Nimbex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nimbex 2 mg/ml injection/infusion solution, 5 mg/ml injection/infusion solution

Cisatracurium
Please read this leaflet carefully before receiving this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What Nimbex is and what it is used for
2. What you need to know before you are given 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. This substance belongs to a group of medicines known as muscle relaxants. Nimbex is used to:

• relax muscles during surgical procedures in adults and children at least 1 month of age, including heart surgery
• facilitate tracheal intubation when a patient requires respiratory support
• relax muscles in patients receiving intensive care.

Ask your doctor if you would like more information about this medicine.

2. What you need to know before you are given Nimbex

Do not use Nimbex:

• if you are allergic to cisatracurium, or to other muscle relaxants, or to any of the excipients in Nimbex (listed in section 6)
• if you previously had an adverse reaction to an anaesthetic. If you think any of these conditions apply to you, do not take Nimbex. If you are unsure, speak to your doctor, nurse or pharmacist first.

Take special care with Nimbex
Before being given this medicine, talk to your doctor, nurse or pharmacist:

• if you have muscle weakness, pain or difficulty coordinating movements (myasthenia gravis), or check also if: (for 10 ml only) you have neuromuscular diseases such as muscular dystrophy, paralysis, motor neuron disease or cerebral palsy
• if you have a burn injury requiring medical treatment. If you are unsure whether any of the above apply to you, ask your doctor, nurse or pharmacist before being given Nimbex.

Other medicines and Nimbex
Inform your doctor if you are taking, have recently taken or might take any other medicines, including those without a prescription. In particular, consult your doctor if you are taking any of the following medicines:

• anaesthetics (used to reduce pain and sensation during surgical procedures)
• antibiotics (used to treat infections)
• medicines for irregular heartbeats (antiarrhythmics)
• medicines for high blood pressure
• diuretics, such as furosemide
• medicines for joint inflammation, such as chloroquine or penicillamine
• steroids
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine
• medicines for mental disorders, such as lithium or chlorpromazine (which may also be used for nausea)
• medicines containing magnesium
• anticholinesterase medicines for the treatment of Alzheimer's disease, such as donepezil.

Pregnancy and breastfeeding
An adverse effect of cisatracurium on the breastfed infant cannot be ruled out; however, this is not expected if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurium is rapidly eliminated from the body. Women should refrain from breastfeeding for 3 hours after discontinuation of treatment.

If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor for advice before taking this medicine.

Driving and using machines
If you have been admitted to hospital for a day case procedure, your doctor will advise you how long to wait before leaving the hospital or driving a car. It may be dangerous to drive too soon after undergoing surgery.

3. How Nimbex is administered

You will never be expected to administer this medicine to yourself. It will always be given to you by a qualified healthcare professional.
Nimbex can be administered:

• as a single intravenous injection (intravenous bolus injection)
• as a continuous intravenous infusion. In this way, the drug is delivered slowly over a prolonged period of time.

The doctor will decide the route of administration and the required dose, which will depend on the following factors:

• body weight
• the amount and duration of muscle relaxation required
• the response to the medicine. This medicine must not be given to children under 1 month of age.

If you receive more Nimbex than you should
Nimbex must always be administered under close supervision. However, if you think you have been given more than you should, inform your doctor or nurse immediately.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Nimbex can cause side effects, although not everyone gets them.
If you experience any side effect, contact your doctor. This includes any possible side effect
not listed in this leaflet.
Allergic reactions (may affect fewer than 1 in 10,000 people)
If you have an allergic reaction, contact your doctor or nurse immediately. Signs of allergy may include:

• sudden shortness of breath, chest pain or chest tightness
• swelling of the eyelids, face, lips, mouth or tongue
• sudden skin rash or hives anywhere on the body
• collapse and shock.

Talk to your doctor, nurse or pharmacist if you notice any of the following side effects:
Common (may affect fewer than 1 in 10 people)

• slow heart rate
• low blood pressure. Uncommon (may affect fewer than 1 in 100 people)
• skin rash or redness of the skin
• shortness of breath or cough. Very rare (may affect fewer than 1 in 10,000 people)
• muscle weakness or muscle pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor, nurse or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nimbex

Keep Nimbex out of the sight and reach of children.
Do not use Nimbex after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep in the original container to protect from light.
If diluted, store the infusion solution between 2°C and 8°C and use within 24 hours. The infusion solution must be discarded if not used within 24 hours.
Do not dispose of any medicine via wastewater. Ask your pharmacist or nurse how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nimbex contains

• The active substance is cisatracurium 2 mg/ml or 5 mg/ml (as besylate).
• The excipients are benzenesulfonic acid (32% w/v) and water for injections.

Description of the appearance of Nimbex and package contents
Nimbex 2 mg/ml solution for injection/infusion is available in:
2.5 ml vials (glass), pack size of 5 vials (each 2.5 ml vial contains 5 mg of cisatracurium)
5 ml vials (glass), pack size of 5 vials (each 5 ml vial contains 10 mg of cisatracurium)
10 ml vials (glass), pack size of 5 vials (each 10 ml vial contains 20 mg of cisatracurium)
25 ml vials (glass), pack size of 2 vials (each 25 ml vial contains 50 mg of cisatracurium).
Nimbex 5 mg/ml solution for injection/infusion is supplied in a 30 ml glass vial. Each
30 ml vial contains 150 mg of cisatracurium.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Tel: +39 0687 502 429

Manufacturers
GlaxoSmithKline Manufacturing S.p.A., Strada Provinciale Asolana n.90, S. Polo di Torrile (Parma), Italy
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
Aspen Pharma Ireland Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

This medicinal product is authorized in European Economic Area countries under the following names:
Nimbex: Austria, Belgium, Denmark, Finland, France, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain
Nimbex 5mg <10 mg: Germany
Cisatracurium: United Kingdom
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The following information is intended exclusively for physicians or healthcare professionals:
This medicinal product is for single use only.
Use only clear, colourless solutions or solutions with a pale yellow or yellow-green tint.
The product must be inspected visually before use; if the visual appearance is altered or if the container is damaged, the product must be discarded.
When diluted to concentrations between 0.1 and 2 mg/ml, Nimbex has been shown to be chemically and physically stable for 24 hours at 5°C and 25°C in the following infusion solutions (both in polyvinyl chloride and polypropylene containers):
Sodium chloride 0.9% w/v
Glucose 5% w/v
Glucose with sodium chloride (4% w/v and 0.18% w/v respectively)
Glucose with sodium chloride (2.5% w/v and 0.45% w/v respectively)
This product does not contain preservatives; dilution should be performed immediately before use, otherwise refer to section 5.
Nimbex has been shown to be compatible with the following drugs commonly used in the perioperative setting, when mixed under conditions simulating intravenous infusion administration via a Y-site injection set: hydrochloride alfentanil, droperidol, citrate fentanyl, hydrochloride midazolam and citrate sufentanil. When other drugs are administered through the same needle or cannula as Nimbex, it is important to flush through each drug with an adequate amount of a suitable infusion solution (e.g. sodium chloride 0.9% w/v) to ensure complete clearance.
As with other intravenously administered drugs, if a small vein is selected as the injection site, Nimbex should be administered into the vein with a suitable intravenous fluid, such as sodium chloride 0.9% w/v for injection.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

Nimbex 2 mg/ml solution for injection/infusion
Instructions for opening the vial (applicable only to the 2 mg/ml vial)
The vials are equipped with a safety pre-scored system and must be opened as follows:

• Hold the lower part of the vial with one hand as shown in Figure 1;
• Place the other hand on the upper part, positioning the thumb over the coloured mark, and apply pressure as shown in Figure 2.

Figure 1
Figure 2