Norditropin FlexPro 5 mg/1.5 ml, solution for injection in pre-filled pen

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

SOMATROPIN

Доступно од:

NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark

АТЦ код:

H01AC01

INN (Међународно име):

SOMATROPIN 3.3 mg/ml

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

SOMATROPIN 3.3 mg/ml

Тип рецептора:

POM

Терапеутска област:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Статус ауторизације:

Authorised

Датум одобрења:

2014-08-18

Информативни летак

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORDITROPIN FLEXPRO 5 MG/1.5 ML SOLUTION FOR INJECTION IN PRE-FILLED
PEN
somatropin
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 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 NORDITROPIN FLEXPRO IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NORDITROPIN FLEXPRO
3.
HOW TO USE NORDITROPIN FLEXPRO
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NORDITROPIN FLEXPRO
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
INSTRUCTIONS ON HOW TO USE NORDITROPIN FLEXPRO
1.
WHAT NORDITROPIN FLEXPRO IS AND WHAT IT IS USED FOR
Norditropin FlexPro contains a biosynthetic human growth hormone
called somatropin which is
identical to the growth hormone produced naturally in the body.
Children need growth hormone to
help them grow, but adults also need it for their general health.
NORDITROPIN FLEXPRO IS USED TO TREAT GROWTH FAILURE IN CHILDREN
•
If they have no or very low production of growth hormone (growth
hormone deficiency)
•
If they have Turner syndrome (a genetic problem which may affect
growth)
•
If they have reduced kidney function
•
If they are short and were born small for gestational age (SGA)
•
If they have Noonan syndrome (a genetic problem which may affect
growth).
NORDITROPIN FLEXPRO IS USED AS A GROWTH HORMONE REPLACEMENT IN ADULTS
In adults Norditropin FlexPro is used to replace growth hormone if
their growth hormone production
has been decreased since childhood or has been lost in adulthood
because of a tumour, treatment of a
tumour, or a disease that affect

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Norditropin FlexPro 5 mg/1.5 ml, solution for injection in pre-filled
pen
Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled
pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Norditropin FlexPro: 5 mg/1.5 ml
One ml of solution contains 3.3 mg somatropin
Norditropin FlexPro: 10 mg/1.5 ml
One ml of solution contains 6.7 mg somatropin
somatropin (recombinant DNA origin produced in E-coli)
1 mg of somatropin corresponds to 3 IU (International Unit) of
somatropin
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled pen
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Children:
Growth failure due to growth hormone deficiency (GHD)
Growth failure in girls due to gonadal dysgenesis (Turner syndrome)
Growth retardation in prepubertal children due to chronic renal
disease
Growth disturbance (current height SDS < -2.5 and parental adjusted
height SDS < -1) in short
children born small for gestational age (SGA), with a birth weight
and/or length below -2 SD, who
failed to show catch-up growth (HV SDS < 0 during the last year) by 4
years of age or later.
Growth failure due to Noonan syndrome.
Adults:
Childhood onset growth hormone deficiency:
Patients with childhood onset GHD should be re-evaluated for growth
hormone secretory capacity
after growth completion. Testing is not required for those with more
than three pituitary hormone
deficits, with severe GHD due to a defined genetic cause, due to
structural hypothalamic pituitary
abnormalities, due to central nervous system tumours or due to
high-dose cranial irradiation, or with
GHD secondary to a pituitary/hypothalamic disease or insult, if
measurements of serum insulin-like
growth factor 1 (IGF-1) is < -2 SDS after at least four weeks off
growth hormone treatment.
In all other patients an IGF-1 measurement and one growth hormone
stimulation test is required.
3
Adult onset growth hormone deficiency