Sugammadex Aspen 100 mg/mL solution for injection (5 ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

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

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2023-01-09

Patient Information leaflet

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ANNEX III
LABELLING AND PACKAGE LEAFLET
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B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
SUGAMMADEX ASPEN 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 Aspen is and what it is used for
2. What you need to know before Sugammadex Aspen is given
3. How Sugammadex Aspen is given
4. Possible side effects
5. How to store Sugammadex Aspen
6. Contents of the pack and other information
1. WHAT SUGAMMADEX ASPEN IS AND WHAT IT IS USED FOR
WHAT SUGAMMADEX ASPEN IS
Sugammadex Aspen 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 ASPEN 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 Aspen
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 child

Summary of Product characteristics

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE MEDICINAL PRODUCT
Sugammadex Aspen 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 with known effect
The total amount of sodium in each mL is up to 9.5 mg sodium.
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:
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_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).
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery
has occurred up to at least
the reappearance of T