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Codeine use in children and ultra-rapid metabolisers
Codeine use in children and ultra-rapid metabolisers

... products in Australia. This is in contrast to other major jurisdictions including the United States, European Union and Canada. Codeine is a commonly used medication that may be perceived by the Australian public to be very safe, especially in light of its availability in OTC preparations. Therefore ...
complaint  - AboutLawsuits.com
complaint - AboutLawsuits.com

... 43. At least as early as 1992, GSK began receiving reports of birth defects associated with the use of Zofran by pregnant women. 44. By 2000, GSK had received at least 32 reports of birth defects arising from Zofran treatment in pregnant women. These reports included ...
April 2015 - PerformRx
April 2015 - PerformRx

Report of the National Lipid Association`s Statin Safety Task Force
Report of the National Lipid Association`s Statin Safety Task Force

... Cardiology. Clinical judgment must guide each physician in weighing the benefits of treatment against the risk of toxicity. References made in the articles may indicate uses of drugs at dosages, for periods of time, and in combinations not included in the current prescribing information. ...
Medicinal properties of Ginger ( Zingiber officinale Article
Medicinal properties of Ginger ( Zingiber officinale Article

... (Linn.) Gaertn (silymarin), Artemisia annua Linn. (artemesinin) and Taxus baccata Linn. (taxol). Randomized, controlled trials have proved the efficacy of some established remedies, for instance Zingiber officinale Rosc. commonly known as ginger. After extensive pharmacological studies, it has been ...
Relationship between Type of Endorser and
Relationship between Type of Endorser and

... there was a correlation between different types of endorsers and specific product types (Friedman, 1977). Friedman identified three types of endorsers: celebrities, experts, and typical consumers. Using the literature about consumers’ perceived risks and the social influence theory, Friedman hypothe ...
Hyaluronidase in Ophthalmology - The Journal of Applied Research
Hyaluronidase in Ophthalmology - The Journal of Applied Research

Herbal Medicines
Herbal Medicines

Epidural Steroid Injections Safety Recommendations by the Multi
Epidural Steroid Injections Safety Recommendations by the Multi

... experts working with the Safe Use Initiative on epidural steroid injections (18). Further, they stated that following the release of the statement, the Safe Use Initiative expert panel, in collaboration with the FDA staff supporting the Safe Use Initiative, decided to involve the 14 societies repres ...
$doc.title

... (Ball 2001) FDA compared exposure levels of infants to ethylmercury from vaccines to existing guidelines for exposure to methylmercury, as there are no existing guidelines for safe exposure to ethylmercury, the metabolite of thimerosal. While this review found no evidence of adverse effects caused b ...
product monograph isoptin sr
product monograph isoptin sr

... not seen in a second study.) No similar changes have been observed in long-term prospective human ophthalmological trials. Renal Renal Insufficiency About 70% of an administered dose of verapamil hydrochloride is excreted as metabolites in the urine. In one study in healthy volunteers, the total bod ...
vancomycin 500mg and 1000mg powder for concentrate for solution
vancomycin 500mg and 1000mg powder for concentrate for solution

... Finished product stability studies have been conducted in accordance with current guidelines. Based on the results, a shelf life of 2 years for the unopened products has been set, with storage instructions “Store below 25°C. Keep the vial in the outer carton in order to protect from light”. This is ...
Provider Portal
Provider Portal

... As a Participating Pharmacy provider, you will receive a fully signed PPA. If your Pharmacy has not received its copy of the PPA, or if you have any questions regarding the PPA, please call our Pharmacy Help Desk at 800-361-4542 (TTY Users may call 711). All Pharmacies are expected to adhere to the ...
Recent changes in Europe`s MDMA/ecstasy market
Recent changes in Europe`s MDMA/ecstasy market

Actavis v ICOS
Actavis v ICOS

... is live before me. The live issue is substantive priority (see below). The other issue is whether an entitlement to make the priority claim has been established (c.f. Edwards Lifesciences v Cook Biotech [2009] FSR 27) and as to that only Actelion maintain the objection. However Lilly and Actelion ag ...
Sedation for diagnostic and therapeutic procedures in children and
Sedation for diagnostic and therapeutic procedures in children and

... Treatment and care should take into account patients’ needs and preferences. Children and young people undergoing sedation and their parents and carers should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If patien ...
Codeine Therapy in the Context of Cytochrome P450 2D6
Codeine Therapy in the Context of Cytochrome P450 2D6

... to variations in the CYP2D6 gene independent of drug metabolism and response. Although there are some isolated reports of CYP2D6 genetic effects on phenotypes other than in relation to drug response,4,5 these findings have not been consistently reproduced in other studies. Other considerations Modif ...
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir
Paritaprevir / Ritonavir / Ombitasvir and Dasabuvir

... Ritonavir, a potent inhibitor of cytochrome P450(CYP) CYP3A4 is not active against Hepatitis C, but acts as a pharmacokinetic enhancer to increase exposure to paritaprevir, which is primarily metabolised by CYP3A.1 ...
July/August 2014
July/August 2014

... during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk. BACKGROUND: Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-c ...
B N ULLETI I N F O R M A T I O...
B N ULLETI I N F O R M A T I O...

... cartridge cleaner,” and “nail enamel remover” for approximately $100 per bottle—much more expensive than comparable products. Law enforcement’s efforts to identify the abuse of GHB analogs are hampered by the fact that routine toxicological screens do not detect the presence of these analogs. In add ...
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION

Strontium Myth and Reality
Strontium Myth and Reality

... Strontium (Sr) is a mineral with a reported effect on the reduction of bone fracture risk. Most of the data on strontium as a bone-building compound comes from its usage as a drug in Europe (as strontium ranelate). Strontium citrate, available as a dietary supplement in the US, is being marketed as ...
Pharmacokinetic Interaction Between Prasugrel and Ritonavir
Pharmacokinetic Interaction Between Prasugrel and Ritonavir

AusPAR: Rifaximin  - Therapeutic Goods Administration
AusPAR: Rifaximin - Therapeutic Goods Administration

... apparatus. The method is considered discriminatory, as evidenced by changes in dissolution rate observed during stability studies. The company claimed a shelf life of 3 years below 25°C on the basis that three batches tested demonstrated compliance with specifications during 2 years’ storage at 25°C ...
LC-Tandem MS Detection of Covalent Binding of Acetaminophen to
LC-Tandem MS Detection of Covalent Binding of Acetaminophen to

... To further characterise the NAPQI-CPF product, and to enable quantification of NAPQI-CPF in patient samples, a large scale synthesis was performed. Acetaminophen (32 mg) was oxidised to NAPQI in 75 mL chloroform, as described above, and stirred vigorously for 2 hours at room temperature with 25 mg C ...
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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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