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Revision 1.2 - (show annotations)
Tue Apr 10 11:02:11 2001 UTC (18 years ago) by dpavlin
Branch: MAIN
CVS Tags: HEAD
Changes since 1.1: +2 -21 lines
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1
2
3 <!--Section Begins--><br>
4
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10 <div align="justify">
11 <p style="text-align: justify;">
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15 </p>
16 </div>
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>GEOTILIN</b><b><sup>®</sup></b><b> P</b>
33
34 </p>
35 </div>
36
37
38
39
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41
42
43
44
45
46
47
48 <div align="justify">
49 <p style="text-align: justify;">
50
51 <i>medicated additive</i>
52
53 </p>
54 </div>
55
56
57
58
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60
61
62
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64
65
66
67 <div align="justify">
68 <p style="text-align: justify;">
69
70
71
72 </p>
73 </div>
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75
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81
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84
85
86 <div align="justify">
87 <p style="text-align: justify;">
88
89 <b><i>Composition</i></b><b></b>
90
91 </p>
92 </div>
93
94
95
96
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98
99
100
101
102
103
104
105 <div align="justify">
106 <p style="text-align: justify;">
107
108 1 kg contains:
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 Oxytetracycline as oxytetracycline hydrochloride 60 g
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 Tiamulin as tiamulin hydrogen fumarate 20 g
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 Carrier and adjuvants up to 1000 g
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
193
194
195
196
197
198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Action</i></b><b></b>
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 GEOTILIN<b><sup>®</sup></b> P is a combination of broad-spectrum antimicrobial antibiotics. In sensitive organisms both antibiotics inhibit protein synthesis. GEOTILIN<b><sup>®</sup></b> P is very potent against mycoplasmas (<i>Mycoplasma</i> <i>hyopneumoniae</i>, <i>M. hyorhinis</i> and <i>M.</i> <i>hyosynoviae</i>) and the species causing bloody scours in swine (<i>Serpulina</i> <i>hyodysenteriae</i>). It also inhibits the growth and multiplication of many gram-positive (<i>Staphylococcus </i>spp., <i>Streptococcus</i> spp., <i>Clostridium perfringens</i>, <i>Listeria monocytogenes</i>, <i>Erysipelothrix</i> <i>insidiosa</i>, <i>Actinomyces pyogenes</i>) and gram-negative bacteria (<i>Pasteurella</i> spp., <i>Klebsiella pneumoniae</i>, <i>Actinobacillus</i> and <i>Haemophylus</i> spp., <i>Fusobacterium necrophorum</i>, <i>Bacteroides</i> spp. and <i>Campylobacter</i> <i>coli</i>) as well as spirochettes (<i>Leptospira</i> spp.), rickettsiae (<i>Eperythrozoon suis</i>) and chlamydiae. Gram-negative intestinal bacteria are not usually sensitive to tiamulin- oxytetracycline combination. When taken orally both active ingredients are very rapidly resorbed and achieve peak plasma-levels in 60-90 minutes. Oxytetracycline and tiamulin are excreted mostly in bile and only partly via urine.
223
224 </p>
225 </div>
226
227
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229
230
231
232
233
234
235
236
237
238 <div align="justify">
239 <p style="text-align: justify;">
240
241
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 <b><i>Indications</i></b>
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 Control and treatment of the following diseases in swine:
280
281 </p>
282 </div>
283
284
285
286
287
288
289
290
291
292
293 <ul>
294 <li>
295
296 <div align="justify">
297 <p style="text-align: justify;">
298
299 mycoplasmal pneumonia;
300
301 </p>
302 </div>
303
304
305
306
307
308
309
310
311
312
313 <li>
314
315 <div align="justify">
316 <p style="text-align: justify;">
317
318 mycoplasmal arthritis caused by <i>Mycoplasma hyosynoviae</i> (treatment alleviates the symptoms of lameness and improves gain and feed conversion);
319
320 </p>
321 </div>
322
323
324
325
326
327
328
329
330
331
332 <li>
333
334 <div align="justify">
335 <p style="text-align: justify;">
336
337 atrophic rhinitis in swine;
338
339 </p>
340 </div>
341
342
343
344
345
346
347
348
349
350
351 <li>
352
353 <div align="justify">
354 <p style="text-align: justify;">
355
356 bloody scours (swine dysentery);
357
358 </p>
359 </div>
360
361
362
363
364
365
366
367
368
369
370 <li>
371
372 <div align="justify">
373 <p style="text-align: justify;">
374
375 bacterial and necrotic enteritis in swine;
376
377 </p>
378 </div>
379
380
381
382
383
384
385
386
387
388
389 <li>
390
391 <div align="justify">
392 <p style="text-align: justify;">
393
394 secondary respiratory and gastrointestinal bacterial infections.
395
396 </p>
397 </div>
398
399
400
401
402
403
404
405
406
407
408 </ul>
409
410 <div align="justify">
411 <p style="text-align: justify;">
412
413
414
415 </p>
416 </div>
417
418
419
420
421
422
423
424
425
426
427
428
429 <div align="justify">
430 <p style="text-align: justify;">
431
432 <b><i>Contraindications</i></b>
433
434 </p>
435 </div>
436
437
438
439
440
441
442
443
444
445
446
447
448 <div align="justify">
449 <p style="text-align: justify;">
450
451 Concomitant administration of ionofore antibiotics (e. g. lasalocid, monensin, maduramicin and semduramicin) with tiamulin, or their intake 7 days before and 7 after tiamulin, should be avoided.
452
453 </p>
454 </div>
455
456
457
458
459
460
461
462
463
464
465
466
467 <div align="justify">
468 <p style="text-align: justify;">
469
470
471
472 </p>
473 </div>
474
475
476
477
478
479
480
481
482
483
484
485
486 <div align="justify">
487 <p style="text-align: justify;">
488
489 The preparation is contraindicated in severe hepatic and renal impairment.
490
491 </p>
492 </div>
493
494
495
496
497
498
499
500
501
502
503
504
505 <div align="justify">
506 <p style="text-align: justify;">
507
508
509
510 </p>
511 </div>
512
513
514
515
516
517
518
519
520
521
522
523
524 <div align="justify">
525 <p style="text-align: justify;">
526
527 Medicated additives containing tiamulin are not recommended to sows and primiparous sows in the first third of pregnancy (approximately during first 5 weeks of pregnancy).
528
529 </p>
530 </div>
531
532
533
534
535
536
537
538
539
540
541
542
543 <div align="justify">
544 <p style="text-align: justify;">
545
546
547
548 </p>
549 </div>
550
551
552
553
554
555
556
557
558
559
560
561
562 <div align="justify">
563 <p style="text-align: justify;">
564
565 <b><i>Administration, dosage and metaphylactic programme</i></b>
566
567 </p>
568 </div>
569
570
571
572
573
574
575
576
577
578
579
580
581 <div align="justify">
582 <p style="text-align: justify;">
583
584 Medicated additive is given mixed in feed over 5 consecutive days. For metaphylactic purpose during stress situations administration may be prolonged, relevant to the risk of infection.
585
586 </p>
587 </div>
588
589
590
591
592
593
594
595
596
597
598
599
600 <div align="justify">
601 <p style="text-align: justify;">
602
603
604
605 </p>
606 </div>
607
608
609
610
611
612
613
614
615
616
617
618
619 <div align="justify">
620 <p style="text-align: justify;">
621
622 Therapeutic dose of Geotilin<b><sup>®</sup></b> P for swine is 0.5 kg/100 kg of feed (oxytetracycline 300 ppm and tiamulin 100 ppm). Usually the treatment lasts for 5 days.
623
624 </p>
625 </div>
626
627
628
629
630
631
632
633
634
635
636
637
638 <div align="justify">
639 <p style="text-align: justify;">
640
641
642
643 </p>
644 </div>
645
646
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649
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651
652
653
654
655
656
657 <div align="justify">
658 <p style="text-align: justify;">
659
660 Metaphylaxis of dysentery and enzootic pneumonia: 0.125-0.250 kg of Geotilin<b><sup>®</sup></b> P/100 kg of feed.
661
662 </p>
663 </div>
664
665
666
667
668
669
670
671
672
673
674
675
676 <div align="justify">
677 <p style="text-align: justify;">
678
679
680
681 </p>
682 </div>
683
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685
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689
690
691
692
693
694
695 <div align="justify">
696 <p style="text-align: justify;">
697
698 Dose and duration of treatment are relevant to severity of the disease and the risk of infection. Medicated additive should be given when clinical manifestations of the disease are most frequent.
699
700 </p>
701 </div>
702
703
704
705
706
707
708
709
710
711
712
713
714 <div align="justify">
715 <p style="text-align: justify;">
716
717
718
719 </p>
720 </div>
721
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725
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727
728
729
730
731
732
733 <div align="justify">
734 <p style="text-align: justify;">
735
736 It is recommended to introduce Geotilin<b><sup>®</sup></b> P during first 10 days post weaning, i. e. to administer therapeutic dose over 5 days (0.5 kg/100 kg of feed), and metaphylactic dose over next 5 days (0.250 kg/100 kg of feed).
737
738 </p>
739 </div>
740
741
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745
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747
748
749
750
751
752 <div align="justify">
753 <p style="text-align: justify;">
754
755
756
757 </p>
758 </div>
759
760
761
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766
767
768
769
770
771 <div align="justify">
772 <p style="text-align: justify;">
773
774 The procedure should be repeated and applied in the same manner on the admittance of swine to the fattening.
775
776 </p>
777 </div>
778
779
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785
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789
790 <div align="justify">
791 <p style="text-align: justify;">
792
793
794
795 </p>
796 </div>
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800
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802
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804
805
806
807
808
809 <div align="justify">
810 <p style="text-align: justify;">
811
812 Geotilin<b><sup>®</sup></b> P premix may be instituted metaphylactically, i. e. prophylactically before or after the above periods. Duration of treatment may be prolonged relevant to the degree and scope of the risk to swine. As a rule, metaphylaxis should be introduced during fattening period, when the animals are 20-50 kg of b. w. In such instances the dose during first 10 days is 0.250 kg/100 kg of feed.
813
814 </p>
815 </div>
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825
826
827
828 <div align="justify">
829 <p style="text-align: justify;">
830
831
832
833 </p>
834 </div>
835
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838
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840
841
842
843
844
845
846
847 <div align="justify">
848 <p style="text-align: justify;">
849
850 <b><i>Side effects</i></b>
851
852 </p>
853 </div>
854
855
856
857
858
859
860
861
862
863
864
865
866 <div align="justify">
867 <p style="text-align: justify;">
868
869 Vomiting has been reported on very rare occasions.
870
871 </p>
872 </div>
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874
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880
881
882
883
884
885 <div align="justify">
886 <p style="text-align: justify;">
887
888
889
890 </p>
891 </div>
892
893
894
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896
897
898
899
900
901
902
903
904 <div align="justify">
905 <p style="text-align: justify;">
906
907 If during administration rubor develops in the area of anus and/or genitalia, Geotilin<b><sup>®</sup></b> P should be discontinued and the animals thoroughly washed with water in order to remove the traces of faeces and urine containing active ingredients.
908
909 </p>
910 </div>
911
912
913
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917
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920
921
922
923 <div align="justify">
924 <p style="text-align: justify;">
925
926
927
928 </p>
929 </div>
930
931
932
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934
935
936
937
938
939
940
941
942 <div align="justify">
943 <p style="text-align: justify;">
944
945 <b><i>Warnings and precautions</i></b><b></b>
946
947 </p>
948 </div>
949
950
951
952
953
954
955
956
957
958
959
960
961 <div align="justify">
962 <p style="text-align: justify;">
963
964 Sick animals taking scarce feed should be treated via drinking water or, preferably by parenteral administration of Geotilin<b><sup>® </sup></b>P.
965
966 </p>
967 </div>
968
969
970
971
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975
976
977
978
979
980 <div align="justify">
981 <p style="text-align: justify;">
982
983
984
985 </p>
986 </div>
987
988
989
990
991
992
993
994
995
996
997
998
999 <div align="justify">
1000 <p style="text-align: justify;">
1001
1002 To avoid interference, with other antimicrobials or medicated additives, Geotilin<b><sup>®</sup></b> P should not be mixed with other antimicrobials or medicated additives.
1003
1004 </p>
1005 </div>
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018 <div align="justify">
1019 <p style="text-align: justify;">
1020
1021
1022
1023 </p>
1024 </div>
1025
1026
1027
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1029
1030
1031
1032
1033
1034
1035
1036
1037 <div align="justify">
1038 <p style="text-align: justify;">
1039
1040 Like with other medicated additives, when using wear face/eyes protection, suitable protective clothing and shoes. Avoid contact with mucosa and skin. After handling in feed mills wash thoroughly with water.
1041
1042 </p>
1043 </div>
1044
1045
1046
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1050
1051
1052
1053
1054
1055
1056 <div align="justify">
1057 <p style="text-align: justify;">
1058
1059
1060
1061 </p>
1062 </div>
1063
1064
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1066
1067
1068
1069
1070
1071
1072
1073
1074
1075 <div align="justify">
1076 <p style="text-align: justify;">
1077
1078 Usual pelleting procedure does not diminish potency of Geotilin<b><sup>®</sup></b> P.
1079
1080 </p>
1081 </div>
1082
1083
1084
1085
1086
1087
1088
1089
1090
1091
1092
1093
1094 <div align="justify">
1095 <p style="text-align: justify;">
1096
1097
1098
1099 </p>
1100 </div>
1101
1102
1103
1104
1105
1106
1107
1108
1109
1110
1111
1112
1113 <div align="justify">
1114 <p style="text-align: justify;">
1115
1116 <b><i>Withdrawal</i></b>
1117
1118 </p>
1119 </div>
1120
1121
1122
1123
1124
1125
1126
1127
1128
1129
1130
1131
1132 <div align="justify">
1133 <p style="text-align: justify;">
1134
1135 Swine: meat, organs and other edible tissues - 5 days.
1136
1137 </p>
1138 </div>
1139
1140
1141
1142
1143
1144
1145
1146
1147
1148
1149
1150
1151 <div align="justify">
1152 <p style="text-align: justify;">
1153
1154
1155
1156 </p>
1157 </div>
1158
1159
1160
1161
1162
1163
1164
1165
1166
1167
1168
1169
1170 <div align="justify">
1171 <p style="text-align: justify;">
1172
1173 <b><i>Storage</i></b>
1174
1175 </p>
1176 </div>
1177
1178
1179
1180
1181
1182
1183
1184
1185
1186
1187
1188
1189 <div align="justify">
1190 <p style="text-align: justify;">
1191
1192 Store in a dry and ventilated place at room temperature (up to 25°C). Keep away from children.
1193
1194 </p>
1195 </div>
1196
1197
1198
1199
1200
1201
1202
1203
1204
1205
1206
1207
1208 <div align="justify">
1209 <p style="text-align: justify;">
1210
1211
1212
1213 </p>
1214 </div>
1215
1216
1217
1218
1219
1220
1221
1222
1223
1224
1225
1226
1227 <div align="justify">
1228 <p style="text-align: justify;">
1229
1230 <b><i>Shelf life</i></b>
1231
1232 </p>
1233 </div>
1234
1235
1236
1237
1238
1239
1240
1241
1242
1243
1244
1245
1246 <div align="justify">
1247 <p style="text-align: justify;">
1248
1249 Denoted on the packaging (18 months in the original pack).
1250
1251 </p>
1252 </div>
1253
1254
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1256
1257
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1259
1260
1261
1262
1263
1264
1265 <div align="justify">
1266 <p style="text-align: justify;">
1267
1268
1269
1270 </p>
1271 </div>
1272
1273
1274
1275
1276
1277
1278
1279
1280
1281
1282
1283
1284 <div align="justify">
1285 <p style="text-align: justify;">
1286
1287 Once prepared use within 3 months.
1288
1289 </p>
1290 </div>
1291
1292
1293
1294
1295
1296
1297
1298
1299
1300
1301
1302
1303 <div align="justify">
1304 <p style="text-align: justify;">
1305
1306
1307
1308 </p>
1309 </div>
1310
1311
1312
1313
1314
1315
1316
1317
1318
1319
1320
1321
1322 <div align="justify">
1323 <p style="text-align: justify;">
1324
1325 <b><i>Legal category</i></b><b></b>
1326
1327 </p>
1328 </div>
1329
1330
1331
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341 <div align="justify">
1342 <p style="text-align: justify;">
1343
1344 On prescription or veterinarian's written request to prepare.
1345
1346 </p>
1347 </div>
1348
1349
1350
1351
1352
1353
1354
1355
1356
1357
1358
1359
1360 <div align="justify">
1361 <p style="text-align: justify;">
1362
1363
1364
1365 </p>
1366 </div>
1367
1368
1369
1370
1371
1372
1373
1374
1375
1376
1377
1378
1379 <div align="justify">
1380 <p style="text-align: justify;">
1381
1382 <b><i>Supply</i></b>
1383
1384 </p>
1385 </div>
1386
1387
1388
1389
1390
1391
1392
1393
1394
1395
1396
1397
1398 <div align="justify">
1399 <p style="text-align: justify;">
1400
1401 Bags with 200 g, 1 kg, 5 kg and 25 kg.
1402
1403 </p>
1404 </div>
1405
1406
1407
1408
1409
1410
1411
1412
1413
1414
1415
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1417 <div align="justify">
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1439 <b><i>Manufacturer</i></b><b></b>
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1441 </p>
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1458 VETERINA Animal Health Ltd., Croatia
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1460 </p>
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