HEXASOL VETERINARY

국가: 이스라엘

언어: 영어

출처: Ministry of Health

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환자 정보 전단 환자 정보 전단 (PIL)
12-09-2022
제품 특성 요약 제품 특성 요약 (SPC)
12-09-2022

유효 성분:

FLUNIXIN AS MEGLUMINE; OXYTETRACYCLINE AS DIHYDRATE

제공처:

COMEX LTD

약제 형태:

SOLUTION FOR INJECTION

구성:

OXYTETRACYCLINE AS DIHYDRATE 30 %W/V; FLUNIXIN AS MEGLUMINE 2 %W/V

관리 경로:

I.M

처방전 유형:

Required

Manufactured by:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

치료 징후:

Hexasol veterinary may be of use in the treatment of disease caused by microorgamisms sensitive to oxytetracycline where anti-inflammatory, anti-pyretic, and anti bacterial effect is required.

승인 날짜:

2022-03-31

환자 정보 전단

                                VETERINARY MEDICINE USER LEAFLET
Veterinarian Prescription Only Medicine
For Animal Use Only
1.
NAME AND FORM OF THE VETERINARY MEDICINE:
_HEXASOL VETERINARY, SOLUTION FOR INJECTION _
2.
ACTIVE INGREDIENTS:
Each 1 ml of the medicine contains:
_Oxytetracycline (as dihydrate) _
_300 mg _
_ _
_Flunixin (as flunixin meglumine) _
_ 20 mg _
The medicine also contains the excipient:
Sodium Formaldehyde Sulphoxylate 0.4% w/v
For a full list of excipients, see section 13 “Further
Information”.
3.
INDICATIONS FOR USE:
Hexasol
Veterinary
is
used
in
the
treatment
of
disease
caused
by
microorganisms sensitive to oxytetracycline where anti-inflammatory,
anti-
pyretic and anti-bacterial effect is required.
THERAPEUTIC GROUP: Antibacterial, anti-inflammatory non-steroidal
drug.
4.
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 the product.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is a
potential risk of increased renal toxicity.
Do not administer other NSAIDs concurrently, or within 24 hours of
each other.
Concurrent use of potentially nephrotoxic drugs should be avoided.
Do not exceed the stated dose or duration of treatment.
5.
ADVERSE REACTIONS:
The use of tetracyclines during the period of tooth and bone
development,
including late pregnancy, may lead to discolouration.
Although the product is well tolerated, occasionally a local reaction
of a
transient nature may be observed.
Hypersensitivity reactions (collapse) may occur very rarely.
Such reactions may evolve to a more severe condition (anaphylaxis),
which
may be life-threatening.
Side effects can be reported to the Ministry of Health by clicking on
the link
“Reporting adverse events due to drug treatment” found on the home
page of
the Ministry of Health website (www.health.gov.il), which refers to
the online
form for reporting adverse events, or by entering the link:
https
                                
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제품 특성 요약

                                Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hexasol Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE _
Oxytetracycline (as dihydrate)
30% w/v [300 mg/ml]
Flunixin (as flunixin meglumine)
2.0% w/v [20 mg/ml]
_EXCIPIENTS _
Sodium Formaldehyde Sulphoxylate
0.4 % w/v
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:
Hexasol
Veterinary
is
used
in
the
treatment
of
disease
caused
by
microorganisms sensitive to oxytetracycline where anti-inflammatory,
anti-
pyretic and anti bacterial 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 the product.
Page 2 of 6
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is a
potential risk of increased renal toxicity.
Do not administer other NSAIDs concurrently, or within 24 hours of
each other.
Concurrent use of potentially nephrotoxic drugs should be avoided.
Do not exceed the stated dose or duration of treatment.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES:
None known.
4.5
SPECIAL PRECAUTIONS FOR USE:
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Avoid intra-arterial injection.
Use in any animals less than 6 weeks of age or in aged animals may
involve
additional risk. If such use cannot be avoided, animals may require a
reduced
dosage and careful clinical management.
It is preferable that prostaglandin inhibiting drugs are not
administered to
animals undergoing general anaesthesia until fully recovered.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT
TO THE ANIMALS:
Avoid eye contact and direct contact with skin.
To avoid possible sensitisation reactions, avoid contact with skin.
Gloves
should be worn during appl
                                
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