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.
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.
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
PACLITAXEL KABI is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, PACLITAXEL KABI is indicated in combination with cisplatin.
PACLITAXEL KABI is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
PACLITAXEL KABI is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
PACLITAXEL KABI in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
PACLITAXEL KABI is indicated for the second-line treatment of AIDS- related Kaposi’s sarcoma.
Indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Short-term treatment of all grades of pain and inflammation in the following acute conditions:
•Post-traumatic pain, inflammation and swelling, e.g. due to sprains.
• acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendonitis, tenosynovitis, bursitis
• Post-operative pain, inflammation and swelling, e.g. following dental or orthopaedic surgery.
• Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis and associated menorrhagia.
• Migraine attacks.
• Acute gout
• Painful syndromes of the vertebral column.
• Non-articular rheumatism.
• As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, e.g. pharyngotonsillitis, otitis.
Broncast pediatric 5mg is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as needed” short-acting β-agonists provide inadequate clinical control of asthma.
Broncast pediatric 5mg may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids
Broncast pediatric 5mg is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Broncast pediatric 5mg is indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 6 years of age and older.
Rheumatoid arthritis Yuflyma in combination with methotrexate, is indicated for:
• The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Yuflyma in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Yuflyma can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Adalimumab has not been studied in patients aged less than 2 years.
Enthesitis-related arthritis
Yuflyma is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Yuflyma is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Axial spondyloarthritis without radiographic evidence of AS
Yuflyma is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Psoriatic arthritis
Yuflyma is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Psoriasis
Yuflyma is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Paediatric plaque psoriasis
Yuflyma is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Hidradenitis suppurativa (HS)
Yuflyma is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
Crohn’s disease
Yuflyma is indicated for treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Paediatric Crohn's disease
Yuflyma is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Ulcerative colitis
Yuflyma is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis
Yuflyma is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Uveitis
Yuflyma is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Paediatric uveitis
Yuflyma is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
