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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease (see section 5.1). ... Tolvaptan may cause adverse reactions related to water loss such as …

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JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The initial dosage for JYNARQUE is 60 mg orally per day as 45 mg taken on waking and 15 mg taken 8 hours later.

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