Jorveza

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Budesonide 0.5mg

Доступна с:

Dr Falk Pharma New Zealand Ltd

дозировка:

0.5 mg

Фармацевтическая форма:

Orodispersible tablet

состав:

Active: Budesonide 0.5mg Excipient: Docusate sodium Macrogol 6000 Magnesium stearate Mannitol Monosodium citrate Povidone Sodium acid citrate Sodium bicarbonate Sucralose

Тип рецепта:

Prescription

Терапевтические показания :

Treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).

Обзор продуктов:

Package - Contents - Shelf Life: Blister pack, Al/Al - 20 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Al/Al - 60 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Al/Al - 100 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Al/Al - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Дата Авторизация:

2021-07-01

тонкая брошюра

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

Характеристики продукта

New Zealand Data Sheet
JORVEZA
®
budesonide, orally disintegrating tablets
Dr Falk Pharma NZ Ltd
JORVEZA DATASHEET v02 2022
1
spcnz-bul0.5-bul1-en1-feb22
DATA SHEET
JORVEZA
®
BUDESONIDE
1.
NAME OF THE MEDICINE
JORVEZA
®
contains 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 (older than 18
years of age).
_ _
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.
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.
A 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 also
section 5.1 PHARMACODYNAMIC PROPERTIES.
JORVEZA DATA SHEET v02 2022
2
spcnz