PHEBURANE sodium phenylbutyrate 483 mg/g granule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium phenylbutyrate, Quantity: 483 mg/g

Available from:

Orpharma Pty Ltd

INN (International Name):

sodium phenylbutyrate

Pharmaceutical form:

Granules

Composition:

Excipient Ingredients: povidone; ethylcellulose; hypromellose; macrogol 1500; sucrose; hydrolysed maize starch

Administration route:

Oral

Units in package:

174 g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pheburane (sodium phenylbutyrate) is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane? should be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, and protein-free calorie supplements)

Product summary:

Visual Identification: White to off-white tasteless coated granules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-05-30

Patient Information leaflet

Pheburane_CMI_V6_11052017
1 of 4
PHEBURANE®
Sodium phenylbutyrate granule
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pheburane.
It does not contain all the available
information. Some of the
information it contains may not
apply to you.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and risks.
In deciding to give you Pheburane,
your doctor has weighed the risks of
you taking Pheburane against the
expected benefits it will have for you.
Always follow the instructions that
your doctor and pharmacist give you
about Pheburane.
If you have any concerns about
taking this medicine, ask your
doctor or pharmacist.
WHAT IS PHEBURANE USED
FOR
Pheburane contains the medicine
sodium phenylbutyrate. Pheburane
belongs to a group of medicines
called nitrogen scavengers.
Nitrogen is a building block of
proteins, which are an essential part
of the food we eat. Waste nitrogen is
converted into ammonia and removed
from the body. Liver enzymes are
necessary to remove ammonia from
the blood stream. In patients with
urea cycle disease (UCD), ammonia
builds up because the body cannot
remove it. Ammonia is especially
toxic for the brain and leads, in severe
cases, to reduced levels of
consciousness and to coma.
Pheburane granules are indicated for
the management of
hyperammonaemia (elevated blood
ammonia) associated with urea cycle
disorders. Pheburane should be used
with dietary protein restriction and, in
some cases, dietary
supplements (e.g. essential amino
acids, arginine, citrulline, and protein-
free calorie supplements).
Pheburane helps the body to eliminate
waste nitrogen, reducing the amount
of ammonia in your body.
Sodium phenylbutyrate can be used in
infants from one month of age and
needs to be taken continuously
throughout the patient’s lifetime.
Your doctor may have prescribed this
medicine for another use. If you want
more information, ask your doctor.
Pheburane is only available on a
doctor's prescription
BEFORE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – Pheburane V3
Page 1 of 21
AUSTRALIAN PRODUCT INFORMATION –
PHEBURANE™ SODIUM PHENYLBUTYRATE GRANULES
1. NAME OF THE MEDICINE
Sodium phenylbutyrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pheburane® granules are sugar-coated spheres containing sodium
phenylbutyrate
Each gram of granules contains 483 mg of sodium phenylbutyrate.
Excipient(s) with known effect:
Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of
sodium and 768 mg of
sucrose. For the full list of excipients, see section 6.1 LIST OF
INGREDIENTS
3. PHARMACEUTICAL FORM
Granules.
White to off-white granules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pheburane
(sodium
phenylbutyrate)
is
indicated
for
the
management
of
hyperammonaemia associated with urea cycle disorders. Pheburane®
should be used
with dietary protein restriction and, in some cases, dietary
supplements (e.g. essential
amino acids, arginine, citrulline, and protein-free calorie
supplements)
AUSTRALIAN PRODUCT INFORMATION – Pheburane V3
Page 2 of 21
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSING CONSIDERATIONS
Pheburane treatment should be initiated and
supervised by a health professional
experienced in the treatment of urea cycle disorders, as part of a
multidisciplinary team.
The daily dose should be individually adjusted according to the
patient’s protein tolerance
and the daily dietary protein intake needed to promote growth and
development.
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
The usual total daily dose of sodium phenylbutyrate is:
•
up to 600 mg/kg/day in neonates, infants and children weighing less
than 20 kg;
•
up to 13.0 g/m
2
/day in children weighing more than 20 kg, adolescents and adults.
The safety and efficacy of doses in excess of 20 g/day have not been
established.
The recommended dose is expressed in terms of milligrams (mg) or grams
(g) of sodium
phenylbutyrate, rather than the weight of the granules.
A
calibrated
dosing
spoon
is
provided
which
dispenses
PHEBURANE
granules
equivalent to amounts up