Nuceiva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Botulinum toxin type A

Tilgængelig fra:

Evolus Pharma B.V.

ATC-kode:

M03AX01

INN (International Name):

botulinum toxin type a

Terapeutisk gruppe:

Other muscle relaxants, peripherally acting agents

Terapeutisk område:

Skin Aging

Terapeutiske indikationer:

Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

Produkt oversigt:

Revision: 5

Autorisation status:

Authorised

Autorisation dato:

2019-09-27

Indlægsseddel

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUCEIVA 50 UNITS POWDER FOR SOLUTION FOR INJECTION
botulinum toxin type A
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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you have any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NUCEIVA is and what it is used for
2.
What you need to know before NUCEIVA is used
3.
How to use NUCEIVA
4.
Possible side effects
5.
How to store NUCEIVA
6.
Contents of the pack and other information
1.
WHAT NUCEIVA IS AND WHAT IT IS USED FOR
NUCEIVA contains the active substance botulinum toxin type A.
It prevents muscles from contracting, leading to a temporary
paralysis. It works by blocking the nerve
impulses to the muscles in which it has been injected.
NUCEIVA is used for the temporary improvement in the appearance of
vertical lines between the
eyebrows. It is used in adults less than 65 years of age in whom those
facial lines have an important
psychological impact.
2.
WHAT YOU NEED TO KNOW BEFORE NUCEIVA IS USED
_ _
NUCEIVA MUST NOT BE USED:
-
if you are allergic to botulinum toxin type A or any of the other
ingredients of this medicine
(listed in section 6);
-
if you have myasthenia gravis or Eaton Lambert syndrome (chronic
diseases affecting the
muscles);
-
if you have an infection or inflammation at the proposed injection
sites.
WARNINGS AND PRECAUTIONS
Side effects possibly related to the spread of botulinum toxin from
the site of injection can occur very
rarely (e.g. muscle weakness, difficulty in swallowing or food or
liquid entering the airways). Patients
receiving recommended doses may have exag

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NUCEIVA 50 Units powder for solution for injection
NUCEIVA 100 Units powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 Units botulinum toxin type A produced by
_Clostridium botulinum._
Each vial contains 100 Units botulinum toxin type A produced by
_Clostridium botulinum. _
_ _
After reconstitution each 0.1 mL of the solution contains 4 Units.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Powder for solution for injection.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NUCEIVA is indicated for the temporary improvement in the appearance
of moderate to severe
vertical lines between the eyebrows seen at maximum frown (glabellar
lines), when the severity of the
above facial lines has an important psychological impact in adults
below 65 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
NUCEIVA should only be administered by physicians with appropriate
qualifications and expertise in
the treatment of glabellar lines and the use of required equipment.
Posology
The recommended injection per muscle site is 4 U/0.1 mL. Five
injection sites (see Figure 1): 2
injections in each corrugator muscle (inferior medial and superior
medial aspect) and 1 injection in the
procerus muscle for a total dose of 20 Units.
Botulinum toxin units are not interchangeable from one product to
another. Doses recommended are
different from other botulinum toxin preparations.
In the absence of adverse reactions during the initial treatment, an
additional course of treatment can
be performed subject to a minimum interval of 3 months between the
initial and repeat treatment.
In the event of treatment failure (no visible improvement of glabellar
lines at maximum frown) one
month after the first course of treatment, the following approaches
may be considered:
•
Examination of the causes of failure, e.g. inappropriate injection
technique, incorrect muscles
injected, and f