Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ACETYLSALICYLIC ACID
PHARMASCIENCE INC
N02BA01
ACETYLSALICYLIC ACID
80MG
TABLET (DELAYED-RELEASE)
ACETYLSALICYLIC ACID 80MG
ORAL
500/1000
OTC
SALICYLATES
Active ingredient group (AIG) number: 0101169013; AHFS:
APPROVED
2007-01-02
PRESCRIBING INFORMATION ASAPHEN ® 80 mg Tablets (Acetylsalicylic acid tablets, USP) ASAPHEN ® E.C. 80 MG 80mg Tablets (Acetylsalicylic acid delayed-release tablets, USP) ANALGESIC, ANTI-INFLAMMATORY, AND ANTIPYRETIC PHARMASCIENCE, INC Date of Preparation: 6111 Royalmount Ave # 100 March 26, 2008 Montreal, Quebec H4P 2T4 Date of Revision: October 16, 2018 www.pharmascience.com ASAPHEN ® is a registered trademark of Pharmascience Inc. Submission Control N o : 220701 _ASAPHEN & ASAPHEN E.C. 80 mg Prescribing Information Page 2 of 10_ PRESCRIBING INFORMATION ASAPHEN ® 80 mg Tablets (Acetylsalicylic acid tablets, USP) ASAPHEN ® E.C. 80 MG 80mg Tablets (Acetylsalicylic acid delayed-release tablets, USP) THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION ANALGESIC, ANTI-INFLAMMATORY, AND ANTI-PYRETIC SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Oral Tablet /80 mg Delayed-Release tablets/ E.C. 80 mg DC Yellow #10, FDC Red #40, Mannitol, Natural Orange Flavor, Pregelatinized Starch, Sodium Saccharin, Stearic Acid. Colloidal Silicon Dioxide, Glyceryl Stearate, Lactose Anhydrous, Methacrylic Acid Copolymer, Methylated Silica, Methylcellulose, Polydimethylsiloxane, Polysorbate, Pregelatinized Starch, Sodium Lauryl Sulfate, Sodium Bicarbonate, Stearic Acid, Sorbic acid, Sulfuric Acid, Talc, Titanium Dioxide, Triethyl Citrate. ACTION AND CLINICAL PHARMACOLOGY ASA interferes with the production of prostaglandins in various organs and tissues through acetylation of the enzyme cyclo-oxygenase. Prostaglandins are themselves powerful irritants and produce headaches and pain on injection in man. Prostaglandins also appear to sensitize pain receptors to other noxious substances such as histamine and bradykinin. By preventing the synthesis and release of prostaglandins in inflammation, ASA may avert the sensitization of pain receptors. The antipyretic activity of ASA is due to its ability to interfere with the production of prostaglandin E 1 in the brain. Prost Přečtěte si celý dokument