Hypercholesterolaemia and mixed dyslipidaemia
Ezetimibe/Bempedoic Acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
·in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
·alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDLC goals with ezetimibe alone,
·in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
Cardiovascular disease
Ezetimibe/Bempedoic Acid is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
·in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
·in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
·in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
Ravulizumab is indicated for:
The treatment of adult and pediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal hemoglobinuria (PNH).
The treatment of adults and pediatric patients with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Ibrutinib as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
·Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least prior therapy.
·Ibrutinib as a single agent is indicated for the treatment of adult patients with Waldenström"s macroglobulinaemia (WM) who have received at least prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
·Ibrutinib in combination with rituximab is indicated for the treatment of adult patients with WM.
Ibrutinib as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
·Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least prior therapy.
·Ibrutinib as a single agent is indicated for the treatment of adult patients with Waldenström"s macroglobulinaemia (WM) who have received at least prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
·Ibrutinib in combination with rituximab is indicated for the treatment of adult patients with WM.
Intravenous administration
Vancomycin is indicated in all age groups for the treatment of the following infections:
• Complicated skin and soft tissue infections (cSSTI)
• Bone and joint infections
• Community acquired pneumonia (CAP)
• Hospital acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
• Infective endocarditis
Vancomycin is also indicated in all age groups for the perioperative antibacterial prophylaxis in patients that are at high risk of developing bacterial endocarditis when undergoing major surgical
procedures.
Oral administration
Vancomycin is indicated in all age groups for the treatment of Clostridium difficile infection (CDI)
Intravenous administration
Vancomycin is indicated in all age groups for the treatment of the following infections:
• Complicated skin and soft tissue infections (cSSTI)
• Bone and joint infections
• Community acquired pneumonia (CAP)
• Hospital acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
• Infective endocarditis
Vancomycin is also indicated in all age groups for the perioperative antibacterial prophylaxis in patients that are at high risk of developing bacterial endocarditis when undergoing major surgical
procedures.
Oral administration
Vancomycin is indicated in all age groups for the treatment of Clostridium difficile infection (CDI)
Hypercholesterolaemia and mixed dyslipidaemia
Bempedoic Acid is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia, as an adjunct to diet:
·in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
·alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Cardiovascular disease
Bempedoic Acid is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
·in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
·alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated
Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Amikacin sulphate is an aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including Pseudomonas spp., Escherichia coli, indole-positive and indole-negative Proteus spp., Klebsiella-Enterobacter-Serratia spp, Salmonella, Shigella, Minea-Herellae, Citrobacter freundii and Providencia spp.
Many strains of these gram-negative organisms resistant to gentamicin and tobramycin may show sensitivity to amikacin in vitro. The principal Gram-positive organism sensitive to amikacin is Staphylococcus aureus, including methicillin-resistant strains. Amikacin has some activity against other Gram-positive organisms including certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. It may also be indicated for the treatment of known or suspected staphylococcal disease.
Consideration should be given to official guidance on the appropriate use of antibacterial agents
Ibrutinib as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Ibrutinib as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Ibrutinib as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Ibrutinib as a single agent is indicated for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. IBRU in combination with rituximab is indicated for the treatment of adult patients with WM
Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
·as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
·in addition to other medicinal products for the treatment of diabetes.
·to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease
·to reduce the risk of sustained eGFR decline, kidney failure including initiation of chronic renal replacement therapy, or death from kidney failure or cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.
