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Direct Healthcare Professional Communication (DHPC) on Giapreza 2.5 mg/ml concentrate for preparation of infusion solution: potentially low fill vials and important information regarding instructions for use PDF, 157KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: angiotensin II

The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.

Direct Healthcare Professional Communication (DHPC) on Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage (number of drops per millilitre) PDF, 274KB, File does not meet accessibility standards Date: 08. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium perchlorate

Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage a different dosage (number of drops per millilitre).

Direct Healthcare Professional Communication (DHPC) on oral retinoids (acitretin, alitretinoin and lsotretinoin): Reminder of existing restrictions to prevent exposure during pregnancy PDF, 383KB, File is accessible Date: 02. May 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: acitretin, alitretinoin, isotretinoin

The marketing authorisation holders of acitretin-, alitretinoin- and isotretinoin-containing medicinal products remind you of the pregnancy prevention program for oral retinoids.

Direct Healthcare Professional Communication (DHPC) on Paxlovid (nirmatrelvir, ritonavir): drug interactions with certain immunosuppressants, including tacrolimus PDF, 371KB, File is accessible Date: 21. March 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nirmatrelvir, ritonavir

Pfizer reminds of already known drug interactions of paxlovid with certain immunosuppressants, including tacrolimus, with potentially life-threatening and fatal consequences.

Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism PDF, 401KB, File is accessible Date: 23. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: chlormadinone acetate, ethinyl estradiol

The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.

Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate PDF, 955KB, File is accessible Date: 19. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.

Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome Date: 15. February 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pseudoephedrine

Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.

Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection PDF, 1MB, File is accessible Date: 21. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Inclisiran

The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.

Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis PDF, 325KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.

Direct Healthcare Professional Communication (DHPC) on etoposide (not etoposide phosphate): hypersensitivity reactions with the use of inline filters PDF, 237KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoposide

The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.