ORFADIN nitisinone 4 mg/mL oral suspension bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

nitisinone, Quantity: 4 mg

Fáanlegur frá:

A Menarini Australia Pty Ltd

Lyfjaform:

Oral Liquid, suspension

Samsetning:

Excipient Ingredients: hypromellose; glycerol; polysorbate 80; sodium benzoate; citric acid monohydrate; sodium citrate; purified water; Flavour

Stjórnsýsluleið:

Oral

Einingar í pakka:

90 mL

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Orfadin (nitisinone) is indicated for the treatment of patients with hereditary tyrosinaemia type 1 in combination with dietary restriction of tyrosine and phenylalanine.

Vörulýsing:

Visual Identification: White slightly viscous opaque suspension with child resistant cap; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2019-02-26

Upplýsingar fylgiseðill

ORFADIN
® ORAL
SUSPENSION
_Nitisinone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ORFADIN oral
suspension. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ORFADIN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ORFADIN IS
USED FOR
ORFADIN contains a medicine
called nitisinone which is used for
the treatment of a disease called
hereditary tyrosinaemia type 1
(HT-1). In this disease the body is
unable to completely break down the
amino acid tyrosine. Harmful
substances can form and accumulate
in the body.
ORFADIN blocks the breakdown of
tyrosine and by doing so the harmful
substances are not formed. However,
tyrosine will remain in the body and
therefore a special diet that is low in
tyrosine and phenylalanine content
must be followed when taking
ORFADIN.
Nitisinone belongs to a group of
medicines called 'other alimentary
and metabolism products'.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
ORFADIN is not addictive.
ORFADIN is available only with a
doctor's prescription.
BEFORE YOU TAKE
ORFADIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ORFADIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
nitisinone.
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR

Vara einkenni

AUSTRALIAN PRODUCT INFORMATION –
ORFADIN
® NITISINONE CAPSULE AND ORAL SUSPENSION
ORFADIN
®
PI vA08-0
Page 1 of 16
1. NAME OF THE MEDICINE
Nitisinone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Capsules_: Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg
nitisinone.
_Oral suspension_: 1 mL contains 4 mg of nitisinone.
Excipients with known effect:
The oral suspension contains glycerol and sodium benzoate (see section
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
_Capsules_: white, opaque, hard gelatin capsules imprinted with
“NTBC 2 mg”, “NTBC 5 mg”,
“NTBC 10 mg” or “NTBC 20 mg” in black ink; and contain a white
to off white powder.
_Oral suspension_: white, slightly viscous, opaque suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ORFADIN (nitisinone) is indicated for the treatment of patients with
hereditary tyrosinaemia
type 1 (HT-1) in combination with dietary restriction of tyrosine and
phenylalanine.
4.2 DOSE AND METHOD OF ADMINISTRATION
ORFADIN treatment should be initiated and supervised by a physician
experienced in the
treatment of HT-1 patients.
Treatment of HT-1 should be initiated as early as possible to increase
overall survival and
avoid complications such as liver failure, liver cancer and renal
disease. Adjunct to the
ORFADIN
treatment,
a
diet
deficient
in
phenylalanine
and
tyrosine
is
mandatory.
The patient should be provided with clear instructions on the
restricted diet and on the
importance of adherence to the restricted diet. The patient’s
compliance to the diet should
be checked regularly by monitoring of phenylalanine and plasma
tyrosine levels.
_Starting dose _
The recommended initial dose is 1 mg/kg body weight /day divided in 2
doses administered
orally. The dose of ORFADIN should be adjusted individually.
________________________________________________________________________
ORFADIN
®
PI vA08-0
Page 2 of 16
_Dose adjustment _
Regular monitoring, should inc