Summary of product characteristics and classifications

Classification of Quality Characteristics Delivering a high quality product starts with: Aligning your product design with your manufacturing process Determining your products specification Analyzing your competition and differentiating yourself from them Capturing your customers needs The 1st step in designing a high quality product is capturing your customers needs. Incorrect The 1st step in designing a high quality product is capturing your customers needs. Question 2 of 4 Category:

Summary of product characteristics and classifications

Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of mg daily as starting dose. However, in these patients caution is recommended. The dose can be reduced if not tolerated. If tolerated, the dose can be increased for lack of efficacy see sections 4. Imatinib pharmacokinetics have not been specifically studied in older people.

No specific dose recommendation is necessary in older people. Caution should be used when taking Glivec with protease inhibitors, azole antifungals, certain macrolides see section 4. Concomitant use of imatinib and medicinal products that induce CYP3A4 e. John's Wort may significantly reduce exposure to Glivec, potentially increasing the risk of therapeutic failure.

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Therefore, concomitant use of strong CYP3A4 inducers and imatinib should be avoided see section 4. Hypothyroidism Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing Summary of product characteristics and classifications replacement during treatment with Glivec see section 4.

Thyroid-stimulating hormone TSH levels should be closely monitored in such patients. In patients with hepatic dysfunction mild, moderate or severeperipheral blood counts and liver enzymes should be carefully monitored see sections 4.

Summary of product characteristics and classifications

It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment. Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib. When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.

Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction see section 4. Fluid retention Occurrences of severe fluid retention pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema have been reported in approximately 2.

Therefore, it is highly recommended that patients be weighed regularly.

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An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken. In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.

Therefore, caution should be exercised in patients with cardiac dysfunction. Patients with cardiac disease Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.

The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding imatinib. Based on the available data, no predisposing factors e.

Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied. In addition, gastric antral vascular ectasia GAVEa rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases see section 4.

When needed, discontinuation of Glivec treatment may be considered. Tumour lysis syndrome Due to the possible occurrence of tumour lysis syndrome TLScorrection of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Glivec see section 4.

Hepatitis B reactivation Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.

Summary of product characteristics and classifications

Some cases resulted in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Glivec. Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology including those with active disease and for patients who test positive for HBV infection during treatment.

Carriers of HBV who require treatment with Glivec should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy see section 4.

Phototoxicity Exposure to direct sunlight should be avoided or minimised due to the risk of phototoxicity associated with imatinib treatment.

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Patients should be instructed to use measures such as protective clothing and sunscreen with high sun protection factor SPF. Laboratory tests Complete blood counts must be performed regularly during therapy with Glivec.

Treatment of CML patients with Glivec has been associated with neutropenia or thrombocytopenia. However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.

Treatment with Glivec may be interrupted or the dose may be reduced, as recommended in section 4. Liver function transaminases, bilirubin, alkaline phosphatase should be monitored regularly in patients receiving Glivec.

In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein AGPan imatinib-binding protein, in these patients.

Patients with renal impairment should be given the minimum starting dose. Patients with severe renal impairment should be treated with caution. The dose can be reduced if not tolerated see section 4.Eliquis 5 mg film-coated tablets - Summary of Product Characteristics (SmPC) by Bristol-Myers Squibb-Pfizer.

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Summary of Product Characteristics Emergent BioSolutions, Inc. Confidential and Proprietary Page 4 of 13 Interaction with other medicinal products and other forms of interaction Use with other vaccines: BioThrax can be given concurrently with any of the following monovalent or combination.

Dangerous goods are divided into nine classes (in addition to several subcategories) on the basis of the specific chemical characteristics producing the risk. Summary of Product Characteristics and Classifications Product Characteristics and Classifications Product Levels: The Customer Value Hierarchy The marketer needs to address five product levels.

Each level adds more customer value, and five constitute a Customer value hierarchy. Core benefit: It is the fundamental level. A chemical formula is a way of expressing information about the proportions of atoms that constitute a particular chemical compound, using a single line of chemical element symbols and numbers.

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