OXYTOCIN 8.3 mcg/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Oxytocin Grindeks, 8.3 micrograms/ml, Solution for Injection/Infusion
3. Oxytocin Grindeks, 16.7 micrograms/ml, Solution for Injection/Infusion
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
4. What Oxytocin Grindeks is and what it is used for
   1. Oxytocin Grindeks is used:
5. Important information before using Oxytocin Grindeks
   1. When not to use Oxytocin Grindeks
   2. Warnings and precautions
   3. Lateks allergy
   4. Children and adolescents
   5. Oxytocin Grindeks with other medicines
   6. Oxytocin Grindeks with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
6. How to use Oxytocin Grindeks
   1. Overdose of Oxytocin Grindeks
   2. Missed dose of Oxytocin Grindeks
   3. Stopping use of Oxytocin Grindeks
7. Possible side effects
   1. Reporting side effects
8. How to store Oxytocin Grindeks
9. Contents of the package and other information
   1. What Oxytocin Grindeks contains
   2. What Oxytocin Grindeks looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the package leaflet: 10/2021

Package Leaflet: Information for the User

Oxytocin Grindeks, 8.3 micrograms/ml, Solution for Injection/Infusion

Oxytocin Grindeks, 16.7 micrograms/ml, Solution for Injection/Infusion

Oxytocin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or nurse. See section 4.

Package Leaflet Contents

• 1. What Oxytocin Grindeks is and what it is used for
• 2. Important information before using Oxytocin Grindeks
• 3. How to use Oxytocin Grindeks
• 4. Possible side effects
• 5. How to store Oxytocin Grindeks
• 6. Contents of the package 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 that causes contractions of the smooth muscle of the uterus.

Oxytocin Grindeks is used:

• to initiate or augment contractions during labor;
• during cesarean section;
• to prevent or control bleeding after childbirth;
• to support post-abortion procedures.

2. Important information before using Oxytocin Grindeks

When not to use Oxytocin Grindeks

• if you are allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);
• if your doctor considers that initiating or intensifying uterine contractions would be inappropriate for you, for example:
• if there is an obstruction that may prevent delivery;
• if uterine contractions are abnormally strong;
• if the baby may be deprived of oxygen.
• If 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 positioned near the cervix or above the cervix;
• if the baby may be deprived of oxygen due to the course of blood vessels across the cervix;
• in case of placental abruption before childbirth;
• if there is one or more loops of the umbilical cord between the baby and the cervix, before or after the rupture of membranes;
• if the uterus is overdistended and there is a greater risk of uterine rupture, for example in multiple pregnancy or with an excessive amount of amniotic fluid in the uterus;
• if you have had five or more previous pregnancies or if you have a uterine scar from a previous cesarean section or other surgical procedure.
• If you have received prostaglandin medicines (used to induce labor or treat stomach ulcers). Oxytocin Grindeks should not be used within 6 hours of vaginal administration of prostaglandins, as this may enhance the effects of both medicines.

Oxytocin Grindeks should not be used for a prolonged period if:

• contractions do not intensify with treatment;
• you have a condition called severe pre-eclampsia (high blood pressure, protein in the urine, and swelling);
• you have severe heart or circulatory problems.

If you have any of these conditions or are unsure, you should discuss this with your doctor before receiving Oxytocin Grindeks.

Warnings and precautions

Oxytocin Grindeks should only be administered by a qualified healthcare professional in a hospital setting.
Before receiving Oxytocin Grindeks, you should discuss this with your doctor or nurse if:

• you have had a previous cesarean section;
• you have a history of heart disease and/or circulatory problems;
• you have a condition called prolonged QT interval (a heart rhythm disorder) or related symptoms, or if you are taking medicines that cause this condition (see "Oxytocin Grindeks with other medicines");
• you have high blood pressure or heart problems;
• you are over 35 years old;
• you have kidney problems, as Oxytocin Grindeks may cause water retention;
• you have had complications during pregnancy (such as diabetes, high blood pressure, thyroid hormone deficiency);
• you are past 40 weeks of gestation.

When Oxytocin Grindeks is administered to induce labor and augment labor, the infusion rate should be adjusted to achieve contractions similar to those during normal labor, and according to individual response. High doses may cause very strong, continuous contractions and possibly uterine rupture, with serious complications for the mother and baby.
Oxytocin Grindeks should not be administered by rapid intravenous injection, as this may cause a drop in blood pressure, sudden short-lived feeling of heat (often over the whole body), and increased heart rate.
Oxytocin Grindeks may rarely cause disseminated intravascular coagulation, leading to symptoms including abnormal blood clotting, bleeding, and anemia.
High doses of Oxytocin Grindeks may cause amniotic fluid to enter the bloodstream. This condition is called amniotic fluid embolism.
Large doses of Oxytocin Grindeks administered over a prolonged period, along with the consumption or infusion of large amounts of fluids, may cause a feeling of fullness in the abdomen, difficulty breathing, and low blood salt levels.
Oxytocin Grindeks should not be administered simultaneously with an intranasal spray containing oxytocin.
If you have any of these conditions or are unsure, you should discuss this with your doctor or nurse before receiving Oxytocin Grindeks.

Lateks allergy

The active substance of Oxytocin Grindeks may cause a severe allergic reaction (anaphylactic shock) in patients allergic to latex. If you know you are allergic to latex, you should inform your doctor.

Children and adolescents

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

Oxytocin Grindeks with other medicines

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The following medicines may interfere with the effects of Oxytocin Grindeks:

• prostaglandins (used to induce labor or treat stomach ulcers) and similar medicines, as the effects of both medicines may be enhanced;
• anesthetics (used to put the patient to sleep during surgery), such as cyclopropane or halothane, as they may cause heart rhythm disorders when used with Oxytocin Grindeks;
• medicines that cause heart rhythm disorders called "prolonged QT interval";
• local anesthetics (used to relieve pain during labor). Oxytocin Grindeks may enhance the vasoconstrictive effects of these medicines and cause high blood pressure.

Oxytocin Grindeks with food and drink

You may be advised to limit your fluid intake.

Pregnancy and breastfeeding

Oxytocin Grindeks may cause labor to start – it should only be used in pregnancy under medical supervision.
Oxytocin Grindeks is present in small amounts in breast milk, but it is not expected to cause harm, as it is rapidly inactivated by the baby's digestive system.
Oxytocin Grindeks does not pose a risk to the newborn during breastfeeding.

Driving and using machines

Oxytocin Grindeks may cause labor to start, so caution should be exercised when driving or operating machinery.

3. How to use Oxytocin Grindeks

Your doctor will decide when and how to administer Oxytocin Grindeks to you. If you think the effect of Oxytocin Grindeks is too strong or too weak, inform your doctor. During administration of Oxytocin Grindeks, you and your baby will be closely monitored.
Oxytocin Grindeks is usually diluted before use and administered as an intravenous infusion (drip) into one of your veins. To prepare the intravenous infusion, your 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 in the following situations:

To initiate or augment contractions during labor

Oxytocin Grindeks should be administered intravenously as an infusion, either by drip or, preferably, using a regulated infusion pump. For infusion by drip, it is recommended to add 5 IU of Oxytocin Grindeks to 500 ml of electrolyte solution (such as sodium chloride 0.9%). In patients where sodium chloride infusion should be avoided, a 5% glucose solution can be used as a diluent.
The initial infusion rate should be set at 2 to 8 drops per minute (1 to 4 milliunits per minute). It can be gradually increased to a maximum of 40 drops per minute (20 milliunits per minute). The infusion rate can usually be decreased after achieving an adequate level of uterine activity (about 3-4 contractions every 10 minutes).
If adequate contractions are not achieved after administration of 1 ml of Oxytocin Grindeks, 5 IU/ml, the attempt to initiate labor should be discontinued and repeated the next day.

Cesarean section

The dose of Oxytocin Grindeks is 5 IU administered as an intravenous infusion (5 IU diluted in sodium chloride solution) or, preferably, using a regulated infusion pump, over 5 minutes, immediately after delivery of the baby.

Prevention of postpartum hemorrhage

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

Treatment of postpartum hemorrhage

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

Abortion

Due to lower receptor expression, the use of oxytocin is recommended from the 14th week of gestation.
The dose of Oxytocin Grindeks, 5 IU/ml, is 5 IU or 1 ml, administered intravenously over 5 minutes, as an intravenous infusion (1.0 ml diluted in sodium chloride solution) or, preferably, using a regulated infusion pump. In some cases, an intravenous infusion may be administered at a rate of 20 to 40 milliunits per minute.

Patients with liver or kidney impairment

There is no information on 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.

Overdose of Oxytocin Grindeks

Due to the fact that the medicine is administered in a hospital, overdose is very unlikely.
In case of accidental administration of this medicine to anyone, you should immediately inform the hospital emergency department or your doctor. You should show your doctor any remaining medicine or empty packaging.
Overdose of Oxytocin Grindeks may cause:

• harm to the baby;
• very strong uterine contractions;
• uterine rupture, including severe complications;
• water retention, vasoconstriction, high blood pressure.

Missed dose of Oxytocin Grindeks

The medicine is administered by a doctor, so it is unlikely that a dose will be missed.
If you have any doubts, you should inform your doctor.
If you have any further questions about the use of this medicine, you should ask your doctor or nurse.

Stopping use of Oxytocin Grindeks

When labor is already in progress, Oxytocin Grindeks can be gradually discontinued.
There are no data on withdrawal effects.

4. Possible side effects

Like all medicines, Oxytocin Grindeks can cause side effects, although not everybody gets them.
You should stop using Oxytocin Grindeks and immediatelyinform your nearest hospital emergency department or doctor if you experience any of the following symptoms:

• severe allergic reaction (anaphylactic/anaphylactoid) with breathing difficulties, dizziness, and fainting, nausea, cold and clammy skin, or rapid or weak pulse. Rare side effects - may affect less than 1 in 1,000 people;
• swelling of the face, lips, tongue, throat, and/or limbs (possible symptoms of angioedema). Rare side effects - may affect less than 1 in 1,000 people;

Other side effects:

Common(may affect less than 1 in 10 people):

• headache;
• rapid heart rate;
• slow heart rate;
• nausea;
• vomiting.

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

• irregular heartbeat.

Rare(may affect less than 1 in 1,000 people):

• skin rash, hives.

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

• bleeding (hemorrhage);
• chest pain (angina pectoris);
• irregular heartbeat;
• excessive or continuous contractions;
• uterine rupture;
• fluid retention (water intoxication). Symptoms may include headache, loss of appetite, nausea or vomiting, stomach pain, slowed thinking, sleepiness, loss of consciousness, low levels of certain chemicals in the blood (such as sodium or potassium), seizures;
• low blood salt levels;
• sudden fluid overload in the lungs;
• rapid intravenous injection of oxytocin may cause a sudden, short-lived drop in blood pressure;
• sudden, short-lived feeling of heat over the whole body;
• abnormal clotting, bleeding, and anemia;
• uterine contractions.

Effects on the baby:
Excessive contractions may cause low blood salt levels, lack of oxygen, suffocation, and death.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the ampoule label after EXP. The expiry date refers to the last day of the 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 precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not use this medicine if the contents of the ampoule are cloudy or contain particles or flakes.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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 ingredients 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

Clear, colorless solution, free from visible particles.
pH between 3.5 and 4.5
Ampoules made of colorless borosilicate glass type I with a break ring or break point, containing 1 ml of solution.
Pack sizes: 5, 10, or 100 ampoules
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Sweden
Oxytocin Grindeks 8.3 micrograms/ml solution for injection/infusion
Oxytocin Grindeks 16.7 micrograms/ml solution for injection and infusion
Austria
Oxytocin Grindeks 8.3 micrograms/ml Injektions-/Infusionslösung
Oxytocin Grindeks 16.7 micrograms/ml Injektions-/Infusionslösung
Belgium
Oxytocin Grindeks 5 IU/ml solution injectable/pour perfusion
Oxytocin Grindeks 10 IU/ml solution injectable/pour perfusion
Czech Republic
Ofost 5 IU/ml injekční/infuzní roztok
Ofost 10 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
Germany
OFOST 10 IU/ml Lösung für Injektion/Infusion
OFOST 10 IU/ml Lösung für Injektion/Infusion
Hungary
Oxytocin Grindeks 5 NE/ml oldatos injekció/infúzió
Oxytocin Grindeks 10 NE/ml oldatos injekció/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 Pharmexon 5 IU/ml soluzione iniettabile/per infusione
Ossitocina Pharmexon 10 IU/ml soluzione iniettabile/per infusion
Latvia
Ofost 10 IU/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 micrograms/ml solution for injection/infusion
Oxytocin Grindeks 16.7 micrograms/ml solution for injection/infusion
Romania
Ofost 8.3 micrograms/ml solutie injectabila/perfuzabila
OFOST 16.7 micrograms/ml soluție injectabilă/perfuzabilă
Portugal
Oxitocina Kabi 5 UI/ml solução injetável ou para perfusão
Oxitocina Kabi 10 UI/ml solução injetável ou para perfusão
Slovakia
Ofost 5 IU/ml injekčný/infúzny roztok (injekcia/infúzia)
Ofost 10 IU/ml injekčný a 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 Kabi 5 IU/ml inyectable y para perfusión
Oxitocina Kabi 10 IU/ml inyectable y para perfusion

Date of last revision of the package leaflet: 10/2021