Bridion 500mg5ml solution for injection vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Sugammadex sodium

Tillgänglig från:

Merck Sharp & Dohme Ltd

INN (International namn):

Sugammadex sodium

Dos:

100mg/1ml

Läkemedelsform:

Solution for injection

Administreringssätt:

Intravenous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: ; GTIN: 5013257002180

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRIDION
® 100 MG/ML SOLUTION FOR INJECTION
sugammadex
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your anaesthetist or doctor.

If you get any side effects, talk to your anaesthetist or other
doctor. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bridion is and what it is used for
2.
What you need to know before Bridion is given
3.
How Bridion is given
4.
Possible side effects
5.
How to store Bridion
6.
Contents of the pack and other information
1.
WHAT BRIDION IS AND WHAT IT IS USED FOR
WHAT BRIDION IS
Bridion contains the active substance sugammadex. Bridion is
considered to be a
_Selective Relaxant _
_Binding Agent_
since it only works with specific muscle relaxants, rocuronium bromide
or vecuronium
bromide.
WHAT BRIDION IS USED FOR
When you have some types of operations, your muscles must be
completely relaxed. This makes it
easier for the surgeon to do the operation. For this, the general
anaesthetic you are given includes
medicines to make your muscles relax. These are called
_muscle relaxants_
, and examples include
rocuronium bromide and vecuronium bromide. Because these medicines
also make your breathing
muscles relax, you need help to breathe (artificial ventilation)
during and after your operation until you
can breathe on your own again.
Bridion is used to speed up the recovery of your muscles after an
operation to allow you to breathe on
your own again earlier. It does this by combining with the rocuronium
bromide or vecuronium
bromide in your body. It can be used in adults whenever rocuronium
bromide or vecuronium bromide
is used and in children and adolescents (aged 2 to 17 years) when
rocuronium bromide is used for a
moderate level of relaxation.
2.
WHAT YOU NEED TO KNOW BEFORE BRIDION IS GIVEN
YOU SHOULD NOT BE GIVEN B

Produktens egenskaper

OBJECT 1
BRIDION 100 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Sep-2016 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Bridion® 100 mg/mL solution for injection
2. Qualitative and quantitative composition
1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg
sugammadex.
Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg
sugammadex.
Excipient(s) with known effect
Each mL contains up to 9.7 mg sodium (see section 4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection (injection).
Clear and colourless to slightly yellow solution.
The pH is between 7 and 8 and osmolality is between 300 and 500
mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Reversal of neuromuscular blockade induced by rocuronium or vecuronium
in adults.
For the paediatric population: sugammadex is only recommended for
routine reversal of rocuronium
induced blockade in children and adolescents aged 2 to 17 years.
4.2 Posology and method of administration
Posology
Sugammadex should only be administered by, or under the supervision of
an anaesthetist.
The use of an appropriate neuromuscular monitoring technique is
recommended to monitor the recovery
of neuromuscular blockade (see section 4.4).
The recommended dose of sugammadex depends on the level of
neuromuscular blockade to be reversed.
The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium or
vecuronium induced neuromuscular
blockade:
_Adults_
Routine reversal:
A dose of 4 mg/kg sugammadex is recommended if recovery has reached at
least 1-2 post-tetanic counts
(PTC) following rocuronium or vecuronium induced blockade. Median time
to recovery of the T
4
/T
1
ratio
to 0.9 is around 3 minutes (see section 5.1).
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery
has occurred up to at least the
reappearance of T
2