ROCURONIUM HIKMA 10 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Rocuronium Hikma 10 mg/ml Solution for Injection and Perfusion EFG

rocuronium bromide

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Rocuronium Hikma and what is it used for
2. What you need to know before you use Rocuronium Hikma
3. How to use Rocuronium Hikma
4. Possible side effects
5. Storage of Rocuronium Hikma
6. Contents of the pack and other information

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

This medicine belongs to a group of medicines called muscle relaxants.

Muscle relaxants are used during an operation as part of a general anaesthetic. When you are having an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.

Normally, nerves send messages to your muscles through impulses. This medicine works by blocking these impulses so that your muscles relax. Because your respiratory muscles also relax, you will need help with your breathing (artificial ventilation) during and after the operation until you can breathe on your own again.

During the operation, your anaesthetist will control the effect of the muscle relaxant and, if necessary, give you more. At the end of the surgery, the effects of the medicine are allowed to wear off and you will start breathing on your own again. Sometimes, the anaesthetist will give you another medicine to help speed up this process.

This medicine can also be used in the intensive care unit to keep your muscles relaxed.

2. What you need to know before you use Rocuronium Hikma

Do not use Rocuronium Hikma

• If you are allergic (hypersensitive) to rocuronium bromide, bromide ion or any of the other ingredients of this medicine (listed in section 6).

Tell your anaesthetist if this applies to you.

Warnings and precautions

Tell your doctor, pharmacist or nurse before you start using this medicine:

• If you are allergic to other muscle relaxants
• If you have kidney, heart, liver or gallbladder disease
• If you have a disease that affects your nerves and muscles
• If you have fluid retention (oedema)
• If you have a history of malignant hyperthermia (sudden fever with palpitations, rapid breathing and stiffness, pain and/or muscle weakness).

Tell your anaesthetist if you are in any of these situations.

Some conditions may influence the effects of this medicine, for example:

• low calcium levels in the blood
• low potassium levels in the blood
• high magnesium levels in the blood
• low protein levels in the blood
• increased carbon dioxide levels in the blood
• dehydration
• loss of too much water from the body, for example, due to illness, diarrhoea or sweating
• breathing too quickly, leading to a decrease in carbon dioxide levels in the blood (alkalosis)
• poor general health
• burns
• being severely overweight (obesity)
• body temperature too low (hypothermia)

If you have any of these conditions, your anaesthetist will take them into account when deciding the correct dose of this medicine for you.

Children and Elderly

This medicine can be used in children (newborns and adolescents) and elderly patients, but your anaesthetist must assess your medical history first.

Other medicines and Rocuronium Hikma

Tell your doctor if you are using, have recently used or might use any other medicines.

This includes medicines or herbal products that you have bought without a prescription.

This medicine may affect other medicines or be affected by them.

Medicines that increase the effect of rocuronium:

• certain antibiotics
• certain medicines used to treat heart diseases or high blood pressure (diuretics, calcium channel blockers, beta-blockers and quinidine)
• certain anti-inflammatory medicines (corticosteroids)
• medicines used to treat manic depression (bipolar disorder)
• magnesium salts
• certain medicines for the treatment of malaria

Medicines that decrease the effect of rocuronium:

• certain medicines used to treat epilepsy
• calcium chloride and potassium chloride
• certain protease inhibitors called gabexate and ulinastatin.

You may be given other medicines during the procedure that may have an influence on the effects of rocuronium. These include certain anaesthetics, other muscle relaxants, medicines such as phenytoin and medicines that reverse the effects of this medicine. Rocuronium may make certain anaesthetics work more quickly. Your doctor will take this into account when deciding the correct dose of rocuronium for you.

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant, might be pregnant or are breast-feeding.

Your anaesthetist may still give you this medicine, but will first discuss it with you. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

You may be given this medicine if you are having a caesarean section.

Breast-feeding should be discontinued for 6 hours after use of this medicine.

Driving and using machines

Do not drive or use machines until you have been told it is safe to do so. Because this medicine is given as part of a general anaesthetic, you may feel tired, weak or dizzy for some time after the operation. Your doctor will be able to advise you how long the effects are likely to last.

Rocuronium Hikma contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial/ampoule; this is essentially “sodium-free”.

3. How to use Rocuronium Hikma

Dose

Your anaesthetist will calculate the dose of this medicine that you need based on:

• the type of anaesthetic,
• the expected duration of the operation,
• other medicines that you are taking,
• your state of health.

The usual dose is 0.6 mg per kg of body weight and its effect lasts for 30 to 40 minutes.

How Rocuronium Hikma is given

This medicine will be given to you by injection into a vein as a single injection or as a continuous infusion (a drip)

If you use more Rocuronium Hikma than you should

Your anaesthetist will closely monitor you while you are under this medicine, so it is unlikely that you will be given too much rocuronium. If this happens, your anaesthetist will make sure that you continue to receive anaesthesia and artificial ventilation until you can breathe on your own again.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If these side effects occur while you are under anaesthesia, your anaesthetist will see them and treat them.

Rare(may affect up to 1 in 1,000 people):

• Increased or decreased effect of the medicine
• Prolonged muscle relaxant effect of the medicine
• Decrease in blood pressure
• Increased heart rate
• Pain at the injection site

Very rare(may affect up to 1 in 10,000 people):

• Allergic reactions (hypersensitivity) (such as difficulty breathing, collapse of the circulation and shock),
• Wheezing in the chest
• Muscle weakness
• Sudden fever with rapid heartbeats, rapid breathing and stiffness, pain and/or muscle weakness
• Swelling, itching or skin rash

Frequency not known (cannot be estimated from the available data):

• Severe allergic spasm of the coronary blood vessels (Kounis syndrome) causing chest pain (angina) or heart attack (myocardial infarction)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Rocuronium Hikma

Keep in the refrigerator (2°C - 8°C).

Storage outside the refrigerator

This medicine can be stored at a temperature not above 25°C for a maximum of 16 weeks, after which it must be discarded. Once removed from the refrigerator, the product must not be returned to it. The storage period must not exceed the shelf-life.

The hospital will store this medicine under the correct storage conditions and will ensure that it is within its expiry date.

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 carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Rocuronium Hikma contains

• The active substance is rocuronium bromide.

• The other ingredients are sodium acetate trihydrate, sodium chloride, sodium hydroxide (for pH adjustment), acetic acid (for pH adjustment), water for injections.

Each ml of this medicine contains 10 mg of rocuronium bromide.

Each vial/ampoule of 5 ml contains 50 mg of rocuronium bromide.

Appearance and packaging

Rocuronium Hikma is a clear, colourless to slightly yellow/orange solution for injection.

It is available in vials containing 50 mg (10 vials per pack) of rocuronium bromide.

Marketing Authorisation Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, nº8, 8A, 8B, Fervença

2705-906 Terrugem SNT

Portugal

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Date of last revision of this leaflet:08/2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es

----------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

• Incompatibilities

Physical incompatibility has been documented for rocuronium when added to solutions containing the following medicines: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, sodium hydrocortisone succinate, insulin, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin.

This medicine must not be mixed with other medicines except those mentioned in section 6.6.

If this medicine is administered through the same infusion line that is also used for other medicines, it is important that this infusion line is properly flushed (e.g. with NaCl 0.9%) between the administration of rocuronium and the medicines for which incompatibility with this medicine has been demonstrated or for which compatibility with this medicine has not been established.

• Duration

Unopened vial: 2 years provided that it is stored in the prescribed conditions (see Special precautions for storage). The date mentioned on the carton and on the label of the vial is the expiry date; this is the date until which this medicine may be used.

Storage outside the refrigerator:

The medicine can be stored at a temperature not above 25°C for a maximum of 16 weeks, after which it must be discarded. The medicine must not be returned to the refrigerator after it has been removed. The storage period must not exceed the shelf-life.

After first opening:

Since this medicine does not contain preservatives, the solution must be used immediately after opening the vial.

After dilution with infusion fluids (see section 6.6), chemical and physical stability has been demonstrated for 24 hours at room temperature (15°C to 25°C). From a microbiological point of view, the diluted product must be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours at 2°C to 8°C.

• Special precautions for disposal and other handling

Compatibility studies have been performed with the following infusion fluids: at nominal concentrations of 1 mg/ml, this medicine has been shown to be compatible with: NaCl 0.9%, Dextrose 5%, Dextrose 5% in saline, Water for Injection and Ringer’s lactate. Administration should be started immediately after mixing and must be completed within 24 hours.

Any unused medicine or waste material should be disposed of in accordance with local requirements.