FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAHs will evaluate the final report of the study, when published, and will update the Core RMP, and where appropriate the Core SPC/PL, to reflect the findings.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo ovrednotili končno poročilo študije po objavi in posodobili načrt obvladovanja tveganja ter po potrebi povzetek glavnih značilnosti zdravila/navodilo za uporabo, da bodo odražali izsledke te študije.
English: The MAHs will evaluate the final report of the study, when published, and will update the RMP, and where appropriate the SPC/PL, to reflect the findings:
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo ovrednotili končno poročilo študije po objavi in posodobili načrt obvladovanja tveganja ter po potrebi povzetek glavnih značilnosti zdravila/navodilo za uporabo, da bodo odražali izsledke te študije:
English: Modified-release capsules, hard
Slovenian: Kapsule s prirejenim sproščanjem, trde
English: 27 mg Prolonged release tablets
Slovenian: 27 mg Tableta s podaljšanim sproščanjem
English: Medikinet tablets
Slovenian: Podatki o zdravilu
English: Equasym tabletter 20 mg tablet
Slovenian: Equasym tabletter 20 mg
English: Modified release capsule, hard
Slovenian: Kapsula s prirejenim sproščanjem, trda
English: modified release capsule oral
Slovenian: Kapsula s prirejenim sproščanjem
English: - have glaucoma (increased pressure in the eye) - have phaeochromocytoma (a tumour of the adrenal gland) - are taking medicines known as monoamine oxidase inhibitors (MAOIs) for depression, or have taken MAOIs in the last 14 days - have thyroid problems - suffer from anorexia nervosa or anorexic disorders - suffer from depression, mood disorders, mania, or have suicidal thoughts - suffer from psychotic symptoms or schizophrenia or psychopathic/borderline personality disorder.
Slovenian: Ne jemljite metilfenidata: - če ste vi ali vaš otrok alergični na (preobčutljivi za) metilfenidat ali katerokoli sestavino metilfenidata; - če imate vi ali vaš otrok glavkom (povišan očesni tlak); - če imate vi ali vaš otrok feokromocitom (tumor nadledvične žleze); - če vi ali vaš otrok jemljete zdravila, znana kot zaviralci monoaminooksidaz, za zdravljenje depresije ali pa ste v zadnjih 14 dnevih vzeli zaviralce monoaminooksidaz; - če imate vi ali vaš otrok težave s ščitnico; - če vi ali vaš otrok trpite za anoreksijo, nervozo ali anoreksičnimi motnjami; - če vi ali vaš otrok trpite za depresijo, motnjami razpoloženja, manijo ali imate samomorilne misli; - če vi ali vaš otrok trpite za psihotičnimi simptomi ali shizofrenijo ali psihopatsko/mejno osebnostno motnjo; - če imate vi ali vaš otrok diagnozo ali anamnezo hude in epizodične bipolarne (afektivne) motnje (tipa I); - če ima vaš otrok težave s srcem, kot so anamneza srčnega infarkta, nerednega bitja srca, bolečine in nelagodja v prsnem košu, odpovedi srca, bolezni srca ali večjih težav v zgradbi ali delovanju srca, ki so bile prisotne ob rojstvu; - če imate vi ali vaš otrok zelo visok krvni tlak ali zožene krvne žile, kar lahko povzroči bolečine v rokah in nogah; - če ima vaš otrok cerebrovaskularno motnjo, kot je kap, možgansko anevrizmo ali žilne nepravilnosti, vključno z možganskim vaskulitisom.
English: Early diagnosis, based on a high index of suspicion, may allow the prompt withdrawal of methylphenidate and early treatment.
Slovenian: Ker pa lahko le zgodnja diagnoza na podlagi močnega suma omogoči takojšnjo ukinitev metilfenidata in zgodnje zdravljenje takih bolnikov, morate pomisliti na to diagnozo pri vsakem bolniku, ki se mu med zdravljenjem z metilfenidatom pojavijo novi nevrološki simptomi, ki bi lahko kazali na možgansko ishemijo.
English: The MAHs will make available the final report of the study, when published, and will update the RMP, and where appropriate the SPC/PL, to reflect the findings.
Slovenian: Imetniki dovoljenj za promet z zdravilom bodo pridobili končno poročilo študije po objavi in posodobili načrt obvladovanja tveganja ter po potrebi povzetek glavnih značilnosti zdravila/navodilo za uporabo, da bodo odražali izsledke te študije.
English: Equasym tabletter 10 mg tablet
Slovenian: Equasym tabletter 10 mg
English: Prolonged-release capsule, hard Oral
Slovenian: Kapsula s podaljšanim sproščanjem, trda
English: Uncommon: constipation
Slovenian: Občasni: sedacija (pomiritev), tremor
English: Very rare: suicidal attempt (including completed suicide)*, transient depressed mood*, abnormal thinking, apathy, repetitive behaviours, over-focussing, Not known: delusions*, thought disturbances*, confusional state, dependence.
Slovenian: Touretteovega sindroma*, hipervigilnost, motnje spanja manija*, zmedenost, motnje libida poskus samomora (vključno z uspešnim samomorom* , prehodno depresivno razpoloženje nenormalno mišljenje, apatija, ponavljanje vedenjskih vzorcev, pretirana osredotočeno st prividi*, motnje razmišljanja*, stanje zmedenosti, Primeri zlorabe in odvisnosti so pogosteje opisali pri farmacevtskih oblikah s takojšnjim sproščanjem.
English: Methylfenidaat HCl AET 10 mg tablets
Slovenian: Methylfenidaat HCl AET 10 mg
English: Equasym tabletter 5 mg tablet
Slovenian: Equasym tabletter 5 mg
English: Dizziness, drowsiness and visual disturbances may occur when taking methylphenidate.
Slovenian: Klinična ocena tesnobe, razburjenosti ali napetosti je potrebna pred zdravljenjem z metilfenidatom.
English: Growth should be monitored during methylphenidate treatment: height, weight and appetite should be recorded at least 6 monthly with maintenance of a growth chart.
Slovenian: Telesno višino, telesno maso in tek je treba beležiti v skladu z bolnikovo starostjo ter ob tem zapisovati diagram rasti.
English: Seizures
Slovenian: Peroralno
English: The Reference Member State was Finland and the Concerned Member State was Germany.
Slovenian: Referenčna država članica je bila Finska, zadevna država članica pa Nemčija.
English: 21 February 2006 EMEA/CHMP/373108/2005
Slovenian: EMEA/CHMP/373108/2005
English: These Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Državi članici nista mogli doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Slovenian: Nemčija je Evropski agenciji za zdravila dne 15. decembra 2004 predložila razloge za nesoglasje.
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol CT-Arzneimittel.
Slovenian: Na sestanku v septembru 2005 je CHMP glede na vse predložene podatke ter znanstvene razprave znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol CTArzneimittel ugodno.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol CT-Arzneimittel 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA Lansoprazol CT-Arzneimittel 15 mg in 30 mg Mednarodno nelastniško ime (INN): Lansoprazol
English: A Marketing Authorisation for Lansoprazol CT-Arzneimittel (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Slovenian: Dovoljenje za promet z zdravilom Lansoprazol CT-Arzneimittel (15 mg in 30 mg) je bilo prvotno dodeljeno družbi ratiopharm GmbH s Finske 7. novembra 2003.
English: Lansoprazol CT-Arzneimittel (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastrooesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Slovenian: Lansoprazol CT-Arzneimittel (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega ezofagitisa, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger-Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve želodčne razjede pri bolnikih z razjedami, povezanimi s H. pylori.
English: Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Slovenian: Odbor za zdravila za uporabo v humani medicini je izrazil strinjanje s spremembami v razdelku 4.2 (Odmerjanje in način uporabe) Povzetka glavnih značilnosti zdravila, ki navajajo natančna priporočila glede odmerjanja za antibiotike v skladu s “Točkami, ki jih je treba upoštevati pri pisanju besedila za eradikacijsko zdravljenje Helicobacter pylori v izbranih poglavjih Povzetka glavnih značilnosti zdravila”, in 15. septembra 2005 sprejel pozitivno mnenje.
English: 0.25 mg Powder for concentrate for solution for infusion
Slovenian: 0,25 mg prašek za koncentrat za raztopino za infundiranje
English: Powder for concentrate for solution for infusion
Slovenian: 1 mg prašek za koncentrat za raztopino za infundiranje
English: It is used in two groups of patients:
Slovenian: Uporablja se pri dveh skupinah bolnikov:
English: It is provided in various strengths.
Slovenian: Na voljo je v različnih jakostih.
English: Further information on Aranesp can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aranesp.
Slovenian: Nadaljnje informacije o zdravilu Aranesp so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/aranesp.
English: It is very slightly different in its
Slovenian: Od njega se malce razlikuje le v zgradbi.
English: The lowest dose that provides adequate control of symptoms should be used.
Slovenian: Uporabiti je treba najmanjši odmerek, ki zagotavlja ustrezen nadzor nad simptomi.
English: The European Medicines Agency decided that Aranesp's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Aranesp večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Aranesp?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Aranesp?
English: Aranesp received a marketing authorisation valid throughout the EU on 8 June 2001.
Slovenian: Za zdravilo Aranesp je bilo 8. junija 2001 izdano dovoljenje za promet, veljavno po vsej EU.
English: • adults and children with chronic renal failure (long-term, decreasing in the ability of the kidneys to work properly);
Slovenian: • odraslih in otrocih s kronično odpovedjo ledvic (dolgotrajnim zmanjševanjem sposobnosti ledvic za pravilno delovanje);
English: • adults who are receiving chemotherapy for non-myeloid cancer (cancer not originating in the bone marrow).
Slovenian: • odraslih, ki prejemajo kemoterapijo za zdravljenje nemieloičnega raka (raka, ki ne izvira iz kostnega mozga).
English: As for all medicines, data on the use of Aranesp are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Aranesp stalno spremljajo.
English: Aranesp is a medicine used to treat anaemia (low red blood cell counts) that is causing symptoms.
Slovenian: Aranesp je zdravilo, ki se uporablja za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki povzroča simptome.
English: The company that markets Aranesp will provide educational packs for patients and healthcare professionals including information on how to self-inject the medicine, a training checklist and a demonstration device.
Slovenian: Podjetje, ki trži zdravilo Aranesp, bo zagotovilo izobraževalno gradivo za bolnike in zdravstvene delavce, vključno z informacijami o tem, kako sami injicirati zdravilo, kontrolni seznam za usposabljanje in predstavitveno napravo.
English: In two studies involving 669 patients receiving chemotherapy, Aranesp was more effective than placebo (a dummy treatment) and fewer patients needed a blood transfusion.
Slovenian: V dveh študijah, v kateri je sodelovalo 669 bolnikov, ki so prejemali kemoterapijo, je bilo zdravilo Aranesp učinkovitejše od placeba (zdravila brez zdravilne učinkovine), prav tako je transfuzijo krvi potrebovalo manj bolnikov.
English: Side effects reported with Aranesp are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Aranesp, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For the full list of side effects and restrictions, see the package leaflet
Slovenian: Za celoten seznam neželenih učinkov in omejitev glejte navodilo za uporabo.
English: Aranesp must not be used in patients who have poorly controlled high blood pressure.
Slovenian: Zdravilo Aranesp se ne sme uporabljati pri bolnikih, pri katerih visok krvni tlak ni zadovoljivo nadzorovan.
English: Because of the slight changes to the structure, darbepoetin alfa remains in the body for longer than natural erythropoietin.
Slovenian: Zaradi teh manjših razlik v zgradbi darbepoetin alfa ostaja v telesu dlje časa kot naravni eritropoetin.
English: Why is Aranesp authorised in the EU?
Slovenian: Zakaj je zdravilo Aranesp odobreno v EU?
English: Aranesp has also been studied in 124 children with chronic renal failure to check that it is absorbed in the same way as in adults.
Slovenian: Zdravilo Aranesp so prav tako proučevali pri 124 otrocih s kronično odpovedjo ledvic, da bi preverili, ali se absorbira enako kot pri odraslih.
English: The dose and frequency of injection depend on why Aranesp is being used, and are adjusted, according to the patient's response, to obtain haemoglobin levels that remain within the recommended range (between 10 and 12 grams per decilitre).
Slovenian: Odmerek in pogostost injiciranja sta odvisna od tega, zakaj se zdravilo Aranesp uporablja, in ju je treba prilagoditi glede na bolnikov odziv, da se doseže raven hemoglobina v priporočenem razponu (od 10 do 12 gramov na deciliter).
English: What benefits of Aranesp have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Aranesp izkazalo v študijah?
English: An overview of Aranesp and why it is authorised in the EU
Slovenian: Pregled zdravila Aranesp in zakaj je odobreno v EU
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aranesp have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Aranesp upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What is Aranesp and what it is used for?
Slovenian: Kaj je zdravilo Aranesp in za kaj se uporablja?
English: What are the risks associated with Aranesp?
Slovenian: Kakšna tveganja so povezana z zdravilom Aranesp?
English: For more information about using Aranesp, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Aranesp glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Aranesp
Slovenian: Druge informacije o zdravilu Aranesp
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem zgoraj omenjenih vrst anemije.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Učinkovina v zdravilu Aranesp, darbepoetin alfa, pri spodbujanju nastajanja rdečih krvnih celic v kostnem mozgu deluje popolnoma enako kot naravni hormon.
English: Aranesp contains the active substance darbepoetin alfa.
Slovenian: Zdravilo Aranesp vsebuje učinkovino darbepoetin alfa.
English: For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin.
Slovenian: Pri bolnikih s kronično odpovedjo ledvic se zdravilo Aranesp lahko injicira v veno ali pod kožo.
English: It must be injected under the skin in patients receiving chemotherapy.
Slovenian: Pri bolnikih, ki prejemajo kemoterapijo, ga je treba injicirati pod kožo.
English: Aranesp can be injected by the patient or their carer if they have been trained.
Slovenian: Zdravilo Aranesp si lahko vbrizga bolnik sam ali mu ga injicira negovalec, če sta bila za to usposobljena.
English: Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen.
Slovenian: Zdravilo Aranesp je na voljo v obliki viale, napolnjene injekcijske brizge ali napolnjenega injekcijskega peresnika.
English: 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.
Slovenian: 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.
English: Aranesp has been shown to be effective in the treatment of chronic renal failure in four studies involving over 1,200 patients.
Slovenian: 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.
English: How is Aranesp used?
Slovenian: Kako se zdravilo Aranesp uporablja?
English: This summary was last updated on 6 January 2012.
Slovenian: Ta povzetek je bil nazadnje posodobljen 6. januarja 2012.
English: Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Slovenian: Pravkar zdravljene živali ne smejo spati v isti postelji s svojimi lastniki, zlasti ne z otroki.
English: These usually disappear without treatment within 24 hours.
Slovenian: Ti simptomi ponavadi izginejo v 24 urah brez zdravljenja.
English: This medicine is specifically developed for dogs and should not be used in any other animal species.
Slovenian: To zdravilo je bilo izdelano posebej za pse in se ne sme uporabljati pri nobeni drugi živalski vrsti.
English: Amitraz is a monoamine oxidase inhibitor (MOAI).
Slovenian: Amitraz je zaviralec monoamin oksidaze (MOAI).
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProMeris Duo on 19 December 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ProMeris Duo, veljavno po vsej Evropski uniji, odobrila dne 19. 12. 2006.
English: 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.
Slovenian: 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.
English: It is recommended that the product is applied in the open air or in a well-ventilated room.
Slovenian: Priporočamo, da zdravilo nanesete v odprtem ali dobro prezračenem prostoru.
English: ProMeris Duo is an ‘ectoparasiticide'.
Slovenian: ProMeris Duo je „ektoparaziticid“.
English: Protective gloves are recommended when handling the medicine.
Slovenian: Pri ravnanju z zdravilom je priporočljiva uporaba zaščitnih rokavic.
English: People taking MOAI-containing medicines, such as antidepressants, should take particular care when handling ProMeris Duo.
Slovenian: Osebe, ki jemljejo zdravila, ki vsebujejo MOAI, kot so na primer antidepresivi, morajo z zdravilom ProMeris Duo še posebno previdno ravnati.
English: 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.
Slovenian: 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.
English: Another study was carried out in dogs with demodicosis in veterinary practices in Italy and Albania.
Slovenian: Druga študija je bila izvedena na psih z demodikozo v italijanskih in albanskih veterinarskih ambulantah.
English: ProMeris Duo must not be used in puppies less than eight weeks old since it has not been sufficiently studied in these animals.
Slovenian: Zdravila ProMeris Duo se ne sme uporabljati pri mladičih, mlajših od osem tednov, saj pri tej skupini živali zdravilo ni bilo zadostno raziskano.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Kot preventivni ukrep se je treba izogibati neposrednemu stiku z zdravljenim psom in preprečiti otrokom igranje z zdravljeno psom, dokler področje nanosa ni suho.
English: Other information about ProMeris Duo:
Slovenian: Druge informacije o zdravilu ProMeris Duo:
English: ProMeris Duo metaflumizone and amitraz
Slovenian: ProMeris Duo metaflumizona in amitraza
English: ProMeris Duo contains components that, on very rare occasions, can irritate the airways in some people.
Slovenian: Zdravilo ProMeris Duo vsebuje sestavine, ki lahko v zelo redkih primerih dražijo dihalne poti nekaterih oseb.
English: The Committee recommended that ProMeris Duo be given a marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo ProMeris Duo odobri dovoljenje za promet z zdravilom.
English: It can also be used as part of a treatment strategy for the control of flea allergy dermatitis, an allergic reaction to flea bites.
Slovenian: Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t.j.