FrancophonIA/ELRC3.0 huggingface dataset:
English: An increase in body temperature of up to 2°C may be observed on the day of vaccination.
Slovenian: Na dan cepljenja je mogoče opaziti povišanje telesne temperature do 2°C.
English: Sows that have been vaccinated according to this scheme before need a single revaccination two to four weeks before the expected farrowing date.
Slovenian: Svinje, ki so bile cepljene po tej shemi, je treba ponovno z enkratnim odmerkom cepiti dva do štiri tedne pred pričakovano prasitvijo.
English: The company has presented data from both laboratory and field studies on the effectiveness of the vaccine against the two bacteria.
Slovenian: Družba je predstavila podatke o učinkovitosti cepiva proti obema bakterijama iz laboratorijskih in terenskih študij.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Porcilis ColiClos on 14 June 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Porcilis ColiClos, veljavno po vsej Evropski uniji, odobrila dne 14/06/2012.
English: A sometimes painful and hard swelling up to 10 cm in diameter may be observed at the injection site for up to 25 days.
Slovenian: Včasih se na mestu injiciranje pojavi boleča in trda oteklina v premeru 10 cm, ki lahko traja do 25 dni.
English: The first injection is given to sows or gilts, six or eight weeks before the expected farrowing (giving birth) date and a second injection is given four weeks later.
Slovenian: Prva injekcija se svinjam in mladicam daje šest ali osem tednov pred pričakovano prasitvijo (kotitvijo), druga pa štiri tedne po prvem.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Slovenian: Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje, meso, jajca ali mleko pa uporabijo za prehrano ljudi.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis ColiClos exceed the risks and recommended that Porcilis ColiClos be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Porcilis ColiClos večje od tveganj, in priporočil, da se zanj odobri dovoljenja za promet.
English: Other information about Porcilis ColiClos:
Slovenian: Druge informacije o zdravilu Porcilis ColiClos:
English: Porcilis ColiClos is given by injection into a muscle in the neck area behind the ear.
Slovenian: Cepivo Porcilis ColiClos se injicira v mišico na vratu v predelu za ušesom.
English: Porcilis ColiClos is a vaccine.
Slovenian: Zdravilo Porcilis ColiClos je cepivo.
English: The withdrawal period for Porcilis ColiClos is zero days for pig meat.
Slovenian: Obdobje karence za zdravilo Porcilis ColiClos za prašičje meso je nič dni.
English: Porcilis ColiClos contains an adjuvant to enhance the immune response.
Slovenian: Zdravilo Porcilis ColiClos vsebuje adjuvans za povečanje imunskega odziva.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the physician.
Slovenian: V primeru nenamernega samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: Porcilis ColiClos is a vaccine that is available as a suspension for injection.
Slovenian: Zdravilo Porcilis ColiClos je cepivo, ki je na voljo v obliki suspenzije za injiciranje.
English: When Porcilis ColiClos is given to sows or gilts, the pig's immune system recognises the inactivated bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko svinje in mladice prejmejo cepivo Porcilis ColiClos, njihov imunski sistem prepozna inaktivirane bakterije kot „tujke“ in proti njim razvije protitelesa.
English: What benefit has Porcilis ColiClos shown during the studies?
Slovenian: Kakšne koristi je zdravilo Porcilis ColiClos izkazalo med študijami?
English: It contains parts of the Escherichia coli (E. coli) bacterium called fimbrial adhesins F4ab, F4ac, F5 and F6 and LT toxoid (weakened toxin), as well as toxoid of the Clostridium perfringens (C. perfringens) bacterium type C.
Slovenian: Vsebuje dele bakterije Escherichia coli (E. coli), imenovane fimbrijski adhezini F4ab, F4ac, F5 in F6 ter toksoid LT (oslabljeni toksin) in toksoid bakterije Clostridium perfringens (C. perfringens) tipa C.
English: Porcilis ColiClos is given to sows (female pigs that have already given birth to piglets) or gilts (female pigs that have not yet given birth to piglets) to provide their offspring with protection against infections caused by E. coli strains that express the components F4ab, F4ac, F5 or F6, and by C. perfringens type C. The vaccine is used to reduce death and clinical signs of infections caused by these bacteria during the first days of life.
Slovenian: Zdravilo Porcilis ColiClos se uporablja za svinje (samice, ki so že imele pujske) ali mladice (samice, ki še niso imele pujskov), da se njihove mladiče zaščiti pred okužbami, ki jih povzročajo sevi bakterije E.coli, ki izločajo komponente F4ab, F4ac, F5 ali F6, in bakterije C. perfringens tipa C. Cepivo se uporablja za zmanjšanje smrtnosti in kliničnih znakov okužb s temi bakterijami v prvih dneh po rojstvu.
English: These antibodies are transferred from the mother to the piglets through the colostrum (first milk), and they help the piglets to fight E. coli or C. perfringens infection if they become exposed after birth.
Slovenian: Protitelesa se prenesejo prek kolostruma (prvega mleka) iz mame na pujske in jim pomagajo, da se spopadejo z okužbo z bakterijo E. coli ali C. perfringens, če so ji izpostavljeni po rojstvu.
English: To demonstrate protection against E.coli infection, studies were also presented with Porcilis Porcoli Diluvac Forte, a vaccine authorised within the EU with the same E. coli components as Porcilis ColiClos.
Slovenian: Za dokaz zaščite proti okužbi z bakterijo E.coli so bile predstavljene tudi študije zdravila Porcilis Porcoli Diluvac Forte, tj. cepiva, ki je odobreno v EU in ima enake komponente bakterije E.coli, kot so prisotne v zdravilu Porcilis ColiClos.
English: What is the risk associated with Porcilis ColiClos?
Slovenian: Kakšna tveganja so povezana z zdravilom Porcilis ColiClos?
English: Porcilis ColiClos has been shown to reduce death and the clinical signs of E. coli or C. perfringens infections such as neonatal piglet diarrhoea and necrotic enterotoxaemia (a severe infection of the intestines).
Slovenian: Dokazano je bilo, da zdravilo Porcilis ColiClos zmanjšuje smrtnost in klinične znake okužb z bakterijami E. coli ali C. perfringens, kot sta neonatalna driska pri pujskih in nekrotična enterotoksemija (huda okužba črevesja).
English: Why has Porcilis ColiClos been approved?
Slovenian: Zakaj je bilo zdravilo Porcilis ColiClos odobreno?
English: E. Coli and C. perfringens vaccine
Slovenian: Porcilis ColiClos cepivo proti bakterijama E. Coli in C. perfringens
English: Reduced activity and lack of appetite on the day of vaccination commonly occurs.
Slovenian: Prav tako se pogosto pojavi zmanjšana dejavnost in izguba teka.
English: Porcilis ColiClos contains parts of the bacteria E. coli and C. perfringens that have been inactivated so that they cannot cause disease.
Slovenian: in C. perfringens, ki sta bili inaktivirani, tako da ne moreta povzročiti bolezni.
English: What is Porcilis ColiClos?
Slovenian: Kaj je zdravilo Porcilis ColiClos?
English: How has Porcilis ColiClos been studied?
Slovenian: Kako je bilo zdravilo Porcilis ColiClos raziskano?
English: What is Porcilis ColiClos used for?
Slovenian: Za kaj se zdravilo Porcilis ColiClos uporablja?
English: How does Porcilis ColiClos work?
Slovenian: Kako zdravilo Porcilis ColiClos deluje?
English: Treatment may be restarted once the patient's condition has stabilised.
Slovenian: Zdravljenje lahko ponovno uvedete, ko se bo bolnikovo stanje stabiliziralo.
English: The review of SGLT2 inhibitors was initiated at the request of European Commission in June 2015, under Article 20 of Regulation (EC) No 726/2004.
Slovenian: Pregled zaviralcev SGLT2 se je začel junija 2015 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: The CHMP opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Slovenian: Mnenje odbora CHMP je bilo nato poslano Evropski komisiji, ki je izdala pravno zavezujočo odločbo, ki je veljavna po vsej Evropski uniji.
English: You may need emergency treatment and your diabetes medicine may need to be changed.
Slovenian: Morda boste potrebovali intenzivno zdravljenje in bo treba vaše zdravilo za zdravljenje sladkorne bolezni zamenjati.
English: Healthcare professionals should be aware of possible atypical cases
Slovenian: Zdravstveni delavci naj se zavedajo možnosti atipičnih primerov.
English: EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Priporočila agencije EMA temeljijo na začetnem pregledu, ki ga je opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC).
English: An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment.
Slovenian: Atipična oblika diabetične ketoacidoze lahko povzroči zamudo pri diagnosticiranju in zdravljenju.
English: • Inform patients of the signs and symptoms of diabetic ketoacidosis and advise them to seek medical advice immediately if they develop such signs and symptoms.
Slovenian: • Bolnike poučite o znakih in simptomih diabetične ketoacidoze in jim svetujte, da v primeru pojava takih znakov in simptomov takoj poiščejo zdravniško pomoč.
English: • SGLT2 inhibitors in the EU are available under the following trade names: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet and Xigduo.
Slovenian: • Zaviralci SGLT2 so v Evropski uniji na voljo pod naslednjimi trgovskimi imeni: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet in Xigduo.
English: • Diabetic ketoacidosis is a serious complication of diabetes.
Slovenian: • Diabetična ketoacidoza je resen zaplet pri sladkorni bolezni.
English: The following SGLT2 inhibitors are authorised in the EU: Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin), Vokanamet (canagliflozin / metformin) and Xigduo (dapagliflozin / metformin).
Slovenian: V Evropski uniji so odobreni naslednji zaviralci SGLT2: Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (kanagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Vokanamet (kanagliflozin/metformin) in Xigduo (dapagliflozin/metformin).
English: Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels.
Slovenian: Diabetična ketoacidoza je resen zaplet pri sladkorni bolezni, ki ga povzroči nizka raven insulina.
English: • If you have any of the symptoms above while taking an SGLT2 inhibitor, contact a doctor or the nearest hospital straightaway even if your sugar level is not particularly high.
Slovenian: • Če jemljete zaviralec SGLT2 in imate katerega koli od zgoraj navedenih simptomov, se takoj posvetujte z zdravnikom ali najbližjo bolnišnico, tudi če vaša raven sladkorja ni zelo visoka.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016 (Invokana, Jardiance) and 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet).
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je dne 25. aprila 2016 (Invokana, Jardiance) in 28. aprila 2016 (Forxiga, XigDuo, Synjardy, Vokanamet) izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines).
Slovenian: Evropska agencija za zdravila (EMA) je 25. februarja 2016 potrdila priporočila1 za zmanjševanje tveganja diabetične ketoacidoze pri bolnikih, ki jemljejo zaviralce SGLT2 (razred zdravil za zdravljenje sladkorne bolezni tipa 2).
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted the Agency's final opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), ki jih je potrdil in sprejel končno mnenje agencije.
English: By blocking the action of SGLT2, these medicines cause more glucose to be removed through the urine, thereby reducing the levels of glucose in the blood.
Slovenian: Ta zdravila z zaviranjem delovanja SGLT2 povzročijo večje izločanje glukoze z urinom in s tem zmanjšajo raven glukoze v krvi.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
English: Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
Slovenian: Zdravstveni delavci morajo zato pomisliti na možnost diabetične ketociadoze pri bolnikih, ki jemljejo zaviralce SGLT2 in imajo simptome, ki ustrezajo tej bolezni, tudi če ravni krvnega sladkorja pri njih niso visoke.
English: They block a protein in the kidneys called SGLT2, which absorbs glucose back from the urine into the bloodstream as the blood is filtered in the kidneys.
Slovenian: Zavirajo beljakovino v ledvicah, imenovano SGLT2, ki pri filtraciji krvi v ledvicah ponovno absorbira glukozo iz urina v krvni obtok.
English: A number of these cases were atypical with patients having only moderately raised blood sugar levels and some of them occurred during offlabel use and clinical trials in patients with type 1 diabetes.
Slovenian: Številni od teh primerov so bili atipični, saj so imeli bolniki le zmerno zvišano raven krvnega sladkorja, nekateri primeri pa so se pojavili pri uporabi, ki ni v skladu z odobrenimi indikacijami, in kliničnem preizkušanju pri bolnikih s sladkorno boleznijo tipa 1.
English: If diabetic ketoacidosis is suspected or confirmed, treatment with SGLT2 inhibitors should be stopped immediately and should not be re-started unless another cause for the ketoacidosis is identified and resolved.
Slovenian: Če obstaja sum na diabetično ketoacidozo oziroma je ta potrjena, je treba zdravljenje z zaviralci SGLT2 takoj prekiniti in se ne sme ponovno uvesti, razen če se ugotovi in odpravi drug sprožilni dejavnik za ketoacidozo.
English: Following a review of the cases, EMA recommended updating the product information of SGLT2 inhibitors to list diabetic ketoacidosis as a rare adverse reaction (affecting up to 1 in 1,000 patients).
Slovenian: Po pregledu primerov je agencija EMA za zaviralce SGLT2 priporočila posodobitev informacij o zdravilu, tako da bi bila diabetična ketoacidoza navedena kot redek neželeni učinek (ki prizadene največ 1 bolnika od 1 000).
English: Healthcare professionals should exercise caution with SGLT2 inhibitors in patients with risk factors for ketoacidosis and inform patients of these factors.
Slovenian: Zdravstveni delavci naj zaviralce SGLT2 pri bolnikih z dejavniki tveganja za ketoacidozo uporabljajo previdno in bolnike o teh dejavnikih poučijo.
English: These include low reserve of insulin-secreting cells, a sudden reduction in insulin dose, an increased requirement for insulin (due to illness, surgery or alcohol abuse) and conditions that restrict food intake or can lead to severe dehydration.
Slovenian: Mednje spadajo majhna rezerva celic, ki izločajo insulin, nenadno zmanjšanje odmerka insulina, povečana potreba po insulinu (zaradi bolezni, kirurškega posega ali čezmernega uživanja alkohola) in stanja, ki omejijo uživanje hrane ali lahko vodijo v hudo dehidracijo.
English: • Stop treatment with SGLT2 inhibitors temporarily in patients undergoing major surgical procedures or hospitalised due to acute serious medical illnesses.
Slovenian: • Zdravljenje z zaviralci SGLT2 začasno prekinite tudi pri bolnikih, ki so imeli večji kirurški poseg ali so bili hospitalizirani zaradi hude akutne bolezni.
English: • Healthcare professionals are reminded that SGLT2 inhibitors are only authorised for treating type 2 diabetes.
Slovenian: • Zdravstvene delavce opominjamo, da so zaviralci SGLT2 odobreni le za zdravljenje sladkorne bolezni tipa 2.
English: In addition, EMA recommended temporarily stopping SGLT2 inhibitors in patients who are undergoing major surgery or are in hospital due to serious illness.
Slovenian: Poleg tega je agencija EMA priporočila začasno prenehanje uporabe zaviralcev SGLT2 pri bolnikih, ki so imeli večje kirurške posege ali so zaradi bolezni hospitalizirani.
English: • Exercise caution in patients with risk factors for ketoacidosis and inform patients of these factors.
Slovenian: • Pri bolnikih z dejavniki tveganja za ketoacidozo bodite previdni in jih poučite o teh dejavnikih.
English: Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes.
Slovenian: Agencija EMA je tudi opomnila zdravstvene delavce, da zaviralci SGLT2 niso odobreni za sladkorno bolezen tipa 1, saj so se primeri ketoacidoze pojavili tudi ob uporabi, ki ni v skladu z odobrenimi indikacijami, in kliničnih preizkušanjih pri sladkorni bolezni tipa 1.
English: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are medicines used to treat type 2 diabetes.
Slovenian: Zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2) so zdravila, ki se uporabljajo za zdravljenje sladkorne bolezni tipa 2.
English: Patients taking these medicines should be aware of the symptoms of diabetic ketoacidosis, including rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Slovenian: Bolniki, ki jemljejo ta zdravila, morajo poznati simptome diabetične ketoacidoze, vključno s hitro izgubo telesne mase, navzejo ali bruhanjem, bolečinami v trebuhu, čezmerno žejo, hitrim in plitvim dihanjem, zmedenostjo, nenavadno zaspanostjo ali utrujenostjo, sladkim zadahom, sladkim ali kovinskim okusom v ustih in spremenjenim vonjem urina ali znoja.
English: Symptoms include rapid weight loss, nausea or vomiting, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to the breath, a sweet or metallic taste in the mouth, or a different odour to urine or sweat.
Slovenian: Simptomi vključujejo hitro izgubo telesne mase, navzejo ali bruhanje, bolečino v trebuhu, čezmerno žejo, hitro in plitvo dihanje, zmedenost, nenavadno zaspanost ali utrujenost, sladek zadah, sladek ali kovinski okus v ustih in spremenjen vonj urina ali znoja.
English: The benefits of these medicines continue to outweigh the risks in the treatment of type 2 diabetes.
Slovenian: Pri zdravljenju sladkorne bolezni tipa 2 koristi teh zdravil še vedno odtehtajo tveganja.
English: • Stop treatment with SGLT2 inhibitors immediately if diabetic ketoacidosis is suspected or confirmed, and do not re-start treatment unless another clear precipitating factor for the condition is identified and resolved.
Slovenian: • Če obstaja sum na diabetično ketoacidozo oziroma je ta potrjena, je treba zdravljenje z zaviralci SGLT2 takoj prekiniti in se ne sme ponovno uvesti, razen če se ugotovi in odpravi drug sprožilen dejavnik za ketoacidozo.
English: • Some of the cases of diabetic ketoacidosis in people taking SGLT2 inhibitors did not show the very high sugar levels normally associated with this condition.
Slovenian: • V nekaterih primerih diabetične ketoacidoze pri ljudeh, ki jemljejo zaviralce SGLT2, raven krvnega sladkorja ni bila zelo visoka, kot je sicer značilno za to stanje.
English: Patients should contact a doctor or the nearest hospital straightaway if they have any of these symptoms.
Slovenian: Če imajo bolniki katerega od teh simptomov, naj se takoj posvetujejo z zdravnikom ali najbližjo bolnišnico.
English: • Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Slovenian: • Pri bolnikih, ki jemljejo zaviralce SGLT2 in imajo neizrazite simptome, kot so navzeja, bruhanje, anoreksija, bolečine v trebuhu, čezmerna žeja, težave z dihanjem, zmedenost, nenavadna utrujenost ali zaspanost, vedno pomislite na možnost diabetične ketoacidoze.
English: • Rare cases of diabetic ketoacidosis, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors, used to treat type 2 diabetes.
Slovenian: Redki primeri tega stanja, vključno z življenjsko nevarnimi, so se pojavili pri bolnikih, ki za zdravljenje sladkorne bolezni tipa 2 jemljejo zaviralce SGLT2.
English: • Rare cases of diabetic ketoacidosis have occurred in people with type 2 diabetes taking diabetes medicines known as SGLT2 inhibitors.
Slovenian: • Pri bolnikih s sladkorno boleznijo tipa 2, ki so jemali zdravila za sladkorno bolezen, znana kot zaviralci SGLT2, so se pojavili redki primeri diabetične ketoacidoze.
English: These include low insulin-producing capacity in the pancreas, a sudden drop in a patient's insulin dose, increased insulin requirement (due to illness, surgery or alcohol abuse) or conditions that can restrict food intake or lead to severe dehydration.
Slovenian: Ti dejavniki so nizka sposobnost trebušne slinavke za tvorbo insulina, nenaden upad bolnikovega odmerka insulina, povečana potreba po insulinu (zaradi
English: • All unused devices or empty containers should be returned systematically according to the local regulation.
Slovenian: • Vse neuporabljene pripomočke in prazne vsebnike je treba sistematično vrniti v skladu z nacionalnim predpisom.
English: • The pharmacist must make use of the checklist for pharmacist
Slovenian: • farmacevt mora uporabljati kontrolni seznam za farmacevta.
English: Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority.
Slovenian: Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim državnim organom za končno obliko izobraževalnega gradiva.
English: • The pharmacist must be familiar with the educational material of PecFent nasal spray before using it in his/her organization
Slovenian: • farmacevt mora natančno poznati izobraževalno gradivo o pršilu za nos PecFent, preden ga začne uporabljati v svoji organizaciji;
English: The MAH shall ensure that, at launch, all physicians, pharmacists and patients expected to prescribe/use PecFent are provided with educational material informing about the correct and safe use of the product.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo ob prihodu zdravila na trg vse zdravnike, farmacevte in bolnike, za katere pričakuje, da bodo predpisovali/uporabljali zdravilo PecFent, oskrbel z izobraževalnim gradivom, ki bo nudilo informacije o pravilni in varni uporabi zdravila.