Increlex
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
11-03-2020
Valmisteyhteenveto
(SPC)
11-03-2020
Julkisesta arviointikertomuksesta
(PAR)
27-07-2015
Aktiivinen ainesosa:
Mecasermin
Saatavilla:
Ipsen Pharma
ATC-koodi:
H01AC03
INN (Kansainvälinen yleisnimi):
mecasermin
Terapeuttinen ryhmä:
Pituitary and hypothalamic hormones and analogues
Terapeuttinen alue:
Laron Syndrome
Käyttöaiheet:
For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD).Severe primary IGFD is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and;growth hormone (GH) sufficiency;exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Tuoteyhteenveto:
Revision: 21
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2007-08-02
Pakkausseloste
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
INCRELEX 10 MG/ML SOLUTION FOR INJECTION
Mecasermin
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 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 INCRELEX is and what it is used for
2.
What you need to know before you use INCRELEX
3.
How to use INCRELEX
4.
Possible side effects
5.
How to store INCRELEX
6.
Contents of the pack and other information
1.
WHAT INCRELEX IS AND WHAT IT IS USED FOR
-
INCRELEX is a liquid that contains mecasermin which is a man-made
insulin-like growth factor-1
(IGF-1), which is similar to the IGF-1 made by your body.
-
It is used to treat children and adolescents from 2 to 18 years old
_ _
who are very short for their age
because their bodies do not make enough IGF-1. This condition is
called primary IGF-1 deficiency.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INCRELEX
_ _
DO NOT USE INCRELEX
-
If you currently have any tumour or growth, either cancerous or
non-cancerous
-
if you have had cancer in the past
-
if you have any conditions which may increase the risk of cancer
-
if you are allergic to mecasermin or any of the other ingredients of
this medicine (listed in section 6).
-
in premature babies or neonates because it contains benzyl alcohol.
WARNINGS AND PRECAUTIONS
There is an increased risk of tumours and growths (both ca
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Valmisteyhteenveto
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
INCRELEX 10 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg of mecasermin*.
Each vial of 4 ml contains 40 mg of mecasermin*.
*Mecasermin is a recombinant DNA-derived human insulin-like growth
factor-1(IGF-1) produced in
_Escherichia coli_
.
Excipient with known effect:
One ml contains 9 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Aqueous, clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the long-term treatment of growth failure in children and
adolescents from 2 to 18 years with confirmed
severe primary insulin-like growth factor-1 deficiency (Primary IGFD).
Severe Primary IGFD is defined by:
•
height standard deviation score
≤
–3.0 and
•
basal IGF-1 levels below the 2.5
th
percentile for age and gender and
•
GH sufficiency.
•
Exclusion of secondary forms of IGF-1 deficiency, such as
malnutrition, hypopituitarism,
hypothyroidism, or chronic treatment with pharmacologic doses of
anti-inflammatory steroids.
Severe Primary IGFD includes patients with mutations in the GH
receptor (GHR), post-GHR signaling
pathway, and IGF-1 gene defects; they are not GH deficient, and
therefore, they cannot be expected to
respond adequately to exogenous GH treatment. In some cases, when
deemed necessary, the physician may
decide to assist in the diagnosis by performing an IGF-I generation
test.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with mecasermin should be directed by physicians who are
experienced in the diagnosis and
management of patients with growth disorders.
3
Posology
The dose should be individualised
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