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CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients; Jorveza® is contraindicated in patients with uncontrolled infections or active tuberculosis. CLINICALLY SIGNIFICANT PRECAUTIONS: Patients with hepatic impairment should not be treated with Jorveza®; Jorveza® is not recommended for use in patients with severe renal impairment; Symptoms of infections can be atypical or masked; observed high frequency of oral, oropharyngeal and oesophageal candida infections in clinical studies conducted with Jorveza®; Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids;  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; Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions and should therefore be monitored for the occurrence of such effects; The safety and efficacy of Jorveza® in children and adolescents under the age of 18 years have not been established and should not be used as it may reduce growth velocity in children; Caution should be exercised in patients ≥ 65 years due to the potential for decreased hepatic, renal or cardiac function, or due to concomitant disease or therapies; Known systemic effects of glucocorticosteroids may occur with Jorveza®, particularly with prolonged use or high doses; Visual disturbance and suppression of the hypothalamic–pituitary–adrenal (HPA) axis may occur. Use in Pregnancy – Category B3. Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza®; Use in Lactation – Budesonide  is excreted in human milk. Minor effects on the breast-fed child are anticipated after oral use of Jorveza® within the therapeutic range; benefit of breast-feeding for a child should be balanced against benefit of therapy for woman. No or negligible influence on ability to drive or operate machinery. CLINICALLY SIGNIFICANT INTERACTIONS; CYP3A4 inhibitors, oestrogens, oral contraceptives, cardiac glycosides, saluretics, grapefruit juice. VERY COMMON AND COMMON ADVERSE EFFECTS; Oesophageal candidiasis,  oral and/or oropharyngeal candidiasis, headache, hypertension, upper abdominal pain, gastroesophageal reflux disease, lip oedema, nausea, oral paraesthesia, fatigue, blood cortisol decrease. There are other known adverse reactions of the corticosteroid and budesonide therapeutic class (frequency not known). Please refer to the full Product Information or Consumer Medicine Information.

Dr Falk Pharma Australia Pty Ltd. ABN 40 631 091 131. Level 10, 815 Pacific Highway, Chatswood NSW 2067. Website: Tel: 1800 DRFALK (1800 373 255). Email: DFPEOE2021.29SEP

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