IMATINIB is indicated for the treatment of
• Adult and pediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
• Adult and pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
• Adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
• Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
• Adult patients with advanced hyper eosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFR rearrangement.
The effect of IMATINIB on the outcome of bone marrow transplantation has not been determined.
IMATINIB is indicated for
• The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
In adult and pediatric patients, the effectiveness of IMATINIB is based on overall hematological and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with IMATINIB Qo in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
IMATINIB is indicated for the treatment of:
• Adult and pediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
• Adult and pediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
• Adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
• Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
• Adult patients with advanced hyper eosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with FIP1L1-PDGFR rearrangement.
The effect of IMATINIB on the outcome of bone marrow transplantation has not been determined.
IMATINIB is indicated for
•The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
• The treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
In adult and pediatric patients, the effectiveness of IMATINIB is based on overall hematological and cytogenetic response rates and progression-free survival in CML, on hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on hematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with IMATINIB Qo in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
For the treatment of adult patients with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis who have not responded sufficiently to other treatment options (e.g.Corticosteroids, immunoglobulins or splenectomy) when there is an increased risk of bleeding due to pronounced thrombocytopenia.
For the treatment of paediatric patients (aged 1 year and older) with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis and a significant tendency to bleed who have not responded to an established treatment (e.g. IVIG, corticosteroids) and for whom splenectomy is not a treatment option.
For the treatment of thrombocytopenia in adult patients aged 18 years and older with chronic hepatitis C virus (HCV) infection, where the degree of thrombocytopenia prevents the initiation of interferon-based therapy and/or the ability to optimally maintain it. Ropirage has not been tested in combination with HCV protease inhibitors (boceprevir, telaprevir).
For the treatment of cytopenias in adult patients with acquired severe aplastic anaemia (SAA) who are either treatment-refractory or who have undergone considerable prior therapy and who are not eligible for a haematopoietic stem cell transplant at the time of indication.
For the first-line treatment of acquired severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy in adult and paediatric patients aged 2 years and over who are unsuitable for haematopoietic stem cell transplantation at the time of diagnosis.
For the treatment of adult patients with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis who have not responded sufficiently to other treatment options (e.g.Corticosteroids, immunoglobulins or splenectomy) when there is an increased risk of bleeding due to pronounced thrombocytopenia.
For the treatment of paediatric patients (aged 1 year and older) with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis and a significant tendency to bleed who have not responded to an established treatment (e.g. IVIG, corticosteroids) and for whom splenectomy is not a treatment option.
For the treatment of thrombocytopenia in adult patients aged 18 years and older with chronic hepatitis C virus (HCV) infection, where the degree of thrombocytopenia prevents the initiation of interferon-based therapy and/or the ability to optimally maintain it. Ropirage has not been tested in combination with HCV protease inhibitors (boceprevir, telaprevir).
For the treatment of cytopenias in adult patients with acquired severe aplastic anaemia (SAA) who are either treatment-refractory or who have undergone considerable prior therapy and who are not eligible for a haematopoietic stem cell transplant at the time of indication.
For the first-line treatment of acquired severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy in adult and paediatric patients aged 2 years and over who are unsuitable for haematopoietic stem cell transplantation at the time of diagnosis.
Amikacin Injection is a semi-synthetic, aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including pseudomonas and some Gram-positive organisms.
Sensitive Gram-negative organisms include; Pseudomonas aeruginosa, Escherichia coli., indolepositive and indole- negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, Citrobacter freundii, Salmonella, Shigella, Acinetobacter and Providencia spp.
Many strains of these Gram-negative organisms resistant to gentamicin and tobramycin show sensitivity to Amikacin in vitro.
The principal Gram-positive organism sensitive to Amikacin is Staphylococcus aureus, including some 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, including Pseudomonas species. Although Amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.
Therapy with Amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated.
Consideration should be given to official guidance on the appropriate use of antibacterial Agents.
Malignant pleural mesothelioma
-Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
-Pemetrexed in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
-Pemetrexed is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
-Pemetrexed is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non small cell lung cancer other than predominantly squamous cell histology.
-Pemetrexed is indicated in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous
NSCLC (non-small cell lung cancer), with no EGFR (Epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) genomic tumor aberrations
Spironolactone is an antagonist of aldosterone indicated for:
·Heart Failure: Initiate treatment at 20 mg daily
·Hypertension: Initiate treatment at 20 to 75 mg daily in either single or divided doses
·Edema associated with Hepatic Cirrhosis: Initiate therapy in a hospital setting and titrate slowly. The initial recommended daily dose is 75 mg in either single or divided doses
Heart Failure
Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction in adult patients to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. Spironolactone oral suspension is usually administered in conjunction with other heart failure therapies
Hypertension
Spironolactone is indicated as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Edema caused by Cirrhosis
Spironolactone is indicated for the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restriction.
Spironolactone is an aldosterone antagonist acting primarily through competitive binding of receptors at the aldosterone-dependent sodium- potassium exchange site in the distal convoluted renal tubule, increasing sodium and water excretion, while retaining potassium. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism.
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
For adult patients with type 2 diabetes mellitus, is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
