Noxafil 40 mg/ml oral suspension
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal 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 13 August 2024
File name
NOXAFIL-Oral-Susp-H-C-0610-PSUSA202310-SPC-IE-en-Aug2024.pdf
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC section 4.4 - interaction with flucloxacillin & photosensitivity reaction added.
SPC section 4.5 – interaction with flucloxacillin added.
SPC section 4.8 – photosensitivity reaction added.
SPC section 10 - the last revision date.
Updated on 13 August 2024
File name
QRD-IE-MT-NOXAFIL-oral susp-LFT-PSUSA202310-082024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Warnings re interaction with flucloxacillin & photosensitivity reaction are added.
Updated on 02 May 2024
File name
QRD-IE-MT-NOXAFIL-oral susp-LFT-N-085-042024.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 22 June 2023
File name
QRD-IE-MT-NOXAFIL-oral-susp-LFT-add Haarlem-062023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 April 2023
File name
NOXAFIL-40mg-ml-oral-susp-H-C-0610-II077-SPC-IE-en-Feb2023.pdf
Reasons for 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – editorial correction in relation to the number of formulations.
Section 4.4 – editorial updates - underline 'Venetoclax toxicity'.
Section 10 – the last revision date.
Updated on 14 February 2023
File name
NOXAFIL 40mg-ml-oral susp-H-C-0610-X063G-II067-SPC-IE-en-Feb 2022.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
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SPC document format updated to html.
Updated on 15 December 2022
File name
QRD-IE-MT-Noxafil-oral susp-LTF-SNC_HEI-Nov2022.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Batch release site name change from 'Schering-Plough Labo nv' to 'Organon Heist bv’ (the legal entity name change only, the address remains the same).
Updated on 18 February 2022
File name
NOXAFIL 40mg-ml-oral susp-H-C-0610-X063G-II067-SPC-IE-en-Feb 2022.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 – reference to paediatric formulation.
Section 4.3, 4.4 & 4.5 – changes relates to interaction with venetoclax.
Section 4.8 – Reference to new formulation (gastro resistant powder and solvent for oral suspension).
Section 5.1 – changes relate to the paediatric population.
Section 10 – The last revision date is updated.
Note: Number of editorial changes throughout the SPC have been made such as extra space deletions etc.
Updated on 18 February 2022
File name
QRD-IE-MT-Noxafil-oral susp-LTF-X063G+II067-Feb2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Change to section 2 - what you need to know – contraindications - changes relates to interaction with venetoclax.
Change to section 2 - what you need to know - warnings and precautions - changes relates to interaction with venetoclax.
Change to section 2 - interactions with other medicines, food or drink - changes relates to interaction with venetoclax.
Change to section 3 - how to take/use – reference to new formulation.
Correction of spelling/typing errors - Number of editorial changes have been made such as extra space deletions etc.
Change to date of revision - The last revision date is updated.
Updated on 11 November 2021
File name
NOXAFIL 40mg-ml-oral susp-H-C-0610-II-062-SPC-IE-en-Oct 2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.1 – Reference is made to the SPCs of Noxafil concentrate for solution for infusion and Noxafil gastro-resistant tablets for use in primary treatment of Invasive Aspergillosis
Section 4.8 – The frequency of side effect ‘pseudoaldosteronism’ is updated from ‘not known’ to ‘rare’
Section 5.1 – New information added - one paragraph is added with the in-vitro data collected in the period from 2010 to 2018 and few other updates are made
Section 5.2 – New information added - the paragraph re: posaconazole clearance related to patients’ weight is updated
Section 10 – The last revision date is updated
Note: Number of editorial changes throughout the SPC have been made such as trade name ‘Noxafil’ replaced with active substance name ‘posaconazole’, spelling corrections, etc.
Updated on 11 November 2021
File name
Noxafil-oral susp-LFT QRD-IE-MT-II-062-Oct 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 2 – What you need to know before you take Noxafil – editorial changes
Change to section 4 – Possible side effects – Frequency of side effect ‘pseudoaldosteronism’ is updated from ‘not known’ to ‘rare’/ editorial changes / spelling corrections / spaces
Updated on 23 September 2021
File name
QRD-IE-MT-Noxafil-oral susp-LFT-PSUSA-Aug2021.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
interaction with other medicines - co-administration of Noxafil with ASTA (also called tretinoin)
Updated on 23 September 2021
File name
NOXAFIL 40mg-mL-oral susp-H-C-0610-PSUSA-SPC-IE-en-Aug2021.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 – effects of co-administration of Noxafil with ASTA (also called tretinoin); Section 10 – Date of the last text revision is updated
Updated on 15 January 2021
File name
QRD-IE-Noxafil-oral susp-LFT-IB-064-Dec2020 (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 October 2020
File name
NOXAFIL 40mg-mL-oral susp-H-C-0610-IB-061-SPC-IE-en-CRT-Sep2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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SPC change details: Sect 2 – Information about Excipients added; Sect 4.4 - Excipients warnings added in line with EU Excipient guideline; Sect 6.1 E number for propylene glycol is added; Sect 10 – Text revision date is updated
Updated on 05 October 2020
File name
QRD-IE-Noxafil PIL 40mg-oral susp-LFT-IB-061-Sep2020 (002).pdf.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 13 November 2019
File name
QRD_IE_Noxafil_40_mg-mL_oral_suspension_PIL_CRT.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Changes to Section 2, Section 4 and Section 6
Updated on 13 November 2019
File name
Noxafil_40_mg-mL_oral_suspension_SPC_CRT.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8: Tabulated list of adverse reactions is updated & Section 10- Date of revision of test is updated
Updated on 18 September 2018
File name
QRD NOXAFIL PIL QRD Oral Soln MAT Brexit updated ml IE.pdf
Reasons for updating
- Change to further information section
Updated on 18 September 2018
File name
QRD NOXAFIL PIL QRD Oral Soln MAT Brexit updated ml.pdf
Reasons for updating
- Change due to harmonisation of PIL
Updated on 10 September 2018
File name
NOXAFIL-H-C-0610-T-054-PI-en-IE Oral Soln.pdf
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to harmonize mL to ml with artworks for Noxafil Oral Solution
Updated on 25 July 2018
File name
QRD NOXAFIL PIL QRD Oral Soln MAT Brexit (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 July 2018
File name
NOXAFIL-H-C-0610-T-054-PI-en-IE Oral Soln (2).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to section 7. Marketing Authorisation Holder and Section 10 – Date of revision of the text following approval of MA Transfer
Updated on 26 May 2017
File name
PIL_14542_701.pdf
Reasons for updating
- New PIL for new product
Updated on 26 May 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 23 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2017
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC change details: Updates to sections 4.4, 4.5, and 10 as a result of approval of Type II variation EMEA/H/C/000610/II/0048 to strengthen language on drug-drug interaction for azole antifungals, including posaconazole, with vincristine.
Updated on 24 February 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 30 September 2016
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 28 September 2016
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 August 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 01 September 2015
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 07 November 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 06 October 2014
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to SPC sections 4.2. 4.4, 4.5, 4.6, 4.7, 4.8, 5.2 & 10
Updated on 02 June 2014
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The changes made to the SPC are as follows:
|
Section 4.1: Therapeutic indications- |
- Noxafil updated to Noxafil oral suspension, editorial changes.
|
|
Section 4.2: Posology and method of administration-
|
- paragraph added to align with Noxafil tablet SPC - Noxafil is also available as 100 mg gastro resistant tablets. Noxafil tablets are the preferred formulation. - Editorial changes to Table 1. Recommended dose according to indication - Paediatric population – and adolescents added |
|
Section 4.4: Special warnings and precautions for use
|
- editorial change in hepatic toxicity paragraph – hepatic insufficiency changed to hepatic impairment - Monitoring of hepatic function – sentence added – Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
|
|
Section 4.5: Interaction with other medicinal products and other forms of interaction
|
- Fosamprenavir – oral suspension added after posaconazole - Phenytoin added as a heading - Headings Alcohol, Herbal medicinal products and Smoking deleted from section 4.4
|
|
Section 4.8: Undesirable effects |
- paragraph added – The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials. The safety profile of tablets was similar to that of the oral Suspension - Tabulated list of Adverse reactions – aligned with Noxafil 100 mg Tablets - Metabolism and nutrition disorders: Common: hypokalaemia; Uncommon: hyperglycaemia - Nervous system disorders: Uncommon: aphasia, insomnia - Cardiac disorders: Uncommon: bradycardia, superventricular extrasystoles, tachycardia - Vascular disorders: Uncommon: vasculitis - Respiratory, thoracic and mediastinal disorders: Uncommon: cough, epistaxis, hiccups, pleuritic pain - Gastrointestinal disorders: Very Common: nausea; Common: constipation; Uncommon: Gastrooesophageal reflux disease, oedema mouth - Skin and subcutaneous tissue disorders: Common: rash, pruritis - Musculoskeletal and connective tissue disorders: Uncommon: pain in extremity - General disorders and administration site conditions: Uncommon: mucosal inflammation
- Reporting of suspected adverse reactions paragraph added .
|
|
Section 5.1: Pharmacodynamic properties |
– ECOFF Values for Aspergillus spp – added - ECOFF values do not equate to clinical breakpoints. Also added study number 0041 |
|
Section 5.3: Preclinical safety data |
– Echocardiography revealed no |
Updated on 30 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
Updated on 04 November 2013
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC update of section 5.1 by inclusion of Epidemiology Cut-off Values (ECOFFs) for Aspergillus spp
5.1 Pharmacodynamic properties
…
Resistance
Clinical isolates with decreased susceptibility to posaconazole have been identified. The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance have been determined by EUCAST methodology.
EUCAST ECOFF values:
Aspergillus Flavus: 0.5 mg/L
Aspergillus fumigatus : 0.25 mg/L
Aspergillus nidulans: 0.5 mg/L
Aspergillus niger: 0.5 mg/L
Aspergillus terreus: 0.25 mg/L
There are currently insufficient data to set clinical breakpoints for Aspergillus spp.
Updated on 12 July 2013
Reasons for updating
- Change to date of revision
Updated on 11 September 2012
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The changes made are as follows:
1. Section 5.1 (Pharmacodynamic properties): addition of EUCAST breakpoints for posaconazole against Candida albicans, Candida tropicalis and Candida parapsilosis. We have also stated the there is currently insufficient data to set breakpoints for the other Candida species.
2. Section 10 (Date of revision of the text): has been updated.
3. Correction of some formatting errors in document.
Updated on 07 September 2012
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 31 January 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 January 2012
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.5 Interaction with other medicinal products and other forms of interaction
Fosamprenavir: Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations. If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended. Repeat dose administration of fosamprenavir (700 mg BID x 10 days) decreased the Cmax and AUC of posaconazole (200 mg QD on the 1st day, 200 mg BID on the 2nd day, then 400 mg BID x 8 Days) by 21 % and 23 %, respectively. The effect of posaconazole on fosamprenavir levels when fosamprenavir is given with ritonavir is unknown.
Paediatric population
Interaction studies have only been performed in adults.
There have also been typograpical changes made throughout the document.
Updated on 06 January 2012
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Change to improve clarity and readability
Updated on 24 October 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 October 2011
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 29 June 2011
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 16 February 2011
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 03 November 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC have been updated:
2 - Glucose is mentioned as an excipient in the medicinal product.
4.2 - Some new headings have been added. Information on patients with severe gastrointestinal dysfunction has been removed and information on paediatric population has been updated. New section on method of administration added.
4.4 - Some new headings added. New information about Gastrointestinal dysfunction added. Information about Rifabutin deleted.
4.5 - Interactions with food, Alcohol, Herbal medicinal products and smoking added
4.6 - Headings, 'Pregnancy and Breast-feeding', have been added and an additional section on fertility including information from preclinical studies has also been added. The following statement is included: There is no clinical experience assessing the impact of posaconazole on fertility in humans.
4.7 - The following has been added to this section:
Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
4.8 - Table headings and other minor changes updated but no additional adverse events.
4.9 - Has been updated with the following statement:
There is no special treatment available in the case of overdose with posaconazole. Supportive care may be considered.
5.2 - New heading added.
6.6 - Updated to include disposal in accordance with local requirements.
Updated on 26 October 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to date of revision
Updated on 25 August 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 25 January 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 16 December 2009
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Title of Pregnancy and lactation changed to "Fertility, pregnancy and lactation"
4.8
Addition of "not known (cannot be estimated from the available data)" to the header of Table 2.
Addition of "not known" and "confusional state" to the psychiatric disorders section of Table 2.
10.0
Change of date from "28 October 2009" to "23 November 2009"
Updated on 24 November 2009
Reasons for 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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Tabel 1: Row 1:Change of "Dose from 400mg (10ml) twice a day...." to 2"00mg (5ml) four times a day. Alternatively, patients who can tolerate food or a nutritional supplement may take 400mg (10ml) twice a day during or immediately followign a meal or nutritional suppliment"
Table 1: Row 2: Addition of "during or immediately after" before "meal..."
Table 1: Row 3: Addition of "during or immediately after" before "meal..."
Paragraph 5: Change of imparment to insufficiency, and change of sentence to explain the same thing (limited data on effect of hepatic insufficiency demonstrates an increase in plasma exposure) and adds that this does not suggest that dose adjustment is necessary.
4.4 PAragraph 2: last sentence replaced with "posaconazole shoudl be used with caution in patients with hepatic insufficiency due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these pateints (see section 5.2)"
4.5 H2 receptor antag paragraph: Removal of text from "Concomintant use of posaconazole and cimetidine.." and replaced with "Co-administration os posaconazole with H2 receptor antagonists shoudl be avoided if possible. Similarly, administration of 400mg posaconazole with esomeprazole (40mg daily) decreased mean Cmax and AUC by 46% and 32% respectively, compared to dosing with 400mg posaconazole alone. co-administration of posaconazole with proton pump inhibitors should be avoided if possible"
5.2 Effect of Food paragraph: Replacement of whole paragraph with "The absorption of posaconazole was significantly increased when posaconazole 400 mg (QD) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively. The AUC of posaconazole is: 4 times greater when administered with a high-fat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5)."
5.2 Hepatic "inpairment" changed to insufficiency and whole paragraph replaced
10. Date of revision changed from 4 December 2008 to 28 October 2009
Updated on 23 December 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 March 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4
From:
Hepatic toxicity: In clinical trials, there were reports of hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) during treatment with posaconazole. Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy. Rarely, more severe hepatic reactions including cholestasis or hepatic failure were reported in patients with serious underlying medical conditions (e.g. hematologic malignancy) during treatment with posaconazole.
Posaconazole should be used with caution in patients with severe hepatic impairment. In these patients, the prolonged elimination half-life may lead to increased exposure.
To:
Hepatic toxicity: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole. Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy. Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Posaconazole should be used with caution in patients with severe hepatic impairment. In these patients, the prolonged elimination half-life may lead to increased exposure.
Section 4.8
The following sentence has been added at the end of this section:
During post marketing surveillance severe hepatic injury with fatal outcome has been reported (see section 4.4).
Section 10
Date of revision of text updated
Updated on 13 November 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)