BLEPHAMIDE S.O.P. OINTMENT

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

SULFACETAMIDE SODIUM; PREDNISOLONE ACETATE

可用日期:

ALLERGAN INC

ATC代码:

S01CA02

INN（国际名称）:

PREDNISOLONE AND ANTIINFECTIVES

剂量:

10%; 0.2%

药物剂型:

OINTMENT

组成:

SULFACETAMIDE SODIUM 10%; PREDNISOLONE ACETATE 0.2%

给药途径:

OPHTHALMIC

每包单位数:

3.5G

处方类型:

Prescription

治疗领域:

SULFONAMIDES

產品總結:

Active ingredient group (AIG) number: 0206094001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2019-07-15

产品特点

PRESCRIBING INFORMATION
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BLEPHAMIDE® S.O.P.
Sulfacetamide sodium 10.0% w/v and prednisolone acetate 0.2% w/v
Sterile ophthalmic ointment
Steroid / Antibacterial
Allergan Inc.
Markham, ON
L6G 0B5
Date of Preparation:
May 22, 2019
Submission Control No: 217874
_ _
_Page 2 of 10_
PRESCRIBING INFORMATION
NAME OF DRUG
Pr
BLEPHAMIDE® S.O.P.
Sulfacetamide sodium 10.0% w/v and prednisolone acetate 0.2% w/v
THERAPEUTIC CLASSIFICATION
Steroid / Antibacterial
MECHANISM OF ACTION
BLEPHAMIDE® S.O.P. (sulfacetamide sodium 10.0% w/v and prednisolone
acetate 0.2% w/v) is a
potent antibacterial (effective against a broad range of pathogens,
including staphylococcus aureus).
The prednisolone content effectively counters the allergic and
inflammatory manifestations of
blepharitis.
INDICATIONS
BLEPHAMIDE® S.O.P. is indicated for the treatment of
corticosteroid-responsive inflammatory
conditions of the palpebral and bulbar conjunctiva, cornea and
anterior segment of the globe where
bacterial infection or a risk of bacterial infection exists.
BLEPHAMIDE® S.O.P. is also indicated in chronic anterior uveitis and
corneal injury from chemical,
radiation or thermal burns.
BLEPHAMIDE® S.O.P. contains an antibacterial ingredient,
sulfacetamide sodium. To reduce the
development of drug-resistant bacteria and maintain the effectiveness
of sulfacetamide sodium,
BLEPHAMIDE® S.O.P. should only be used for the authorized indication.
CONTRAINDICATIONS
Do not use BLEPHAMIDE® S.O.P. if you have:

superficial (or epithelial) herpes simplex keratitis (dendritic
keratitis), purulent untreated
infections, vaccinia, varicella and most other viral diseases of the
cornea and conjunctiva

mycobacterial infection of the eye

ocular tuberculosis, fungal diseases of the eye

individuals with known or suspected hypersensitivivity to sulfonamides
or to any components
of the medication, other corticosteroids
WARNINGS AND PRECAUTIONS
In diseases due to microorganisms, infection may be masked, enhanced
o