natgillin/translations-raw huggingface dataset:
The safety of Genvoya in 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) was evaluated through 96 weeks in an open-label clinical study (GS-US-292-0112).
Sigurnost lijeka Genvoya u 248 bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (n = 6) ili im je virus bio suprimiran (n = 242) s blagim do umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije Cockcroft-Gaultovom metodom [eGFRCG]: 30-69 ml/min) procijenjena je tijekom 96 tjedana u otvorenom kliničkom ispitivanju (GS-US-292-0112).
The safety of Genvoya in HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106).
Sigurnost lijeka Genvoya u pedijatrijskih bolesnika u dobi od 12 do < 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-0106).
The safety of Genvoya was evaluated in approximately 70 HIV/HBV co-infected patients currently receiving treatment for HIV in an open-label clinical study (GS-US-292-1249).
Sigurnost lijeka Genvoya procijenjena je u približno 70 bolesnika koji su bili istodobno zaraženi HIV-om i HBV-om te koji su liječili HIV infekciju u otvorenom kliničkom ispitivanju (GS-US-292-1249).
The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renaldisease (ESRD) requiring haemodialysis.
Sigurnost lijeka Harvoni nije procijenjena u pacijenata s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega (ESRD) koji zahtijeva hemodijalizu.
The safety of Hexacima in children over 24 months of age has not been studied in clinical trials. b- Tabulated list of adverse reactions
Sigurnost cjepiva Hexacima u djece starije od 24 mjeseca nije ispitivana u kliničkim ispitivanjima. b- Tablični prikaz nuspojava
The safety of Hexyon in children over 24 months of age has not been studied in clinical trials. b- Tabulated list of adverse reactions
Sigurnost cjepiva Hexyon u djece starije od 24 mjeseca nije ispitivana u kliničkim ispitivanjima. b- Tablični prikaz nuspojava
The safety of Hizentra has been assessed in several preclinical studies, with particular reference to the excipient L-proline.
Sigurnost Hizentre procijenjena je u nekoliko pretkliničkih studija, s posebnim osvrtom na pomoćnu tvar L-prolin.
The safety of Ilaris compared to placebo was investigated in two pivotal Phase III studies (see section 5.1).
Sigurnost primjene Ilarisa u usporedbi s placebom ispitivana je u dva ključna ispitivanja faze III (vidjeti dio 5.1).
The safety of Ilaris compared with placebo was investigated in a pivotal phase III trial that consisted of an 8-week, open-label period (Part I), a 24- week, randomised, double-blind and placebo-controlled withdrawal period (Part II), and a 16-week open label period on Ilaris (Part III).
Sigurnost primjene Ilarisa u usporedbi s placebom ispitivana je u ključnom ispitivanju faze III koje se sastojalo od 8-tjednog otvorenog razdoblja (I. dio), 24-tjednog randomiziranog, dvostruko slijepog i placebom kontroliranog razdoblja ustezanja (II. dio) te 16-tjednog otvorenog razdoblja liječenja Ilarisom (III. dio).
The safety of IMVANEX has been assessed in 18 clinical trials in which 5,028 Vaccinia-naïve individuals received two doses 1 x 108 TCID50 four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose.
Sigurnost cjepiva IMVANEX ocijenjena je u 18 kliničkih ispitivanja u kojima je 5028 osoba koje prethodno nisu bile cijepljene cjepivom s virusom vakcinije primilo dvije doze od 1 x 108 TCID50 u razmaku od četiri tjedna, dok su 534 osobe koje su prethodno bile cijepljene cjepivom s virusom vakcinije i cjepivom IMVANEX primile jednu booster dozu za docjepljivanje.
The safety of Ixiaro was assessed in controlled and uncontrolled clinical studies in 5,021 healthy adults (from non-endemic countries) and 1,559 children and adolescents (mostly from endemic countries).
Sigurnost cjepiva IXIARO procjenjivana je u kontroliranim i nekontroliranim kliničkim ispitivanjima na 5021 zdravih odraslih osoba (iz ne-endemskih zemalja) i 1559 djece i adolescenata (većinom iz endemskih zemalja).
The safety of Jakavi was assessed in 110 patients with PV in an open-label, randomised, controlled phase 3 RESPONSE study.
Sigurnost Jakavija ocjenjivala se u 110 bolesnika s PV-om u otvorenom, randomiziranom, kontroliranom ispitivanju faze 3 RESPONSE.
The safety of Kaletra has been investigated in over 2600 patients in Phase II-IV clinical trials, of which over 700 have received a dose of 800/200 mg (6 capsules or 4 tablets) once daily.
Sigurnost primjene lijeka Kaletra je ispitana u kliničkim ispitivanjima faze II-IV na preko 2600 bolesnika, od kojih je preko 700 primilo dozu od 800/200 mg (6 kapsula ili 4 tablete) jednom dnevno.
The safety of Kentera was evaluated in patients with urge urinary incontinence in a randomised, double-blind, placebo-controlled, parallel group Phase 3 study that included 789 patients (with 389 patients receiving Kentera and 400 patients receiving placebo).
Sigurnost Kentere ocijenjena je u bolesnika s urgentnom urinarnom inkontinencijom u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju faze III s usporednom skupinom koja je obuhvaćala 789 bolesnika (od kojih je 389 bolesnika uzimalo Kenteru, a 400 bolesnika placebo).
The safety of Ketoconazole HRA has been evaluated based on published literature and use of ketoconazole as an antifungal treatment.
Sigurnost Ketoconazolea HRA ocijenjena je na temelju objavljene literature i primjene ketokonazola kao antimikotika.
The safety of lacosamide in children aged below 16 years has not yet been established.
Sigurnost primjene lakozamida u djece mlađe od 16 godina nije još utvrđena.
The safety of liposomal mifamurtide has been assessed in more than 700 patients with various kinds and stages of cancer and in 21 healthy adult subjects (see section 4.8).
Sigurnost liposomalnog mifamurtida ispitana je u više od 700 bolesnika s različitim vrstama i stupnjevima karcinoma te u 21 zdravog odraslog ispitanika (vidjeti dio 4.8).
The safety of lurasidone has been evaluated at doses of 18.5 -148 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks and in the post-marketing setting.
Sigurnost lurasidona procjenjivana je s dozamaod 18,5-148 mg u kliničkim ispitivanjima u bolesnika sa shizofrenijom liječenih do 52 tjedna i nakon stavljanja lijeka u promet.
The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis).
Neškodljivost maropitanta tijekom liječenja dužeg od 5 dana nije bila istražena u ciljnoj populaciji (tj. u mladih pasa koji boluju od virusnog enteritisa).
The safety of maropitant during treatment beyond 5 days has not been explored in the target population (i.e. young dogs suffering from viral enteritis)..
Neškodljivost maropitanta tijekom liječenja više od 5 dana nije bila istražena u ciljnoj populaciji (tj. u mladih pasa koji boluju od virusnog enteritisa).
The safety of microspheres in patients on mechanical ventilation has not been established.
Sigurnost mikrosfera u bolesnika na mehaničkoj ventilaciji nije utvrđena.
The safety of more than one treatment course of Xiapex for Peyronie’s disease is not known.
Sigurnost više od jedne kure liječenja Xiapexom u liječenju Peyronijeve bolesti nije poznata.
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF 4411).
Sigurnost peroralne primjene ibandronatne kiseline 2,5 mg jedanput dnevno ispitana je u 1251 bolesnika u četiri placebo kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF4411).
Sigurnost peroralne primjene ibandronatne kiseline 2,5 mg jedanput dnevno ispitana je u 1251 bolesnika u četiri placebo kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF 4411).
Sigurnost peroralne primjene ibandronatne kiseline 2,5 mg jedanput dnevno ispitana je na 1251 bolesnika u četiri placebo kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three-year fracture study (MF 4411).
Sigurnost peroralne primjene ibandronatne kiseline 2,5mg jedanput dnevno ispitana je na 1251 bolesnika u četiri placebom kontrolirana klinička ispitivanja, od kojih je većina bolesnika bila prethodno uključena u pivotalno trogodišnje kliničko ispitivanje o prijelomima (MF 4411).
The safety of oritavancin has been evaluated in over 2,400 patients with acute bacterial skin and skin structure infections in clinical studies.
Sigurnost oritavancina procijenjena je u preko 2400 bolesnika s akutnim bakterijskim infekcijama kože i kožnih struktura u kliničkim ispitivanjima.
The safety of ospemifene has been assessed in 1,892 VVA patients with doses ranging from 5 – 90 mg per day.
Sigurnost primjene opemifena procijenjena je na 1892 bolesnice s VVA, u rasponu doze od 5 do 90 mg na dan.
The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the following:
Neškodljivost primjene Palladije kod pasa s tumorom mastocita procijenjena je sljedećim nalazima:
The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS- related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Sigurnost Panretina procijenjena je u kliničkim ispitivanjima u više od 469 bolesnika s KS povezanim s AIDS-om, od kojih je 439 bilo liječeno alitretinoinom u koncentraciji od 0,1%.
The safety of Perjeta administered for more than 6 cycles in the neoadjuvant setting has not been established.
Nije utvrđena sigurnost lijeka Perjeta tijekom primjene dulje od 6 ciklusa u neoadjuvantnim uvjetima.
The safety of Perjeta has been evaluated in more than 1,600 patients in the randomized trials CLEOPATRA (n=808), NEOSPHERE (n=417) and TRYPHAENA (n=225) and in Phase I and phase II trials conducted in patients with various malignancies and predominantly treated with Perjeta in combination with other antineoplastic agents.
Sigurnost lijeka Perjeta ocijenjena je u više od 1600 bolesnika u randomiziranim ispitivanjima CLEOPATRA (n=808), NEOSPHERE (n=417) i TRYPHAENA (n=225) i u ispitivanjima faze I i faze II u kojima su sudjelovali bolesnici s različitim zloćudnim tumorima koji su uglavnom bili liječeni lijekom Perjeta u kombinaciji s drugim antineoplasticima.
The safety of Perjeta in Phase I and II studies was generally consistent with that observed in the CLEOPATRA, NEOSPHERE and TRYPHAENA trials, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether Perjeta was administered as monotherapy or with concomitant anti-neoplastic agents.
Sigurnost lijeka Perjeta u ispitivanjima faze I i II načelno je bila u skladu s onom primijećenom u ispitivanjima CLEOPATRA, NEOSPHERE i TRYPHAENA, iako su se incidencija i najčešće nuspojave lijeka razlikovale ovisno o tome je li se Perjeta primjenjivala u monoterapiji ili istodobno s antineoplasticima.
The safety of Pixuvri was evaluated in 407 patients.
Sigurnost primjene Pixuvria procijenjena je na 407 bolesnika.
The safety of Rasilez HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Sigurnost Rasilez HCT-a ispitivana je u 9 kliničkih ispitivanja s više od 3900 bolesnika, uključujući više od 700 bolesnika liječenih dulje od 6 mjeseci te više od 190 bolesnika liječenih dulje od 1 godine.
The safety of reinitiating Avastin therapy in patients previously experiencing PRES is not known.
Nije poznata sigurnost pri ponovnom uvođenju lijeka Avastin u bolesnika koji su prethodno imali PRES.
The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly.
Sigurnost ovih ponavljanih doza nije potvrđena kod djece i adolescenata (od 2 godine i starije), kod bolesnika s oštećenom funkcijom bubrega niti kod starijih osoba.
The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin capsules in combination with interferon alfa-2b, two trials studied ribavirin capsules in combination with peginterferon alfa-2b.
Sigurnost ribavirina procijenjena je na temelju podataka prikupljenih u četiri klinička ispitivanja u bolesnika koji prethodno nisu bili liječeni interferonom: u dva ispitivanja proučavane su kapsule lijeka Ribavirin Mylan u kombinaciji s interferonom alfa-2b, a u preostala dva ispitivanja u kombinaciji s peginterferonom alfa•2b.
The safety of rivaroxaban has been evaluated in eleven phase III studies including 32,625 patients exposed to rivaroxaban (see Table 1).
Sigurnost rivaroksabana procjenjivana je u fazi III jedanaest ispitivanja, uključujući 32 625 bolesnika koji su bili izloženi rivaroksabanu (vidjeti tablicu 1).
The safety of rivaroxaban has been evaluated in eleven phase III studies including 32,625 patients exposed to rivaroxaban (see Table 1).
Sigurnost rivaroksabana procjenjivana je u fazi III jedanaest ispitivanja, uključujući 32625 bolesnika koji su bili izloženi rivaroksabanu (vidjeti tablicu 1).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Sigurnost sildenafila nije ispitana u sljedećim podskupinama bolesnika te je njegova primjena stoga kontraindicirana: teško oštećenje funkcije jetre, hipotenzija (krvni tlak <90/50 mmHg), anamnezanedavnog moždanog udara ili infarkta miokarda i poznati nasljedni degenerativni poremećaji retine kao što su retinitis pigmentosa (manji dio tih bolesnika ima genetske poremećaje retinalnih fosfodiesteraza).
The safety of sildenafil has not been studied in the following sub-groups of patients, and its use is therefore contraindicated:
Sigurnost sildenafila nije ispitana u sljedećim podskupinama bolesnika te je njegova primjena stoga kontraindicirana:
The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Sigurnost primjene silodozina ispitana je u četiri dvostruko slijepa, kontrolirana klinička ispitivanja faze II-III (u kojima je 931 bolesnik primao silodozin od 8 mg jedanput na dan, a 733 bolesnika je primalo placebo) i u dva dugotrajna produžetka ispitivanja otvorenog tipa.
The safety of SonoVue was evaluated in 4653 adult patients who participated in 58 clinical trials.
Sigurnost lijeka SonoVue ocijenjena je na 4653 odraslih bolesnika koji su sudjelovali u 58 kliničkih ispitivanja.
The safety of Sovaldi has not been assessed in patients with severe renal impairment or ESRD (see section 4.4).
Sigurnost Sovaldija nije procijenjena u bolesnika s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega (vidjeti dio 4.4).
The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR
Sigurnost Sovaldija nije procijenjena u ispitanika s teškim oštećenjem bubrega (eGFR
The safety of subcutaneous tocilizumab in RA includes a double-blind, controlled, multicenter study, SC-I.
Ocjena sigurnosti tocilizumaba za supkutanu primjenu u bolesnika s RA uključuje dvostruko slijepo, kontrolirano, multicentrično ispitivanje SC-I.
The safety of Taltz in combination with other immunomodulatory agents or phototherapy has not been evaluated.
Nije se ocjenjivala sigurnost lijeka Taltz u kombinaciji s drugim imunomodulacijskim lijekovima ili fototerapijom.
The safety of tedizolid phosphate has been evaluated in a total of 1,485 subjects receiving at least one dose of tedizolid phosphate administered either orally or intravenously.
Sigurnost tedizolidfosfata procijenjena je na ukupno 1485 ispitanika koji su dobili najmanje jednu dozu tedizolidfosfata primijenjenu peroralno ili intravenski.
The safety of tenofovir disoproxil fumarate in the setting of ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sigurnost tenofovirdizoproksilfumarata primijenjenog uz ledipasvir/sofosbuvir i farmakokinetički pojačivač nije ustanovljena.
The safety of tenofovir disoproxil fumarate in the setting of ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sigurnost tenofovirdizoproksilfumarata u primijenjenog uz ledipasvir/sofosbuvir i farmakokinetički pojačivač nije ustanovljena.
The safety of tenofovir disoproxil fumarate when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sigurnost tenofovirdizoproksilfumarata kad se primjenjuje istovremeno s ledipasvirom/sofosbuvirom i farmakokinetičkim pojačivačem nije ustanovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. cobicistat) has not been established.
Sigurnost tenofovirdizoproksilfumarata prilikom primjene uz ledipasvir/sofosbuvir i farmakokinetički pojačivač (npr. kobicistat) nije ustanovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Sigurnost tenofovirdizoproksilfumarata prilikom istovremene primjene s ledipasvirom/sofosbuvirom i farmakokinetičkim pojačivačem (npr. ritonavirom ili kobicistatom) nije ustanovljena.
The safety of tenofovir disoproxil fumarate when used with ledipasvir/sofosbuvir and a pharmacokinetic enhancer (e.g. ritonavir or cobicistat) has not been established.
Sigurnost tenofovirdizoproksilfumarata prilikom primjene uz ledipasvir/sofosbuvir i farmakokinetički pojačivač (npr. ritonavir ili kobicistat) nije ustanovljena.
The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir and a pharmacokinetic enhancer has not been established.
Sigurnost tenofovirdizoproksila pri istodobnoj primjeni s ledipasvirom/sofosbuvirom i farmakokinetičkim pojačivačem nije ustanovljena.
The safety of the product has not been established in dogs less than 2 months of age and weighing less than 1.4 kg, during pregnancy, lactation, or in breeding dogs.
Neškodljivost proizvoda nije bila utvrđena u pasa mlađih od 2 mjeseca i koji teže manje od 1,4 kg, tijekom graviditeta, laktacije ili u rasplodnih pasa.
The safety of the product has only been evaluated in dogs classified as either Class 1 or 2 for heartworm disease in laboratory studies and in a few Class 3 dogs in a field study.
Neškodljivost proizvoda procijenjena je samo kod pasa svrstanih u skupinu 1 ili 2 za srčanu dirofilriozu, u laboratorijskim ispitivanjima i u nekoliko pasa skupine 3 u terenskim ispitivanjima.
The safety of the recommended dose has been demonstrated in puppies treated every two weeks, on up to five occasions.
Neškodljivost kod preporučene doze dokazana je kod štenaca tretiranih svaka dva tjedna, čak do pet puta.
The safety of the veterinary medicinal product during pregnancy has not been established in horses during pregnancy and the product should not be used during pregnancy.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u konja za vrijeme graviditeta, te se lijek ne smije koristiti tijekom graviditeta.
The safety of the veterinary medicinal product during pregnancy has not been established in horses.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena u konja za vrijeme graviditeta, te se lijek ne smije koristiti tijekom graviditeta.
The safety of the veterinary medicinal product has not been established during breeding, pregnancy or lactation.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta, laktacije ili nesenja.
The safety of the veterinary medicinal product has not been established during lay.
Nema dostupnih informacija o neškodljivosti veterinarsko-medicinskog proizvoda kod ptica u nesenju.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation
Neškodljivost veterinarsko medicinskog proizvoda nije utvrđena tijekom graviditeta i laktacije.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Neškodljivost veterinarsko - medicinskog proizvoda nije praćena tijekom graviditeta i laktacije (vidi 4.3)
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see 4.3).
Neškodljivost veterinarsko - medicinskog proizvoda nije praćena tijekom graviditeta i laktacije (vidi 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).
Neškodljivost ovog veterinarsko-medicinskog proizvoda za vrijeme graviditeta i laktacije nije utvrđena (vidjeti dio 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).
Neškodljivost veterinarsko - medicinskog proizvoda nije praćena tijekom graviditeta i laktacije (vidi 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).
Sigurnost veterinarsko-medicinskog proizvoda nije ustanovljena za vrijeme graviditeta i laktacije (vidi dio 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta, laktacije ili na životinjama namijenjenim za parenje.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost ovog veterinarsko medicinskog proizvoda tijelom graviditeta i laktacije nije utvrđena.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost ovog veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije. .
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost ovog veterinarsko-medicinskog proizvoda za vrijeme graviditeta i laktacije nije utvrđena (vidjeti dio 4.3).
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Neškodljivost tulatromicina tijekom graviditeta i laktacije nije utvrđena kod goveda i svinja.