JORVEZA budesonide 0.5 mg orally disintegrating tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

budesonide, Quantity: 0.5 mg

Διαθέσιμο από:

Dr Falk Pharma Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, orally disintegrating

Σύνθεση:

Excipient Ingredients: magnesium stearate; mannitol; macrogol 6000; sodium acid citrate; sodium dihydrogen citrate; sodium bicarbonate; sucralose; povidone; docusate sodium

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

100 tablets, 20 tablets, 200 tablets, 60 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Jorveza? is indicated for the treatment of eosinophilic oesophagitis (EoE) in adults.

Περίληψη προϊόντος:

Visual Identification: White or almost white, round, biplane tablet with a smooth surface and facet, one side embossed with "0.5"; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-09-06

Φύλλο οδηγιών χρήσης

JORVEZA V08 09/2021
1
JORVEZA
®
_Budesonide 0.5 mg and 1 mg orally disintegrating tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
JORVEZA tablets. 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 risk of you taking
this medicine against the benefits
it is expected to 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 JORVEZA IS
USED FOR
JORVEZA tablets contain the
active ingredient, budesonide.
Budesonide belongs to a group
of medications called
corticosteroids. JORVEZA
tablets are used to treat
eosinophilic oesophagitis (EoE)
which is an inflammatory
condition of the gullet (food
pipe) that causes problems with
swallowing food.
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.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
JORVEZA is only available on a
doctor’s prescription.
There is not enough information
to recommend the use of this
medicine for children or
adolescents.
BEFORE YOU TAKE
JORVEZA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
budesonide
•
any 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 TAKE JORVEZA IF YOU
HAVE UNCONTROLLED INFECTIONS OR
ACTIVE TUBERCULOSIS.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU HAVE ANY
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES OR DYES.
TELL YOUR DOCTOR IF YOU ARE

Αρχείο Π.Χ.Π.

JORVEZA
®
PI v09 1221
1
AUSTR 322645/AUSTR 350996
pi-approved-1221
1 / 11
AUSTRALIAN PRODUCT INFORMATION – JORVEZA
® (BUDESONIDE)
ORALLY DISINTEGRATING TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Budesonide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orally disintegrating tablet contains either 0.5 mg or 1 mg of
budesonide.
Each budesonide orally disintegrating tablet also contains sucralose
and sodium.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Orally disintegrating tablet
Jorveza
®
0.5 mg tablet: White or almost white, round, biplane orally
disintegrating tablet with ‘0.5’
debossed on one side.
Jorveza
®
1 mg tablet: White or almost white, round, biplane orally
disintegrating tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jorveza
®
is indicated for the treatment of eosinophilic oesophagitis (EoE) in
adults.
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
The treatment with this medicinal product should be initiated by a
physician experienced in the
diagnosis and treatment of eosinophilic oesophagitis.
Dosage
The recommended daily dose for induction treatment is 2 mg budesonide
as one 1 mg tablet in the
morning and one 1 mg tablet in the evening.
The usual duration of induction treatment is 6 weeks. For patients who
are not appropriately
responding during 6 weeks the treatment can be extended to up to 12
weeks.
If a dose is missed, treatment should be continued at the prescribed
dosage. A double dose should not
be used to make up for a forgotten dose.
The recommended daily dose for maintenance of remission is 1 mg
budesonide as one 0.5 mg tablet in
the morning and one 0.5 mg tablet in the evening, or 2 mg budesonide
as one 1 mg tablet in the
morning and one 1 mg tablet in the evening, depending on the
individual clinical requirement of the
patient.
The maintenance dose of 1 mg budesonide twice daily is recommended for
patients with a long
standing disease history and/or high extent of oesophageal
inflammation in their acute disease state,
see a