Prospecto: information for the user

Oxitocina Kabi 10 UI/ml injectable solution and for perfusion EFG

oxitocina

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

1.What is Oxitocina Kabi and for what it is used

2.What you need to know before starting to use Oxitocina Kabi

3.How to use Oxitocina Kabi

4.Possible adverse effects

5.Storage of Oxitocina Kabi

6.Contents of the package and additional information

Each vial of Oxitocina Kabi contains 16.7 micrograms of oxytocin (equivalent to 10 IU). Oxytocin is a hormone that acts by contracting the smooth muscle of the uterus.

Oxitocina Kabi is used:

• to initiate or help with contractions during labor
• during a cesarean section

• to prevent and control bleeding after delivery of your baby
• to help in the treatment of a spontaneous abortion.

No useOxitocina Kabi

• If you are allergic to oxytocin or any of the other components of this medication (listed in section 6).
• If your doctor considers it inappropriate for you to initiate or increase uterine contractions, for example:

• In cases of obstructions that may prevent delivery
• In cases where uterine contractions are unusually strong
• In cases where your baby may have a lack of oxygen.

• In cases where vaginal delivery or childbirth is not recommended, for example:

• If your baby's head is too large to pass through your pelvis
• If your baby is malpositioned in the birth canal
• If the placenta is located near or over the cervix of your uterus
• If your baby lacks oxygen due to blood vessels crossing the cervix of your uterus
• If the placenta separates from your uterus before your baby is born
• If there is one or more umbilical cord twists between your baby and the cervix of your uterus, before or after the water breaks
• If your abdomen is excessively distended and is more likely to rupture, for example, if you are carrying more than one baby or have too much amniotic fluid in your abdomen
• If you have had five or more previous pregnancies or if your abdomen has a scar from a previous cesarean section or other surgery.

• If you have been administered medications called prostaglandins (used to induce labor or treat stomach ulcers). Oxitocina Kabi should not be used during the 6 hours after vaginal prostaglandins, as the effects of both medications may increase.

Oxitocina Kabi should not be used for prolonged periods if:

• Your contractions do not increase with treatment
• You have a severe condition called preeclampsia (high blood pressure, presence of protein in the urine, and edema)
• You have severe cardiovascular disorders.

If you are in any of these situations or have doubts, consult with your doctor before using Oxitocina Kabi.

Warnings and precautions

Oxitocina Kabi should only be administered by healthcare professionals in a hospital setting.

Consult with your doctor or nurse before starting to use Oxitocina Kabi if:

• You have had a previous cesarean section
• You are prone to chest pain due to pre-existing heart and/or circulation problems
• You have a known irregular heartbeat (long QT syndrome) or symptoms related to it, or are taking medications known to cause this syndrome (see sectionUse of Oxitocina Kabi with other medications)
• You have high blood pressure or cardiovascular problems
• You are over 35 years old
• You have kidney problems, as Oxitocina Kabi may cause fluid retention
• You have had complications during your pregnancy (such as diabetes, high blood pressure, thyroid hormone deficiency)
• You are over 40 weeks pregnant.

When administering Oxitocina Kabi to initiate or help contractions during labor, the infusion rate should be adjusted to maintain a contraction pattern similar to a normal and adjusted labor, and tailored to the individual's response. High doses may cause continuous and very strong contractions, and possibly uterine rupture, with serious complications for you and your baby.

Oxitocina Kabi should not be administered as a rapid injection into a vein, as this may cause a decrease in blood pressure, a sudden and brief sensation of heat (often throughout the body), and an increase in heart rate.

Oxitocina Kabi may, in rare cases, cause disseminated intravascular coagulation, which may cause symptoms such as abnormal blood clotting, bleeding, and anemia.

High doses of Oxitocina Kabi may cause amniotic fluid to pass from your uterus into your bloodstream. This is known as amniotic fluid embolism.

Administering high doses over a long period of time while drinking or receiving large volumes of fluid may cause your stomach to feel very full, cause difficulty breathing, and lower your blood sodium levels.

Do not administer simultaneously with a nasal spray containing oxytocin.

If you are in any of the above situations or are unsure, speak with your doctor or nurse before using Oxitocina Kabi.

Allergy to latex

The active ingredient in Oxitocina Kabi may cause a severe allergic reaction (anaphylactic reaction) in patients allergic to latex. Inform your doctor if you are allergic to latex.

Children and adolescents

Oxitocina Kabi is not intended for use in children or adolescents.

Use of Oxitocina Kabi with other medications

Inform your doctor that you are using, have used recently, or may need to use any other medication.

The following medications may interact with Oxitocina Kabi:

• Prostaglandins (used to induce labor or treat stomach ulcers) and similar medications, as the effects of both medications may increase
• Anesthetics (used to induce sleep during surgery), for example, cyclopropane or halothane, as their use with Oxitocina Kabi may cause heart rhythm problems
• Medications known to cause a disorder in heart rhythm called 'long QT syndrome'
• Epidural anesthetics (used to relieve pain during labor). Oxitocina Kabi may increase the effect of blood vessel constriction and cause an increase in blood pressure.

Use of Oxitocina Kabi with food and drinks

You may be advised to minimize the amount of liquids you ingest.

Pregnancy, breastfeeding, and fertility

Oxitocina Kabi may induce labor - it should only be used during pregnancy under medical supervision.

Oxitocina Kabi may be found in small amounts in breast milk, but it is not expected to have any adverse effects, as it is rapidly inactivated by your baby's digestive system.

Oxitocina Kabi will not affect your newborn baby during breastfeeding.

Driving and operating machinery

Oxitocina Kabi may induce labor, so you should exercise caution when driving or operating machinery.

Your doctor will decide when and how to treat you with Oxitocina Kabi. If you think the effect of Oxitocina Kabi is too strong or too weak, inform your doctor. While you are receiving Oxitocina Kabi, both you and your baby will be closely monitored.

Oxitocina Kabi is usually diluted before use and administered as an intravenous infusion (drip) in one of your veins. To prepare the intravenous infusion, your doctor may use half of a dose of Oxitocina Kabi 10 UI/ml injectable solution for infusion.

In certain circumstances, 1 ml of undiluted Oxitocina Kabi 5-10 UI may be injected into a muscle.

The usual dose is different in the following circumstances:

To initiate or help contractions during labor

Oxitocina Kabi will be administered as an intravenous infusion by drip in a vein or, preferably, through a variable speed infusion pump. In the case of infusion by drip, it is recommended to add 5 UI of Oxitocina Kabi to 500 ml of a physiological electrolyte solution (such as sodium chloride 0.9%). For patients in whom the infusion of sodium chloride should be avoided, a 5% dextrose solution may be used as a diluent.

The infusion rate will start at 2-8 drops per minute (1-4 milliunits per minute). This may be increased gradually to a maximum rate of 40 drops per minute (20 milliunits per minute). The infusion may often be reduced once contractions reach an adequate level (over 3-4 contractions every 10 minutes).

If your contractions do not reach an adequate level after 0.5 ml of Oxitocina Kabi 10 UI/ml, the attempt to initiate labor should be stopped and repeated the next day.

Cesarean delivery

The dose is 0.5 ml of Oxitocina Kabi 10 UI/ml administered as an intravenous infusion by drip (5 UI diluted in physiological sodium chloride solution) or, preferably, through a variable speed infusion pump for 5 minutes in a vein after delivery of your baby.

Prevention of postpartum hemorrhage

The usual dose is 5 UI by intravenous infusion (5 UI diluted in a physiological saline solution) or 5 to 10 UI by intramuscular injection after expulsion of the placenta.

Treatment of postpartum hemorrhage

The usual dose is 5 UI of Oxitocina Kabi by intravenous infusion (5 UI diluted in a physiological saline solution) or 5 to 10 UI by intramuscular injection. In some cases, this may be followed by an intravenous infusion by drip of a solution containing 5-20 UI of oxytocin in 500 ml of a physiological saline solution.

Spontaneous abortion

Given the lesser expression of receptors, it is recommended to use oxytocin from week 14 of pregnancy. The dose is 5 UI or 0.5 ml of Oxitocina Kabi 10 UI/ml administered as an intravenous infusion by drip (5 UI diluted in physiological sodium chloride solution) or, preferably, through a variable speed infusion pump for 5 minutes in a vein, if necessary followed by an intravenous infusion at a rate of 20 to 40 milliunits/minute.

Patients with liver or renal insufficiency

There is no information on use in patients with renal or hepatic insufficiency.

Older adults

There are no indications for the use of Oxitocina Kabi in older adults.

If you use more Oxitocina Kabi than you should

Since this medication will be administered to you in the hospital, it is very unlikely that you will receive an overdose. If an accidental overdose occurs, inform the hospital and emergency services or a doctor immediately. Show your doctor the medication or the empty container.

An overdose of Oxitocina Kabi could cause:

• harm to your baby;
• very strong contractions of the uterus;
• damage to the uterus that could include rupture;
• fluid retention, blood vessel spasms, high blood pressure.

If you forget to use Oxitocina Kabi

Since this medication is administered by a doctor, it is unlikely that you will forget a dose. If you have any concerns, speak with your doctor.

If you have any doubts about the use of this medication, consult with your doctor or nurse.

If you interrupt treatment with Oxitocina Kabi

The infusion of Oxitocina Kabi may be withdrawn gradually once labor progresses.

There is no information about adverse effects.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Oxitocina Kabi and contact a doctor or go to the nearest emergency serviceimmediatelyif you experience any of the following symptoms:

• Severe allergic reaction (anaphylactic/anaphylactoid) with difficulty breathing, dizziness, feeling of dizziness, nausea, cold and clammy skin, or a 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 side effects that may occur:

Frequent(may affect more than 1 in 100 patients):

• Headache
• Fast heart rate
• Slow heart rate
• Nausea
• Vomiting

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

• Irregular heartbeat

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

• Skin eruptions, urticaria

Unknown frequency

• Bleeding (hemorrhage)
• Chest pain (angina)
• Irregular heartbeat
• Excessive or continuous contractions
• Uterine rupture
• Fluid retention (hydric intoxication). Symptoms may include headache, anorexia (loss of appetite), discomfort, stomach pain, lethargy, drowsiness, unconsciousness, low levels of certain substances in the blood (e.g., sodium or potassium), attacks
• Low sodium levels in the blood
• Sudden fluid overload in the lungs
• A rapid intravenous injection of oxytocin may cause a sudden drop in blood pressure for a short period, a brief and sudden feeling of heat all over the body
• Abnormal coagulation, bleeding, and anemia
• Uterine muscle spasms.

Effects on the baby:

Excessive contractions may cause low sodium levels, lack of oxygen, asphyxia, and death.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the ampoule label after CAD. The expiration date is the last day of the month indicated.

After the first opening: the medicine must be used immediately.

After dilution for infusion: from a microbiological point of view, unless the opening/reconstitution/dilution method excludes the risk of microbial contamination, the medicine must be used immediately. If not used immediately, storage times and previous conditions for use are the responsibility of the user and are normally not greater than 24 hours at a temperature of 2 to 8 °C.

Do not use any container that is damaged or shows signs of manipulation.

Do not use this medicine if you observe that the ampoule content is cloudy or has particles or lumps.

Medicines should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition ofOxitocina Kabi

• The active ingredient is oxytocin.

1 ml of solution contains 16.7 micrograms of oxytocin (10 UI)

• The other components are sodium acetate trihydrate, glacial acetic acid, sodium chloride, sodium hydroxide, water for injection preparations.

Appearance of the product and contents of the container

Clear, colorless, and particle-free liquid.

The pH of the solution is 3.5-4.5.

1 ml glass type I (borosilicate) ampoules with break ring or O.P.C. opening system. Container sizes of 5, 10, or 100 ampoules.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España, S.A.U.

Marina 16-18, 08005 – Barcelona

Spain

Responsible for manufacturing

AS Grindeks

Krustpils iela 53,

Riga, LV-1057, Latvia

This medicine is authorized in the member states of the European Economic Area with the following names:

SwedenOxytocin Grindeks 16.7 mikrogram/ml injection-/infusion fluid, solution

AustriaOxytocin Grindeks16,7 Mikrogramm/ml Injections-/Infusions solution

BelgiumOxytocin Grindeks10 IU/ml injectable/pour perfusion solution

Czech RepublicOfost 10 IU/ml injekční/infuzní solution

FranceOxytocine Grindeks 10 U.I./1 mL, injectable/pour perfusion solution

GermanyOFOST 10 IU/ml solution for injection/infusion

HungaryOxytocin Grindeks 10 NE/ml oldatos injection/infusion

IrelandOfost 10 IU/mlconcentrate for solution for infusion or solution for intramuscular injection

ItalyOssitocina Pharmexon 10 IU/ml injectable/per infusion solution

LatviaOfost 10 IU/ml šķidruma injekcijam/infuzijam

LithuaniaOfost 10 TV/ml injekcinis ar infuzinistirpalas

PolandOxytocin Grindeks16,7mikrogramów/ml solution for injection/infusion

PortugalOxitocina Kabi10UI/ml injectable or for perfusion solution

RomaniaOfost 16.7 micrograme/ml injectable/perfusion solution

SlovakiaOfost 10 IU/ml injekčný a infúzny solution(injekcia/infúzia)

SloveniaOfost 10 i.e./ml solution for injection/infusion

SpainOxitocina Kabi 10 UI/ml solutioninjectable and for perfusion EFG

This leaflet has been revised in October 2021.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es