Otodex Skin Cream

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

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下载 产品特点 (SPC)
31-01-2023

有效成分:

Chlorocresol, Lidocaine Hydrochloride, Phenoxyethanol, Zinc Oxide

可用日期:

Petlife International Ltd

ATC代码:

QD08AE99

INN(国际名称):

Chlorocresol, Lidocaine Hydrochloride, Phenoxyethanol, Zinc Oxide

药物剂型:

Cream

处方类型:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

治疗组:

Cats, Dogs

治疗领域:

Antiseptic

授权状态:

Authorized

授权日期:

1995-10-04

产品特点

                                Revised: August 2008
AN: 01063/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Otodex Skin Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance(s)
Chlorocresol
0.500% w/w
Phenoxyethanol
0.720% w/w
(constituent of Phenonip preservative, see below)
Zinc Oxide
9.000% w/w
Lidocaine Hydrochloride
0.050% w/w
Excipients
Quinoline Yellow dye
0.005% w/w
Phenonip (preservative)
1.000% w/w
(comprising 0.720% w/w phenoxyethanol (above)
and 0.28%w/w mixed hydroxybenzoate esters)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
Pale yellow, oily cream with the odour of fern for topical
application.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid in the treatment of eczema, sore spots, abrasions and minor
burns.
Revised: August 2008
AN: 01063/2008
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
NONE.
4.5
SPECIAL PRECAUTIONS FOR USE
_i) Special precautions for use in animals_
For external use only. Use sparingly in cases where large areas of
skin
are damaged or affected.
_ii) Special precautions to be taken by the person administering the _
_veterinary medicinal product to animals_
Wash hands after use. In the event of accidental eye contact wash
immediately with copious amounts of water. If the skin or eye
irritation
persists – seek medical attention showing the product label to the
doctor.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Cats are particularly susceptible to CNS effect, of phenols, including
vomiting, in coordination, depression and coma. When Chlorocresol
has been absorbed systemically treatment should be symptomatic.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not contraindicated during pregnancy but should not be used during
lactation.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Contact with non-ionic surfactants may reduce the activity of certain
phenols.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINIS
                                
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