Label: Information for the User

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

Rocuronio, bromide

Read this label carefully before this medicine is administered to you, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your anesthesiologist or another doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this label. See section 4.

Rocuronio Tamarang 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 makes it easier for the surgeon to perform the operation. Normally, nerves send messages to muscles through impulses. Rocuronio Tamarang 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, the effects of the medication will be allowed 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.

Rocuronio Tamarang can also be used in the Intensive Care Unit for short-term use to keep your muscles relaxed.

You should not receive Rocuronio Tamarang

Inform your anesthesiologist if this applies to you

Warnings and precautions

Consult your anesthesiologist before the administration of Rocuronio Tamarang

Some conditions may affect the effects of Rocuronio Tamarang, for example:

If you have any of these conditions, your anesthesiologist will take this into account when deciding on the correct dose of Rocuronio Tamarang for you

Children and the elderly

Rocuronio Tamarang can be used in children (newborns and adolescents) and the elderly, but your anesthesiologist must first evaluate your medical history.

Other medications and Rocuronio Tamarang

Inform your anesthesiologist if you are taking,have taken recently or may need to take any other medication. Rocuronio Tamarang may affect other medications or be affected by them.

Medications that increase the effect of Rocuronio Tamarang:

Medications that decrease the effect of Rocuronio Tamarang:

• prolonged use of medications for the treatment ofepilepsy(phenytoin and carbamazepine)
• someprotease inhibitorscalled gabexate and utinastatin
• inhibitors of acetylcholinesterase, medications for the treatment ofmyasthenia gravis(neostigmine, edrophonium, pyridostigmine)
• calcium chlorideandpotassium chloride

In addition, you may be given other medications before or during surgery that can alter the effects of rocuronio. These include certain anesthetics, other muscle relaxants, medications such as phenytoin and medications that reverse the effect of Rocuronio Tamarang. Rocuronio may make certain anesthetics act more quickly. Your anesthesiologist will take this into account when deciding on the correct dose of Rocuronio Tamarang for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your anesthesiologist before this medication is administered.

Your anesthesiologist may give you this medication, but first they must discuss it with you. You may be given Rocuronio Tamarang if you are to undergo a cesarean section.Lactation should be suspended 6 hours after administration of this medication.

Driving and operating machinery

Do not drive or operate machinery until you are told it is safe to do so. Since Rocuronio Tamarang is administered as part of general anesthesia, you may feel tired, weak or dizzy for some time after. Your anesthesiologist will be able to advise you on the probable duration of the effects.

Rocuronio Tamarang contains sodium

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

Dosage

Your anesthesiologist will calculate the dosage of this medication based on:

• the type of anesthetic,
• the expected duration of the operation
• other medications you are taking
• your health status

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

How Rocuronio Tamarang is Administered

Your anesthesiologist will administer Rocuronio Tamarang intravenously (into a vein), either as single injections or as a continuous infusion (a drip).

This medication is for single use only. Any unused solution for injection/infusion must be discarded.

If more Rocuronio Tamarang than recommended is administered

Since your anesthesiologist will closely monitor your condition, it is unlikely that too much Rocuronio Tamarang will be administered. However, if this occurs, your anesthesiologist will keep you breathing artificially (with a ventilator) until you start breathing on your own again. You will remain asleep during this time.

Like all medications, this medication may produce adverse effects, although not everyone 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 100 people):

• Increased heart rate
• Decreased blood pressure
• Increased or decreased effect of the medication
• Prolonged muscle relaxant effect of the medication
• 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
• Swelling, rash, or hives, skin redness
• Chronic muscle alteration, typically observed after concomitant administration of rocuronium bromide and anti-inflammatory medications (corticosteroids) in critically ill patients in the Intensive Care Unit (steroid myopathy)
• Respiratory tract complication due to anesthesia

Unknown Frequency

(cannot be estimated from available data):

• Severe allergic spasm and coronary artery spasm (Kounis syndrome) that causes chest pain (angina) or heart attack (myocardial infarction).
• Dilated pupils (mydriasis) or fixed pupils that do not change size with light or other stimuli.

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

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

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

Store in refrigerator (2 °C - 8 °C).

Do not freeze.

Store the vial/ampoule in the outer carton packaging to protect it from light.

Rocuronio Tamarang can also be stored outside the refrigerator at a temperature not exceeding 25° C for a maximum period of 12 weeks.

The medication should be used immediately after opening the vial/ampoule.

Stability period of the diluted medication: Chemical and physical stability has been demonstrated after dilution with infusion fluids (see section 6.6) for 24 hours at 25 ° C. From a microbiological point of view, the medication should be used immediately.

If not used immediately, the previous storage times and conditions for use are the responsibility of the user and should not exceed 24 hours at 2 ºC – 8 º, unless the dilution was carried out under validated aseptic conditions.

Do not use Rocuronio Tamarang if you observe that the solution is not transparent or free of particles.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Rocuronio Tamarang Composition

The active principle is bromide of rocuronio.

Each ml of injectable and perfusion solution contains 10 mg of bromide of rocuronio.

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

Each vial/ampoule of 10 ml contains 100 mg of bromide of rocuronio.

The other components are:

Sodium acetate trihydrate

Sodium chloride

Acetic acid 99% (to adjust pH)

Acetic acid 30% (to adjust pH)

Injectable water

Sodium hydroxide (to adjust pH)

Appearance of the product and contents of the package

Rocuronio Tamarang 10 mg/ml injectable and perfusion solution is a transparent, colorless or pale yellow-brown solution.

Vials/ampoules of 5 ml and 10 ml

Formats:

Packages of 10 vials/ampoules x 5 ml

Packages of 12 vials/ampoules x 5 ml

Packages of (6x 10) vials/ampoules x 5 ml

Packages of 10 vials/ampoules x 10 ml

Packages of (2x 10) vials/ampoules x 10 ml

Not all formats may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Tamarang, S.A.

Balmes 85 P 2

08008 Barcelona

Spain

Responsible manufacturer

SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH

Industriestrasse 3

34212 Melsungen

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:01/2024

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