natgillin/translations-raw huggingface dataset:
The safety data of elotuzumab have been assessed from a total of 554 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients) or bortezomib and dexamethasone (103 patients) pooled across 6 clinical trials.
Ocijenjeni su objedinjeni podaci o sigurnosti elotuzumaba prikupljeni u ukupno 554 bolesnika s multiplim mijelomom liječena elotuzumabom u kombinaciji s lenalidomidom i deksametazonom (451 bolesnik) ili bortezomibom i deksametazonom (103 bolesnika) u 6 kliničkih ispitivanja.
The safety data of TAGRISSO reflects exposure from 411 previously treated T790M mutation- positive NSCLC patients who received a dose of 80 mg daily.
Podaci o sigurnosti lijeka TAGRISSO odražavaju izloženost 411 prethodno liječenih bolesnika s NSCLC-om s pozitivnom T790M mutacijom, koji su primali dozu od 80 mg dnevno.
The safety data provided in the sections below are based on the global, double-blind randomised pivotal phase 3 trial 1199.13 (LUME-Lung 1) comparing treatment with nintedanib plus docetaxel against placebo plus docetaxel in patients with locally advanced, or metastatic, or recurrent NSCLC after first-line chemotherapy.
Podaci o sigurnosti primjene, navedeni u nastavku, temelje se na globalnom, dvostruko slijepom, randomiziranom, pivotalnom ispitivanju faze 3, 1199.13 (LUME-Lung 1), u kojem se uspoređivalo liječenje kombinacijom nintedaniba i docetaksela naspram kombinacije placebo i docetaksel u bolesnika s lokalno uznapredovalim, metastatskim ili rekurentnim NSCLC-om nakon kemoterapije kao prve linije liječenja.
The safety data were evaluated in 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Podaci o sigurnosti primjene procijenjeni su u 34 bolesnika u dobi između 2 i manje od 6 godina, 61 bolesnika u dobi između 6 i manje od 12 godina te 94 bolesnika u dobi između 12 i manje od 18 godina.
The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients.
Baza podataka o sigurnosti primjene u neobrezanih muškaraca pri primjeni kreme tri puta tjedno uz svakodnevnu higijenu prepucija uključuje manje od 100 bolesnika.
The safety database to support once daily dosing in paediatric patients comes from the ARROW Trial (COL105677) in which 669 HIV-1 infected paediatric subjects (from 12 months to ≤17 years old). received abacavir and lamivudine either once or twice daily (see section 5.1).
Baza podataka o sigurnosti koja podržava doziranje jedanput na dan u pedijatrijskih bolesnika dolazi iz ispitivanja ARROW (COL105677) u kojem je 669 pedijatrijskih ispitanika zaraženih s HIV-1 (u dobi od 12 mjeseci do ≤17 godina) primalo abakavir i lamivudin jedanput ili dvaput na dan (vidjeti dio 5.1).
The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
Zaštita za iglu sprečava ozljede iglom nakon uporabe, stoga nema nekih posebnih mjera opreza prilikom zbrinjavanja.
The safety device will be activated immediately.
Odmah će se aktivirati sigurnosna
The safety endpoints of major bleeding, the composite of major and clinically relevant non-major (CRNM) bleeding, and all bleeding showed similar rates for patients treated with apixaban 2.5 mg compared with enoxaparin 40 mg (see Table 5).
Sigurnosni ishodi koji uključuju značajno krvarenje, kombinaciju većeg i klinički značajnog ali ne velikog krvarenja te sva krvarenja, imali su podjednake stope u bolesnika liječenih apiksabanom u dozi od 2,5 mg u usporedbi s bolesnicima liječenim enoksaparinom u dozi od 40 mg (vidjeti Tablicu 5).
The safety evaluation of Provenge is based on data from 601 prostate cancer patients in four randomized, controlled clinical trials (3 studies in metastatic castrate resistant prostate cancer and 1 study in androgen dependent prostate cancer) and post-marketing surveillance.
Sigurnosna procjena lijeka Provenge temelji se na podacima prikupljenim od 601 bolesnika s rakom prostate u četiri randomizirana, kontrolirana klinička ispitivanja (3 studije metastatskog raka prostate rezistentnog na kastraciju i jedno ispitivanje androgenski ovisnog raka prostate) i postmarketinškom praćenju.
The safety experience with Brimica Genuair comprised exposure at the recommended therapeutic dose for up to 12 months.
Iskustvo sigurnosti s Brimica Genuairom sastoji se od izlaganja preporučenoj terapijskoj dozi do 12 mjeseci.
The safety experience with Duaklir Genuair comprised exposure at the recommended therapeutic dose for up to 12 months.
Iskustvo sigurnosti s Duaklir Genuairom sastoji se od izlaganja preporučenoj terapijskoj dozi do 12 mjeseci.
The safety experience with trivalent Fluenz is relevant to the use of Fluenz Tetra because Fluenz Tetra (influenza vaccine -live attenuated, nasal) is identical to Fluenz with the only difference being the addition of a fourth strain (a second B strain) to Fluenz Tetra.
Sigurnosno iskustvo za trovalentno cjepivo Fluenz je relevantno i za primjenu cjepiva Fluenz Tetra jer je Fluenz Tetra (cjepivo protiv influence – oslabljeni živi virus, nazalno) identičan sa cjepivom Fluenz, a jedina je razlika dodatak četvrtoga soja (drugi tip B soj) u Fluenz Tetra.
The safety has not been established in cats weighing less than 0.6 kg.
Neškodljivost nije ustanovljena kod pasa koji teže manje od 0,6 kg.
The safety has not been established in cats younger than 8 weeks of age.
Neškodljivost nije ustanovljena kod pasa mlađih od 8 tjedna starosti.
The safety has not been established in dogs weighing less than 1.5 kg.
Neškodljivost nije ustanovljena kod pasa koji teže manje od 1,5 kg.
The safety has not been established in dogs younger than 8 weeks of age.
Neškodljivost nije ustanovljena kod pasa mlađih od 8 tjedna starosti.
The safety in paediatric patients has not been established.
Nije utvrđena sigurnost primjene u pedijatrijskoj populaciji.
The safety information that became available in this reporting period is generally consistent with the known safety profile of vinflunine.
Informacije o sigurnosti primjene koje su postale dostupne u ovom razdoblju izvještavanja općenito su sukladne s poznatim sigurnosnim profilom vinflunina.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06 – 0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljene parenteralne doze u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje oštećenje (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06-0,6 mg/kg na dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze namijenjene ljudima.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06-0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljene parenteralne doze u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje štetni događaj (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06 - 0,6 mg/kg na dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze namijenjene ljudima.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljene parenteralne doze u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje štetne učinke (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06 - 0,6 mg/kg na dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze namijenjene ljudima.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljene parenteralne doze u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna razina koja ne uzrokuje štetni događaj (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06 - 0,6 mg/kg na dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze namijenjene ljudima.
The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06–0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Dugotrajna ispitivanja ponovljenih parenteralnih doza u životinja pokazala su uzak raspon sigurnosti s obzirom na učinke na bubrege, ali najviša kumulativna doza koja ne uzrokuje oštećenje (NOAEL) u ispitivanjima jednostruke doze (1,6 mg/kg) i višestrukih doza u trajanju do jednog mjeseca (0,06-0,6 mg/kg/dan) nije imala učinke na bubrege pri dozama jednakima ili višima od najviše terapijske doze za ljude.
The safety objectives should focus on hypersensitivity reactions, particularly anti-drug antibodies development impacting response to drug.
usredotočeni na reakcije preosjetljivosti, posebice na razvoj protutijela na lijek i
The safety of Activyl has not been established in dogs and cats younger than 8 weeks of age.
Neškodljivost Activyla nije utvrđena kod pasa i mačaka mlađih od 8 tjedana starosti.
The safety of Activyl has not been established in dogs weighing less than 1.5 kg and in cats weighing less than 0.6 kg.
Neškodljivost Activyla nije utvrđena kod pasa koji imaju manje od 1,5 kg i mačaka koje imaju manje od 0,6 kg.
The safety of Activyl Tick Plus has not been established in dogs weighing less than 1.2 kg.
Neškodljivost Actyvila Tick Plus nije ustanovljena u pasa koji teže manje od 1.2 kg.
The safety of Activyl Tick Plus has not been established in dogs younger than 8 weeks of age.
Neškodljivost Actyvila Tick Plus nije ustanovljena u pasa mlađih od 8 tjedana.
The safety of Adempas has been evaluated in phase III studies of 681 patients with CTEPH and PAH receiving at least one dose of riociguat (see section 5.1).
Sigurnost lijeka Adempas procijenjena je u ispitivanjima faze III u više od 681 bolesnika s KTEPH-om i PAH-om koji su primili najmanje jednu dozu riocigvata (vidjeti dio 5.1).
The safety of alogliptin between the elderly (≥ 65 years old) and non-elderly (< 65 years old) was similar.
Sigurnost alogliptina kod starijih osoba (≥ 65 godina starosti) i odraslih (< 65 godina starosti) bila je slična.
The safety of alogliptin between the elderly (≥ 65 years old) and non-elderly (< 65 years old) was similar.
Sigurnost alogliptina u starijih (≥ 65 godina starosti) i odraslih osoba < 65 godina starosti bila je slična.
The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Sigurnost primjene apremilasta nije procijenjena u bolesnika s psorijatičnim artritisom ili psorijazom i oštećenjem funkcije jetre.
The safety of AUBAGIO in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies.
Budući da se u kliničkim ispitivanjima nije provodio sustavni probir na tuberkulozu, sigurnost lijeka AUBAGIO u osoba s latentnom tuberkulozom nije poznata.
The safety of Benlysta in patients with SLE has been evaluated in 3 placebo-controlled studies.
Sigurnost lijeka Benlysta u bolesnika sa SLE-om ocjenjivana je u 3 studije kontrolirane placebom.
The safety of Betmiga was evaluated in 8433 patients with OAB, of which 5648 received at least one dose of mirabegron in the phase 2/3 clinical program, and 622 patients received Betmiga for at least 1 year (365 days).
Sigurnost primjene lijeka Betmiga procijenjena je na 8433 bolesnika s OAB-om, od kojih je 5648 primilo najmanje jednu dozu mirabegrona u fazi 2/3 kliničkog programa, a 622 bolesnika je primalo lijek Betmiga najmanje 1 godinu (365 dana).
The safety of Bexsero was evaluated in 14 studies including 10 randomised controlled clinical trials with 8776 subjects (from 2 months of age) who received at least one dose of Bexsero.
Sigurnost Bexsera procjenjivana je u 14 ispitivanja, uključujući 10 randomiziranih, kontroliranih kliničkih ispitivanja sa 8776 ispitanika (od 2 mjeseca starosti) koji su primili najmanje jednu dozu Bexsera.
The safety of both treatments was evaluated in the full analysis data set (or safety data set, i.e.
U oba liječenja neškodljivost je procijenjena na cijelom skupu podataka za analizu (ili sigurnosni skup podataka, tj.
The safety of BRINAVESS has been evaluated in clinical studies involving 1148 subjects (patients and healthy volunteers) who received treatment with BRINAVESS.
Sigurnost primjene lijeka BRINAVESS ispitana je u kliničkim ispitivanjima sa 1148 ispitanika (bolesnici i zdravi dobrovoljci) koji su liječeni lijekom BRINAVESS.
The safety of Cabometyx is similar to other tyrosine kinase inhibitors used in renal cell carcinoma, and side effects are considered manageable.
Sigurnosni profil lijeka Cabometyx sličan je onom drugih inhibitora tirozin kinaze koji se primjenjuju za liječenje karcinoma bubrežnih stanica, a nuspojave je moguće kontrolirati.
The safety of cangrelor has been evaluated in over 12,700 treated patients undergoing PCI.
Sigurnost kangrelora procijenjena je u više od 12 700 liječenih bolesnika podvrgnutih PCI.
The safety of CE/bazedoxifene was evaluated in 4,868 post-menopausal women who participated in 5 Phase 3 trials.
Sigurnost KE/bazedoksifena ispitivana je u 4868 postmenopauzalnih žena koje su sudjelovale u pet kliničkih ispitivanja 3. faze.
The safety of Celvapan in pregnancy and lactation has been assessed in a limited number of pregnant women.
Sigurnost Celvapana tijekom trudnoće i dojenja ispitana je na ograničenom broju trudnica.
The safety of cobicistat is based on 144-week data from a phase 3, randomised, active-controlled clinical study (GS-US-216-0114), in which 692 treatment-naïve patients received at least one dose of cobicistat-boosted atazanavir (n = 344) or ritonavir-boosted atazanavir (n = 348) administered with emtricitabine and tenofovir disoproxil fumarate fixed-dose combination.
Sigurnost kobicistata temelji se na podacima iz 144. tjedna faze 3 randomiziranog, djelatnom tvari kontroliranog kliničkog ispitivanja (GS-US-216-0114) u kojemu su 692 pacijenta koji prethodno nisu bili liječeni primili najmanje jednu dozu kobicistatom pojačanog atazanavira (n = 344) ili ritonavirom pojačanog atazanavira (n = 348) koji je primjenjen s kombinacijom fiksne doze emtricitabina i tenofovir- dizoproksilfumarata.
The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products.
Na sigurnost kombinirane primjene avanafila i alfa blokatora mogu utjecati druge varijable, uključujući gubitak intravaskularnog volumena i druge antihipertenzivne lijekove.
The safety of continuing somatropin treatment in patients with acute critical illness in intensive care units due to complications following open-heart or abdominal surgery, multiple accidental trauma or acute respiratory failure receiving replacement doses for approved indications has not been established.
Neškodljivost nastavka liječenja somatotropinom kod bolesnika s akutnom kritičnom bolesti u jedinicama intenzivne njege zbog komplikacija nakon kirurških zahvata na otvorenom srcu ili abdomenu, višestrukih ozljeda u nesrećama ili akutnog zatajenja disanja nije utvrđena.
The safety of Convenia has not been assessed in animals suffering from severe renal dysfunction.
Neškodljivost Convenije nije ocijenjena u životinja koje pate od teškog poremećaja bubrežne funkcije.
The safety of Convenia in dogs and cats has not been established during pregnancy and lactation.
Neškodljivost Convenije kod pasa i mačaka nije utvrđena tijekom graviditeta i laktacije.
The safety of dabrafenib in combination with trametinib has been evaluated in 2 Phase III studies, MEK115306 and MEK116513, where an analysis of the safety of dabrafenib in combination with trametinib has been conducted in 209 and 350 patients, respectively, with BRAF V600 mutation positive unresectable or metastatic melanoma receiving dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) combination therapy (see information on combination therapy in section 5.1).
Sigurnost dabrafeniba u kombinaciji s trametinibom ocijenjena je u 2 ispitivanja faze III, MEK115306 i MEK116513, gdje je analiza sigurnosti primjene dabrafeniba u kombinaciji s trametinibom provedena na 209 odnosno 350 bolesnika, s neoperabilnim ili metastatskim melanomom s pozitivnom BRAF V600 mutacijom koji su primali kombiniranu terapiju dabrafenibom (150 mg dvaput na dan) i trametinibom (2 mg jedanput na dan) (za informacije o kombiniranoj terapiji vidjeti dio 5.1).
The safety of dexmedetomidine has not been established during pregnancy and lactation in the target species.
Neškodljivost deksmedetomidina u ciljnih vrsta životinja nije utvrđena tijekom graviditeta i laktacije.
The safety of Dukoral was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT).
Sigurnost primjene Dukorala procijenjena je u kliničkim ispitivanjima koja su uključivala i odrasle i djecu u dobi od 2 godine nadalje, provedenim u zemljama poznatim po endemskoj ili neendemskoj pojavi kolere i enterotoksične bakterije Escherichia coli (ETEC) koja proizvodi termolabilan enterotoksin (LT).
The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label trial (N=43) in which 12 patients (28%) were treated for > 6 months and 9 patients (21%) were treated for
Sigurnost eltrombopaga kod teške aplastične anemije ocijenjena je u otvorenom ispitivanju s jednom skupinom (N=43) u kojem se 12 bolesnika (28%) liječilo > 6 mjeseci, a 9 bolesnika (21%) liječilo se
The safety of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet 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 fiksne kombinacije emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti procijenjena je u pribliţno 70 bolesnika koji su bili istodobno zaraţeni HIV-om i HBV- om te koji su liječili HIV infekciju u otvorenom kliničkom ispitivanju (GS-US-292-1249).
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an open- label clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-0106) u kojem su pedijatrijski bolesnici u dobi od 12 do < 18 godina zaraţeni virusom HIV-1 koji prethodno nisu bili liječeni primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
The safety of emtricitabine+tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet 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 emtricitabina+tenofoviralafenamida u kombinaciji s elvitegravirom+kobicistatom u obliku tablete s fiksnom kombinacijom procijenjena je u približno 70 bolesnika koji su bili istodobno zaraženi HIV-om/HBV-om te koji su u tom trenutku liječili HIV infekciju u otvorenom kliničkom ispitivanju (GS-US-292-1249).
The safety of emtricitabine+tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine+tenofovir alafenamide in combination with elvitegravir+cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina+tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-0106) u kojem je 50 pedijatrijskih bolesnika u dobi od 12 do < 18 godina zaraženih virusom HIV-1 koji prethodno nisu bili liječeni primali emtricitabina+tenofoviralafenamid u kombinaciji s elvitegravirom i kobicistatom u obliku tablete s fiksnom kombinacijom.
The safety of Epclusa has not been assessed in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Sigurnost lijeka Epclusa nije procijenjena u bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega koji zahtijeva hemodijalizu.
The safety of Esbriet has been evaluated in clinical studies including 1,650 volunteers and patients.
Sigurnost primjene lijeka Esbriet ispitana je u kliničkim ispitivanjima koja su uključivala 1650 dobrovoljaca i bolesnika.
The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.
Sigurnost Fampyre je procijenjena u nasumičnim kontroliranim kliničkim ispitivanjima, u otvorenim dugoročnim ispitivanjima kao i postmarketinškom okruženju.
The safety of fondaparinux 2.5 mg has been evaluated in:
Sigurnost primjene fondaparinuksa 2,5 mg procijenjena je:
The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous Thrombo- Embolism and treated with fondaparinux for an average of 7 days.
Sigurnost primjene fondaparinuksa procijenjena je u 2517 bolesnika liječenih fondaparinuksom zbog venske tromboembolije tijekom prosječno 7 dana.
The safety of Fortacin was evaluated based on 596 male patients who applied it during clinical trials.
Sigurnost lijeka Fortacin procijenjena je na temelju 596 muških pacijenata koji su ga koristili tijekom kliničkih ispitivanja.
The safety of FORTEKOR PLUS has not been tested in breeding, pregnant or lactating dogs.
Neškodljivost FORTEKORA PLUS nije bila utvrđena na skotnim, gravidnim ili kujama u laktaciji.
The safety of gamithromycin during pregnancy and lactation has not been evaluated in cattle and pigs.
Neškodljivost primjene gamitromicina tijekom graviditeta i laktacije kod krava i svinja nije procjenjivana.