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THORENS – VITAMIN D3


SUPPLEMENT


MANY FACES. ONE SOLUTION.


SAVE 56% vs. the market-leading brand*1,2


Suitable for newborn infants to adults, including pregnant and breastfeeding women†3,4


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* Comparison based on the maximum adult weekly dose of Thorens (50,000 I.U.) vs. the maximum adult weekly dose of the market-leading licensed vitamin D3


supplement (22,400 I.U.) taken for the maximum respective licensed treatment length needed to achieve up to a total of approximately 300,000 I.U. Comparison based on Thorens 25,000 I.U./2.5ml oral solution 4 pack and on drug acquisition costs.





Thorens 10,000 I.U./ml oral drops, solution is licensed for the prevention of vitamin D deficiency during pregnancy and breastfeeding; high dose cholecalciferol products such as Thorens 25,000 I.U./2.5ml oral solution are not recommended for use in pregnant and breastfeeding women.


CHOLECALCIFEROL (VITAMIN D3)


Vitamin D that’s simple in practice


THORENS 10,000 I.U./ml oral drops, solution and THORENS 25,000 I.U./2.5ml oral solution: Please refer to the Summaries of Product Characteristics (SPCs) before prescribing.


Abbreviated Prescribing Information. Presentation: Both presentations of THORENS consist of a clear and colourless to greenish-yellow oily solution without visible solid particles and/or precipitate. THORENS 10,000 I.U./ml oral drops, solution: 10ml oral drops solution per bottle (corresponding to 500 drops, with one drop containing 200 I.U. cholecalciferol); each pack contains 1 bottle and 1 dropper applicator cap. THORENS 25,000 I.U./2.5ml oral solution: 2.5ml oral solution per single-dose bottle containing 25,000 I.U. cholecalciferol (equivalent to 0.625mg). 1ml solution of both presentations is equivalent to 0.25mg cholecalciferol. Indications: Prophylaxis and treatment of rickets and osteomalacia in children and adults; prophylaxis of rickets in preterm newborns and prophylaxis of vitamin D deficiency in children and adults with an identified risk or with malabsorption. Dosage and administration: THORENS 10,000 I.U./ml oral drops, solution: Treatment of deficiency: Children aged 0-18 years: 2,000 I.U./ day (10 drops) for 6 weeks, followed by maintenance therapy of 400-1,000 I.U./day (2-5 drops). Prevention of deficiency: Children aged 0-1 years: 400 I.U./day (2 drops); children aged 1-18 years: 600 I.U./day (3 drops); doses of up to 1,000 I.U./day (5 drops) may be required in some children. Adults: 600-800 I.U./day (3-4 drops); higher doses may be required in certain situations. Pregnancy and breastfeeding: 400 I.U./day (2 drops) although doses of up to 2,000 I.U./day (10 drops) may be required in some women and even higher doses may be required during breast-feeding if the infant is not given a vitamin D3


800 I.U./day (4 drops). THORENS 25,000 I.U./2.5ml oral solution: Treatment of deficiency: Children aged 0-18 years: 25,000 I.U. (1 bottle) once every 2 weeks for 6 weeks, followed by maintenance therapy of 400-1,000 I.U./day. Adults: 50,000 I.U./week (2 bottles) for 6-8 weeks, followed by maintenance therapy (1,400-2,000 I.U./day may be required; follow-up 25(OH)D measurements should be made approximately 3 to 4 months after initiating maintenance therapy to confirm that the target level has been achieved). Pregnancy and breastfeeding: the 25,000 I.U./2.5ml formulation is not recommended. Prevention of deficiency: Children aged 0-1 years: 25,000 I.U. (1 bottle) every 8 weeks; children aged 1-18 years: 25,000 I.U. (1 bottle) every 6 weeks. Adults: 25,000 I.U./month (1 bottle); higher doses may be required in certain situations. Pregnancy and breastfeeding: the 25,000 I.U./2.5ml formulation is not recommended. As an adjunct to specific therapy for osteoporosis: Adults:


supplement. As an adjunct to specific therapy for osteoporosis: Adults:


25,000 I.U./month (1 bottle). Patients should be advised to take THORENS preferably with a meal. Refer to the SPCs for full details on method of administration for both products and the instructions for use for the THORENS 10,000 I.U./ml oral drops, solution. Contraindications: Hypersensitivity to the active ingredient or any of the excipients contained in THORENS. Hypercalcaemia, hypercalciuria, hypervitaminosis D and kidney stones (nephrolithiasis, nephrocalcinosis) in patients with current, chronic hypercalcaemia. Warnings and Precautions: THORENS should be used with caution in patients with renal function impairment 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. Caution is also required in patients with sarcoidosis due to a possible increase in the metabolism of vitamin D3


urinary calcium levels should be monitored). Allowances should be made for the total dose of vitamin D3


with use of treatments already containing vitamin D, foods enriched with vitamin D3


in its active form (serum and , milk enriched


with vitamin D and the patient’s level of sun exposure. Renal stones are a plausible risk, despite no clear evidence for causation, especially in the context of concomitant calcium supplementation; the need for calcium supplementation should be considered for individual patients and given under close medical supervision. Oral high-dose vitamin D3


(500,000 I.U. by single annual bolus) has


been reported to result in an increased risk of fractures in the elderly, with the greatest increase occurring during the first 3 months after dosing. Serum calcium values must be monitored during long-term treatment with a daily dose exceeding 1,000 I.U. Interactions: Effect of vitamin D3


may


be reduced by metabolic inactivation by concomitant use of anticonvulsants (such as phenytoin), barbiturates and possibly other drugs that induce hepatic enzymes. Monitoring of serum calcium is recommended in cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium. Concomitant use of glucocorticoids can decrease the effect of vitamin D3


. Strict medical


supervision is needed, with serum calcium and electrocardiographic monitoring if necessary, in cases of treatment with drugs containing digitalis and other cardiac glycosides, as the vitamin D3


may increase the risk of digitalis toxicity (arrhythmia). Gastrointestinal absorption of vitamin D3


may be reduced by ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil. Actinomycin and imidazole antifungal agents interfere with vitamin D3 activity by inhibiting conversion of 25-hydroxyvitamin D3


to 1,25-dihydroxyvitamin D3 by the kidney


enzyme, 25-hydroxyvitamin D-1 hydroxylase. Fertility, pregnancy and lactation: THORENS 25,000 I.U./2.5ml oral solution is not recommended in pregnancy and lactation. There are no or limited


can be prescribed while the patient is breastfeeding, if necessary. This supplementation does not replace the administration of vitamin D3 D3


to a breast-fed child, the practitioner should consider the dose of vitamin D3


amount of data from the use of cholecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. Refer to dosage and administration section for recommended dose. During pregnancy women should follow the advice of their medical practitioner as requirements may vary. Vitamin D3


in the neonate; however, when prescribing vitamin given to the mother.


Effects on ability to drive and use machines: There are no data on the effects of THORENS on the ability to drive. However, an effect is unlikely. Undesirable effects: Uncommon (>1/1,000 and <1/100): hypercalcaemia and hypercalciuria; rare (>1/10,000 and <1/1,000): pruritus, rash and urticaria. Overdose: Refer to SPCs. Legal Category: POM. NHS Price: THORENS 10,000 I.U./ml oral drops, solution: £5.85 per bottle. THORENS 25,000 I.U./2.5ml oral solution: £1.55 per single- dose bottle; £5.85 per 4-pack. Marketing Authorisation Holder: Italfarmaco S.p.A., Viale Fulvio Testi, 330 – 20126 – Milano, Italy. MA Number: THORENS 10,000 I.U./ml oral drops, solution: PL 13297/0001. THORENS 25,000 I.U./2.5ml oral solution: PL 13297/0002. Full prescribing information available from: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, United Kingdom. Date of Preparation: June 2015.


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Galen Limited on 028 3833 4974 and select the customer services option,


or e-mail customer.services@galen-pharma.com. Medical information enquiries should also be directed to Galen Limited.


References 1. Data on File 01 Galen Limited. 2. MIMS, December 2015. 3. Thorens 10,000 I.U./ml oral drops, solution. Summary of Product Characteristics, January 2015. 4. Thorens 25,000 I.U./2.5ml oral solution. Summary of Product Characteristics, January 2015.


PMR-JAN-2016-0023 Date of Preparation: January 2016


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