ROCURONIO 10 mg /Ml Roztwór Do Infuzji

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1. Rocuronio bromuro SALF 10 mg/ml injectable solution for infusion
   1. What is Rocuronio bromuro SALF and what it is used for
   2. What you need to know before you are given Rocuronium bromide SALF
   3. How Rocuronio bromuro SALF is administered
   4. Possible side effects
   5. How Rocuronium bromide SALF is stored
   6. Package contents and other information

Rocuronio bromuro SALF 10 mg/ml injectable solution for infusion

Rocuronium bromide

Read this leaflet carefully before this medicine is administered to you as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your anesthesiologist or doctor.
• If any side effects occur, including those not listed in this leaflet, ask your anesthesiologist or doctor. See section 4.

Contents of this leaflet:

• 1. What Rocuronio bromuro SALF is and what it is used for
• 2. What you need to know before Rocuronio bromuro SALF is administered to you
• 3. How Rocuronio bromuro SALF is administered
• 4. Possible side effects
• 5. How Rocuronio bromuro SALF is stored
• 6. Contents of the pack and other information

1. What is Rocuronio bromuro SALF and what it is used for

Rocuronio bromuro SALF belongs to a class of medicines called muscle relaxants.
Muscle relaxants are used during surgery as part of general anesthesia. When you undergo
surgery your muscles need to be completely relaxed. This makes it easier for the surgeon to
perform the operation.
Normally the nerves send messages to the muscles called impulses. Rocuronio bromuro SALF works
by blocking these impulses so that the muscles relax. Since even the muscles responsible for
breathing will be relaxed, you will need help to breathe (artificial ventilation) during and after
the operation, until you can breathe on your own again.
During the operation the anesthesiologist will monitor the effects of the muscle relaxant and, if necessary, administer
a little more. At the end of the operation, the effects of the medicine will wear off and you will be able to breathe
autonomously. In some cases the anesthesiologist will administer another medicine to speed up this process.
Rocuronio Bromuro SALF can be used in Intensive Care for a limited time to keep
your muscles relaxed.

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

You must not be given Rocuronium bromide SALF
if you are allergic (hypersensitive) to rocuronium, the bromide ion or any of the other ingredients
of this medicine (listed in section 6). Tell your anaesthetist if this is the case.
Warnings and precautions
Speak to your anaesthetist before you are given this medicine:

• if you are allergicto muscle relaxants
• if you have had a kidney, heart, liveror gallbladderdisease
• if you have had a disease that affects the nerves and muscles(for example poliomyelitis, myasthenia gravis)
• if you have fluid retention( oedema)
• if you have a history of malignant hyperthermia (sudden fever with a rapid heartbeat, rapid breathing and stiffness, pain and/or muscle weakness)

Certain conditions can 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
• excessive amount of carbon dioxide in the blood ( acidosis)
• excessive loss of body fluids, for example diarrhoea or sweating ( dehydration)
• increased breathing that leads 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 give you.

Children and the elderly
Rocuronium bromide SALF can be used in children (newborns and adolescents) and the elderly but your
anaesthetist will assess your medical history first.

Other medicines and Rocuronium bromide SALF
Tell the anaesthetist if you are taking,have recently taken or might take any other
medicines. Rocuronium bromide SALF can affect the effect of other medicines or be affected by them.

Medicines that increase the effect of Rocuronium bromide SALF:

• some antibiotics
• some medicines used for heart diseaseor high blood pressure( diuretics, calcium channel blockers, beta blockers and quinines)
• some anti-inflammatory medicines ( corticosteroids)
• magnesium salts
• some medicines used for bipolar disorder( lithium salts)
• some medicines used to treat malaria( quinine)
• some medicines used to make you fall asleepduring operations ( anaesthetics)
• some medicines that can increase the amount of urine( diuretics)
• some local anaesthetics( lidocaine and bupivacaine)
• some medicines used for epilepsyduring an operation ( phenytoin)
• some medicines used to induce temporary muscle relaxationin anaesthesia or intensive care ( succinylcholine)

Medicines that decrease the effect of Rocuronium bromide SALF:

• medicines used long-term for epilepsy( phenytoin and carbamazepine)
• some protease inhibitorscalled gabesateand ulinastatin
• acetylcholinesterase inhibitors, medicines for the treatment of myasthenia gravis(for example neostigmine, edrophonium, pyridostigmine)
• calcium chlorideand potassium chloride

In addition, you may be given other medicines before or during surgery that
can alter the effect of rocuronium. These include certain anaesthetics (for example local anaesthetics,
inhalation anaesthetics), other muscle relaxants, phenytoin and medicines that neutralise the effect of
Rocuronium bromide SALF. Rocuronium can make some 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 might be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your anaesthetist for advice before you are given this medicine.
Your anaesthetist may still give you Rocuronium Bromide SALF, but this needs to be discussed
first. Rocuronium bromide SALF can be given if you need to have a caesarean section.
Breastfeeding must be stopped 6 hours after the administration of this medicine.

Driving and using machines
Do not drive or use machines until you are told it is safe. Because Rocuronium
bromide is given as part of a general anaesthetic, you may feel tired, weak or dizzy for a while.
The anaesthetist will be able to advise you on how long the 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 Rocuronio bromuro SALF is administered

Dose
Your anesthesiologist will determine the necessary dose of Rocuronio bromuro SALF based on:

• type of anesthetic
• 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 30 - 40 minutes.

How Rocuronio bromuro SALF is administered
Rocuronio bromuro SALF will be administered by your anesthesiologist. Rocuronio bromuro SALF is
administered intravenously (into a vein), either as a single injection or as a continuous infusion
(drip).
This medicine is for single use. Any unused injectable solution for infusion must be discarded.

If you are given too much Rocuronio bromuro SALF
Since the anesthesiologist will carefully monitor your condition, it is unlikely that you will be given too much
Rocuronio bromuro SALF. However, if this should happen, the anesthesiologist will ensure that you continue
to breathe artificially (with a ventilator) until you are able to do so independently.
During this operation you will be kept asleep.

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 anesthesia, they will be detected and treated
by the anesthesiologist.

Uncommon(may affect up to 1 in 100 people)

• Increased heart rate
• Low blood pressure
• The medicine is too effective or not effective enough
• The medicine works for longer than it should
• Pain near 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, hives or redness of the skin
• Long-term muscle dysfunction, usually observed when rocuronium bromide and anti-inflammatory drugs (corticosteroids) are administered simultaneously in Intensive Care in severely ill patients (steroid myopathies)
• Airway complications following anesthesia

Not known(frequency cannot be estimated from 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 with light or other stimuli.

If any side effect becomes serious,including those not listed in this leaflet, tell your
anesthesiologist or doctor.

Reporting of side effects
If you get any side effects, talk to your anesthesiologist or doctor. You can also report side effects directly through 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 which is stated on the label and the packaging 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/ampoule in the cardboard box to protect it from light.
Rocuronium bromide SALF can also be stored outside the refrigerator at a temperature up to 25°C
for a maximum of 12 weeks.
The solution must be used immediately after opening the vial/ampoule.
In-use shelf life of the medicinal product after dilution:
After dilution with infusion fluids (see section 6.6), chemical and physical stability in use has been
demonstrated for 24 hours at 25°C. From a microbiological point of view, the medicine must be used
immediately. If not used immediately, the storage times and conditions before use are 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 and validated aseptic 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 ingredient is: rocuronium bromide.
Each ml of injectable solution for infusion contains 10 mg of rocuronium bromide.
Each vial/bottle with 5 ml contains 50 mg of rocuronium bromide.
Each vial/bottle with 10 ml contains 100 mg of rocuronium bromide.
The other ingredients 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 injectable solution for infusion is a clear solution, from colorless to
light yellowish-brown.
Vials/bottles of 5 and 10 ml.
Packs
10x 5 ml
12x 5 ml
(6x 10) x 5 ml
10x 10 ml
(2x 10) x 10 ml
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
S.A.L.F. S.p.A. Laboratorio Farmacologico
Via Marconi, 2
24069 Cenate Sotto (BG)
Manufacturer
Solupharm Pharmazeutische Erzeugnisse GmbH
Industriestrasse 3
34212 Melsungen (Germany)

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:

The following information is intended exclusively for physicians or healthcare professionals:
For single use only.
Discard any unused solution.
The solution must be used immediately after opening the vial.
Rocuronio bromuro SALF has been shown to be compatible with: sodium chloride 9 mg/ml
(0.9%), glucose 50 mg/ml (5%), glucose 33 mg/ml (3.3%) in sodium chloride 3 mg/ml
(0.3%), water for injections and Ringer Lactate.
Rocuronio bromuro SALF must not be mixed with other medicinal products except for those
mentioned above.
Physical incompatibility of Rocuronio bromuro SALF has been demonstrated when added to solutions containing
the following active ingredients: 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 Rocuronio bromuro SALF is administered via the same infusion line used for other
medicinal products, it is important that said infusion line is adequately flushed (e.g. with a solution
of sodium chloride 9 mg/ml (0.9% w/v) between the administration of Rocuronio bromuro SALF and medicinal products
that are declared incompatible with Rocuronio bromuro SALF or whose compatibility with Rocuronio bromuro
SALF has not been demonstrated.