natgillin/translations-raw huggingface dataset:
The full EPAR for Forcaltonin is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Forcaltonin je na voljo tukaj.
Why has Forcaltonin been approved?
Zakaj je bilo zdravilo Forcaltonin odobreno?
They decided that Forcaltonin's benefits are greater than its risks for prevention of bone loss due to sudden immobilisation, such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile), for treatment of Paget's disease, and treatment of hypercalcaemia of malignancy.
Odbor je zato odločil, da so koristi zdravila Forcaltonin večje od z njim povezanih tveganj pri preprečevanju izgubljanja kostnine zaradi nenadne nepokretnosti, kot na primer pri bolnikih z nedavnim osteoporoznim zlomom (osteoporoza je bolezen, pri kateri postanejo kosti krhke), za zdravljenje Pagetove bolezni in zdravljenje hiperkalciemije zaradi maligne bolezni.
Forcaltonin is a clear solution for injection.
Zdravilo Forcaltonin je prozorna raztopina za injiciranje.
Forcaltonin is used in adults to prevent bone loss due to sudden immobilisation such as in patients with recent bone fractures caused by osteoporosis (a disease that makes bones fragile).
Zdravilo Forcaltonin se uporablja pri odraslih za preprečevanje izgubljanja kostnine zaradi nenadne nepokretnosti, kot na primer pri bolnikih z nedavnim osteoporoznim zlomom (osteoporoza je bolezen, pri kateri postanejo kosti krhke).
They recommended that Forcaltonin be given marketing authorisation.
Odbor je za zdravilo Forcaltonin priporočil odobritev dovoljenja za promet z zdravilom.
How is Forcaltonin used?
Kako se zdravilo Forcaltonin uporablja?
For the full list of side effects reported with Forcaltonin, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Forcaltonin, najdete v Navodilih za uporabo.
What is Forcaltonin used for?
Za kaj se zdravilo Forcaltonin uporablja?
What is Forcaltonin?
Kaj je zdravilo Forcaltonin?
How does Forcaltonin work?
Kako zdravilo Forcaltonin deluje?
Kύπρος
á
Number of
Številka EU
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
VIRACEPT 50 mg/g oral powder Nelfinavir
50 mg/g peroralni prašek peroralna uporaba steklenica (HDPE) 144 g
Each bottle contains 144 grams of oral powder and is supplied with a 1 gram (white) and a 5 gram (blue) polypropylene scoop.
1 steklenica + 1-g in 5-g polipropilenska merica
Date of first authorisation: 24/07/2008 Date of last renewal: 15/07/2013
Datum pridobitve dovoljenja za promet: 24/07/2008 Datum zadnjega podaljšanja dovoljenja za promet: 15/07/2013
MIC90: 32
MIK90: 32
Pigs: 16 days.
Prašiči: 16 dni.
The cap may be safely punctured up to 60 times.
Zaporka se lahko varno prebode do 60 krat.
Sheep: 29 days.
Ovce: 29 dni.
Avoid contact with skin or eyes.
Izogibajte se stiku zdravila s kožo ali očmi.
The injection volume should not exceed 5 ml per injection site.
Volumen injekcije ne sme preseči 5 ml na mesto dajanja.
4, Chemin du Calquet 31000 Toulouse France
4, Chemin du Calquet 31000 Toulouse Francija
The bioavailability of the compound was > 98 % with no gender differences.
Biorazpoložljivost učinkovine je >98%, brez razlik med spoloma.
MBC90s µg/ml
MBK90s µg/ml
Cattle and sheep: subcutaneous injection.
NAVEDBA UČINKOVINE IN DRUGE(IH) SESTAVIN
MIC90s
MIK90s
MIC µg/ml
MIK µg/ml
Use only according to the risk/benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Interaction with other medicinal products and other forms of interaction: Cross resistance may occur with other macrolides.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Lahko se pojavi navzkrižna rezistenca z drugimi makrolidi.
The periodic safety update report (PSUR) cycle should be re-started for submission of 6- monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.
Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih.
The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment.
Otekline se običajno zmanjšajo v 3 do 14 dneh, vendar lahko pri posameznih živalih izjemoma vztrajajo do 35 dni po zdravljenju.
Clinical studies have demonstrated the wide margin of safety for gamithromycin injection in the target species.
Klinične študije so pokazale široko varnost uporabe gamitromicina za injiciranje pri ciljnih živalskih vrstah.
For the full list of excipients, see section 6.1.
1 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
These local reactions are transient and typically resolve within 2 (pigs) to 4 (sheep) days.
Te lokalne reakcije so prehodne in običajno minejo v 2 (prašiči) do 4 (ovce) dneh.
Gamithromycin may cause irritation to eyes and/or skin.
Gamitromicin lahko draži oči in/ali kožo.
Wash hands after use.
Po dajanju zdravila si umijte roke.
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local policies on the use of antimicrobials in farm animals.
Uporaba zdravila za uporabo v veterinarski medicini naj temelji na testiranju občutljivosti in naj bo v skladu z uradnimi in lokalnimi načeli uporabe protimikrobnih zdravil pri proizvodnih živalih.
Cross resistance may occur with other macrolides.
Lahko se pojavi navzkrižna rezistenca z drugimi makrolidi.
The compound is absorbed rapidly into the target tissue for SRD.
Učinkovina se zelo hitro absorbira v tarčno tkivo za SRD.
France
NEMČIJA
Muscle Skin and fat in natural proporti ons
Mišice Koža in maščoba v naravnih razmerjih
Colourless to pale yellow solution.
Brezbarvna do svetlo rumena raztopina.
Do not use this veterinary medicinal product after the expiry date which is stated on the vial after EXP. Shelf-life after first opening the container: 28 days.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na viali, po EXP. Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
Macrolides in general have both bacteriostatic and bactericidal action mediated through disruption of bacterial protein synthesis.
Makrolidi v splošnem delujejo tako bakteriostatično kot baktericidno z zaviranjem sinteze bakterijskih proteinov.
The in vitro data show that gamithromycin acts in a bactericidal manner.
In vitro podatki kažejo, da gamitromicin deluje baktericidno.
The active substance in ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Učinkovina v zdravilu ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče je dovoljena učinkovina, kot je navedena v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
The mechanisms involve the alteration of the ribosomal target site, the utilization of active efflux mechanism and the production of inactivating enzymes.
Mehanizmi zajemajo spremembo tarčnega mesta na ribosomu, pospešitev mehanizma aktivnega izločanja antibiotika iz celice in produkcijo inaktivacijskih encimov.
For multiple vial entry, an automatic dosing device is recommended to avoid excessive broaching of the stopper.
V primeru da je potrebno večkratno prebadanje, je priporočljiva uporaba naprave za avtomatsko doziranje v izogib prepogostega prebadanja.
People with known hypersensitivity to the macrolide class should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na makrolidne antibiotike naj se izogibajo stiku z zdravilom.
The 500 ml vial is for cattle and pigs only.
500 ml viala je namenjena le govedu in prašičem.
• Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
- zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja študij o kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
This is often referred to as MLSB resistance as it affects macrolides, lincosamides and streptogramins.
To je t.i. MLSB rezistenca, ker zajema makrolide, linkozamide in streptogramine.
The bioavailability of gamithromycin was > 92 %.
Biorazpoložljivost učinkovine je > 92%.
Injection site reactions were noted in a dose related manner.
Reakcije na mestu dajanja so bile povezane z odmerkom.
The volume of distribution at steady-state was approximately 39 l/kg.
Volumen distribucije pri ustaljenem stanju je 39 l/kg.
Treatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.
Zdravljenje nalezljive šepavost ovac (foot rot), povezane z viruletnima Dichelobacter nodosus in Fusobacterium necrophorum, ki zahteva sistemsko zdravljenje.
Accumulation of gamithromycin in the lung has been demonstrated by high and sustained concentrations in the lung and bronchial fluid which far exceed those in blood plasma.
Akumulacija gamitromicina v pljučih je bila dokazana z visoko in dolgotrajno koncentracijo v pljučih in bronhialni tekočini, ki daleč presegajo vsebnost v krvni plazmi.
Meat and offal: Cattle: 64 days.
Meso in organi: Govedo: 64 dni.
Three mechanisms are generally considered responsible for resistance to the macrolide class of compounds.
Za nastanek rezistence na makrolidni razred so navadno odgovorni trije mehanizmi.
Do not use this veterinary medicinal product simultaneously with other macrolides or lincosamides (see section 4.8).
Ne uporabite tega zdravila za uporabo v veterinarski medicini sočasno z drugimi makrolidnimi antibiotiki ali linkozamidi (glejte poglavje 4.8).
Monothioglycerol Succinic Acid Glycerol Formal
Monotioglicerol Sukcinilna kislina Glicerol formal
Based on laboratory animal data, gamithromycin has not produced any evidence of specific developmental or reproductive effects.
S študijami na laboratorijskih živalih niso bili ugotovljeni nobeni specifični učinki gamitromicina na razvoj ali reprodukcijo.
A single dose of 6 mg gamithromycin/kg body weight (equivalent to 1 ml/25 kg body weight) into the neck (cattle and pigs) or anterior to the shoulder (sheep).
En odmerek s 6 mg gamitromicina/kg telesne teže (kar ustreza 1 ml/25 kg telesne teže) v področje vratu (govedo in prašiči) ali prednji del ramena (ovce).
This special chemistry facilitates rapid absorption at physiological pH and a long duration of action at the target tissues, the lung and the skin.
Ta kemijska posebnost omogoča izjemno hitro absorbcijo pri fiziološkem pH in dolgotrajno učinkovanje v ciljnem tkivu,
During clinical trials transient injection site swellings were observed.
Med kliničnimi testiranji so bile opažene prehodne otekline na mestu dajanja.
The efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management.
Učinkovitost protimikrobnega zdravljenja nalezljive šepavosti ovc je lahko zmanjšana zaradi drugih dejavnikov, kot so mokri pogoji okolja in tudi neprimerni pogoji reje.
To ensure correct dose, 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.
Gamithromycin is an azalide, 15-membered semisynthetic macrolide class antibiotic with uniquely positioned alkylated nitrogen at 7a-position of the lactone ring.
Gamitromicin je azalid, antibiotik iz razreda 15-tih polsintetičnih makrolidnih antibiotikov z edinstvenim 7a položajem alkiliziranega dušika na laktonskem obroču.
EXP Once opened, use by __/__/__
EXP Odprto zdravilo uporabite do __/__/__
The volume of distribution at steady-state was 25 l/kg.
Volumen distribucije pri ustaljenem stanju je 25 l/kg.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle, sheep and pigs.
Varnost uporabe gamitromicina v obdobju brejosti in laktacije pri kravah, svinjah in ovcah ni bila raziskana.
Antibiotic treatment of benign foot rot is not considered appropriate.
Zdravljenje benigne šepavosti ovac z antibiotiki je neprimerno.
In young adult cattle, sheep and pig studies, gamithromycin was administered by injection at 6, 18, and 30 mg/kg (1, 3, and 5 times the recommended dose) and repeated three times at 0, 5 and 10 days (three times the recommended duration of use).
V študijah na mladem odraslem govedu, ovcah in na prašičih, so injicirali 6, 18 in 30 mg/kg gamitromicina (1, 3 in 5-kraten priporočen odmerek zdravila) in dajanje ponovili trikrat pri 0, 5 in 10 dneh (tri-kratno priporočeno trajanje zdravljenja).
For treatment of cattle over 250 kg and sheep over 125 kg body weight, divide the dose so that no more than 10 ml (cattle) or 5 ml (sheep) are injected at a single site.
Za zdravljenje goveda težjega od 250 kg in ovc težjih od 125 kg razdelite odmerek tako, da na eno mesto ne aplicirate več kot 10 ml (govedo) ali 5 ml (ovce) zdravila.
Cardboard box containing 1 vial of 50, 100, 250 or 500 ml.
Kartonska škatla z 1 vialo po 50, 100, 250 ali 500 ml.
The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Pomožne snovi, navedene v poglavju 6.1 SPC, so dovoljene snovi, za katere tabela 1 priloge Uredbe
Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.
Ob zdravljenju nalezljive šepavosti ovac je torej potrebno sočasno uvesti tudi druge ukrepe za izboljšanje pogojev reje, na primer živalim zagotoviti suho okolje.
Gamithromycin levels in lung reached a maximum in less than 24 hr, with lung-to-plasma ratio of > 264 indicating that gamithromycin was absorbed rapidly into the target tissue for BRD.
Višek koncentracije gamitromicina v pljučih je v manj kot 24 urah, z razmerjem pljuča - plazma >264, kar kaže na izjemno hitro absorbcijo gamitromicina v tarčno tkivo za BRD.
Biliary excretion of the unchanged drug was the major route of elimination.
Najpomembnejša pot izločanja nespremenjenega zdravila je z biliarno ekskrecijo.
Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients.
Ne uporabite v primeru preobčutljivosti na določeno vrsto antibiotikov, ki jim pravimo makrolidi, ali na katero od pomožnih snovi.
In vitro plasma protein binding studies determined that the mean concentration of the free active substance was 74 %.
In vitro študije vezanja plazemskih proteinov kažejo, da je povprečna koncentracija proste aktivne učinkovine 74 %.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
The MIC and MBC data (cattle and pig) are reported from a representative sample of isolates from field materials within different EU geographic areas.
podatki so pridobljeni iz reprezentativnih vzorcev izolatov s terena iz različnih geografskih področij
If skin exposure occurs, wash the affected area immediately with clean water.
Če pride do stika zdravila s kožo, takoj umijte izpostavljene dele s čisto vodo.
Active substance: 150 mg of gamithromycin Excipients: 1 mg of monothioglycerol Colourless to pale yellow solution.
1 ml raztopine vsebuje Aktivna učinkovina:150 mg gamitromicina Pomožne snovi: 1 mg monotioglicerola Brezbarvna do bledo rumena raztopina.
Macrolides inhibit bacterial protein biosynthesis by binding to the 50S ribosomal subunit and by preventing peptide chain elongation.
Biosintezo bakterijskih proteinov zavirajo z vezavo na 50S ribosomne podenote in preprečijo podaljševanje polipeptidne verige.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (50 ml / 100 ml / 250 ml)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (50ml/100ml/250 ml)
• Visible injection site swellings associated with occasional slight pain may develop very commonly in cattle for one day.
- Vidne otekline na mestu dajanja, ki so povezane z občasno, blago bolečino, ki traja en dan se lahko zelo pogosto pojavijo pri govedu.
• Mild to moderate injection site swelling has been reported commonly in sheep and pigs in clinical trials, with occasional slight pain evident for one day in sheep.
- Blaga do zmerna oteklina na mestu dajanja je bila pogosto opisana pri prašičih in ovcah med kliničnimi študijami, z včasih pridruženo blažjo bolečino pri ovcah v trajanju en dan.
If eye exposure occurs, flush eyes immediately with clean water.
Če pride do stika zdravila z očmi, takoj sperite s čisto vodo.
Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
Ne uporabite v primerih preobčutljivosti na makrolidne antibiotike ali pomožne snovi.
Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months (cows, heifers) or 1 month (ewes) of expected parturition.
Ne uporabite pri brejih živali, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev (krave in telice) ali 1 meseca (ovce) pred pričakovanim porodom.
Do not use this veterinary medicinal product simultaneously with other macrolides or antibiotics known as lincosamides.
Ne uporabite tega zdravila za uporabo v veterinarski medicini sočasno z drugimi makrolidnimi antibiotiki ali antibiotiki, ki jim pravimo linkozamidi .
Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zdravljenje in metafilaksa respiratorne bolezni govedi (BRD) povezane z okužbami z Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
SC (cattle, sheep), IM (pigs)
s.c. (govedo, ovce), i.m.
The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Actinobacillus pleuropneumoniae,Haemophilus parasuis and Bordetella bronchiseptica, the bacterial pathogens most commonly associated with BRD and SRD, and also Fusobacterium necrophorum and Dichelobacter nodosus.
Širok spekter protimikrobnega delovanja gamitromicina vključuje Manheimia haemolytica, Pasteurella multocida,Histophilus somni, Actinobacillus pleuropneumoniae, Haemophilus parasuis in Bordetella bronchiseptica, bakterijske povzročitelje, ki so najpogosteje povezani z BRD in SRD,
The presence of the disease in the herd should be established before metaphylactic use.
Pred metafilaktičnim zdravljenjem je potrebno potrditi prisotnost bolezni v čredi.
Avoid simultaneous administration of antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Izogibajte se istočasnemu dajanju antibiotikov s podobnim načinom delovanja, kot so na primer makrolidi in linkozamidi.
Gamithromycin administered subcutaneously into the neck of sheep at a single dose of 6 mg/kg body weight is rapidly absorbed, and maximum plasma concentrations were observed between 15 minutes and 6 hours after dosing (2.30 hours on average) with high absolute bioavailability of 89%.
Po subkutani aplikaciji gamitromicina v vrat pri ovcah v enkratnem odmerku 6 mg/kg telesne teže, je učinkovine hitra, z viškom koncentracije v plazmi med 15 minut in 6 ur po dajanju (povprečje 2,30 ure) in z visoko absolutno biorazpoložljivostjo > 89%.
50 μg/kg 300 μg/kg 200 μg/kg
50 μg/kg 50 μg/kg 300 μg/kg 200 μg/kg
Pharmacotherapeutic group: Antibacterials for systemic use, macrolides ATC vet code: QJ01FA95.
Oznaka ATC vet: QJ01FA95.
Polypropylene vial of 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Polipropilenska viala s 100, 250 ali 500 ml, s klorobutilnim gumijastim zamaškom, polipropilensko zaporko in aluminijastim tesnilom.
Type 1 glass vial of 50, 100, 250 or 500 ml with a chlorobutyl rubber stopper, a polypropylene cap and an aluminium crimp seal.
Steklena viala (steklo tip 1) s 50, 100, 250 ali 500 ml, s klorobutilnim gumijastim zamaškom, polipropilensko zaporko in aluminijastim tesnilom.
1 ml contains 150 mg of gamithromycin,
1 ml raztopine vsebuje 150 mg gamitromicina,
Cattle, sheep and pigs.
Govedo, ovce in prašiči.
Subcutaneous injection.
Subkutano injiciranje.
Treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida,Haemophilus parasuis and Bordetella bronchiseptica.
Zdravljenje respiratorne bolezni prašičev (SRD), povezane z okužbami z Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis in Bordetella bronchiseptica.
1 ml contains 150 mg of gamithromycin
1 ml vsebuje 150 mg gamitromicina.
• Rare (more than 1 but less than 10 animals in 10,000 animals treated)
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Not for use in animals producing milk for human consumption
Ni dovoljena uporaba pri živalih v laktaciji, ki proizvajajo mleko za prehrano ljudi
Gamithromycin skin concentrations were much higher than the plasma concentrations resulting in skin/plasma concentration ratios of approximately 21, 58, and 138 at two, five and ten days post-dosing, respectively, demonstrating extensive distribution and accumulation in skin tissue.
Koncentracije gamitromicina v koži so veliko večje kot koncentracije v krvni plazmi, z razmerjem koncentracij koža/plazma približno 21, 58
Cattle, sheep, pigs
Govedo, ovce, prašiči
Shelf life after first opening the container: 28 days Once opened, use by __/__/__
Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
SC (cattle) IM (pigs) Read the package leaflet before use.
(prašiči) Pred uporabo preberite navodilo za uporabo.
In vitro plasma protein binding studies determined that the mean concentration of the free active drug was 77 %.
In vitro študije vezave na proteine plazme kažejo, da je povprečna koncentracija proste učinkovine 77%, Najpomembnejša pot izločanja nespremenjenega zdravila je z biliarno ekskrecijo.
Do not use in pregnant cows and heifers which are intended to produce milk for human consumption, within 2 months of expected parturition.
Ne uporabite pri brejih kravah in telicah, katerih mleko je namenjeno prehrani ljudi, v obdobju
Overdose:
Inkompatibilnosti:
Pigs: intramuscular injection.
Prašiči: Intramuskularno
Gamithromycin administered subcutaneously into the neck of cattle at a single dose of 6 mg/kg body weight, resulted in rapid absorption with peak plasma concentrations observed after 30 to 60 min with a long plasma half-life (> 2 days).
Govedo Po subkutani aplikaciji gamitromicina v predel vratu pri govedu v enkratnem odmerku 6 mg/kg telesne teže, je absorbcija učinkovine izjemno hitra, z viškom koncentracije v plazmi po 30 do
Cattle and pigs: None.
Govedo in prašiči:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE VIAL 100 ml, 250 ml
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Viala 100 ml, 250 ml
ZACTRAN 150 mg/ml solution for injection for cattle and pigs gamithromycin
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo in prašiče Gamitromicin
Pigs Intramuscular injection.
Prašiči: intramuskularno
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče
ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs gamithromycin
ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče Gamitromicin
PACKAGE LEAFLET: ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs
NAVODILO ZA UPORABO ZACTRAN 150 mg/ml raztopina za injiciranje za govedo, ovce in prašiče