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Revision 1.2 - (show annotations)
Tue Apr 10 11:02:11 2001 UTC (22 years, 11 months ago) by dpavlin
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1
2
3 <!--Section Begins--><br>
4
5
6
7
8
9
10 <div align="justify">
11 <p style="text-align: justify;">
12
13 <b></b>
14
15 </p>
16 </div>
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25
26
27
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 KLOKSAVET<b><sup>®</sup></b><b> M</b>
33
34 </p>
35 </div>
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37
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45
46
47
48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>suspension for intramammary (i/mam) administration </i>
52
53 </p>
54 </div>
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56
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67 <div align="justify">
68 <p style="text-align: justify;">
69
70 treatment of mastitis in lactating cows
71
72 </p>
73 </div>
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86 <div align="justify">
87 <p style="text-align: justify;">
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89
90
91 </p>
92 </div>
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102
103
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105 <div align="justify">
106 <p style="text-align: justify;">
107
108 <b><i>Composition</i></b>
109
110 </p>
111 </div>
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113
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120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
126
127 Each injector with 5 mL of suspension contains:
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129 </p>
130 </div>
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132
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140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 Cloxacillin as cloxacillin sodium monohydrate 200 mg
147
148 </p>
149 </div>
150
151
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156
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160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165 Prednisolone as prednisolone acetate 10 mg
166
167 </p>
168 </div>
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175
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179
180
181 <div align="justify">
182 <p style="text-align: justify;">
183
184 Base - white paraffin and liquid paraffin up to 5 mL
185
186 </p>
187 </div>
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189
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198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203
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205 </p>
206 </div>
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217
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219 <div align="justify">
220 <p style="text-align: justify;">
221
222
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224 </p>
225 </div>
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227
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234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241 <b><i>Action</i></b><b></b>
242
243 </p>
244 </div>
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254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260 Kloksavet<b><sup>®</sup></b><sup> </sup>i/mam suspension contains an efficient combination of antibiotic cloxacillin and glucocorticoid prednisolone with synergistic action against the commonest causes of mastitis in the lactating cows.
261
262 </p>
263 </div>
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273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
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281 </p>
282 </div>
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293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298 Cloxacillin, a semi-synthetic penicillin, inhibits the action of transpeptidase during re-arrangement of the cell wall in the sensitive bacteria. It is stable in the presence of penicillinase (beta-lactamase) and acts bactericidally on benzylpenicillin-resistant staphylococci and streptococci. Its important feature is its activity against major gram-positive causes of mastitis - <i>Streptococcus agalactiae</i>, <i>Staphylococcus aureus</i>, <i>Actinomyces pyogenes</i> etc. Injected into the udder it is slowly released from the base without causing tissue irritation. Administration should be repeated after 48 hours.
299
300 </p>
301 </div>
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314 <div align="justify">
315 <p style="text-align: justify;">
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319 </p>
320 </div>
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329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336 Prednisolone, a synthetic glucocorticoid, alleviates inflammation, formation of exudate and fibrin and facilitates treatment of mastitis by enabling penetration of cloxacillin into deeper inflammatory foci in the mammary gland.
337
338 </p>
339 </div>
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349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
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357 </p>
358 </div>
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368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 <b><i>Indications</i></b>
375
376 </p>
377 </div>
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390 <div align="justify">
391 <p style="text-align: justify;">
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393 Mastitis in the lactating dairy cows caused by staphylococci, streptococci and other gram-positive bacteria sensitive to cloxacillin.
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395 </p>
396 </div>
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409 <div align="justify">
410 <p style="text-align: justify;">
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412
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414 </p>
415 </div>
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428 <div align="justify">
429 <p style="text-align: justify;">
430
431 <b><i>Contraindications</i></b><b></b>
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433 </p>
434 </div>
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447 <div align="justify">
448 <p style="text-align: justify;">
449
450 Do not administer to dry cows.
451
452 </p>
453 </div>
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466 <div align="justify">
467 <p style="text-align: justify;">
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471 </p>
472 </div>
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485 <div align="justify">
486 <p style="text-align: justify;">
487
488 Hypersensitivity to ingredients or the whole preparation, which is extremely rare.
489
490 </p>
491 </div>
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502
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504 <div align="justify">
505 <p style="text-align: justify;">
506
507 <b><i></i></b>
508
509 </p>
510 </div>
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523 <div align="justify">
524 <p style="text-align: justify;">
525
526 Administration and dosage
527
528 </p>
529 </div>
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541
542 <div align="justify">
543 <p style="text-align: justify;">
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545 Milk out the udder, clean and disinfect the teat end. Shake the injector and warm it in the hand. Introduce carefully its tip into the beginning of the teat canal and slowly infuse the contents into the milk cistern, ducts and alveoli. Then press firmly the teat end with the thumb and forefinger of one hand and with the other hand gently massage the udder upward, from the teats to the udder base to ensure even distribution of the suspension in the upper parts of the udder.
546
547 </p>
548 </div>
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561 <div align="justify">
562 <p style="text-align: justify;">
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566 </p>
567 </div>
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578
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580 <div align="justify">
581 <p style="text-align: justify;">
582
583 Treat the affected quarter 3 times in 48-hour intervals. Milk out the treated quarter during every milking.
584
585 </p>
586 </div>
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599 <div align="justify">
600 <p style="text-align: justify;">
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604 </p>
605 </div>
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617
618 <div align="justify">
619 <p style="text-align: justify;">
620
621 <b><i>Side effects</i></b>
622
623 </p>
624 </div>
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637 <div align="justify">
638 <p style="text-align: justify;">
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640 Unknown.
641
642 </p>
643 </div>
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656 <div align="justify">
657 <p style="text-align: justify;">
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661 </p>
662 </div>
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675 <div align="justify">
676 <p style="text-align: justify;">
677
678 <b><i>Warnings and precautions</i></b><b></b>
679
680 </p>
681 </div>
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694 <div align="justify">
695 <p style="text-align: justify;">
696
697 If more cows in a herd are diseased, it is recommended to perform sensitivity test before the onset of treatment.
698
699 </p>
700 </div>
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713 <div align="justify">
714 <p style="text-align: justify;">
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718 </p>
719 </div>
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732 <div align="justify">
733 <p style="text-align: justify;">
734
735 The milkers must observe compulsory hygienic measures.
736
737 </p>
738 </div>
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751 <div align="justify">
752 <p style="text-align: justify;">
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756 </p>
757 </div>
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770 <div align="justify">
771 <p style="text-align: justify;">
772
773 It is not advisable to concomitantly administer intramammary penicillins and systemic tetracycline antibiotics.
774
775 </p>
776 </div>
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789 <div align="justify">
790 <p style="text-align: justify;">
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794 </p>
795 </div>
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808 <div align="justify">
809 <p style="text-align: justify;">
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813 </p>
814 </div>
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827 <div align="justify">
828 <p style="text-align: justify;">
829
830 <b><i>Withdrawal</i></b><b></b>
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832 </p>
833 </div>
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846 <div align="justify">
847 <p style="text-align: justify;">
848
849 Milk from the treated quarters is not suitable for human consumption during the treatment and 72 hours after the last infusion. In other words, if the cows are milked twice daily, milk is suitable for consumption 6 milkings from the last dose of KLOKSAVET<b><sup>®</sup></b> M.
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851 </p>
852 </div>
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865 <div align="justify">
866 <p style="text-align: justify;">
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870 </p>
871 </div>
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884 <div align="justify">
885 <p style="text-align: justify;">
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887 Meat, organs and other edible tissues - 7 days.
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889 </p>
890 </div>
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903 <div align="justify">
904 <p style="text-align: justify;">
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908 </p>
909 </div>
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922 <div align="justify">
923 <p style="text-align: justify;">
924
925 <b><i>Storage</i></b>
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927 </p>
928 </div>
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940
941 <div align="justify">
942 <p style="text-align: justify;">
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944 Store in a cool place up to 15°C. Keep away from children.
945
946 </p>
947 </div>
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960 <div align="justify">
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965 </p>
966 </div>
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979 <div align="justify">
980 <p style="text-align: justify;">
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982 <b><i>Shelf life</i></b><b></b>
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984 </p>
985 </div>
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998 <div align="justify">
999 <p style="text-align: justify;">
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1001 Denoted on the packaging (18 months).
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1003 </p>
1004 </div>
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1018 <p style="text-align: justify;">
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1022 </p>
1023 </div>
1024
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1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 <b><i>Legal category</i></b><b></b>
1040
1041 </p>
1042 </div>
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1055 <div align="justify">
1056 <p style="text-align: justify;">
1057
1058 On prescription only.
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1060 </p>
1061 </div>
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1075 <p style="text-align: justify;">
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1079 </p>
1080 </div>
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1093 <div align="justify">
1094 <p style="text-align: justify;">
1095
1096 <b><i>Supply</i></b><b></b>
1097
1098 </p>
1099 </div>
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1111
1112 <div align="justify">
1113 <p style="text-align: justify;">
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1115 Box with 12 injectors of 5 mL suspension.
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1117 </p>
1118 </div>
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1125
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1131 <div align="justify">
1132 <p style="text-align: justify;">
1133
1134 <b></b>
1135
1136 </p>
1137 </div>
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1150 <div align="justify">
1151 <p style="text-align: justify;">
1152
1153 <b><i>Manufacturer</i></b><b></b>
1154
1155 </p>
1156 </div>
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1170 <p style="text-align: justify;">
1171
1172 VETERINA Animal Health Ltd., Croatia
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1174 </p>
1175 </div>
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1188 <div align="justify">
1189 <p style="text-align: justify;">
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1193 </p>
1194 </div>
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1207 <div align="left">
1208 <p style="text-align: left;">
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1212 </p>
1213 </div>
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1217
1218
1219
1220
1221 <!--Section Ends-->
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