JORVEZA 1 MG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

BUDESONIDE

זמין מ:

RAFA LABORATORIES LTD

קוד ATC:

A07EA06

טופס פרצבטיות:

TABLETS ORODISPERSIBLE

הרכב:

BUDESONIDE 1 MG

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

DR. FALK PHARMA, GERMANY

איזור תרפויטי:

BUDESONIDE

סממני תרפויטית:

Treatment of eosinophilic esophagitis (EoE) in adults.

תאריך אישור:

2019-12-30

עלון מידע

1
Patient Leaflet According to the Pharmacists' Regulations
(Preparations) – 1986
This medicine is sold with a doctor's prescription only
Jorveza® 0.5 mg
Jorveza® 1 mg
Orodispersible tablets
Active ing
redient:
Each Jorveza 0.5 mg orodispersible tablet contains: 0.5 mg budesonide.
Each Jorveza 1 mg orodispersible tablet contains: 1 mg budesonide.
For the list of the additional ingredients, see section 6. See also
'Important information about some of the
medicine's ingredients' in section 2.
Read this entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions, please refer
to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. What is the medicine intended for?
The medicine is intended for the treatment of eosinophilic esophagitis
in adults.
Therapeutic group: steroidal (corticosteroidal) anti-inflammatory
medicine with local activity.
2. Before using the medicine
Do not use the medicine if:
You are sensitive (allergic) to the active ingredient (budesonide) or
to any of the other ingredients the
medicine contains (for a list of the other ingredients, see section
6).
Special warnings regarding the use of this medicine:
Before starting the treatment with the medicine, tell your doctor if:
•
You have tuberculosis, high blood pressure, osteoporosis.
•
You or someone in your family has diabetes.
•
You have ulcers in the stomach or in the intestine.
•
You have increased pressure in your eye (which can cause glaucoma),
glaucoma, eye problems such as
clouding of the lens (cataract), or if someone in your family has
glaucoma.
•
You have liver or kidney disease.
If you have any of the conditions mentioned above, you may be at an
increased risk of side effects. Your
doctor will decide whether the medicine is suitable for you and
whether appropriate monitoring is necess

מאפייני מוצר

1
Jorveza 1 mg-DL-April 2023
1.
NAME OF THE MEDICINAL PRODUCT
Jorveza 0.5 mg
Jorveza 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jorveza 0.5 mg orodispersible tablets
Each orodispersible tablet contains 0.5 mg of budesonide.
_ _
_Excipient with known effect _
Each 0.5 mg orodispersible tablet contains 26 mg sodium.
Jorveza 1 mg orodispersible tablets
Each orodispersible tablet contains 1 mg of budesonide.
_ _
_Excipient with known effect _
Each 1 mg orodispersible tablet contains 26 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible white round tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jorveza is indicated for the treatment of eosinophilic esophagitis
(EoE) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment with this medicinal product should be initiated by a
gastroenterologist or a physician
experienced in the diagnosis and treatment of eosinophilic
esophagitis.
Posology
_Induction of remission _
_ _
The recommended daily dose 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.
_Maintenance of remission_
The recommended daily dose 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 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 long standing
disease history and/or high extent of esophageal inflammation in their
acute disease state, see also
section 5.1.
The duration of maintenance therapy is determined by the treating
physician.
_Special populations _
_Renal impairment _
2
There are currently no data available for patients with renal
impairment. Because budesonide is not
excreted via the kidneys, patie