Rocuronium Bromide 10mg/ml Solution for Injection/Infusion

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Rocuronium bromide

Διαθέσιμο από:

Hospira UK Limited

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:

Authorised

Ημερομηνία της άδειας:

2014-08-22

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROCURONIUM BROMIDE 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 anaesthetist.
-
If you get any side effects, talk to your doctor or anaesthetist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rocuronium Bromide is and what it is used for
2.
What you need to know before you use Rocuronium Bromide
3.
How to take Rocuronium Bromide
4.
Possible side effects
5.
How to store Rocuronium Bromide
6.
Contents of the pack and other information
1.
WHAT ROCURONIUM BROMIDE IS AND WHAT IT IS USED FOR
Rocuronium Bromide belongs to a group of medicines called muscle
relaxants.
Under normal circumstances your nerves send messages to the muscles by
impulses.
Rocuronium Bromide 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 Bromide may be
used to ease the insertion of a tube into your windpipe (trachea), to
help with mechanical
assistance of breathing and to ensure 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 and whilst you are receiving mechanical breathing). You may
also receive this
medicine whenever there is an emergency situation and you need to
receive a tube into your
windpipe very quickly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ROCURONIUM BROMIDE
YOU SHOULD NOT RECEIVE ROCURONIUM BROMIDE:
-
if you are allergic to rocuronium, the bromide ion or any of t

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
21 December 2018
CRN008HJS
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rocuronium Bromide 10mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Rocuronium Bromide contains 10mg of rocuronium bromide.
Each 5ml vial contains 50 mg rocuronium bromide.
Each 10ml vial contains 100 mg rocuronium bromide.
Excipient(s) with known effect:
Each 5 ml of Rocuronium Bromide contains 7.8 mg of sodium.
Each 10 ml of Rocuronium Bromide contains 15.6 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection/Infusion.
Clear, colourless to yellow-orange solution
pH of the solution: 3.8 to 4.2
Osmolality: 256-312 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rocuronium Bromide is indicated in adult and paediatric patients (from
term
neonates to adolescents [aged 0 to 18 years]) as an adjunct to general
anaesthesia to
facilitate tracheal intubation during routine 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 tracheal intubation and mechanical ventilation for short
term use (See also
sections 4.2 and 5.1).
Health Products Regulatory Authority
21 December 2018
CRN008HJS
Page 2 of 21
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Like other neuromuscular blocking agents, Rocuronium Bromide should
only be
administered by, or under supervision of, experienced clinicians who
are familiar with
the action and use of these drugs.
Like other neuromuscular blocking agents, the dosage of Rocuronium
Bromide
should be individualized for 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 drugs that
are
administered concomitantly, and t