Ngenla

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

somatrogon

Dostupné z:

Pfizer Europe MA EEIG

ATC kód:

H01AC08

INN (Medzinárodný Name):

somatrogon

Terapeutické skupiny:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Terapeutické oblasti:

Growth and Development

Terapeutické indikácie:

Indicated for the long-term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone

Prehľad produktov:

Revision: 4

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2022-02-14

Príbalový leták

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NGENLA 24 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
somatrogon
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 or the child in your care
only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours or those of the child
in your care.
-
If you or the child in your care 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 Ngenla is and what it is used for
2.
What you need to know before you use Ngenla
3.
How to use Ngenla
4.
Possible side effects
5.
How to store Ngenla
6.
Contents of the pack and other information
1.
WHAT NGENLA IS AND WHAT IT IS USED FOR
Ngenla contains the active substance somatrogon, a modified form of
human growth hormone. Natural
human growth hormone is needed for bones and muscles to grow. It also
helps your fat and muscle
tissues to develop in the right amounts. Ngenla is used to treat
children and adolescents from 3 years
of age who do not have enough growth hormone and are not growing at
the normal rate.
The active substance in Ngenla is made by 'recombinant DNA
technology'. This means that it is grown
in cells that have been modified in the laboratory so that they can
produce it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NGENLA
DO NOT USE NGENLA
-
If you or the child in your care are allergic to somatrogon (see
Warnings and precautions) or any
of the other ingredients of this medicine (l

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
Ngenla 24 mg solution for injection in pre-filled pen
Ngenla 60 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ngenla 24 mg solution for injection in pre-filled pen
One mL of solution contains 20 mg of somatrogon*.
Each pre-filled pen contains 24 mg somatrogon in 1.2 mL solution.
Each pre-filled pen delivers doses from 0.2 mg to 12 mg in a single
injection in 0.2 mg increments.
Ngenla 60 mg solution for injection in pre-filled pen
One mL of solution contains 50 mg of somatrogon.
Each pre-filled pen contains 60 mg somatrogon in 1.2 mL solution.
Each pre-filled pen delivers doses from 0.5 mg to 30 mg in a single
injection in 0.5 mg increments.
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO)
cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is a clear and colourless to slightly light yellow
solution with a pH of 6.6.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ngenla is indicated for the treatment of children and adolescents from
3 years of age with growth
disturbance due to insufficient secretion of growth hormone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and monitored by physicians who are
qualified and experienced in the
diagnosis and management of paediatric patients with growth hormone
deficiency (GHD).
Posology
The recommended dose is 0.66 mg/kg body weight administered once
weekly by subcutaneous
injection.
3
Each pre-filled pen is capable of setting and delivering the dose
prescribed by the physician. Dose may
be rounded up or down based on the physician’s expert knowledge of
the individual patient