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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (23 years ago) by dpavlin
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CVS Tags: HEAD
File MIME type: text/html
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
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 <b>HIBISTREP</b><b><sup>®</sup></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>soluble powder</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 <b></b>
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 <b><i>Composition</i></b>
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 1 g contains 250 mg of streptomycin sulphate and 35 mg of chlorhexidine hydrochloride.
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
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 <b><i>Action</i></b>
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 A combination of the active ingredients ensures synergistic action based on structural changes in the cell membrane lipids caused by chlorhexidine. This facilitates bacterial penetration of the antibiotic and enhances its activity there. In sensitive bacteria streptomycin inhibits protein synthesis, while its therapeutic doses act bactericidally. Antimicrobial activity covers mostly gram-negative and many gram-positive and acidoresistant organisms (<i>Actinomyces</i> spp., <i>E</i>. <i>coli</i>, <i>Pasteurella</i> spp., <i>Salmonella</i> spp., <i>Campylobacter</i> spp. and <i>Actinobacillus</i> spp.).
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
185
186 </p>
187 </div>
188
189
190
191
192
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194
195
196
197
198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203 Chlorhexidine has a broad spectrum of activity against gram-positive and gram-negative bacteria as well as against fungi and algae. Orally administered streptomycin is vary hardly resorbed (only 2 -4% of it), and because it is resistant to gastric hydrochloric acid it achieves high intestinal levels. Poor solubility of chlorhexidine hydrochloride contributes to the prolonged antibacterial activity, which makes the preparation very suitable in the control of intestinal infections.
204
205 </p>
206 </div>
207
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210
211
212
213
214
215
216
217
218
219 <div align="justify">
220 <p style="text-align: justify;">
221
222
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 <b><i>Indications</i></b><b></b>
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 Treatment and control of:
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 - gastrointestinal bacterial infections in domestic animals (colibacillosis, salmonellosis, pasteurellosis);
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 - non-specific enteritis in chicks and turkeys;
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 - ulcerative enteritis in chicks, turkeys and quails;
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 - early deaths in fowl;
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 - diarrhoea in the weaned piglets.
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 Boosting of productivity in animals (improving weight gain and feed conversion).
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>Contraindications</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 Unknown.
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>Administration and dosage</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 <b><i>Suckling piglets</i></b><i>: </i>1 g of powder/kg of b. w. daily dissolved in water or milk.
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 <i>Swine:</i> 1 g of powder per 1 L of drinking water or 0.3% with feed (mix homogeneously 0.3 kg of Hibistrep<b><sup>®</sup></b> powder with 100 kg of feed).
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
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 <i>Poultry:</i> 2 g of powder in 1 L of drinking water. Increase the dose to 6 g/1 L of water when treating ulcerative enteritis. If administered with feed, the dose is 0.6% (mix homogeneously 0.6 kg of Hibistrep<b><sup>®</sup></b> powder with 100 kg of feed). Apply twice, e. g. from days 1-7 and 30-40 of the fattening period.
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
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 <i>Calves, foals:</i><b><i> </i></b>4-8 g of powder daily dissolved in drinking water, milk or milk substitute and divided in two subdoses.
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
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 <i>Lambs: </i>2-4 g of powder daily dissolved in drinking water or milk and divided in two subdoses.
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
660
661 </p>
662 </div>
663
664
665
666
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669
670
671
672
673
674
675 <div align="justify">
676 <p style="text-align: justify;">
677
678 In case of individual treatment, the powder is administered in 12-24 hour intervals and usually given over 3-5 days.
679
680 </p>
681 </div>
682
683
684
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
704
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>
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 Always prepare a fresh solution.
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>
758
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761
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765
766
767
768
769
770 <div align="justify">
771 <p style="text-align: justify;">
772
773 To ensure the intake of the medicated drinking water, the animals should be restricted from other sources of liquid during the treatment.
774
775 </p>
776 </div>
777
778
779
780
781
782
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 Once prepared use within 24 hours.
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
837
838
839
840
841
842
843
844
845
846 <div align="justify">
847 <p style="text-align: justify;">
848
849 <b><i>Withdrawal</i></b><b></b>
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 Meat, organs and other edible tissues
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 broilers and turkeys 4 days
888
889 </p>
890 </div>
891
892
893
894
895
896
897
898
899
900
901
902
903 <div align="justify">
904 <p style="text-align: justify;">
905
906 Swine, cattle, sheep 10 days
907
908 </p>
909 </div>
910
911
912
913
914
915
916
917
918
919
920
921
922 <div align="justify">
923 <p style="text-align: justify;">
924
925 Eggs 0 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
954
955
956
957
958
959
960 <div align="justify">
961 <p style="text-align: justify;">
962
963 <b><i>Storage</i></b><b></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 dark and dry place at room temperature (up to 25°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>Legal category</i></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 On prescription only.
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>Shelf life</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 Denoted on the packaging (3 years in the original pack).
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 <b></b>
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 Boxes with bags of 10 x 20 g and bag with 1000 g.
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
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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