Scenesse

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

afamelanotide

Dostupné z:

Clinuvel Europe Limited

ATC kód:

D02BB02

INN (Medzinárodný Name):

afamelanotide

Terapeutické skupiny:

Emollients and protectives

Terapeutické oblasti:

Protoporphyria, Erythropoietic

Terapeutické indikácie:

Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Prehľad produktov:

Revision: 9

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2014-12-22

Príbalový leták

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SCENESSE 16 MG IMPLANT
afamelanotide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SCENESSE is and what it is used for
2.
What you need to know before you receive SCENESSE
3.
How SCENESSE is given
4.
Possible side effects
5.
How SCENESSE is stored
6.
Contents of the pack and other information
1.
WHAT SCENESSE IS AND WHAT IT IS USED FOR
SCENESSE contains the active substance afamelanotide (as acetate).
Afamelanotide is a synthetic
form of a body hormone called alpha-melanocyte stimulating hormone
(α-MSH). Afamelanotide
works in a way similar to the natural hormone, by making skin cells
produce eumelanin which is a
brown-black type of melanin pigment in the body.
Afamelanotide is used to increase the tolerance to sunlight in adults
with a confirmed diagnosis of
erythropoietic protoporphyria (EPP). EPP is a condition in which
patients have an increased sensitivity
to sunlight, which can cause toxic effects such as pain and burning.
By increasing the amount of
eumelanin, SCENESSE can help to delay the onset of pain due to skin
photosensitivity (sensitive to
sunlight).
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SCENESSE
DO NOT USE SCENESSE
-
if you are allergic to afamelanotide or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have any severe condition of the liver.
-
if you have liver problems.
-
if you have kidney problems.
WARNINGS AND PRECAUTIONS

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
SCENESSE 16 mg implant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The implant contains 16 mg of afamelanotide (as acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant.
Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm
in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SCENESSE is indicated for prevention of phototoxicity in adult
patients with erythropoietic
protoporphyria (EPP).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
SCENESSE should only be prescribed by specialist physicians in
recognised porphyria centres and
administration should be performed by a physician trained and
accredited by the marketing
authorisation holder to administer the implant.
_ _
Posology
One implant is administered every 2 months prior to expected and
during increased sunlight exposure,
e.g. from spring to early autumn. Three implants per year are
recommended, depending on the length
of protection required. The recommended maximum number of implants is
four per year. The overall
duration of treatment is at the specialist physician’s discretion
(see section 4.4).
Special populations
For patients with renal or hepatic impairment see sections 4.3 and
5.2.
_Elderly population _
Due to limited data in treatment of elderly patients, the use of
afamelanotide is not recommended (see
section 4.4).
_Paediatric population _
The safety and efficacy of afamelanotide in children and adolescents
aged 0 to 17 years have not yet
been established.
No data are available.
3
Method of administration
_ _
For subcutaneous use.
Instruction for use
_ _
-
Take the packed implant out of the refrigerator and allow the
medicinal product to warm up to
ambient temp