Hexasol LA Solution for Injection

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Oxytetracycline dihydrate; Flunixin meglumine

থেকে পাওয়া:

Norbrook Laboratories (Ireland) Limited

এটিসি কোড:

QJ01AA56

INN (International Name):

Oxytetracycline dihydrate; Flunixin meglumine

ডোজ:

300,20 milligram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

প্রেসক্রিপশন টাইপ:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

oxytetracycline, combinations

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

1999-02-05

পণ্য বৈশিষ্ট্য

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