Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CALCITONIN, SALMON
Novartis Ireland Limited
H05BA01
CALCITONIN, SALMON
200 International Unit
Nasal Spray Solution
Product subject to prescription which may be renewed (B)
calcitonin (salmon synthetic)
2000-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Miakaril 200 IU Nasal Spray, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose delivers 200 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal Spray, solution. Miakaril 200 IU Nasal Spray is a liquid dosage form for local application using a spray device. The liquid takes the form of a clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures. A reduction in hip fractures has not been demonstrated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The recommended dosage of intranasal calcitonin for the treatment of established post-menopausal osteoporosis is 200 IU once a day. Use of intranasal calcitonin is recommended in conjunction with an adequate calcium and vitamin D intake. Treatment is to be administered on a long-term basis,_ (see section 5.1, Pharmacodynamic properties)._ It is recommended to administer Miakaril Nasal Spray per actuation to alternating nostrils. USE IN ELDERLY, HEPATIC AND RENAL IMPAIRMENT PATIENTS Extensive experience with the use of intranasal calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. The same applies to patients with altered renal or hepatic function. USE IN CHILDREN There is insufficient evidence to support the use of salmon calcitonin in conditions associated with paediatric osteoporosis. Use of salmon calcitonin in children 0 to 18 years is therefore not recommended. NOTE Full instructions for use by the patient are given in the package leaflet. 4.3 CONTRAINDICATIONS Hypersensitivity to calcitonin (see section 4.8.) or to any of the excipients listed in section 6.1. Calcitonin is also contraindicated in patients with hypocalcaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE N Soma hati kamili