Rocuronium bromide Salf

Package leaflet: Information for the patient

Rocuronium bromide SALF 10 mg/ml infusion solution for injection

Rocuronium bromide

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, ask your anaesthetist or doctor.
• If you experience any side effects, including those not listed in this leaflet, inform your anaesthetist or doctor. See section 4.

Contents of this leaflet:

1. What Rocuronium bromide SALF is and what it is used for
2. What you need to know before being administered Rocuronium bromide SALF
3. How Rocuronium bromide SALF is administered
4. Possible side effects
5. How to store Rocuronium bromide SALF
6. Contents of the pack and other information

1. What Rocuronium bromide SALF is and what it is used for

Rocuronium bromide SALF belongs to a class of medicines called muscle relaxants.
Muscle relaxants are used during surgery as part of general anaesthesia. When you undergo surgery, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the procedure.
Normally, nerves send signals to the muscles called impulses. Rocuronium bromide SALF works by blocking these impulses, causing the muscles to relax. Since the muscles responsible for breathing will also be relaxed, you will need assistance with breathing ( artificial ventilation ) during and after the operation, until you are able to breathe on your own again.
During the procedure, the anaesthetist will monitor the effects of the muscle relaxant and, if necessary, administer additional doses. At the end of the procedure, the effects of the medicine will wear off and you will be able to breathe independently. In some cases, the anaesthetist may give another medicine to speed up this process.
Rocuronium bromide SALF may be used in Intensive Care for limited periods of time to keep your muscles relaxed.

2. What you need to know before being given Rocuronium bromide SALF

Do not be given Rocuronium bromide SALF
if you are allergic (hypersensitive) to rocuronium, bromide ion, or to any of the other ingredients
of this medicine (listed in section 6). Inform your anaesthetist if this applies to you.
Warnings and precautions
Talk to your anaesthetist before you are given this medicine:

• if you are allergic to muscle relaxants
• if you have had kidney, heart, liver or gallbladder disease
• if you have had a disease affecting nerves and muscles (e.g. poliomyelitis, myasthenia gravis)
• if you have fluid retention ( edema )
• if you have a history of malignant hyperthermia (sudden fever with rapid heartbeat, fast breathing, and muscle stiffness, pain and/or weakness)

Certain conditions may affect the effects of Rocuronium bromide SALF, for example:

• low levels of calcium in the blood
• low levels of potassium in the blood
• high levels of magnesium in the blood
• low levels of protein in the blood
• excess carbon dioxide in the blood ( acidosis )
• excessive loss of body fluids, such as from diarrhoea or sweating ( dehydration )
• increased breathing leading to low levels of carbon dioxide in the blood ( alkalosis )
• general health problems
• being overweight ( obesity )
• burns
• very low body temperature ( hypothermia )

If you have any of these conditions, your anaesthetist will take them into account when deciding the correct
dose of Rocuronium bromide SALF to administer to you.
Children and elderly
Rocuronium bromide SALF may be used in children (neonates and adolescents) and elderly patients, but your
anaesthetist will first evaluate your medical history.
Other medicines and Rocuronium bromide SALF
Inform your anaesthetist if you are taking, have recently taken, or might take any other
medicines. Rocuronium bromide SALF may affect the effect of other medicines or be affected by them.
Medicines that increase the effect of Rocuronium bromide SALF:

• certain antibiotics
• certain medicines used for heart disease or high blood pressure ( diuretics, calcium channel blockers, beta-blockers and quinine )
• certain anti-inflammatory medicines ( corticosteroids )
• magnesium salts
• certain medicines used for bipolar disorder ( lithium salts )
• certain medicines used to treat malaria ( quinine )
• certain medicines used to induce sleep during surgery ( anaesthetics )
• certain medicines that can increase urine volume ( diuretics )
• certain local anaesthetics ( lidocaine and bupivacaine )
• certain medicines used for epilepsy during surgery ( phenytoin )
• certain medicines used to induce temporary muscle relaxation in anaesthesia or intensive care ( succinylcholine )

Medicines that decrease the effect of Rocuronium bromide SALF:

• medicines used long-term for epilepsy ( phenytoin and carbamazepine )
• certain protease inhibitors called gabexate and ulinastatin
• acetylcholinesterase inhibitors, medicines for the treatment of myasthenia gravis (e.g. neostigmine, edrophonium, pyridostigmine )
• calcium chloride and potassium chloride

In addition, you may be given other medicines before or during surgery that could alter the effect of rocuronium. These include certain anaesthetics (e.g. local anaesthetics, inhalational anaesthetics), other muscle relaxants, phenytoin, and medicines that reverse the effect of Rocuronium bromide SALF. Rocuronium may make certain anaesthetics work more quickly. Your anaesthetist will take this into account when deciding the correct dose of Rocuronium bromide SALF for you.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your anaesthetist before being given this medicine.
Your anaesthetist may still administer Rocuronium bromide SALF to you, but this should be discussed beforehand. Rocuronium bromide SALF may be administered if you need to undergo a caesarean section.
Breastfeeding should be discontinued for 6 hours after administration of this medicine.
Driving and using machines
Do not drive or operate machinery until you are told it is safe to do so. Since Rocuronium
bromide is administered as part of a general anaesthetic, you may feel tired, weak, or dizzy for some time. Your anaesthetist will be able to advise you on how long these effects may last.
Rocuronium bromide SALF contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial/bottle, i.e. essentially “sodium-free”.

3. How Rocuronium bromide SALF is administered

Dosage
Your anaesthetist will determine the required dose of Rocuronium bromide SALF based on:

• type of anaesthetic
• expected duration of the surgery
• other medicines you are taking
• your health status

The usual dose is 0.6 mg per kg of body weight, and its effect lasts 30–40 minutes.
How Rocuronium bromide SALF is administered
Rocuronium bromide SALF will be administered to you by your anaesthetist. Rocuronium bromide SALF is given intravenously (into a vein), either as a single injection or as a continuous infusion.
This medicine is for single use only. Any unused injectable solution for infusion must be discarded.
If you are given more Rocuronium bromide SALF than you should
Since your anaesthetist will closely monitor your condition, it is unlikely that you will receive more Rocuronium bromide SALF than intended. However, if this does happen, your anaesthetist will ensure that you continue to breathe artificially (using a ventilator) until you are able to breathe on your own again.
During this time, you will remain unconscious.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these effects occur while you are under anaesthesia, they will be detected and treated by the anaesthetist.

Uncommon (may affect up to 1 in 100 people)

• Increased heart rate
• Lowering of blood pressure
• The medicine is too effective or not effective enough
• The medicine lasts longer than expected
• Pain at the injection site

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

• Allergic reactions ( hypersensitivity ) (such as breathing difficulties, circulatory collapse and shock)
• Wheezing
• Muscle weakness
• Swelling, skin rash, hives or redness of the skin
• Long-term muscle dysfunction, usually observed when rocuronium bromide and anti-inflammatory medicines (corticosteroids) are given together in Intensive Care to severely ill patients (steroid myopathy)
• Airway complications following anaesthesia

Not known (frequency 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).
• Dilated pupils (mydriasis) or fixed pupils that do not change size in response to light or other stimuli.

If any side effect becomes severe, including those not listed in this leaflet, consult the anaesthetist or doctor.

Reporting of side effects

If you get any side effects, including those not listed in this leaflet, consult the anaesthetist or doctor. You can also report side effects directly via the national reporting system at: 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 Rocuronium bromide SALF is stored

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "EXP."
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the cardboard container to protect it from light.
Rocuronium bromide SALF may also be stored outside the refrigerator at a temperature up to 25°C
for a maximum of 12 weeks.
The solution should be used immediately after opening the vial.
In-use stability of the diluted medicine:
After dilution with infusion fluids (see section 6.6), chemical and physical in-use stability has been demonstrated
for 24 hours at 25°C. From a microbiological standpoint, the medicine should be used immediately.
If not used immediately, the times and conditions of storage prior to use are under the responsibility of the user/administrator
and generally should not exceed 24 hours at 2-8°C, unless the dilution is carried out under controlled, aseptic, and validated conditions.
Do not use this medicine if you notice that the solution is not clear and free from particles.

6. Package contents and other information

What Rocuronio bromuro SALF contains
The active substance is: rocuronium bromide.
Each ml of injectable solution for infusion contains 10 mg of rocuronium bromide.
Each 5 ml vial/bottle contains 50 mg of rocuronium bromide.
Each 10 ml vial/bottle contains 100 mg of rocuronium bromide.
The other components are:
sodium acetate trihydrate,
sodium chloride,
acetic acid 99% (for pH adjustment),
acetic acid 30% (for pH adjustment),
water for injections,
sodium hydroxide (for pH adjustment).

Description of the appearance of Rocuronio bromuro SALF and package contents
Rocuronio bromuro SALF 10 mg/ml solution for infusion is a clear, colourless to pale yellowish-brown solution.
Vials/bottles of 5 ml and 10 ml.

Pack sizes:
10 x 5 ml
12 x 5 ml
(6 x 10) x 5 ml
10 x 10 ml
(2 x 10) x 10 ml

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2
24069 Cenate Sotto (BG), Italy

Manufacturer
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
34212 Melsungen (Germany)

This medicinal product is authorised in the European Economic Area (EEA) and the United Kingdom (Northern Ireland) under the following names:

The following information is intended exclusively for doctors or healthcare professionals:
For single use only.
Discard any unused solution residue.
The solution must be used immediately after opening the vial.
It has been demonstrated that Rocuronium bromide SALF is compatible with: sodium chloride solution 9 mg/ml (0.9%), glucose solution 50 mg/ml (5%), glucose 33 mg/ml (3.3%) in sodium chloride solution 3 mg/ml (0.3%), water for injections, and Ringer's Lactate.
Rocuronium bromide SALF must not be mixed with other medicinal products except those listed above.
Physical incompatibility of Rocuronium bromide SALF has been demonstrated when added to solutions containing the following active substances: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone, diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, intralipid, methohexital, methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim, and vancomycin.
If Rocuronium bromide SALF is administered through the same infusion line used for other medicinal products, it is important that the infusion line be adequately flushed (e.g., with a sodium chloride 9 mg/ml (0.9% w/v) solution) between the administration of Rocuronium bromide SALF and medicinal products declared incompatible with Rocuronium bromide SALF or those whose compatibility with Rocuronium bromide SALF has not been established.