INCRELEX

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

MECASERMIN

Fáanlegur frá:

MEDISON PHARMA LTD

ATC númer:

H01AC03

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

MECASERMIN 10 MG / 1 ML

Stjórnsýsluleið:

S.C

Gerð lyfseðils:

Required

Framleitt af:

IPSEN PHARMA, FRANCE

Lækningarsvæði:

MECASERMIN

Ábendingar:

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 ≤–3.0and* basal IGF-1 levels below the 2.5th percentile for age and genderand* 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 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.

Leyfisdagur:

2020-01-27

Upplýsingar fylgiseðill

INFORMATION FOR PARENTS, CAREGIVERS
AND PATIENTS ABOUT HYPOGLYCEMIA
AND WHAT TO DO IF IT DEVELOPS.
This leaflet contains important information. Please read the entire
leaflet
carefully before starting to use the product.
This medication is subject to additional monitoring in order to allow
the
rapid identification of new safety
information. You can help by reporting any side effects that your
child may
experience. See the information regarding how to report side effects
at the
end of this leaflet.
Before using the product, read the package leaflet, which includes
detailed
injection instructions.
MECASERMIN
The word "hypoglycemia" is the medical term for a low blood sugar
level. If
your child has been prescribed with Increlex, you must be familiar
with the
phenomenon of hypoglycemia and how to deal with it if it occurs.
Increlex is similar to insulin, a naturally occurring hormone in the
body
that controls blood sugar levels, and therefore, Increlex can affect
blood
sugar levels and has a growth-promoting effects. As a result,
hypoglycemia
is a possible side effect of treatment with Increlex.
If hypoglycemia develops, it usually occurs in the first month of
treatment,
and the problem lessens as the treatment continues.
It is important that you read the following information because the
chances of hypoglycemia developing, and any problems that it may cause
can easily be minimized by taking some very simple precautions.
What is hypoglycemia and why do I need to know about it?
Two of the most important risk factors for hypoglycemia are:
1. INSUFFICIENT FOOD CONSUMPTION; FOR EXAMPLE, POSTPONING OR MISSING
MEALS
2. PHYSICAL ACTIVITY WITHOUT EATING ENOUGH
The following advice should be followed closely throughout the
treatment
with Increlex:
Increlex injections should be administered shortly before or
immediately after a meal (within 20 minutes)
If a dose of Increlex cannot be administered shortly before or just
after a meal, that dose should not be administered. The regular dose
must be administered at the next schedul

Vara einkenni

INCR-SPC-1222-V1
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Increlex
.
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
Colourless to slightly yellow and clear to slightly opalescent liquid.
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, 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
PATIENT SAFETY INFORMATION CARD
The marketing of Increlex is subject to a risk management plan
(RMP) including a ‘Patient safety information Card’, emphasizes
important safety information that the patient should be aware of
before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
INCR-SPC-1222-V1
Page 2 of 13
Treatment with mecasermin should be directed by physicians who are
experienced in the
d