FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be based on prior confirmation of the Salmonella serovars involved or at least the availability of epidemiological data confirming the presence of this serovar.
Slovenian: Salmonella ali vsaj na razpoložljivosti epidemioloških podatkov, ki potrjujejo prisotnost tega serovarja.
English: Apramycin was shown to be effective as measured by increased weight gain, improved feed efficiency, reduction of mortality rate, and the reduction in severity of diarrhoea and clinical signs.
Slovenian: Dokazali so, da je apramicin učinkovit, kar so ugotovili glede na povečano pridobivanje telesne mase, izboljšan krmni izkoristek, zmanjšanje umrljivosti ter zmanjšanje resnosti driske in kliničnih znakov.
English: Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius.
Slovenian: Apramicin je širokospektralni aminociklitolni antibiotik, ki ga proizvaja sev bakterije Streptomyces tenebrarius.
English: IU 2 x 106 IU
Slovenian: 2 x 106 i.e.
English: Chickens were given up to 5 times the recommended level for 15 days with no untoward reaction.
Slovenian: Piščanci so 15 dni prejemali do petkrat večji odmerek od priporočenega,
English: • Any use of antimicrobials in poultry will increase the risk of emergence and spread of resistance in zoonotic bacteria such as Salmonella spp.
Slovenian: • „Vsakršna uporaba protimikrobnih zdravil pri perutnini poveča tveganje za pojav in širjenje odpornosti zoonotskih bakterij, kot je Salmonella spp.
English: With regard to the withdrawal period, of all the residue depletion studies provided, only one was considered adequate to be statistically analysed.
Slovenian: Kar zadeva karenco, je bila le ena od vseh predloženih študij o izločanju ostankov primerna za statistično analizo.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenj za promet z zdravilom v državah članicah
English: Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
Slovenian: Prašiči: prašiči so z vodo za pitje 28 dni prejemali do devetkrat večji odmerek od priporočenega, ne da bi se pojavile neželene reakcije.
English: The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, but absorption may be increased in young animals and in animals with disrupted intestinal barrier.
Slovenian: Peroralno dajanje apramicina je namenjeno za protimikrobno delovanje v črevesju; apramicin se slabo absorbira, vendar je absorpcija pri mladih živalih in živalih z okrnjeno črevesno pregrado lahko večja.
English: Antimicrobial treatment of meat-producing birds increases the risk of carcase contamination with resistant Salmonella spp.
Slovenian: Protimikrobno zdravljenje ptic za proizvodnjo mesa poveča tveganje za kontaminacijo trupel z odpornimi bakterijami Salmonella spp.
English: Apramycin sulfate
Slovenian: Apramicinijev sulfat
English: The CVMP considered that the use of antimicrobials in Salmonella would increase selective pressure and potentially promote antimicrobial resistance dissemination.
Slovenian: Odbor CVMP je presodil, da bi uporaba protimikrobnih zdravil proti bakteriji Salmonella povečala selektivni pritisk in morebiti povečala širjenje protimikrobne odpornosti.
English: The data provided also indicated that resistance to apramycin is not very common among E. coli isolates of cattle origin.
Slovenian: Predloženi podatki so pokazali tudi, da odpornost proti apramicinu med izolati E. coli govejega izvora ni zelo pogosta.
English: With regard to field studies, twenty-three trials were provided using Girolan soluble powder for the treatment of post-weaning colibacillosis.
Slovenian: Kar zadeva terenske študije, je bilo predloženih 23 preskušanj, pri katerih so uporabljali zdravilo Girolan v obliki topnega praška za zdravljenje kolibaciloze po odstavitvi.
English: arizonae Infection in Humans' J. Clin.
Slovenian: Humans' J. Clin.
English: In case of onset of symptoms after exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru pojava simptomov po izpostavljenosti, kot je kožni izpuščaj, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: In case of skin contact, wash thoroughly with soap and water.
Slovenian: V primeru stika s kožo temeljito sperite z milom in vodo.
English: 15 Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1)link
Slovenian: 15 Guideline on stability testing of existing active substances and related finished products (EMEA/CVMP/846/99-Rev.1) - link značilnosti zdravila, označevanje in navodilo za uporabo.
English: Apramycin is a broad-spectrum bactericidal aminoglycoside antibiotic whose action results from the binding to the 30S subunit of the ribosome, preventing protein synthesis and disrupting the membrane permeability of bacteria.
Slovenian: Apramicin je širokospektralni baktericidni aminoglikozidni antibiotik, katerega delovanje je posledica vezave na podenoto ribosoma 30 S, s čimer preprečuje sintezo beljakovin in poruši permeabilnost bakterijskih membran.
English: Dosing 10 kg pigs with 14C apramycin resulted in approximately 83% being recovered from the faeces, and 4% from the urine, as 14C apramycin.
Slovenian: Po dajanju s 14C označenega apramicina 10-kilogramskim prašičem so 83% s 14C označenega apramicina ugotovili v blatu in 4% v urinu.
English: ADVERSE REACTIONS None known.
Slovenian: ne da bi se pojavile neželene reakcije.
English: Do not use within 4 weeks of the start of the laying period.
Slovenian: Ne uporabite v obdobju štirih tednov pred začetkom obdobja nesnosti.
English: Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programs for the control of salmonella in poultry - link 10 Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the
Slovenian: Regulation (EC) No 1177/2006 implementing Regulation (EC) No 2160/2003 of the European Parliament and of the Council as regards requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry - link
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Izpolni država članica.
English: The weight of the animals should be determined as accurately as possible to avoid underdose.
Slovenian: Čim natančneje je treba ugotoviti telesno maso živali, da ne pride do premajhnega odmerjanja.
English: • the CVMP considered the scope of the referral was the harmonisation of the summary of product characteristics, labelling and package leaflet;
Slovenian: • odbor CVMP je presodil, da je bil namen napotitve uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: • If antimicrobials are used in breeding flocks or their immediate descendants there is a risk that any resistant bacteria which are selected may be disseminated to multiple flocks via contamination of hatching eggs and the hatchery environment.
Slovenian: • Če se protimikrobna zdravila uporabljajo v matičnih jatah ali njihovih neposrednih potomcih, obstaja tveganje, da se odporne bakterije po selekciji prek kontaminacije valilnih jajc in valilnega okolja razširijo na več jat.
English: The following indications for Girolan and its associated names can be supported based on the data provided:
Slovenian: Na podlagi predloženih podatkov je mogoče podpreti naslednje indikacije za zdravilo Girolan in povezana imena:
English: Chicken:
Slovenian: Piščanci:
English: Having considered the grounds for referral and the data provided by the marketing authorisation holder, the CVMP concluded that the benefit-risk balance of the product remains positive subject to the recommended changes in the product information.
Slovenian: Po proučitvi razlogov za napotitev in podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je odbor CVMP ugotovil, da je razmerje med koristmi in tveganjem zdravila še naprej pozitivno ob upoštevanju priporočenih sprememb informacij o zdravilu.
English: Cattle: The use is not intended during pregnancy or lactation.
Slovenian: Govedo: Uporaba med brejostjo ali laktacijo ni predvidena.
English: In conclusion, the documentation provided supports the therapeutic use of Girolan for collibacilosis in chickens.
Slovenian: Dokumentacija je torej podprla terapevtsko uporabo zdravila Girolan za kolibacilozo pri piščancih.
English: 100 g powder contain 100 g apramycin sulfate
Slovenian: 100 g praška vsebuje 100 g apramicinijevega sulfata
English: Rabbits have been previously authorised in France, Italy and Spain.
Slovenian: Uporaba pri kuncih je bila predhodno odobrena v Franciji, Italiji in Španiji.
English: Seven trials were conducted as a blind study in Greece, Italy, Spain and the UK.
Slovenian: V obliki slepih študij so opravili sedem preskušanj v Grčiji, Italiji, Španiji in Združenem kraljestvu.
English: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Slovenian: Ne uporabite pri kokoših nesnicah in v obdobju štirih tednov pred začetkom obdobja nesnosti.
English: With regard to the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration, which is consistent with the information available in published literature.
Slovenian: Kar zadeva karenco, so podatki o izločanju ostankov pokazali, da se apramicin po peroralnem dajanju na splošno ne absorbira dobro iz črevesja, kar je skladno z informacijami, na voljo v objavljeni literaturi.
English: Chicken: There was no mortality when chickens were given a single oral dose of 1,000 mg/kg of bodyweight.
Slovenian: Piščanci: ko so piščanci prejeli enkratni peroralni odmerek 1.000 mg/kg telesne mase, ni prišlo do nobenega smrtnega primera.
English: Bottle (booklet) and bag (label)
Slovenian: Plastenka (knjižica) in vreča (označevanje)
English: These trials were conducted in Greece, Italy, Spain, the United Kingdom, USA and Canada.
Slovenian: Preskušanja so izvajali v Grčiji, Italiji, Španiji, Združenem kraljestvu, ZDA in Kanadi.
English: Based on historical batch data, a target potency of 552,000 IU/g apramycin was established and all references to ‘g of apramycin activity' in the product information were replaced with the equivalent in IU/g product.
Slovenian: Na podlagi starih podatkov o serijah je bila določena ciljna jakost 552 000 i.e./g apramicina, vse navedbe „gramov apramicinske dejavnosti“ v informacijah o zdravilu pa so bile zamenjane z ustrezno vrednostjo i.e./g zdravila.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Slovenian: Uporaba zdravila naj bo v skladu z uradnimi, nacionalnimi in regionalnimi doktrinami protimikrobnega zdravljenja.
English: in bovine species.
Slovenian: pri govedu.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation in sows.
Slovenian: Varnost zdravila v obdobju brejosti in laktacije pri svinjah ni bila ugotovljena.
English: 1 g powder contains 500 mg apramycin as apramycin sulfate in 2.2 ml equivalent to 1 g powder
Slovenian: 1 g praška vsebuje 500 mg apramicina v obliki apramicinijevega sulfata v 2,2 ml, kar ustreza 1 g praška
English: The studies analysed the effect of apramycin dosages between 3.45 mg/kg bodyweight (bw)/day and 75 mg/kg bw/day, via drinking water, during 3, 5 or 7 consecutive days.
Slovenian: V študijah so analizirali učinek odmerkov apramicina v razponu od 3,45 mg/kg telesne mase/dan do 75 mg/kg telesne mase/dan, danih z vodo za pitje v obdobju 3, 5 ali 7 dni zapored.
English: IU (bag)
Slovenian: (vrečka)
English: Apramycin is effective against Gram-negative bacteria (Salmonella and Escherichia coli).
Slovenian: Apramicin deluje proti gram negativnim bakterijam (Salmonella in Escherichia coli).
English: European Control programmes of Salmonella in poultry in Europe have been focused on Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow and Salmonella Infantis, as the five most frequent serovars in human salmonellosis (Regulation (EC) No 2160/20039).
Slovenian: Evropski programi nadzora bakterije Salmonella pri perutnini v Evropi so se osredotočili na serovarje Salmonella Enteritidis, Salmonella Typhimurium, Salmonella Hadar, Salmonella Virchow in Salmonella Infantis, kar je pet
English: After the beginning of medication, the cumulative mortality increased similarly, with noinferiority results in the apramycin group versus colistin group.
Slovenian: Po začetku zdravljenja se je skupna umrljivost povečala podobno, pri čemer v skupini z apramicinom v primerjavi s skupino s kolistinom ni bila ugotovljena neinferiornost.
English: The dosages of apramycin base or apramycin sulfate used were 0, 5.5, 11, 22 and/or 44 mg/kg bw/day during 5 or 10 consecutive days.
Slovenian: Odmerki apramicinijeve baze ali apramicinijevega sulfata so bili 0 mg, 5,5 mg, 11 mg, 22 mg in/ali 44 mg/kg telesne mase/dan pet ali deset dni zapored.
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 8 μg/ml or less and the resistance proportion of E. coli of chicken origin against apramycin was below 10%.
Slovenian: Dokazali so, da je MIK90 evropskih izolatov bakterije E. coli za apramicin 8 μg/ml ali manj, delež odpornosti pri bakteriji E. coli piščančjega izvora proti apramicinu pa je bil pod 10%.
English: 'Salmonella Dublin in Irish cattle' Vet Ireland J 4:642-3
Slovenian: 'Salmonella Dublin in Irish cattle' Vet Ireland J 4:642-3 6 Henderson, K. and Mason, C. 2017.
English: Pigs (piglets and growers)
Slovenian: Prašiči (prašički in pitanci)
English: DATE ON WHICH THE LABEL WAS LAST APPROVED <DD/MM/YYYY>
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO <DD/MM/LLLL>
English: In the case of calves it can be administered in milk or milk replacer.
Slovenian: Pri teletih se zdravilo lahko daje z mlekom oziroma mlečnim nadomestkom.
English: Regarding the indication in Salmonella, recent data were provided indicating good susceptibility to apramycin for Salmonella spp., however the only data specific to Salmonella Gallinarum was from Nigeria (Agbaje et al., 20107) and Korea (Kang et al., 20108) and the epidemiological situation in Europe might be different.
Slovenian: za apramicin, vendar so podatki, specifični za bakterijo Salmonella Gallinarum, izhajali iz Nigerije (Agbaje idr., 20107) in Koreje (Kang idr., 20108), epidemiološka situacija v Evropi pa je morda drugačna.
English: The presence of the disease in the herd must be established before the product is used.
Slovenian: Pred uporabo zdravila je treba potrditi prisotnost bolezni v čredi.
English: Possible intoxications can be recognised by the following symptoms: soft faeces, diarrhoea, vomiting (weight loss, anorexia, and similar), renal impairment and effects on the central nervous system (reduced activity, loss of reflexes, convulsions, etc.).
Slovenian: (hujšanje, anoreksija in podobno), ledvična okvara in učinki na centralni živčni sistem (zmanjšana aktivnost, izguba refleksov, konvulzije ipd).
English: Manufacturer responsible for batch release: To be completed nationally.
Slovenian: Proizvajalec odgovoren za sproščanje serij: izpolni država članica.
English: Treatment resulted in an almost linear dose/response in percent survival for apramycin dosages up to 22 mg/kg bw.
Slovenian: Pri zdravljenju je bilo razmerje med odmerkom in odzivom v odstotku preživetja pri odmerkih apramicina do 22 mg/kg telesne mase skoraj linearno.
English: • The use of antimicrobials is never totally effective for the control of Salmonella spp.
Slovenian: • Uporaba protimikrobnih zdravil ni nikoli popolnoma učinkovita za nadzor bakterije Salmonella spp., saj iz okužene jate ni mogoče odstraniti vseh organizmov.
English: Salmonella strains were considered generally susceptible to apramycin (MIC≤16 μg/ml) and <5% of Salmonella Dublin strains were shown to be resistant to apramycin.
Slovenian: Sevi bakterije Salmonella na splošno veljajo za občutljive za apramicin (MIK ≤ 16 μg/ml), proti apramicinu pa je bilo odpornih < 5% sevov Salmonella Dublin.
English: Girolan and its associated name Apralan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Slovenian: Zdravilo Girolan in povezano ime Apralan je prašek za dajanje v vodo/mleko za pitje, ki vsebuje apramicinijev sulfat kot zdravilno učinkovino.
English: • In general, from a food safety/public health viewpoint, using antimicrobials to control Salmonella spp.
Slovenian: • Na splošno je s stališča prehranske varnosti/javnega zdravja uporaba protimikrobnih zdravil za nadzor okužbe z bakterijo Salmonella spp.
English: In this sense, in a scientific opinion (2017) of EFSA13, Salmonella infection in poultry (Salmonella Pullorum, Salmonella Gallinarum and Salmonella arizonae) has been assessed according to the criteria of the Animal Health Law.
Slovenian: V tem smislu je bila v nedavnem znanstvenem mnenju agencije EFSA (2017)13 ocenjena okužba z bakterijo Salmonella pri perutnini (Salmonella Pullorum, Salmonella Gallinarum in Salmonella arizonae) v skladu z merili zakona o zdravju živali.
English: While it was considered that Salmonella strains are generally susceptible to apramycin (MIC≤16 μg/ml) it should be noted that only Salmonella outbreaks with clinical signs (in the case of calves, caused by Salmonella Dublin) should be treated with apramycin.
Slovenian: Ocenjeno je bilo, da so sevi bakterije Salmonella na splošno občutljivi za apramicin (MIK ≤ 16 μg/ml), vendar je treba opozoriti, da se sme z apramicinom zdraviti samo izbruhe salmonele s kliničnimi znaki (pri teletih jih povzroča bakterija Salmonella Dublin).
English: Do not use in calves with functional rumen.
Slovenian: Ne uporabite pri teletih s funkcionalnim vampom.
English: It was demonstrated that 22 to 44 mg apramycin per kg bw during 5-10 consecutive days resulted in effective therapy against experimental salmonellosis in calves.
Slovenian: Dokazali so, da od 22 do 44 mg apramicina na kilogram telesne mase v obdobju 510 dni zapored zagotavlja učinkovito zdravljenje eksperimentalne salmoneloze pri teletih.
English: The total clinical score in the 40 mg apramycin/kg bw group improved more rapidly than the 20 mg apramycin/kg bw group which improved more rapidly than the 0 mg apramycin/kg bw group.
Slovenian: Skupni klinični rezultat v skupini, ki se je zdravila s 40 mg apramicina/kg telesne mase, se je izboljševal hitreje kot v skupini, ki se je zdravila z 20 mg apramicina/kg telesne mase, pri tej pa se je rezultat izboljševal hitreje kot v skupini, ki je prejemala 0 mg apramicina/kg telesne mase.
English: Colloquially, those five serovars are known as zoonotic in national control programmes established in poultry in Europe.
Slovenian: Pogovorno v nacionalnih programih nadzora pri perutnini v Evropi teh pet serovarjev imenujemo zoonotski serovarji.
English: The proposed indication was ‘Treatment of colibacillosis caused by Escherichia coli and not zoonotic Salmonella (Salmonella Pullorum and Salmonella Gallinarum) susceptible to apramycin'.
Slovenian: Predlagana indikacija je bila „zdravljenje kolibaciloze, ki jo povzroča Escherichia coli, in okužb z nezoonotsko bakterijo Salmonella (Salmonella Pullorum in Salmonella Gallinarum), ki sta občutljivi za apramicin“.
English: Taking into account the available information the proposed withdrawal period of zero days for chicken meat and offal was considered acceptable.
Slovenian: Z upoštevanjem razpoložljivih informacij je bila predlagana karenca nič dni za piščančje meso in organe ocenjena kot sprejemljiva.
English: Apramycin administered orally to calves once daily for five days at 20 mg apramycin/kg bw or 40 mg apramycin/kg bw was effective in reducing mortality.
Slovenian: Apramicin, ki so ga dajali teletom peroralno enkrat na dan v obdobju petih dni v odmerku 20 mg apramicina/kg telesne mase ali 40 mg apramicina/kg telesne mase, je bil učinkovit pri zmanjševanju umrljivosti.
English: Elanco Europe Ltd Lilly House Priestley Road Basingstoke RG24 9NL United Kingdom
Slovenian: Nizozemska Elanco Europe Ltd Lilly House Priestley Road Basingstoke RG24 9NL
English: The limited MIC data indicated a MIC90 for apramycin of 3.5 μg/ml for E. coli isolates of rabbit origin and a proportion of <20% resistant strains.
Slovenian: Navedeni podatki o MIK so pokazali, da je MIK90 za apramicin 3,5 μg/ml pri izolatih E. coli kunčjega izvora in da je delež odpornih sevov < 20%.
English: In order to obtain the correct dose, the concentration of the veterinary medicinal product has to be adjusted accordingly.
Slovenian: Koncentracijo zdravila za uporabo v veterinarski medicini je treba ustrezno prilagoditi, da je odmerek pravilen.
English: Evaluation and conclusions on the benefit-risk balance Girolan and its associated name Apralan has been shown to be efficacious in the indications in pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits listed above.
Slovenian: Dokazali so, da je zdravilo Girolan in povezano ime Apralan učinkovito pri indikacijah pri zgoraj navedenih prašičih (odstavljenih prašičkih), teletih pred začetkom prežvekovanja, (pitovnih) piščancih in kuncih.
English: Chickens have been authorised in Ireland, Italy, the Netherlands, Portugal, Spain and the UK.
Slovenian: Uporaba pri piščancih je bila odobrena na Irskem, v Italiji, na Nizozemskem, Portugalskem, v Španiji in Združenem kraljestvu.
English: The results obtained from these trials showed that for both treatment and prevention of experimental salmonellosis in calves, apramycin sulfate and apramycin base perform equally.
Slovenian: Rezultati teh preskušanj so pokazali, da sta apramicinijev sulfat in apramicinijeva baza enako učinkovita pri zdravljenju in preprečevanju eksperimentalne salmoneloze pri teletih.
English: MIC90 of European isolates of E. coli for apramycin was demonstrated to be 16 μg/ml with a wild-type cut-off value of ≥32 μg/ml.
Slovenian: Dokazali so, da je MIK90 evropskih izolatov bakterije E. coli za apramicin 16 μg/ml, z mejno vrednostjo za divji tip ≥ 32 μg/ml.
English: Girolan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Slovenian: Zdravilo Girolan je prašek za dajanje v vodo/mleko za pitje, ki kot zdravilno učinkovino vsebuje apramicinijev sulfat.
English: Block bottomed laminated paper bag closed by pressurized heat-sealing jaws.
Slovenian: Laminirana papirnata vreča z ravnim dnom, toplotno zavarjena s čeljustmi pod pritiskom.
English: The CVMP noted that throughout the product information of Girolan the active substance was expressed as ‘g of apramycin activity'.
Slovenian: Odbor CVMP je opozoril, da je bila količina zdravilne učinkovine v celotnih informacijah o zdravilu za zdravilo Girolan izražena v „gramih apramicinske dejavnosti“.
English: Dose/response was clearly observed for the mortality rate.
Slovenian: Pri stopnji umrljivosti je bila jasno vidna povezava med odmerkom in odzivom.
English: With regard to quality, a target potency of 552,000 IU/g of apramycin sulfate has been established for the medicinal product, based on the historical batch data provided.
Slovenian: Kar zadeva kakovost, je bila za zdravilo na podlagi starih podatkov o serijah določena ciljna jakost 552 000 i.e./g apramicinijevega sulfata.
English: Rabbits: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects.
Slovenian: Kunci: Dokazali so, da imajo peroralni odmerki apramicina, ki se dajejo od 6. do 18. dneva brejosti (vključno z odmerki, manjšimi od terapevtskih), fetotoksičen učinek.