Myalepta

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Metreleptin

Tilgængelig fra:

Amryt Pharmaceuticals DAC

ATC-kode:

A16AA

INN (International Name):

metreleptin

Terapeutisk gruppe:

Other alimentary tract and metabolism products,

Terapeutisk område:

Lipodystrophy, Familial Partial

Terapeutiske indikationer:

Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and abovewith confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

Produkt oversigt:

Revision: 9

Autorisation status:

Authorised

Autorisation dato:

2018-07-29

Indlægsseddel

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYALEPTA 3 MG POWDER FOR SOLUTION FOR INJECTION
metreleptin
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, pharmacist or
nurse.
-
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 get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Myalepta is and what it is used for
2.
What you need to know before you use Myalepta
3.
How to use Myalepta
4.
Possible side effects
5.
How to store Myalepta
6.
Contents of the pack and other information
1.
WHAT MYALEPTA IS AND WHAT IT IS USED FOR
Myalepta contains the active substance metreleptin. Metreleptin is
similar to a human hormone called
leptin.
WHAT MYALEPTA IS USED FOR
Myalepta is used to treat the complications of not having enough
leptin in patients with lipodystrophy.
It is used in adults, adolescents and children 2 years or over:
-
who have generalised lipodystrophy (the whole of your body does not
have enough fatty
tissue)
It is used, when other treatments have been ineffective, in adults,
and adolescents 12 years or over:
-
who have partial lipodystrophy which is inherited (also called
congenital or familial
lipodystrophy)
-
or partial lipodystrophy has been caused by your body’s response to
something such as a viral
illness (also called acquired lipodystrophy)
HOW MYALEPTA WORKS
Natural leptin is produced by fatty tissue and has many functions in
the body including

Produktets egenskaber

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
Myalepta 3 mg powder for solution for injection.
Myalepta 5.8 mg powder for solution for injection.
Myalepta 11.3 mg powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Myalepta 3 mg powder
for solution for injection
Each vial contains 3 mg of metreleptin*.
After reconstitution with 0.6 mL water for injections (see section
6.6), each mL contains 5 mg of
metreleptin.
Myalepta 5.8 mg powder
for solution for injection
Each vial contains 5.8 mg of metreleptin*.
After reconstitution with 1.1 mL water for injections (see section
6.6), each mL contains 5 mg of
metreleptin.
Myalepta 11.3 mg powder for solution for injection
Each vial contains 11.3 mg of metreleptin*.
After reconstitution with 2.2 mL water for injections (see section
6.6), each mL contains 5 mg of
metreleptin.
*Metreleptin is a recombinant human leptin analogue (produced in
Escherichia coli cells by
recombinant DNA technology to form recombinant methionyl-human
leptin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
White lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myalepta is indicated as an adjunct to diet as a replacement therapy
to treat the complications of leptin
deficiency in lipodystrophy (LD) patients:
•
with confirmed congenital generalised LD (Berardinelli-Seip syndrome)
or acquired generalised
LD (Lawrence syndrome) in adults and children 2 years of age and above
3
•
with confirmed familial partial LD or acquired partial LD
(Barraquer-Simons syndrome), in
adults and children 12 years of age and above for whom standard
treatments have failed to
achieve adequate metabo