OSTULEX

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

CALCITONIN, SALMON

Beschikbaar vanaf:

Novartis Ireland Limited

ATC-code:

H05BA01

INN (Algemene Internationale Benaming):

CALCITONIN, SALMON

Dosering:

200 International Unit

farmaceutische vorm:

Nasal Spray Solution

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

calcitonin (salmon synthetic)

Autorisatie datum:

2000-01-07

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ostulex 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 the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, solution.
Ostulex 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 Ostulex 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
Na