INCRELEX mecasermin 10 mg/mL solution for injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Mecasermin, Quantity: 10 mg/mL

थमां उपलब्ध:

Ipsen Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, solution

रचना:

Excipient Ingredients: sodium chloride; benzyl alcohol; polysorbate 20; glacial acetic acid; sodium acetate trihydrate; water for injections

प्रशासन का मार्ग:

Subcutaneous

पैकेज में यूनिट:

1 vial

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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 less than or equal to ?3.0 and,? Baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and,? basal IGF-1 levels below the 2.5th 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.,IGF-1 and GH levels must be performed using validated assays with paediatric normal ranges.

उत्पाद समीक्षा:

Visual Identification: Clear and colourless solution in a 5 mL clear glass vial with a grey stopper and aluminium flip-off seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2019-11-22

सूचना पत्रक

INCRELEX
®
1

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. You can report side
effects to your doctor, or directly at
www.tga.gov.au/reporting-problems.
INCRELEX
®
_mecasermin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INCRELEX. It does
not contain all the available
information. It does not take the
place of talking to your child's doctor
or pharmacist.
All medicines have risks and
benefits. Your child's doctor has
weighed the risks of them being
given INCRELEX against the
benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD BEING GIVEN THIS
MEDICINE, ASK YOUR CHILD'S DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INCRELEX IS
USED FOR
INCRELEX is a solution for
injection that contains mecasermin
which is a synthetic 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR CHILD.
Your child's doctor may have
prescribed it for another reason.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend the use of this medicine
for children under the age of 2 years.
BEFORE GIVING
INCRELEX
_WHEN YOUR CHILD MUST NOT BE _
_GIVEN IT _
DO NOT GIVE INCRELEX IF YOUR
CHILD:

CURRENTLY HAS ANY TUMOUR OR
GROWTH, EITHER CANCEROUS OR
NON-CANCEROUS

HAVE HAD CANCER IN THE PAST

HAS ANY CONDITIONS WHICH MAY
INCREASE THE RISK OF CANCER.
There is an increased risk of tumours
and growths (both cancerous and
non-cancerous) in children and
adolescents treated with INCRELEX.
If any new growth, skin lesio

उत्पाद विशेषताएं

Increlex Product Information v1, 22 November 2019
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
INCRELEX
®
MECASERMIN 10 MG/ML SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
mecasermin
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 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colourless aqueous 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
•
Baseline height velocity less than the 25th percentile for bone age,
based on two
measurements over 12 months and
•
basal IGF-1 levels below the 2.5th percentile for age and gender and
•
GH sufficiency.
▼

Increlex Product Information v1, 22 November 2019
2
•
Exclusion of secondary forms of IGF-1 deficiency, such as
malnutrition,
hypopituitarism, hypothyroidism, or chronic treatment with
pharmacologic doses of
anti-inflammatory steroids.
IGF-1 and GH levels must be performed using validated assays with
paediatric normal
ranges.
4.2
DOSE AND METHOD OF ADMINISTRATION
INCRELEX is supplied as a multi-dose solution. Each vial is for use in
one patient only.
Treatment with mecasermin should be under the supervision of a
paediatric endocrinologist.
There should be documented confirmation of the diagnosis of severe
IG