FrancophonIA/ELRC3.0 huggingface dataset:
English: Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
Croatian: Plastična kutija s 30 bočica s 1 dozom liofilizata i 30 bočica s 1 ml otapala.
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
Croatian: Plastična kutija s 10 bočica s 1 dozom liofilizata i 10 bočica s 1 ml otapala.
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
Croatian: Plastična kutija s 25 bočica s 1 dozom liofilizata i 25 bočica s 1 ml otapala.
English: BATCH NUMBER
Croatian: s.c primjena
English: 3 doses.
Croatian: Druga doza nakon 3 tjedna.
English: 5 doses.
Croatian: 1 doza 3 doze 5 doza
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
Croatian: Plastična kutija s 5 bočica s 1 dozom liofilizata i 5 bočica s 1 ml otapala.
English: After reconstitution of the lyophilisate with the solvent, shake gently and administer immediately one dose of 1 ml subcutaneously according to the following vaccination schedule: Primary vaccination course: - First dose from 6 months of age, - Second dose 3 weeks later, - Third dose 3 weeks after the 2
Croatian: Nakon rekonstitucije liofilizata s otapalom blago protresti i odmah aplicirati jednu dozu od 1 ml potkožno prema sljedećem rasporedu cijepljenja:
English: Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
Croatian: Plastična kutija s 15 bočica s 1 dozom liofilizata i 15 bočica s 1 ml otapala.
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
Croatian: Plastična kutija s 1 bočicom s 1 dozom liofilizata i 1 bočicom s 1 ml otapala.
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
Croatian: Plastična kutija s 50 bočica s 1 dozom liofilizata i 50 bočica s 1 ml otapala.
English: Solvent
Croatian: Liofilizat
English: This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Croatian: Očekuje se da će se ta neznatna razlika u koncentraciji (5,93 %) još više smanjiti s pomoću sline u ustima.
English: • The Committee considered (Co-)Rapporteur's assessment report;
Croatian: • Odbor je razmotrio izvješće o procjeni (su)izvjestitelja;
English: Grounds for the CHMP opinion
Croatian: Razlozi za mišljenje CHMP-a
English: The CHMP also considered that the different amount of cyclodextrins is not of concern.
Croatian: CHMP je također smatrao da različita količina ciklodekstrina nije zabrinjavajuća.
English: This justification was accepted by the CHMP.
Croatian: CHMP je prihvatio to obrazloženje.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
Croatian: • Odbor je razmotrio cjelokupne podatke koje je podnositelj zahtjeva dostavio u vezi s iznesenim primjedbama o potencijalnom ozbiljnom riziku za javno zdravlje te pitanja koja je postavio CHMP;
English: Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Croatian: Stoga se smatra da je ta razlika u koncentraciji beznačajna i klinički nevažna s obzirom na to da se naposljetku lokalno primjenjuje ista doza.
English: However, there are some quantitative and qualitative differences among the products which concern:
Croatian: Međutim, postoje neke kvantitativne i kvalitativne razlike među lijekovima koje se odnose na:
English: The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Croatian: Lijek inhibira sintezu prostaglandina putem kombinacije inhibicije enzima COX-1/COX-2 i određene selektivnosti prema enzimu COX-1.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Croatian: Informacije o lijeku i dalje su u skladu sa završnom verzijom donesenom tijekom postupka Koordinacijske skupine kako je navedeno u Prilogu III. mišljenju CHMP-a.
English: • The Committee was of the view that the submitted in-vitro studies and bibliographical data demonstrate sufficiently the safety and efficacy of the medicinal product.
Croatian: • Odbor je smatrao da dostavljena in-vitro ispitivanja i bibliografski podatci dovoljno dokazuju sigurnost primjene i djelotvornost ovog lijeka.
English: Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Croatian: Podatci iz literature (Radkova et al., 2017., Imai et al., 1988.) pokazuju da su različite formulacije flurbiprofena (sprej i pastile) imale usporedive profile djelotvornosti i sigurnosti, unatoč nedostatku ciklodekstrina u pastilama, te su oni također uzeti u obzir.
English: So in the hypothetical scenario of a difference in the amount of produced saliva this would not impact on the absorbed amount of the active substance.
Croatian: Stoga u hipotetskom scenariju postojanja razlike u količini proizvedene sline to ne bi utjecalo na apsorbiranu količinu djelatne tvari.
English: The removal of one of the flavours from the formulation had been discussed as a factor that could potentially affect the saliva secretion resulting in an unequal contribution to the local action.
Croatian: O uklanjanju jedne arome iz formulacije raspravljalo se kao o čimbeniku koji potencijalno može utjecati na izlučivanje sline, zbog čega dolazi do nejednakog doprinosa lokalnom djelovanju.
English: The CHMP considered that the removal of the mint flavour is considered clinically irrelevant in this specific case.
Croatian: CHMP je smatrao da je uklanjanje arome metvice u ovom konkretnom slučaju klinički nevažno.
English: The proposed indication is short-term symptomatic relief of sore throat.
Croatian: Predložena indikacija kratkotrajno je simptomatsko olakšanje grlobolje.
English: The applicant has requested a waiver of the need to conduct clinical studies.
Croatian: Podnositelj zahtjeva zatražio je izuzeće od potrebe za provođenjem kliničkih ispitivanja.
English: The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Croatian: Predložena indikacija jest „ublažavanje boli pri blagim do umjerenim simptomima akutne grlobolje”.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC;
Croatian: • Odbor je razmotrio postupak upućivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ;
English: If bioequivalence has been established among such different formulations, the minor differences in the present case will not affect the pharmacokinetic and clinical profile of the test product.
Croatian: Ako je utvrđena bioekvivalencija između formulacija koje su toliko različite, neznatne razlike u ovom slučaju neće utjecati na farmakokinetički i klinički profil ispitivanog lijeka.
English: The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Croatian: Podnositelj zahtjeva tvrdio je da je terapijska ekvivalencija dokazana samo na temelju in vitro podataka.
English: During the decentralised procedure (DCP) and the CMDh procedure, the RMS (ES) considered that the above mentioned differences were minor and without a clinical impact on the efficacy and safety of the test product.
Croatian: Tijekom decentraliziranog postupka (DCP) i postupka CMDh-a referentna država članica (ES) smatrala je da su navedene razlike neznatne i bez kliničkog utjecaja na djelotvornost i sigurnost ispitivanog lijeka.
English: The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Croatian: Izvorni je lijek Strepflam 8,75 pastile tvrtke Crookes Healthcare/Reckitt Benckiser Healthcare, koji je registriran od lipnja 2001.
English: No clinical studies have been contacted and instead the applicant requested a biowaiver.
Croatian: Nisu provedena klinička ispitivanja te je podnositelj zahtjeva umjesto toga zatražio izuzeće od ispitivanja bioekvivalencije.
English: On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Croatian: Uza sve to flurbiprofen je lijek visoke propusnosti koji se pasivno apsorbira, a njegova se propusnost ne mijenja zbog razlike u koncentraciji.
English: The CHMP considered that the noted differences between the reference and test product are minor and the applicant has sufficiently demonstrated why these differences do not affect the local efficacy, safety or the systemic absorption of the product.
Croatian: CHMP je smatrao da su uočene razlike između referentnog i ispitivanog lijeka neznatne te da je podnositelj zahtjeva na zadovoljavajući način dokazao zašto te razlike ne utječu na lokalnu djelotvornost, sigurnost ili sistemsku apsorpciju lijeka.
English: Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Croatian: Drugo, flurbiprofen se umjereno veže za ciklodekstrine te je oslobađanje djelatne tvari pri kontaktu s bukalnom ovojnicom trenutačno.
English: The reference medicinal product was Strefen Direct 8,75 mg Oromucosal spray (UK/H/5072/001).
Croatian: Referentni lijek bio je Strefen Direct 8,75 mg sprej za usnu sluznicu (UK/H/5072/001).
English: Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Croatian: Nadalje, naglašeno je da je za izvorni lijek dokazana bioekvivalencija između spreja za usnu sluznicu (Strefen Direct 8,75 mg sprej za usnu sluznicu) i pastila (Strepflam 8,75 mg pastile), koji imaju značajnije razlike u formulaciji.
English: With regards to the different concentration (17.16 mg/ml vs. 16.20 mg/ml), it was noted that that due to the different sprayed volumes (0.17 mL vs. 0.18 mL), the delivered dose is eventually the same.
Croatian: U pogledu različite koncentracije (17,16 mg/ml nasuprot 16,20 mg/ml), uočeno je da je zbog različitih volumena raspršivanja (0,17 ml nasuprot 0,18 ml) isporučena doza naposljetku ista.
English: ii) the amount of cyclodextrins: the amount of cyclodextrins is lower in the test product compared to this of the reference medicinal product;
Croatian: ii. količinu ciklodekstrina: količina ciklodekstrina u ispitivanom lijeku niža je u odnosu na referentni lijek;
English: The application for Strefen Direct 8,75 mg Oromucosal spray was made under Article 8(3) of Directive 2001/83/EC.
Croatian: Zahtjev za lijek Strefen Direct 8,75 mg sprej za usnu sluznicu podnesen je u skladu s člankom 8. stavkom 3. Direktive 2001/83/EZ.
English: The assessment was performed having in mind that this was this is a hybrid application under Article 10(3) of Directive 2001/83/EC.
Croatian: Procjena je provedena imajući na umu da je riječ o zahtjevu za hibridni lijek u skladu s člankom 10. stavkom 3. Direktive 2001/83/EZ.
English: Flurbiprofen belongs to the non-steroidal anti-inflammatory class of medicines (NSAID) which have analgesic, antipyretic, and anti-inflammatory properties.
Croatian: Flurbiprofen pripada skupini lijekova naziva nesteroidni protuupalni lijekovi (NSAID) koji imaju analgetska, antipiretska i protuupalna svojstva.
English: First, the lower amount of cyclodextrins is preferable from a safety point of view.
Croatian: Prvo, manja količina ciklodekstrina poželjna je sa stajališta sigurne primjene.
English: Overall summary of the scientific evaluation by the CHMP Flurbiprofen Geiser 8,75 mg oromucosal spray, is a non-steroidal anti-inflammatory (NSAID) with analgesic, antipyretic, and anti-inflammatory properties.
Croatian: Cjelokupan sažetak znanstvene ocjene CHMP-a Flurbiprofen Geiser 8,75 mg sprej za usnu sluznicu jest nesteroidni protuupalni lijek (NSAID) koji ima analgetska, antipiretska i protuupalna svojstva.
English: The application was submitted under Article 10(3) of Directive 2001/83/EC.
Croatian: Zahtjev je podnesen u skladu s člankom 10. stavkom 3. Direktive 2001/83/EZ.
English: Results from the in-vitro tests performed by the applicant have shown equivalence in the critical quality attributes that were tested (single actuation content, droplet size distribution, drug small particles, spray pattern, plum geometry and priming), suggesting that the quantitative and qualitative differences between the reference and the test medicinal products do not affect the deposition of the spray in the site of action (the buccal cavity).
Croatian: Rezultati in vitro testova koje je proveo podnositelj zahtjeva pokazali su ekvivalentnost u ispitivanim kritičnim kvalitativnim obilježjima lijeka (sadržaj jednog potiska, distribucija veličine kapljica, sitne čestice lijeka, uzorak raspršivanja, geometrija raspršenog oblaka i priprema za primjenu), što upućuje na to da kvantitativne i kvalitativne razlike između referentnog i ispitivanog lijeka ne utječu na taloženje spreja na mjestu djelovanja (bukalna šupljina).
English: Based on the in-vitro tests, equivalence has been shown between the reference and the test products with respect to the following quality attributes: amount of active substance in each dose, the particle size, the plume geometry and the spray pattern.
Croatian: Na temelju in vitro testova dokazana je ekvivalencija referentnog i ispitivanog lijeka s obzirom na sljedeća kvalitativna obilježja: količina djelatne tvari u svakoj dozi, veličina čestica, geometrija i uzorak raspršenog oblaka.
English: On the other hand, the waiver of clinical studies supporting equivalent efficacy and safety has been questioned by one of the CMS (NL) because the difference in concentration of the active substance, the qualitative difference in flavours and the quantitative difference in cyclodextrins that in their view could potentially have an impact on the efficacy and the safety of the medicinal product.
Croatian: S druge strane, jedna od predmetnih država članica (NL) dovela je u pitanje izuzeće od kliničkih ispitivanja kojima se podupire istovjetna djelotvornost i sigurnost lijeka zbog razlike u koncentraciji djelatne tvari, kvalitativne razlike u aromama i kvantitativne razlike u ciklodekstrinima koje bi, prema mišljenju predmetne države članice, mogle utjecati na djelotvornost i sigurnost lijeka.
English: The saliva secretion does not play a relevant contribution in the in-vivo performance of the buccal spray since most of the content of the spray is swallowed as a consequence of gag the reflex caused by the impact of the spray in the throat, without any time to be affected by the secretion of saliva.
Croatian: Izlučivanje sline ne pridonosi značajno in vivo učinkovitosti bukalnog spreja jer se najveći dio spreja proguta kao posljedica faringealnog refleksa prouzročenog učinkom spreja na grlo te nema vremena da izlučivanje sline utječe na lijek.
English: The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Croatian: Odbor posljedično smatra da je omjer koristi i rizika lijeka Flurbiprofen Geiser 8,75 mg sprej za usnu sluznicu u obliku otopine i pridružena imena povoljan te stoga preporučuje izdavanje odobrenja za stavljanje u promet lijeka navedenog u Prilogu I. mišljenju CHMP-a.
English: The present referral was triggered on the grounds that the waiver for clinical studies is not in line with the “Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract” (CPMP/EWP/239/95 Rev.1) and that the differences may impact on the clinical performance of the test product.
Croatian: Ovo je upućivanje sastavljeno jer izuzeće od kliničkih ispitivanja nije u skladu sa „Smjernicom o ispitivanju ekvivalencije za dokazivanje terapijske ekvivalencije za lijekove s lokalnim djelovanjem u gastrointestinalnom sustavu koji se primjenjuju lokalno” (CPMP/EWP/239/95 Rev.1) i jer razlike mogu utjecati na kliničku učinkovitost ispitivanog lijeka.
English: i) different concentration: 17.16 mg/ml in the test product versus 16.20 mg/ml in the reference product (0.096% difference of content of drug substance in weight/volume)
Croatian: i. različita koncentracija: 17,16 mg/ml u ispitivanom lijeku nasuprot 16,20 mg/ml u referentnom lijeku (razlika od 0,096 % udjela tvari u lijeku prema težini/volumenu);
English: i) the concentration: 17.16 mg/ml in the test medicinal product versus 16.20 mg/ml in the reference product;
Croatian: i. koncentraciju: 17,16 mg/ml u ispitivanom lijeku nasuprot 16,20 mg/ml u referentnom lijeku;
English: The benefit-risk balance of the applied medicinal product is considered positive.
Croatian: Smatra se da je omjer koristi i rizika lijeka za koji je podnesen zahtjev povoljan.
English: Acknowledging that deviations from the guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) could be accepted if they are justified appropriately and having reviewed all the data submitted and the responses submitted by the applicant, the CHMP considered that the waiver of the clinical trials to demonstrate therapeutic equivalence has been adequately substantiated.
Croatian: S obzirom na to da se odstupanja od „Smjernice o ispitivanju ekvivalencije za dokazivanje terapijske ekvivalencije za lijekove s lokalnim djelovanjem u gastrointestinalnom sustavu koji se primjenjuju lokalno” (CPMP/EWP/239/95 Rev.1) mogu prihvatiti ako su primjereno obrazložena te nakon što je CHMP pregledao sve dostavljene podatke i odgovore podnositelja zahtjeva, CHMP je smatrao da je izuzeće od kliničkih ispitivanja za dokazivanje terapijske ekvivalencije dovoljno potkrijepljeno.
English: Differences with respect to the reference medicinal product are possible in the context of a hybrid application, as long as these differences do not affect the therapeutic equivalence between the reference and the test products.
Croatian: Razlike u odnosu na referentni lijek moguće su u kontekstu zahtjeva za hibridni lijek ako te razlike ne utječu na terapijsku ekvivalenciju referentnog i ispitivanog lijeka.
English: According to the Guideline on the equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract (CPMP/EWP/239/95 Rev.1) preclinical and clinical trials are considered necessary in order to bridge the test to the reference medicinal product in case the definition of a generic medicinal product is not met.
Croatian: U skladu sa Smjernicom o ispitivanju ekvivalencije za dokazivanje terapijske ekvivalencije za lijekove s lokalnim djelovanjem u gastrointestinalnom sustavu koji se primjenjuju lokalno (CPMP/EWP/239/95 Rev.1) smatra se da su potrebna pretklinička i klinička ispitivanja kako bi se ispitivani lijek povezao s referentnim lijekom u slučaju da nisu zadovoljeni kriteriji definicije generičkog lijeka.
English: iii) the flavours: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference medicinal product (cherry and mint)
Croatian: iii. arome: u ispitivanom lijeku koristi se jedna aroma (trešnja), umjesto dvije koje se koriste u referentnom lijeku (trešnja i metvica).
English: Differences with respect to the reference medicinal product are possible, as long as it is demonstrated that these differences do not affect the therapeutic equivalence between the reference and the test product.
Croatian: Razlike u odnosu na referentni lijek moguće su ako se dokaže da one ne utječu na terapijsku ekvivalenciju referentnog i ispitivanog lijeka.
English: The test product has some quantitative and qualitative differences with the reference product, namely;
Croatian: Postoje određene kvantitativne i kvalitativne razlike između ispitivanog lijeka i referentnog lijeka, to jest:
English: submitted an application under the decentralised procedure for Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names (ES/H/0552/001/DC).
Croatian: Podnositelj zahtjeva Geiser Pharma S.L. podnio je zahtjev u skladu s decentraliziranim postupkom za lijek Flurbiprofen Geiser 8,75 mg sprej za usnu sluznicu u obliku otopine i pridružena imena (ES/H/0552/001/DC).
English: For this application, in order to demonstrate therapeutic equivalence, the applicant has submitted invitro studies.
Croatian: Kako bi dokazao terapijsku ekvivalenciju, podnositelj zahtjeva u ovom je zahtjevu dostavio rezultate in vitro ispitivanja.
English: ii) lower amount of cyclodextrins iii) one flavour less: in the test product one flavour is employed (cherry) instead of two flavours employed in the reference product (cherry and mint)
Croatian: iii. jedna aroma manje: u ispitivanom lijeku koristi se jedna aroma (trešnja), umjesto dvije koje se koriste u referentnom lijeku (trešnja i metvica).
English: In addition, published evidence underline that completely different formulations of flurbiprofen (e.g. lozenge, granules and spray) applied to the oral cavity has demonstrated bioequivalence.
Croatian: Osim toga, u objavljenim dokazima ističe se da je dokazana bioekvivalencija pri primjeni potpuno različitih formulacija flurbiprofena (npr. pastile, granule i sprej) u usnoj šupljini.
English: Before opening: 30 months.
Croatian: Prije otvaranja: 30 mjeseci.
English: At the request of the European Medicines Agency;
Croatian: na zahtjev Europske agencije za lijekove;
English: Normally this soon disappears.
Croatian: To obično brzo nestane.
English: Seek medical advice immediately:
Croatian: Odmah zatražite medicinski savjet:
English: Elderly (≥ 65 years old)
Croatian: Stariji (≥ 65 godina)
English: Your medicine might be harmful to their health.
Croatian: Vaš lijek bi mogao naškoditi njihovu zdravlju.
English: Before every injection:
Croatian: Prije svake injekcije:
English: • Get an infection and/or a fever.
Croatian: • dobijete infekciju i/ili vrućicu.
English: • Eat too little or miss a meal.
Croatian: • jedete premalo ili preskočite obrok.
English: This will make sure you get the full dose.
Croatian: Tako ćete biti sigurni da ste primili cijelu dozu.
English: These reactions are usually of a transitory nature.
Croatian: Te su reakcije obično prolazne naravi.
English: How and where to inject
Croatian: Kako i gdje injicirati
English: They must not give you any food or drink, because you may choke.
Croatian: Oni Vam ne smiju davati nikakvu hranu ni piće jer biste se mogli ugušiti.
English: ATC code: A10AD01.
Croatian: A10AD01.
English: Careful monitoring is recommended.
Croatian: Preporučuje se pomno praćenje.
English: If not, change the needle and repeat the procedure no more than 6 times.
Croatian: U suprotnom, promijenite iglu i ponovite postupak, ali ne više od 6 puta.
English: • If signs of allergy spread to other parts of your body.
Croatian: • ako se znakovi alergije prošire na druge dijelove tijela.
English: If an adjustment is needed, it may occur with the first dose or during the first few weeks or months.
Croatian: Ako je prilagodba potrebna, može se provesti već pri prvoj dozi ili tijekom prvih nekoliko tjedana ili mjeseci.
English: Trials have indicated a t½ of about 5-10 hours.
Croatian: Ispitivanja su pokazala da t½ iznosi približno 5-10 sati.
English: Your InnoLet is designed to work accurately and safely.
Croatian: Vaš InnoLet napravljen je tako da radi točno i sigurno.
English: This is especially important if you take more than one type of insulin.
Croatian: To je osobito važno ako primjenjujete više od jedne vrste inzulina.