Zenagam 100 mg/ml solution for injection - 2ml vial

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Zenthique Limited Level 2 The Fort, Hardrocks Business Park, Burmarrad Road, Naxxar, NXR 6345, , Malta

ATC code:

V03AB35

INN (International Name):

SUGAMMADEX 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

SUGAMMADEX 100 mg/ml

Prescription type:

POM

Therapeutic area:

ALL OTHER THERAPEUTIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2023-12-21

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENAGAM 100 MG/ML SOLUTION FOR INJECTION
_sugammadex sodium _
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 any further questions, ask your anaesthetist or doctor.
-
If you get any side effects, talk to your anaesthetist or doctor. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
Zenagam 100 mg/ml solution for injection is refered as Zenagam
WHAT IS IN THIS LEAFLET
1.
What Zenagam is and what it is used for
2.
What you need to know before Zenagam is given
3.
How Zenagam is given
4.
Possible side effects
5.
How to store Zenagam
6.
Contents of the pack and other information
1.
WHAT ZENAGAM IS AND WHAT IT IS USED FOR
WHAT ZENAGAM IS
Zenagam 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 ZENAGAM 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.
Zenagam 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 moder

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zenagam 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 mg sugammadex (as sugammadex sodium).
Each vial of 2 ml contains 200 mg sugammadex (as sugammadex sodium).
Each vial of 5 ml contains 500 mg sugammadex (as sugammadex sodium).
Excipient with known effect
Each ml of solution contains up to 9.45 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
A clear solution free from visible particles.
pH of solution is between 7 and 8.
Osmolality 300-500 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.
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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
following rocuronium or vecuronium induced blockade. Median time to
recovery of the T
4
/T
1
ratio to 0.9 is around 2 m