DORZOLAMIDE-TIMOLOL PF SOLUTION
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
04-10-2023
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)
थमां उपलब्ध:
MICRO LABS LIMITED
ए.टी.सी कोड:
S01ED51
INN (इंटरनेशनल नाम):
TIMOLOL, COMBINATIONS
डोज़:
5MG; 20MG
फार्मास्यूटिकल फॉर्म:
SOLUTION
रचना:
TIMOLOL (TIMOLOL MALEATE) 5MG; DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG
प्रशासन का मार्ग:
OPHTHALMIC
पैकेज में यूनिट:
100
प्रिस्क्रिप्शन प्रकार:
Prescription
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 0237301001; AHFS:
प्राधिकरण का दर्जा:
APPROVED
प्राधिकरण की तारीख:
2023-10-25
उत्पाद विशेषताएं
_DORZOLAMIDE-TIMOLOL PF _
_(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL PF
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
(Preservative-Free)
Solution, 20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5
mg/mL timolol (as
timolol maleate), Ophthalmic
USP
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Manufactured by:
Micro Labs Limited
Bangalore– 560001
INDIA
Date of Initial Authorization:
October 4, 2023
Canadian Importer/Distributor:
13187811 Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 255253
_DORZOLAMIDE-TIMOLOL PF _
_(Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution)_
Page 2 of 38
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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