Cisatracurium Hikma

Package Leaflet: Information for the User

Cisatracurium Hikma 2 mg/ml solution for injection/infusion

Cisatatracurium
Generic medicine
Please read this leaflet carefully before you start using this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• 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 Cisatracurium Hikma is and what it is used for
2. What you need to know before using Cisatracurium Hikma
3. How to use Cisatracurium Hikma
4. Possible side effects
5. How to store Cisatatracurium Hikma
6. Contents of the pack and other information

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

what it is used for
Cisatracurium Hikma contains a medicine called cisatracurium. This belongs to a
group of medicines known as muscle relaxants.
Cisatracurium Hikma is used:

• to relax muscles during surgery, including heart surgery, in adults and children over one month of age
• to help insertion of a tube into the windpipe (tracheal intubation), when a person needs assistance with breathing
• to relax muscles in adults in intensive care. Ask your doctor if you would like further explanation about this medicine.

2 Before you are given Cisatracurium Hikma

2. What you need to know before using Cisatracurium Hikma

Do not use Cisatracurium Hikma:

• if you are allergic to cisatracurium, to any other muscle relaxant, or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously had a bad reaction to an anaesthetic.

Do not use Cisatracurium Hikma if any of these conditions apply to you. If you are unsure, consult your
doctor, nurse, or pharmacist before using Cisatracurium Hikma.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Cisatracurium Hikma if:

• you have muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis)
• you suffer from a neuromuscular disease, such as a condition involving muscle deterioration, paralysis, motor neuron disease, or cerebral palsy
• you have a burn requiring medical treatment
• you have ever had an allergic reaction to any muscle relaxant used during surgery.

If you are unsure whether any of these conditions apply to you, discuss them with your doctor, nurse, or pharmacist before receiving Cisatracurium Hikma.

Other medicines and Cisatracurium Hikma
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including
those not requiring a prescription. In particular, inform your doctor if you are taking any of the
following:

• anaesthetics (used to reduce sensation and pain 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 D-penicillamine
• steroids
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine
• medicines for mental health conditions, such as lithium, monoamine oxidase inhibitors (MAO inhibitors), or chlorpromazine (which may also be used for nausea)
• medicines containing magnesium
• medicines for Alzheimer's disease (e.g. donepezil, anticholinesterases).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor before this medicine is administered to you.
Driving and using machines
If you are staying in hospital for only a day, your doctor will advise you how long to wait before
leaving hospital or before driving a vehicle. It may be dangerous to drive too soon after surgery.
3 How Cisatracurium Hikma is given

3. How to use Cisatracurium Hikma

You will never be able to administer this medicine to yourself. It will always be given to you by a qualified person. Cisatracurium Hikma may be administered:

• as a single intravenous injection (intravenous bolus injection)
• by continuous intravenous infusion. This is when the medicine is slowly administered to you over a long period of time.

The doctor will decide the route of administration and the dose you will receive. This will depend on:

• body weight
• the amount and duration of muscle relaxation required
• your response to the medicine. Children under 1 month of age must not receive this medicine.

If you are given more Cisatracurium Hikma than you should
Cisatracurium Hikma will always be administered under closely controlled conditions. However, if you think you have been given more medicine than you should, inform your doctor or nurse immediately.

4. Possible side effects

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, nurse or pharmacist.

Allergic reactions (affect fewer than 1 in 10,000 people)
If you have an allergic reaction, contact your doctor or nurse immediately. Signs may include:

• sudden breathlessness, chest pain or tightness in the chest
• swelling of the eyelids, face, lips, mouth or tongue
• a rash or 'hives' appearing anywhere on the body
• collapse

Talk to your doctor, nurse or pharmacist if you notice any of the following effects:

Common (affects fewer than 1 in 10 people)

• decreased heart rate
• decreased blood pressure

Uncommon (affects fewer than 1 in 100 people)

• skin rash or redness
• shortness of breath or cough

Very rare (affects fewer than 1 in 10,000 people)

• weak or painful muscles

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor. You can also report side effects directly via the national reporting system at the relevant website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cisatracurio Hikma

• 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 container, following 'Exp'. The expiry date refers to the last day of that month.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep in the original packaging to protect from light.
• If diluted, store the infusion solution at 25 °C or between 2 °C and 8 °C and use within 24 hours. Any infusion solution used must be discarded 24 hours after preparation.
• Medicines must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any medicine no longer required. These measures will help protect the environment.

6. Package contents and other information

Further on
What Cisatracurio Hikma contains

• The active substance is cisatracurium (as besilate) 2 mg/ml.
• The other components are benzenesulfonic acid and water for injections.

Appearance of Cisatracurio Hikma and contents of the pack
Cisatracurio Hikma 2 mg/ml solution for injection/infusion:

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

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A and 8B - Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219 608 410
Fax: +351 219 615 102
[email protected]

Manufacturer
Hikma Italia S.p.A.
Viale Certosa 10
27100 Pavia
Italy

This medicinal product is authorised in EEA Member States under the following names:
Austria: Cisatracurium Hikma 2 mg/ml Injektionslösung oder Infusionslösung
Germany: Cisatracurium Hikma 2 mg/ml Injektionslösung /Infusionslösung
Italy: Cisatracurio Hikma 2 mg/ml Soluzione iniettabile infusione
Netherlands: Cisatracurium Hikma 2 mg/ml Oplossing voor injectie/infusie
Portugal: Besilato de cisatracúrio Hikma 2 mg/ml
United Kingdom: Cisatracurium 2mg/ml Solution for injection/infusion

This leaflet was last reviewed on
The following information is intended for healthcare professionals only:
This product is for single use only. Use only clear solutions ranging from almost colourless to slightly yellow/greenish-yellow. The product must be visually inspected before use, and if there is any change in appearance or if the container is damaged, the product must be discarded.

Diluted Cisatracurio Hikma is physically and chemically stable for up to 24 hours at 2–8 °C and at 25 °C, in concentrations between 0.1 and 2 mg/ml, in the following infusion solutions, whether in polyvinyl chloride or polypropylene containers:

• Sodium chloride intravenous solution (0.9% w/v)
• Glucose intravenous solution (5% w/v)
• Sodium chloride (0.18% w/v) and glucose (0.45% w/v) intravenous solution
• Sodium chloride (0.45% w/v) and glucose (5% w/v) intravenous solution

However, since the product contains no antimicrobial preservatives, dilution should be carried out immediately before use; otherwise, storage must follow the instructions specified in section 5 of the Summary of Product Characteristics.

Cisatracurio Hikma has been shown to be compatible with the following commonly used peri-operative medications when mixed under conditions simulating intravenous infusion administration via a Y-site injection port: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate. When other medications are administered through the same needle or cannula as Cisatracurio Hikma, it is recommended that each medication be flushed through with an appropriate volume of compatible intravenous fluid, for example, sodium chloride intravenous infusion (0.9% w/v).

As with other intravenously administered drugs, when a small vein is selected as the injection site, Cisatracurio Hikma should be administered intravenously with a compatible intravenous fluid, for example, sodium chloride intravenous infusion (0.9% w/v).