grindeks to the patient will be made by the physician. If the patient feels that the effect of Oxytocin Grindeks is too strong or too weak, this should be reported to the doctor. During administration of Oxytocin Grindeks, both the patient and the baby will be closely monitored.

Oxytocin Grindeks is usually diluted before use and administered as an intravenous infusion (drip) into one of the veins. To prepare the intravenous infusion, the doctor may use Oxytocin Grindeks 5 IU, solution for injection/infusion.

In certain circumstances, 1 ml of undiluted Oxytocin Grindeks may be administered intramuscularly.

The usual dose varies depending on the following situations:

To initiate or augment uterine contractions during labour
Oxytocin Grindeks should be administered intravenously as a continuous infusion, preferably by an infusion pump with adjustable flow rate, or alternatively by drip infusion. For drip infusion, it is recommended to add 5 IU of Oxytocin Grindeks to 500 ml of an isotonic electrolyte solution (such as 0.9% sodium chloride). In patients in whom sodium chloride infusion should be avoided, 5% glucose solution may be used as the diluent.

The initial infusion rate should be set between 2 and 8 drops per minute (1 to 4 milliunits per minute) and may be gradually increased up to a maximum of 40 drops per minute (20 milliunits per minute). The infusion rate can usually be reduced once an adequate level of uterine activity has been achieved (approximately 3–4 contractions every 10 minutes).

If adequate uterine contractions are not achieved after administration of 1 ml of Oxytocin Grindeks 5 IU/ml, the attempt to induce labour should be discontinued and repeated the following day.

Caesarean section
The dose of Oxytocin Grindeks is 5 IU administered intravenously over 5 minutes as a drip infusion (5 IU diluted in isotonic sodium chloride solution) or, preferably, by an infusion pump with adjustable flow rate, immediately after delivery of the baby.

Prevention of postpartum haemorrhage
The usual dose is 5 IU administered as an intravenous infusion (5 IU diluted in isotonic electrolyte solution) or 5–10 IU administered intramuscularly, after delivery of the placenta.

Treatment of postpartum haemorrhage
The dose of Oxytocin Grindeks is 5 IU administered as an intravenous infusion (5 IU diluted in isotonic electrolyte solution) or 5–10 IU administered intramuscularly. Subsequently, in some cases, an intravenous drip infusion containing 5 to 20 IU of oxytocin in 500 ml of isotonic electrolyte solution may be administered.

Abortion
Due to lower receptor expression, oxytocin administration is recommended from week 14 of pregnancy onwards.

The dose of Oxytocin Grindeks 5 IU/ml is 5 IU or 1 ml administered intravenously over 5 minutes as a drip infusion (1.0 ml diluted in isotonic sodium chloride solution) or, preferably, by an infusion pump with adjustable flow rate. In some cases, subsequent administration may be continued as an intravenous infusion at a rate of 20 to 40 milliunits per minute.

Patients with hepatic or renal impairment
There is no information available regarding the use of Oxytocin Grindeks in patients with renal or hepatic impairment.

Elderly patients
There are no indications for the use of Oxytocin Grindeks in elderly patients.

Use of a higher than recommended dose of Oxytocin Grindeks
Since the medicine is administered in a hospital setting, overdose is very unlikely. However, if this medicine is accidentally administered to any person, the hospital emergency department or a doctor should be contacted immediately. Any remaining medicine or empty packaging should be shown to the doctor.

Overdose of Oxytocin Grindeks may cause:

• fetal injury;
• very strong uterine contractions;
• uterine damage, including rupture;
• water retention, vasoconstriction, high blood pressure.

Missing a dose of Oxytocin Grindeks
Since the medicine is administered by a physician, it is unlikely that a recommended dose will be missed. If the patient has any concerns, she should inform her doctor.

If you have any further questions about the use of this medicine, please consult your doctor or nurse.

Stopping treatment with Oxytocin Grindeks
When labour is well established, Oxytocin Grindeks may be gradually discontinued.
There is no data available on adverse effects.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Oxytocin Grindeks and immediately contact the nearest
hospital emergency department or doctor if the patient experiences any of the following symptoms:

• Severe allergic reaction (anaphylactic/pseudoanaphylactic) with breathing difficulties, dizziness and feeling faint, fainting, nausea, cold and clammy skin, or rapid or weak pulse. Rare adverse reactions – may occur in less than 1 in 1000 people;
• Swelling of the face, lips, tongue, throat, and (or) limbs (possible symptoms of angioedema). Rare adverse reactions – may occur in less than 1 in 1000 people.

Other adverse reactions:
Common (may occur in less than 1 in 10 people):

• Headache;
• Fast heartbeat;
• Slow heartbeat;
• Nausea;
• Vomiting.

Uncommon (may occur in less than 1 in 100 people):

• Irregular heartbeat.

Rare (may occur in less than 1 in 1000 people):

• Skin rash, urticaria.

Frequency not known (frequency cannot be estimated from available data):

• Bleeding (haemorrhage);
• Chest pain (angina);
• Irregular heartbeat;
• Excessive or prolonged contractions;
• Uterine rupture;
• Fluid retention (water intoxication). Symptoms may include headache, anorexia (loss of appetite), nausea or vomiting, abdominal pain, lethargy, drowsiness, loss of consciousness, low levels of certain chemicals in the blood (e.g. sodium or potassium), seizures;
• Low blood salt levels;
• Sudden excess of fluid in the lungs;
• Rapid intravenous injection of oxytocin may cause a sudden, short-lived drop in blood pressure;
• Sudden, brief feeling of warmth throughout the body;
• Abnormal blood clotting, bleeding and anaemia;
• Uterine muscle contraction.

Effect on the baby:
Excessive contractions may lead to low blood salt levels, hypoxia, asphyxia and death.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Oxytocin Grindeks

Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label
of the ampoule following: EXP. The expiry date refers to the last day of the stated month.
After first opening: the medicinal product should be used immediately.
After dilution for infusion: from a microbiological point of view, unless the method
of opening/reconstitution/dilution excludes the risk of microbiological contamination,
the product should be used immediately. If it is not used immediately, the responsibility
for storage conditions and duration prior to use lies with the user and should usually not exceed
24 hours at a temperature of 2 to 8°C.
Do not use this medicine if the packaging is damaged or if there are visible signs of tampering.
Do not use this medicine if the solution in the ampoule is cloudy or contains particles or flakes.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer in use. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Oxytocin Grindeks contains

• The active substance is oxytocin. 1 ml of solution contains 8.3 micrograms of oxytocin (5 IU). 1 ml of solution contains 16.7 micrograms of oxytocin (10 IU).
• The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, sodium hydroxide (for pH adjustment), water for injections.

What Oxytocin Grindeks looks like and contents of the pack
A colourless, clear solution, free from visible particles.
pH between 3.5 and 4.5
Ampoules made of colourless borosilicate glass type I with a break ring or breakpoint, containing 1 ml of solution.
Pack sizes: 5, 10 or 100 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Sweden  Oxytocin Grindeks 8.3 microgram/ml injektions-/infusionsvätska, lösning
       Oxytocin Grindeks 16.7 microgram/ml injektions-/infusionsvätska, lösning
Austria  Oxytocin Grindeks 5 I.E./ml Injektions-/Infusionslösung
       Oxytocin Grindeks 10 I.E./ml Injektions-/Infusionslösung
Belgium  Oxytocin Grindeks 5 U.I./1 mL, solution injectable/pour perfusion
       Oxytocin Grindeks 10 U.I./1 mL, solution injectable/pour perfusion
       Oxytocin Grindeks 5 IU/ml Injektions-/Infusionslösung
       Oxytocin Grindeks 10 IU/ml Injektions-/Infusionslösung
       Oxytocin Grindeks 5 IU/ml oplossing voor injectie/infusie
       Oxytocin Grindeks 10 IU/ml oplossing voor injectie/infusie
Czech Republic Ofost 5 IU/ml injekční/infuzní roztok
France    OXYTOCINE GRINDEKS 5 U.I./1 mL, solution injectable/pour perfusion
       OXYTOCINE GRINDEKS 10 U.I./1 mL, solution injectable/pour perfusion
Hungary  Oxytocin Grindeks 5 NE/ml oldatos injekció vagy infúzió
       Oxytocin Grindeks 10 NE/ml oldatos injekció vagy infúzió
Ireland  Ofost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injection
       Ofost 10 IU/ml concentrate for solution for infusion or solution for intramuscular injection
Italy    Ossitocina Grindeks 8,3 microgrammi (5 U.I.)/mL soluzione iniettabile/per infusione
       Ossitocina Grindeks 16,7 microgrammi (10 U.I.)/mL soluzione iniettabile/per infusione
Latvia   Ofost 10 SV/ml šķīdums injekcijām/infūzijām
Lithuania Ofost 5 TV/ml injekcinis ar infuzinis tirpalas
       Ofost 10 TV/ml injekcinis ar infuzinis tirpalas
Poland  Oxytocin Grindeks 8.3 mikrogramów/ml roztwór do wstrzykiwań/do infuzji
       Oxytocin Grindeks 16.7 mikrogramów/ml roztwór do wstrzykiwań/do infuzji
Romania Ofost 8.3 micrograme/ml solutie injectabila/perfuzabila
       OFOST 16,7 micrograme/ml soluție injectabilă/perfuzabilă
Portugal Oxitocina Grindeks 5 UI/1 ml solução injetável ou para perfusão
       Oxitocina Grindeks 10 UI/1 ml solução injetável ou para perfusão
Slovakia Ofost 5 IU/ml injekčný/infúzny roztok (injekcia/infúzia)
       Ofost 10 IU/ml injekčný/infúzny roztok (injekcia/infúzia)
Slovenia Ofost 5 i.e./ml raztopina za injiciranje/infundiranje
       Ofost 10 i.e./ml raztopina za injiciranje/infundiranje
Spain  Oxitocina Grindeks 5 UI/ml solución inyectable y para perfusión EFG
       Oxitocina Grindeks 10 UI/ml solución inyectable y para perfusión EFG