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Revised: March 2017 AN: 00756/2016 SUMMARY OF PRODUCT
Revised: March 2017 AN: 00756/2016 SUMMARY OF PRODUCT

... If more than 10 mg per day is required animals should be monitored particularly carefully. Use of the product in cats with renal dysfunction should be subject to careful risk : benefit assessment by the clinician. Due to the effect thiamazole can have on reducing the glomerular filtration rate, the ...
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... • a candidate originally developed by Novazyme, a company in the U.S. that was acquired by Genzyme in 2001. Genzyme completes a major analysis of the research ndings for all four candidates in an e ort nicknamed “The Mother of All Experiments.” This analysis indicates that the product candidate deve ...
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... a potent, specific and tight-binding kallikrein inhibitor - small recombinant protein - 60-amino acid polypeptide - 7054 Daltons  Mechanism : blocks bradykinin production  Effective acute treatment for all types of attacks  3x 1mL or 2x 1,5mL SC injections; requires ...
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... 2. Generic biological medicines must duplicate the innovative process of the innovator. It is intended to have an fast aproval process  Classification of medicines: biologicals and biosimilars 1. The applicant receives a user guide showing the relevant guidelines 2. The biosimilar medicines are app ...
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... are thus presumed to be the same substances for data exclusivity purpose. This is unless “they differ significantly in properties with regard to safety and/or efficacy.” The EMA has recently released a Reflection Paper on this issue. 3 The preferred way for rebutting the presumption rule is through ...
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... c. An active drug is given more effectiveness by the addition of an inactive drug which creates an effect greater than doubling the active drug. d. have opposite effects, so that they cancel out the other's effects. 37. Differentiate between drug tolerance and tachyphylaxis. The longer a person take ...
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... 4.5 Special precautions for use Special precautions for use in animals If more than 10 mg per day is required animals should be monitored particularly carefully. Use of the product in cats with renal dysfunction should be subject to careful risk : benefit assessment by the clinician. Due to the effe ...
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... largely dependent on target receptor uptake, differences in receptor density between healthy volunteers and target population (e.g. over-expression of receptors in tumours or inflamed tissues) can create important pharmacokinetic difference in e.g. half-life, which should be considered when using he ...
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September 2015 - Institute For Safe Medication Practices

... bacterial infections, reactivation of hepatitis virus, and cancer. Intensive marketing and extensive patient contact by manufacturers or their agents also contribute to the high volume of reports. The adverse event reports for oral anticoagulants confirm the evidence that long-term use remains one o ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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