Increlex 40mg4ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mecasermin

Available from:

Ipsen Ltd

ATC code:

H01AC03

INN (International Name):

Mecasermin

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06070400; GTIN: 5036611000158

Patient Information leaflet

page 1 of 13
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.
-
INCRELEX 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 are allergic to mecasermin or any of the other ingredients of
this medicine (listed in section 6).
-
if you have cancer.
-
in premature babies or neonates because it contains benzyl alcohol.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using INCRELEX
-
if you have a curved spine (scoliosis). You should be monitored for
progression of scoliosis.
-
if you develop a limp or hip or knee pain
-
if you have enlarged tonsils

Summary of Product characteristics

OBJECT 1
INCRELEX 10MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 22-Sep-2017 | Ipsen Ltd
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 4ml 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 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. It is recommended to
confirm the diagnosis by
conducting an IGF-1 generation test.
4.2 Posology and method of administration
Treatment with INCRELEX should be directed by physicians who are
experienced in the diagnosis and
management of patients with growth disorders.
Posology
The dose should be individualised for each pat