OXYTOCIN 16.7 mcg/ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: 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 leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Oxytocin Grindeks and what is it 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. Allergy to latex
   4. Children and adolescents
   5. Oxytocin Grindeks and 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. Using more than the recommended dose of Oxytocin Grindeks
   2. Missing a dose of Oxytocin Grindeks
   3. Stopping the use of Oxytocin Grindeks
7. Possible side effects
   1. Reporting side effects
8. How to store Oxytocin Grindeks
9. Contents of the packaging 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 leaflet: 10/2021

Leaflet attached to the packaging: 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 leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Oxytocin Grindeks and what is it 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 packaging and other information

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

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

Oxytocin Grindeks is used:

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

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:
• 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 is 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 excessive amniotic fluid in the uterus;
• if the patient has been pregnant at least five times or if there is a uterine scar after a previous cesarean section or other surgical procedure.
• If the patient has received prostaglandin medications (used to induce labor or treat stomach ulcers). Oxytocin Grindeks should not be used within 6 hours of administering prostaglandins vaginally, as this may enhance the effects of both medicines.

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

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

If the patient experiences any of the above conditions or is unsure, they should discuss this with their doctor before receiving Oxytocin Grindeks.

Warnings and precautions

Oxytocin Grindeks should only be administered by medical professionals in a hospital setting. Before receiving Oxytocin Grindeks, the patient should discuss this with their doctor or nurse if:

• they have had a cesarean section in the past;
• they have a history of chest pain due to heart disease and/or circulatory disorders;
• they have a diagnosed heart rhythm disorder ("long QT syndrome") or related symptoms, or are taking medications that cause this syndrome (see "Oxytocin Grindeks and other medicines");
• they have high blood pressure or heart disease;
• they are over 35 years old;
• they have kidney problems, as Oxytocin Grindeks may cause water retention;
• there were complications during pregnancy (such as diabetes, high blood pressure, thyroid hormone deficiency);
• the pregnancy is over 40 weeks.

When administering Oxytocin Grindeks to induce labor and support labor, the infusion rate should be set so that contractions occur similarly to those during normal labor, and in accordance with the individual response. Excessive doses may cause very strong, continuous contractions and possibly uterine rupture, with serious complications for the patient and their baby. Oxytocin Grindeks should not be administered as a rapid intravenous injection, as this may cause a drop in blood pressure, sudden short-term feeling of heat (often over the entire body), and rapid 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 longer 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 salt levels in the blood. Oxytocin Grindeks should not be administered simultaneously with a nasal spray containing oxytocin. If the patient experiences any of the above conditions or is unsure, they should discuss this with their doctor or nurse before receiving Oxytocin Grindeks.

Allergy to latex

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

Children and adolescents

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

Oxytocin Grindeks and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The following medicines may interfere with the action 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 "long QT syndrome";
• local anesthetics (used to relieve pain during labor). Oxytocin Grindeks may enhance the vasoconstrictive effect of these medicines and cause high blood pressure.

Oxytocin Grindeks with food and drink

The patient may be advised to limit their fluid intake to a minimum.

Pregnancy and breastfeeding

Oxytocin Grindeks may cause labor to start – it should only be used during 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 machines.

3. How to use Oxytocin Grindeks

The doctor will decide when and how to administer Oxytocin Grindeks to the patient. If the patient thinks that the effect of Oxytocin Grindeks is too strong or too weak, they should inform their doctor. During the administration of Oxytocin Grindeks, 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 is different in the following situations:

Oxytocin Grindeks should be administered intravenously as an infusion by drip method or, preferably, using an infusion pump with a regulated rate of administration. For infusion administered by drip method, it is recommended to add 5 IU of Oxytocin Grindeks to 500 ml of physiological electrolyte solution (such as sodium chloride 0.9%). In patients who should avoid sodium chloride infusion, 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 reduced after achieving the desired level of uterine activity (about 3-4 contractions per 10 minutes). If it is not possible to achieve the desired level of contractions after administering 1 ml of Oxytocin Grindeks, 5 IU/ml, the attempt to induce labor should be stopped and repeated the next day.

The dose of Oxytocin Grindeks is 5 IU administered as an infusion by drip method (5 IU diluted in physiological sodium chloride solution) or, preferably, using an infusion pump with a regulated rate of administration, intravenously within 5 minutes, immediately after childbirth.

The usual dose is 5 IU in intravenous infusion (5 IU diluted in physiological electrolyte solution) or 5-10 IU intramuscularly, after placental delivery.

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

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

There is no information on the use of Oxytocin Grindeks in patients with liver or kidney impairment.

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

Using more than the recommended dose of Oxytocin Grindeks

Due to the fact that the medicine is administered in a hospital, overdose is very unlikely. If the medicine is accidentally administered to anyone, they should immediately inform the hospital emergency department or doctor. They should show the doctor any remaining medicine or empty packaging. Overdose of Oxytocin Grindeks may cause:

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

Missing a dose of Oxytocin Grindeks

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

Stopping the use of Oxytocin Grindeks

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

4. Possible side effects

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

• severe allergic reaction (anaphylactic/anaphylactoid) with breathing problems, dizziness, and fainting, nausea, cold and sweaty skin, or rapid or weak pulse. Rare side effects - may occur in less than 1 in 1000 people;
• swelling of the face, lips, tongue, throat, and/or limbs (possible symptoms of angioedema). Rare side effects - may occur in less than 1 in 1000 people;

Other side effects:

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

• irregular heartbeat.

• skin rash, hives.

• 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, slowing, drowsiness, loss of consciousness, low levels of certain chemicals in the blood (e.g. sodium or potassium), seizures;
• low salt levels in the blood;
• sudden fluid overload in the lungs;
• rapid intravenous injection of oxytocin may cause a sudden, short-term drop in blood pressure;
• sudden, short-term feeling of heat over the entire body;
• abnormal clotting, bleeding, and anemia;
• uterine contractions.

Excessive contractions may cause low salt levels in the blood, lack of oxygen, suffocation, and death.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their 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, Tel: +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, more information can be gathered on the safety of the 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 stated. 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Oxytocin Grindeks contains

• The active substance of Oxytocin Grindeks 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 (to adjust pH), 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 size: 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 microgram/ml solution for injection/infusion, Oxytocin Grindeks 16.7 microgram/ml solution for injection and infusion. Austria: Oxytocin Grindeks 8,3 Mikrogramm/ml Injektions-/Infusionslösung, Oxytocin Grindeks 16,7 Mikrogramm/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 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 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 leaflet: 10/2021