INVITAD3

Posology Paediatric posology: - Due to a lack of clinical data, invitaD3 is not recommended. Pregnancy and breastfeeding: - Due to a lack of clinical data, invitaD3 is not recommended. Adults: - Treatment of vitamin D deficiency (<25 nmol/l) 50,000 IU/week (1single-dose oral solution) for 6-8 weeks, followed by maintenance therapy (equivalent to 1400-2000 IU/day, such as 1 single-dose 50,000 IU oral solution per month) may be required; follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved).

, anticonvulsant medications, glucocorticoids) - Patients with malabsorption, including inflammatory bowel disease and coeliac disease - Those recently treated for vitamin D deficiency, and requiring maintenance therapy. Special populations Renal impairment invitaD3 should not be used in combination with calcium in patients with severe renal impairment.

Hepatic impairment No posology adjustment is required in patients with hepatic impairment. 2 Pharmacokinetic properties - “Absorption”).

Administration to adults:

The single-dose oral solution should be either emptied into the mouth and swallowed orally, or emptied onto a spoon and taken orally. invitaD3 can also be taken by mixing with a small amount of cold or lukewarm food/drink immediately prior to use.

6, Special precautions for handling and disposal.

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).

Metabolism and nutrition disorders Uncommon:

Hypercalcaemia and hypercalciuria Skin and subcutaneous disorders: Rare: pruritus, rash, and urticaria.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. Caution is required in patients receiving treatment for cardiovascular disease (see section

• Hypersensitivity to the active substance(s) or to any of the excipients. • Hypercalcaemia and/or hypercalciuria. • Nephrolithiasis and/or nephrocalcinosis • Serious renal impairment • Hypervitaminosis D • Pseudohypoparathyroidism as the vitamin D requirement may be reduced due to phases of normal vitamin D sensitivity, involving the risk of prolonged overdose.

Better-regulatable vitamin D derivatives are available for this.