NutropinAq
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-07-2023
Charakterystyka produktu
(SPC)
20-07-2023
Sprawozdanie z oceny publicznego
(PAR)
06-06-2015
Składnik aktywny:
somatropin
Dostępny od:
Ipsen Pharma
Kod ATC:
H01AC01
INN (International Nazwa):
somatropin
Grupa terapeutyczna:
Pituitary and hypothalamic hormones and analogues
Dziedzina terapeutyczna:
Turner Syndrome; Dwarfism, Pituitary
Wskazania:
Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.Long-term treatment of growth failure associated with Turner syndrome.Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation.Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment.
Podsumowanie produktu:
Revision: 20
Status autoryzacji:
Authorised
Data autoryzacji:
2001-02-15
Ulotka dla pacjenta
32
B.
PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTROPINAQ 10 MG/2 ML (30 IU) SOLUTION FOR INJECTION
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 NutropinAq is and what it is used for
2.
What you need to know before you use NutropinAq
3.
How to use NutropinAq
4.
Possible side effects
5.
How to store NutropinAq
6.
Contents of the pack and other information
1.
WHAT NUTROPINAQ IS AND WHAT IT IS USED FOR
NutropinAq contains somatropin which is a recombinant growth hormone
similar to the human’s
natural growth hormone made by your body. It is recombinant, meaning
it is made outside of the
body by a special process. Growth Hormone (GH) is a chemical messenger
made by a small gland in
your brain called the pituitary. In children it tells the body to
grow, help the bones to develop
normally and, in later adult life, GH helps to maintain a normal body
shape and metabolism.
IN CHILDREN, NUTROPINAQ IS USED:
•
When your body does not make enough growth hormone and for this reason
you are not
growing properly.
•
When you have Turner syndrome. Turner syndrome is a genetic
abnormality in girls (absence
of female sexual chromosome(s)) that prevents growth.
•
When your kidneys are damaged and they lose their ability to function
normally with an impact
on growth.
In adults NutropinAq is used for:
•
If your body does not make enough growth hormone as an adult. This can
start during adult life
or continue from when you were a child.
BENEFITS IF USING THIS MEDICINE
In childre
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NutropinAq 10 mg/2 ml (30 IU) solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains 5 mg of somatropin*
One cartridge contains 10 mg (30 IU) of somatropin
*
Somatropin is a human growth hormone produced in
_Escherichia coli _
cells by recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Paediatric population _
-
Long-term treatment of children with growth failure due to inadequate
endogenous growth
hormone secretion.
-
Long-term treatment of girls from 2 years old with growth failure
associated with Turner
syndrome.
-
Treatment of prepubertal children with growth failure associated with
chronic renal
insufficiency up to the time of renal transplantation.
_Adult population _
-
Replacement of endogenous growth hormone in adults with growth hormone
deficiency of
either childhood or adult-onset etiology. Growth hormone deficiency
should be confirmed
appropriately prior to treatment.
In adults with growth hormone deficiency the diagnosis should be
established depending on
the etiology:
_Adult-onset: _
The patient must have growth hormone deficiency as a result of
hypothalamic or
pituitary disease, and at least one other hormone deficiency diagnosed
(except for prolactin).
Test for growth hormone deficiency should not be performed until
adequate replacement
therapy for other hormone deficiencies have been instituted.
_Childhood-onset: _
Patients who have had growth hormone deficiency as a child should be
retested to confirm growth hormone deficiency in adulthood before
replacement therapy with
NutropinAq is started.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Diagnosis and therapy with somatropin should be initiated and
monitored by physicians who are
appropriately qualified and experienced in the diagnosis and
management of patients with the
therapeutic indic
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