ROCURONIO 10 mg /Ml Roztwór Do Wstrzykiwań Lub Infuzji

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1. Rocuronio bromuro Noridem 10 mg/mL injectable solution or for infusion
   1. What is Rocuronio bromuro Noridem and what is it used for
   2. What you need to know before using Rocuronio bromide Noridem
   3. How to use Rocuronio bromuro Noridem
   4. Possible side effects
   5. How to store Rocuronio bromuro Noridem
   6. Contents of the pack and other information

Rocuronio bromuro Noridem 10 mg/mL injectable solution or for infusion

rocuronium bromide
Generic Medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Rocuronio bromuro Noridem is a muscle relaxant. Muscle relaxants are used during surgical
procedures to facilitate general anesthesia. During a surgical procedure, the muscles must be
completely relaxed. This makes it easier for the surgeon to perform the procedure. Normally, the nerves
send signals to the muscles. Rocuronio bromuro Noridem is able to temporarily block these signals,
thus relaxing the muscles. Since the respiratory muscles will also relax, artificial respiration will be started
until natural breathing is restored. During the surgical procedure, the effect of the muscle relaxant
is constantly monitored and, if necessary, further Rocuronio bromuro Noridem is administered. At the
end of the procedure, the effects of Rocuronio bromuro Noridem are allowed to diminish to promote the return
of natural breathing. In certain cases, another medicine is administered to accelerate recovery.
Rocuronio bromuro Noridem can also be used in intensive care.

2. What you need to know before using Rocuronio bromide Noridem

Do not use Rocuronio bromide Noridem

• if you are allergic to rocuronium or any of the other ingredients of this medicine (listed in section 6). Tell your doctor if this is the case.

Warnings and precautions

• Your medical history may affect how you receive Rocuronio bromide Noridem. Talk to your doctor if you have, or have had, any of the following conditions:
• allergy to muscle relaxant medicines
• poor kidney function (renal insufficiency) or a kidney disease
• a cardiovascular disease
• formation of edema (fluid retention, e.g. in the ankles)
• liver disease, gallbladder disease or bile duct disease or poor liver function
• a disease that affects the nerves and muscles
• a history of malignant hyperthermia (sudden fever with a rapid heartbeat, rapid breathing and stiffness, pain and/or muscle weakness)
• Some diseases may affect how Rocuronio bromide Noridem works. For example:
• a low level of potassium in the blood (hypokalemia)
• a high level of magnesium in the blood (hypermagnesemia), e.g. when toxemia in pregnancy is treated with magnesium salts
• a low level of calcium in the blood (hypocalcemia)
• a low level of protein in the blood (hypoproteinemia)
• lack of fluids (dehydration)
• an increase in the amount of acid in the blood (acidosis)
• an increase in the amount of carbon dioxide in the blood (hypercapnia)
• conditions of general weakness
• overweight
• burns. If you have any of the conditions described above, your doctor will take this into account to establish the most suitable dose of Rocuronio bromide Noridem for you.

Children/elderly
Rocuronio bromide Noridem can be used in children (from newborns to puberty) and the elderly.

Other medicines and Rocuronio bromide Noridem
Tell your doctor if you are taking, have recently taken or might take any other medicines. This will help the
doctor to establish the most suitable dose of Rocuronio bromide Noridem for you.
The following medicines may affect the effect of Rocuronio bromide Noridem:

• Medicines that increase the effect of Rocuronio bromide Noridem:
• some anesthetics
• concomitant use of corticosteroids (anti-inflammatory medicines) with Rocuronio bromide Noridem in intensive care
• some medicines used to treat bacterial infections (antibiotics)
• some medicines used for manic-depressive illness (lithium)
• some medicines for heart disease or high blood pressure (quinidine, calcium antagonists, beta-blockers)
• some medicines used to treat malaria (quinine)
• diuretics
• magnesium salts
• local anesthetics (lidocaine and bupivacaine)
• short-term use of medicines for epilepsy (phenytoin), e.g. during surgery.
• medicines that decrease the effect of Rocuronio bromide Noridem:
• long-term use of corticosteroids (anti-inflammatory medicines) or medicines for epilepsy (phenytoin and carbamazepine)
• medicines for pancreatitis, blood clotting problems and acute bleeding (protease inhibitors: gabexate, ulinastatin).
• medicines with a variable effect on Rocuronio bromide Noridem:
• other muscle relaxants.

Rocuronio bromide Noridem may affect the effect of the following medicines:

• the effect of some local anesthetics (lidocaine) may be increased.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before being given this medicine.
Pregnancy
No harmful effects have been found in studies on animals, however no data are available from clinical studies
relating to the use of rocuronium bromide
in pregnancy. Therefore, rocuronium bromide should be used with caution in pregnant women.
Cesarean section
A doctor will decide whether rocuronium bromide can be used during a cesarean section. It has been shown
that a dose of 0.6 mg of rocuronium bromide per
kilogram of body weight can be safely used during a cesarean section, without any harmful effects on the newborn.
Breastfeeding
After using this medicine, breastfeeding should be discontinued for the next 6 hours.

Driving and operating machinery
Your doctor will tell you if you can resume driving or using dangerous machinery after using
Rocuronio bromide Noridem.

Rocuronio bromide Noridem contains sodium
Each vial/ampoule contains 8.2 mg (0.36 mmol) of sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per vial/ampoule, i.e.
essentially “sodium-free”.

3. How to use Rocuronio bromuro Noridem

Dosage
The doctor will determine the dosage of Rocuronio bromuro Noridem based on:

• type of anesthetic used
• expected duration of the surgical procedure
• other medicines used
• age and state of health.

Rocuronio bromuro Noridem will be administered to you before and/or during a surgical procedure. The normal dose is 0.6 mg of rocuronium bromide per kilogram of body weight and the effect lasts from 30 to 40 minutes.
During the procedure, it will be verified that Rocuronio bromuro Noridem is still working. Additional doses will be administered to you, if necessary.

How Rocuronio bromuro Noridem is administered
Rocuronio bromuro Noridem is not indicated for self-administration. Rocuronio bromuro
Noridem will be administered to you as a solution in a vein, as a single injection or as an
infusion.
Injections must be administered by a doctor or a nurse.

If you use more Rocuronio bromuro Noridem than you should
Medical personnel will keep you under close monitoring, therefore it is unlikely that you will be
administered too much Rocuronio bromuro Noridem. However, if this were to happen, artificial respiration will continue until you are able to breathe independently again. It is possible to
counteract the effects of (too much) Rocuronio bromuro Noridem and accelerate recovery using a
medicine that counteracts the effects of Rocuronio bromuro Noridem.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If these side effects occur during anesthesia, they will be observed and
treated by the doctor.
The following side effects may occur:

Common (may affect less than 1 in 10 people)

• fast heartbeat (tachycardia) in children (from newborns to adolescents)

Uncommon/rare (may affect less than 1 in 100/1,000 people)

• fast heartbeat (tachycardia) in adults
• low blood pressure (hypotension)
• absent, increased or insufficient effect of Rocuronium bromide Noridem
• pain at the injection site
• redness or itching at the injection site
• prolonged muscle relaxing effect of Rocuronium bromide Noridem
• delayed recovery from anesthesia.

Very rare (may affect less than 1 in 10,000 people)

• allergic reactions, such as difficulty breathing, changes in blood pressure or heart rate, shock (significant decrease in blood pressure) due to insufficient blood circulation or skin changes (e.g. fluid accumulation, redness or rash)
• wheezing due to spasms of the airway muscles (bronchospasm)
• muscle weakness or paralysis
• long-term muscle disorders when Rocuronium bromide Noridem is used in combination with corticosteroids (anti-inflammatory medicines) in intensive care in severely ill patients (steroidal myopathy)
• sudden fluid accumulation in the skin or mucous membranes (e.g. throat or tongue), difficulty breathing and/or itching or rash, often as in an allergic reaction (angioedema)
• fluid accumulation (edema) in the face
• problems with the airways due to anesthesia
• skin rash, sometimes with itching and severe blisters (urticaria)
• redness of the skin
• flushing.

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.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. You can also report side effects directly through the
Website:
https://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 to store Rocuronio bromuro Noridem

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2  C – 8  C).
Rocuronio bromuro Noridem must be used immediately after opening the vial or
ampoule.
The diluted product is physically and chemically stable for 72 hours at 28°C – 32°C or 72 hours at 2°C

• 8°C. From a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2°C - 8ºC, unless the dilution has taken place under controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the pack, on the
ampoule label or on the vial after EXP. The expiry date refers to the last day of that month.
The medicine must be visually inspected before use. The solution must be
used only if it is clear and practically free from particles, in an undamaged container.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate the medicines
that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rocuronio bromide Noridem contains

• The active substance is rocuronium bromide. 1 mL of solution contains 10 mg of rocuronium bromide.
• The other components are sodium acetate trihydrate, sodium chloride, glacial acetic acid and water for injections.

Description of the appearance of Rocuronio bromide Noridem and contents of the pack
Rocuronio bromide Noridem is a transparent, colourless to pale yellow solution for injection or infusion containing 10 mg of rocuronium bromide per millilitre.
Rocuronio bromide Noridem is available in 3 presentations:

• Glass vials with 50 mg of rocuronium bromide (10 or 50 vials per pack)
• Glass ampoules with 50 mg of rocuronium bromide (10 or 50 ampoules per pack)
• Plastic ampoules with 50 mg of rocuronium bromide (10 or 50 ampoules per pack)

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Noridem Enterprises Ltd.
Evagorou & Makariou,
Mitsi Building 3, Office 115,
Nicosia 1065, Cyprus

Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY
21st Km National Road Athens-Lamia
14568 Greece

T:+30 210 8161802, F:+30 210816158

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

<[To be completed at national level]>
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The following information is intended for healthcare professionals:

Preparation and handling
Incompatibilities
Physical incompatibility has been documented when Rocuronio bromide Noridem is added to solutions
containing the following medicinal products: amphotericin, amoxicillin, azathioprine, cefazolin, cloxacillin, dexamethasone,
diazepam, enoximone, erythromycin, famotidine, furosemide, hydrocortisone sodium succinate, insulin, methosital,
methylprednisolone, prednisolone sodium succinate, thiopental, trimethoprim and vancomycin. Rocuronium bromide
Noridem is also incompatible with soybean oil.
This medicinal product must not be mixed with other medicinal products except those mentioned in the
paragraph “Method of administration”.
If Rocuronio bromide Noridem is administered in the same infusion line used for
other medicinal products, it is important that the infusion line is adequately flushed (e.g. with 0.9% NaCl) between the administration of Rocuronio bromide Noridem and that of medicinal products whose incompatibility with
Rocuronio bromide Noridem has already been demonstrated or whose compatibility with Rocuronio bromide Noridem has not
yet been established.

Dosage and method of administration
In adults, the following recommended doses can be used as a general guide for endotracheal intubation, for muscle relaxation in short to long duration surgeries and for use in intensive care.

Surgical interventions
Endotracheal intubation
The standard dose for intubation during standard induction is 0.6 mg/kg of rocuronium bromide, which
is sufficient in almost all patients to establish suitable conditions for intubation within 60 seconds. To facilitate
endotracheal intubation during rapid sequence induction of anaesthesia, a dose of
1.0 mg/kg of rocuronium bromide is recommended, which is sufficient in almost all patients to establish suitable conditions for intubation within 60 seconds. If rocuronium bromide is administered at a dose of 0.6 mg/kg for rapid sequence induction of anaesthesia, it is recommended to wait 90 seconds after administration of rocuronium bromide before intubating the patient.
Caesarean section
Doses of rocuronium bromide of 0.6 mg/kg do not affect the Apgar score, fetal muscle tone or
cardiorespiratory adaptation. Umbilical cord blood analysis indicates that rocuronium bromide crosses the placenta only to a minimal extent without causing any observable adverse clinical effects on the newborn.
Doses of 1.0 mg/kg have been studied in rapid sequence induction of anaesthesia, but not in patients undergoing caesarean section.
High doses
If the administration of higher doses is necessary: initial doses of up to 2 mg/kg of rocuronium bromide have been administered without any adverse cardiovascular effects being observed.
The use of higher dosages reduces the latency time and prolongs the duration of action.
Maintenance doses
The recommended maintenance dose is 0.15 mg/kg of rocuronium bromide; in case of long-term inhalational anaesthesia, the dose should be reduced to 0.075-0.1 mg/kg of rocuronium bromide. Maintenance doses should preferably be administered when the amplitude of the neuromuscular response has returned to 25% of the control value, or when 2 or 3 responses to train-of-four stimulation (Train Of Four, TOF) are present.
Continuous infusion
If rocuronium bromide is administered by continuous infusion, it is recommended to start with a loading dose of
0.6 mg/kg of rocuronium bromide. Continuous infusion administration can be started
when the amplitude of the neuromuscular response begins to return. The infusion rate
must be adjusted to maintain the amplitude of the neuromuscular response at 10% of the control value and to maintain 1 or 2 responses to TOF stimulation. In adults undergoing intravenous anaesthesia,
this corresponds to an infusion rate of 0.3 to 0.6 mg/kg .h, while for those undergoing
inhalational anaesthesia it corresponds to an infusion rate of 0.3 to 0.4 mg/kg .h. Continuous monitoring of neuromuscular block is recommended, as the amount required varies from patient to patient and depending on the anaesthetic technique used.
Paediatric population
For neonates (0 – 27 days), infants (28 days – 2 months), young children (3 – 23 months), children
(2 – 11 years) and adolescents (12 – 17 years), the recommended dose for intubation during standard anaesthesia and the maintenance dose are similar to those recommended for adults.
However, the duration of action of a single dose for intubation will be longer in neonates and infants than in children.
For continuous infusion in paediatrics, except in the case of children (2 – 11 years), the infusion rates are the same as those used for adults. In the case of children aged between 2 and 11 years, higher infusion rates may be necessary.
In children (2-11 years) it is therefore recommended to start with the same initial infusion rate used
for adults and then adjust it to maintain the amplitude of the neuromuscular response at 10% of the control value or to maintain 1 or 2 responses to TOF stimulation.
In paediatric patients, experience with rocuronium bromide for rapid sequence induction of anaesthesia is limited.
The use of rocuronium bromide to facilitate
endotracheal intubation during rapid sequence induction is therefore not recommended in this patient category.
Geriatric patients and patients with liver and/or biliary diseases and/or renal insufficiency
The standard dose for intubation of geriatric patients and those with liver and/or biliary diseases and/or
renal insufficiency during routine anaesthesia is 0.6 mg/kg of rocuronium bromide. In case of
rapid sequence induction of anaesthesia in patients for whom a prolonged duration of action is expected, a dose of 0.6 mg/kg of rocuronium bromide should be considered. Regardless of the anaesthetic technique used, the recommended maintenance dose for this category of patients is 0.075-0.1 mg/kg of
body weight of rocuronium bromide, with an infusion rate of 0.3 – 0.4 mg/kg .h (see
Continuous infusion).
Overweight and obese patients
When the medicinal product is used in overweight or obese patients (defined as patients with a body weight
more than 30% above ideal weight), the dosage must be reduced taking into account the ideal body weight.

Short-term use in intensive care
Endotracheal intubation
Regarding endotracheal intubation, reference should be made to the same doses indicated above
with regard to surgical interventions.
Maintenance doses
The administration of an initial bolus of rocuronium bromide of 0.6 mg/kg of body
weight is recommended, followed by continuous infusion as soon as the amplitude of the response returns to 10% or from the
moment of reappearance of 1 or 2 responses to TOF stimulation. The dosage must always be titrated in
relation to the effect observed in each individual patient. In adult patients, the recommended initial infusion rate for maintaining a neuromuscular block of 80-90% (presence of 1 or 2 responses to
TOF stimulation) is 0.3-0.6 mg mg/kg .h of body weight for the first hour of administration. The
infusion rate should then be reduced in the following 6-12 hours based on the individual response.
After this period, the individual dose required remains relatively constant in each patient
individual. Rocuronio bromide Noridem should be used for short periods; however, the total duration should not
exceed 7 days, due to the lack of sufficient data on long-term use.
Clinical studies have shown a marked variability in the infusion rate. The average infusion rate
varied from 0.2 to 0.5 mg/kg .h of body weight depending on the nature and extent of organ
insufficiency, concomitant medications and the characteristics of the individual patient. To ensure optimal patient control, continuous monitoring of neuromuscular transmission is strongly recommended. Administration has been studied for a period of up to 7 days.

Special patient populations
Rocuronio bromide Noridem is not indicated for facilitating mechanical ventilation in intensive care in
paediatric and geriatric patients, as there is a lack of data on safety and efficacy.

Method of administration
Rocuronio bromide Noridem is administered intravenously both as a bolus and as a continuous
infusion.
Compatibility studies have been performed with the following infusion fluids. At nominal concentrations of
0.5 mg/mL and 2.0 mg/mL Rocuronio bromide Noridem has been found to be compatible with: 0.9% NaCl, 5% glucose,
5% glucose in 0.9% NaCl, water for injections, Ringer’s lactate solution and
Haemaccel. Administration must be started immediately after mixing and completed within 24 hours.
For single use.
Bring the glass ampoules to room temperature before piercing them to reduce the possibility of
fragmentation. Unused solution must be discarded.

Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Rocuronio bromide Noridem does not contain preservatives, therefore it is recommended to use it immediately
after opening the vial or ampoule.
The diluted product is physically and chemically stable for 72 hours at 28  C – 32°C or 72 hours at 2  C – 8  C. From a
microbiological point of view, the product must be used immediately after dilution. If not
used immediately, the storage times and conditions before use are under the
responsibility of the user and should not normally exceed 24 hours at 2  C – 8ºC, unless the
dilution has taken place under controlled and validated aseptic conditions.

Disposal and other handling
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with
current local regulations.

Overdosage
In case of overdosage and prolonged neuromuscular block, the patient must remain on controlled ventilation
and under sedation. In this situation, there are two options for reversing the neuromuscular block: 1) in adults, sugammadex can be used to reverse a deep and profound block.
The dose of sugammadex to be administered depends on the level of neuromuscular block;

• 2) an acetylcholinesterase inhibitor (neostigmine, edrophonium, pyridostigmine) or sugammadex can be used at the first signs of spontaneous recovery in correct doses. If the administration of anticholinesterases fails to antagonize the neuromuscular effects of rocuronium bromide, ventilation should be continued until spontaneous breathing resumes. Repeated administration of acetylcholinesterase inhibitors may be dangerous.

In studies conducted on animals, a severe impairment of cardiovascular function was observed, which
resulted in cardiac failure, only after the administration of a cumulative dose equal to 750 x
ED (135 mg/kg body weight of rocuronium bromide).