FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the immune response and hence the effect of the vaccination can be diminished by high glucocorticoid doses.
Slovenian: Vendar pa lahko veliki odmerki glukokortikoidov zmanjšajo imunski odziv in posledično učinek cepljenja.
English: • Midazolam, due a reduction in midazolam plasma levels by CYP3A4 induction.
Slovenian: • midazolam, saj se zaradi indukcije CYP3A4 zmanjša koncentracija midazolama v plazmi.
English: • Obligation to conduct post-authorisation measures N/A
Slovenian: • Obveznost za izvajanje ukrepov po pridobitvi dovoljenja za promet z zdravilom Navedba smiselno ni potrebna.
English: Neofordex 40 mg tablets dexamethasone
Slovenian: Neofordex 40 mg tablete deksametazon
English: How to take Neofordex
Slovenian: Kako jemati zdravilo Neofordex
English: The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients).
Slovenian: Kombinacija lenalidomida in deksametazona je pri bolnikih z recidivnim ali proti zdravljenju odpornim multiplim mielomom povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9,9 % oziroma 1,4 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 2,3 % oziroma 0,0 % pri bolnikih, ki so prejemali placebo/deksametazon).
English: • Indinavir, due to a strong reduction of indinavir plasma levels by intestinal CYP3A4 induction.
Slovenian: • indinavir, saj se zaradi indukcije CYP3A4 v črevesju močno zmanjša koncentracija indinavirja v plazmi;
English: When Neofordex is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Neofordex.
Slovenian: Uporaba v kombinaciji z enim ali več drugimi zdravili za multipli mielom Če se bo zdravilo Neofordex uporabljalo v kombinaciji z drugimi zdravili, je treba pred uvedbo zdravila Neofordex prebrati povzetek glavnih značilnosti zdravila za ta druga zdravila.
English: Neofordex contains lactose, a sugar.
Slovenian: Zdravilo Neofordex vsebuje laktozo (sladkor).
English: The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients).
Slovenian: Kombinacija lenalidomida in deksametazona je pri bolnikih z recidivnim ali proti zdravljenju odpornim multiplim mielomom povezana s povečano incidenco nevtropenije 4. stopnje (5,1 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 0,6 % pri bolnikih, ki so prejemali placebo/deksametazon).
English: The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients) (see section 4.8).
Slovenian: Kombinacija deksametazona in lenalidomida je pri bolnikih z multiplim mielomom povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9,9 % oziroma 1,4 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 2,3 % oziroma 0,0 % pri bolnikih, ki so prejemali placebo/deksametazon) (glejte poglavje 4.8).
English: • With rifampicin, due to reduction of dexamethasone plasma concentrations and efficacy by an increase of its hepatic metabolism.
Slovenian: • rifampicin, saj se zaradi povečane jetrne presnove deksametazona zmanjšata njegova koncentracija v plazmi in učinkovitost;
English: The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Slovenian: Kombinacija deksametazona in lenalidomida je pri bolnikih z multiplim mielomom povezana s povečano incidenco nevtropenije 4. stopnje (5,1 % pri bolnikih, ki so prejemali lenalidomid/deksametazon, v primerjavi z 0,6 % pri bolnikih, ki so prejemali placebo/deksametazon; glejte poglavje 4.8).
English: • Rifabutin, due to reduced rifabutin plasma levels by induction of intestinal and hepatic CYP3A4.
Slovenian: • rifabutin, saj se zaradi indukcije CYP3A4 v črevesju in jetrih zmanjša koncentracija rifabutina v plazmi;
English: • Ephedrine, due to a reduction in dexamethasone plasma levels by increased metabolic clearance.
Slovenian: • efedrin, saj se zaradi povečanega presnovnega očistka zmanjšajo koncentracije deksametazona v plazmi;
English: What Neofordex looks like and contents of the pack Each tablet is white, oblong in shape, with a score line on one face.
Slovenian: Vsaka tableta je bela, podolgovata in ima na eni strani razdelilno zarezo.
English: How to store Neofordex
Slovenian: Shranjevanje zdravila Neofordex
English: Common: Atrial fibrillation, supraventricular extrasystoles, tachycardia, palpitations;
Slovenian: Srčne bolezni pogosti: atrijska fibrilacija, supraventrikularne ekstrasistole, tahikardija, palpitacije; občasni: srčna ishemija, bradikardija; neznana pogostnost: kongestivno srčno popuščanje.
English: • Aminogluthetimide, due to a reduction of the efficacy of dexamethasone through an increase of its hepatic metabolism.
Slovenian: • aminoglutetimid, saj se zaradi povečane jetrne presnove deksametazona zmanjša njegova učinkovitost;
English: You must avoid getting pregnant during treatment with Neofordex.
Slovenian: Med jemanjem zdravila Neofordex morate preprečiti zanositev.
English: Effects of dexamethasone on other medicinal products Dexamethasone is a moderate inducer of CYP3A4 and of P-gp.
Slovenian: Deksametazon je zmeren induktor CYP3A4 in P-gp.
English: Concomitant administration of erythropoietic medicinal products or previous history of deep vein thrombosis may also increase thrombotic risk in these patients.
Slovenian: Trombotično tveganje pri teh bolnikih se lahko poveča tudi zaradi sočasne uporabe eritropoetičnih zdravil ali anamneze globoke venske tromboze.
English: Very common: Muscular weakness, muscle cramps; Common: Myopathy, musculoskeletal pain, arthralgia, pain in extremity;
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti: mišična šibkost, mišični krči; pogosti: miopatija, mišično-skeletna bolečina, artralgija, bolečine v udih; neznana pogostnost: patološki zlom, osteonekroza, osteoporoza, pretrganje kite.
English: • Aprepitant and fosaprepitant, due to an increase of dexamethasone plasma concentrations by a reduction of its hepatic metabolism.
Slovenian: • aprepitant in fosaprepitant, saj se zaradi zmanjšane jetrne presnove deksametazona poveča njegova koncentracija v plazmi;
English: Common: Vomiting, diarrhoea, nausea, dyspepsia, stomatitis, gastritis, abdominal pain, dry mouth, abdominal distension, flatulence;
Slovenian: Bolezni prebavil zelo pogosti: zaprtost; pogosti: bruhanje, driska, navzea, dispepsija, stomatitis, gastritis, bolečina v trebuhu, suha usta, distenzija trebuha, flatulenca; neznana pogostnost: pankreatitis, predrtje prebavil, gastrointestinalna krvavitev, razjeda v prebavilih.
English: Common: Pollakiuria; Uncommon: Renal failure.
Slovenian: Bolezni sečil pogosti: polakisurija; občasni: odpoved ledvic.
English: Signs of a developing infection may be masked by dexamethasone therapy.
Slovenian: Zdravljenje z deksametazonom lahko prikrije znake razvijajoče se okužbe.
English: Inform your doctor immediately if you are pregnant or if you become pregnant during treatment.
Slovenian: Če ste noseči ali če zanosite med zdravljenjem, takoj obvestite zdravnika.
English: Common: Neutropenia, anaemia, thrombocytopenia, lymphopenia, leukopenia, leukocytosis;
Slovenian: Bolezni krvi in limfatičnega sistema pogosti: nevtropenija, anemija, trombocitopenija, limfopenija, levkopenija, levkocitoza; občasni: febrilna nevtropenija, pancitopenija, koagulopatija.
English: Do not drive, use any tools or machines or carry out any hazardous tasks if you experience side effects, such as confusion, hallucinations, dizziness, tiredness, sleepiness, fainting or blurred vision.
Slovenian: Če se pri vas pojavijo neželeni učinki, kot so zmedenost, halucinacije, omotica, utrujenost, zaspanost, omedlevica ali zamegljen vid, ne smete upravljati vozil in uporabljati nobenih orodij ali strojev ter opravljati nevarnih opravil.
English: Potassium supplementation should be given particularly if there is a risk of cardiac arrhythmia or concurrent hypokalaemic medicinal products.
Slovenian: Dodajanje kalija je potrebno predvsem pri bolnikih s tveganjem za srčno aritmijo in tistih, ki sočasno uporabljajo zdravila, ki znižujejo ravni kalija.
English: You must tell your doctor immediately if you experience shortness of breath, chest pain or swelling in the arms or legs.
Slovenian: Če opazite kratko sapo, bolečino v prsnem košu ali otekanje rok ali nog, se takoj posvetujte z zdravnikom.
English: Neofordex is used to treat adult patients with multiple myeloma, a cancer of the blood affecting the white blood cells that produce antibodies.
Slovenian: krvnim rakom, ki prizadene bele krvne celice, ki proizvajajo protitelesa.
English: − Ulcers, perforations and/or bleeding in the oesophagus (gullet), stomach or intestine, inflamed pancreas
Slovenian: − razjede, predrtje in/ali krvavitve, ki se pojavijo v požiralniku, želodcu ali črevesju, vnetje trebušne slinavke (ki se lahko kaže z bolečino v hrbtu in trebuhu);
English: Not known: Adrenal atrophy, steroid withdrawal syndrome, adrenal insufficiency, hirsutism, menstrual irregularity.
Slovenian: Bolezni endokrinega sistema pogosti: Cushingov sindrom; občasni: hipotiroidizem; neznana pogostnost: atrofija nadledvične žleze, odtegnitveni sindrom po prenehanju jemanja steroidov, insuficienca nadledvične žleze, hirzutizem, neredne menstruacije.
English: Common: Rash, erythema, hyperhidrosis, pruritus, dry skin, alopecia;
Slovenian: Bolezni kože in podkožja pogosti: izpuščaj, eritem, hiperhidroza, pruritus, suha koža, alopecija; občasni: urtikarija; neznana pogostnost: atrofija kože, akne.
English: Common: Hypokalaemia, diabetes mellitus, anorexia, increased or decreased appetite, hypoalbuminaemia, fluid retention, hyperuricaemia;
Slovenian: Presnovne in prehranske motnje zelo pogosti: hiperglikemija; pogosti: hipokaliemija, sladkorna bolezen, neješčnost, povečan ali zmanjšan tek, hipoalbuminemija, zastajanje tekočin, hiperurikemija; občasni: dehidracija, hipokalciemija, hipomagneziemija; neznana pogostnost: zmanjšana toleranca za glukozo, zastajanje natrija, presnovna alkaloza.
English: Uncommon: Conjunctivitis, increased lacrimation; Not known: Chorioretinopathy, glaucoma.
Slovenian: Očesne bolezni pogosti: zamegljen vid, katarakta; občasni: konjunktivitis, povečano solzenje; neznana pogostnost: horioretinopatija, glavkom.
English: Pharmaceutical Form Route of administration
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: Following the absence of agreement between the Reference Member State (the United Kingdom) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Slovenian: Ker ni bilo strinjanja med referenčno državo članico (Združenim kraljestvom) in eno od zadevnih držav članic (Španijo) na 90. dan postopka, je bila zadeva dne 2. oktobra 2009 napotena na CVMP.
English: Thus, the overall the benefit/risk balance is considered to be positive.
Slovenian: Tako šteje celokupno razmerje med koristmi in tveganji za pozitivno.
English: For breeding pigs…”
Slovenian: Pri prašičih za razplod…“
English: ADVICE ON CORRECT ADMINISTRATION
Slovenian: NASVET O PRAVILNI UPORABI
English: There are both practical reasons as well as clinical advantages to administering these 2 products together which leads to an overall improvement in animal welfare.
Slovenian: Obstajajo praktični razlogi in klinične prednosti dajanja teh dveh zdravil skupaj, kar vodi do celokupnega izboljšanja stanja živali.
English: 2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products.
Slovenian: 2.3 Potencialni vpliv na parameter učinkovitosti trajanje imunosti zaradi interference, ki jo povzroči mešanje obeh zdravil.
English: 3) The minimum efficacious titre is 4.0 TCID50
Slovenian: 3) najmanjši učinkovit titer je 4,0 TCID50;
English: Benefit/Risk assessment
Slovenian: Ocena koristi in tveganj
English: Intramuscular injection: 2 ml in the neck.
Slovenian: Intramuskularno dajanje: 2 ml na vratu.
English: Given that a lack of interference has been demonstrated at a specific time point the duration of immunity remains the same as originally proven.
Slovenian: Ker je bilo dokazano pomanjkanje medsebojnih vplivov, ostaja specifična časovna točka trajanja imunosti enaka, kot je bila dokazana na začetku.
English: Intervet GmbH Siemensstrasse 107 1210 Wien Austria
Slovenian: Intervet GmbH Siemensstrasse 107 1210 Wien Avstrija
English: 2) The apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Slovenian: 2) očitno zmanjšanje po 1 uri iz titra ob sprostitvi (6,4/6,2 TCID50) je 0,12/-0,02
English: Finishing pigs: a single vaccination is sufficient for protection until slaughter.
Slovenian: Prašiči pitanci: Eno cepljenje zadošča za zaščito do zakola.
English: To maintain a high and homologous level of immunity, revaccination at regular intervals is recommended, either before each next gestation or at random at 4 month intervals.
Slovenian: Za ohranitev visoke in homologne ravni imunosti, priporočajo redno revakcinacijo pred vsako naslednjo brejostjo ali v 4-mesečnih razmikih.
English: It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards.
Slovenian: Priporočeno je cepiti vse ciljne prašiče v čredi od najzgodnejše priporočene starosti.
English: 1) The claimed in-use shelf life for the “mixed” product is one hour;
Slovenian: 1) predlagani rok uporabnosti „mešanega“ zdravila je ena ura;
English: In addition, it was not known whether the studies were performed with batches of vaccines approaching the end of their shelf life.
Slovenian: Poleg tega ni bilo znano, ali so bile študije izvedene s serijami cepiv, ki so se bližala izteku roka uporabnosti.
English: Use sterile syringes and needles or clean intradermal equipment.
Slovenian: Uporabite sterilne brizge in igle ali čisto opremo za intradermalno uporabo.
English: The solvent includes dl--tocopherol acetate as adjuvant.
Slovenian: Vehikel vsebuje dl--tokoferol acetat kot adjuvans.
English: The marketing authorisation holder considers that the reduction of clinical signs is the direct effect of reduction of viraemia.
Slovenian: Imetnik dovoljenja za promet z zdravilom meni, da je zmanjšanje kliničnih znakov neposreden učinek zmanjšanja viremije.
English: It should be noted that local and systemic reactions were unremarkable (mild and seen in a small proportion of animals) and consistent with those seen when vaccines were used alone.
Slovenian: Poudariti je treba, da so bile lokalne in sistemske reakcije nepomembne (blage in opažene le pri majhnem številu živali) in enake kot pri samostojni uporabi cepiv.
English: The in-use stability of the mixed vaccines has been adequately demonstrated over an in-use period of an hour which is sufficient to vaccinate the number of animals representative of a realistic scenario.
Slovenian: Stabilnost mešanih cepiv med uporabo je bila ustrezno dokazana v obdobju uporabe ene ure, kar zadošča za cepljenje tolikšnega števila živali, ki je reprezentativno za realistični scenarij.
English: It should be noted that the general claim to reduce viraemia has only been demonstrated in laboratory studies.
Slovenian: Treba je poudariti, da je bila splošna zahteva (zmanjšanje viremije) dokazana le v laboratorijskih študijah.
English: 4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour.
Slovenian: 4) to pomeni, da v najslabšem primeru pri mešanju serije ob izteku roka uporabnosti ni statistično značilnega zmanjšanja pod minimalni titer po predlaganem roku uporabnosti 1 ure.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Slovenian: Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila odločamo od primera od primera.
English: It should be borne in mind that PRRS is a multifactorial disease and therefore all clinical signs may not always be seen in laboratory studies (animals kept free from other agents) as in field studies.
Slovenian: Zavedati se je treba, da je prašičji reprodukcijski in respiratorni sindrom (PRRS) multifaktorska bolezen, zato v laboratorijskih študijah niso vedno vidni vsi klinični znaki (na živali ne vplivajo drugi dejavniki) tako kot v terenskih študijah.
English: Volume (ml) of diluent needed for
Slovenian: Potreben volumen (ml) vehilka za
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis PRRS in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Slovenian: Imetnik dovoljenja za promet družba Intervet International BV je predložil vlogo za spremembo tipa II, ki je predmet postopka medsebojnega priznavanja dovoljenj za promet z zdravilom za uporabo v veterinarski medicini Porcilis PRRS v okviru člena 6 Uredbe Komisije (ES) št. 1084/2003.
English: 0.02 (mean 0.05) which is within assay variability;
Slovenian: (povprečje 0,05), kar je v okviru variabilnosti testa;
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Slovenian: Porcilis PRRS je imunološko veterinarsko zdravilo, ki vsebuje virus prašičjega reprodukcijskega in respiratornega sindroma (PRRS).
English: Pharmaceutical form
Slovenian: Farmacevtsk a oblika
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS PRRS (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PORCILIS PRRS (GLEJTE DODATEK I)
English: Intradermal application: 0.2 ml on top or to the left or right side of the neck, or along the muscles of the back, using an intradermal device.
Slovenian: Intradermalno dajanje: 0,2 ml v zgornji ali stranska predela vratu ali vzdolž hrbtnih mišic z napravo za intradermalno dajanje.
English: A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.
Slovenian: Majhna in prehodna intradermalna zatrdlina, ki se pojavi po intradermalnem dajanju, je znak pravilne tehnike dajanja cepiva.
English: Specific claims For finishing pigs, the effect of the virus on the respiratory system is most relevant.
Slovenian: Posebne navedbe Pri zakolu prašičev je najbolj pomemben učinek virusa na dihalni sistem.
English: The specific claims for finishing pigs to improve the rearing results have not been demonstrated.
Slovenian: Specifične navedbe za prašiče, ki se redijo za zakol, glede izboljšanja rezultata pri vzreji niso bile dokazane.
English: Reduction of viraemia was shown in two laboratory efficacy studies and this was considered sufficient by the marketing authorisation holder for the assessment of the clinical efficacy.
Slovenian: Zmanjšanje viremije je bilo dokazano v dveh laboratorijskih študijah učinkovitosti, kar je bilo za imetnika dovoljenja za promet dovolj za oceno klinične učinkovitosti.
English: The CVMP therefore considers that the efficacy of the mixed vaccine regarding the PRRS component has been sufficiently supported.
Slovenian: CVMP zato meni, da je bila učinkovitost mešanega zdravila glede komponente PRRS zadostno dokazana.
English: Number of doses per vial intramuscular injection intradermal application
Slovenian: Število odmerkov v viali intramuskularno dajanje intradermalno dajanje
English: The guideline on data requirements to support in-use stability claims for veterinary vaccines1, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.”
Slovenian: Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini1 med njihovo uporabo , navaja, da je „pri inaktiviranih cepivih v primeru, da je predlagan rok uporabnosti krajši od enega delovnega dne (največ 10 ur), sprejemljivo, da se v študiji stabilnosti roka uporabnosti test jakosti izpusti“.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: O varnosti in učinkovitosti sočasne uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicine, razen z zgoraj navedenim, ni podatkov.
English: However the argumentation provided by the marketing authorisation holder to date raised some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Slovenian: Vendar pa utemeljitev, ki jo je doslej predložil imetnik dovoljenja za promet z zdravilom, zbuja določene pomisleke, da z mešanjem zdravil nekatere zahteve učinkovitosti monovalentnih zdravil ne bi bile izpolnjene.
English: After mixing with Porcilis M Hyo: 1 hour (at room temperature)
Slovenian: Po mešanju s Porcilisom M Hyo: 1 ura (pri sobni temperaturi)
English: There is no reason to believe that other efficacy parameters would be influenced any differently in the field.
Slovenian: Iz tega razloga tudi za druge parametre učinkovitosti ni pričakovati, da bi bil v terenskih študijah vpliv nanje drugačen.
English: The safety of the regimen for the both individual and mixed vaccines has been supported.
Slovenian: Varnost režima za samostojno dajana in mešana cepiva je podprta.
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Slovenian: Nacionalni pristojni organ Španije je izrazil zaskrbljenost, da nekateri vidiki kakovosti, varnosti in učinkovitosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo) niso bili ustrezno utemeljeni.
English: Do not mix with any other veterinary medicinal product, except the diluent supplied with the product or with Porcilis M Hyo.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s priloženim vehihlom ali Porcilisom M Hyo.
English: In both of them, there was no gain in the average daily weight of the vaccinated animals, even when there were indications that PRRS infection had occurred.
Slovenian: V nobeni od njiju ni bilo opaziti pridobivanja telesne mase pri cepljenih živalih, tudi če ni bilo znakov o okužbi z PRRS.
English: This would support an in-use shelf life of one hour, except for the lack of information necessary to properly evaluate the results: the batch release protocols of the batches used and the protocols with the conditions of the assay were not provided.
Slovenian: To podpira rok uporabnosti po mešanju (ena ura), vendar ni dovolj informacij, ki so potrebne za pravilno ocenitev rezultatov: protokoli za sproščanje serije pri uporabljenih serijah in protokoli s pogoji testa niso bili predloženi.
English: The amendments of the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Slovenian: Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so navedene v Dodatku III.