Company:
Kora HealthcareStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 August 2022
File name
Imunovir-spc.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2022
File name
Imunovir-PIL.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 26 June 2017
File name
PIL_15458_441.pdf
Reasons for updating
- New PIL for new product
Updated on 26 June 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
Updated on 14 August 2015
Reasons for updating
- Change to drug interactions
- Addition of information on reporting a side effect.
Updated on 11 March 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 March 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.4 the following text has been added:
In some people acute hypersensitivity reactions (urticarial, angioedema, anaphylaxis) may occur. Treatment with Imunovir should be withdrawn in these cases.
Imunovir contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.
In Section 4.5 the following text has been added:
Isoprinosine may be administered after but not concomitantly with immunosuppressive agents, as there may be a pharmacokinetic influence on the desired therapeutic effects.
Concomitant use with AZT increases AZT nucleotide formation through multiple mechanisms involving increased plasma AZT bioavailability and increased intracellular phosphorylation in human blood monocytes.
As a result Imunovir increases the effect of AZT.
Section 4.8 has been reformatted and includes the details for reporting of suspected adverse reactions.
In some people acute hypersensitivity reactions (urticarial, angioedema, anaphylaxis) may occur. Treatment with Imunovir should be withdrawn in these cases.
Imunovir contains wheat starch. Suitable for people with coeliac disease. Patients with wheat allergy (different from coeliac disease) should not take this medicine.
In Section 4.5 the following text has been added:
Isoprinosine may be administered after but not concomitantly with immunosuppressive agents, as there may be a pharmacokinetic influence on the desired therapeutic effects.
Concomitant use with AZT increases AZT nucleotide formation through multiple mechanisms involving increased plasma AZT bioavailability and increased intracellular phosphorylation in human blood monocytes.
As a result Imunovir increases the effect of AZT.
Section 4.8 has been reformatted and includes the details for reporting of suspected adverse reactions.
Updated on 24 August 2012
Reasons for updating
- New PIL for medicines.ie
Updated on 03 April 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Product Notice
Safety Notice
This product is not marketed in Ireland. UK-registered product (PL 39972/0001) is supplied to Kora Healthcare under Exempt Medicinal Product Supply Agreement.
Kora Healthcare
Address:
20 Harcourt Street, Dublin 2, D02 H364, IrelandMedical Information E-mail:
medinfo@korahealthcare.comTelephone:
+353 1 890 0406Fax:
+353 1 890 3016Website:
https://www.korahealthcare.com