FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Slovenian: TOOKAD 183 mg prašek za raztopino za injiciranje Ena viala vsebuje 183 mg padeliporfina (v obliki dikalijeve soli).
English: TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
Slovenian: Zdravilo TOOKAD je pripravljeno z rekonstitucijo praška za raztopino za injiciranje: - z 20 ml 5-odstotne raztopine glukoze za zdravilo TOOKAD 183 mg, - s 40 ml 5-odstotne raztopine glukoze za zdravilo TOOKAD 366 mg. Vialo je nato treba 2 minuti nežno sukati.
English: Post-procedural urine leak Procedural pain Post-procedural discharge Fall
Slovenian: občasni ponovljen kirurški postopek kontuzija uhajanje urina po postopku bolečina zaradi postopka izcedek po postopku padec
English: - General and musculoskeletal pain (muscle/bony pain, pain in the end of the limbs, back pain or bleeding into the joints), - Haematospermia (presence of blood in the ejaculate), - High blood pressure, - Increases in blood lipids, lactate dehydrogenase increased, white blood cell increased, creatine phosphokinase increased, potassium decreased, prostatic specific antigen (PSA) increased, - Skin reaction, erythema (reddening), rash, dryness, pruritus, depigmentation, - Abnormal blood tests related to coagulation, - Discomfort in the abdominal region, - Fatigue (tiredness).
Slovenian: - Povečanje števila lipidov v krvi, povišana raven laktat dehidrogenaze, povečano število belih krvnih celic, povišana raven kreatin fosfokinaze, zmanjšana raven kalija, povečana raven prostatičnega specifičnega antigena (PSA).
English: Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
Slovenian: 1 Okužba spolovil in sečil (okužba sečil, orhitis, epididimitis, cistitis).
English: See section 4.5 for interactions with photosensitizing medicinal products.
Slovenian: Za medsebojno delovanje z zdravili, ki povzročajo preobčutljivost na svetlobo glejte poglavje 4.5.
English: TOOKAD is locally activated immediately after injection by laser light at 753 nm delivered via interstitial optical fibres from a laser device at a power of 150 mW/cm of fibre, delivering an energy of 200 J/cm over 22 minutes 15 seconds.
Slovenian: Osvetlitev za fotoaktivacijo zdravila TOOKAD Zdravilo TOOKAD je takoj po injiciranju za 22 minut in 15 sekund lokalno aktivirano z lasersko svetlobo valovne dolžine 753 nm, ki prihaja iz intersticijskih optičnih vlaken iz laserske naprave z močjo 150 mW/cm na vlakno, ki dovaja energijo 200 J/cm.
English: Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
Slovenian: 11 Bolečina v spolovilih (bolečina v penisu, bolečina v modniku, nenalezljivi orhitis, vnetje semenovoda, kontuzija spolovil).
English: The activated medicine then causes the death of the cancer cells.
Slovenian: Rakave celice nato zaradi aktiviranega zdravila odmrejo.
English: - Fever, pain and swelling in the area of the operation might occur after the procedure.
Slovenian: - Po postopku se lahko pojavijo povišana telesna temperatura, bolečina in otekanje.
English: Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Slovenian: Če po zdravljenju s postopkom TOOKAD-VTP pride do izpostavitve svetlobi, obstaja tveganje preobčutljivosti kože in oči na svetlobo.
English: Reconstitution of the TOOKAD powder for solution for injection The solution must be prepared in a dimmed-light environment due to the photosensitizing properties of the medicine.
Slovenian: Ker zdravilo povzroča preobčutljivost na svetlobo, je treba raztopino pripraviti v okolju s pridušeno svetlobo.
English: The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration.
Slovenian: Druga zdravila, ki lahko medsebojno delujejo z zdravilom TOOKAD Na dan uporabe zdravila TOOKAD in vsaj 24 ur po uporabi se je treba izogibati zdravilom, kot so repaglinid, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan in gliburid.
English: - You have abnormal blood clotting.
Slovenian: Preiskave pogosti nenormalno strjevanje krvi14
English: proctalgia (pain in the anal region), - Problems with bowels (including diarrhoea or occasional soiling),
Slovenian: - Težave s črevesjem (vključno z drisko ali občasnim uhajanjem blata).
English: Use in patients on a controlled potassium diet
Slovenian: Bolniki, ki so na dieti z nadzorovanim vnosom kalija To zdravilo vsebuje kalij.
English: Table 2 gives baseline characteristics by arm.
Slovenian: V preglednici 2 so predstavljene izhodiščne značilnosti glede na krak.
English: White blood cell count increased
Slovenian: krvavitev v prostati otekanje mod
English: There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
Slovenian: Pri bolnikih, ki so prejemali intraokularno zdravljenje proti vaskularnemu endotelijskemu rastnemu faktorju (VEGF), lahko obstaja dodatno tveganje preobčutljivosti oči na svetlobo.
English: • Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide.
Slovenian: • razlago postopka, kot tudi ustreznih rezultatov glede varnosti in učinkovitosti zdravila
English: Photosensitivity Strong light may cause skin reactions and eye discomfort while TOOKAD is in the blood stream.
Slovenian: Dokler je zdravilo TOOKAD v krvnem obtoku, lahko močna svetloba povzroča kožne reakcije in nelagodne občutke v očeh.
English: Number of subjects with
Slovenian: Število oseb s/z
English: Eye irritation Photophobia
Slovenian: Očesne bolezni občasni draženje očesa fotofobija
English: The study had two co-primary endpoints for TOOKAD-VTP in comparison to AS: - A: The rate of absence of definite cancer based on histology at 24 months, - B: The difference in rate of treatment failure associated with observed progression of disease from low to moderate or higher risk prostate cancer.
Slovenian: - B: razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni od nizko prek zmerno do visoko tveganega raka prostate.
English: • Patient information guide • Physician guideline
Slovenian: • smernice za zdravnike.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora občasni dispneja ob naporu
English: Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Slovenian: 6 Disurija (bolečina v mehurju, krči mehurja, hipertonični mehur, krči sečnice, bolečina v sečilih).
English: Antiplatelet agents (medicines that decrease platelet aggregation (stickiness) in the blood and reduce clotting)
Slovenian: Antikoagulanti (zdravila, ki preprečujejo strjevanje krvi)
English: See also under “Other medicines and TOOKAD” for photosensitizing medicines.
Slovenian: Zdravila, ki povzročajo preobčutljivost na svetlobo, si oglejte tudi v poglavju „Druga zdravila in zdravilo TOOKAD“.
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
Slovenian: TOOKAD 366 mg prašek za raztopino za injiciranje padeliporfin
English: How TOOKAD is stored
Slovenian: Shranjevanje zdravila TOOKAD
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
Slovenian: TOOKAD 183 mg prašek za raztopino za injiciranje padeliporfin
English: Adjusted Hazard Ratio (95% CI) = 0.31 (0.20 ; 0.50) ; p value ≤ 0.001
Slovenian: eRazmerje tveganja (95 % CI) = 4,39 (2,18; 8,83); vrednost p < 0,001 fRazmerje tveganja (95 % CI) = 4,61 (2,60; 8,16); vrednost p < 0,001
English: - You have a history of a narrowing of the urethra or urinary flow problems.
Slovenian: - po postopku VTP čutite kakršno koli nenormalno bolečino; - imate anamnezo zoženja sečnice ali težave s pretokom urina;
English: Rectal haemorrhage (anal haemorrhage).
Slovenian: - Hematospermija (prisotnost krvi v ejakulatu).
English: VTP procedure.
Slovenian: VTP.
English: Ureteric haemorrhage Urethral haemorrhage Urinary tract disorders
Slovenian: Bolezni ledvic in sečil zelo pogosti zastajanje urina hematurija disurija6 motnje uriniranja7
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin
Slovenian: Navodilo za uporabo TOOKAD 183 mg prašek za raztopino za injiciranje TOOKAD 366 mg prašek za raztopino za injiciranje padeliporfin Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Perineal injury, perineal pain and prostatitis
Slovenian: pogosti prostatitis bolečina v spolovilih11 bolečina v prostati12
English: Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%)
Slovenian: B: Razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni Število oseb, pri katerih je bolezen v 24. mesecu napredovala, n (%)
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priprava raztopine mora potekati v okolju s pridušeno svetlobo.
English: Perineal pain (pelvic pain).
Slovenian: - Učinkovina je padeliporfin.
English: Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity
Slovenian: Bolezni mišičnega sistema in vezivnega tkiva pogosti bolečine v hrbtu občasni bolečina v dimljah krvavitev v mišici hemartroza bolečina v mišično-skeletnem sistemu bolečina v udu
English: The median time to onset of genito-urinary infections was 22.5 days (4-360).
Slovenian: Srednja vrednost časa do nastopa okužbe sečil in spolovil je znašala 22,5
English: PHARMACEUTICAL FORM Powder for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje Prašek je liofilizat temne barve.
English: Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
Slovenian: 39 (50,0)j gPrilagojeno razmerje tveganja (95 % CI) = 0,34 (0,24; 0,46); vrednost p ≤ 0,001 hPrilagojeno razmerje tveganja (95 % CI) = 0,31 (0,20; 0,50); vrednost p ≤ 0,001 iPrilagojeno razmerje tveganja (95 % CI) = 0,17 (0,12; 0,27); vrednost p ≤ 0,001 Prilagojeno razmerje tveganja (95 % CI) = 0,11 (0,05; 0,25); vrednost p ≤ 0,001
English: Haematoma Hypertension
Slovenian: Žilne bolezni pogosti hematom hipertenzija
English: In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
Slovenian: (39 mg) kalija, kar v bistvu pomeni, da je pravzaprav „brez kalija“.
English: TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm
Slovenian: - trije pozitivni stebrički rakastega tkiva z najdaljšo dolžino stebrička rakastega tkiva 5 mm v katerem koli stebričku ali 1-2 pozitivna stebrička rakastega tkiva s prisotnostjo rakastega tkiva, ki je v katerem koli stebričku ≥ 50 % v kateremkoli stebričku, ali gostota PSA ≥ 0,15
English: How TOOKAD is stored Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TOOKAD
English: This appearance is normal
Slovenian: Takšen videz je normalen.
English: (cases/controls)
Slovenian: (primeri/kontrole)
English: America; 11 countries
Slovenian: Latinska Amerika; 11 držav
English: * Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Slovenian: * Ker so bili ti dogodki poročani spontano, njihove pogostnosti ni mogoče zanesljivo oceniti.
English: Sustained efficacy up to 3 years of age in Asia
Slovenian: Dolgotrajna učinkovitost do 3. leta starosti v Aziji
English: Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract.
Slovenian: Bond et al. (2018) navaja nekatera neskladja s tem priporočilom v nedavnem abstraktu za konferenco.
English: not less than 106.0 CCID50
Slovenian: ne manj kot 106,0 CCID50
English: These data should be interpreted with caution.
Slovenian: Te podatke je treba interpretirati previdno.
English: There is limited evidence of a smaller increased risk following the second dose.
Slovenian: Malo je dokazov o manjšem povečanju tveganja po drugem odmerku.
English: (5) Vaccine effectiveness was calculated using neighborhood controls.
Slovenian: (5) Učinkovitost cepiva je bila izračunana z uporabo kontrol iz soseščine.
English: Impact on hospitalisation§
Slovenian: Vpliv na hospitalizacije§
English: 10, 14 weeks and 6, 10, 14 weeks (Pooled)
Slovenian: 10, 14 teden in 6, 10, 14 teden (združeno)
English: Date of latest renewal: 14 January 2016
Slovenian: Datum zadnjega podaljšanja: 14. januar 2016
English: Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls.
Slovenian: Ocena učinkovitosti cepiva temelji na 41 v celoti cepljenih primerih in 175 v celoti cepljenih kontrol.
English: 50 tubes
Slovenian: 50 tub
English: All of these strains are circulating worldwide.
Slovenian: Vsi ti sevi krožijo po celem svetu.
English: If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Slovenian: Če se rekonstituirano cepivo ne uporabi v 24 urah, ga je treba zavreči.
English: As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Slovenian: Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
English: Frequencies are reported as:
Slovenian: Pogostnost je navedena kot:
English: South Africa, Malawi
Slovenian: Južnoafriška republika, Malavi
English: *Produced on Vero cells
Slovenian: *Pridobljen na Vero celicah
English: These strains are circulating worldwide.
Slovenian: Ti sevi krožijo po celem svetu.
English: 2°C to 8°C
Slovenian: 2°C - 8°C
English: No point estimate was available for the remaining study.
Slovenian: Za preostale študije ocenjene vrednosti niso na voljo.
English: Impact on mortality§
Slovenian: Vpliv na umrljivost§
English: • You do not need to twist.
Slovenian: • Ni vam treba vrteti.
English: This was supported by a very short time-to-onset (from immediate onset to a few hours), the absence of coadministered vaccines or drugs, and the rapid resolution of the event, with or without treatment.
Slovenian: To podpira zelo kratek čas do nastanka (od takojšnjega nastanka do nekaj ur), odsotnost sočasno danih cepiv ali zdravil in hitra rešitev dogodka, z ali brez zdravljenja.
English: (1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given.
Slovenian: (1) Navedeno je število v celoti cepljenih (2 odmerka) in necepljenih primerov in kontrol.
English: Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).
Slovenian: Klinične študije, na katerih temeljijo podatki o učinkovitosti, so bile izvedene v Evropi, Centralni ter Južni Ameriki, Afriki in Aziji (glejte poglavje 5.1).
English: Rotavirus infection is the most common cause of severe diarrhoea in infants and young children.
Slovenian: Okužba z rotavirusi je najpogostejši vzrok hude driske pri dojenčkih in mlajših otrocih.
English: When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Slovenian: Ko so te vzorce blata testirali na prisotnost živega vakcinalnega seva virusa, je bilo pozitivnih le 17 % vzorcev.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Slovenian: Blažja okužba, kot je npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem vseeno pogovorite z zdravnikom;
English: The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy.
Slovenian: Incidenca hudega RV gastroenteritisa, povezanega s posameznimi genotipi, je bila premajhna, da bi dopuščala izračun učinkovitosti.
English: • Turn the cap upside down (180°).
Slovenian: • Obrnite zaporko na glavo (180°).
English: • if your child has previously had any allergic reaction to rotavirus vaccines or any of the other ingredients of this vaccine (listed in section 6).
Slovenian: • če je predhodno imel kakršnokoli alergijsko reakcijo na cepiva proti rotavirusom ali katerokoli sestavino tega cepiva (navedeno v poglavju 6).
English: Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.
Slovenian: Obvestite svojega zdravnika, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katerokoli drugo zdravilo, ali če je bil pred kratkim cepljen s katerimkoli cepivom.
English: Some cases of overdose have been reported.
Slovenian: Poročali so o nekaj primerih prevelikega odmerjanja.
English: Natural fluctuations of the incidence of the disease may also influence the observed temporal effect.
Slovenian: Na opaženi časovni učinek lahko vpliva tudi naravno nihanje incidence bolezni.
English: g) Pull it from the connecting bar.
Slovenian: g) Povlecite jo od povezovalne ploščice.
English: If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C.
Slovenian: čas shranjevanja med uporabo ne sme presegati 24 ur pri temperaturi od 2°C do 25 °C.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Slovenian: Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
English: Oral suspension 1 tube
Slovenian: peroralna suspenzija 1 tuba
English: This is so that the unused oral tubes can be used for the next vaccination.
Slovenian: To morate narediti zato, da lahko neporabljene tube uporabite za naslednje cepljenje.
English: Other special populations
Slovenian: Posebne populacije
English: Your child will receive two doses of the vaccine.
Slovenian: Otrok bo prejel dva odmerka cepiva.
English: No cases of intussusception were reported.
Slovenian: Opisan ni bil noben primer invaginacije.
English: All RVGE
Slovenian: Vsi RVGE
English: Do not hold the body of the oral tube, you may squeeze out some of the vaccine.
Slovenian: Ne držite telesa tube, saj lahko iz nje iztisnete nekaj cepiva.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2006
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2006
English: Schedule Studies conducted in
Slovenian: Študije izvedene v
English: • If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
Slovenian: Kaj narediti, če membrana ni prebodena • Če membrana ni prebodena, se vrnite na točko B in ponovite korake 2,3 in 4.
English: Abdominal pain, flatulence
Slovenian: Občasni abdominalna bolečina, flatulenca
English: Similar studies in Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% between 2 and 4 years after vaccine introduction.
Slovenian: Podobne študije v Armeniji, Avstraliji, Braziliji, Kanadi, El Salvadorju in Zambiji so pokazale zmanjšanja od 45 % do 93 % dve do štiri leta po uvedbi cepiva.
English: e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand.
Slovenian: e) Držite dno ločene tube v eni roki in povezovalno ploščico v drugi.
English: To separate one oral tube from the others starting at one end: a) Hold the tab of one of the end oral tubes to separate it from the others.
Slovenian: Za ločitev ene tube od ostalih, začnite na enem koncu: a) Primite dno ene od krajnih tub, da jo ločite od ostalih.
English: The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Slovenian: Cepivo je treba aplicirati peroralno brez mešanja z drugimi cepivi ali raztopinami.
English: • Provide, on a 6-month basis, updates on the progress being made on the activities set out in the implementation plan for the development of a PCV-free vaccine, as agreed by CHMP on 15 September 2016: every June and December until the PCV-free Rotarix application.
Slovenian: • vsakih 6 mesecev predal posodobljene informacije o doseženem napredku pri dejavnostih, določenih v implementacijskem načrtu za razvoj cepiva brez PCV, kot je bilo dogovorjeno z odborom CHMP 15. septembra 2016: vsak junij in december, do oddaje vloge za cepivo brez PCV;
English: It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).
Slovenian: Nepojasnjeno ostaja, ali cepiva proti rotavirusom vplivajo na celotno pogostnost invaginacije pri daljših obdobjih spremljanja (glejte poglavje 4.4).
English: High Income countries
Slovenian: Države z visokim prihodkom
English: Severity of gastro-enteritis (GE) was defined according to WHO criteria.
Slovenian: Resnost gastroenteritisa (GE) je bila definirana po kriterijih Svetovne zdravstvene organizacije.
English: Check that each individual oral tube is not damaged and is still sealed.
Slovenian: Preverite, da nobena posamezna tuba ni poškodovana in je še vedno zapečatena.
English: • There is a small spike inside the top of the cap - in the centre.
Slovenian: • V notranjosti vrha zaporke je majhna konica - v sredini.
English: • Give the vaccine straight away.
Slovenian: • Cepivo uporabite takoj.
English: C Check the tube has opened correctly 1.
Slovenian: C Preverite, da ste tubo pravilno odprli 1.
English: • he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system.
Slovenian: • ima otrok katerokoli bolezen ali jemlje katerokoli zdravilo, ki zmanjšuje njegovo odpornost na okužbe ali je njegova mati med nosečnostjo jemala katerokoli zdravilo, ki lahko oslabi imunski sistem.
English: - Pre-filled oral applicator: 3 years
Slovenian: - Napolnjen peroralni aplikator: 3 leta
English: Rotarix should not be used in children over 24 weeks of age.
Slovenian: Cepivo Rotarix se ne sme uporabljati pri otrocih, starejših od 24 tednov.
English: 3, 5 months Finland, Italy 180
Slovenian: Finska, Italija 180
English: • There should be a hole at the top of the tube.
Slovenian: • Na vrhu tube mora biti luknjica.
English: • Check the tube has not been damaged nor is already open.
Slovenian: • Preverite, da tuba ni poškodovana ali že odprta.
English: • Very rare: hives (urticaria)
Slovenian: • zelo redki: koprivnica (urtikarija)
English: A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8).
Slovenian: Klinična študija pri majhnem številu asimptomatskih ali blago simptomatskih HIV-pozitivnih dojenčkov ni pokazala očitnih težav z varnostjo (glejte poglavje 4.8).
English: Unused oral tubes that are still attached to the connecting bar must be put back in the fridge immediately after an oral tube has been used.
Slovenian: Neporabljene tube, ki so še vedno pritrjene na povezovalno ploščico, morate shraniti nazaj v hladilnik takoj po tem, ko ste eno tubo porabili.
English: • Keep the cap - you need this to pierce the membrane.
Slovenian: • Zaporko obdržite - potrebujete jo, da boste prebodli membrano.
English: • inflammation of the skin
Slovenian: • napihnjenost • vnetje kože
English: • Squeeze the liquid gently into the side of the child's mouth - towards the inside of their cheek.
Slovenian: • Nežno stisnite tekočino na stran otrokovih ust - proti notranjosti lica.