MIAKARIL

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

CALCITONIN, SALMON

Доступна с:

Novartis Ireland Limited

код АТС:

H05BA01

ИНН (Международная Имя):

CALCITONIN, SALMON

дозировка:

200 International Unit

Фармацевтическая форма:

Nasal Spray Solution

Тип рецепта:

Product subject to prescription which may be renewed (B)

Терапевтические области:

calcitonin (salmon synthetic)

Дата Авторизация:

2000-01-07

Характеристики продукта

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
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