Cisatracurium accordpharma

Package leaflet: Information for the user

Cisatracurium Accordpharma, 2 mg/mL, solution for injection / for infusion
Cisatracurium
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Cisatracurium Accordpharma is and what it is used for
2. What you need to know before you are given Cisatracurium Accordpharma
3. How Cisatracurium Accordpharma is given
4. Possible side effects
5. How to store Cisatracurium Accordpharma
6. Contents of the pack and other information

1. What Cisatracurium Accordpharma is and what it is 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 endotracheal intubation (placement of a breathing tube) when a patient requires assisted ventilation;
• to relax muscles in patients in intensive care units.

For additional information regarding the use of this medicine, please consult your 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 medicine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an adverse reaction to anaesthesia.

Do not use Cisatracurium Accordpharma if any of the above situations apply to the patient.
If in doubt, consult a doctor, nurse, or pharmacist before starting treatment with Cisatracurium Accordpharma.

Warnings and precautions
Before starting treatment with Cisatracurium Accordpharma, discuss with a doctor, nurse, or pharmacist if:

• the patient has muscle weakness, fatigue, or difficulty with motor coordination (myasthenia gravis);
• the patient has neuromuscular disorders such as muscle atrophy, paralysis, motor neuron disease, or cerebral palsy;
• the patient is suffering from burns and requires treatment.

If in doubt whether any of the above conditions apply to the patient, consult a doctor, nurse, or pharmacist before starting treatment with Cisatracurium Accordpharma.

Cisatracurium Accordpharma and other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use.
In particular, inform the doctor if the patient is taking any of the following medicines:

• anaesthetics (used to prevent pain during surgical procedures),
• antibiotics (used to treat infections),
• antiarrhythmics (used to control heart rhythm),
• medicines used to treat high blood pressure,
• diuretics (water pills), such as furosemide,
• medicines used to treat arthritis, such as chloroquine or D-penicillamine,
• steroid medicines,
• antiepileptic drugs, such as phenytoin or carbamazepine,
• medicines used to treat psychiatric conditions, such as lithium or chlorpromazine (also used as an antiemetic),
• medicines containing magnesium,
• medicines used in Alzheimer's disease (acetylcholinesterase inhibitors, such as donepezil).

Pregnancy and breastfeeding
A harmful effect of cisatracurium on a breastfed infant cannot be excluded; however, no effect is expected if breastfeeding is resumed after the effect of the drug has worn off. Cisatracurium is rapidly eliminated from the body. Breastfeeding should be avoided for 3 hours after completion of drug administration.

Driving and operating machinery
If the patient is undergoing a day-case hospital procedure, the doctor will inform the patient when it is safe to leave the hospital or drive. Driving too soon after surgery may be dangerous.

3. How to take Cisatracurium Accordpharma

How the injection is administered
The patient will never receive this medicine on their own. The medicine will always be administered to the patient by a suitably qualified person.
Cisatracurium Accordpharma may be given as:

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

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

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

This medicine should not be used in children under 1 month of age.
Administration of a higher than recommended dose of Cisatracurium Accordpharma
Cisatracurium Accordpharma will always be administered under strict supervision. However, if the patient thinks they may have received too much of the medicine, they should immediately inform the doctor or nurse.
If there are any further doubts regarding the use of this medicine, consult the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, inform your doctor, nurse, or pharmacist immediately.
This also applies to adverse reactions not listed in this leaflet.

Allergic reactions (occurring less frequently than in 1 out of 10,000 patients)
If the patient experiences an allergic reaction, inform the doctor or nurse immediately.
Symptoms of an allergic reaction may include:

• sudden onset of wheezing, pain or tightness in the chest,
• swelling of the eyelids, face, lips, mouth or tongue,
• lumpy rash or hives anywhere on the body,
• collapse and shock.

Inform the doctor, nurse or pharmacist if the patient notices any of the following adverse reactions:

Common (occurring less frequently than in 1 out of 10 patients)

• slow heart rate,
• low blood pressure.

Uncommon (occurring less frequently than in 1 out of 100 patients)

• skin rash or redness,
• cough or wheezing.

Very rare (occurring less frequently than in 1 out of 10,000 patients)

• muscle weakness or muscle pain.

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

By reporting adverse reactions, further information on the safety of the medicine can be collected.
Adverse reactions may also be reported to the responsible entity.

5. How to store the medicine Cisatracurium Accordpharma

Keep the medicine out of the 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 stated 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 portions of the solution must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

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

What Cisatracurium Accordpharma looks like and contents of the pack
Cisatracurium Accordpharma 2 mg/ml is an injection/infusion solution, colourless to pale yellow or greenish-yellow, practically free from visible solid particles, with pH 3.0–5.0.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names: