Sugammadex Pharmazac Solution for Injection 100mg/ml (2ml vial)

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

SUGAMMADEX

Disponível em:

Pharmazac, S.A. 31 Naousis Str., 104 47, Athens,, Greece

Código ATC:

V03AB35

DCI (Denominação Comum Internacional):

SUGAMMADEX 200 mg

Forma farmacêutica:

SOLUTION FOR INJECTION

Composição:

SUGAMMADEX 200 mg

Tipo de prescrição:

POM

Área terapêutica:

ALL OTHER THERAPEUTIC PRODUCTS

Status de autorização:

Authorised

Data de autorização:

2019-01-25

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX PHARMAZAC 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 Sugammadex is and what it is used for
2. What you need to know before Sugammadex is given
3. How Sugammadex is given
4. Possible side effects
5. How to store Sugammadex
6. Contents of the pack and other information
1. WHAT SUGAMMADEX IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX IS
Sugammadex contains the active substance sugammadex. Sugammadex is
considered to be a
_Selective Relaxant Binding Agent _
since it only works with specific muscle relaxants, rocuronium
bromide or vecuronium bromide.
WHAT SUGAMMADEX 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.
Sugammadex 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 SUGA

Características técnicas

PAGE 1 OF 15 1. NAME OF THE MEDICINAL PRODUCT
Sugammadex Pharmazac 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 9.5 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/brown solution free from
visible particles.
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 T4/T1 ratio to 0.9 is
around 3 minutes (see section 5.1).
PAGE 2 OF 15
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery
has occurred up to at least the
reappearance of T
2
following rocuronium or vecuronium induced blockade. Median t