In Setion 4.8 removal of first paragraph and addition of last paragraph:
4.2 Posology and method of administration
For subcutaneous or intramuscular injection or intravenous infusion (product specific), Miacalcic is to be used in individuals aged 18years or more.
Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy.
Prevention of acute bone loss:
The recommended dosage is 100 IU daily or 50 IU twice daily for 2 to 4 weeks, administered subcutaneously or intramuscularly. The dose may be reduced to 50 IU daily at the start of remobilisation. The treatment should be maintained until patients are fully mobilized.
Paget’s disease:
The recommended dosage is 100 IU per day administered subcutaneously or intramuscularly, however, a minimum dosage regimen of 50 IU three times a week has achieved clinical and biochemical improvement. Dosage is to be adjusted to the individual patient’s needs. The duration of treatment depends on the indication for treatment and the patient’s response. The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline. The dose may be reduced after the condition of the patient has improved.
Hypercalcemia of malignancy:
The recommended starting dose is 100 IU every 6 to 8 hours by subcutaneous or intramuscular injection. In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration.
If the response is not satisfactory after one or two days, the dose may be increased to a maximum of 400 IU every 6 to 8 hours. In severe or emergency cases, intravenous infusion with up to 10 IU/kg body weight in 500ml 0.9%w/v sodium chloride solution may be administered over a period of at least 6 hours.
As salmon calcitonin is a peptide, adsorption onto the plastic of the infusion set may occur. This has the potential to reduce the total dose delivered to the patient. Frequent monitoring of the clinical and laboratory response including the measurement of serum calcium is recommended especially in the early phases of treatment. The dosing of Miacalcic should be individualized to the patient’s specific requirements.
Use in elderly, hepatic and renal impairment patients
Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements. The same applies to patients with altered hepatic function. The metabolic clearance is much lower in patients with end-stage renal failure than in healthy subjects. However, the clinical relevance of this finding is not known (see section 5.2).
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.
In Section 10 date of revision of text changes:
10. DATE OF REVISION OF THE TEXT
11 November 2009
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