Palynziq

Country: Evrópusambandið

Tungumál: enska

Heimild: EMA (European Medicines Agency)

Virkt innihaldsefni:

Pegvaliase

Fáanlegur frá:

BioMarin International Limited

ATC númer:

A16AB19

INN (Alþjóðlegt nafn):

pegvaliase

Meðferðarhópur:

Other alimentary tract and metabolism products

Lækningarsvæði:

Phenylketonurias

Ábendingar:

Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.

Vörulýsing:

Revision: 7

Leyfisstaða:

Authorised

Leyfisdagur:

2019-05-03

Upplýsingar fylgiseðill

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALYNZIQ 2.5 MG
solution for injection in pre-filled syringe
PALYNZIQ 10 MG
solution for injection in pre-filled syringe
PALYNZIQ 20 MG
solution for injection in pre-filled syringe
PEGVALIASE
▼
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Palynziq is and what it is used for
2.
What you need to know before you use Palynziq
3.
How to use Palynziq
4.
Possible side effects
5.
How to store Palynziq
6.
Contents of the pack and other information
1.
WHAT PALYNZIQ IS AND WHAT IT IS USED FOR
Palynziq contains the active substance pegvaliase, an enzyme that can
break down a substance called
phenylalanine in the body. Palynziq is a treatment for patients aged
16 years and older with
phenylketonuria (PKU), a rare inherited disorder that causes
phenylalanine from proteins in food to
build up in the body. People who have PKU have high levels of
phenylalanine and this can lead to
serious health problems.
_ _
Palynziq reduces the levels of phenylalanine in the blood of patients
who
have PKU whose blood phenylalanine levels cannot be kept below 600
micromol/l by other means
such as by diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PALYNZIQ
_ _
DO NOT USE PALYNZIQ
-
if you have a severe allergy to pegvaliase

Vara einkenni

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
Palynziq 2.5 mg solution for injection in pre-filled syringe
Palynziq 10 mg solution for injection in pre-filled syringe
Palynziq 20 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mg pre-filled syringe contains 2.5 mg pegvaliase in 0.5 ml
solution.
Each 10 mg pre-filled syringe contains 10 mg pegvaliase in 0.5 ml
solution.
Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml
solution.
The strength indicates the quantity of the phenylalanine ammonia lyase
(rAvPAL) moiety of
pegvaliase without consideration of the PEGylation.
The active substance is a covalent conjugate of the protein
phenylalanine ammonia lyase (rAvPAL)*
with NHS-methoxypolyethylene glycol (NHS-PEG).
*
_Anabaena variabilis_
rAvPAL produced by recombinant DNA technology in
_Escherichia coli._
The potency of this medicinal product should not be compared to any
other PEGylated or
non-PEGylated protein of the same therapeutic class. For more
information, see section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Colourless to pale yellow, clear to slightly opalescent solution with
pH 6.6 – 7.4.
2.5 mg pre-filled syringe:
Osmolality: 260 – 290 mOsm/kg
10 mg and 20 mg pre-filled syringe:
Osmolality: 285 – 315 mOsm/kg, viscous solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palynziq is indicated for the treatment of patients with
phenylketonuria (PKU) aged 16 years and older
who have inadequate blood phenylalanine control (blood phenylalanine
levels greater than
600 micromol/l) despite prior management with available treatment
options.
3
4.2
POSOLOGY AND METHOD OF ADMINISTR