Sapropterine DZ 100 mg oplosbare tabletten

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

SAPROPTERINEDIHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; SAPROPTERINE 76,8 mg/stuk

INN（国際名）:

SAPROPTERINEDIHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; SAPROPTERINE 76,8 mg/stuk

医薬品形態:

Oplosbare tablet

構図:

ASCORBINEZUUR (L-) (E 300) ; CROSPOVIDON (E 1202) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; RIBOFLAVINE (E 101), ASCORBINEZUUR (L-) (E 300) ; CROSPOVIDON (E 1202) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; RIBOFLAVINE

投与経路:

Oraal gebruik

承認日:

2022-04-04

情報リーフレット

1
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
SAPROPTERINE DZ 100 MG OPLOSBARE TABLETTEN
Sapropterin dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 [Product name] is and what it is used for
2.
What do you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance sapropterin which is a
synthetic copy of a body’s own
substance called tetrahydrobiopterin (BH4). BH4 is required by the
body to use an amino acid called
phenylalanine in order to build another amino acid called tyrosine.
[Product name] is used to treat hyperphenylalaninaemia (HPA) or
phenylketonuria (PKU) in patients
of all ages. HPA and PKU are due to abnormally high levels of
phenylalanine in the blood which can
be harmful. [Product name] reduces these levels in some patients who
respond to BH4 and can help
increase the amount of phenylalanine that can be included in the diet.
This medicine is also used to treat an inherited disease called BH4
deficiency in patients of all ages, in
which the body cannot produce enough BH4. Because of very low BH4
levels phenylalanine is not
used properly and its levels rise, resulting in harmful effects. By
replacing the BH4 that the body
cannot produce, [Product name] reduces the harmful excess of
phenylalanine in the blood and
increases the dietary tolerance to phenylalanine.

製品の特徴

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Sapropterine DZ 100 mg oplosbare tabletten
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, round (of diameter about 9.5 mm) tablet,
with “L71” imprinted on one side
and “T” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] 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).
[Product name] 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 [Product name] 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 this medicinal
product 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, [Product name] is intended for long-term use (see
section 5.1).
Posology
_PKU _
The starting dose of [Product name] 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
adequate blood phenylalanine levels as defined by the physician.
_BH4 deficiency _
The starting dose of [Product name] in adult and paediatric patients
with BH4 deficiency is 2 to 5
mg/kg body weight total daily dose. Doses may be adjusted up to a
total of 20 mg/kg per day.
2
[Product