ΠΑΡΑΡΤΗΜΑ 1: SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CLOXALENE DRY COW , 100 mg/ml, intramammary ointment for dry cows.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5-ml syringe contains :
Active substance:
cloxacillin
500 mg
equivalent to cloxacillin benzathine 635mg
Excipients: q.s. to
5 ml
For a full list of excipients,see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary ointment.
4.
CLINICAL PARTICULARS
4.1.
Target species
Dry cows.
4.2.
Indications use, specifying the target species
CLOXALENE DRY COW is indicated at the time of drying off for
therapy of existing subclinical infections due to Gram positive
microorganisms sensitive to cloxacillin(Staph. aureus,Str.
agalactiae,Str. dysgalactiae, Str. uberis, coagulase-negative Staph.,
A. pyogenes) for prevention of mastitis arising during the functional
rest period of the udder and to reduce the risk of acute mastitis,
arising at calving, with the beginning of milk production.
4.3.
Contraindications
 Do not administer to cows with known hypersensitivity to
cloxacillin or to any of the excipients.
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4.4.
Special warnings for each target species
None.
4.5.
Special precautions for use
Special precautions for use in animals
Inappropriate use of the product can increase the incidence of
bacteria resistant to cloxacillin and reduce the efficacy of treatment
with other beta-lactam antibiotics,owing to the possible appearance
of cross-resistance.
When possible, cloxacillin should be used only on the basis of
sensitivity testing.In the case of occurrence of allergic
phenomena,the
Veterinary
surgeon
may,
at
his/her
discretion,interrupt administration and begin suitable symptomatic
treatment. Perform the administrations adopting a suitable aseptic
technique. Use of the product other than in the instructions supplied
in the Summary of Product Characteristics may lead to an increase
in the incidence of bacteria resistant to the active substance and
may negatively affect this efficacy.
Special attention must be given to improving management
procedures in the rearing establishment, to avoid any stressing
conditions for the animals.
Special precautions to be taken by the person administering
the veterinary medicinal product to animals
People with known sensitivity to cloxacillin must avoid contact with
the product.
4.6.
Adverse reaction(frequency and severity)
In subjects hypersensitive to the penicillins,allergic reactions may
occur. In these cases, at the discretion of the Veterinary surgeon,
administration of the medicinal product may be interrupted and a
suitable symptomatic treatment establishment.
4.7.
Use during pregnancy, lactation and egg lay
Use is contemplated in the final two months of pregnancy. Do not
administer to cows in milk production.
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4.8.
Interaction with other medicinal and other forms of interaction
The bactericidal effect of cloxacillin is neutralised by the
simultaneous
use
of
drugs
with
bacteriostatic
activity(macrolides,sulfonamides and tetracyclines)
4.9.
Amounts to be administered and administration route
Administer just once, after the final milking at the time of drying off,
one intramammary syringe per udder quarter.
Administration by the intramammary route.
Method of administration
Milk and drip off each udder quarter, then clean and disinfect the
teats(in particular the orifice) using a suitable preparation.
Remove the protection of the cannula of the syringe for partial
insertion, while for complete administration, the "partial insertion"
cylinder must also be removed. Introduce the cannula into the teat
duct and inject the entire contents of the syringe. Insert the canulla,
grip with the fingers of the hand the end of the teat and with the
thumb and index finger of the other hand push the product
contained in the teat duct delicately upwards. Then massage the
quarter delicately with both hands, always pushing upwards to
spread the product uniformly throughout the cistern.
Cloxalene Dry Cow is available in intramammary syringes with the
“Twinsert”* system.
The “Twinsert”* system, permits both partial and complete insertion
of the syringe canulla into the teat canal, according to operating
requirements.
Antimastitic treatment through partial insertion of the canulla in the
teat canal permits a notable reduction in the onset of new udder
infections. In fact, complete insertion of the cannula dilates the teat
sphincter, facilitating the entry of bacteria and, at the same time, it
may transport the bacteria which are present in the keratin layer
covering the teat duct, directly into the teat cistern. With partial
insertion, the cannula enters only a few millimetres in the teat canal,
avoiding dilatation of the sphincter, destruction of the keratin layer
and also depositing the antibiotic along the teat canal.
In very agitated cows, when there are lesions to the teat or in other
special situations, complete insertion of the cannula may be
simpler.
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4.10.
Overdose (symptoms, emergency procedures, antidotes)if
necessary
Data not available.
4.11. Withdrawal periods
Meat: 42 days
Milk: 72 hours(6 milkings)
5.
PHARMACOLOGICAL PROPERTIES AND PHARMACOKINETIC
PARTICULARS
Pharmacotherapeutic group:Antibacterial agents for intramammary use.
ATCvet Code:QJ51CF02
5.1. Pharmacodynamic particulars
Cloxacillin is a bactericidal beta-lactam isoxazolyl penicillin antibiotic.
The mechanism of action of cloxacillin (inhibition of cell wall
mucopeptide synthesis) is bactericidal. The antimicrobial spectrum of
action of cloxacillin includes Gram-positive microorganisms: Staph.
aureus, Str. agalactiae, Str. dysgalactiae, Str. uberis, coagulasenegative staphylococci, A. pyogenes. A feature characteristic of the
isoxazolyl penicillins is resistance to beta- lactamase which,
hydrolysing the beta- lactam ring of the sensitive penicillins,
transforms 6-aminopenicillanic acid into peniciillic acid,which is
devoid of antibacterial activity.
The spectrum of action of cloxacillin therefore includes not only
penicillin-sensitive but also penicillin-resistant microorganisms,
which many staphylococcal strains associated with mastitis.
5.2. Pharmacokinetic particulars
The benzathine salt of cloxacillin is only slightly soluble in water,
therefore giving rise to a therapeutic response extended over time
and concentrated especially in the udder.
6.
PHARMACOKINETIC PARTICULARS
6.1.
List of excipients
Glycerol monostearate 40-55
Macrogol cetostearyl ether
Paraffin,light liquid
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6.2.
Incompatibilities
None known.
6.3.
Shelf-life
Shelf life of the medicinal product as packaged for sale: 2 years.
6.4.
Special precautions for storage
Store in a cool place protected from light.
6.5.
Nature and composition of immediate packaging
Cardboard box containing 4x5 ml polyethylene intramammary
syringes, in PVC/paper aluminium blister.
Cardboard box containing 12x5 ml polyethylene intramammary
syringes, in PVC/paper aluminium blister.
Cardboard box containing 60x5 ml polyethylene intramammary
syringes.
Not all pack sizes may be marketed.
6.6.
7.
Special precautions for the disposal of unused veterinary
medicinal product or waste derived from the use of such
products
Any unused veterinary medicinal product or waste materials derived
from such veterinary medicinal products should be disposed of in
accordance with local requirements.
MARKETING AUTHORISATION HOLDER
FATRO S.p.A. - Via Emilia, 285 - Ozzano Emilia (BO), Italy.
8.
MARKETING AUTHORISATION NUMBER
11232
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/6/1987
10. DATE OF REVISION OF THE TEXT
29/7/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
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