Rocuronium bromide 100mg/10ml solution for injection vials

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Rocuronium bromide

Disponible depuis:

Pfizer Ltd

Code ATC:

M03AC09

DCI (Dénomination commune internationale):

Rocuronium bromide

Dosage:

10mg/1ml

forme pharmaceutique:

Solution for injection

Mode d'administration:

Intravenous

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 15010500; GTIN: 5015997107774

Notice patient

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

Résumé des caractéristiques du produit

OBJECT 1
ROCURONIUM BROMIDE HOSPIRA 10 MG/ML SOLUTION
FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 11-Jun-2018 | Hospira UK
Ltd
1. Name of the medicinal product
Rocuronium Bromide Hospira 10 mg/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).
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 the condition of the pati