FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: antibacterials for systemic use, macrolides.
Romanian: PROPRIETĂŢI FARMACOLOGICE Grupa farmacoterapeutică: antibacteriene pentru uz sistemic, macrolide.
English: Species
Romanian: Specii
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Romanian: CMI50 (µg/ml) CMI90 (µg/ml)
English: Following the maximum recommended injection site volume of 5 ml, injection site reactions resolved completely within 21 days.
Romanian: In urma administrarii la locul de injectare a unui volum maxim recomandat la o injectare de 5ml, reactiile de la locul de injectare se remit complet in 21 de zile.
English: The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.
Romanian: Prezenţa bolii trebuie confirmată în efectiv înainte de implementarea metafilaxiei.
English: Administer strictly intramuscularly.
Romanian: Se administrează strict intramuscular.
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection.
Romanian: Se recomandă ca animalele să se trateze în faza incipientă a bolii şi să se evalueze răspunsul la tratament la 2-3 zile după injectare.
English: In very rare cases, individual shock reactions with a potentially fatal outcome might occur.
Romanian: În cazuri foarte rare, pot să apară reactii de șoc individuale cu potential letal.
English: METHOD AND ROUTE OF ADMINISTRATION Intramuscular injection
Romanian: MOD ŞI CALE DE ADMINISTRARE injectie intramusculara.
English: Needle diameter (mm)
Romanian: Diametru ac (mm)
English: Muscle Fat
Romanian: Muschi Grasime
English: Intramuscular injection Read the package leaflet before use.
Romanian: MOD ŞI CALE DE ADMINISTRARE Injectie intramusculara Citiţi prospectul înainte de utilizare.
English: The mean terminal half-life is approximately 9 days.
Romanian: Media pentru sfarsitul perioadei de injumatatire este de 9 zile.
English: Another animal developed treatment related shock after the first administration and was euthanized on welfare grounds.
Romanian: Alt animal a prezentat şoc in urma primei adminstrări a tratamentului şi a fost eutanasiat din principii de bunastare.
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Romanian: Metafilaxia implică faptul că animalelor sănătoase clinic, fiind în contact direct cu animale bolnave, le sunt administrate produsul în acelaşi timp cu tratamentul animalelor bolnave clinic pentru a reduce riscul de dezvoltare a semnelor clinice.
English: Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs.
Romanian: Metafilaxia implică faptul că animalelor sănătoase clinic, care sunt în contact direct cu animale bolnave, le este administrat produsul medicinal veterinar, în acelaşi timp cu tratamentul animalelor bolnave clinic, pentru a reduce riscul de dezvoltare a semnelor clinice.
English: During clinical trials, pain on injection and injection site swellings were seen very commonly in treated pigs.
Romanian: Pe parcursul testelor clinice, durere la injectare si umflaturi la locul de injectare au fost vazute foarte des la porcii tratati.
English: Cattle (meat and offal): 47 days.
Romanian: Bovine (carne si organe): 47 zile.
English: Generally, cross-resistance between tildipirosin and other macrolides, lincosamides or streprogramins is to be expected.
Romanian: In general, este de asteptat să apară rezistenta incrucisata dintre tildipirosin si alte macrolide, lincosamide si streprogramine.
English: 200 μg/kg 2000 μg/kg 3000 μg/kg
Romanian: 2000 μg/kg 3000 μg/kg
English: Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients.
Romanian: Nu se utilizează în caz de hipersensibilitate la antibiotice macrolide sau la oricare din excipienţi.
English: Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to good veterinary practice.
Romanian: Trebuie acordată o atentie deosebită la alegerea locului adecvat de injectare si a dimensiunii si lungimii acului (conform taliei si greutatătii animalului), în conformitate cu regulile de Bună Practică Veterinară.
English: Special attention should be paid to using the appropriate injection site and to use the appropriate needle size and length (adjusted to the size and weight of animal) according to Good Veterinary Practice.
Romanian: Trebuie acordată o atentie deosebită la alegerea locului adecvat de injectare si a dimensiunii si lungimii acului (conform taliei si greutatătii animalului), în conformitate cu regulile de bună practică veterinară.
English: To ensure correct dose, body weight should be determined as accurately as possible to avoid underdosing.
Romanian: Pentru a asigura o doza corecta, greutatea corporala trebuie determinata cat mai precis posibil, pentru a evita subdozarea.
English: Not authorised for use in lactating animals producing milk for human consumption.
Romanian: Nu este autorizat pentru a fi utilizat la animalele in lactatie care produc lapte pentru consum uman.
English: Piglet, newborn Piglet, 3-4 weeks Growing
Romanian: Purcei, nou nascuti Purcei, 3-4 saptamani Faza de crestere Crestere- Finisare Finisare/Scroafe/Vieri
English: 800 μg/kg 5,000 μg/kg 10,000 μg/kg
Romanian: 5,000 μg/kg 10,000 μg/kg
English: Recommended needle size and diameter per production stage
Romanian: Marimile de ace recomandate si diametrul in functie de stadiul de pruductie
English: It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection.
Romanian: Se recomanda ca animalele sa se trateze in faza incipienta a bolii si sa se evalueze raspunsul la tratament in 48 de ore dupa injectare.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid (collected post mortem), which far exceed those in blood plasma.
Romanian: Acumularea in zona de infectie a tractului respirator este demonstrata prin concentratii mari si sustinute de tildipirosin in fluidul bronsic si pulmonar (colectate post-mortem), care depasesc cu mult pe cea din plasma sangvina.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE C. STATEMENT OF THE MRLs
Romanian: B. CONDIŢII SAU RESTRICŢII PRIVIND ELIBERAREA SAU UTILIZAREA C. DECLARAŢIE REFERITOARE LA LIMITELE MAXIME DE REZIDUURI
English: For E. coli, Campylobacter and Enterococci, both wild type and non-wild type phenotypes were observed (MIC range 1-> 64 µg/ml).
Romanian: Coli, Campylobacter şi Enterococci, au fost luate în evidenţă ambele fenotipuri, de tip salbatic si de tip nonsalbatic (CMI interval 1->64).
English: Do not use in case of hypersensitivity to macrolide antibiotics, citric acid monohydrate or propylene glycol.
Romanian: Nu se utilizează în caz de hipersensibilitate la antibiotice macrolide, acid citric monohidrat sau propilen glicol.
English: In vitro, the effect of tildipirosin is bacteriostatic against Pasteurella multocida and B. bronchiseptica, and bactericidal for A. pleuropneumoniae and H. parasuis.
Romanian: In vitro, efectul tildipirosin este bacteriostatic impotriva Pasteurellei multocida si B. bronchiseptica si bactericid pentru A. pleuropneumoniae si H. parasuis.
English: Accumulation at the site of respiratory tract infection is demonstrated by high and sustained tildipirosin concentrations in lung and bronchial fluid, which far exceed those in blood plasma.
Romanian: Acumularea in zona de infectie a tractului respirator este demonstrata prin concentratii mari si sustinute de tildipirosin in fluidul bronsic si pulmonar, care depasesc cu mult pe cea din plasma sangvina.
English: Needle length (cm)
Romanian: Lungime ac (cm)
English: In pigs, it is postulated that the metabolism of tildipirosin proceeds by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by dihydroxylation and by S-cysteine and S-glutathione conjugation.
Romanian: La porci, este cunoscut faptul ca metabolizarea de tildipirosin se realizeaza prin reductie si sulfatconjugarea cu hidratare ulterioara (sau inel de deschidere), prin demetilare, prin dihidroxilare si prin conjugarea de S-cisteina si S-glutationa.
English: Pain on injection and injection site swellings are very common in treated animals.
Romanian: Durere la injectare si umflaturi la locul injectarii sunt intalnite des la animalele tratate.
English: Disk content
Romanian: Continut disc
English: Box
Romanian: Cutie
English: In vitro binding of tildipirosin to bovine plasma and bronchial fluid proteins is limited with approximately 30%.
Romanian: In vitro, legarea tildipirosinei de proteinele plasmatice bovine este limitata la aproximativ 30%.
English: Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals.
Romanian: In urma administrarii printr-o injectare a unui volum maxim recomandat (10 ml), umflaturile de la locul injectarii se pot asocia cu durere la palpare pentru aproximativ o zi la unele animale.
English: Muscle Skin+fat Liver Kidney
Romanian: Muschi Piele+grasime
English: In vitro, the effect of tildipirosin is bactericidal against M. haemolytica and H. somni, and bacteriostatic against P. multocida.
Romanian: In vitro, efectul tildipirosin este bactericid impotriva Mannheimia haemolytica si H. somni si bacteriostatic impotriva P. multocida.
English: Vial (100 ml, 250 ml)
Romanian: Flacon (100 ml, 250 ml)
English: In target animal safety studies, administration of the maximum recommended injection volume (5 ml) very commonly caused slight swellings at the injection site that were not painful on palpation.
Romanian: In studiile de siguranta pe speciile tinta, administrarea unui volum maxim recomandat la o injectare (5ml), poate cauza foarte des usoare umflaturi la locul de injectare, care nu sunt dureroase la palpare.
English: Overdoses of 10 times the recommended dose as well as repeated subcutaneous administration of the veterinary medicinal product only led to transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in calves.
Romanian: La vitei, o singura injectare subcutanata a unei doze de 10 ori mai mare decat doza recomandata precum si repetarea administrarii subcutanate de produs medicinal veterinar a fost bine tolerata, cu excepția de semnele clinice tranzitorii atribuite disconfortului si umflaturilor de la locul de injectare asociate cu durerea la vitei.
English: Other provisions
Romanian: ALTE INFORMAŢII
English: In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
Romanian: La vitei, o singura injectare subcutanata a unei doze de 10 ori mai mare decat doza recomandata (40 mg/kg greutate corporala) si administrarea repetata subcutanata de tildipirosin (de trei ori la interval de 7 zile) de 4, 12 si 20 mg/kg (de 1, 3 si 5 ori doza clinica recomadata) a fost bine tolerata, in afara de semnele clinice tranzitorii atribuite disconfortului si umflaturilor de la locul de injectare asociate cu durerea la unele animale.
English: In cattle, it is postulated that metabolism of tildipirosin proceeds by cleavage of the mycaminose sugar moiety, by reduction and sulphate conjugation with subsequent hydration (or ring opening), by demethylation, by mono- or dihydroxylation with subsequent dehydration and by S-cysteine and Sglutathione conjugation.
Romanian: La bovine, este postulat faptul ca metabolizarea de tildipirosin se realizeaza prin clavaj al fractiunii de zahar, prin reductia si conjugarea ulterioara a sulfatului (sau inel de deschidere), prin demetilare, prin mono sau dihidroxilare cu dehidrare ulterioara si prin conjugarea de S-cisteina si S-glutationa.
English: Pathomorphological injection site reactions resolved completely within 21 days.
Romanian: Reactiile locale patomorfologice s-au rezolvat complet in decurs de 21 zile.
English: Injection site reactions will largely resolve within 35 days.
Romanian: Reactii la locul de injectare se remit in general in 35 de zile.
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with bovine respiratory disease (BRD).
Romanian: Mannheimia haemolytica, Pasteurella multocida si Histophilus somni, agentii patogeni bacterieni cei mai des asociati cu boala respiratorie bovina (SRB).
English: Not for use in animals from which milk is produced for human consumption.
Romanian: Nu se utilizeaza la animalele care produc lapte pentru consumul uman.
English: Tildipirosin administered subcutaneously to cattle at a single dose of 4 mg/kg body weight resulted in rapid absorption with average peak plasma concentration of 0.7 µg/ml within 23 minutes (Tmax) and high absolute bioavailability (78.9%).
Romanian: Tildipirosin administrat subcutanat la bovine in doza unica de 4 mg/kg greutate corporala a fost absorbit rapid, atingand media concentratiei plasmatice maxime de 0.7 µg/ml in 23 minute (Tmax) si o mare biodisponibilitate absoluta (78.9%).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Cattle
Romanian: INFORMAŢII MINIME CARE TREBUIE ÎNSCRISE PE UNITĂŢILE MICI DE AMBALAJ
English: Tildipirosin administered intramuscularly to pigs at a single dose of 4 mg/kg body weight was rapidly absorbed reaching average peak plasma concentration of 0.9 µg/ml within 23 minutes (Tmax).
Romanian: Tildipirosin administrat intramuscular la purcei in doza unica de 4 mg/kg greutate corporala a fost absorbit rapid, atingand media concentratiei plasmatice maxime de 0.9 µg/ml in 23 minute (Tmax).
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Romanian: Nu se utilizează la animale gestante care sunt destinate producţiei de lapte pentru consum uman, în interval de 2 luni până la data aşteptată a fătării.
English: For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.
Romanian: INDICAŢIE (INDICAŢII) Tratamentul si prevenirea bolilor respiratorii la bovine (BRB) asociate cu with Mannheimia haemolytica, Pasteurella multocida si Histophilus somni sensibile la tildipirosin.
English: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis, which are the bacterial pathogens most commonly associated with swine respiratory disease (SRD).
Romanian: Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica si Haemophilus parasuis, care sunt agentii patogeni bacterieni cei mai des asociati cu boala respiratorie suina (BRS).
English: Clear yellowish solution.
Romanian: Solutie limpede, de culoare galbuie
English: Meat and offal: 9 days.
Romanian: Carne si organe: 9 zile.
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only.
Romanian: Se administreaza 4 mg tildipirosin/kg greutate corporala (echivalent cu 1 ml/45 kg greutate corporala) o singura data.
English: Citric acid monohydrate Propylene glycol Water for injections
Romanian: Acid citric monohidrat
English: Box containing 1 vial of 20 ml, 50 ml, 100 ml or 250 ml.
Romanian: Cutie de carton care contine 1 flacon de 20 ml, 50 ml, 100 ml sau 250 ml.
English: Special precautions for use in animals:
Romanian: ATENŢIONARE (ATENŢIONĂRI) SPECIALĂ (SPECIALE) Precauţii pentru utilizare la animale:
English: Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/10 kg body weight) once only.
Romanian: Se administreaza 4 mg tildipirosin/kg greutate corporala (echivalent cu 1 ml/10 kg greutate corporala) o singura data.
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.
Romanian: INDICAŢIE (INDICAŢII) Tratamentul şi metafilaxia bolilor respiratorii la suine (BRS) asociate cu Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica si Haemophilus parasuis sensibile la tildipirosin.
English: Zone diameter (mm) MIC breakpoint (µg/ml) S I
Romanian: Diametrul zonei (mm) Punct de rupere CMI (µg/ml)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin
Romanian: DECLARAREA SUBSTANŢELOR ACTIVE ŞI A ALTOR SUBSTANŢE 180 mg/ml de Tildipirosin
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin
Romanian: CANTITATEA DE SUBSTANŢĂ (SUBSTANŢE) ACTIVĂ (ACTIVE) 180 mg/ml de Tildipirosin
English: SPECIAL WARNINGS Read the package leaflet before use.
Romanian: ATENŢIONARE (ATENŢIONĂRI) SPECIALĂ (SPECIALE), DUPĂ CAZ Citiţi prospectul înainte de utilizare.
English: Tildipirosin Bovine 400 μg/kg
Romanian: Bovine 400 μg/kg 200 μg/kg
English: In piglets, intramuscular administration of tildipirosin (on three occasions in intervals of 4 days) at 8, 12 and 20 mg/kg body weight (BW) (2, 3 and 5 times the recommended clinical dose), resulted in transient slightly subdued behaviour in one piglet each from the 8 and 12 mg/kg BW group and 2 piglets from the 20 mg/kg BW group following the first or second injection.
Romanian: La purcei, administrarea intramsuculară de tildipirosin (de trei ori la interval de 4 zile) în doze de 8, 12 şi 20 mg/kg greutate corporală ( de 2, 3 şi 5 ori doza clinică recomandată) a avut ca rezultat un comportament uşor modificat la un purcel din fiecare grup de 8 şi 12 mg/kg greutate corporală (GC) şi la 2 purcei din grupul cu 20 mg/kg GC după prima sau a doua injectare.
English: If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.
Romanian: Daca semnele clinice ale bolii respiratorii persistă sau se agravează, sau dacă recidivează, tratamentul trebuie schimbat, utilizând alt antibiotic si continuând până când semnele clinice dispar.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Romanian: Precauţii care trebuie luate de persoana care administrează produsul:
English: Muscle tremors to the hind legs were observed following the first treatment in one pig each from the 12 and 20 mg/kg BW group.
Romanian: S-a observat tremor muscular localizat la membrele posterioare după primul tratament la câte un purcel din fiecare grup de 12 si 20 mg/kg GC.
English: PHARMACEUTICAL FORM Solution for injection.
Romanian: FORMA FARMACEUTICĂ Soluţie injectabila Soluţie limpede, de culoare gălbuie.
English: In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur.
Romanian: In cazuri foarte rare, pot apare reactii anafilactice cu un potential final letal,
English: Meat and offal: 47 days
Romanian: Carne si organe: 47 zile.
English: WITHDRAWAL PERIOD Meat and offal: 9 days.
Romanian: TIMP DE AŞTEPTARE Carne si organe: 9 zile.
English: Vial (20 ml, 50 ml)
Romanian: Suine Flacon (20 ml, 50 ml)
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) The veterinary medicinal product is a clear yellowish solution for injection containing 40 mg/ml of tildipirosin
Romanian: Produsul medicinal veterinar este o solutie injectabila limpede, de culoare galbuie care contine 40 mg/ml de tildipirosin.
English: Type I amber glass vial with chlorobutyl rubber stopper and an aluminium cap.
Romanian: Flacoane din sticla maronie de tip I cu dop de cauciuc si capsa de aluminiu.
English: Pigs
Romanian: Suine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cattle
Romanian: INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJUL SECUNDAR Bovine
English: Tildipirosin Porcine 1,200 μg/kg
Romanian: Suine 1,200 μg/kg 800 μg/kg
English: PACKAGE LEAFLET FOR: ZUPREVO 180 mg/ml solution for injection for cattle
Romanian: ZUPREVO 180 mg/ml solutie injectabila pentru bovine
English: 4.2 Indications for use, specifying the target species
Romanian: 4.4 Atenţionări speciale pentru fiecare specie ţintă
English: PHARMACEUTICAL FORM Solution for injection
Romanian: Solutie injectabila
English: The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) common (more than 1 but less than 10 animals in 100 animals) uncommon (more than 1 but less than 10 animals in 1,000 animals) rare (more than 1 but less than 10 animals in 10,000 animals) very rare (less than 1 animals in 10,000 animals, including isolated reports).
Romanian: • Mai puţin frecvente (mai mult de 1 dar mai puţin de 10 animale din 1,000 de animale)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin
Romanian: ZUPREVO 180 mg/ml solutie injectabila pentru bovine Tildipirosin
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) ZUPREVO is a clear yellowish solution for injection containing 180 mg/ml of tildipirosin
Romanian: Produsul medicinal veterinar este o solutie injectabila limpede, de culoare galbuie care contine 180 mg/ml de tildipirosin.
English: Liver Kidney
Romanian: Propilen glicol
English: PACKAGE LEAFLET FOR: ZUPREVO 40 mg/ml solution for injection for pigs
Romanian: ZUPREVO 40 mg/ml solutie injectabilă pentru suine
English: QUANTITY OF THE ACTIVE SUBSTANCE 40 mg/ml of tildipirosin
Romanian: 40 mg/ml de Tildipirosin
English: Pathomorphological injection site reactions will largely resolve within 35 days.
Romanian: Reactiile morfopatologice de la locul de injectare se remit complet in 35 de zile.
English: Target tissues
Romanian: Tildipirosin Tildipiro sin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pigs
Romanian: INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJULPRIMAR Suine
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs tildipirosin
Romanian: ZUPREVO 40 mg/ml solutie injectabila pentru suine Tildipirosin
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Pigs
Romanian: INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJUL SECUNDAR Suine
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/007
Romanian: NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/007
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/005
Romanian: NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/005
English: M. haemolytica
Romanian: Rinichi
English: MANUFACTURER'S BATCH NUMBER Batch:
Romanian: NUMĂRUL DE FABRICAŢIE AL SERIEI DE PRODUS
English: MRL
Romanian: I.M.
English: See package leaflet.
Romanian: Citiţi prospectul.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/003
Romanian: NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/003
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/124/001-004
Romanian: NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE EU/2/11/124/001
English: Antibiotics
Romanian: Antibiot iceMacr olide