Summary of Product Characteristics
last updated on the eMC:
27/01/2010
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 27/01/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 11-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 4.2 amended wording under Use in Children:
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).
It is recommended to administer Miacalcic 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
As intranasal calcitonin is indicated for post-menopausal women, its use in children is not appropriate. 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.
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Updated on 17/12/2008 and displayed until 27/01/2010
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 07-May-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SECTION 9:
Date of renewal of authorisation corrected
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Updated on 05/12/2007 and displayed until 17/12/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Addition of the following information:
"It is recommended to administer Miacalcic Nasal Spray per actuation to alternating nostrils."
Section 4.5: Addition of the following information
"Concomitant use of calcitonin and lithium may lead to a reduction in plasma lithium concentrations. The dose of lithium may need to be adjusted."
Section 4.7: Section has been reworded.
Section 4.8: Rewording and reclassification of undesirable effects.
Section 5.2: Section has been reworded.
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Updated on 28/09/2006 and displayed until 05/12/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 17/01/2006 and displayed until 28/09/2006
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Updated on 10/03/2005 and displayed until 17/01/2006
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Updated on 09/11/2001 and displayed until 10/03/2005
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Reasons for adding or updating:
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