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
Plasma-Lyte 148 (pH 7.4) is indicated:
- for fluid replacement (e.g. after burns, head injury, fracture, infection, and peritoneal irritation
- as intraoperative fluid replacement,
- in haemorrhagic shock and clinical conditions requiring rapid blood transfusions
- in mild to moderate metabolic acidosis, also in case of lactate metabolism impairment.
Omacillin capsules is indicated for the treatment of the following infections in adults and children:
•Acute bacterial sinusitis
•Acute otitis media
•Acute streptococcal tonsillitis and pharyngitis
•Acute exacerbations of chronic bronchitis
•Community acquired pneumonia
•Acute cystitis
•Asymptomatic bacteriuria in pregnancy
•Acute pyelonephritis
•Typhoid and paratyphoid fever
•Dental abscess with spreading cellulitis
•Prosthetic joint infections
•Helicobacter pylori eradication
•Lyme disease
Omacillin capsule is also indicated for the prophylaxis of endocarditis.
Indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Dexrofex is also indicated for the treatment of chronic iron overload due to blood transfusions when Feroxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. Ferox is also indicated for the treatment of chronic iron overload requiring chelation therapy when Feroxamine therapy is contraindicated or inadequate in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older.
Indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Dexrofex is also indicated for the treatment of chronic iron overload due to blood transfusions when Feroxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. Ferox is also indicated for the treatment of chronic iron overload requiring chelation therapy when Feroxamine therapy is contraindicated or inadequate in patients with non-transfusion- dependent thalassaemia syndromes aged 10 years and older.
Clodreb is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features
Ovarian cancer
Olaparib BOS is indicated as monotherapy for the:
• maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first line platinum-based chemotherapy.
• maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Olaparib BOS in combination with bevacizumab is indicated for the:
• maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.
Breast cancer
Olaparib BOS is indicated as:
• monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germlineBRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
• monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxanein the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
Adenocarcinoma of the pancreas
Olaparib BOS is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutationswho have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
Prostate cancer
Olaparib BOS is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included anew hormonal agent.
SITFORT is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
SITFORT is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
SITFORT is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
SITFORT is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control
SITFORT is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
SITFORT is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
SITFORT is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
SITFORT is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control
Indicated for treatment Adults with
·Major depressive episodes
·Obsessive-compulsive disorder
·Bulimia nervosa: Fluxetyl is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Indicated for Children and adolescents aged 8 years and above
Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression in combination with a concurrent psychological therapy.
