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JORVEZA is a brand name for Budesonide, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: JORVEZA (budesonide orodispersible tablets) is indicated for: • Induction and maintenance of clinico-pathological remission in adults with eosinophilic esophagitis (EoE). 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 08/2024 7 WARNINGS AND PRECAUTIONS, Skin 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
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) and should therefore be monitored for the occurrence of such effects. In these patients, caution should be exercised and the benefits of an oral glucocorticosteroid must be weighed against its risks. JORVEZA should not be used in patients with active tuberculosis, or uncontrolled infection.
Driving and Operating Machinery JORVEZA has no or negligible influence on the ability to drive and use machines. Endocrine and Metabolism Glucocorticoids may cause suppression of the hypothalamus-pituitary-adrenal (HPA) axis and reduce the stress response.
Where patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended. Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely psychiatric/behavioral effects (see 8 ADVERSE REACTIONS).
5 mg and 1 mg budesonide Anhydrous monosodium citrate, Disodium hydrogen citrate, Docusate sodium, Macrogol (6000), Magnesium stearate, Mannitol (E 421), Povidone (K25), Sodium hydrogen carbonate and Sucralose. , prednisolone). Tapering of the dose of such conventional therapy when treatment with JORVEZA is initiated and monitoring of adrenocortical function may be needed in these patients.
, pain in muscles and joints), or experience flare up of allergies previously controlled by the conventional systemic corticosteroid drug. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting occur.
In these cases a temporary adjustment in the dose of systemic glucocorticosteroids may sometimes be necessary. Hepatic/Biliary/Pancreatic Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure.
, Skin 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 9 8 ADVERSE REACTIONS ..................................................................................................
13 9 DRUG INTERACTIONS ................................................................................................ 15 10 CLINICAL PHARMACOLOGY .......................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 16 PART II: SCIENTIFIC INFORMATION .......................................................................................
JORVEZA is contraindicated in patients who: • Are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Have uncontrolled infections. • Have active tuberculosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in Canada.
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The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased. However, no systematic data are available. Patients with hepatic impairment should therefore not be treated with JORVEZA. Immune Infections Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
Symptoms of infections can be atypical or masked;severe bacterial infections have been reported in clinical studies. JORVEZA should not be used in patients with uncontrolled infections, or with active tuberculosis. In clinical studies conducted with JORVEZA, oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see 8 ADVERSE REACTIONS).
If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with JORVEZA. Chickenpox, herpes zoster and measles can have a more serious or even fatal course in patients treated with glucocorticosteroids.
In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure. If patients are infected or suspected of being infected, consider reduction or discontinuation of glucocorticoid treatment.
Vaccines The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines. The antibody response to other vaccines may be diminished. Ophthalmologic Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Psychiatric Particular care is required when considering the use of systemic corticosteroids in patients with current or previous history of severe affective disorders, or such history in any of the first-degree relatives. Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods.
Such effects may include psychiatric/behavioral effects. JORVEZA (budesonide) Page 8 of 31 Renal Renal impairment There are currently no data available for patients with renal impairment. Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
JORVEZA is not recommended for use in patients with severe renal impairment.
Reproductive Health:
Female and Male Potential • Fertility There are no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Skin Angioedema has been reported with the use of JORVEZA, mostly as part of allergic reactions which included rash and itching. If signs of angioedema are observed, the treatment should be stopped. 1 Pregnant Women Administration during pregnancy should be avoided unless there are compelling reasons for therapy with JORVEZA.
In the absence of adequate studies in pregnant women, JORVEZA should be used during pregnancy only if the potential benefits to the mother clearly outweigh the risks to the fetus. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause fetal malformations and abnormalities (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental […]
17 13 PHARMACEUTICAL INFORMATION ............................................................................ 17 14 CLINICAL TRIALS ........................................................................................................
20 15 MICROBIOLOGY ........................................................................................................ 23 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 PATIENT MEDICATION INFORMATION .................................................................................. 26 JORVEZA (budesonide) Page 4 of 31 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JORVEZA (budesonide orodispersible tablets) is indicated […]