natgillin/translations-raw huggingface dataset:
In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile. 
V podrobnostih o podlagi za svojo prošnjo za ponovno preučitev mnenja MAH trdi, da je treba tri izmed osmih vzorcev ledvic s koncentracijami amoksicilina višjimi od MRL na 21. in 27. dan po zadnjem dajanju, imeti za artefakte zaradi nenormalnega kinetičnega profila izločanja ostankov.
Strength Animal species Frequency and route of administration 
Živalska vrsta Pogostost in način uporabe zdravila
Furthermore, the method provided was validated over a range using fortified samples. 
Poleg tega je bila uporabljena metoda potrjena z uporabo ojačanih vzorcev v določenem obsegu.
In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment. 
Da bi zagotovili usklajen sklep o določitvi karenc, je močno priporočljivo, da se morebitne nove raziskave izločanja ostankov, namenjene za odpravo začasnega preklica dovoljenja za promet, predložijo v oceno CVMP.
The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated. 
Nazadnje je MAH trdil, da je bilo z uporabljeno fluorimetrično metodo možno zaznati ostanke produktov, ki nastanejo ob razgradnji amoksicilina, in so torej sporočene koncentracije lahko previsoko ocenjene.
Assuming the MAH has a valid scientific point, and thus the method should have included an additional clean-up step to improve recovery, the weakness of this argument was that all sample results could therefore be understated. 
Ob predpostavki, da MAH ponuja veljavno znanstveno razlago in bi torej metoda za izboljšanje obnovljivosti morala vključevati dodaten očiščevalni korak, pa je bil ta argument pomanjkljiv, saj bi to pomenilo, da bi lahko bili vsi rezultati iz vzorcev nezadostni.
15 mg amoxicillin/kg bw (equivalent to 1ml/10 kg) 
15 mg amoksicilina/kg tt (enakovredno 1ml/10 kg)
As a validated method was used with appropriate controls, the CVMP did not consider it appropriate to invalidate the method whilst arguing for its validity for all other results. 
Ker je bila potrjena metoda uporabljena z ustreznimi kontrolami, je CVMP menil, da je ni primerno razveljaviti, in hkrati trditi, da je veljavna za vse druge rezultate.
In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox. 
V dopolnilni raziskavi je bilo zaklanih osem prašičev 30 in 36 dni po zdravljenju z zdravilom Suramox.
The data available did not allow establishing a reliable withdrawal period based on residues in kidney by either the statistical or the alternative method. 
Razpoložljivi podatki niso omogočali zanesljive določitve karence glede na ostanke v ledvicah niti po statistični niti po alternativni metodi.
As the validation data fell within accepted specifications, the CVMP could not agree that it was appropriate to simply dismiss the findings above the MRL as artefacts. 
Ker so potrjeni podatki znotraj sprejetih specifikacij, se CVMP ne more strinjati, da je primerno izsledke, ki presegajo MRL, enostavno prezreti kot artefakte.
These samples were chilled, homogenized and stored at -80°C until analysis 4 to 6 months later; the storage stability was confirmed. 
Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri -80 °C; obstojnost skladiščenja je bila potrjena.
For the referral procedure, the MAH presented one residue study in cattle and one in pigs. 
Za napotitveni postopek obravnave je MAH predstavil eno raziskavo ostankov pri govedu in eno pri prašičih.
- the CVMP considered that based on the residue depletion data provided concerning the depletion of residues of amoxicillin when administered by injection it was not possible to establish a withdrawal period for cattle and pigs as: 
- CVMP je menil, da na podlagi predloženih podatkov o izločanju ostankov v zvezi z izločanjem ostankov amoksicilina, kadar je ta injiciran, ni bilo mogoče določiti karence za govedo in prašiče, ker:
Liver Kidney Milk 
Mišica Maščoba Jetra Ledvica Mleko
When providing oral explanations to the Committee concerning the new data submitted the MAH agreed however that withdrawal periods for cattle could not be set on the basis of the data available. 
Vendar pa se je pri podajanju ustne razlage v zvezi z novo predloženimi podatki Odboru imetnik dovoljenja za promet strinjal, da na podlagi razpoložljivih podatkov ni mogoče določiti karenc za govedo.
Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘positive' samples found. 
Ob upoštevanju, da je bila raziskava v skladu z dobro laboratorijsko prakso, CVMP ne more kar tako prezreti teh rezultatov, zlasti ker so bili v celoti najdeni trije "pozitivni" rezultati.
Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990. 
Na 36. seji Skupnega strokovnega odbora FAO/WHO za aditive za živila (JECFA) leta 1990 je bil obravnavan benzilpenicilin.
Establishment of the withdrawal period following consideration of all residue studies for pigs and cattle available 
Določitev karence na podlagi upoštevanja vseh razpoložljivih raziskav ostankov pri prašičih in govedi
From the original residue depletion study in pigs, the CVMP concluded that the kidney was the limiting tissue for the establishment of a withdrawal period. 
Na podlagi prvotne študije o izločanju ostankov pri prašičih je CVMP zaključil, da so bila ledvice omejevalno tkivo za določitev karence.
However, the residue depletion profile in kidney indicated a non-regular profile. 
Vendar je profil izločanja ostankov v ledvicah pokazal neredno izločanje.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3 
ZNANSTVENI ZAKLJUČKI SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SURAMOX 15 %
Pharmacologically active substance 
Farmakološka učinkovina
The injection sites contained the highest residue concentrations followed by kidney. 
Mesta injiciranja so vsebovala najvišje koncentracije ostankov, na drugem mestu so sledile ledvice.
With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method. 
Ob predložitvi novih raziskav ostankov za govedo je imetnik dovoljenja za promet predlagal karenco 96 dni, temelječo na statistični metodi.
In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary. 
Za odpravo umika dovoljenja za promet z zdravilom bi bili potrebni podatki o izločanju ostankov za kasnejše časovne točke, ki bi omogočali določitev karenc za meso in drobovino govedi in prašičev.
Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox. 
Šestnajst glav govedi je bilo zaklanih 7, 14, 46 in 57 dni po zdravljenju z zdravilom Suramox.
Residues in kidney ranged from below the limit of quantification to 150 µg/kg at 7 days and were below the limit of quantification at later time points. 
Ostanki v ledvicah so bili po 7 dneh v razponu od vrednosti pod mejo kvantifikacije do 150 µg/kg, ob drugih časovnih točkah pa pod mejo kvantifikacije.
However, taking into account also the two new residue depletion studies in pigs, the CVMP concludes that the totality of the data indicates that the residue depletion at the injection site will determine the withdrawal period. 
Vendar pa CVMP, upoštevaje tudi dve novi raziskavi izločanja ostankov pri prašičih, ugotavlja, da celokupni podatki nakazujejo, da je za določitev karence odločilno izločanje ostankov.
These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed). 
Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri -80 °C (obstojnost skladiščenja potrjena).
For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues. 
Pri prašičih, težkih 40-50 kg, je bila na podlagi ostankov na mestih injiciranja določena karenca 35 dni.
Sixteen pigs were slaughtered at 7, 14, 21 and 27 days after treatment with Suramox. 
Šestnajst prašičev je bilo zaklanih 7, 14, 21 in 27 dni po zdravljenju z zdravilom Suramox.
All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/kg for all tissues. 
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-UV (HPLC-fluorescenca za jetra) z zahtevano mejo kvantifikacije 25 µg/kg za vsa tkiva.
The results reported indicated residue values below the muscle MRL at all time points except for 1 animal at the last time point, which had a concentration of 6 times above the muscle MRL. For one animal the result at 30 days was not reported. 
Rezultati, o katerih so poročali, so nakazovali vrednosti ostankov pod MRL za mišično maso ob vseh časovnih točkah, razen pri eni živali ob zadnji časovni točki, pri kateri je bila koncentracija šestkrat večja od MRL za mišično maso.
With the submission of the new residue studies for pigs the MAH proposed a withdrawal period of 38 days based on the two studies provided. 
Ob predložitvi novih študij o ostankih zdravila za prašiče je imetnik dovoljenja za promet predlagal karenco 38 dni, temelječo na dveh predloženih študijah.
All samples were analysed for amoxicillin concentrations using an HPLC-UV method with a claimed limit of quantification of 25 µg/kg for all tissues. 
Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-UV z zahtevano mejo kvantifikacije 25 µg/kg za vsa tkiva.
Suramox 15% LA contains amoxicillin which is a beta lactam antibiotic belonging to the group of penicillins. 
beta-laktamski antibiotik iz skupine penicilinov.
In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), fat (mixed sample of perirenal/omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth). 
Poleg tega so vzeli vzorce mišic (mešani vzorec zadnje in sprednje četrti), maščobe (mešani vzorec perirenalne maščobe/maščobe pečice), cela jetra, obe ledvici in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
An alternative method could not be used because at the last time point residue concentrations at the injection site were up to 5 times the MRL for muscle. 
Alternativne metode ni bilo mogoče uporabiti, ker so bile koncentracije ostankov na mestu injiciranja v zadnji časovni točki do petkrat višje od MRL za mišično maso.
In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg). 
Pri prašičih je deset samcev in deset samic (tt 42 ± 7 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15 % LA z odmerkom 15 mg/kg tt (1 ml na 10 kg).
In cattle ten male and ten female (body weight: 184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg). 
Pri govedu je deset samcev in deset samic (telesna teža: 184 ± 24 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15 % LA z odmerkom 15 mg/kg tt (1 ml na 10 kg).
GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS 
PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth). 
Poleg tega so vzeli vzorce mišic (mešan vzorec zadnje in sprednje četrti), kože in maščobe v naravnem razmerju, cela jetra, obe ledvici, in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
The CVMP noted that the MAH excluded two observations as being outliers when calculating the withdrawal period. 
CVMP je ugotovil, da je MAH pri izračunavanju karence izključil dva dobljena rezultata kot posamični napaki.
o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations in kidneys were still above the MRL at the last slaughter time point; 
o so bile pri govedu koncentracije ostankov na mestu injiciranja v zadnji časovni točki, to je ob zakolu, še vedno višje od MRL; o so bile pri prašičih koncentracije ostankov v ledvicah še v zadnji časovni točki, to je ob zakolu, še vedno višje od MRL;
In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/kg at day 1, 358 to 5429 µg/kg at day 7, 182 to 2816 µg/kg at day 14, below the limit of quantification to 211 µg/kg at day 21 and below the limit of quantification to 38 µg/kg at day 27. 
Na mestih injiciranja so bile koncentracije amoksicilina 14209 do 109535 µg/kg na 1. dan, 358 to 5429 µg/kg na 7. dan, 182 to 2816 µg/kg na 14. dan, pod mejo kvantifikacije do 211 µg/kg na 21. dan in pod mejo kvantifikacije do 38 µg/kg na 27. dan.
Therefore kidney was considered the tissue determining the withdrawal period. 
Zato so bile ledvice upoštevane kot tkivo za določitev karence.
2.1 Calculation of withdrawal periods for Suramox 15% LA 
2.1 Izračun karence za zdravilo Suramox 15 % LA
In kidney, amoxicillin concentrations were 5446 to 9896 µg/kg at day 1, 45 to 811 µg/kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/kg at day 21 and below the limit of quantification to 62 µg/kg at day 27. 
V ledvicah so bile koncentracije amoksicilina 5446 do 9896 µg/kg 1. dan, 45 do 811 µg/kg na 7. dan, pod mejo kvantifikacije na 14. dan, pod mejo kvantifikacije do 180 µg/kg na 21. dan in pod mejo kvantifikacije do 62 µg/kg na 27. dan.
Thus, the MRLs established by the CVMP for benzylpenicillin were 50 µg/kg for edible tissues. 
Tako je CVMP določil, da je najvišja mejna vrednost ostankov benzilpenicilina v užitnem tkivu 50 µg/kg..
Residues in muscle, fat, liver and kidney were below the MRL at all time points. 
Ob vseh časovnih točkah so bili ostanki v mišični masi, maščevju, jetrih in ledvicah manjši od MRL.
150 mg/ml 
150 mg/ml govedo, prašiči
Residues in the injection sites were high and still up to 5 times above the muscle MRL at the latest time point. 
Ostanki na mestih injiciranja so bili visoki in ob zadnji časovni točki še vedno petkrat višji od MRL za mišično maso.
For cattle the injection site was the withdrawal time determining tissue and the residue concentrations of amoxicillin in the injection sites were still above the MRL at the last slaughter time point. 
Pri govedu je bilo tkivo za določitev karence mesto injiciranja, vendar so bile koncentracije amoksicilina na mestih injiciranja še pri zadnji časovni točki (ob zakolu) višje od MRL.
One new GLP-study in cattle and two complementary GLP-residue studies in pigs were submitted during the procedure for the reconsideration of the opinion. 
Med postopkom ponovne preučitve mnenja je bila predložena ena nova raziskava, skladna z dobro laboratorijsko prakso, pri govedu in dve dopolnilni raziskavi ostankov, skladni z dobro laboratorijsko prakso, pri prašičih.
Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection. 
Razpon vbrizgane količine je segal od 15,0 do 25,9 ml. Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 36 dni po zadnjem injiciranju.
Residues in muscle, fat and liver were below the MRL at all time points. 
Ob vseh časovnih točkah so bili ostanki v mišični masi, maščevju in jetrih manjši od MRL.
However, the residues in kidney showed an irregular depletion profile and concentrations above the MRL were still observed at the last slaughter time point. 
Vendar je profil izločanja ostankov v ledvicah nereden, koncentracije pa so bile še pri zadnji časovni točki (ob zakolu) višje od MRL.
Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection. 
Razpon vbrizgane količine je segal od 2,88 do 5,52 ml. Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 27 dni po zadnjem injiciranju.
In the injection sites, the amoxicillin concentrations were 5822 to 149831 µg/kg at day 1, below the limit of quantification to 21724 µg/kg at day 7, below the limit of quantification to 1651 µg/kg at day 14, below the limit of quantification to 472 µg/kg at day 21 and below the limit of quantification to 162 µg/kg at day 36. 
kvantifikacije do 21724 µg/kg na 7. dan, pod mejo kvantifikacije do 1651 µg/kg na 14. dan, pod mejo kvantifikacije do 472 µg/kg na 21. dan in pod mejo kvantifikacije do 162 µg/kg na 36. dan.
France2 
LA3
The statistical nor the alternative method could be used as at the last time point residues at the injection site were up to 6 times the MRL for muscle. 
Ker so bile koncentracije ostankov na mestu injiciranja v zadnji časovni točki do šestkrat višje od MRL za mišično maso, ni bilo mogoče uporabiti ne statistične ne alternativne metode.
This summary was last updated on 14/01/2010. 
Povzetek je bil nazadnje posodobljen dne 14/01/2010.
The European Commission granted a marketing authorisation valid throughout the European Union, for RESPIPORC FLU3 to IDT Biologika GmbH on 14/01/2010. 
Evropska komisija je dovoljenje za promet z zdravilom RESPIPORC FLU3, veljavno po vsej Evropski uniji, odobrila družbi IDT Biologika GmbH dne 14/01/2010.
Sometimes, a slight increase in the rectal temperature might occur after vaccination. 
Občasno se lahko po cepljenju prehodno rahlo poviša rektalna temperatura.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RESPIPORC FLU3 EPAR summary for the public 
EMEA/V/C/153 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) RESPIPORC FLU3 Povzetek EPAR za javnost
Other information about RESPIPORC FLU3: 
Druge informacije o zdravilu RESPIPORC FLU3:
RESPIPORC FLU3 is a vaccine. 
RESPIPORC FLU3 je cepivo.
RESPIPORC FLU3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed). 
RESPIPORC FLU3 je cepivo, ki vsebuje tri različne seve virusa prašičje gripe A, ki so bili inaktivirani (uničeni).
RESPIPORC FLU3 is a suspension for injection. 
Zdravilo RESPIPORC FLU3 je suspenzija za injiciranje.
In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses. 
Ob ponovni izpostavitvi virusom v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
RESPIPORC FLU3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth. 
Zdravilo RESPIPORC FLU3 se uporablja tudi za cepljenje brejih svinj po zaključeni prvi imunizaciji, z dajanjem enega odmerka 14 dni pred prasitvijo, da mleko svinj vsebuje dovolj protiteles, ki pujske ščitijo pred prašičjo gripo vsaj 33 dni po rojstvu.
What benefit has RESPIPORC FLU3 shown during the studies? 
Kakšne koristi je zdravilo RESPIPORC FLU3 izkazalo med študijami?
RESPIPORC FLU3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness. 
Zdravilo RESPIPORC FLU3 vsebuje majhne količine modificirane in zatem inaktivirane oblike virusa prašičje gripe, ki povzroča lezije in bolezen.
Use of the RESPIPORC FLU3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus. 
Uporaba cepiva RESPIPORC FLU3 pri prašičih zmanjša klinične znake in količino virusa v pljučih po okužbi, ki jo povzroči virus prašičje gripe A.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of RESPIPORC FLU3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that RESPIPORC FLU3 be given a marketing authorisation. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila RESPIPORC FLU3 za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti prašičji gripi, ki jo povzročajo podtipi H1N1, H3N2 in H1N2, za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih po okužbi večje od z njim povezanih tveganj, in priporočil, da se za zdravilo RESPIPORC FLU3 odobri dovoljenje za promet.
The effectiveness of RESPIPORC FLU3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza. 
Učinkovitost zdravila RESPIPORC FLU3 so proučevali pri prašičih, starejših od 56 dni, in pri svinjah pred in med brejostjo, te študije pa dokazujejo, da cepivo zagotavlja zaščito pred prašičjo gripo.
A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days. 
Pri majhnem številu prašičev se lahko na mestu injiciranja pojavi manjša oteklina, ki običajno izgine v 2 dneh.
What is the risk associated with RESPIPORC FLU3? 
Kakšna tveganja so povezana z zdravilom RESPIPORC FLU3?
Why has RESPIPORC FLU3 been approved? 
Zakaj je bilo zdravilo RESPIPORC FLU3 odobreno?
RESPIPORC FLU3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs. 
Zdravilo RESPIPORC FLU3 se uporablja za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti prašičji gripi za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih.
What is RESPIPORC FLU3? 
Kaj je zdravilo RESPIPORC FLU3?
How has RESPIPORC FLU3 been studied? 
Kako je bilo zdravilo RESPIPORC FLU3 raziskano?
How does RESPIPORC FLU3 work? 
Kako zdravilo RESPIPORC FLU3 deluje?
What is RESPIPORC FLU3 used for? 
Za kaj se zdravilo RESPIPORC FLU3 uporablja?
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
DODATEK POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
Details of the operation of the surveillance programme/registry shall be agreed with the National Competent Authorities in each Member State. 
O podrobnostih glede delovanja programa/registra nadzorovanja se je treba dogovoriti s pristojnimi državnimi organi v vsaki državi članici.
The data to be collected shall be agreed with the CHMP. 
O zbiranju podatkov se je treba dogovoriti s CHMP.
• The need for regular pregnancy tests 
• potrebno je redno izvajati teste nosečnosti
• That hormonal contraceptives on their own are not effective 
• da samo hormonska kontracepcija ni učinkovita
The patient information booklet for patients prescribed Tracleer should include the following key elements: 
Navodila za uporabo za bolnike, ki jim je predpisano zdravilo Tracleer, morajo vsebovati naslednje ključne elemente:
• Information about Tracleer 
• podatke o zdravilu Tracleer
• That pregnant women must not take Tracleer 
• da nosečnice ne smejo jemati zdravila Tracleer