Rocuronium 10 mg/ml solution for injection/infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Rocuronium bromide

Διαθέσιμο από:

B. Braun Melsungen AG

Φαρμακολογική κατηγορία (ATC):

M03AC; M03AC09

INN (Διεθνής Όνομα):

Rocuronium bromide

Δοσολογία:

10 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection/infusion

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Θεραπευτική περιοχή:

Other quaternary ammonium compounds; rocuronium bromide

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2008-11-13

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROCURONIUM B. BRAUN 10 MG/ML SOLUTION FOR INJECTION / INFUSION
Rocuronium Bromide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
●
Keep this leaflet. You may need to read it again.
●
If you have any further questions, ask your doctor or pharmacist or
nurse.
●
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
●
If you get any side effects, talk to your doctor or pharmacist or
nurse. this includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Rocuronium name is and what it is used for
2.
What you need to know before you use Rocuronium name
3.
How to use Rocuronium name
4.
Possible side effects
5.
How to store Rocuronium name
6.
Contents of the pack and other information
1.
WHAT ROCURONIUM NAME IS AND WHAT IT IS USED FOR
Rocuronium name belongs to a group of medicines called muscle
relaxants.
Under normal circumstances your nerves send messages to the muscles by
impulses. Rocuronium
name acts by blocking these impulses so that the muscles become
relaxed.
When you have an operation your muscles must be completely relaxed.
This makes it easier for the
surgeon to perform the operation.
In
_adults and children, _
if you are under general anaesthesia
_,_
rocuronium name may be used to ease the
insertion of a tube into your windpipe (trachea) to help you breath
(mechanical assistance of breathing)
and to assure that your muscles are relaxed during surgery.
If you are an
_adult_
your doctor may also use this medicine for a short time as an
additional medicine in
the intensive care unit (ICU) (e.g. to ease the insertion of a tube
into your windpipe). In addition you
may also receive this medicine whenever there is an emergency
situation and you need to receive a
tube into your windpipe very quickly to prepare for surgery.
2.
WHAT YOU NEED TO KNOW

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
19 May 2020
CRN009QK4
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rocuronium 10 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection / infusion contains 10 mg rocuronium
bromide.
Each ampoule with 5 ml contains 50 mg rocuronium bromide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection / infusion
Clear, colourless to pale brownish-yellow solution
pH of the solution: 3.8 to 4.2
Osmolality: 270– 310 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rocuronium bromide is indicated in adults and paediatric patients
(from term neonates to adolescents, 0 to < 18 years) as an
adjunct to general anaesthesia to facilitate tracheal intubation
during routine sequence induction and to provide skeletal
muscle relaxation during surgery.
In adults, rocuronium bromide is also indicated to facilitate tracheal
intubation during rapid sequence induction and as an
adjunct in the intensive care unit (ICU) to facilitate intubation and
mechanical ventilation, for short term use.
See also section 4.2 and 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
As with other neuromuscular blocking agents, the dosage of Rocuronium
bromide should be individualised in each patient. The
method of anaesthesia and the expected duration of surgery, the method
of sedation and the expected duration of mechanical
ventilation, the possible interaction with other medicinal products
that are administered concomitantly and the condition of
the patient should be taken into account when determining the dose.
The use of an appropriate neuromuscular monitoring
technique is recommended for the evaluation of the neuromuscular block
and recovery.
_Surgical procedures_
Inhalational anaesthetics potentiate the neuromuscular blocking
effects of Rocuronium bromide. This potentiation becomes
clinically relevant during the course of anaesthesia when a certain
tissue concentr