Land: Canada
Taal: Engels
Bron: Health Canada
DIBUCAINE HYDROCHLORIDE; ESCULIN; FRAMYCETIN SULFATE; HYDROCORTISONE
APTALIS PHARMA CANADA ULC
C05AA01
HYDROCORTISONE
5MG; 10MG; 10MG; 5MG
SUPPOSITORY
DIBUCAINE HYDROCHLORIDE 5MG; ESCULIN 10MG; FRAMYCETIN SULFATE 10MG; HYDROCORTISONE 5MG
RECTAL
12/24
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0404592002; AHFS:
CANCELLED POST MARKET
2020-05-27
PRESCRIBING INFORMATION PROCTOSEDYL ® (Hydrocortisone BP - Framycetin sulfate BP - Cinchocaine hydrochloride BP - Aesculin) Anorectal Therapy APTALIS PHARMA CANADA INC. Version Date: 597 Laurier Blvd. April 26, 2012 Mont-St-Hilaire, Quebec Canada J3H 6C4 Control Number: 154596 PROCTOSEDYL ® Anorectal Therapy Prescribing Information _________________________________________________________________________________ Aptalis Pharma Canada Inc. 2 February 23, 2012 PRESCRIBING INFORMATION NAME OF DRUG PROCTOSEDYL ® (Hydrocortisone BP - Framycetin sulfate BP - Cinchocaine hydrochloride BP - Aesculin) THERAPEUTIC CLASSIFICATION Anorectal Therapy INDICATIONS: The reduction of swelling, pain and inflammation of hemorrhoids and other rectal lesions. The management of acute and chronic nonspecific proctitis, acute internal hemorrhoids, cryptitis, fissures and incomplete fistulas, internal and external pruritus ani. May be used in pre- and postoperative hemorrhoidectomy and repair of fissures. CONTRAINDICATIONS: Hydrocortisone must not be used in the presence of tuberculosis, fungal and viral infections. Sensitivity to any of the components. PRECAUTIONS: Discontinue use if sensitization occurs. Hydrocortisone should not be used until an adequate proctologic examination is completed and a diagnosis made. Other specific measures against infections, allergy, and other causal factors must not be neglected. The possibility, however rare, that prolonged use of this preparation might produce systemic corticosteroid effects, should be borne in mind. Patients should be advised to inform subsequent physicians of the previous use of hydrocortisone. PROCTOSEDYL ® Anorectal Therapy Prescribing Information _________________________________________________________________________________ Aptalis Pharma Canada Inc. 3 February 23, 2012 The safe use of topical corticosteroids during pregnancy has not been fully established. Therefore, during pregnancy, they should not be used unnecessarily on extended areas, in large amounts or for prolonge Lees het volledige document