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Thu Apr 5 12:26:37 2001 UTC (23 years 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>
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24
25
26
27
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 GEOMYCIN<b><sup>®</sup></b><b> L 10%</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>injection solution</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
71
72 </p>
73 </div>
74
75
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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 mL 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 100 mg
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 hydrochloride
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 Lidocaine hydrochloride (local anaesthetic) 20 mg
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 Carrier and adjuvants up to 1.0 mL
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
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 <b><i>Action</i></b><b></b>
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 Geomycin<b><sup>®</sup></b> is a broad-spectrum antibiotic active against many pathogens in which it inhibits protein synthesis. It is active against haemolytic and non-haemolytic streptococci, clostridiae, brucellae, Haemophylus and klebsiellae. Moderate sensitivity to it is shown in actinomycetes, pasteurellae, salmonellae, <i>E. coli</i> and the causative organisms of anthrax and erysipelas. Species from <i>Proteus</i>, <i>Pseudomonas</i>, <i>Enterococcuss faecalis</i> and <i>Staphylococcus</i> spp. genera are relatively resistant. In addition to its action against bacteria, Geomycin<b><sup>®</sup></b><sup> </sup>is also active against spirochettes and rickettsiae.
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
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267
268
269
270
271
272
273
274
275
276 <div align="justify">
277 <p style="text-align: justify;">
278
279 Given parenterally, oxytetracycline very rapidly penetrates into the blood and tissues where it achieves high concentrations. Being bound to plasma proteins to relatively high percentage, its therapeutic levels in the body are maintained over a long period. Therefore, it is sufficient to administer one dose in 24 hours. Therapeutic doses are non-toxic. Local anaesthetic lindocaine ensures rapid and efficient anaesthesia of the administration site, which alleviates soreness of parenteral administration.
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
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 <b><i>Indications</i></b>
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 Prophylaxis and treatment of primary and secondary bacterial infections and bacterial pneumonia in all animals:
337
338 </p>
339 </div>
340
341
342
343
344
345
346
347
348
349
350 <ul>
351 <li>
352
353 <div align="justify">
354 <p style="text-align: justify;">
355
356 complications accompanying and following acute viral respiratory diseases in cattle and infectious pyelonephritis in cattle;
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 distemper, erysipelas, leptospirosis, septic conditions during inflammation of the udder and uterus;
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 local treatment of suppurative processes, parenteral treatment phlegmona, treatment of umbilical infection, prophylaxis of bacterial infections in suckling piglets by treating the sows several hours before or immediately after farrowing; actinomycosis, etc.
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 Injections should not be administered by i. v. route.
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 Geomycin<b><sup>®</sup></b> L 10% is contraindicated in hypersensitivity to tetracyclines or the preparation.
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
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510 </p>
511 </div>
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513
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518
519
520
521
522
523
524 <div align="justify">
525 <p style="text-align: justify;">
526
527 The drug should not be given to bitches during last three 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 and dosage</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 Large animals: i. m., s. c. and i. ut.
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 Small animals: i. m. and s.c.
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 After administration massage the site of injection.
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
647
648
649
650
651
652
653
654
655
656
657 <div align="justify">
658 <p style="text-align: justify;">
659
660 <i>Cattle, horses, sheep, goats, swine</i>: 1-5 mL/50 kg of b. w./day (2-10 mg/kg/day) over 4-5 days.
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 <i>Dogs, cats</i>: 0.5-2 mL/10 kg of b. w./day (5-20 mg/kg/day), over 4-5 days.
680
681 </p>
682 </div>
683
684
685
686
687
688
689
690
691
692
693
694
695 <div align="justify">
696 <p style="text-align: justify;">
697
698 <i>Sows:</i> a single dose of 10 mL several hours prior to farrowing or immediately after it.
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 <i>Intrauterine</i> <i>route</i><b><i>:</i></b> administer 5 mL using a sterile catheter. For better distribution in the uterus, it is recommended to priorly dilute the solution with 10-15 mL of sterile lukewarm water.
718
719 </p>
720 </div>
721
722
723
724
725
726
727
728
729
730
731
732
733 <div align="justify">
734 <p style="text-align: justify;">
735
736 <i>Locally:</i> in the treatment of actinomycosis in cattle inject Geomycin<b><sup>®</sup></b> L 10% directly into the affected tissue.
737
738 </p>
739 </div>
740
741
742
743
744
745
746
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
762
763
764
765
766
767
768
769
770
771 <div align="justify">
772 <p style="text-align: justify;">
773
774 <b><i>Warnings and precautions</i></b>
775
776 </p>
777 </div>
778
779
780
781
782
783
784
785
786
787
788
789
790 <div align="justify">
791 <p style="text-align: justify;">
792
793 Intramuscular injection of Geomycin<b><sup>®</sup></b> L is given deeply into the muscles. If the injecting volume is high, apply at two sites. Avoid administration at the same site after 24 hours. After administration massage the injection site.
794
795 </p>
796 </div>
797
798
799
800
801
802
803
804
805
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807
808
809 <div align="justify">
810 <p style="text-align: justify;">
811
812
813
814 </p>
815 </div>
816
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818
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820
821
822
823
824
825
826
827
828 <div align="justify">
829 <p style="text-align: justify;">
830
831 Animals with severe hepatic and renal impairment should be treated with care.
832
833 </p>
834 </div>
835
836
837
838
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841
842
843
844
845
846
847 <div align="justify">
848 <p style="text-align: justify;">
849
850
851
852 </p>
853 </div>
854
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861
862
863
864
865
866 <div align="justify">
867 <p style="text-align: justify;">
868
869 Allergic, i. e. anaphylactic reactions are extremely rare.
870
871 </p>
872 </div>
873
874
875
876
877
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879
880
881
882
883
884
885 <div align="justify">
886 <p style="text-align: justify;">
887
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890 </p>
891 </div>
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900
901
902
903
904 <div align="justify">
905 <p style="text-align: justify;">
906
907 To avoid interference with antimicrobials, oxytetracycline should not be given concurrently with beta-lactam or aminoglycosidal antibiotics.
908
909 </p>
910 </div>
911
912
913
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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
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937
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940
941
942 <div align="justify">
943 <p style="text-align: justify;">
944
945 If in an opened bottle the solution changes its colour (e. g. darkens), but is still clear and without precipitate, its potency and tolerance need not be changed.
946
947 </p>
948 </div>
949
950
951
952
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957
958
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960
961 <div align="justify">
962 <p style="text-align: justify;">
963
964
965
966 </p>
967 </div>
968
969
970
971
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973
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975
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977
978
979
980 <div align="justify">
981 <p style="text-align: justify;">
982
983 <b><i>Withdrawa</i></b>l
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 Meat, organs and other edible tissues 15 days
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 Milk 4 days
1022
1023 </p>
1024 </div>
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037 <div align="justify">
1038 <p style="text-align: justify;">
1039
1040
1041
1042 </p>
1043 </div>
1044
1045
1046
1047
1048
1049
1050
1051
1052
1053
1054
1055
1056 <div align="justify">
1057 <p style="text-align: justify;">
1058
1059 <b><i>Storage</i></b>
1060
1061 </p>
1062 </div>
1063
1064
1065
1066
1067
1068
1069
1070
1071
1072
1073
1074
1075 <div align="justify">
1076 <p style="text-align: justify;">
1077
1078 Store in a dark place at 8-15°C. Keep away from children.
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
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1105
1106
1107
1108
1109
1110
1111
1112
1113 <div align="justify">
1114 <p style="text-align: justify;">
1115
1116 <b><i>Legal category</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 On prescription only.
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>Shelf life</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 Denoted on the packaging (3 years in the original pack).
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>Supply</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 Pierced bottles with 50 mL and 100 mL.
1250
1251 </p>
1252 </div>
1253
1254
1255
1256
1257
1258
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 <b><i>Manufacturer</i></b><b></b>
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 VETERINA Animal Health Ltd., Croatia
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
1326
1327 </p>
1328 </div>
1329
1330
1331
1332
1333
1334
1335
1336
1337
1338
1339
1340
1341 <div align="left">
1342 <p style="text-align: left;">
1343
1344
1345
1346 </p>
1347 </div>
1348
1349
1350
1351
1352
1353
1354
1355 <!--Section Ends-->
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