KUVAN

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

SAPROPTERIN DIHYDROCHLORIDE

Boleh didapati daripada:

MEDISON PHARMA LTD

Kod ATC:

A16AX07

Borang farmaseutikal:

TABLETS SOLUBLE

Komposisi:

SAPROPTERIN DIHYDROCHLORIDE 100 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

BIOMARIN INTERNATIONAL LIMITED, IRELAND

Kawasan terapeutik:

SAPROPTERIN

Tanda-tanda terapeutik:

Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.

Tarikh kebenaran:

2017-12-06

Risalah maklumat

1
The format of this leaflet was determined by the Ministry of Health
and its contents were
inspected and approved in 12/2015 and updated in accordance with the
instructions of the
Ministry of Health in 02/2019.
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATION) - 1986
This medicine requires a doctor’s prescription
KUVAN
®
SOLUBLE TABLETS
Active ingredient:
Each soluble TABLET CONTAINS 100 MG OF
Sapropterin dihydrochloride (EQUIVALENT TO 77 MG SAPROPTERIN)
Inactive ingredients - See Section 6.
PLEASE READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
THIS LEAFLET
CONTAINS INFORMATION THAT IS IMPORTANT FOR YOU.
•
Keep this leaflet. You may want to read it again.
•
This leaflet contains concise information about the medicine. If you
have any
further queries, contact a doctor or pharmacist.
•
This medicine has been prescribed for your treatment. Do not pass it
on to
others. It may cause them harm, even if it seems to you that their
medical
condition is similar to yours.
In this leaflet:
1.
What is the intended use of the medicine?
2.
Before using the medicine
3.
How should this medicine be used?
4.
Side-effects
5.
How to store the medicine
6.
Additional information
1. WHAT IS THE INTENDED USE OF THE MEDICINE?
KUVAN
®
is intended for the treatment of high blood levels of the amino acid
phenylalanine in adults and children of all ages. High blood levels of
phenylalanine
can be harmful. These conditions are called hyperphenylalaninaemia
(HPA) or
phenylketonuria (PKU). KUVAN decreases these levels in patients who
respond
to BH4. This makes it possible for these patients to increase the
amount of
phenylalanine in their diet.
KUVAN can also treat a genetic disease known as BH4 deficiency in
adults and
children of all ages, where the body is unable to produce enough BH4.
Because of
the low BH4 level, the phenylalanine consumption is abnormal, its
level rises, and the
phenylalanine accumulation is harmful. Administering KUVAN, which is a
substitute
for the BH4 that th

Ciri produk

1
PRESCRIBING INFORMATION
KUVAN
®
1.
NAME OF THE MEDICINAL PRODUCT
Kuvan
®
100 mg soluble tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soluble tablet contains 100 mg of sapropterin dihydrochloride
(equivalent to 77 mg of
sapropterin).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soluble tablet.
Off-white to light yellow soluble tablet with “177” imprinted on
one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kuvan
is indicated for the treatment of hyperphenylalaninaemia_ _(HPA) in
adults and
paediatric patients of all ages with phenylketonuria (PKU) who have
been shown to be
responsive to such treatment (see section 4.2).
Kuvan is also indicated for the treatment of hyperphenylalaninaemia
(HPA) in adults and
paediatric patients of all ages with tetrahydrobiopterin (BH4)
deficiency who have been
shown to be responsive to such treatment (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Kuvan must be initiated and supervised by a physician
experienced in the
treatment of PKU and BH4 deficiency.
Active management of dietary phenylalanine and overall protein intake
while taking Kuvan is
required to ensure adequate control of blood phenylalanine levels and
nutritional balance._ _
As HPA due to either PKU or BH4 deficiency is a chronic condition,
once responsiveness is
demonstrated, Kuvan is intended for long-term use. However, there are
limited data
regarding the long-term use of Kuvan.
_ _
_Posology _
Kuvan is provided as 100 mg tablets. The calculated daily dose based
on body weight should
be rounded to the nearest multiple of 100. For instance, a calculated
dose of 401 to 450 mg
should be rounded down to 400 mg corresponding to 4 tablets. A
calculated dose of 451 mg
to 499 mg should be rounded up to 500 mg corresponding to 5 tablets.
2
_PKU _
The starting dose of Kuvan in adult and paediatric patients with PKU
is 10 mg/kg body weight
once daily. The dose is adjusted, usually between 5 and 20 mg/kg/day,
to achieve and
maintain adequat