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revision 1.2 by dpavlin, Tue Apr 10 11:02:10 2001 UTC revision 1.3 by dpavlin, Wed Nov 7 10:29:28 2001 UTC
# Line 10  Line 10 
10  <div align="left">  <div align="left">
11  <p style="text-align: left;">  <p style="text-align: left;">
12    
13    <b>AMPIVET</b><b><sup>® </sup></b><b>K</b><b> forte</b>
14    
15  </p>  </p>
16  </div>  </div>
# Line 26  Line 26 
26    
27    
28    
29  <div align="justify">  <div align="left">
30  <p style="text-align: justify;">  <p style="text-align: left;">
31    
32  <b>AMPIVET</b><b><sup>® </sup></b><b>K</b>  intramammary suspension
33    
34  </p>  </p>
35  </div>  </div>
# Line 45  Line 45 
45    
46    
47    
48  <div align="justify">  <div align="left">
49  <p style="text-align: justify;">  <p style="text-align: left;">
50    
51    
 suspension for intramammary administration against mastitis in the lactating cows  
52    
53  </p>  </p>
54  </div>  </div>
# Line 64  suspension for intramammary administrati Line 64  suspension for intramammary administrati
64    
65    
66    
67  <div align="justify">  <div align="left">
68  <p style="text-align: justify;">  <p style="text-align: left;">
   
69    
70    Composition
71    
72  </p>  </p>
73  </div>  </div>
# Line 83  suspension for intramammary administrati Line 83  suspension for intramammary administrati
83    
84    
85    
86  <div align="justify">  <div align="left">
87  <p style="text-align: justify;">  <p style="text-align: left;">
88    
89  <b><i>Composition</i></b>  Each injector (=5 ml of suspension) contains
90    
91  </p>  </p>
92  </div>  </div>
# Line 102  suspension for intramammary administrati Line 102  suspension for intramammary administrati
102    
103    
104    
105  <div align="justify">  <div align="left">
106  <p style="text-align: justify;">  <p style="text-align: left;">
107    
108  5 mL contain:  75 mg ampicilline as ampicilline sodium
109    
110  </p>  </p>
111  </div>  </div>
# Line 121  suspension for intramammary administrati Line 121  suspension for intramammary administrati
121    
122    
123    
124  <div align="justify">  <div align="left">
125  <p style="text-align: justify;">  <p style="text-align: left;">
126    
127  Cloxacillin as cloxacillin sodium               100 mg  200 mg cloxacilline as cloxacilline sodium
128    
129  </p>  </p>
130  </div>  </div>
# Line 140  Cloxacillin as cloxacillin sodium              100 m Line 140  Cloxacillin as cloxacillin sodium              100 m
140    
141    
142    
143  <div align="justify">  <div align="left">
144  <p style="text-align: justify;">  <p style="text-align: left;">
145    
146  Ampicillin as ampicillin trihydrate             200 mg  Auxiliary substances: vaseline white, paraffin liquid
147    
148  </p>  </p>
149  </div>  </div>
# Line 159  Ampicillin as ampicillin trihydrate            200 Line 159  Ampicillin as ampicillin trihydrate            200
159    
160    
161    
162  <div align="justify">  <div align="left">
163  <p style="text-align: justify;">  <p style="text-align: left;">
164    
165    
 Base - white paraffin and liquid paraffin       up to 5 mL  
166    
167  </p>  </p>
168  </div>  </div>
# Line 178  Base - white paraffin and liquid paraffi Line 178  Base - white paraffin and liquid paraffi
178    
179    
180    
181  <div align="justify">  <div align="left">
182  <p style="text-align: justify;">  <p style="text-align: left;">
183    
184    
185    
# Line 197  Base - white paraffin and liquid paraffi Line 197  Base - white paraffin and liquid paraffi
197    
198    
199    
200  <div align="justify">  <div align="left">
201  <p style="text-align: justify;">  <p style="text-align: left;">
202    
203  <b><i>Action</i></b>  <b><i>Action</i></b>
204    
# Line 219  Base - white paraffin and liquid paraffi Line 219  Base - white paraffin and liquid paraffi
219  <div align="justify">  <div align="justify">
220  <p style="text-align: justify;">  <p style="text-align: justify;">
221    
222  AMPIVET<sup>® </sup>K is a combination of semi-synthetic penicillins (ampicillin and cloxacillin) which inhibit cross-linking of peptoglycan threads and act bactericidally on the growing bacteria. It has antimicrobial action against major gram-positive and gram-negative pathogens: <i>Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Staphylococcus aureus, E. coli, Actinomyces pyogenes</i>, etc. Both penicillin ingredients exert an additive and partially synergistic effect. Given the resistance of bacterial beta-lactamase to cloxacillin, AMPIVET<sup>® </sup>K successfully treats inflammations caused by benzylpenicillin-resistant strains of staphylococci. Intramammary infusion has batericidal effect and does not cause local tissue irritation. The treatment should be long enough to achieve clinical cure.  AMPIVET<sup>® </sup>Forte is a combination of semi-synthetic penicillines, ampicillines and cloxacillines. These antibiotics inhibit transversal binding of peptidoglycane fibres in the walls of susceptible bacteria and have bactericidal effect in their growth phase. AMPIVET<sup>® </sup>Forte has an antimicrobial activity against major gram-positive and gram-negative agents of mastitis: Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Staphylococcus aureus, E. coli, Corynebacterium pyogenes etc. At that, both penicillines demonstrate additive and partly synergistic effect. Since cloxacilline is resistant to bacterial -lactamase, it is successful in the treatment of inflammations caused by staphylococci strains resistant to bensylpenicilline. Intramammary application of AMPIVET<sup>® </sup>K Forte in the udder, bactericidal effect is achieved and it doesn't cause local tissue enervation.
223    
224  </p>  </p>
225  </div>  </div>
# Line 235  AMPIVET<sup>® </sup>K is a combination o Line 235  AMPIVET<sup>® </sup>K is a combination o
235    
236    
237    
238  <div align="justify">  <div align="left">
239  <p style="text-align: justify;">  <p style="text-align: left;">
240    
241    
242    
# Line 254  AMPIVET<sup>® </sup>K is a combination o Line 254  AMPIVET<sup>® </sup>K is a combination o
254    
255    
256    
257  <div align="justify">  <div align="left">
258  <p style="text-align: justify;">  <p style="text-align: left;">
259    
260  <b><i>Indications</i></b>  Indication
261    
262  </p>  </p>
263  </div>  </div>
# Line 276  AMPIVET<sup>® </sup>K is a combination o Line 276  AMPIVET<sup>® </sup>K is a combination o
276  <div align="justify">  <div align="justify">
277  <p style="text-align: justify;">  <p style="text-align: justify;">
278    
279  Treatment of lactating cows against clinical and subclinical mastitis caused by ampicillin- and cloxacillin-sensitive gram-positive and gram-negative bacteria. AMPIVET<sup>® </sup>K is particularly indicated against udder inflammations caused by streptococci, staphylococci, <i>E. coli</i> and <i>Actinomyces pyogenes </i>species.  Treatment of clinical and subclinical mastitis in lactating cows.
280    
281  </p>  </p>
282  </div>  </div>
# Line 292  Treatment of lactating cows against clin Line 292  Treatment of lactating cows against clin
292    
293    
294    
295  <div align="justify">  <div align="left">
296  <p style="text-align: justify;">  <p style="text-align: left;">
297    
298    
299    
# Line 311  Treatment of lactating cows against clin Line 311  Treatment of lactating cows against clin
311    
312    
313    
314  <div align="justify">  <div align="left">
315  <p style="text-align: justify;">  <p style="text-align: left;">
316    
317  <b><i>Contraindications</i></b>  Contraindications
318    
319  </p>  </p>
320  </div>  </div>
# Line 333  Treatment of lactating cows against clin Line 333  Treatment of lactating cows against clin
333  <div align="justify">  <div align="justify">
334  <p style="text-align: justify;">  <p style="text-align: justify;">
335    
336  AMPIVET<sup>® </sup>K should not be given to the cows during dry period.  The drug shouldn't be administered to animals susceptible to penicillin antibiotics. Cows in dry period shouldn't be treated.
337    
338  </p>  </p>
339  </div>  </div>
# Line 349  AMPIVET<sup>® </sup>K should not be give Line 349  AMPIVET<sup>® </sup>K should not be give
349    
350    
351    
352  <div align="justify">  <div align="left">
353  <p style="text-align: justify;">  <p style="text-align: left;">
354    
355    
356    
# Line 368  AMPIVET<sup>® </sup>K should not be give Line 368  AMPIVET<sup>® </sup>K should not be give
368    
369    
370    
371  <div align="justify">  <div align="left">
372  <p style="text-align: justify;">  <p style="text-align: left;">
373    
374  <b><i>Administration and dosage</i></b>  Administration and dosage
375    
376  </p>  </p>
377  </div>  </div>
# Line 390  AMPIVET<sup>® </sup>K should not be give Line 390  AMPIVET<sup>® </sup>K should not be give
390  <div align="justify">  <div align="justify">
391  <p style="text-align: justify;">  <p style="text-align: justify;">
392    
393  Immediately prior to administration of AMPIVET<sup>® </sup>K milk out the udder. Teat ends and orifices must be clean and disinfected. Introduce the tip of the injector into the beginning of the teat canal and slowly inject the contents.    Wash the diseased quarter and disinfect tit top, insert injector in the tit channel and push in its contents. Contents of one injector should be inserted in the diseased udder quarter.
394    
395  </p>  </p>
396  </div>  </div>
# Line 409  Immediately prior to administration of A Line 409  Immediately prior to administration of A
409  <div align="justify">  <div align="justify">
410  <p style="text-align: justify;">  <p style="text-align: justify;">
411    
412    The drug is applied on three occasions with 12- hour intervals.
413    
414  </p>  </p>
415  </div>  </div>
# Line 428  Immediately prior to administration of A Line 428  Immediately prior to administration of A
428  <div align="justify">  <div align="justify">
429  <p style="text-align: justify;">  <p style="text-align: justify;">
430    
431  After administration of AMPIVET<sup>® </sup>K gently massage the udder upward, from the teat to the udder base, to evenly distribute the drug over the milk cistern, through the canals and alveoli of the mammary gland.  In severe infections it is recommended to administer the drug not only in the diseased quarter but 1 injector in the remaining udder quarters.
432    
433  </p>  </p>
434  </div>  </div>
# Line 444  After administration of AMPIVET<sup>® </ Line 444  After administration of AMPIVET<sup>® </
444    
445    
446    
447  <div align="justify">  <div align="left">
448  <p style="text-align: justify;">  <p style="text-align: left;">
   
   
   
 </p>  
 </div>  
   
   
   
   
   
   
   
   
   
   
449    
450    
 <div align="justify">  
 <p style="text-align: justify;">  
   
 Inject the contents of one injector into each affected quarter in 12- hour intervals. Milk out the udder before each administration.  
451    
452  </p>  </p>
453  </div>  </div>
# Line 482  Inject the contents of one injector into Line 463  Inject the contents of one injector into
463    
464    
465    
466  <div align="justify">  <div align="left">
467  <p style="text-align: justify;">  <p style="text-align: left;">
   
468    
469    Withdrawal period
470    
471  </p>  </p>
472  </div>  </div>
# Line 504  Inject the contents of one injector into Line 485  Inject the contents of one injector into
485  <div align="justify">  <div align="justify">
486  <p style="text-align: justify;">  <p style="text-align: justify;">
487    
488  <b><i>Warnings, precautions and interactions</i></b>  Meat is not suitable for human consumption during administration or 7 days after the last drug dose.
489    
490  </p>  </p>
491  </div>  </div>
# Line 523  Inject the contents of one injector into Line 504  Inject the contents of one injector into
504  <div align="justify">  <div align="justify">
505  <p style="text-align: justify;">  <p style="text-align: justify;">
506    
507  Manifestations of allergic reactions in the animals hypersensitive to penicillin antibiotics have been reported extremely rarely. Concurrent intramammary infusion of penicillins with systemic tetracycline or macrolide antibiotics is not recommended.  Milk is not suitable for human consumption during administration or 3 days after the last drug dose when cows are milked twice a day.
508    
509  </p>  </p>
510  </div>  </div>
# Line 558  Manifestations of allergic reactions in Line 539  Manifestations of allergic reactions in
539    
540    
541    
542  <div align="justify">  <div align="left">
543  <p style="text-align: justify;">  <p style="text-align: left;">
   
 If more animals in a herd are affected, it is recommended to perform sensitivity tests before the treatment.  
   
 </p>  
 </div>  
   
   
   
   
   
   
   
   
   
   
   
   
 <div align="justify">  
 <p style="text-align: justify;">  
   
544    
545    Note
546    
547  </p>  </p>
548  </div>  </div>
# Line 599  If more animals in a herd are affected, Line 561  If more animals in a herd are affected,
561  <div align="justify">  <div align="justify">
562  <p style="text-align: justify;">  <p style="text-align: justify;">
563    
564  After removal of the protective cap, care should be taken not to contaminate tip of the injector.  Simultaneous intramammary and parenteral administration of tetracyclines, macrolides or chloramphenycol is not recommended.
565    
566  </p>  </p>
567  </div>  </div>
# Line 618  After removal of the protective cap, car Line 580  After removal of the protective cap, car
580  <div align="justify">  <div align="justify">
581  <p style="text-align: justify;">  <p style="text-align: justify;">
582    
583    Animals which are overly susceptible to penicillin antibiotics can exert allergic reactions after drug application.
584    
585  </p>  </p>
586  </div>  </div>
# Line 634  After removal of the protective cap, car Line 596  After removal of the protective cap, car
596    
597    
598    
599  <div align="justify">  <div align="left">
600  <p style="text-align: justify;">  <p style="text-align: left;">
   
 <b><i>Withdrawal</i></b>  
   
 </p>  
 </div>  
   
   
   
   
   
   
   
   
   
   
601    
602    
 <div align="justify">  
 <p style="text-align: justify;">  
   
 Meat, organs and other edible tissues - 0 days.  
603    
604  </p>  </p>
605  </div>  </div>
# Line 672  Meat, organs and other edible tissues - Line 615  Meat, organs and other edible tissues -
615    
616    
617    
618  <div align="justify">  <div align="left">
619  <p style="text-align: justify;">  <p style="text-align: left;">
   
620    
621    Side-effects
622    
623  </p>  </p>
624  </div>  </div>
# Line 691  Meat, organs and other edible tissues - Line 634  Meat, organs and other edible tissues -
634    
635    
636    
637  <div align="justify">  <div align="left">
638  <p style="text-align: justify;">  <p style="text-align: left;">
639    
640  Milk - 3 days. Milk of the cows that are milked twice daily can be used after the sixth milking.  Unknown.
641    
642  </p>  </p>
643  </div>  </div>
# Line 710  Milk - 3 days. Milk of the cows that are Line 653  Milk - 3 days. Milk of the cows that are
653    
654    
655    
656  <div align="justify">  <div align="left">
657  <p style="text-align: justify;">  <p style="text-align: left;">
658    
659    
660    
# Line 729  Milk - 3 days. Milk of the cows that are Line 672  Milk - 3 days. Milk of the cows that are
672    
673    
674    
675  <div align="justify">  <div align="left">
676  <p style="text-align: justify;">  <p style="text-align: left;">
677    
678  <b><i>Storage</i></b>  Storage
679    
680  </p>  </p>
681  </div>  </div>
# Line 751  Milk - 3 days. Milk of the cows that are Line 694  Milk - 3 days. Milk of the cows that are
694  <div align="justify">  <div align="justify">
695  <p style="text-align: justify;">  <p style="text-align: justify;">
696    
697  Store in a cool place up to 15ËšC. Keep away from children. Avoid freezing.  Store below 15°C and out of the reach of children.
698    
699  </p>  </p>
700  </div>  </div>
# Line 767  Store in a cool place up to 15ËšC. Keep Line 710  Store in a cool place up to 15ËšC. Keep
710    
711    
712    
713  <div align="justify">  <div align="left">
714  <p style="text-align: justify;">  <p style="text-align: left;">
715    
716    
717    
# Line 786  Store in a cool place up to 15ËšC. Keep Line 729  Store in a cool place up to 15ËšC. Keep
729    
730    
731    
732  <div align="justify">  <div align="left">
733  <p style="text-align: justify;">  <p style="text-align: left;">
734    
735  <b><i>Shelf life</i></b>  Legal category
736    
737  </p>  </p>
738  </div>  </div>
# Line 805  Store in a cool place up to 15ËšC. Keep Line 748  Store in a cool place up to 15ËšC. Keep
748    
749    
750    
751  <div align="justify">  <div align="left">
752  <p style="text-align: justify;">  <p style="text-align: left;">
753    
754  Denoted on the packaging (2 years).  On veterinary prescription.
755    
756  </p>  </p>
757  </div>  </div>
# Line 824  Denoted on the packaging (2 years). Line 767  Denoted on the packaging (2 years).
767    
768    
769    
770  <div align="justify">  <div align="left">
771  <p style="text-align: justify;">  <p style="text-align: left;">
772    
773    
774    
# Line 843  Denoted on the packaging (2 years). Line 786  Denoted on the packaging (2 years).
786    
787    
788    
789  <div align="justify">  <div align="left">
790  <p style="text-align: justify;">  <p style="text-align: left;">
791    
792  <b><i>Legal category</i></b>  Shelf life
793    
794  </p>  </p>
795  </div>  </div>
# Line 862  Denoted on the packaging (2 years). Line 805  Denoted on the packaging (2 years).
805    
806    
807    
808  <div align="justify">  <div align="left">
809  <p style="text-align: justify;">  <p style="text-align: left;">
810    
811  On prescription only.  Indicated on packaging.
812    
813  </p>  </p>
814  </div>  </div>
# Line 881  On prescription only. Line 824  On prescription only.
824    
825    
826    
827  <div align="justify">  <div align="left">
828  <p style="text-align: justify;">  <p style="text-align: left;">
829    
830    
831    
# Line 900  On prescription only. Line 843  On prescription only.
843    
844    
845    
846  <div align="justify">  <div align="left">
847  <p style="text-align: justify;">  <p style="text-align: left;">
848    
849  <b><i>Supply</i></b>  Supply
850    
851  </p>  </p>
852  </div>  </div>
# Line 922  On prescription only. Line 865  On prescription only.
865  <div align="justify">  <div align="justify">
866  <p style="text-align: justify;">  <p style="text-align: justify;">
867    
868  Box with 12 injectors of 5 mL.  Box with 12 injectors of 5 ml suspension.
869    
870  </p>  </p>
871  </div>  </div>
# Line 983  VETERINA Animal Health Ltd., Croatia Line 926  VETERINA Animal Health Ltd., Croatia
926    
927  </p>  </p>
928  </div>  </div>
   
   
   
   
   
   
   
   
   
   
   
   
 <div align="left">  
 <p style="text-align: left;">  
   
   
   
 </p>  
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 <div align="left">  
 <p style="text-align: left;">  
   
   
   
 </p>  
 </div>  
929    
930    
931    
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