Nimbex

NIMBEX 2 mg/ml, solution for injection and infusion
( Cisatracurium )
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Nimbex is and what it is used for

Nimbex contains a substance called cisatracurium (as cisatracurium besilate) and belongs to a group of medicines known as muscle relaxants.
Nimbex is used:

• to relax muscles during surgical procedures (including cardiac surgery) in adults and children over 1 month of age,
• to facilitate insertion of a tube into the trachea (endotracheal intubation) when mechanical ventilation is required,
• to relax muscles in patients in intensive care units. For further information about the medicine, please consult your doctor.

2. Important information before using Nimbex

When not to use Nimbex

• if the patient is allergic (hypersensitive) to cisatracurium, any other muscle relaxant, or any of the other ingredients of Nimbex (see section 6),
• if the patient has previously experienced an abnormal reaction to anaesthetic agents.

If any of the above situations apply to the patient, Nimbex should not be administered. In case of doubt, consult a doctor or nurse.

Warnings and precautions
Contact a doctor or nurse if:

• the patient suffers from muscle weakness and fatigue or difficulties with motor coordination (myasthenia),
• the patient has a neuromuscular disorder such as muscular atrophy, paralysis, amyotrophic lateral sclerosis (ALS), or cerebral palsy,
• the patient has burns requiring treatment.

If in doubt whether any of the above conditions apply to the patient, consult a doctor or nurse before administering Nimbex.

Nimbex and other medicines
Inform the doctor or nurse about all medicines currently used or recently taken by the patient, including herbal medicines, over-the-counter medicines, and any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

• anaesthetics (used to block sensation and pain during surgical procedures),
• antibiotics (used to treat infections),
• medicines used to treat heart rhythm disorders (antiarrhythmics),
• medicines used to treat high blood pressure,
• diuretics (water pills), such as furosemide,
• medicines used to treat joint inflammatory conditions, such as chloroquine or D-penicillamine,
• steroids,
• medicines used to treat seizures (epilepsy), such as phenytoin or carbamazepine,
• medicines used to treat psychiatric disorders, such as lithium salts or chlorpromazine (also used as an antiemetic),
• medicines containing magnesium,
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, e.g. donepezil).

Pregnancy and breastfeeding
A harmful effect of cisatracurium on breastfed infants cannot be excluded; however, no effect is expected if breastfeeding is resumed after the drug's action has worn off. Cisatracurium is rapidly eliminated from the body. Breastfeeding should be avoided for 3 hours after completion of Nimbex administration.
Consult a doctor before using any medicine.

Driving and operating machinery
If the patient is undergoing a day-case hospital procedure, the doctor will advise how long to wait before leaving the hospital or before driving. Driving too soon after a surgical procedure may be dangerous.

3. How to use Nimbex

The patient must never administer this medicine on their own. The medicine will always be given by a qualified person.

Nimbex can be administered:

• as a single intravenous injection (intravenous bolus),
• as a continuous intravenous infusion. In this case, the medicine is given slowly over a prolonged period.

The doctor will decide in which form the medicine will be administered and what dose the patient will receive. This will depend on:

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

Nimbex must not be used in children below 1 month of age.

Use of a higher than recommended dose of Nimbex
Nimbex will always be administered under controlled medical conditions. However, if the patient thinks that too high a dose of the medicine has been administered, they should immediately inform the doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions (may occur in less than 1 in 10,000 patients)
If an allergic reaction occurs, inform your doctor or nurse immediately.
Symptoms may include:

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

If any of the following symptoms occur, inform your doctor, nurse or pharmacist:
Frequent adverse effects (may occur in less than 1 in 10 patients)

• slow heart rate
• low blood pressure.

Uncommon adverse effects (may occur in less than 1 in 100 patients)

• skin rash or redness
• wheezing or cough.

Very rare adverse effects (may occur in less than 1 in 10,000 patients)

• muscle weakness or muscle pain.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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.
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nimbex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Store in a refrigerator (2 °C – 8 °C). Protect from light. Do not freeze.
After dilution, Nimbex should be stored at 2 °C – 8 °C and used within 24 hours. All unused portions of the infusion solution should be discarded within 24 hours of preparation.
Medicines must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of medicines that are no longer required. This practice helps protect the environment.

6. Contents of the pack and other information

What Nimbex contains

• The active substance in Nimbex is cisatracurium (in the form of cisatracurium besylate).
• The other components of Nimbex are: benzenesulfonic acid solution 32% w/v and water for injections.

What Nimbex looks like and contents of the pack
Nimbex 2 mg/ml solution for injection and infusion is available in packs containing
5 vials made of colourless glass with a volume of 2.5 ml, 5 ml or 10 ml.

• Each 2.5 ml vial contains 5 mg of cisatracurium.
• Each 5 ml vial contains 10 mg of cisatracurium.
• Each 10 ml vial contains 20 mg of cisatracurium.

Marketing Authorisation Holder:
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel: 0048 221253376

Manufacturer:
Aspen Pharma Ireland Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24
Ireland
or
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma
Italy
or
Importer:
Aspen Bad Oldesloe, GmbH,
Industriestrasse 32-36,
23843 Bad Oldesloe
Germany

Information intended exclusively for medical professionals:

The Nimbex product is intended for single use only. Only clear, nearly colorless solutions with tolerance up to light yellow or greenish-yellow should be used. The solution's appearance should be checked before administration. If the solution has changed in appearance or if the ampoule is damaged, the product must be discarded.

Nimbex, when diluted to concentrations of 0.1 to 2.0 mg/mL, is physically and chemically stable in the following infusion fluids for at least 24 hours when stored at 5°C to 25°C in containers made of polyvinyl chloride (PVC) or polypropylene:

• 0.9% sodium chloride infusion solution,
• 5% glucose infusion solution,
• 0.18% sodium chloride and 4% glucose infusion solution,
• 0.45% sodium chloride and 2.5% glucose infusion solution.

Since Nimbex does not contain preservatives, it should be diluted immediately before use. Otherwise, follow the recommendations for storage after opening the ampoule provided in section 5 of the package leaflet.

Under conditions simulating Y-site infusion, Nimbex has shown no pharmaceutical incompatibilities with the following drugs commonly used in the perioperative period: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate. If other drugs are administered through the same indwelling needle or cannula used for Nimbex, it is recommended to flush the line with an appropriate volume of compatible infusion fluid (e.g., 0.9% sodium chloride infusion solution) after administration of each drug.

Similarly, as with other intravenously administered drugs, if a small vein is selected as the injection site, the vein should be flushed with an appropriate infusion fluid (e.g., 0.9% sodium chloride infusion solution) following administration of Nimbex.