URSO Ursodeoxycholic acid 250mg/5mL oral liquid bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

ursodeoxycholic acid, Quantity: 50 mg/mL

Disponibil de la:

Dr Falk Pharma Australia Pty Ltd

INN (nume internaţional):

Ursodeoxycholic acid

Forma farmaceutică:

Oral Liquid, suspension

Compoziție:

Excipient Ingredients: benzoic acid; glycerol; citric acid; sodium chloride; purified water; sodium citrate dihydrate; propylene glycol; xylitol; sodium cyclamate; microcrystalline cellulose; carmellose sodium; Flavour

Calea de administrare:

Oral

Unități în pachet:

250ml

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Treatment of chronic cholestatic liver diseases.

Rezumat produs:

Visual Identification: White, homogenous suspension containing small air bubbles.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2006-11-15

Prospect

_Consumer Medicine Information _
_URSO_
_ _
URSO
URSODEOXYCHOLIC ACID
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about URSO. It does not
contain all of the
available information. Reading this leaflet 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 URSO
against the benefits they expect it will have for you or your child.
IF YOU HAVE ANY CONCERNS ABOUT TAKING URSO, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You or your child may want to read it again.
WHAT URSO IS USED FOR
URSO contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile
acid, which may have a
protective effect on the liver by reducing the absorption of other
potentially toxic bile salts.
URSO may be used to treat liver diseases such as primary biliary
cholangitis (PBC), primary
sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related
cholestasis.
However, your doctor may prescribe this medicine for another use.
IF YOU OR YOUR CHILD WANTS MORE INFORMATION, ASK YOUR DOCTOR.
ASK YOUR DOCTOR IF YOU OR YOUR CHILD HAS ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN
PRESCRIBED FOR YOU OR YOUR CHILD.
URSO is not addictive.
URSO does not cause any negative effect on driving ability and
operating machinery.
BEFORE YOU OR YOUR CHILD TAKES URSO
URSO is not suitable for everyone.
_WHEN YOU OR YOUR CHILD MUST NOT TAKE _
_URSO _
DO NOT TAKE URSO IF:
•
you or your child is allergic to ursodeoxycholic acid or any other
ingredients listed at the end of
this leaflet
•
you or your child has a bile duct or gall bladder that is swollen,
painful or blocked
•
the packaging is torn or shows signs of tampering
•
the capsules, tablets or suspension, look to be deteriorating in any
way
•
the expiry date (EXP) printed on the pack has passed, as it may not
work as well
•
do not use URSO suspension after 4 months of opening the bottle
IF YOU ARE NOT SURE WHETHER YOU OR YOUR CHILD SHOULD START TAKIN

Caracteristicilor produsului

_Product Information _
_ _
_URSO_
_®_
1
PRODUCT INFORMATION
URSO
®
(Ursodeoxycholic Acid)
NAME OF THE MEDICINE
The chemical structure of ursodeoxycholic acid is as follows:
CAS number: 128-13-2
DESCRIPTION
Ursodeoxycholic acid (UDCA) is a white or almost white powder. It is
practically
insoluble in water, readily soluble in alcohol, sparingly soluble in
acetone, in
chloroform and in ether. It melts at 200 - 204ºC. The IUPAC chemical
name of
UDCA is 3
α
, 7ß-dihydroxy-5-cholan-24-oic acid.
URSO Capsule contains UDCA 250 mg, maize starch, colloidal anhydrous
silica,
magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate
and purified
water.
URSO Suspension contains UDCA 50 mg/mL, benzoic acid, purified water,
xylitol,
glycerol, Avicel RC-591, propylene glycol, sodium citrate dihydrate,
sodium
cyclamate, citric acid, sodium chloride and 87017 lemon flavour.
URSO Tablet contains UDCA 500 mg, magnesium stearate, polysorbate 80,
povidone, microcrystalline cellulose, colloidal anhydrous silica,
crospovidone,
purified talc, hypromellose and macrogol 6000.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
The mechanism of action of UDCA in liver and cholestatic disorders has
not yet been
explained totally. However, UDCA alters bile acid composition,
resulting in
_Product Information _
_ _
_URSO_
_®_
2
increases in the concentration of UDCA and decreases in the
concentrations of the
more hydrophobic and potentially toxic bile acids, cholic and
chenodeoxycholic acids.
UDCA also has a choleretic effect, resulting in increased bile acid
output and bile
flow. There is some evidence for immunological effects, including a
reduction of
abnormal expression of HLA Class I antigens on hepatocytes and a
suppression of
immunoglobulin and cytokine production.
PHARMACOKINETIC PROPERTIES
UDCA occurs naturally in the body. After oral administration of a
single 500 mg
dose of UDCA to healthy volunteers, peak plasma concentrations were
2.7 to 6.3
μg/mL. T
max
occurs at 60 minutes and a second peak plasma concentration occurs at
18