I have installed the latest version of nitro pro 13 (13.53.3.1073) about a week or two ago and have an issue with windows explorer suspending every 60 seconds. This happens even if nitro pro is not open. I had this issue before with the same computer but running an older version of nitro pro 13 and thought updating to the newest would resolve it. I'm also running the latest windows updates as of a 1-2 weeks ago when I installed the newest version of nitro pro 13. Is there a specific version of nitro pro 13 I should be running to resolve this issue?
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I have already completely wiped the computer and reinstalled the software. I waited a couple weeks before installing nitro pro 13 to confirm that there was not an issue being caused by one of the other programs. Everything was running perfectly until I installed nitro pro. The issue also went away after uninstalling nitro pro. Any information on how to resolve this issue would be great as the product is completely unusable in its current state.
Nitro's desktop products are available on Windows and Mac. Nitro Cloud is compatible with any web browser on any machine. Nitro PDF Pro is proprietary trialware, while Nitro Reader is freeware for both personal and professional use.
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The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities.
EU regulators first became aware of nitrosamines in medicines in mid-2018 when nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were detected in blood pressure medicines known as 'sartans'.
EMA finalised a review under Article 5(3) of Regulation (EC) No 726/2004 in June 2020 to provide guidance to marketing authorisation holders on how to avoid the presence of nitrosamine impurities in human medicines.
The CHMP asked marketing authorisation holders to review all chemical and biological human medicines for the possible presence of nitrosamines and test products at risk by following the guidance on this page.
EMA and national competent authorities will continue to monitor the presence of nitrosamine impurities in medicines, in co-operation with regulators from outside the European Union (EU), and will work with marketing authorisation holders to find rapid solutions to address any adverse findings.
The group contains representatives from the CHMP, CMDh, EMA working parties, EDQM and EMA staff. It also acts as the main interface for the pharmaceutical industry stakeholders to discuss regulatory and scientific developments on nitrosamines with EMA and the European medicines regulatory network.
Marketing authorisation holders should review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.
Marketing authorisation holders should inform the national competent authorities for nationally authorised products or EMA for centrally authorised products as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected.
Marketing authorisation holders for centrally authorised products should send the completed template(s) only to nitrosamines.review.cap@ema.europa.eu using the subject 'Risk evaluation outcome/Risk identified or No risk identified/Marketing authorisation holder's name/Product name', as appropriate.
Marketing authorisation holders should only use the ''Step 2 - Nitrosamine detected above acceptable intake or new nitrosamine detected response template' if they have detected a nitrosamine in their product and it meets at least one of the following criteria:
Marketing authorisation holders for centrally authorised products should send the completed template(s) to nitrosamines.review.cap@ema.europa.eu using the subject 'Confirmatory testing outcome/Risk confirmed or Risk not confirmed/Marketing authorisation holder's name/Product name', as appropriate.
The extension aims to enable companies to perform a thorough investigation and to establish any required risk mitigating actions in light of new scientific developments since 2020, in particular those concerning active substance-derived nitrosamines.
In June 2020, the European medicines regulatory network published the outcome of a lessons learned exercise on the presence of nitrosamines in sartan medicines (also known as angiotensin II receptor antagonists). This includes recommendations to help reduce the risk of impurities in medicines and ensure that regulators are better prepared to manage cases of unexpected impurities:
This is a precautionary step to ensure patient safety while the investigation is ongoing. It is in line with the measures introduced by EMA's Article 5(3) review to limit the presence of nitrosamines in human medicines.
The risk to patients from not taking their rifampicin medicines far outweighs any potential risk from MeNP. Healthcare professionals should therefore continue to prescribe rifampicin medicines as normal in accordance with the product information.
The CHMP concluded that the marketing authorisation holder should make changes to Champix's authorisation to ensure that it conforms to acceptable nitrosamine intake limits for EU medicines, calculated in line with the ICH M7 guideline.
Such active substances contain vulnerable amine functional groups that can undergo a reaction called nitrosation (often a secondary amine). Nitrosamines are thought to form when the nitrosatable amine group in the active substances and trace nitrite impurities in the inactive ingredients (excipients) react.
If a risk is confirmed, they should prioritise confirmatory testing. If testing confirms the presence of nitrosamines, companies should immediately report their findings to the relevant competent authority. 2ff7e9595c
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