Cisatracurium Noridem

Package Leaflet: Information for the User

Cisatracurium Noridem, 2 mg/ml, Solution for Injection/Infusion

Cisatracurium

Read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of this medicine is Cisatracurium Noridem.

For the rest of this leaflet, Cisatracurium Noridem will be called Cisatracurium.

Table of Contents of the Leaflet

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

1. What is Cisatracurium and what is it used for

The active substance is Cisatracurium besylate, which belongs to a group of medicines called muscle relaxants.
Cisatracurium is used:

• To relax muscles during surgery in adults and children over 1 month old, including heart surgery.
• To help insert a plastic tube into the patient's windpipe (endotracheal intubation) if the patient needs help breathing.
• In intensive care units to relax muscles.
• For more information about Cisatracurium, consult your doctor.

2. Important information before using Cisatracurium

When not to use Cisatracurium:

• If the patient is allergic to the active substance, any other muscle relaxant, or any of the other ingredients of Cisatracurium (listed in section 6).
• If the patient has had an abnormal reaction to anesthetics in the past.
• If any of the above applies to the patient, do not use Cisatracurium. If in doubt, consult a doctor, pharmacist, or nurse before using Cisatracurium.

When to use Cisatracurium with caution

Consult a doctor, nurse, or pharmacist:

• If the patient has muscle weakness or fatigue, or difficulty coordinating movements (myasthenia).
• If the patient has a nerve-muscle disease, such as muscular dystrophy, paralysis, amyotrophic lateral sclerosis, cerebral palsy.
• If the patient has a burn that requires treatment.

If in doubt whether any of the above applies to the patient, consult a doctor or nurse before using Cisatracurium.

Cisatracurium and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, including herbal products and those bought without a prescription.
In particular, tell your doctor if the patient is taking any of the following medicines:

• Anesthetics (used to numb the body and relieve pain during surgery).
• Antibiotics (used to treat infections).
• Medicines used to treat heart rhythm disorders (anti-arrhythmic medicines).
• Medicines used to treat high blood pressure.
• Diuretics (such as furosemide).
• Medicines used to treat joint inflammation, such as chloroquine or D-penicillamine.
• Steroids.
• Medicines used to treat seizures (epilepsy), such as phenytoin or carbamazepine.
• Medicines used to treat mental disorders, such as lithium or chlorpromazine (also used as an anti-emetic).
• Medicines containing magnesium.
• Anticholinesterases used to treat Alzheimer's disease, such as donepezil.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult a doctor before using this medicine.
The risk of Cisatracurium to the breastfed child cannot be excluded, however, it is not expected to affect the child if breastfeeding is resumed after the effects of Cisatracurium have worn off.
Cisatracurium is rapidly eliminated from the body. The woman should not breastfeed for 3 hours after the end of the administration of Cisatracurium.

Driving and using machines

If the patient is in the hospital for only one day, the doctor will decide how long to wait before leaving the hospital or driving a vehicle. Driving too soon after surgery can be dangerous.

3. How to use Cisatracurium

The patient will never use this medicine by themselves. Cisatracurium will always be given to the patient by a qualified person.
Cisatracurium can be given:

• As a single intravenous injection (intravenous bolus)
• As a continuous intravenous infusion; the medicine is then given slowly over a long time.
• The method of administration and the dose given to the patient will be decided by the doctor. This will depend on:
• The patient's weight,
• The requirements for the duration and degree of muscle relaxation,
• The expected response of the patient to the medicine.

Use in children

Cisatracurium should not be used in children under 1 month old.

Overdose of Cisatracurium

Cisatracurium will always be given under medical supervision. However, if the patient thinks they have been given too much medicine, they should tell their doctor or nurse immediately.
If the patient has any further questions about the use of this medicine, they should ask their doctor.

4. Possible side effects

Like all medicines, Cisatracurium can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if the patient notices any side effects not listed in this leaflet, they should tell their doctor.

Allergic reactions (may affect up to 1 in 10,000 people)

If an allergic reaction occurs, the patient should tell their doctor or nurse immediately.
Possible symptoms:

• Sudden wheezing, pain, or tightness in the chest
• Swelling of the eyelids, face, lips, mouth, or tongue
• Hives or itching on any part of the body
• Shock or collapse.

If the patient experiences any of the following symptoms, they should tell their doctor or nurse:

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

• Slowing of the heart rate.
• Low blood pressure.

Uncommon side effects (may affect up to 1 in 100 people)

• Rash or redness of the skin
• Wheezing or coughing.

Allergic reactions (may affect up to 1 in 10,000 people)

• Muscle weakness or pain.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the
Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cisatracurium

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (at a temperature between 2°C and 8°C). Do not freeze.
• Store in the original package to protect from light.
• The diluted infusion solution should be stored in a refrigerator (at a temperature between 2°C and 8°C) and used within 24 hours. Any unused infusion solution should be discarded after 24 hours.
• Medicines should not be disposed of via wastewater or household waste. The doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

What Cisatracurium contains

• The active substance is cisatracurium (as cisatracurium besylate).
• The other ingredients are benzenesulfonic acid and water for injections.

What Cisatracurium looks like and contents of the pack

Cisatracurium is packaged in transparent glass ampoules, in boxes of 5 and 1 piece each.
Each 10 ml ampoule contains 20 mg of cisatracurium.
Each 5 ml ampoule contains 10 mg of cisatracurium.
Each 2.5 ml ampoule contains 5 mg of cisatracurium.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:Noridem Enterprises Limited, Evagorou & Makariou, Mitsi Building 3,
Office 115, 1065 Nicosia, Cyprus.
Manufacturer:DEMO S.A., PHARMACEUTICAL INDUSTRY 21 km National Road Athens-Lamia,
14568 Krioneri, Attica, Greece, T:+30 210 8161802, F:+30 2108161587.

This medicine is authorized in the Member States of the European Economic Area under the following names:

IE: Cisatracurium 2 mg/ml Solution for injection/infusion
EL: CISATRAL 2 mg/ml Διάλυμα για ένεση/έγχυση
DE: Cisatracurium Noridem 2 mg/ml Injektions-/Infusionslösung
AT: Cisatracurium Noridem 2 mg/ml Injektions-/Infusionslösung
PL: Cisatracurium Noridem
Date of last revision of the leaflet:10/2024

The following information is intended for medical professionals or healthcare workers only.

The product is for single use only. Only clear and almost colorless yellow or greenish-yellow solutions should be used. Before administration, the appearance of the solution should be checked. If the appearance of the solution is changed or the container is damaged, the product should be discarded.
The diluted Cisatracurium Noridem product is physically and chemically stable for at least 24 hours at 5°C and 25°C at concentrations of 0.1 – 1 mg/ml in the following infusion solutions, in polypropylene containers:
sodium chloride 0.9% w/v solution for infusion
glucose 5% w/v solution for infusion
sodium chloride 0.18% w/v and glucose 4% w/v solution for infusion
sodium chloride 0.45% w/v and glucose 2.5% w/v solution for infusion
However, since the product does not contain antimicrobial preservatives, it should be diluted immediately before use. Otherwise, it should be stored in accordance with the recommendations given in section 6.3.
Under simulated Y-site infusion conditions, Cisatracurium Noridem has been shown to be compatible with the following commonly used perioperative medicines: fentanyl citrate and midazolam hydrochloride.
If other medicines are administered through the same intravenous line or cannula as Cisatracurium Noridem, it is recommended that the line or cannula be flushed with a suitable infusion solution, such as sodium chloride 0.9% w/v solution for infusion, between each medicine administration.
As with other intravenous medicines, if a small vein is chosen for injection, the vein should be flushed with a suitable infusion solution, such as sodium chloride 0.9% w/v solution for infusion, after administration of Cisatracurium Noridem.