BRINEURA

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

CERLIPONASE ALFA

Διαθέσιμο από:

MEDISON PHARMA LTD

Φαρμακολογική κατηγορία (ATC):

A16AB17

Φαρμακοτεχνική μορφή:

SOLUTION FOR INFUSION

Σύνθεση:

CERLIPONASE ALFA 30 MG / 1 ML

Οδός χορήγησης:

I.V

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

BIOMARIN INTERNATIONAL LIMITED, IRELAND

Θεραπευτική περιοχή:

CERLIPONASE ALFA

Θεραπευτικές ενδείξεις:

Brineura is indicated for the treatment of patients with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Ημερομηνία της άδειας:

2020-08-18

Αρχείο Π.Χ.Π.

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brineura 150 mg solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Brineura contains 150 mg of cerliponase alfa* in 5 ml of
solution.
Each ml of solution for infusion contains 30 mg of cerliponase alfa.
* Produced in mammalian Chinese Hamster Ovary cells.
Excipients with known effect:
Each vial contains 17.4 mg of sodium in 5 ml of solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear to slightly opalescent and colourless to pale yellow solution,
that may occasionally contain thin
translucent fibres or opaque particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brineura is indicated for the treatment of patients with neuronal
ceroid lipofuscinosis type 2 (CLN2) disease,
also known as tripeptidyl peptidase 1 (TPP1) deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Brineura must only be administered by a trained healthcare
professional knowledgeable in
intracerebroventricular administration in a healthcare setting.
Posology
The recommended dose is 300 mg cerliponase alfa administered once
every other week by
intracerebroventricular infusion.
In patients less than 2 years of age, lower doses are recommended, see
paediatric population section.
Pre-treatment of patients with antihistamines with or without
antipyretics is recommended 30 to 60 minutes
prior to the start of infusion.
Continuation of long-term treatment should be subject to regular
clinical evaluation whether the benefits are
considered to outweigh the potential risks to individual patients.
_ _
2
_Dose adjustments _
Consideration of dose adjustments may be necessary for patients who
may not tolerate the infusion. The dose
may be reduced by 50% and/or the infusion rate decreased to a slower
rate.
If the infusion is interrupted due to a hypersensitivity reaction, it
should be restarted at approximately one-
half the initial infusion rate at which the hypersensitivity reaction
occurred.
The