Last Updated on eMC 14-04-2016 View medicine  | Sandoz Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:01-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Text crossed out has been removed. Emboldened text has been added.

Section 4.2

In children under 1 year of age the medicinal product should only be used with one of these spacer devices.


Section 4.4

AirSalb

for respiratory disease, should be warned to seek medical advice if they

 

experience chest pain or other symptoms of worsening heart disease.


Section 4.9

In case

or of more pronounced hypotension

 


Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:30-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8: Additional information was added.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator. Sabumalin should be discontinued immediately, the patient assessed, and, if necessary, alternative therapy instituted.

Section 6.6: Additional information in disposal was added.


 

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:28-10-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2:
Minor gramtical changes, a repleaced by the.

Section 4.1:
indication of adults, adolescents and childeren also aged specified.

Section 4.2:
addition of sub sectio posology.
Age specification for Adolecensts.
addition of sub section paediatric polulation.
Indication of dosage increase if required in children.
Indication of maximum dosage in a day.

Section 4.3:
addtion of 'listed in section 6.1'

Section 4.4:
Airslab repleaced with salbutamol.

Section 4.6:
Section name updated.
lactaion replaced with Breast-feeding.

Seciton 4.8:
Organ system -adverse reactions class updated for immune system disorders.
Addition of reporting of side effects.

Section 4.9:
minor gramatical changes; are repleaced with is.

Section 5.1:
Salbutamol replaced with Airslab.
Addtion of sepcial pouplations sub section indicating children under 4 years of age.

Section 6.6:
Section name updated to add other handling.

Section 10.:
Date repleaced with 28/10/2015>









Reasons for adding or updating:

  • Change of product licence name

Date of revision of text on the SPC:24-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Product name change to AirSalb CFC-free inhaler 100 microgram/dose.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to MA holder contact details

Date of revision of text on the SPC:01-11-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Correction of Medicinal Product Name
Address details of MA holder amended.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:17-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1, name changed to Salbumalin 100mcg/dose inhaler
Section 10, date updated

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO