Oxitocin-rihter

Leaflet attached to the packaging: patient information

Oxytocin-Richter

Infusion solution, 5 IU/ml
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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Oxytocin-Richter and what is it used for
• 2. Important information before using Oxytocin-Richter
• 3. How to use Oxytocin-Richter
• 4. Possible side effects
• 5. How to store Oxytocin-Richter
• 6. Package contents and other information

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

Oxytocin-Richter is a medicine used to induce or strengthen uterine contractions.
Its action is identical to that of endogenous oxytocin produced by the posterior pituitary gland.
Oxytocin-Richter may be used in the following cases:

• to induce labor;
• to stimulate labor contractions;
• to prevent postpartum hemorrhage;
• in the treatment of incomplete or inevitable abortion;
• in high-risk pregnancies, Oxytocin-Richter may be used to perform a so-called oxytocin test.

2. Important information before using Oxytocin-Richter

When not to use Oxytocin-Richter:

• -if the patient is allergic to oxytocin or any of the other ingredients of this medicine (listed in section 6);
• -in case of abnormal disproportion between the fetal head and the maternal pelvis (significant fetal-pelvic disproportion);
• -in case of abnormal fetal presentation (transverse lie);
• -induction of labor and stimulation of uterine contractions are also contraindicated in case of umbilical cord prolapse and placenta previa;
• -in case the fetus is hypoxic (fetal distress) and labor has not yet started;
• -in case of preeclampsia, which is a severe condition characterized by high blood pressure and edema;

Oxytocin-Richter should not be used for a long time if:

• there are no labor contractions;
• the patient has severe preeclampsia (high blood pressure, protein in the urine, and edema);
• oxytocin should not be administered for 6 hours after the administration of prostaglandins vaginally.

Warnings and precautions

Before starting to use Oxytocin-Richter, the patient should discuss it with their doctor:

• in cases of premature labor and fetal-pelvic disproportion;
• in case of previous major surgical procedures on the uterus or cervix (including cesarean section);
• in case of multiple pregnancies - if the patient has given birth two or more times;
• if the patient has cervical cancer;
• if the uterus is overdistended;
• if the patient has kidney disease or water retention;
• if the patient has heart rhythm disorders.

To avoid complications during oxytocin infusion, the following should be continuously monitored:

• uterine contractions,
• maternal and fetal heart rate,
• maternal blood pressure.

Latex allergy
The active substance of Oxytocin-Richter 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.
Oxytocin should not be administered as a rapid intravenous injection (bolus).
Oxytocin can only be administered via one route of administration: intramuscularly or intravenously.

Children and adolescents

Oxytocin-Richter is not intended for use in children.

Oxytocin-Richter 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.
A severe form of high blood pressure (hypertension) may occur after oxytocin administration, 3 to 4 hours after the administration of vasoconstrictor drugs during spinal anesthesia in the lumbar region.
Oxytocin should not be used for 6 hours after the administration of certain medicines that induce labor (prostaglandins administered vaginally).
The use of oxytocin is not recommended in patients with heart rhythm disorders (e.g., long QT syndrome) or those taking medicines that affect heart rhythm (may cause QT prolongation).
Cyclopropane, enflurane, halothane, and isoflurane used during anesthesia may modify the effect of oxytocin on the cardiovascular system, causing unexpected side effects, such as hypotension.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
It is unlikely that this medicine, when used as directed, will cause harmful effects on the fetus. In the first trimester, oxytocin is indicated only in cases of spontaneous or induced abortion.
Breastfeeding:
Oxytocin may pass into breast milk in small amounts. However, oxytocin should not cause harmful effects in the newborn, as it is inactivated in the gastrointestinal tract.

Driving and using machines:

Women receiving oxytocin should not drive or operate machinery.

Oxytocin-Richter, infusion solution contains ethanol (alcohol).

The medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

Oxytocin-Richter, infusion solution contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Oxytocin-Richter

This medicine should always be used exactly as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
When used to induce labor, Oxytocin-Richter is administered as an intravenous drip.
The dose of the medicine should be determined individually (depending on the patient's and fetus's response to oxytocin).
If the medicine is indicated for the prevention of postpartum hemorrhage, oxytocin can be administered intravenously in a drip infusion or intramuscularly.
This medicine should be used in accordance with the doctor's recommendations regarding dose, method of administration, and duration of treatment.
Oxytocin infusions should be used in the dose, manner, and for the duration specified by the doctor.

• When used to induce and strengthen labor, Oxytocin-Richter should be administered only as an intravenous drip, in a hospital setting, and under the supervision of qualified medical personnel. When used as directed, Oxytocin-Richter strengthens uterine contractions - similar to the action of endogenous oxytocin during natural labor. However, in women with hypersensitivity to oxytocin, unusually strong uterine contractions may occur. Therefore, during the administration of Oxytocin-Richter, the patient will be under the continuous supervision of a doctor monitoring contractions, blood pressure, and fetal heart rate. The dose will be determined individually (depending on the patient's and fetus's response to oxytocin)
• In case of prevention of postpartum hemorrhage, Oxytocin-Richter may be administered as a drip infusion or intramuscularly.

Oxytocin should not be used for 6 hours after the administration of prostaglandins vaginally.

• Oxytocin can only be administered via one route of administration: intramuscularly or intravenously.

Oxytocin may be administered only with the use of one route of administration: intramuscularly or intravenously.

Overdose of Oxytocin-Richter

Essentially, an overdose of Oxytocin-Richter may occur in relation to uterine sensitivity to oxytocin - which should be clearly distinguished from an allergy (hypersensitivity) to the active substance.
Too high doses may cause:

• very rapid (precipitous) labor,
• uterine rupture (disruption of the uterine wall),
• cervical and vaginal lacerations,
• postpartum hemorrhage,
• reduced blood flow between the uterus and placenta,
• fetal heart rate abnormalities,
• fetal hypoxia (fetal distress),
• limb muscle contractions associated with water retention after oxytocin administration,
• fetal death.

These reactions require the implementation of appropriate emergency treatment.
In case of any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects related to the mother:

• heart rhythm disorders, rapid heart rate, partial or complete blockage of coronary arteries (myocardial ischemia),
• decreased blood pressure,
• blood clots in small blood vessels throughout the body (disseminated intravascular coagulation),
• increased bleeding,
• increased fluid in the lungs (pulmonary edema),
• nausea or vomiting,
• water intoxication,
• headache,
• uterine rupture (uterine tear),
• excessive uterine contractions,
• tetanic uterine contractions,
• allergic reaction and hypersensitivity.

Side effects related to the fetus:

• low Apgar scores within the first 5 minutes after birth (assessment of the newborn's physical condition),
• heart rhythm disorders, decreased and increased heart rate,
• bleeding into the retina (retinal hemorrhage),
• fetal distress,
• fetal death,
• low sodium levels in the blood,
• hypoxia (fetal distress),
• brain damage.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. 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
PL-02 222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Oxytocin-Richter

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Store in the original packaging.

Do not use Oxytocin-Richter if

the oxytocin infusion solution was prepared more than 8 hours ago.
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. Package contents and other information

Composition:

1 ampoule of 1 ml contains:
active substance:5 international units (IU) of oxytocin
Excipients: glacial acetic acid, chlorobutanol hemihydrate, ethanol 96%, acetic acid 20% (for pH adjustment), sodium hydroxide 10% (for pH adjustment), water for injections.

Packaging:

Cardboard box containing colorless glass ampoules.
5 ampoules of 1 ml each

Marketing authorization holder and manufacturer:

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary
For more information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
[email protected]
Fax: +48 (22) 755 96 24

Date of last revision of the leaflet: