Label: Information for the User

Rocuronio Hikma 10 mg/ml Injectable Solution and for Infusion EFG

rocuronium bromide

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

This medication belongs to a group of medications called muscle relaxants.

Muscle relaxants are used during an operation as part of a general anesthesia. When undergoing an operation, your muscles must be completely relaxed. This facilitates the surgeon's performance of the operation.

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

During the operation, your anesthesiologist will control the effect of the muscle relaxant and, if necessary, give you more. At the end of the surgery, it is allowed for the effects of the medication to wear off and you will begin breathing on your own. Sometimes, the anesthesiologist will give you another medication to help speed up this process.

This medication may also be used in the intensive care unit to keep your muscles relaxed.

No use Rocuronio Hikma

Inform your anesthetist if this applies to you.

Warnings and Precautions

Consult your doctor, pharmacist or nurse before starting to use this medication:

Inform your anesthetist if you are in any of these situations.

Some conditions may affect the effects of this medication, for example:

If you have any of these conditions, your anesthetist will take this into account when deciding on the correct dose of this medication for you.

Children and the Elderly

This medication can be used in children (newborns and adolescents) and the elderly, but your anesthetist must first evaluate your medical history.

Other Medications and Rocuronio Hikma

Inform your doctor if you are using, have used recently or may need to use any other medication.

This includes medications or herbal products that you have purchased without a prescription.

This medication may affect other medications or be affected by them.

Medications that increase the effect of rocuronio:

Medications that decrease the effect of rocuronio:

You may be given other medications during the procedure that may affect the effects of rocuronio. These include certain anesthetics, other muscle relaxants, medications such as phenytoin and medications that reverse the effects of this medication. Rocuronio may make certain anesthetics act more quickly. Your doctor will take this into account when deciding on the correct dose of rocuronio for you.

Pregnancy and Breastfeeding

Inform your anesthetist if you are pregnant, may be pregnant or are breastfeeding.

Your anesthetist may still give you this medication, but first they must discuss it. If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

You may be given this medication if you are undergoing a cesarean section.

Breastfeeding should be suspended 6hours after using this medication.

Driving and Operating Machines

Do not drive or operate machines until you are told it is safe to do so. Because this medication is administered as part of a general anesthesia, you may feel tired, weak or dizzy for some time after. Your doctor will be able to advise you on how long the effects are likely to last.

Rocuronio Hikma contains sodium

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

Dosage

Your anesthesiologist will calculate the dose of this medication you need based on:

• the type of anesthetic,

• the expected duration of the operation,

• other medications you are taking,

• your health status.

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

How Rocuronio Hikma is administered

This medication will be administered to you intravenously (into a vein) as a single injection or as a continuous infusion (a drip)

If you use more Rocuronio Hikma than you should

Your anesthesiologist will closely monitor you under medication with this medication, therefore it is unlikely that you will be given too much rocuronio. If this happens, your anesthesiologist will ensure that anesthesia and artificial ventilation continue until you breathe on your own again.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

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

• Increased or decreased effect of the medication
• Prolonged effect of the muscle relaxant medication
• Decreased 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, circulatory collapse, and shock),
• Wheezing in the chest
• Muscle weakness
• Sudden fever with rapid heartbeats, rapid breathing, and stiffness, pain, and/or weakness in the muscles
• Swelling, itching, or skin rash

Frequency Not Known (cannot be estimated from available data):

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

If any of the adverse effects worsen or if you notice any adverse effect not mentioned in this prospectus, inform your anesthesiologist or other doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store in refrigerator (2 °C - 8 °C).

Storage outside the refrigerator

This medication can be stored at a temperature not exceeding 25°C for a maximum period of 16 weeks, after which it must be discarded. Once outside the refrigerator, the product must not be returned to it. The storage period must not exceed the expiration date.

The hospital will store this medication according to the correct storage conditions and ensure it is within its expiration date.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Rocuronio Hikma Composition

• The active ingredient is rocuronium bromide.

• The other components are sodium acetate trihydrate, sodium chloride, sodium hydroxide (to adjust pH), acetic acid (to adjust pH), and water for injection.

Each milliliter of this medication contains 10 mg of rocuronium bromide.

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

Product Appearance and Packaging Contents

Rocuronio Hikma is a transparent, colorless to slightly yellow/orange injectable solution.

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

Marketing Authorization Holder and Responsible Manufacturer

Hikma Farmacêutica (Portugal), S.A.

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

2705-906 Terrugem SNT

Portugal

For Further Information, Please Contact the Local Representative of the Marketing Authorization Holder:

Hikma España, S.L.U.

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

28108 - Alcobendas, Madrid

Spain

Last Review Date of This Leaflet:08/2021

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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The following information is intended for healthcare professionals only:

• Incompatibilities

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

This medication should not be mixed with other medications except those mentioned in section 6.6.

If this medication is administered through the same infusion line as other medications, it is essential to properly clean this infusion line (e.g., with 0.9% NaCl) between the administration of rocuronium and the medications for which incompatibility with this medication has been demonstrated or for which compatibility with this medication has not been established.

•Duration

Unopened vial: 2 years, provided it is stored under the prescribed conditions (see Special Precautions for Storage). The date mentioned on the box and on the vial label is the expiration date; this is the date until which this medication can be used.

Storage at Room Temperature:

The medication can be stored at a temperature not exceeding 25 ° C for a maximum of 16 weeks, after which it must be discarded. The medication should not be re-stored in the refrigerator after being removed from it. The storage period should not exceed the shelf life.

After the first opening:

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

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

•Special Precautions for Disposal and Other Handling

Compatibility studies have been performed with the following infusion liquids: at nominal concentrations of 1 mg/ml, it has been demonstrated that this medication is compatible with: 0.9% NaCl, 5% Dextrose, 5% Dextrose in saline solution, Sterile Water for Injection, and Lactate Buffer. Administration should begin immediately after mixing and should be completed within 24 hours.

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