Oxytocin Grindex: detailed information

Package leaflet: Information for the user

Oxytocin Grindeks 8.3 micrograms (5 IU/mL) solution for injection/infusion

(Injection/Infusion)
Oxytocin Grindeks 16.7 micrograms (10 IU/mL) solution for injection/infusion
(Injection/Infusion)
Oxytocin
Generic medicine
Read 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 questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

What Oxytocin Grindeks is and what it is used for
What you need to know before receiving Oxytocin Grindeks
How to use Oxytocin Grindeks
Possible side effects
How to store Oxytocin Grindeks
Contents of the pack and other information

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

Each vial of Ossitocina Grindeks contains 8.3 micrograms (equivalent to 5 IU) or 16.7 micrograms (equivalent to 10 IU) of oxytocin in 1 mL of solution. Oxytocin is a hormone that contracts the smooth muscles of the uterus.
Ossitocina Grindeks is used:

to initiate or maintain uterine contractions during labour;
during caesarean section;
to prevent and control bleeding after childbirth;
as an adjunctive treatment in cases of spontaneous abortion.

2. What you need to know before receiving Ossitocina Grindeks

Do not receive Ossitocina Grindeks

if you are allergic to oxytocin or to any of the other ingredients of this medicine (listed in section 6);
if your doctor considers that initiating or increasing uterine contractions is not suitable for you, for example:
- if there are obstructions preventing childbirth;
- if uterine contractions are exceptionally strong;
- if the baby is deprived of oxygen.
When vaginal delivery or labor is not advisable, for example:
- if the fetal head is too large to pass through the pelvis;
- if the fetus is in an abnormal position in the birth canal;
- if the placenta is positioned over or near the cervix;
- if the baby lacks oxygen due to blood vessels crossing the cervix;
- if the placenta separates from the uterus before the baby is born;
- if there is one or more loops of the umbilical cord between the baby and the cervix, before or after rupture of membranes;
if the uterus is excessively distended and therefore more prone to rupture, as in multiple pregnancies or excessive amniotic fluid production;
if you have had five or more previous pregnancies or if you have a uterine scar due to a previous caesarean section or other surgical procedures.
- If you have been given medicines called prostaglandins (used to induce labor or treat stomach ulcers). Ossitocina Grindeks must not be used within 6 hours after vaginal prostaglandins, as the effects of both medicines may be enhanced.

Ossitocina Grindeks must not be used for prolonged periods if:

contractions do not increase following treatment;
you have a condition known as severe pre-eclamptic toxemia (high blood pressure, protein in urine, and swelling);
you have serious heart or circulatory problems.

If any of the conditions described above apply to you or if you have any doubts, consult your doctor before receiving Ossitocina Grindeks.
Warnings and precautions
Ossitocina Grindeks must be administered only by healthcare professionals in a hospital setting.
Inform your doctor or nurse before receiving Ossitocina Grindeks if:

you have previously had a caesarean section;
you suffer from chest pain due to pre-existing heart and/or circulatory problems;
you have known disturbances in heart rhythm ('long QT syndrome') or related symptoms, or if you are taking medicines known to cause this syndrome (see section Other medicines and Ossitocina Grindeks);
you have high blood pressure or heart problems;
you are over 35 years of age;
you have kidney problems, as Ossitocina Grindeks may cause fluid retention;
you have experienced complications during pregnancy (e.g. diabetes, high blood pressure, thyroid hormone deficiency);
gestational age exceeds 40 weeks.

When Ossitocina Grindeks is administered to assist contractions during labor, the infusion rate must be adjusted to maintain a contraction pattern similar to natural labor and modified according to individual response. Excessive doses may cause prolonged, intense contractions and even uterine rupture, leading to serious complications for both mother and baby.
Ossitocina Grindeks must not be administered as a rapid intravenous injection, as this may cause a drop in blood pressure, a sudden brief sensation of warmth (often throughout the body), and an increased heart rate.
Ossitocina Grindeks may rarely cause disseminated intravascular coagulation, which leads to symptoms including abnormal blood clotting, bleeding, and anemia.
High doses of Ossitocina Grindeks may force amniotic fluid from the uterus into the bloodstream. This phenomenon is known as amniotic fluid embolism.
Prolonged administration of high doses of oxytocin together with large volumes of fluids may cause stomach fullness, breathing difficulties, and low sodium levels in the blood.
Ossitocina Grindeks must not be administered concomitantly with nasal sprays containing oxytocin.
If any of the conditions described above apply to you or if you have any doubts, consult your doctor or nurse before receiving Ossitocina Grindeks.
Latex allergy
The active substance in Ossitocina Grindeks may cause a severe allergic reaction (anaphylaxis) in patients with latex allergy. Inform your doctor if you know you are allergic to latex.
Children and adolescents
Ossitocina Grindeks must not be used in children and adolescents.
Other medicines and Ossitocina Grindeks
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
The following medicines may interact with Ossitocina Grindeks:

prostaglandins (used to initiate labor or treat stomach ulcers) and similar medicines, as the effects of both medicines may be enhanced;
anesthetics (used to induce sleep during surgery), e.g. cyclopropane or halothane, as their use with Ossitocina Grindeks may cause heart rhythm disturbances;
medicines known to cause disturbances in heart rhythm called 'long QT syndrome';
epidural anesthetics (used to relieve pain during labor). Ossitocina Grindeks may enhance the vasoconstrictive effect of these medicines and cause an increase in blood pressure.

Ossitocina Grindeks with food and drink
You may be advised to minimize your fluid intake.
Pregnancy and breastfeeding
Ossitocina Grindeks can initiate labor – it should be used during pregnancy only under strict medical supervision.
Ossitocina Grindeks may be present in small amounts in breast milk, but harmful effects are not expected because it is rapidly inactivated by the infant's digestive system.
Ossitocina Grindeks will not cause harm to the newborn during breastfeeding.
Driving and using machines
Ossitocina Grindeks may induce labor; therefore, exercise particular caution when driving or operating machinery.

3. How to use Ossitocina Grindeks

Your doctor will decide when and how to administer Ossitocina Grindeks to you. If you feel that the effect of Ossitocina Grindeks is too strong or too weak, inform your doctor. While you are receiving Ossitocina Grindeks, both you and your baby will be closely monitored.
Ossitocina Grindeks is generally diluted before use and administered as an intravenous infusion (drop by drop) into a vein. To prepare the intravenous infusion, your doctor may use Ossitocina Grindeks 5 IU injectable solution/for infusion.
In some cases, 1 mL of Ossitocina Grindeks may be injected into the muscle without dilution.
The usual dose varies under the following circumstances:

To initiate or maintain contractions during labour
Ossitocina Grindeks will be administered as an intravenous infusion drop by drop or, preferably, by means of a variable-rate infusion pump. For drop-by-drop infusion, it is recommended to add 5 IU of Ossitocina Grindeks to 500 mL of an electrolyte physiological solution (such as 0.9% sodium chloride). For patients in whom sodium chloride infusion must be avoided, 5% dextrose solution may be used as the diluent.
The initial infusion rate will be 2-8 drops per minute (1-4 milliunits per minute). This may be gradually increased to a maximum rate of 40 drops per minute (20 milliunits per minute). The infusion rate can often be reduced once contractions reach an adequate level, approximately 3-4 contractions every 10 minutes.
If your contractions do not reach an adequate level after administration of 1 mL of Ossitocina Grindeks 5 IU/mL, the attempt to initiate labour should be discontinued and repeated the following day.

Caesarean section
The dose of Ossitocina Grindeks is 5 IU administered as a drop-by-drop infusion (5 IU diluted in sodium chloride physiological solution) or, preferably, by means of a variable-rate infusion pump over 5 minutes into a vein after delivery.

Prevention of postpartum bleeding
The usual dose is 5 IU by intravenous infusion (5 IU diluted in electrolyte physiological solution) or 5-10 IU into a muscle after expulsion of the placenta.

Treatment of postpartum bleeding
The dose is 5 IU of Ossitocina Grindeks by intravenous infusion (5 IU diluted in electrolyte physiological solution) or 5-10 IU into a muscle. Sometimes this may be followed by a continuous intravenous infusion containing 5-20 IU of oxytocin in 500 mL of electrolyte physiological solution.

Spontaneous abortion/abortion
Due to lower receptor expression, the use of oxytocin is recommended starting from the 14th week of pregnancy.
The dose is 5 IU or 1 mL of Ossitocina Grindeks 5 IU/mL administered as a drop-by-drop infusion (1 mL diluted in sodium chloride physiological solution) or, preferably, by means of a variable-rate infusion pump over 5 minutes into a vein, if necessary followed by an intravenous infusion at a rate of 20-40 milliunits/minute.

Patients with hepatic or renal impairment
There is no information on the use of Ossitocina Grindeks in patients with renal or hepatic impairment.

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

If you receive more Ossitocina Grindeks than you should
Since this medicine is administered in a hospital setting, it is highly unlikely that you will receive an overdose. However, if someone accidentally receives this medicine, inform the emergency department or a doctor immediately. Show the remaining medicine or empty packaging to the doctor.
An overdose of Ossitocina Grindeks may cause:

harm to the baby;
very strong uterine contractions;
damage to the uterus including rupture;
fluid retention, blood vessel spasms, high blood pressure.

If you miss a dose of Ossitocina Grindeks
Since this medicine is administered by a doctor, it is unlikely that you will miss a dose. If you have any concerns, inform your doctor.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

If treatment with Ossitocina Grindeks is stopped
Once labour is established, the infusion of Ossitocina Grindeks may be gradually discontinued. There is no information available regarding adverse effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Oxytocin Grindeks and contact a doctor or go immediately to the nearest emergency room if you experience any of the following symptoms:

a severe allergic (anaphylactic/anaphylactoid) reaction with difficulty breathing, dizziness,

drowsiness, feeling faint, nausea, cold sweat, or rapid or weak pulse. Rare - may affect up to 1 in 1,000 people

swelling of the face, lips, tongue, throat and/or extremities (possible signs of angioedema). Rare - may affect up to 1 in 1,000 people

Other possible side effects:
Common (may affect up to 1 in 10 people):

headache;
increased heart rate;
slowed heart rate;
nausea;
vomiting.

Uncommon (may affect up to 1 in 100 people):

irregular heartbeat.

Rare (may affect up to 1 in 1,000 people):

rash, urticaria.

Frequency not known (frequency cannot be estimated from the 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), malaise or feeling unwell, stomach pain, lethargy, drowsiness, loss of consciousness, low levels of certain substances in the blood (e.g. sodium or potassium), seizures;
low blood salt levels;
sudden fluid overload in the lungs;
rapid intravenous injection of oxytocin may cause a rapid drop in blood pressure, brief sudden sensation of warmth often affecting the whole body;
abnormal blood clotting, bleeding and anaemia;
uterine muscle spasms.

Effects in the newborn:
Excessive contractions may cause low levels of salts in the blood, lack of oxygen, asphyxia and death.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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. After first opening, the medicinal product must be used immediately.
After dilution for infusion: from a microbiological standpoint, unless the method of opening/dilution excludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, the duration and storage conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date refers to the last day of that month.
Do not use the pack if it is damaged or shows any signs of tampering.
Do not use this medicinal product if you notice that the solution in the vial is cloudy or if particles or flakes are present.
Do not dispose of any medicinal product 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

What Ossitocina 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.

Description of the appearance of Ossitocina Grindeks and contents of the pack
Clear, colourless liquid with a characteristic odour, free from visible particles. pH of solutions: 3.5–4.5.
1 mL transparent vials made of type I borosilicate glass with a break ring or score mark.
Pack sizes: 5, 10 or 100 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

This medicinal product is authorized in the European Economic Area countries under the following names:

Sweden
Oxytocin Grindeks 8.3 mikrogram/ml injektions-/infusionsvätska, lösning
Oxytocin Grindeks 16.7 mikrogram/ml injektions-/infusionsvätska, lösning

Austria
Oxytocin Grindeks 8,3 Mikrogramm/ml Injektions-/Infusionslösung
Oxytocin Grindeks 16,7 Mikrogramm/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
Ossitocina Grindeks

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/infuzji
Oxytocin Grindeks 16.7 mikrogramów/ml roztwór do wstrzykiwań/infuzji

Portugal
Oxitocina Grindeks 5 UI/1 ml solução injetável ou para perfusão
Oxitocina Grindeks 10 UI/1 ml solução injetável ou para perfusão

Romania
Ofost 8.3 micrograme/ml solutie injectabilă/perfuzabilă
Ofost 16.7 micrograme/ml soluție injectabilă/perfuzabilă

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