Summary of Product Characteristics
last updated on the eMC:
18/01/2012
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 18/01/2012 and displayed until Current
|
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: 19-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.8
Sections principally reformated into a tabular format, with some rewording to the text and also to change the frequency of intracranial haemorrhage from uncommon, to rare.
Section10
Date of revision of text amended to 19 December 2011.
|
|
Updated on 04/08/2011 and displayed until 18/01/2012
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
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 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 29-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.3
Sentence added: "Also contraindicated is the use of the alpha-1 adrenoceptor antagonist alfuzosin, and sildenafil when used for the treatment of pulmonary arterial hypertension."
Section 4.4
Text deleted "current antiretroviral therapy has not been proven to prevent the risk of transmission of HIV to others through blood or sexual contact" and replaced with "there is still a risk of passing HIV to others through blood or sexual contact when taking APTIVUS".
Paragraphs also added on Colchicine, Salmeterol and Bosentan.
Section 4.5
Lines added regarding "Integrase strand transfer inhibitors", "Colchicine", "Bosentan", "Salmeterol", "Nucleoside analogue DNA polymerase inhibitors", "Alpha 1-adrenoreceptor antagonists". Updated information in line for "Sildenafil/Vardenafil" and "Tadalafil".
Section 5.1
Paragraph added on ECG evaluation.
Section 10
Date of revision amended.
|
|
Updated on 26/10/2010 and displayed until 04/08/2011
|
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 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2
Title of Posology added above paragraph beginning "Patients should be advised of the need ....."
Title of Paediatrics amended to Paediatric popution.
Information regarding use in children under 2 - minor editorial changes.
Addition of Paragraph Method of Administration - regarding taking with food at end of this section.
Section 4.4
Sentence "Therfore tipranavir with ritonavir should not be used in treatment-naive patients."
Section 4.6
The word "Fertility" included in heading, sub-headings of Pregnancy, Contraception in males and females, breastfeeding and Fertility with new paragraph on fertility included.
Section 4.8
This SPC change is following renewal of the licence, this section has been re-ordered, with too many changes to list in detail here.
Section 4.9
Sentence added "Human experience with tipranavir overdose is very limited. No specific signs and symptoms of overdose are known. Generally, an increased frequency and higher severity of undesirable effects may result from overdose."
Section 5.1
"Antivirals for systemic use" added after Pharmacotherapeutic group.
Paediatric patients changed to Paediatric population.
Section 5.2
Sub-heading of metabolism amended to Biotransformation.
Sub-heading of Paediatrics amended to Paediatric population.
Section 9
Date of latest renewal added.
Section 10
Date of revision of text amended.
|
|
Updated on 25/01/2010 and displayed until 26/10/2010
|
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 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 23-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2
Additional paragraph shown below added:
Patients should be advised of the need to take APTIVUS and ritonavir every day as prescribed. If a dose is missed by more than 5 hours, the patient should be instructed to wait and then to take the next dose of APTIVUS and ritonavir at the regularly scheduled time. If a dose is missed by less than 5 hours, the patient should be instructed to take the missed dose immediately, and then to take the next dose of APTIVUS and ritonavir at the regularly scheduled time.
Section 4.4
Spelling of Haemophiliac corrected.
Paragraphs starting Atorvastin and Omeprazole slightly amended
Section 4.5 re-written into a tabular format.
Section 4.8 typographical errors in spelling of paediatric, Diarrhoea, Anaemia and pruritic corrected.
Section 5.2 "Data are awaited to substantiate the influence of food on oral absorption." deleted.
Section 10
Date of revision amended
|
|
Updated on 13/10/2009 and displayed until 25/01/2010
|
Reasons for adding or updating:
|
|
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
