By Stefania Spada
Formerly, getting access to information at the record of presently licensed bio biopharmaceuticals has been exhausting and patchy. This quantity brings jointly key info on quite a few elements of those compounds, together with: clinical and alternate identify, 12 months and areas licensed, authorized symptoms, manudacturer, advertising correct, approach to manufacture, clinical review, and healing homes. This finished and constant procedure will shop execs within the pharmaceutical hiurs spent trawling the literature - and offers a singlr source for destiny reference. Read more...
content material: booklet conceal; Half-Title; name; Copyright; commitment; Preface; Authors; desk of Contents; Actimmune; Activase; Aldurazyme; Ambirix; Amevive; Avonex; BeneFIX; Beromun; Betaferon/Betaseron; Bexxar; Bio-Tropin (Tev-Tropin or Zomacton); Bioclate; CEA-Scan; Cerezyme; Comvax; Ecokinase (withdrawn from market); Enbrel; Engerix-B; Epogen/Procrit; Fabrazyme; Fasturtec/Elitek; Forcaltonin; Forsteo/Forteo; Genotropin; GlucaGen; Glucagon; Gonal-F; HBVAXPRO; Helixate NexGen/Helixate FS/Kogenate FS; Hepacare (withdrawn from market); Herceptin; Hexavac; Humalog; HumaSPECT; Humatrope; Humira; Humulin. Indimacis one hundred twenty five (withdrawn from market)InductOs; INFANRIX HepB; Infanrix Hexa; Infanrix Penta/Pediarix; Infergen; InFUSE Bone Graft/LT-CAGE Lumbar Tapered Fusion Device'; Insuman; Intron A; Kineret; Lantus; Leukine; LeukoScan; Liprolog (withdrawn from market); Luveris; LYMErix (withdrawn from market); MabCampath/Campath-1H; MabThera/Rituxan; Metalyse/TNKase; Mylotarg; Myoscint (withdrawn from market); Natrecor; NeoRecormon; Nespo/Aranesp; Neulasta; Neumega; Neupogen; Nordi.
summary: formerly, having access to facts at the checklist of presently authorized bio biopharmaceuticals has been hard and patchy. This quantity brings jointly key info on a variety of features of those compounds, together with: medical and alternate identify, yr and areas licensed, authorized symptoms, manudacturer, advertising and marketing correct, approach to manufacture, clinical review, and healing houses. This entire and constant strategy will retailer pros within the pharmaceutical hiurs spent trawling the literature - and gives a singlr source for destiny reference
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Extra resources for Directory of Approved Biopharmaceuticals
Betaferon treatment has been shown to reduce the frequency and severity of relapses, increasing the interval between relapses and reducing the progression of the disease. Hospitalization of MS patients decreased after Betaferon treatment, compared to patients receiving placebos, and a delay was observed in patients becoming wheelchair bound. fm Page 25 Monday, July 19, 2004 8:43 AM like symptoms. Rare but severe hypersensitivity reactions have been observed, as well as muscular hypertonia and rare cases of cardiomyopathy.
Additional purification steps are then undertaken to remove undigested antibody, additional fragments and pepsin. The final product is presented in a lyophilized form consisting mainly of the anti-CEA Fab'-SH but also containing F(ab')2 and H- and L-chain fragments and the following excipients: stannous chloride, sodium chloride, sucrose, argon, sodium potassium tartrate, sodium acetate, and traces of acetic acid and hydrochloric acid for a final buffered solution at pH 5 to 7. , HPLC, IEF, GC, SDS-PAGE, ITLC, and DNA hybridization), the potency of the product (immunoreactivity assay), microbiological and viral safety (mycoplasma assay, XC plaque assay, S+L- focus-forming assay, reverse transcriptase assay, and electron microscopy), and the presence of endotoxins and pyrogens.
Hypersensitivity, cardiovascular, and gastrointestinal symptoms have been reported. Most of the patients developed antibodies against Fabrazyme, but no reduction in efficacy was observed. In order to prevent organ damage that could be difficult to reverse, administration of Fabrazyme before the disease develops should be considered. Fabrazyme should not be administered with chloroquine, amiodarone, benoquin, or gentamicin. No safety and efficacy studies were carried out on patients under 16 or over 65 years old.