CALCITONIN Solution for injection / infusion Ref.[49935] Active ingredients: Calcitonin

Salmon calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy.

Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose.

Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures

The recommended dosage is 100 IU daily or 50 IU twice daily administered subcutaneously or intramuscularly. The dose may be reduced to 50 IU daily at the start of remobilisation. The recommended treatment duration is 2 weeks and should not exceed 4 weeks in any case due to the association of the increased risk of malignancies and long term calcitonin use.

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. Treatment should be discontinued once the patient has responded and symptoms have resolved. Duration of treatment should not normally exceed 3 months due to evidence of an increased risk of malignancies with long term calcitonin use. Under exceptional circumstances, e.g. in patients with impending pathologic fracture, treatment duration may be extended up to a recommended maximum of 6 months. Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4). The effect of calcitonin may be monitored by measurement of suitable markers of bone remodeling, 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 Calcitonin should be individualized to the patient’s specific requirements.

Older people

Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements.

Patients with hepatic impairment

Experience with the use of calcitonin in patients with altered hepatic function has shown no evidence of reduced tolerability or altered dosage requirements.

Patients with renal impairment

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).

Paediatric population

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.

Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally. Single doses (up to 10,000 IU) of injectable salmon calcitonin have been administered without adverse reactions, other than nausea and vomiting, and exacerbation of pharmacological effects.

Should symptoms of overdose appear, treatment should be symptomatic.

5 years.

Store in a refrigerator (2°C-8°C). Do not freeze

From a microbiological point of view, this medicine should be used immediately after it has reached room temperature if it is to be injected or immediately after dilution in 0.9% w/v sodium chloride in soft PVC bags only, if it is to be infused

For additional instructions please refer to sections 6.3 and 6.6.

Type I, clear glass ampoule containing 1ml of solution. Calcitonin ampoules 50 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. Not all pack sizes may be marketed.

Calcitonin ampoules 50 IU/ml should be inspected visually. If the liquid is not clear and colourless, or contains any particles, or the ampoule is damaged, do not use the medicine.

Solutions for infusion should be prepared immediately before use in soft plastic PVC infusion bags. Glass or hard plastic i.v. containers should not be used.

The ampoules are for single use only. Remaining contents should be discarded. Allow to reach room temperature before intramuscular or subcutaneous use.