KUVAN sapropterin dihydrochloride 100 mg soluble tablet bottle

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

sapropterin dihydrochloride, Quantity: 100 mg

थमां उपलब्ध:

BioMarin Pharmaceutical Australia Pty Ltd

INN (इंटरनेशनल नाम):

sapropterin dihydrochloride

फार्मास्यूटिकल फॉर्म:

Tablet, soluble

रचना:

Excipient Ingredients: sodium stearylfumarate; calcium hydrogen phosphate; mannitol; crospovidone; ascorbic acid; riboflavin

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30 tablets, 240 tablets, 120 tablets

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

KUVAN is indicated for the treatment of hyperphenylalaninemia (HPA) in sapropterin-responsive adult and paediatric patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION for definition of sapropterin responsiveness)

उत्पाद समीक्षा:

Visual Identification: Round, off-white to light yellow mottled soluble tablet, debossed '177'; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2010-10-28

सूचना पत्रक

Kuvan®
1
KUVAN®
.
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING KUVAN?
Kuvan contains the active ingredient sapropterin dihydrochloride which
is a synthetic copy of the body’s own substance called
tetrahydrobiopterin. Kuvan is used to treat hyperphenylalaninemia
(HPA) by reducing blood phenylalanine levels in patients
with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
For more information, see Section 1. Why am I using
Kuvan? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KUVAN?
Do not use if you have ever had an allergic reaction to Kuvan or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Kuvan? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Kuvan and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE KUVAN?
•
Take Kuvan with meals.
•
Place the number of tablet(s) or sachet(s) your doctor has told you to
take in a glass or cup of water or apple juice and stir
until dissolved. Your doctor will tell you how much water or juice to
use to dissolve the tablet(s) or powder, and the
amount of the medicine mixture to take. You must take Kuvan exactly as
explained by your doctor.
•
You may mix the crushed tablets in a small amount of soft food such as
yoghurt or mashed banana.
More instructions can be found in Section 4. How do I use Kuvan? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KUVAN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Kuvan
•
Keep all your doctor's appointments so your progress can be checked.
•
Call your doctor straight a

उत्पाद विशेषताएं

Kuvan_PI_v010b
Page 1 of 24
Supersedes: KUV-AUST-010
AUSTRALIAN PRODUCT INFORMATION
KUVAN
®
Sapropterin dihydrochloride
1.
NAME OF THE MEDICINE
sapropterin dihydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soluble tablet contains 100 mg of sapropterin dihydrochloride
(equivalent to 77 mg of
sapropterin).
Each 100 mg sachet contains 100 mg of sapropterin dihydrochloride
(equivalent to 77 mg of
sapropterin).
Each 500 mg sachet contains 500 mg of sapropterin dihydrochloride
(equivalent to 384 mg of
sapropterin).
Excipients with known effect
Contains 171.18 mg mannitol per tablet, 169.06 mg mannitol per 100 mg
sachet and 845.31
mg mannitol per 500 mg sachet. Products containing mannitol may have a
laxative effect or
may cause diarrhoea.
Contains 12 mg potassium per 100 mg sachet, 62 mg potassium per 500 mg
sachet and
sucralose (sachets only).
For the full list of excipients see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Soluble tablets
KUVAN is supplied as immediate release soluble tablet, off-white to
light yellow with “177”
imprinted on one face.
Powder for oral solution
The powder is off-white to light yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KUVAN is indicated for the treatment of hyperphenylalaninemia (HPA) in
sapropterin-
responsive adult and paediatric patients with phenylketonuria (PKU) or
tetrahydrobiopterin
Kuvan_PI_v010b
Page 2 of 24
Supersedes: KUV-AUST-010
(BH4) deficiency (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION
for
definition of sapropterin responsiveness).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with KUVAN must be initiated and supervised by a physician
experienced in the
treatment of PKU and BH4 deficiency.
KUVAN should be administered with a meal to increase absorption.
For patients with PKU, KUVAN should be administered as a single daily
dose, and at the
same time each day, preferably in the morning.
For patients with BH4 deficiency, divide the total daily dose into 2
or 3 administrations,
distributed over the day.
Active manageme