Skytrofa (previously Lonapegsomatropin Ascendis Pharma)

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

Lonapegsomatropin

Tilgjengelig fra:

Ascendis Pharma Endocrinology Division A/S

ATC-kode:

H01AC09

INN (International Name):

lonapegsomatropin

Terapeutisk gruppe:

Pituitary and hypothalamic hormones and analogues

Terapeutisk område:

Growth and Development

Indikasjoner:

Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD]),

Produkt oppsummering:

Revision: 4

Autorisasjon status:

Authorised

Autorisasjon dato:

2022-01-11

Informasjon til brukeren

69
B. PACKAGE LEAFLET
70
PACKAGE LEAFLET: INFORMATION FOR THE USER
SKYTROFA
3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
3.6 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
4.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
5.2 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
6.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
7.6 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
9.1 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
11 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
SKYTROFA
13.3 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN CARTRIDGE
lonapegsomatropin
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 OR YOUR CHILD START
USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD.
-
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 get 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 Skytrofa is and what it is used for
2.
What you or your child need to know before you or your child use
Skytrofa
3.
How to use Skytrofa
4.
Possible side effects
5.
How to store Skytrofa
6.
Contents of the pack and other information
1.
WHAT SKYTROFA
IS AND WHAT IT IS USED FOR
Skytrofa is a medicine that contains the active substance
lonapegsomatropin. This is a substance that
the body can convert into somatropin, also called human growth hormone
(hGH). Som

Preparatomtale

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
Skytrofa 3 mg powder and solvent for solution for injection in
cartridge
Skytrofa 3.6 mg powder and solvent for solution for injection in
cartridge
Skytrofa 4.3 mg powder and solvent for solution for injection in
cartridge
Skytrofa 5.2 mg powder and solvent for solution for injection in
cartridge
Skytrofa 6.3 mg powder and solvent for solution for injection in
cartridge
Skytrofa 7.6 mg powder and solvent for solution for injection in
cartridge
Skytrofa 9.1 mg powder and solvent for solution for injection in
cartridge
Skytrofa 11 mg powder and solvent for solution for injection in
cartridge
Skytrofa 13.3 mg powder and solvent for solution for injection in
cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Skytrofa consists of somatropin transiently conjugated to a
methoxypolyethylene glycol carrier
(mPEG) via a proprietary TransCon Linker. The strength of Skytrofa
always indicates the quantity of
the somatropin moiety.
Skytrofa 3 mg powder and solvent for solution for injection in
cartridge
Each dual-chamber cartridge contains 3 mg of somatropin* equivalent to
8.6 mg of lonapegsomatropin
and 0.279 mL of solvent. After reconstitution the concentration based
on somatropin** protein
is 11 mg/mL.
Skytrofa 3.6 mg powder and solvent for solution for injection in
cartridge
Each dual-chamber cartridge contains 3.6 mg of somatropin* equivalent
to 10.3 mg of
lonapegsomatropin and 0.329 mL of solvent. After reconstitution the
concentration based on
somatropin** protein is 11 mg/mL.
Skytrofa 4.3 mg powder and solvent for solution for injection in
cartridge
Each dual-chamber cartridge contains 4.3 mg of somatropin* equivalent
to 12.3 mg of
lonapegsomatropin and 0.388 mL of solvent. After reconst