Hexasol LA Solution for Injection

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

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17-03-2023
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03-08-2023

有效成分:

Oxytetracycline dihydrate; Flunixin meglumine

可用日期:

Norbrook Laboratories (Ireland) Limited

ATC代码:

QJ01AA56

INN(国际名称):

Oxytetracycline dihydrate; Flunixin meglumine

剂量:

300,20 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗领域:

oxytetracycline, combinations

授权状态:

Authorised

授权日期:

1999-02-05

产品特点

                                SUMMARY OF PRODUCT
CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL
PRODUCT
Hexasol LA Solution for
Injection (IE)
Hexasol Solution for Injection for Cattle (AT, PT)
Covunil (FR)
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each ml
contains:
_Active substance: _
Oxytetracylcine (as oxytetracycline dehydrate)
300mg
Flunixin (as flunixin meglumine)
20 mg
_Excipients: _
Sodium Formaldehyde Sulphoxylate
4.0
mg
For a full list of excipients, see section
6.1
3.
PHARMACEUTICAL FORM
Solution for
injection.
A clear dark amber
solution.
4. CLINICAL
PARTICULARS
4.1 TARGET
SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET
SPECIES
For the treatment of acute respiratory disease caused by
oxytetracycline sensitive
_ Mannheimia _
_(Pasteurella) haemolytica _
and
_Pasteurella multocida _
where an anti-inflammatory and anti-pyretic
effect is
required.
4.3
CONTRAINDICATIONS
Use is contraindicated in animals suffering from cardiac, hepatic or
renal disease, where there
is a possibility of
gastrointestinal
ulceration or bleeding or where there is hypersensitivity to
one of the ingredients of the
product.
Avoid use in dehydrated hyopyolaemic or hypotensive animals as there
is a potential risk of
increased renal toxicity. Do not use in cases of known resistance to
tetracyclines.
Refer to section
4.11
4.4 SPECIAL WARNINGS FOR EACH TARGET
SPECIES
None.
4.5 SPECIAL PRECAUTIONS
FOR
USE
Special
Precautions
for use in
animals:
Use in any animals less than 6 weeks of age or in aged
animals may involve additional risk due to the anti-prostaglandin
effects
of
flunixin on renal
function. If such use cannot be avoided, animals may require careful
clinical
management.
Use of the product should be based on susceptibility testing of the
bacteria isolated from the
animal. If this is not possible,
therapy
should be based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Flunixin is toxic to avian scavengers. Do not administer to animals
susceptible to enter wild fauna
food chain. In
                                
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