לפני מתן מרשם יש לעיין בעלון לרופא כפי שאושר על ידי משרד הבריאות

1.FORXIGA prescribing information, MOH approved
2.XIGDUO ® XR prescribing information, MOH approved

INDICATIONS:
FORXIGA is indicated in adults aged 18 years and older for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance.
• in addition to other medicinal products for the treatment of type 2 diabetes.
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.
to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Limitations of Use
• FORXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FORXIGA is not expected to be effective in these populations.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients on dialysis

XIGDUO XR (dapagliflozin and metformin hydrochloride extended-release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate [see Clinical Studies (14)].
Limitations of Use
XIGDUO XR is not recommended for patients with type 1 diabetes mellitus or diabetic ketoacidosis
Contraindications
XIGDUO XR is contraindicated in patients with:
• severe renal impairment (eGFR below 30 mL/min/1.73 m2 end stage renal disease or patients on dialysis [see Warnings and Precautions (5.1)].
• History of a serious hypersensitivity reaction to dapagliflozin such as anaphylactic reactions or angioedema or hypersensitivity to metformin hydrochloride [see Adverse Reactions (6.1)].
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1) and Warnings and Precautions (5.2)].

IL-3815 FEB 2023