natgillin/translations-raw huggingface dataset:
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of a hormone called erythropoietin, or by the body not responding well enough to erythropoietin.
Pri bolnikih, ki prejemajo kemoterapijo, ali tistih z ledvičnimi težavami je vzrok za anemijo lahko pomanjkanje hormona, imenovanega eritropoetina, ali nezadostna odzivnost telesa na eritropoetin.
Aranesp can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating the types of anaemia mentioned above.
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem zgoraj omenjenih vrst anemije.
In kidney failure patients, the most common side effects with Aranesp (which may affect more than 1 in 10 people) are hypersensitivity (allergy) and hypertension (high blood pressure) while in cancer patients the most common are hypersensitivity and oedema (fluid retention).
Najpogostejši neželeni učinki zdravila Aranesp (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so pri bolnikih z odpovedjo ledvic preobčutljivostne (alergijske) reakcije in hipertenzija (visok krvni tlak), pri bolnikih z rakom pa preobčutljivostne reakcije in edem (zastajanje tekočine).
The active substance in Aranesp, darbepoetin alfa works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Učinkovina v zdravilu Aranesp, darbepoetin alfa, pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu deluje popolnoma enako kot naravni hormon.
Aranesp contains the active substance darbepoetin alfa.
Zdravilo Aranesp vsebuje učinkovino darbepoetin alfa.
For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin.
Pri bolnikih s kronično odpovedjo ledvic se zdravilo Aranesp lahko injicira v veno ali pod kožo.
It must be injected under the skin in patients receiving chemotherapy.
Pri bolnikih, ki prejemajo kemoterapijo, ga je treba injicirati pod kožo.
Aranesp can be injected by the patient or their carer if they have been trained.
Zdravilo Aranesp si lahko vbrizga bolnik sam ali mu ga injicira negovalec, če sta bila za to usposobljena.
Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen.
Zdravilo Aranesp je na voljo v obliki viale, napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels and at keeping these levels maintained, whether given as an injection into a vein or under the skin.
Zdravilo Aranesp je bilo pri zviševanju ravni hemoglobina in ohranjanju teh ravni, ne glede na to, ali je bilo injicirano v veno ali pod kožo, enako učinkovito kot rekombinantni humani eritropoetin.
Aranesp has been shown to be effective in the treatment of chronic renal failure in four studies involving over 1,200 patients.
Zdravilo Aranesp se je v štirih študijah, v katere je bilo vključenih več kot 1 200 bolnikov, pri zdravljenju kronične odpovedi ledvic izkazalo za učinkovito.
How is Aranesp used?
Kako se zdravilo Aranesp uporablja?
This summary was last updated on 6 January 2012.
Ta povzetek je bil nazadnje posodobljen 6. januarja 2012.
Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Pravkar zdravljene živali ne smejo spati v isti postelji s svojimi lastniki, zlasti ne z otroki.
These usually disappear without treatment within 24 hours.
Ti simptomi ponavadi izginejo v 24 urah brez zdravljenja.
This medicine is specifically developed for dogs and should not be used in any other animal species.
To zdravilo je bilo izdelano posebej za pse in se ne sme uporabljati pri nobeni drugi živalski vrsti.
Amitraz is a monoamine oxidase inhibitor (MOAI).
Amitraz je zaviralec monoamin oksidaze (MOAI).
The European Commission granted a marketing authorisation valid throughout the European Union for ProMeris Duo on 19 December 2006.
Evropska komisija je dovoljenje za promet z zdravilom ProMeris Duo, veljavno po vsej Evropski uniji, odobrila dne 19. 12. 2006.
It is given to dogs with a pre-filled spot-on pipette, a small plastic container that is already filled with the correct amount of ProMeris Duo needed to treat one dog.
Daje se psom na kožo s predhodno napolnjeno merilno kapalko, majhno plastično cevko, ki je že napolnjena z ustrezno količino zdravila ProMeris Duo, potrebno za zdravljenje enega psa.
It is recommended that the product is applied in the open air or in a well-ventilated room.
Priporočamo, da zdravilo nanesete v odprtem ali dobro prezračenem prostoru.
ProMeris Duo is an ‘ectoparasiticide'.
ProMeris Duo je „ektoparaziticid“.
Protective gloves are recommended when handling the medicine.
Pri ravnanju z zdravilom je priporočljiva uporaba zaščitnih rokavic.
People taking MOAI-containing medicines, such as antidepressants, should take particular care when handling ProMeris Duo.
Osebe, ki jemljejo zdravila, ki vsebujejo MOAI, kot so na primer antidepresivi, morajo z zdravilom ProMeris Duo še posebno previdno ravnati.
Data were provided on pharmaceutical quality, the safety of the medicine in dogs and its safety in humans (people who come into contact with the medicine) and in the environment.
Predloženi so bili podatki o farmacevtski kakovosti, varnosti zdravila za pse ter njegovi varnosti za ljudi (osebe, ki pridejo v stik z zdravilom) in okolje.
Another study was carried out in dogs with demodicosis in veterinary practices in Italy and Albania.
Druga študija je bila izvedena na psih z demodikozo v italijanskih in albanskih veterinarskih ambulantah.
ProMeris Duo must not be used in puppies less than eight weeks old since it has not been sufficiently studied in these animals.
Zdravila ProMeris Duo se ne sme uporabljati pri mladičih, mlajših od osem tednov, saj pri tej skupini živali zdravilo ni bilo zadostno raziskano.
The most common side effects in dogs are sedation (sleepiness), lethargy (a lack of energy), reduced nervous system activity, hyperglycaemia (high blood sugar levels), bradycardia (slow heart rate), and slow, shallow breathing.
Najpogostejši neželeni učinki pri psih so sedacija (zaspanost), letargija (neodzivnost), zmanjšana odzivnost živčnega sistema, hiperglikemija (visoke ravni sladkorja v krvi), bradikardija (počasen srčni utrip) in počasno, plitvo dihanje.
As a precautionary measure, avoid direct contact with the treated dog and do not allow children to play with the treated dog until the application site is dry.
Kot preventivni ukrep se je treba izogibati neposrednemu stiku z zdravljenim psom in preprečiti otrokom igranje z zdravljeno psom, dokler področje nanosa ni suho.
Other information about ProMeris Duo:
Druge informacije o zdravilu ProMeris Duo:
ProMeris Duo metaflumizone and amitraz
ProMeris Duo metaflumizona in amitraza
ProMeris Duo contains components that, on very rare occasions, can irritate the airways in some people.
Zdravilo ProMeris Duo vsebuje sestavine, ki lahko v zelo redkih primerih dražijo dihalne poti nekaterih oseb.
The Committee recommended that ProMeris Duo be given a marketing authorisation.
Odbor je priporočil, da se za zdravilo ProMeris Duo odobri dovoljenje za promet z zdravilom.
It can also be used as part of a treatment strategy for the control of flea allergy dermatitis, an allergic reaction to flea bites.
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t.j.
ProMeris Duo is available in five different sizes for various weights of dog.
Zdravilo ProMeris Duo je na voljo v petih različnih velikostih za različno težke pse.
ProMeris Duo should not enter surface water, as this may be harmful for fish and other aquatic organisms.
Zdravilo ProMeris Duo ne sme zaiti v površinske vode, ker je to lahko nevarno za ribe ali druge vodne organizme.
The effectiveness was measured looking at the clinical signs and the number of Demodex mites in skin scrapings taken every four weeks, for several weeks following monthly administration of the treatment.
Učinkovitost so merili s proučevanjem kliničnih znakov in števila garjavcev Demodex v vzorcih kože, ki so bili odvzeti vsake štiri tedne, nekaj tednov po mesečnem zdravljenju.
What benefit has ProMeris Duo shown during the studies?
Kakšne koristi je zdravilo ProMeris Duo izkazalo med študijami?
The medicine killed most fleas within 24 hours, most ticks within 48 hours and most lice within a week of treatment.
Zdravilo je uničilo večino bolh v 24 urah, večino klopov v 48 urah in večino uši teden po nanosu.
What is the risk associated with ProMeris Duo?
Kakšna tveganja so povezana z zdravilom ProMeris Duo?
Do not smoke, eat or drink when applying ProMeris Duo.
Med dajanjem zdravila ProMeris Duo ne kadite, pijte ali jejte.
As for other products in this group, ProMeris Duo should not be used in sick dogs, dogs that have just recovered from an illness or dogs that are suffering from heat stress.
Kot to velja za ostala zdravila iz te skupine zdravil, se zdravilo ProMeris Duo ne sme uporabljati pri bolnih živalih, psih, ki so pravkar okrevali, ali psih, ki so bili izpostavljeni vročinskemu stresu.
If a dog licks the application area, the dog might salivate considerably for a short period.
Če pes poliže mesto nanosa, se lahko pojavi kratko obdobje prekomernega slinjenja.
This means that it will kill parasites that live on or in the skin or in the fur of animals, such as fleas, ticks, lice and Demodex mites (mites that cause demodicosis or ‘mange').
To pomeni, da uničuje zajedavce, ki živijo na koži, v njej ali v dlaki živali, kot so denimo bolhe, klopi, uši in garjavci Demodex (iz rodu pršic, ki povzročajo demodikozo, kožno bolezen).
In very rare cases, temporary local hair loss may occur.
Zelo redko dlaka na tem mestu začasno izpade.
The effectiveness of ProMeris Duo against flea, lice and tick infestations and Demodex mites has been studied in a number of studies, including one study in dogs infested with fleas or ticks carried out at veterinary practices in Germany and France.
Učinkovitost zdravila ProMeris Duo proti bolham, ušem, klopom in garjavcem Demodex so raziskali v številnih študijah, tudi v študijo na psih z bolhami ali klopi, ki so jo izvedli v nemških in francoskih veterinarskih ambulantah.
Dogs were treated with ProMeris Duo or the combination of imidacloprid and moxidectin (another medicine authorised in the EU for this indication).
Psi so bili zdravljeni z zdravilom ProMeris Duo ali s kombinacijo imidaklopridina in moksidektina (drugega zdravila, ki je bilo v EU odobreno za to indikacijo).
A further study compared the effectiveness of ProMeris Duo with that of fipronil (another medicine for the treatment of lice).
V nadaljnji študiji so primerjali učinkovitost zdravila ProMeris Duo z učinkovitostjo fipronila (drugega zdravila za zatiranje uši).
Why has ProMeris Duo been approved?
Zakaj je bilo zdravilo ProMeris Duo odobreno?
The effectiveness of ProMeris Duo lasted for at least six weeks against fleas and for four weeks against ticks.
Učinek zdravila ProMeris Duo je trajal najmanj šest tednov pri zatiranju bolh in štiri tedne pri zatiranju klopov.
Dogs of various breeds, ages and weights were treated with ProMeris Duo or with other medicines authorised in the European Union (EU) for flea and tick infestation.
Psi različnih pasem, starosti in telesnih mas so bili zdravljeni z zdravilom ProMeris Duo ali drugimi zdravili, odobrenimi v Evropski uniji (EU) za zatiranje bolh in klopov.
The effectiveness was measured looking at the number of live ticks or number of fleas on the dogs up to two months after application.
Učinkovitost so merili s štetjem živih klopov ali bolh na psih do dveh mesecev po uporabi zdravila.
In rare cases, temporary irritation may occur at the site of application.
Redko se na mestu nanosa pojavi začasna razdraženost.
Avoid touching the skin with the pipette's contents.
Pazite, da vsebina kapalke ne pride v stik s kožo.
ProMeris Duo is used in dogs over eight weeks of age to treat and to prevent tick and flea infestations, and to treat demodicosis (caused by Demodex mites) and lice infestations.
Zdravilo ProMeris Duo se uporablja pri psih, starejših od osem tednov, za zatiranje klopov in bolh in preprečevanje njihovega pojava ter za zdravljenje demodikoze (ki jo povzročajo garjavci Demodex) in ušivosti.
Both active substances in ProMeris Duo, metaflumizone and amitraz, interfere with the neural activity of the parasites and consequently lead to their death.
Zdravilni učinkovini v zdravilu ProMeris Duo, metaflumizon in amitraz, ovirata živčne funkcije zajedavcev, kar povzroča njihovo uničenje.
ProMeris Duo is a clear, yellow-to-amber solution that contains metaflumizone and amitraz as active substances.
Zdravilo ProMeris Duo je bistra, rumenojantarna raztopina, ki vsebuje zdravilni učinkovini metaflumizon in amitraz.
The effectiveness was measured by looking at the number of lice on the dogs after treatment.
Učinkovitost je bila merjena s štetjem uši na psih po zdravljenju.
There may also be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Na mestu nanosa se lahko pojavijo spremembe dlake (masten videz, vozlanje in zlepljenje dlake).
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris Duo exceed the risks for the treatment and prevention of flea and tick infestations, and the treatment of demodicosis and lice infestation in dogs.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila ProMeris Duo za zatiranje bolh in klopov in preprečevanje njihovega pojava pri psih ter za zdravljenje demodikoze in ušivosti večje od z njim povezanih tveganj.
The results of the studies showed that ProMeris Duo is effective in the treatment and prevention of flea and tick infestations, and in the treatment of demodicosis and lice infestation in dogs.
Rezultati študij so pokazali, da je zdravilo ProMeris Duo učinkovito pri zatiranju bolh in klopov in preprečevanju njihovega pojava pri psih ter pri zdravljenju demodikoze in ušivosti pri psih.
What is ProMeris Duo used for?
Za kaj se zdravilo ProMeris Duo uporablja?
The contents of the pipette are squeezed onto the skin after parting the fur at the back of the head.
Psu razmaknemo dlako na zadnji strani glave, da se prikaže koža, na katero stisnemo vsebino merilne kapalke.
What is ProMeris Duo?
Kaj je zdravilo ProMeris Duo?
How has ProMeris Duo been studied?
Kako je bilo zdravilo ProMeris Duo raziskano?
Wash the skin and rinse eyes with water, if accidental exposure occurs.
Če zdravilo po nesreči pride v stik s kožo ali z očmi, jih dobro sperite z vodo.
How does ProMeris Duo work?
Kako zdravilo ProMeris Duo deluje?
This summary was last updated in 05-2009.
Povzetek je bil nazadnje posodobljen 05-2009.
The recommended dose is one tablet once a day.
Priporočeni odmerek je ena tableta enkrat dnevno.
Ref.: EMEA/280173/2009 EMEA/H/C/1016
: EMEA/485921/2009 EMEA/H/C/1016
It is available as brown tablets (250 mg).
Na voljo je v obliki rjavih tablet (250 mg).
The main measure of effectiveness was survival (how long the patients lived).
Glavno merilo učinkovitosti je bilo preživetje (kako dolgo je bolnik živel).
Iressa gefitinib EPAR summary for the public
Iressa gefitinib Povzetek EPAR za javnost
The main measure of effectiveness was how long the patients lived without the disease getting worse.
Glavno merilo učinkovitosti je bilo, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
Other information about Iressa:
Druge informacije o zdravilu Iressa:
The effects of Iressa were first tested in experimental models before being studied in humans.
Učinki zdravila Iressa so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The European Commission granted a marketing authorisation valid throughout the European Union for Iressa to AstraZeneca AB on 24 June 2009.
Evropska komisija je dovoljenje za promet z zdravilom Iressa, veljavno po vsej Evropski uniji, odobrila družbi AstraZeneca AB dne 24. junija 2009.
The Committee recommended that Iressa be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Iressa odobri dovoljenje za promet.
Treatment with Iressa should be started and supervised by a doctor who has experience with anticancer treatments.
Zdravljenje z zdravilom Iressa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
It must not be used in mothers who are breastfeeding.
Zdravila ne smejo uporabljati doječe matere.
What benefit has Iressa shown during the studies?
Kakšne koristi je zdravilo Iressa izkazalo med študijami?
The most common side effects with Iressa (seen in more than 1 patient in 10) are loss of appetite, diarrhoea, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), increased level of alanine aminotransferase (a liver enzyme) in the blood, skin reactions such as pustular rash, and asthenia (weakness).
Najpogostejši neželeni učinki zdravila Iressa (opaženi pri več kot 1 bolniku izmed 10) so izguba apetita, driska, bruhanje, navzea (slabost), stomatitis (vnetje ustne sluznice), povišane koncentracije alanin aminotransferaze (jetrnega encima) v krvi, kožne reakcije, kot je pustulozen izpuščaj, in astenija (šibkost).
Among patients with the EGFR mutation, those who took Iressa lived for an average of nine and a half months without the disease getting worse, compared with about six months for those who took the combination therapy.
Bolniki z mutacijo receptorja za epidermalni rastni dejavnik, ki so jemali zdravilo Iressa, so v povprečju živeli devet in pol mesecev brez poslabšanja stanja bolezni, v primerjavi s šestimi meseci pri tistih, ki so jemali kombinacijsko terapijo.
This means that it blocks specific enzymes known as tyrosine kinases.
To pomeni, da zavira določene encime, ki jim pravimo tirozin kinaze.
It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Uporablja se pri bolnikih, katerih rakave celice imajo mutacijo v genih, ki vsebujejo zapis za beljakovino, imenovano receptor za epidermalni rastni dejavnik (EGFR).
Iressa should not be used in people who may be hypersensitive (allergic) to gefitinib or any of the other ingredients.
Zdravila Iressa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) gefitinib ali katerokoli drugo sestavino zdravila.
What is the risk associated with Iressa?
Kakšna tveganja so povezana z zdravilom Iressa?
The active substance in Iressa, gefitinib, is a protein tyrosine kinase inhibitor.
Zdravilna učinkovina v zdravilu Iressa, gefitinib, je zaviralec protein tirozin kinaze.
In the first main study, Iressa was more effective at preventing the cancer from worsening than the combination.
V prvi glavni študiji je bilo zdravilo Iressa pri preprečevanju poslabšanja rakavega obolenja učinkovitejše od kombinacije dveh zdravil.
For the full list of all side effects reported with Iressa, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Iressa, glejte navodilo za uporabo.
Iressa is a medicine that contains the active substance gefitinib.
Iressa je zdravilo, ki vsebuje zdravilno učinkovino gefitinib.
Why has Iressa been approved?
Zakaj je bilo zdravilo Iressa odobreno?
Iressa is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Zdravilo Iressa se uporablja za zdravljenje odraslih z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom (pri katerem se celice raka širijo iz izvornega mesta v druge dele telesa).
The tablet can be dispersed in water for patients who have difficulty swallowing.
Bolniki, ki imajo težave s požiranjem, lahko tableto raztopijo v vodi.
In the second main study, patient survival among all patients who took Iressa was similar to those who took docetaxel.
V drugi glavni študiji je bilo preživetje v obeh skupinah bolnikov, ki so jemali zdravilo Iressa, podobno tistemu pri bolnikih, ki so jemali docetaksel.
EGFR is involved in the growth and spread of cancer cells.
Receptor za epidermalni rastni dejavnik sodeluje pri rasti in širjenju rakavih celic.
In a second main study involving 1,466 patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with docetaxel (another anticancer medicine).
V drugi glavni študiji, ki je vključevala 1 466 bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, so zdravilo Iressa primerjali z zdravilom docetaksel (drugim zdravilom proti raku).
In one main study involving 1,217 adult patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with a combination of carboplatin and paclitaxel (other anticancer medicines).
V eni glavni študiji, ki je vključevala 1 217 odraslih bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, so zdravilo Iressa primerjali s kombinacijo karboplatina in paklitaksela (drugima zdraviloma proti raku).
The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa's benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Iressa pri zdravljenju odraslih z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom z aktivacijsko mutacijo receptorja za epidermalni rastni dejavnik, večje od z njim povezanih tveganj.
These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Ker se ti encimi se nahajajo na površini rakavih celic, se tudi receptor za epidermalni rastni dejavnik nahaja na površini celic nedrobnoceličnega pljučnega raka.
The full EPAR for Iressa can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Iressa je na voljo tukaj.
There is also a risk of interstitial lung disease in patients taking Iressa.
Pri bolnikih, ki jemljejo zdravilo Iressa, obstaja tudi tveganje za intersticijsko pljučno bolezen.
By blocking EGFR, Iressa helps to slow down the growth and spread of the cancer.
Zdravilo Iressa z zaviranjem receptorja za epidermalni rastni dejavnik pomaga upočasniti rast in širjenje raka.
Both studies included patients with and without the EGFR mutation.
Obe študiji sta vključevali bolnike z mutacijo receptorja za epidermalni rastni dejavnik in tiste brez mutacije.
What is Iressa used for?
Za kaj se zdravilo Iressa uporablja?
How does Iressa work?
Kako zdravilo Iressa deluje?
Iressa works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Zdravilo Iressa deluje samo na celice nedrobnoceličnega pljučnega raka, ki imajo mutacijo receptorja za epidermalni rastni dejavnik.
What is Iressa?
Kaj je zdravilo Iressa?
How has Iressa been studied?
Kako je bilo zdravilo Iressa raziskano?
How is Iressa used?
Kako se zdravilo Iressa uporablja?
1 August 2017 EMA/443893/2017
1. avgust 2017 EMA/443893/2017
Most cases of allergic reactions occurred in patients under 12 years of age.
Alergijske reakcije so se večinoma pojavile pri bolnikih, mlajših od 12 let.
• If you have any questions or concerns, speak with your doctor or pharmacist.
• Če imate dodatna vprašanja ali pomisleke, se posvetujte z zdravnikom ali farmacevtom.
The above recommendations are based on analyses of spontaneous reports of suspected adverse effects and a review of published literature.
Zgornja priporočila temeljijo na analizah spontanih poročil o domnevnih neželenih učinkih in pregledu objavljene literature.
On 31 July 2017 the CMDh adopted its position by consensus, so the measures recommended by the PRAC will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Skupina CMDh je 31. julija 2017 soglasno sprejela svoje stališče, zato bodo morale države članice, v katerih so zdravila odobrena, v skladu z dogovorjeno časovnico neposredno izvajati ukrepe, ki jih je priporočil odbor PRAC.