natgillin/translations-raw huggingface dataset:
The following adverse reactions were observed during the clinical trials (pooled data*):
Med kliničnimi preskušanji (skupni podatki *) so ugotovili naslednje neželene učinke:
vomiting: occasional (≤ 3x)
bruhanje: občasno (≤ 3- krat)
vomiting: repeated (> 3 x) diarrhoea / soft stools
bruhanje: ponavljajoče (> 3- krat) driska/ mehko blato
anorexia / decreased appetite lethargy / weakness
anoreksija/ zmanjšan tek letargija/ šibkost
* data from 360 dogs over the whole treatment period.
* Podatki za 360 psov za celotno obdobje zdravljenja.
3/ 20 4.9 Amounts to be administered and administration route
4. 9 Odmerjanje in pot uporabe
Administer orally once daily at 0.63 mg mitratapide/ kg bodyweight (1 ml of the product per 8 kg) given for 2 periods of 21 days with 14 days without treatment in between.
Odmerjajte enkrat dnevno 0, 63 mg mitratapida/ kg telesne teže peroralno (1 ml zdravila na 8 kg) v dveh obdobjih po 21 dni, z vmesnim presledkom brez zdravljenja, ki traja 14 dni.
In order to allow proper dosing, the dog should be weighed on day 1 and on day 35 (i. e. at the start of each treatment period).
Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi in 35. dan (na začetku vsakega obdobja zdravljenja).
During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
3/ 20 V prvih 21 dneh zdravljenja lahko količina hrane, ki jo prejme žival, ostane nespremenjena.
The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
Pri psih so po 3 - do 5- kratnem prevelikem odmerjanju opazili naslednje klinične znake: zmehčano ali tekoče blato, bruhanje, slinjenje, anoreksija, huda izguba telesne teže, videz izčrpanosti, dehidracija in blede sluznice.
Peripherally acting antiobesity products, ATCvet Code:
Farmakoterapevtska skupina: zdravila proti debelosti s perifernim delovanjem, oznaka ATCvet:
weight loss category
Kategorija izgube
EU field trial
preskušanje v
US field trial
Skupni podatki
pooled data
telesne teže
*: in line with the recommended treatment schedule
* Skladno s priporočenim režimom zdravljenja.
4/ 20 5.2 Pharmacokinetic particulars
4/ 20 5. 2 Farmakokinetični podatki
Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/ kg.
Po peroralni uporabi je biološka uporabnost mitratapida (izvirne spojine in presnovkov) med 55 in 69%, volumen distribucije pa približno 5 l/ kg.
Mitratapide and its metabolites bind very extensively (> 99%) to plasma proteins and distribute to the tissues.
Mitratapid in njegovi presnovki se večinoma (> 99%) vežejo na beljakovine v plazmi in porazdelijo v tkivih.
After multiple dosing, the highest concentrations are present in the adrenal glands, liver, jejunum and kidney, but there is no exposure in the brain, excluding any central effect of the product.
Izpostavljenosti možganov ni, torej se lahko izključijo učinki zdravila na osrednje živčevje.
In fed dogs, a single dose of 0.63 mg mitratapide/ kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 µg/ ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 µg/ ml and 0.0168 µg/ ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 µg/ ml after 17.5 hours.
Pri hranjenih psih je enkratni odmerek 0, 63 mg mitratapida/ kg telesne teže povzročil največje koncentracije izvirne snovi v plazmi, katerih povprečje je 0, 012 µg/ ml, doseženo 3, 5 ure po odmerjanju; presnovka sulfoksida največjo koncentracijo dosežeta po 6, 5 ure, ko je njeno povprečje 0, 0136 µg/ ml, in 8, 5 ure, ko je njeno povprečje 0, 168 µg/ ml; presnovek sulfona po 17, 5 ure doseže koncentracijo 0, 0092 µg/ ml.
At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 µg/ ml, the sulphoxide metabolites 0.0089 µg/ ml and 0.0167 µg/ ml, respectively, the sulphone 0.0471 µg/ ml.
Na koncu tritedenskega odmerjanja mitratapid doseže povprečne koncentracije dinamičnega ravnovesja 0, 0068 µg/ ml, presnovka sulfoksida 0, 0089 µg/ ml in 0, 0167 µg/ ml ter presnovek sulfona 0, 0471 µg/ ml.
The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Končni razpolovni čas v plazmi za mitratapid je 6, 3 ure, za sulfokside 9, 8 in 11, 7 ure ter 44, 7 ure za presnovek sulfona.
Sucralose Butylated hydroxyanisole Macrogol 400
Sukraloza Butiliran hidroksianizol Makrogol 400
3 years Shelf-life after first opening the immediate packaging:
Rok uporabnosti po prvem odpiranju stične ovojnine:
3 months
3 mesece.
Do not refrigerate. This veterinary medicinal product does not require any special storage conditions.
Po vsakem odmerjanju je treba pipeto oprati in posušiti ter spet tesno priviti pokrovček.
After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly.
6. 5 Vrsta ovojnine in vsebina
55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
55 -, 120 - ali 210- mililitrska rumenorjava steklenička (tipa III) s propilensko zaporko, varno za otroke, in pipeto za odmerjanje.
The dosing pipette has a gradation in body weight: • up to 36 kg for the 55 ml bottle • up to 36 kg for the 120 ml bottle • up to 48 kg for the 210 ml bottle
Pipeta za odmerjanje ima lestvico, prilagojeno telesni teži: • do 36 kg za 55- mililitrsko stekleničko; • do 36 kg za 120- mililitrsko stekleničko; • do 48 kg za 210- mililitrsko stekleničko.
5/ 20 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
5/ 20 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
6/ 20 ANNEX II
6/ 20 DODATEK II
STATEMENT OF THE MRLs
D NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
8/ 20 ANNEX III
8/ 20 DODATEK III
10/ 20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 20 PODATKI NA ZUNANJI OVOJNINI
55 ml: ≤ 10 kg BW 120 ml: ≤ 22 kg BW 210 ml: ≤ 40 kg BW
55 ml: ≤ 10 kg telesne teže; 120 ml: ≤ 22 kg telesne teže; 210 ml: ≤ 40 kg telesne teže.
EXP:
EXP (mesec/ leto):
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI" IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO "ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM"
B-2340 Beerse, Belgium
B- 2340 Beerse, Belgija
12/ 20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
LABEL AMBER GLASS BOTTLE 55 ML
NALEPKA NA RUMENORJAVI 55- MILILITRSKI STEKLENIČKI
EXP {month/ year} Once opened, use within 3 months.
EXP {mesec/ leto} Odprto zdravilo uporabite v 3 mesecih.
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
BESEDILO "SAMO ZA ŽIVALI"
13/ 20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
13/ 20 PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI
LABEL AMBER GLASS BOTTLE 120 and 210 ml
NALEPKA NA RUMENORJAVI 120 - IN 210- MILILITRSKI STEKLENIČKI
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI"
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) V REGISTRU SKUPNOSTI ZDRAVILA
16/ 20 PACKAGE LEAFLET Yarvitan 5 mg/ ml oral solution for dogs
16/ 20 NAVODILO ZA UPORABO Yarvitan 5 mg/ ml peroralna raztopina za pse
Read all of this leaflet carefully before you start administering the medicine to your dog: • Keep this leaflet.
Preden svojemu psu daste to zdravilo, natančno preberite navodilo: • Navodilo shranite.
You may need to read it again • If you have further questions, please ask your veterinary surgeon or your pharmacist • This medicine has been prescribed for your dog only and you should not pass it on to others.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z veterinarjem ali farmacevtom. • Zdravilo je bilo predpisano samo vašemu psu in ga ne smete dajati drugim.
Yarvitan 5 mg/ ml oral solution for dogs Mitratapide
Yarvitan 5 mg/ ml peroralna raztopina za pse Mitratapid
Mitratapide 5 mg/ ml Butylated hydroxyanisole (E 320) Yarvitan is a colourless to slightly yellow solution.
Mitratapid 5 mg/ ml Butiliran hidroksianizol (E 320) Yarvitan je brezbarvna do rahlo rumena raztopina.
Do not administer Yarvitan: • if your dog has impaired liver function. • if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients. • if your dog is pregnant or during lactation. • in dogs less than 18 months of age. • if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism. (this is due to a malfunction of the adrenal gland).
Zdravila Yarvitan pri psu ne uporabljajte, če: • ima poslabšano delovanje jeter; • je preobčutljiv za (alergičen na) mitratapid ali katero koli sestavino; • e psica breja ali doji; • je mlajši od 18 mesecev; • čezmerno težo ali adipoznost povzroča sočasna sistemska bolezen, kot je hipotiroidizem (ki je posledica okvarjenega delovanja ščitnice) ali hiperadrenokorticizem (ki je posledica okvarjenega delovanja nadledvične žleze).
Tell your veterinary surgeon if you notice any of the following: • significant loss of appetite.
Če opazite katerega od spodnjih neželenih učinkov, obvestite svojega veterinarja: • izrazita izguba teka.
This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days). • vomiting • diarrhoea • softened stools
To je povezano z načinom delovanja zdravila in ni neželeni učinek, razen če postane zelo izrazit (to pomeni, da pes v dveh zaporednih dneh odklanja hrano); • bruhanje; • driska; • zmehčano blato.
In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
V laboratorijskih študijah so po uporabi zdravila v priporočenem odmerku opazili zmanjšanje vrednosti albumina, globulina, skupnih beljakovin, kalcija in alkalne fosfataze v serumu ter povečanje vrednosti alanin- aminotransferaze (ALT) in aspartat - aminotransferaze (AST).
The usual dose is once daily 0.63 mg mitratapide/ kg bodyweight (1 ml of the product per 8 kg).
Navadni odmerek je 0, 63 mg mitratapida/ kg telesne teže (1 ml zdravila na 8 kg) enkrat dnevno.
Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Izdelek uporabljajte peroralno v dveh 21- dnevnih obdobjih z vmesnim presledkom 14 dni brez zdravljenja.
Day 1-21
1. – 21. dan
Day 22-35
22. – 35. dan
Day 36-56
36. – 56. dan
treatment
zdravljenje
18/ 20 During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
18/ 20 V prvih 21 dneh zdravljenja lahko količina hrane, ki jo prejme žival, ostane nespremenjena.
Special precautions for use in animals The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Posebni previdnostni ukrepi za uporabo pri živalih Varnost zdravila med brejostjo in laktacijo ni bila dokazana.
Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Ob nenamerni samoaplikaciji se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Pack sizes – amber glass bottles containing:
Velikosti pakiranja – rumenorjave stekleničke, ki vsebujejo:
55ml: ≤ 10 kg bodyweight, 120ml: ≤ 22 kg bodyweight, 210ml: ≤ 40 kg bodyweight.
55 ml: ≤ 10 kg telesne teže, 120 ml: ≤ 22 kg telesne teže, 210 ml: ≤ 40 kg telesne teže.
What is Zactran?
Kaj je zdravilo Zactran?
Zactran is a solution for injection for cattle that contains the active substance gamithromycin (150 mg/ ml).
Zdravilo Zactran je raztopina za injiciranje za govedo, ki vsebuje zdravilno učinkovino gamitromicin (150 mg/ ml).
What is Zactran used for?
Za kaj se zdravilo Zactran uporablja?
Zactran is an anibiotic.
Zdravilo Zactran je antibiotic.
It is used in cattle to treat or to prevent Bovine Respiratory Disease (BRD) caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Uporablja se za zdravljenje ali preventivno zdravljenje respiratorne bolezni govedi (BRD), ki jo povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
When using Zactran to prevent BRD the presence of the disease in the herd should be established first.
Kadar se zdravilo Zactran uporablja za preventivno zdravljenje respiratorne bolezni govedi, je treba najprej ugotoviti, ali je bolezen v čredi prisotna.
Zactran is given as a single subcutaneous (under the skin) injection.
Zdravilo Zactran se injicira subkutano (pod kožo).
The dose to use is calculated based on the weight of the animal being treated.
Odmerek se izračuna na podlagi telesne mase zdravljene živali.
Animals weighing more than 250 kg will need to be injected at more than one site.
Živalim, ki tehtajo več kot 250 kg, bo treba zdravilo injicirati na več mestih.
It works by blocking the bacteria’ s ribosomes, which are the parts of the cells where proteins are produced, and consequently inhibiting the growth of bacteria.
Deluje tako, da blokira ribosome bakterij, t. j. dele celice, kjer se tvorijo beljakovine, in s tem preprečuje rast bakterij.
How has Zactran been studied?
Kako je bilo zdravilo Zactran raziskano?
Appropriate studies have been made to show the effectiveness of Zactran in cattle.
Učinkovitost zdravila Zactran pri govedu so dokazali v ustreznih študijah.
The main clinical studies were carried out on farms in a number of countries in Europe, as well as outside the EU.
Glavne klinične študije so bile izvedene na kmetijah v številnih evropskih državah in zunaj EU.
For the treatment of BRD, the effect of Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) already authorised in the EU, in cattle already affected by the disease.
Učinkovitost zdravila Zactran pri zdravljenju respiratorne bolezni govedi so preučevali tako, da so njegovo uporabo pri že okuženem govedu primerjali z drugim makrolidnim antibiotikom (tulatromicinom), ki je že odobren v EU.
For the prevention of BRD the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely to also develop the disease.
Učinkovitost zdravila Zactran pri preventivnem zdravljenju respiratorne bolezni govedi so preučevali tako, da so ga primerjali s placebom (zdravilom brez zdravilne učinkovine) pri govedu, ki je bilo v stiku z okuženimi živalmi na isti kmetiji in pri katerem posledično obstaja večja verjetnost, da zbolijo za to boleznijo.
What benefit has Zactran shown during the studies?
Kakšne koristi je zdravilo Zactran izkazalo med študijami?
Zactran has been shown to be efficacious in the treatment and prevention of BRD, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zdravilo Zactran se je izkazalo kot učinkovito pri zdravljenju in preventivnem zdravljenju respiratorne bolezni govedi, povezane z okužbo z bakterijami Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
In the treatment of BRD Zactran has been shown to be as effective as tulathromycin.
Pri zdravljenju respiratorne bolezni govedi se je zdravilo Zactran izkazalo za enako učinkovito kot tulatromicin.
What is the risk associated with Zactran?
Kakšna tveganja so povezana z zdravilom Zactran?
After injection of Zactran, up to 45% of animals will show some swelling at the site of injection.
Pri 45% živali se po injiciranju zdravila Zactran pojavi oteklina na mestu injiciranja.
The animals may also show some signs of slight pain for one day.
Pojavijo se lahko tudi znaki blažje bolečine, ki pa ne trajajo več kot en dan.
The swelling generally resolves in 3 to 14 days but may persist in some animals for up to 35 days after treatment.
Oteklina se običajno zmanjša v 3 do 14 dneh, pri posameznih živalih pa lahko izjemoma traja do 35 dni po uporabi zdravila.
People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran.
Osebe z znano preobčutljivostjo za (alergijo na) sorodne antibiotike (iz skupine makrolidov) naj se izogibajo stiku z zdravilom Zactran.
Zactran may cause irritation to the eyes or the skin.
Zdravilo Zactran lahko draži oči ali kožo, zato se izogibajte stiku zdravila s temi deli telesa.
Therefore, contact with skin or eyes should be avoided.
Če pride do stika zdravila Zactran z očmi, jih takoj sperite s čisto vodo.
If Zactran comes in direct contact with the eyes, they should be flushed immediately with clean water.
Če pride do stika zdravila s kožo, takoj umijte izpostavljene dele s čisto vodo.
Similarly, if Zactran comes into direct contact with skin the affected area should be washed immediately with clean water.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
After the last administration of Zactran, cattle should not be slaughtered for 64 days.
Goveda se ne sme zaklati 64 dni po uporabi zdravila Zactran.
What is the time to allow before milk can be taken from the animal for human consumption?
Koliko časa je treba počakati, preden se mleko živali lahko uporabi za prehrano ljudi?
As the safety of Zactran in breeding animals has not been studied, the medicine should not be used in lactating cows or heifers producing milk for human consumption.
Varnost uporabe zdravila Zactran pri živalih, namenjenih za razplod, ni bila raziskana, zato se zdravila ne sme uporabljati pri kravah v obdobju laktacije ali telicah, ki dajejo mleko za prehrano ljudi.
It should also not be used in pregnant cows or heifers which are intended to produce milk for human consumption within 2 months of calving.
Zdravila ne dajemo brejim kravam ali telicam, katerih mleko je namenjeno prehrani ljudi, v obdobju dveh mesecev pred pričakovanim porodom.
Why has Zactran been approved?
Zakaj je bilo zdravilo Zactran odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Zactran exceeded the risks for the therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, (the presence of the disease in the herd should be established before preventive treatment) and recommended that Zactran should be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da koristi zdravila Zactran presegajo z njim povezana tveganja pri zdravljenju in preventivnem zdravljenju respiratorne bolezni govedi, povezane z okužbo z bakterijami Mannheimia haemolytica, Pasteurella multocida in Histophilus somni (pred preventivnim zdravljenjem je treba oceniti prisotnost bolezni v čredi), in priporočil, da se za zdravilo Zactran odobri dovoljenje za promet.
Other information about Zactran:
stran 2/ 3 Druge informacije o zdravilu Zactran:
The European Commission granted a marketing authorisation valid throughout the European Union, for Zactran to Merial on 24/ 07/ 2008.
Evropska komisija je dovoljenje za promet z zdravilom Zactran, veljavno po vsej Evropski uniji, odobrila družbi Merial dne 24/ 07/ 2008.
This summary was last updated in July 2008.
Povzetek je bil nazadnje posodobljen julija 2008.
EU/ 2/ 08/ 082/ 001 Zactran
EU/ 2/ 08/ 082/ 001 Zactran EU/ 2/ 08/ 082/ 002
Cardboard box with one vial
Kartonska škatla z vialo
Glass vial 100ml
Steklena viala
64 days.
64 dni.
Not permitted for use in lactating animals.
Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
EU/ 2/ 08/ 082/ 002 Zactran
Zactran
Glass vial 250ml
Steklena viala
Glass vial 500ml
Steklena viala
ZACTRAN 150mg/ ml solution for injection for cattle
ZACTRAN 150 mg/ ml raztopina za injiciranje za govedo
Therapeutic and preventive treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zdravljenje in preventivno zdravljenje respiratorne bolezni govedi (BRD) povezane z okužbami z Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
The presence of the disease in the herd should be established before preventive treatment.
Pred preventivnim zdravljenjem je potrebno oceniti prisotnost bolezni v čredi.
Do not use the product simultaneously with other macrolides or lincosamides (see section 4.8).
Ne uporabite sočasno z drugimi makrolidnimi antibiotiki ali linkozamidi (glejte poglavje 4. 8).
Do not use in lactating cattle producing milk for human consumption.
Ne uporabite pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
2/ 17 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 17 Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Gamithromycin may cause irritation to eyes or/ and skin.
Gamitromicin lahko draži oči ali/ in kožo.
Avoid contact with skin or eyes If eye exposure occurs, flush eyes immediately with clean water.
Če pride do stika zdravila z očmi, takoj sperite s čisto vodo.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
During clinical trials no treatment related abnormalities were observed except some transient injection site swellings.
Med kliničnimi testiranji niso ugotovili nobenih drugih z zdravljenjem povezanih sprememb, razen prehodne otekline na mestu dajanja.
Visible injection site swellings may develop in up to 45% of treated animals associated with occasional, slight pain evident for one day.
Oteklino lahko občasno spremlja blažja bolečina, ki je ne traja več kot en dan.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle.
Varnost uporabe gamitromicina v obdobju brejosti in laktacije pri kravah ni bila raziskana.
Use only according to the risk/ benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno tveganja pristojnega veterinarja.
A single subcutaneous injection of 6 mg gamithromycin/ kg body weight (equivalent to 1 ml/ 25 kg body weight) in the neck.
Subkutano injiciranje enkratnega odmerka 6 mg gamitromicina/ kg telesne teže (kar ustreza 1ml/ 25 kg telesne teže) v področje vratu.
For treatment of cattle over 250 kg body weight, divide the dose so that no more than 10 ml are injected at one site.
Za zdravljenje goveda težjega od 250 kg razdelite odmerek tako, da na eno mesto ne aplicirate več kot 10 ml zdravila.
To ensure correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Za pravilno odmerjanje zdravila je potrebna kar se da natančna ocena telesne teže, da ne pride do premajhnega odmerjanja.
Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in cattle.
Klinične študije so pokazale široko varnost uporabe gamitromicina za injiciranje pri govedu.