ROCURONIO 10 mg /Ml Инъекционный Раствор

Содержание инструкции

1. Rocuronio Hikma
2. Rocuronio bromide
   1. What is Rocuronio Hikma and what it is used for
   2. What you need to know before using Rocuronio Hikma
   3. How to use Rocuronio Hikma
   4. Possible side effects
   5. How to store Rocuronio Hikma
   6. Package contents and other information

Rocuronio Hikma

10 mg/ml, injectable solution/for infusion
Generic medicine

Rocuronio bromide

Read this leaflet carefully before you start to use 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 or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Rocuronio Hikma and what it is used for

Rocuronio Hikma belongs to a group of medicines called muscle relaxants
Muscle relaxants are used during a surgical intervention 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.
Generally your nerves send messages, called impulses, to your muscles.
Rocuronio Hikma works by blocking these impulses so that your muscles
relax. Since your respiratory muscles also relax, you will need
help to breathe (artificial ventilation) during and after the operation, until you can
breathe independently again.
During the operation your anesthesiologist will continue to monitor the effect of the muscle
relaxant, and, if necessary, administer more of it. At the end of the operation, the effects of the
drug will wear off and you will start breathing independently again. In some cases the anesthesiologist will
administer another drug to help speed up this process.
Rocuronio Hikma can also be used in Intensive Care Units to keep your
muscles relaxed.

2. What you need to know before using Rocuronio Hikma

Do not use Rocuronio Hikma:

• if you are allergic (hypersensitivity) to rocuronium, bromide ions or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your anesthesiologist.
Warnings and precautions
Talk to your doctor or nurse before using Rocuronio Hikma:

• if you are allergic to muscle relaxants,
• if you have had kidney, heart, liver or gallbladder problems,
• if you have suffered from nerve and muscle diseases,
• if you suffer from fluid retention (edema),
• if you have a history of malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or muscle weakness)

Tell your anesthesiologist if any of these cases applies to you.
Some conditions can affect the effects of Rocuronio Hikma – 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,
• too much carbon dioxide in the blood,
• loss of too much water from the body, for example when you are sick, with diarrhea or sweating
• excessive breathing that causes a level that is too low of carbon dioxide in the blood (alkalosis),
• a general state of illness,
• burns,
• being considerably overweight (obesity),
• very low body temperature (hypothermia).

If you suffer from any of these conditions, your anesthesiologist will take this into account when
deciding the correct dosage of Rocuronio Hikma for you.

Children and the elderly
Rocuronio Hikma can be used in children (newborns and adolescents) and the elderly but
your anesthesiologist must first check their medical history.

Other medicines and Rocuronio Hikma
Tell your doctor if you are taking, have recently taken or may take other
medicines.
This includes medicines or herbal products that you may have bought without a prescription.
Rocuronio Hikma can have effects on/or be affected by other drugs.
Medicines that can increase the effects of Rocuronio Hikma

• certain antibiotics
• certain medicines used for the treatment of heart disorders or for high blood pressure (diuretics, calcium channel blockers, beta-blockers and quinidine)
• certain anti-inflammatory medicines (corticosteroids)
• medicines for manic depressive disorders (bipolar disorders)
• magnesium salts
• certain medicines used to treat malaria Medicines that can decrease the effects of Rocuronio Hikma
• certain medicines for epilepsy
• calcium chloride and potassium chloride
• certain protease inhibitors called gabesate and ulinastatin.

In addition, you may be given other medicines before or during surgery,
which may alter the effects of Rocuronio Hikma. These medicines include some
anesthetics, other muscle relaxants, medicines such as phenytoin and medicines that have
opposite effects to those of Rocuronio Hikma.
Rocuronio Hikma can make some anesthetics work faster. Your
anesthesiologist will take this into account when deciding the correct dosage of Rocuronio Hikma for you.

Pregnancy and breastfeeding
Tell your anesthesiologist if you are pregnant or think you may be pregnant or are breastfeeding
breastfeeding.
Your anesthesiologist may still give you Rocuronio Hikma, but you should first
talk to him.
If you are pregnant, suspect or are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Rocuronio Hikma may be given to you if you have to undergo a Cesarean section.
Breastfeeding should be discontinued for 6 hours after use of this medicine.

Driving and operating machinery
Do not drive vehicles and do not operate machinery until you are told you can. From
since Rocuronio Hikma is administered as part of general anesthesia, you
may feel tired, weak or dizzy for a while afterwards. Your doctor will
inform you about the duration of the effects of the drug.

Rocuronio Hikma contains sodium.
This medicine contains less than 1 mmol of sodium (23mg) per dose, so it is essentially
“sodium-free”.

3. How to use Rocuronio Hikma

Dosage
Your anesthesiologist will calculate the dosage of Rocuronio Hikma you need based on:

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

The recommended dosage is 0.6 mg/kg of body weight and the effect will last 30–40
minutes.
How Rocuronio Hikma is administered
Rocuronio Hikma will be administered by your anesthesiologist. Rocuronio Hikma is
administered intravenously (into a vein), either as a single injection or as a continuous
infusion (via drip).

If you use more Rocuronio Hikma than you should
Because your anesthesiologist will carefully monitor your condition, it is unlikely that you will be
given too much Rocuronio Hikma. However, if this happens, your anesthesiologist
will continue to help you breathe artificially (using a ventilator) until you are able to
do so independently. You will be kept asleep while this happens.

4. Possible side effects

Like all medicines, this drug can cause side effects, although not everyone gets them.
If these side effects occur while you are under the effect of the anesthetic, they will be
noticed and treated by your anesthesiologist.

Uncommon side effects(may affect up to 1 in 100 people)

• the drug is too effective, or is not effective enough
• the drug acts for a longer time than it should
• reduction of blood pressure,
• increased heart rate,
• pain at the injection site.

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

• allergic reactions (hypersensitivity) (such as difficulty breathing, circulatory collapse and shock),
• shortness of breath,
• muscle weakness,
• sudden fever with rapid heartbeat, rapid breathing and stiffness, pain and/or weakness in the muscles
• swelling, rash or redness of the skin.

Not known(frequency cannot be estimated from available data):

• Severe allergic spasm of the coronary blood vessels (Kounis syndrome) leading to chest pain (angina) or heart attack (myocardial infarction).

If a side effect becomes serious or if you experience any side effect not

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. You can also report side effects directly
through the national reporting system, via the website:
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 Hikma

Store in a refrigerator (2°C – 8°C)
Storage outside the refrigerator:
the medicine can be stored at a temperature up to 25°C for a maximum of 16
weeks, after which it must be discarded. The medicine must not be returned
to the refrigerator after being kept outside the refrigerator. The storage period must not exceed the expiry date.
The hospital will store Rocuronio Hikma following the correct storage conditions of the
product for the entire period until the expiry date.
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 on the packaging
after the wording EXP.

6. Package contents and other information

What Rocuronio Hikma contains

• The active ingredient is Rocuronium Bromide
• The other ingredients are sodium acetate trihydrate, sodium chloride, sodium hydroxide, acetic acid, water for injections. Each ml of Rocuronio Hikma contains 10 mg of rocuronium bromide. Each vial of 5 ml contains 50 mg of rocuronium bromide.

Description of the appearance of Rocuronio Hikma and contents of the pack
Rocuronio Hikma is a clear injectable solution, from colourless to slightly yellow/orange.
It is available in vials containing 50 mg (10 vials per pack) of rocuronium
bromide.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A, 8B, Fervença
2705-906 Terrugem SNT
Portugal
Sales concessionaire for Italy
Hikma Italia Spa
Viale Certosa 10
27100 Pavia
The following information is intended only for healthcare professionals

• Incompatibilities Physical incompatibility has been documented for rocuronium when added to solutions containing the following drugs: 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.

This medicine must not be mixed with other drugs, except for those mentioned in
section 6.6.
If Rocuronio Hikma is administered through the same route that has also been used for
the administration of other drugs, between the administration of Rocuronio Hikma and that of
other drugs for which incompatibility with Rocuronio Hikma has been demonstrated or for
which incompatibility has not been established, the infusion line must be
adequately flushed (e.g., with sodium chloride (NaCl) 0.9%).

• Shelf life

Unopened vial: 2 years if stored under the recommended conditions (see section
Special precautions for storage). The date on the pack and vial label is the expiry date; this is the date until which Rocuronio Hikma can be
used.
Storage outside the refrigerator:
the medicine can be stored at a temperature up to 25°C for a maximum of 16
weeks, after which it must be discarded. The medicine must not be returned to the refrigerator after being kept outside the refrigerator. The storage period must not exceed the expiry date.
After first opening:
Since Rocuronio Hikma does not contain preservatives, the solution must be used
immediately after opening the vial.
After dilution with infusion fluids (see section 6.6), chemical and physical stability “in

use”has been demonstrated for 24 hours at room temperature (15°C - 25°C). From a
microbiological point of view, the diluted product must be used immediately. If not used
immediately, the in-use storage times and conditions preceding use are the responsibility of the user/administrator and, normally, should not exceed
24 hours at temperature 2°C – 8°C.

• Special precautions for disposal and handling Compatibility studies have been performed with the following infusion fluids: at nominal concentrations of 1 mg/ml, Rocuronio Hikma has been found to be compatible with: sodium chloride (NaCl) 0.9%, dextrose 5%, dextrose 5% in physiological saline, water for injections and Ringer lactate. Administration must begin immediately after mixing and must be completed within 24 hours. Unused medicine and waste derived from such medicine must be disposed of in accordance with local regulations

• 0.9%, dextrose 5%, dextrose 5% in physiological saline, water for injections and Ringer lactate. The administration must begin immediately after the mixing and must be completed within 24 hours. The unused medicine and waste derived from such medicine must be disposed of in conformity with the current local regulations