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Revision 1.1 - (show annotations)
Thu Apr 5 12:26:37 2001 UTC (22 years, 11 months ago) by dpavlin
Branch: MAIN
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>
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26
27
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29 <div align="justify">
30 <p style="text-align: justify;">
31
32 <b>GEOMYCIN</b><b><sup>®</sup></b><b> retard 20%</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 <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 mL contains oxytetracycline dihydrate in the amount equivalent to 200 mg of oxytetracycline base.
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><b></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 Geomycin<b><sup>®</sup></b> retard 20% is a broad antimicrobial antibiotic. It is active against many gram-positive and gram-negative bacteria, against mycoplasmas, spirochetes, rickettsiae, chlamydiae and protozoa (<i>Anaplasma</i> spp., <i>Theileria</i> spp. and <i>Cowdria</i> spp.). In sensitive strains it interferes with protein synthesis and exerts bacteriostatic effect. Given by intramuscular injection, Geomycin<b><sup>®</sup></b> retard solution has markedly prolonged action. Oxytetracycline exerts specific affinity for pulmonary tissue, which makes Geomycin<b><sup>®</sup></b> retard 20% a drug of choice in the management of pneumonia. Its single dose achieves efficient blood- and tissue- levels that are maintained over 3-4 days.
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
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192
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194
195
196
197
198
199
200 <div align="justify">
201 <p style="text-align: justify;">
202
203 <b><i>Indications</i></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 Treatment of acute and chronic, primary and secondary infections of respiratory, urinary and gastrointestinal tracts caused by oxytetracycline-sensitive microorganisms in cattle, calves (not ruminating yet), steers, dairy cows, swine and sows.
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
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 Some major indications are:
261
262 </p>
263 </div>
264
265
266
267
268
269
270
271
272
273
274 <ul>
275 <li>
276
277 <div align="justify">
278 <p style="text-align: justify;">
279
280 respiratory infections caused by species of <i>Pasteurella</i>, <i>Corynebacterium</i>,<i> Klebsiella</i>,<i> Haemophilus</i> and <i>Bordetella</i> genera;
281
282 </p>
283 </div>
284
285
286
287
288
289
290
291
292
293
294 <li>
295
296 <div align="justify">
297 <p style="text-align: justify;">
298
299 stomach and intestinal inflammations caused by hypersensitive serotypes of <i>Salmonella</i> and <i>Escherichia </i>genera;
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 genitourinary infections (<i>cystitis</i>,<i> metritis</i>, MMA syndrome, etc.) caused by the species from <i>Corynebacterium</i>, <i>Escherichia</i>, <i>Bacillus, Klebsiella</i>,<i> Staphylococcus</i> and <i>Streptococcus</i> genera;
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 inflammation of the mammary gland caused by the species from <i>Staphylococcus</i>, <i>Streptococcus </i>and<i> Corynebacterium</i> genera and mycoplasmas - these cases require concurrent intramammary treatment;
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 wound and umbilical infections caused by staphylococci and streptococci;
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 arthritis caused by the species from <i>Erysipelothrix</i>, <i>Staphylococcus</i>,<i> Haemophilus</i>, <i>Corynebacterium, Salmonella</i> and <i>Escherichia </i>genera;<i></i>
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 infectious bovine keratoconjunctivitis caused by <i>Moraxella bovis</i>;
395
396 </p>
397 </div>
398
399
400
401
402
403
404
405
406
407
408 <li>
409
410 <div align="justify">
411 <p style="text-align: justify;">
412
413 supportive treatment of hoof diseases in the presence of the infection caused by <i>Fusobacterium necrophorum</i> and paronychia and specific traumatic hoof ulceration.
414
415 </p>
416 </div>
417
418
419
420
421
422
423
424
425
426
427 <li>
428
429 <div align="justify">
430 <p style="text-align: justify;">
431
432 mouth cavity infections (actinomycosis and actinobacillosis due to <i>Actinobacillus lignieresi</i>);
433
434 </p>
435 </div>
436
437
438
439
440
441
442
443
444
445
446 <li>
447
448 <div align="justify">
449 <p style="text-align: justify;">
450
451 anaplasmosis, Q-fever, listeriosis, leptospirosis, erysipelas, atrophic rhinitis, anthrax and clostridial infections.
452
453 </p>
454 </div>
455
456
457
458
459
460
461
462
463
464
465 </ul>
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 <b><i>Administration and dosage</i></b>
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 Geomycin<b><sup>®</sup></b><sup> </sup>retard 20% is administered by a deep i. m. injection.
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
528
529 </p>
530 </div>
531
532
533
534
535
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537
538
539
540
541
542
543 <div align="justify">
544 <p style="text-align: justify;">
545
546 It is recommended not to administer to cattle more than 20 mL at one site, to swine up to 10 mL and to sheep and goats up to 5 mL.
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
566
567 </p>
568 </div>
569
570
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572
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576
577
578
579
580
581 <div align="justify">
582 <p style="text-align: justify;">
583
584 Subcutaneous administration is only for piglets below 10 kg of body weight (ca 1 mL).
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 The dose of Geomycin<b><sup>® </sup></b>retard 20% is 1 mL per 10 kg of b. w., i. e. 20 mg of oxytetracycline/kg of b. w.
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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651
652
653
654
655
656
657 <div align="justify">
658 <p style="text-align: justify;">
659
660 After a single dose therapeutic level of oxytetracycline is maintained over 3-4 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
680
681 </p>
682 </div>
683
684
685
686
687
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689
690
691
692
693
694
695 <div align="justify">
696 <p style="text-align: justify;">
697
698 Usually one injection is sufficient for successful treatment. Severe cases may require additional administration after 3-4 days.
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
722
723
724
725
726
727
728
729
730
731
732
733 <div align="justify">
734 <p style="text-align: justify;">
735
736 <b><i>Contraindications</i></b>
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 Hypersensitivity to tetracyclines (which is very rare) or severe hepatic and renal impairment.
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
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 <b><i>Side effects</i></b>
794
795 </p>
796 </div>
797
798
799
800
801
802
803
804
805
806
807
808
809 <div align="justify">
810 <p style="text-align: justify;">
811
812 Geomycin<b><sup>®</sup></b> retard 20% is a topic irritant, causing sometimes at the site of administration a transient swelling which disappears in several days.
813
814 </p>
815 </div>
816
817
818
819
820
821
822
823
824
825
826
827
828 <div align="justify">
829 <p style="text-align: justify;">
830
831
832
833 </p>
834 </div>
835
836
837
838
839
840
841
842
843
844
845
846
847 <div align="justify">
848 <p style="text-align: justify;">
849
850 Allergic reactions to Geomycin<b><sup>®</sup></b> retard 20% are very rare. They are managed by instantaneous administration of adrenaline, antihistaminic and, if necessary, corticosterroid.
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
870
871 </p>
872 </div>
873
874
875
876
877
878
879
880
881
882
883
884
885 <div align="justify">
886 <p style="text-align: justify;">
887
888 <b><i>Warnings and precautions</i></b>
889
890 </p>
891 </div>
892
893
894
895
896
897
898
899
900
901
902
903
904 <div align="justify">
905 <p style="text-align: justify;">
906
907 Geomycin<b><sup>®</sup></b> retard 20% is not recommended in cats, dogs and horses.
908
909 </p>
910 </div>
911
912
913
914
915
916
917
918
919
920
921
922
923 <div align="justify">
924 <p style="text-align: justify;">
925
926
927
928 </p>
929 </div>
930
931
932
933
934
935
936
937
938
939
940
941
942 <div align="justify">
943 <p style="text-align: justify;">
944
945 If in the opened bottle the solution turns dark, but is still clear and without precipitate, its potency and tolerance need not be changed.
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
965
966 </p>
967 </div>
968
969
970
971
972
973
974
975
976
977
978
979
980 <div align="justify">
981 <p style="text-align: justify;">
982
983 <b><i>Withdrawal</i></b>
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 21 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 7 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 room temperature (up to 25°C). Keep away from children. Avoid freezing.
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>Legal category</i></b><b></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 (2 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 <b></b>
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 100 mL and 500 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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