Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for:
- Reflux oesophagitis.
Pantoprazole is indicated in adults for:
- Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
- Gastric and duodenal ulcer.
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:
monotherapy
• When metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. combination therapy
• in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control
Lacosamide is indicated as monotherapy in the treatment of partial- seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epi-lepsy.
Lacosamide is indicated as adjunctive therapy
• in the treatment of partial- seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
This medicinal product is for diagnostic use.
Ultravist-240, -300, -370:
–Angiography, angiocardiography, digital subtraction angiography
–Contrast enhancement in computerised tomography
–Urography
–Visualization of body cavities
(Exception: myelography, ventriculography, cisternography)
Ultravist-300/-370:
Used in adult women for contrast-enhanced mammography to assess and detect known or suspicious lesions of the breast,
–in addition to mammography (with or without ultrasound) or
–as an alternative to magnetic resonance imaging (MRI) if MRI is contraindicated or not available.
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.
