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Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 692 255
Fax: +44 (0)1276 698 449
Medical Information Direct Line: +44 (0)1276 698 370
Medical Information e-mail: medinfo.uk@novartis.com
Customer Care direct line: +44 (0)845 741 9442

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 23/01/2012
SPC Miacalcic 400 IU/2ml Solution for Injection and Infusion

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 23/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following changes have been made as shown below:

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Multidose vials containing calcitonin BP 400IU/ml

 

For the full list of excipients, see section 6.1.

 

4.3  Contra-indications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Calcitonin is also contraindicated in patients with hypocalcaemia.


4.6  Pregnancy and lactation

 

Pregnancy

Calcitonin has not been studied in pregnant women.  Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.


Breast-feeding

It is not known if the substance is excreted in human milk.  In animals, salmon calcitonin has been shown to decrease lactation and to be excreted in milk (see 5.3).  Therefore, breast-feeding is not recommended during treatment.

8.    MARKETING AUTHORISATION NUMBER

 

PL 00101/0203

 
Updated on 19/12/2011 and displayed until 23/01/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Updated to Section 4.8 to include 'tremor' as an unknown adverse drug reaction.

Nervous system disorders:

Common:                         Dizziness, headache, dysgeusia

Not known:                        Tremor
Updated on 13/10/2010 and displayed until 19/12/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The following paragraph has been added to the beginning of Section 4.2:

The solution provided in the multidose vial can be used for subcutaneous or intramuscular injection or for continuous i.v. infusion , but is not suitable for i.v. bolus injection as it contains phenol (5mg/mL) as a preservative.
Updated on 18/12/2009 and displayed until 13/10/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
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
The following changes have been made to section 4.2:

The following text has been deleted:

"For subcutaneous, intramuscular or intravenous use, in individuals aged 18 years or more."

The following text has been added:

"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."
Updated on 24/09/2008 and displayed until 18/12/2009
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   30-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SECTION 4.2

 

The following paragraph has been added:

 

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 phase of treatment. The dosing of Miacalcic should be  individualized to the patient’s specific requirements.

 

SECTION 4.5

 

The following has been added:

 

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

 

Fatigue and visual disturbances added

 

SECTION 4.8

 

·        The following footnotes have been added:

 

1 Neutralising antibodies to calcitonin rarely develop.  The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product. The presence of antibodies appears to bear no relationship to allergic reactions, which are rare.  Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long term therapy.

 

2Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin. The effect is more evident on initiation of therapy and tends to decrease or disappear with continued administration or a reduction in dose. An antiemetic may be administered, if required. Nausea/vomiting are less frequent when injection is done in the evening and after meals.

 

3In case of patients with high bone remodelling (Paget’s disease and young patients) a transient  decrease of calcemia may occur  between the 4th and the 6th hour after administration, usually asymptomatic.

 

4Flushing (facial or upper body)is not an allergic reaction but is due to pharmacological effect, and is usually observed 10 to 20 minutes after administration.

 

·        The following have been added:

 

The most frequently observed undesirable effects are nausea, vomiting and flushing. They are dose dependent and are more frequent after i.v. than after i.m. or s.c administration.

 

Headache, dysgeusia, visual disturbance, abdominal pain, polyuria, pruritus, hypertension.

 

The frequencies of the above listed undesirable effects are partly based on results from clinical trials with Miacalcic Nasal Spray

 

SECTION 5.2

 

·        The following has been added to the 1st paragraph:

 

After subcutaneous administration, peak plasma levels are reached in about 23 minutes.

 

·        The following heading has been added:

 

     General characteristics of the active substance

 

·        The following sentence has been added to the 3rd paragraph:

 

The elimination half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for subcutaneous administration
Updated on 28/09/2006 and displayed until 24/09/2008
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
 Separate text for MDV and Amps submitted (was previously on eMC as a joint text)
Updated on 26/05/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   11/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
 
Previously on eMC as joint text (ampoules and multidose vial). Resubmitted as separate text for multidose vial only

Active Ingredients/Generics

 
  calcitonin (salmon)