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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 22 July 2020

Nephrolithiasis (kidney stones) has been added as an adverse event of unknown frequency.

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 07 August 2020

Polyneuropathy has been reported in treated patients therefore SPC advises that before starting therapy, and periodically thereafter, patients should be evaluated for history or signs of...

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 07 August 2020

SPC does not recommend co-administration of glecaprevir/pibrentasvir with Atripla and due to occasional reports of contraceptive failure with etonogestrel in efavirenz-exposed pts, a reliable method...

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 07 August 2020

Use in now contraindicated in severe renal insufficiency (creatinine clearance < 10 ml/min) and haemodialysis. Based on safety and efficacy data which do not indicate any malformative or...

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 07 August 2020

SPC details that this vaccine complies with the WHO recommendation (northern hemisphere) and EU recommendation for the 2020/2021 season.

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 07 August 2020

The following immune-related adverse reactions have been observed in patients treated with monotherapy: meningitis (rare), encephalitis and Guillain-Barre syndrome (both frequency unknown).

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 06 August 2020

Information on colestipol affecting the absorption of chlorothiazide has been added to the SPC. It also notes that colestipol may reduce mycophenolic acid exposure and potentially reduce efficacy of...

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 06 August 2020

Sections 4.4 and 4.5 have been updated with information on a drug-drug interaction with rifampicin and clopidogrel, based on a literature review and a review of the marketing authorisation holder’s...

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Prescribing and Technical Information (Remove filter)

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electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 06 August 2020

The pregnancy section has been updated with data from two large observational studies (one EU and one US); these do not suggest an overall increased risk of major congenital malformation, but the...

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SPS comment

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Prescribing and Technical Information (Remove filter)

Source:

electronic Medicines Compendium - eMC (Remove filter)

Published by electronic Medicines compendium, 31 July 2020

SPC updated with warnings regarding risk of interstitial lung disease and pneumonitis and related dose modification recommendations including dose interruption, reduction or discontinuation depending...

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Prescribing and Technical Information (Remove filter)