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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.

Direct Healthcare Professional Communication (DHPC) on Furosemid-hameln 10 mg/ml (250 mg in 25 ml; 10 x 25 ml ampoules; PZN 16833989): visible particles PDF, 155KB, File is accessible Date: 12. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: furosemide

Furosemide-hameln ampoules may contain isolated visible particles. The batches mentioned should be checked visually before use.

Direct Healthcare Professional Communication (DHPC) on hydroxyethyl starch (HES) solutions for infusion: measures to minimise risks associated with off-label use PDF, 187KB, File is accessible Date: 21. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) has decided that the conditions for lifting the suspension are meanwhile fulfilled. Infusion solutions containing HES may only be used in the approved indications.

DHPC (Rote-Hand-Brief) on Profact Depot 9.45 mg 3-month implant: Risk of premature implant dissolution/future adjustment of the storage temperature PDF, 142KB, File is accessible Date: 17. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Buserelin

The company Cheplapharm Arzneimittel GmbH informs about an insufficient release of the active substance in the last time fraction (day 78 - 91) of the in vitro dissolution test.

Direct Healthcare Professional Communication (DHPC) on omega-3 fatty acid-containing drugs: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors PDF, 251KB, File is accessible Date: 16. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: omega-3 fatty acid

The marketing authorisation holders of medicines containing omega-3 fatty acids inform that systematic reviews and meta-analyses of randomised controlled trials show a dose-dependent increased risk of atrial fibrillation.

Direct Healthcare Professional Communication (DHPC) on topiramate: New restrictions to prevent exposure during pregnancy PDF, 206KB, File is accessible Date: 02. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: topiramate

The marketing authorisation holders of medicinal products containing topiramate provide information on the implementation of a pregnancy prevention programme for topiramate.

Direct Healthcare Professional Communication (DHPC) on InfectoCillin powder for oral solution: Defective sealing insert in the cap PDF, 152KB, File does not meet accessibility standards Date: 28. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Phenoxymethylpenicillin potassium

The company InfectoPharm Arzneimittel und Consilium GmbH informs about a quality defect of the medicinal products InfectoCillin 400 powder for oral solution, 100 ml and InfectoCillin 500 powder for oral solution, 100 ml due to a defect of the cap.

Direct Healthcare Professional Communication (DHPC) on fentanyl-containing transdermal patches: late inclusion of a warning on accidental use PDF, 426KB, File is accessible Date: 01. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

Marketing authorization holders of fentanyl-containing transdermal patches provide information on the delayed inclusion of an accidental use warning on the outer packaging and, if applicable, the patches sachets.

Information Letter on Zeposia (Ozanimod): Modified dosing recommendation for mild or moderate chronic hepatic impairment (Child-Pugh class A or B) PDF, 134KB, File is accessible Date: 18. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ozanimod

Bristol Myers Squibb provides information on the recommendation for dose reduction in mild or moderate chronic hepatic impairment.

The restrictions on the use of mitomycin preparations from Medac GmbH for intravenous administration are lifted PDF, 484KB, File does not meet accessibility standards Date: 17. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

Medac GmbH informs about the lifting of the restrictions on the use of its mitomycin preparations for intravenous administration.

Information Letter on Octenident antiseptic (octenidine dihydrochloride): Reducing drug and application risks PDF, 146KB, File is accessible Date: 14. August 2023 Type: Direct Healthcare Professional Communication

Active substance: octenidine dihydrochloride

Information Letter for healthcare professionals on reducing drug and application risks of Octenident antiseptic.

Direct Healthcare Professional Communication (DHPC) on Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL PDF, 243KB, File is accessible Date: 01. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vosoritide

BioMarin International Limited in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that from August 2023, Voxzogo co-packs will contain new solvent needles and …

Direct Healthcare Professional Communication (DHPC) on L-Thyroxin Aristo (levothyroxine sodium): Tablets in new composition - information and close monitoring of patients during the switch PDF, 850KB, File does not meet accessibility standards Date: 17. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levothyroxin sodium

Aristo Pharma GmbH informs about a new composition of L-thyroxine Aristo tablets, which will be available from August 2023. A close control is recommended.

Direct Healthcare Professional Communication (DHPC) on Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion of the company Medac: Recall of three batches PDF, 232KB, File does not meet accessibility standards Date: 14. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Dacarbazine

Medac Gesellschaft für klinische Spezialpräparate mbH informs about a precautionary recall of the batches G220299AH, D220154AB and D220154AF of the medicinal product Detimedac 500 mg and Detimedac 100 mg powder for solution for infusion.

Direct Healthcare Professional Communication (DHPC) on Noxafil (posaconazole): new dosage form – risk of medication error PDF, 434KB, File does not meet accessibility standards Date: 07. July 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: posaconazole

Merck Sharp & Dohme B.V. provides information about the new dosage form of Noxafil and the risk of associated medication errors.

Direct Healthcare Professional Communication (DHPC) on Gavreto▼ (pralsetinib): Increased risk for tuberculosis and measures to minimize this risk PDF, 389KB, File is accessible Date: 16. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pralsetinib

Roche Pharma AG informs about the occurrence of mostly extrapulmonary tuberculosis in patients treated with Gavreto.

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolone antibiotics: reminder on restrictions of use PDF, 379KB, File does not meet accessibility standards Date: 07. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin

The marketing authorisation holders of fluoroquinolone antibiotics in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), would like to remind of the recent study data which suggest that …

Direct Healthcare Professional Communication (DHPC) on Cyclophosphamid beta 500 mg/ml, 1000 mg/2 ml, 2000 mg/4 ml concentrate for solution for injection/infusion (cyclophosphamide): Contraindicated in children and adolescents due to alcohol content PDF, 120KB, File is accessible Date: 01. June 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyclophosphamide

betapharm Arzneimittel GmbH informs that cyclophosphamide beta concentrate for solution for injection/infusion is contraindicated for children and adolescents due to the alcohol content.

Direct Healthcare Professional Communication (DHPC) on recall of the epinephrine auto-injector Emerade® 300/500 microgramm pre-filled pen: Patients should replace product PDF, 1MB, File is accessible Date: 26. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Epinephrine

The marketing authorisation holder Pharma Swiss Česká republika s.r.o. and the distributor Dr. Gerhard Mann chem.-pharm. Fabrik GmbH inform in consultation with the local competent authority (Landesamt für Gesundheit und Soziales, Berlin), that all …

Direct Healthcare Professional Communication (DHPC) on propofol: risk of sepsis with multiple withdrawals from one container PDF, 172KB, File is accessible Date: 16. May 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: propofol

The marketing authorisation holders of propofol-containing medicinal products provide information that propofol-containing medicinal products are only authorised for single use in a single patient.

Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation Date: 17. March 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Janus kinase inhibitors

AbbVie, Galapagos, Lilly and Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the updated recommendations for risk minimisation regarding the …