Cisatracurium Accordpharma

Package Leaflet: Information for the User

Cisatracurium Accordpharma, 2 mg/mL, Solution for Injection/Infusion

Cisatracurium

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Cisatracurium Accordpharma and what is it used for

Cisatracurium Accordpharma contains the active substance cisatracurium, in the form of cisatracurium besylate, which belongs to a group of medicines called muscle relaxants.
Cisatracurium Accordpharma is used:

• to relax muscles during surgical procedures, including heart surgery in adults and children over 1 month of age;
• to facilitate the introduction of an endotracheal tube (endotracheal intubation), if the patient requires respiratory support;
• to relax muscles in patients in intensive care units.

To obtain additional information about the use of the medicine, consult a doctor.

2. Important information before using Cisatracurium Accordpharma

When not to use Cisatracurium Accordpharma

• if the patient is allergic to cisatracurium, any other muscle relaxant, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an adverse reaction to anesthesia in the past.

Do not use Cisatracurium Accordpharma if any of the above situations apply to the patient.
In case of doubts, consult a doctor, nurse, or pharmacist before starting to use Cisatracurium Accordpharma.

Warnings and precautions

Before starting to take Cisatracurium Accordpharma, discuss it with a doctor, nurse, or pharmacist:

• if the patient has muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis);
• if the patient has neuromuscular disorders, such as muscle atrophy, paralysis, motor neuron disease, or cerebral palsy;
• if the patient is burned and requires treatment;

In case of doubts whether any of the above situations apply to the patient, consult a doctor, nurse, or pharmacist before starting to use Cisatracurium Accordpharma.

Cisatracurium Accordpharma and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particularly, inform the doctor about the use of the following medicines:

• anesthetics (used to relieve pain during surgical procedures),
• antibiotics (used to treat infections),
• antiarrhythmic medicines (used to control heart rhythm),
• medicines used to treat high blood pressure,
• diuretics, such as furosemide,
• medicines used to treat arthritis, such as chloroquine or D-penicillamine,
• corticosteroids,
• antiepileptic medicines, such as phenytoin or carbamazepine,
• medicines used to treat mental illnesses, such as lithium or chlorpromazine (also used as an antiemetic)
• medicines containing magnesium,
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, such as donepezil).

Pregnancy and breastfeeding

The harmful effect of cisatracurium on the breastfed child cannot be excluded, however, it is not expected to have an effect if breastfeeding is resumed after the effect of the medicine has ceased. Cisatracurium is rapidly eliminated from the body. The woman should not breastfeed for 3 hours after the administration of the medicine has ended.

Driving and using machines

In case the patient is in the hospital for only one day, the doctor will inform the patient when they can leave the hospital or drive a car. Driving a car too soon after surgery may be dangerous.

3. How to take Cisatracurium Accordpharma

How the injection is administered

The patient will never take this medicine by themselves. The medicine will always be administered to the patient by a qualified person.
Cisatracurium Accordpharma can be administered as:

• a single intravenous injection (rapid intravenous injection),
• a continuous intravenous infusion. The medicine is administered slowly into the patient's vein over a longer period.

The method of administration and dose of Cisatracurium Accordpharma will be decided by the doctor, based on:

• the patient's body weight,
• the required degree and duration of muscle relaxation,
• the patient's predicted response to the medicine.

This medicine should not be used in children under 1 month of age.

Using a higher dose of Cisatracurium Accordpharma than recommended

Cisatracurium Accordpharma will always be administered under close supervision. However, if the patient thinks they may have received too much medicine, they should immediately inform their doctor or nurse.
In case of any further doubts about the use of this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any side effects are observed, the doctor, nurse, or pharmacist should be informed immediately. This also applies to side effects not listed in this leaflet.

Allergic reactions (occurring in less than 1 in 10,000 patients)

If an allergic reaction occurs, the doctor or nurse should be informed immediately.
Symptoms of an allergic reaction may include:

• sudden wheezing, pain, or feeling of pressure in the chest,
• swelling of the eyelids, face, lips, mouth, or tongue,
• hives or itching in any part of the body,
• collapse and shock.

The doctor, nurse, or pharmacist should be informed if the patient notices any of the following side effects:

Common (occurring in less than 1 in 10 patients)

• slow heart rate,
• low blood pressure.

Uncommon (occurring in less than 1 in 100 patients)

• skin rash or redness,
• cough or wheezing.

Rare (occurring in less than 1 in 10,000 patients)

• muscle weakness or muscle pain.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of the 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
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Cisatracurium Accordpharma

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after: EXP.
The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original packaging to protect from light.
The diluted solution should be stored at 2°C - 8°C and used within 24 hours. After 24 hours, any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cisatracurium Accordpharma contains

1 mL of solution for injection/infusion contains 2 mg of cisatracurium, in the form of 2.68 mg of cisatracurium besylate.
One 2.5 mL vial of solution for injection/infusion contains 5 mg of cisatracurium, in the form of 6.7 mg of cisatracurium besylate.
One 5 mL vial of solution for injection/infusion contains 10 mg of cisatracurium, in the form of 13.4 mg of cisatracurium besylate.
One 10 mL vial of solution for injection/infusion contains 20 mg of cisatracurium, in the form of 26.8 mg of cisatracurium besylate.
The other ingredients are: benzenesulfonic acid, solution, and water for injections.

What Cisatracurium Accordpharma looks like and contents of the package

Cisatracurium Accordpharma, 2 mg/mL, is a solution for injection/infusion, colorless to pale yellow or greenish-yellow, practically free from visible particles, with a pH of 3.0-5.0.

• Vials of 2.5 mL in packs of 5 vials (each 2.5 mL vial contains 5 mg of cisatracurium).
• Vials of 5 mL in packs of 5 vials (each 5 mL vial contains 10 mg of cisatracurium).
• Vials of 10 mL in packs of 5 vials (each 10 mL vial contains 20 mg of cisatracurium).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer

• B. BRAUN MEDICAL S.A

Ronda de Los Olivares, parcela 11
Pol. Ind. Los Olivares,
23009 Jaén, Spain

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

National Authorization Names:

Date of last revision of the leaflet: December 2023