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Thu Apr 5 12:26:37 2001 UTC (18 years, 6 months ago) by dpavlin
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smpc for veterina

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>
17
18
19
20
21
22
23
24
25
26
27
28
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>
36
37
38
39
40
41
42
43
44
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>
55
56
57
58
59
60
61
62
63
64
65
66
67 <div align="justify">
68 <p style="text-align: justify;">
69
70 treatment of mastitis in lactating cows
71
72 </p>
73 </div>
74
75
76
77
78
79
80
81
82
83
84
85
86 <div align="justify">
87 <p style="text-align: justify;">
88
89
90
91 </p>
92 </div>
93
94
95
96
97
98
99
100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 <b><i>Composition</i></b>
109
110 </p>
111 </div>
112
113
114
115
116
117
118
119
120
121
122
123
124 <div align="justify">
125 <p style="text-align: justify;">
126
127 Each injector with 5 mL of suspension contains:
128
129 </p>
130 </div>
131
132
133
134
135
136
137
138
139
140
141
142
143 <div align="justify">
144 <p style="text-align: justify;">
145
146 Cloxacillin as cloxacillin sodium 200 mg
147
148 </p>
149 </div>
150
151
152
153
154
155
156
157
158
159
160
161
162 <div align="justify">
163 <p style="text-align: justify;">
164
165 monohydrate
166
167 </p>
168 </div>
169
170
171
172
173
174
175
176
177
178
179
180
181 <div align="justify">
182 <p style="text-align: justify;">
183
184 Prednisolone as prednisolone 10 mg
185
186 </p>
187 </div>
188
189
190
191
192
193
194
195
196
197
198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203 acetate
204
205 </p>
206 </div>
207
208
209
210
211
212
213
214
215
216
217
218
219 <div align="justify">
220 <p style="text-align: justify;">
221
222 Base - white paraffin and liquid up to 5 mL
223
224 </p>
225 </div>
226
227
228
229
230
231
232
233
234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241 paraffin
242
243 </p>
244 </div>
245
246
247
248
249
250
251
252
253
254
255
256
257 <div align="justify">
258 <p style="text-align: justify;">
259
260
261
262 </p>
263 </div>
264
265
266
267
268
269
270
271
272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 <b><i>Action</i></b><b></b>
280
281 </p>
282 </div>
283
284
285
286
287
288
289
290
291
292
293
294
295 <div align="justify">
296 <p style="text-align: justify;">
297
298 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.
299
300 </p>
301 </div>
302
303
304
305
306
307
308
309
310
311
312
313
314 <div align="justify">
315 <p style="text-align: justify;">
316
317
318
319 </p>
320 </div>
321
322
323
324
325
326
327
328
329
330
331
332
333 <div align="justify">
334 <p style="text-align: justify;">
335
336 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.
337
338 </p>
339 </div>
340
341
342
343
344
345
346
347
348
349
350
351
352 <div align="justify">
353 <p style="text-align: justify;">
354
355
356
357 </p>
358 </div>
359
360
361
362
363
364
365
366
367
368
369
370
371 <div align="justify">
372 <p style="text-align: justify;">
373
374 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.
375
376 </p>
377 </div>
378
379
380
381
382
383
384
385
386
387
388
389
390 <div align="justify">
391 <p style="text-align: justify;">
392
393
394
395 </p>
396 </div>
397
398
399
400
401
402
403
404
405
406
407
408
409 <div align="justify">
410 <p style="text-align: justify;">
411
412 <b><i>Indications</i></b>
413
414 </p>
415 </div>
416
417
418
419
420
421
422
423
424
425
426
427
428 <div align="justify">
429 <p style="text-align: justify;">
430
431 Mastitis in the lactating dairy cows caused by staphylococci, streptococci and other gram-positive bacteria sensitive to cloxacillin.
432
433 </p>
434 </div>
435
436
437
438
439
440
441
442
443
444
445
446
447 <div align="justify">
448 <p style="text-align: justify;">
449
450
451
452 </p>
453 </div>
454
455
456
457
458
459
460
461
462
463
464
465
466 <div align="justify">
467 <p style="text-align: justify;">
468
469 <b><i>Contraindications</i></b><b></b>
470
471 </p>
472 </div>
473
474
475
476
477
478
479
480
481
482
483
484
485 <div align="justify">
486 <p style="text-align: justify;">
487
488 Do not administer to dry cows.
489
490 </p>
491 </div>
492
493
494
495
496
497
498
499
500
501
502
503
504 <div align="justify">
505 <p style="text-align: justify;">
506
507
508
509 </p>
510 </div>
511
512
513
514
515
516
517
518
519
520
521
522
523 <div align="justify">
524 <p style="text-align: justify;">
525
526 Hypersensitivity to ingredients or the whole preparation, which is extremely rare.
527
528 </p>
529 </div>
530
531
532
533
534
535
536
537
538
539
540
541
542 <div align="justify">
543 <p style="text-align: justify;">
544
545 <b><i></i></b>
546
547 </p>
548 </div>
549
550
551
552
553
554
555
556
557
558
559
560
561 <div align="justify">
562 <p style="text-align: justify;">
563
564 Administration and dosage
565
566 </p>
567 </div>
568
569
570
571
572
573
574
575
576
577
578
579
580 <div align="justify">
581 <p style="text-align: justify;">
582
583 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.
584
585 </p>
586 </div>
587
588
589
590
591
592
593
594
595
596
597
598
599 <div align="justify">
600 <p style="text-align: justify;">
601
602
603
604 </p>
605 </div>
606
607
608
609
610
611
612
613
614
615
616
617
618 <div align="justify">
619 <p style="text-align: justify;">
620
621 Treat the affected quarter 3 times in 48-hour intervals. Milk out the treated quarter during every milking.
622
623 </p>
624 </div>
625
626
627
628
629
630
631
632
633
634
635
636
637 <div align="justify">
638 <p style="text-align: justify;">
639
640
641
642 </p>
643 </div>
644
645
646
647
648
649
650
651
652
653
654
655
656 <div align="justify">
657 <p style="text-align: justify;">
658
659 <b><i>Side effects</i></b>
660
661 </p>
662 </div>
663
664
665
666
667
668
669
670
671
672
673
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 Unknown.
679
680 </p>
681 </div>
682
683
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685
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687
688
689
690
691
692
693
694 <div align="justify">
695 <p style="text-align: justify;">
696
697
698
699 </p>
700 </div>
701
702
703
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705
706
707
708
709
710
711
712
713 <div align="justify">
714 <p style="text-align: justify;">
715
716 <b><i>Warnings and precautions</i></b><b></b>
717
718 </p>
719 </div>
720
721
722
723
724
725
726
727
728
729
730
731
732 <div align="justify">
733 <p style="text-align: justify;">
734
735 If more cows in a herd are diseased, it is recommended to perform sensitivity test before the onset of treatment.
736
737 </p>
738 </div>
739
740
741
742
743
744
745
746
747
748
749
750
751 <div align="justify">
752 <p style="text-align: justify;">
753
754
755
756 </p>
757 </div>
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761
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764
765
766
767
768
769
770 <div align="justify">
771 <p style="text-align: justify;">
772
773 The milkers must observe compulsory hygienic measures.
774
775 </p>
776 </div>
777
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779
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783
784
785
786
787
788
789 <div align="justify">
790 <p style="text-align: justify;">
791
792
793
794 </p>
795 </div>
796
797
798
799
800
801
802
803
804
805
806
807
808 <div align="justify">
809 <p style="text-align: justify;">
810
811 It is not advisable to concomitantly administer intramammary penicillins and systemic tetracycline antibiotics.
812
813 </p>
814 </div>
815
816
817
818
819
820
821
822
823
824
825
826
827 <div align="justify">
828 <p style="text-align: justify;">
829
830
831
832 </p>
833 </div>
834
835
836
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838
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840
841
842
843
844
845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849
850
851 </p>
852 </div>
853
854
855
856
857
858
859
860
861
862
863
864
865 <div align="justify">
866 <p style="text-align: justify;">
867
868 <b><i>Withdrawal</i></b><b></b>
869
870 </p>
871 </div>
872
873
874
875
876
877
878
879
880
881
882
883
884 <div align="justify">
885 <p style="text-align: justify;">
886
887 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>.
888
889 </p>
890 </div>
891
892
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898
899
900
901
902
903 <div align="justify">
904 <p style="text-align: justify;">
905
906
907
908 </p>
909 </div>
910
911
912
913
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915
916
917
918
919
920
921
922 <div align="justify">
923 <p style="text-align: justify;">
924
925 Meat, organs and other edible tissues - 7 days.
926
927 </p>
928 </div>
929
930
931
932
933
934
935
936
937
938
939
940
941 <div align="justify">
942 <p style="text-align: justify;">
943
944
945
946 </p>
947 </div>
948
949
950
951
952
953
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955
956
957
958
959
960 <div align="justify">
961 <p style="text-align: justify;">
962
963 <b><i>Storage</i></b>
964
965 </p>
966 </div>
967
968
969
970
971
972
973
974
975
976
977
978
979 <div align="justify">
980 <p style="text-align: justify;">
981
982 Store in a cool place up to 15°C. Keep away from children.
983
984 </p>
985 </div>
986
987
988
989
990
991
992
993
994
995
996
997
998 <div align="justify">
999 <p style="text-align: justify;">
1000
1001
1002
1003 </p>
1004 </div>
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017 <div align="justify">
1018 <p style="text-align: justify;">
1019
1020 <b><i>Shelf life</i></b><b></b>
1021
1022 </p>
1023 </div>
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036 <div align="justify">
1037 <p style="text-align: justify;">
1038
1039 Denoted on the packaging (18 months).
1040
1041 </p>
1042 </div>
1043
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055 <div align="justify">
1056 <p style="text-align: justify;">
1057
1058
1059
1060 </p>
1061 </div>
1062
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074 <div align="justify">
1075 <p style="text-align: justify;">
1076
1077 <b><i>Legal category</i></b><b></b>
1078
1079 </p>
1080 </div>
1081
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093 <div align="justify">
1094 <p style="text-align: justify;">
1095
1096 On prescription only.
1097
1098 </p>
1099 </div>
1100
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112 <div align="justify">
1113 <p style="text-align: justify;">
1114
1115
1116
1117 </p>
1118 </div>
1119
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131 <div align="justify">
1132 <p style="text-align: justify;">
1133
1134 <b><i>Supply</i></b><b></b>
1135
1136 </p>
1137 </div>
1138
1139
1140
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150 <div align="justify">
1151 <p style="text-align: justify;">
1152
1153 Box with 12 injectors of 5 mL suspension.
1154
1155 </p>
1156 </div>
1157
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169 <div align="justify">
1170 <p style="text-align: justify;">
1171
1172 <b></b>
1173
1174 </p>
1175 </div>
1176
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188 <div align="justify">
1189 <p style="text-align: justify;">
1190
1191 <b><i>Manufacturer</i></b><b></b>
1192
1193 </p>
1194 </div>
1195
1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207 <div align="justify">
1208 <p style="text-align: justify;">
1209
1210 VETERINA Animal Health Ltd., Croatia
1211
1212 </p>
1213 </div>
1214
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226 <div align="justify">
1227 <p style="text-align: justify;">
1228
1229
1230
1231 </p>
1232 </div>
1233
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245 <div align="left">
1246 <p style="text-align: left;">
1247
1248
1249
1250 </p>
1251 </div>
1252
1253
1254
1255
1256
1257
1258
1259 <!--Section Ends-->
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