OXYTOCIN-GRINDEX 5 IU/ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet:
2. What Oxytocin-Grindex is and what it is used for
3. Important information before using Oxytocin-Grindex
   1. When not to use Oxytocin-Grindex:
   2. Warnings and precautions
   3. Children
   4. Oxytocin-Grindex and other medicines
   5. Oxytocin-Grindex with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
4. How to use Oxytocin-Grindex
   1. Overdose of Oxytocin-Grindex
   2. Missed dose of Oxytocin-Grindex
   3. Stopping treatment with Oxytocin-Grindex
5. Possible side effects
   1. Reporting side effects
6. How to store Oxytocin-Grindex
7. Contents of the pack and other information
   1. What Oxytocin-Grindex contains
   2. What Oxytocin-Grindex looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: 06/2018

Package Leaflet: Information for the Patient

OXYTOCIN-GRINDEX, 5 IU/ml, solution for injection and infusion
Oxytocin

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• 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 those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

• 1. What Oxytocin-Grindex is and what it is used for
• 2. Important information before using Oxytocin-Grindex
• 3. How to use Oxytocin-Grindex
• 4. Possible side effects
• 5. How to store Oxytocin-Grindex
• 6. Contents of the pack and other information

1. What Oxytocin-Grindex is and what it is used for

Oxytocin-Grindex contains oxytocin, a synthetic, cyclic 9-amino acid peptide with the structure of a hormone produced by the posterior pituitary gland. Oxytocin causes contractions of the smooth muscle of the uterus and the myoepithelial cells of the mammary gland.
Oxytocin-Grindex is used in hospital settings for:

• induction and stimulation of labor in cases of weak uterine contractions, as well as in patients with the following medical indications for termination of pregnancy: pregnancy-induced hypertension and/or pre-eclampsia, chronic hypertension, diabetes, chronic diseases of pregnancy (non-advanced, stabilized), intrauterine infection, serological conflict, fetal hypotrophy, abnormal test results suggesting fetal hypoxia, history of intrauterine fetal death, fetal developmental abnormalities, premature rupture of membranes,
• acceleration of labor: oxytocin induction may be indicated in cases of pregnancies lasting longer than 42 weeks, as well as in cases of fetal death or fetal growth restriction, and in cases of prolonged labor or uterine atony,
• control of postpartum hemorrhage and uterine atony,
• as adjunctive treatment after incomplete or missed abortion,
• diagnosis: to assess fetal respiratory function in high-risk pregnancies (stress test).

2. Important information before using Oxytocin-Grindex

When not to use Oxytocin-Grindex:

• if the patient is allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has excessive (hypertonic) uterine contractions, fetal distress (fetal hypoxia);
• if there is a disproportion between the size of the fetus and the maternal pelvis, transverse or oblique fetal position, placenta previa, vasa previa, placental abruption,

prolapse or umbilical cord prolapse, predisposition to uterine rupture as in multiple pregnancy, polyhydramnios, multiple gestations, and presence of uterine scars after major surgical procedures including cesarean section.
Avoid prolonged use in cases of uterine atony resistant to oxytocin, severe preeclampsia with eclampsia (proteinuria), and severe cardiovascular disease.

Warnings and precautions

Before starting treatment with Oxytocin-Grindex, consult your doctor, pharmacist, or nurse.
Oxytocin administered to induce or augment labor should be given only by intravenous drip infusion and under medical supervision in a hospital setting.
It is essential to closely monitor the infusion rate. Additionally, it is crucial to carefully monitor uterine contractions, fetal heart rate, fetal position, maternal blood pressure, and the patient's overall health.
Special precautions should be taken in the following cases:

• borderline disproportion between the fetal head and the maternal pelvis (in cases of significant disproportion, oxytocin should be avoided);
• secondary uterine atony (decrease in contraction frequency after a wave of intense contractions);
• mild to moderate pregnancy-induced hypertension or heart disease;
• women over 35 years of age;
• women who have had a lower uterine segment incision during cesarean section;
• intrauterine fetal death;
• presence of meconium - discolored amniotic fluid (may cause amniotic fluid embolism). It is believed that pharmacologically induced labor with oxytocin may increase the risk of a very rare condition: postpartum disseminated intravascular coagulation (DIC). The increased risk applies to women over 35 years of age, women who have had complications during pregnancy, and women whose pregnancy has lasted more than 40 weeks. In these patients, oxytocin should be used with caution, and the doctor should pay attention to DIC symptoms (i.e., check for fibrinolysis). If too much oxytocin is administered too quickly, it may cause fluid overload or hyponatremia
• avoid administering the drug in a high-volume infusion and limit oral fluid intake. The therapeutic effect of oxytocin may be enhanced by concurrent administration of prostaglandins (requires careful monitoring). Oxytocin administered 3-4 hours after prophylactic administration of vasoconstrictors, including epidural anesthesia, may cause severe hypertension. It is essential to remember the possible risk of fluid overload, especially when high doses of oxytocin are used for a long time. It is recommended to use small volumes of infusions and, in such cases, to use oxytocin in an electrolyte solution, not in a glucose solution. In case of suspected electrolyte imbalance, it is necessary to monitor serum electrolyte levels. Oxytocin infusions should not be administered using the same apparatus used for blood or plasma transfusions, as this may cause oxytocin inactivation. Oxytocin is incompatible with solutions containing sodium bisulfite used as a stabilizing agent. Allergy to latex The active substance of Oxytocin-Grindex 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

Oxytocin-Grindex is not intended for use in children.

Oxytocin-Grindex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Oxytocin should not be administered earlier than 6 hours after vaginal administration of prostaglandins.
Certain inhaled anesthetics (cyclopropane, halothane) may enhance the hypotensive effect of oxytocin and weaken its labor-stimulating effect. Their concurrent use with oxytocin may cause cardiac arrhythmias.
Oxytocin administered concurrently with vasoconstrictor sympathomimetics may enhance their effect.
Oxytocin administered during or after epidural anesthesia may potentiate the hypertensive effect of vasoconstrictor sympathomimetics.

Oxytocin-Grindex with food and drink

The patient may be asked to limit fluid intake to a minimum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Oxytocin-Grindex should only be used to induce labor when medically indicated.
Only small amounts of oxytocin pass into breast milk; however, it is not expected to harm the baby, as it is rapidly inactivated in the gastrointestinal tract.

Driving and using machines

Not applicable.

3. How to use Oxytocin-Grindex

This medicine should always be used as directed by your doctor. Your doctor will decide when and how to administer Oxytocin-Grindex. If you have any doubts, consult your doctor or pharmacist.
Induction and stimulation of labor
5-10 IU of oxytocin, dissolved in 500 ml of Ringer's solution or a multi-electrolyte solution, should be administered intravenously using an infusion pump at a rate of 1-6 mIU/minute, increasing the infusion rate as needed.
After delivery of the newborn, it is recommended to administer oxytocin to the mother in a dose of 3 to 5 IU intravenously in a bolus or intramuscularly.
Cesarean section
5 IU should be administered slowly intravenously (5 IU should be diluted with physiological electrolyte solution and administered as an intravenous drip infusion or, more conveniently, using a variable-speed rotary pump over 5 minutes) immediately after delivery to stimulate uterine contractions and reduce blood loss.
Control of postpartum hemorrhage
initially 5 IU of oxytocin in slow intravenous infusion (5 IU should be diluted with physiological electrolyte solution and administered as an intravenous drip infusion or, more conveniently, using a variable-speed rotary pump over 5 minutes), the dose may be repeated, then in infusion (40 IU in 500 ml of Singer's solution at a rate of 125 ml/hour), unless fluid intake needs to be restricted.
Adjunctive treatment of incomplete or missed abortion (ongoing abortion)
10 IU of oxytocin dissolved in 500 ml of physiological saline or 5% glucose solution should be administered as an intravenous drip infusion at a rate of 20-40 drops/minute.
Stress test
Intravenous drip infusion - initially, 0.5 mIU/minute is administered, then the dose is doubled every 20 minutes, if necessary, until an effective dose is achieved (usually 5-6 mIU/minute, maximum 20 mIU/minute). After the occurrence of three moderate uterine contractions (lasting 40-60 seconds) within a 10-minute period, the infusion should be discontinued and then the decreased fetal heart rate should be monitored.
Patients with renal and/or hepatic impairment
There are no data on the use of oxytocin in patients with renal and/or hepatic impairment.
Elderly patients
Oxytocin is not indicated for use in elderly patients.

Overdose of Oxytocin-Grindex

As this medicine is administered in a hospital setting, it is unlikely that the patient will receive a higher dose than recommended.
There is no antidote known.
Overdose may lead to placental abruption, amniotic fluid embolism, excessive uterine activity, severe (hypertonic) and/or prolonged (tetanic) contractions, and consequently to uterine rupture, cervical and vaginal lacerations, severe postpartum hemorrhage, fetal arrhythmia (irregular heartbeat), hypoxia, and even fetal or maternal death.
In case of overdose, the infusion should be discontinued immediately, and normal diuresis should be maintained.
Supportive therapy is required, and the use of hypertonic fluids containing electrolytes is recommended.

Missed dose of Oxytocin-Grindex

As the medicine is administered by a doctor, it is unlikely that a dose will be missed.
If the patient has any doubts, they should consult their doctor.
A double dose should not be administered to make up for a missed dose.

Stopping treatment with Oxytocin-Grindex

When labor is already in progress, oxytocin can be gradually discontinued.
There are no data on withdrawal effects.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Oxytocin-Grindex can cause side effects, although not everybody gets them.
Uterine contractions (may occur with small doses).
Oxytocin-Grindex administered in high doses or to women with hypersensitivity may cause increased uterine tone with severe (hypertonic) and/or prolonged (tetanic) contractions, leading to uterine rupture and soft tissue damage, and in the fetus: bradycardia (slow heart rate), arrhythmias, asphyxia (suffocation), and acute hypoxia, as well as possible fetal death or maternal death.
Administration of large volumes of electrolyte-free fluid may cause fluid overload with pulmonary edema, seizures, coma, hyponatremia (low sodium levels in the blood), and even death. Nausea, vomiting, rash, and anaphylactic reactions (with shortness of breath, low blood pressure, or shock) may occur.
Severe hypertension and subarachnoid hemorrhage (bleeding into the space between the brain and the tissues surrounding it) may lead to maternal death. Observed postpartum hemorrhage and afibrinogenemia leading to death (lack of fibrinogen in the blood) may be obstetric complications. It is possible to experience rare postpartum disseminated intravascular coagulation (see section 4.4).
Rapid intravenous injection may cause acute, transient hypotension, accompanied by flushing and reflex tachycardia.
There are reports of neonatal jaundice and retinal hemorrhage associated with oxytocin use during labor.
Common(may affect more than 1 in 100 patients):

• headache,
• bradycardia, tachycardia,
• nausea,
• vomiting.

Uncommon(may affect more than 1 in 1000 patients):

• arrhythmia (irregular heartbeat).

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

• severe allergic reactions with difficulty breathing, low blood pressure, or shock,
• rash.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: [email protected]. 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-Grindex

Store in a temperature below 25°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Oxytocin-Grindex contains

• The active substance is oxytocin (Oxytocin)
• 1 ml of solution contains 5 IU of oxytocin The other ingredients are chlorobutanol hemihydrate, glacial acetic acid, water for injections

What Oxytocin-Grindex looks like and contents of the pack

Colorless, clear solution.
The pack contains 10 ampoules of colorless borosilicate glass.

Marketing authorization holder and manufacturer

AS GRINDEKS.
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Tel.: +371 67083205
Fax: +371 67083505
e-mail: [email protected]

Date of last revision of the leaflet: 06/2018