Kraj: Kanada
Język: angielski
Źródło: Health Canada
HYDROCORTISONE; DIBUCAINE HYDROCHLORIDE; FRAMYCETIN SULFATE; ESCULIN
ODAN LABORATORIES LTD
C05AA01
HYDROCORTISONE
0.5%; 0.5%; 1%; 1%
OINTMENT
HYDROCORTISONE 0.5%; DIBUCAINE HYDROCHLORIDE 0.5%; FRAMYCETIN SULFATE 1%; ESCULIN 1%
RECTAL
15G/30G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0404592001; AHFS:
APPROVED
2003-05-06
PRESCRIBING INFORMATION Including Patient Medication Information PR PROCTOL ® OINTMENT and PR PROCTOL ® SUPPOSITORIES (Cinchocaine Hydrochloride, Esculin, Framycetin Sulfate, Hydrocortisone) Anorectal Therapy ODAN LABORATORIES LTD. 325 Stillview Ave., Pointe Claire, (QC) H9R 2Y6 Submission Control No: 220680 Date of Revision: January 31, 2019 www.odanlab.com 2 PRESCRIBING INFORMATION PROCTOL OINTMENT AND PROCTOL SUPPOSITORIES (Cinchocaine Hydrochloride, Esculin, Framycetin Sulfate, Hydrocortisone) 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. PROCTOL OINTMENT and PROCTOL SUPPOSITORIES contain an antibacterial ingredient, framycetin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of framycetin, PROCTOL OINTMENT and PROCTOL SUPPOSITORIES should only be used for the authorized indication and clinical use. 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. 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 prolonged periods Przeczytaj cały dokument