N O T I C E S O F C O M P L I A N C E BIOLOGIC PRODUCTS FOR HUMAN USE January - December, 1993 ----------------------------------------------------------------- Brand Name: Act-HIB Source: Connaught Active Ingredient: Haemophilus b conjugate vaccine (Tetanus protein-conjugate) Comments: New expiration date Date: 93-02-03 ----------------------------------------------------------------- Brand Name: Act-HIB Source: Connaught Active Ingredient: Haemophilus b Conjugate Vaccine (Tetanus protein-conjugate) Comments: Revised product monograph Date: 93-04-02 ----------------------------------------------------------------- Brand Name: Botox Source: Allergan Active Ingredient: Clostridium botulinum toxin type A Comments: New indication Date: 93-10-04 ----------------------------------------------------------------- Brand Name: DPT Polio Adsorbed Source: Connaught Active Ingredient: Diphtheria and Tetanus Toxoids and Pertussis and Inactivated Poliomyelitis vaccines adsorbed Comments: Change in manufacturing Date: 93-10-18 ----------------------------------------------------------------- Brand Name: Eprex Sterile Solution Source: Ortho-McNeil Active Ingredient: Recombinant human erythropoietin Comments: New expiration date Date: 93-03-24 ----------------------------------------------------------------- Brand Name: Gamimune N Source: Miles Canada Active Ingredient: Immune globulin, human, IV Comments: New indication Date: 93-08-13 ----------------------------------------------------------------- Brand Name: Gamimune N Source: Miles Canada Active Ingredient: Immune globulin, human, IV Comments: New dosage regimen Date: 93-11-30 ----------------------------------------------------------------- Brand Name: HibTiter Source: Lederle-Cyanamid Active Ingredient: Haemophilus b conjugate vaccine (Diphtheria CRM197 protein conjugate) Comments: Change in manufacturing Date: 93-03-24 ----------------------------------------------------------------- Brand Name: Honey Bee Venom Source: ALK Laboratories Active Ingredient: Apis mellifera venom extract Comments: New expiration date Date: 93-04-02 ----------------------------------------------------------------- Brand Name: Humulin Source: Eli Lilly Active Ingredient: Insulin human biosynthetic Comments: Alternate manufacturing site Date: 93-09-10 ----------------------------------------------------------------- Brand Name: Humulin N, 10/90, 20/80, 30/70, 40/60, 50/50 Source: Eli Lilly Active Ingredient: Insulin isophane human biosynthetic Comments: Change in formulation Date: 93-09-03 ----------------------------------------------------------------- Brand Name: Hypogon Source: Novo Nordisk Active Ingredient: Glucagon Comments: PWS (1 mg & 1 mL) IM, IV, SC Date: 93-08-11 ----------------------------------------------------------------- Brand Name: Inactivated Poliomyelitis Vaccine Source: Connaught Active Ingredient: Inactivated poliomyelitis vaccine (Diploid cell origin) Comments: Revised product monograph Date: 93-07-29 ----------------------------------------------------------------- Brand Name: Intron A Source: Schering Canada Active Ingredient: Interferon-alfa-2b Comments: Alternate manufacturing site Date: 93-10-21 ----------------------------------------------------------------- Brand Name: JE-VAX Source: Connaught Active Ingredient: Japanese encephalitis virus vaccine inactivated Comments: PWS (1, 10 doses) SC Date: 93-09-10 ----------------------------------------------------------------- Brand Name: Kogenate Source: Miles Canada Active Ingredient: Antihemophilic factor, recombinant Comments: PWS (250, 500, 1000 IU) IV Date: 93-07-22 ----------------------------------------------------------------- Brand Name: Lysatec rt-PA Source: Boehringer Ingelheim Active Ingredient: Alteplase Comments: Alternate manufacturing site Date: 93-07-29 ----------------------------------------------------------------- Brand Name: Measles Virus Vaccine, Live Attenuated (Dried) Source: Connaught Active Ingredient: Measles Virus Vaccine, Live Attenuated (Dried) Comments: Change in manufacturing, revised product monograph Date: 93-09-28 ----------------------------------------------------------------- Brand Name: Mixed Vespid Vemon Protein Source: ALK Laboratires Active Ingredient: Yellow Jacket, Yellow Hornet and White Faced Hornet Venom Protein Comments: New expiration date Date: 93-04-02 ----------------------------------------------------------------- Brand Name: Neupogen Source: Amgen Canada Active Ingredient: Filgrastim (Recombinant methionyl human granulocyte colony stimulating factor) Comments: New indication Date: 93-10-28 ----------------------------------------------------------------- Brand Name: Neupogen Source: Amgen Canada Active Ingredient: Filgrastim (Recombinant methionyl human granulocyte colony stimulating factor) Comments: Change in manufacturing site Date: 93-12-30 ----------------------------------------------------------------- Brand Name: Novolin ge 10/90, 20/80, 30/70, 40/60, 50/50 Penfill Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic / insulin isophane, human biosynthetic Comments: SUS (10 / 90, 20 / 80, 30 / 70, 40 / 60, 50 / 50 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge 30/70 Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic / insulin isophane, human biosynthetic Comments: SUS (30 / 70 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge Lente Source: Novo Nordisk Active Ingredient: Insulin zinc suspension - medium human biosynthetic Comments: SUS (100 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge NPH Source: Novo Nordisk Active Ingredient: Insulin isophane, human biosynthetic Comments: SUS (100 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge NPH Penfill Source: Novo Nordisk Active Ingredient: Insulin isophane, human biosynthetic Comments: SUS (100 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge Toronto Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic Comments: SOL (100 u/mL) SC, IV, IM Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge Toronto Penfill Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic Comments: SOL (100 u/mL) SC, IV, IM Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Novolin ge Ultralente Source: Novo Nordisk Active Ingredient: Insulin zinc suspension - prolonged human biosynthetic Comments: SUS (100 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: NovolinSet ge 10/90, 20/80, 30/70, 40/60, 50/50 Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic / insulin isophane, human biosynthetic Comments: SUS (10 / 90, 20 / 80, 30 / 70, 40 / 60, 50 / 50 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: NovolinSet ge NPH Source: Novo Nordisk Active Ingredient: Insulin isophane, human biosynthetic Comments: SUS (100 u/mL) SC Date: 93-03-22 ----------------------------------------------------------------- Brand Name: NovolinSet ge Toronto Source: Novo Nordisk Active Ingredient: Insulin injection, human biosynthetic Comments: SOL (100 u/mL) SC, IV, IM Date: 93-03-22 ----------------------------------------------------------------- Brand Name: Orthoclone OKT*3 Source: Ortho-McNeil Active Ingredient: Muromonab-CD3 Comments: Change in manufacturing Date: 93-03-24 ----------------------------------------------------------------- Brand Name: Orthoclone OKT*3 Source: Ortho-McNeil Active Ingredient: Muromonab-CD3 Comments: Change in manufacturing Date: 93-05-19 ----------------------------------------------------------------- Brand Name: Photofrin Source: Cyanamid Canada Active Ingredient: Porfimer sodium Comments: PWS (15, 75 mg) IV Date: 93-04-19 ----------------------------------------------------------------- Brand Name: Protropin Source: Genentech Active Ingredient: Somatrem Comments: Change in manufacturing Date: 93-05-19 ----------------------------------------------------------------- Brand Name: Pulmozyme Source: Genentech Canada Active Ingredient: Dornase alfa Comments: LIQ (1 mg/mL) INH Date: 93-12-30 ----------------------------------------------------------------- Brand Name: Roferon A Source: Hoffmann La Roche Active Ingredient: Interferon alfa-2a Comments: New indication Date: 93-02-16 ----------------------------------------------------------------- Brand Name: Streptase Source: Hoechst-Roussel Active Ingredient: Streptokinase Comments: INJ PWS (250,000, 750,000, 1,500,000 I.U./Vial) IV Date: 93-01-29 ----------------------------------------------------------------- Brand Name: Survanta Source: Abbott Active Ingredient: Beractant Comments: SUS (25 mg/mL) ITR Date: 93-01-29 ----------------------------------------------------------------- Brand Name: Trasylol Source: Miles Canada Active Ingredient: Aprotinin Comments: Change in manufacturing Date: 93-12-15 ----------------------------------------------------------------- Brand Name: Tri-Immunol Source: Lederle-Cyanamid Active Ingredient: Diphtheria toxoids / Tetanus toxoids / Pertussis Vaccine Adsorbed Comments: INJ SOL (12.5 LF / 5.0 LF / 4 U per dose) IM Date: 93-02-24 ----------------------------------------------------------------- Brand Name: Wasp Venom Protein Source: ALK Laboratories Active Ingredient: Polistes spp venom protein extract Comments: New expiration date Date: 93-04-02 ----------------------------------------------------------------- Brand Name: White Faced Hornet Venom Protein Source: ALK Laboratories Active Ingredient: Dolichovespula maculata venom protein extract Comments: New expiration date Date: 93-04-02 ----------------------------------------------------------------- Brand Name: WinRho Source: Rh Pharmaceuticals Active Ingredient: Rho(D) immune globulin (human) Comments: Change in manufacturing Date: 93-01-29 ----------------------------------------------------------------- Brand Name: WinRho SD Source: Rh Pharmaceuticals Active Ingredient: Rho(D) immune globulin (human) Comments: PWS (120, 300 mcg/vial) IM or IV Date: 93-04-01 ----------------------------------------------------------------- Brand Name: Yellow Hornet Venom Protein Source: ALK Laboratories Active Ingredient: Dolichovespula arenaria venom protein extract Comments: New expiration date Date: 93-04-02 ----------------------------------------------------------------- Brand Name: Yellow Jacket Venom Protein Source: ALK Laboratories Active Ingredient: Yellow Jacket Venom Protein Comments: New expiration date Date: 93-04-02 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