natgillin/translations-raw huggingface dataset:
Perineal injury (post-procedural haematoma, necrosis, perineal haematoma, pelvic haematoma).
15 Poškodba presredka (hematom, nastal po postopku, nekroza, hematom v presredku, hematom v medenici).
Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
7 Motnje uriniranja (siljenje na vodo, polakiurija, nokturija, zmanjšan pretok urina, napenjanje ob uriniranju).
Posology The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of padeliporfin.
Priporočeno odmerjanje zdravila TOOKAD je en sam odmerek padeliporfina 3,66 mg/kg.
Allow the opaque syringe to rest in a vertical position for 3 minutes to ensure any foam disappears.
Pustite, da neprosojna brizga brez dodatnega stresanja in premikanja 3 minute miruje v pokončnem položaju, da morebitna pena izgine.
Standard handling of syringes should follow.
Nato je treba z brizgami ravnati po standardnem postopku.
There is limited biopsy data beyond 2 years after TOOKAD treatment, so long-term efficacy has not been determined.
Spremljanje po postopku TOOKAD-VTP Podatki o biopsiji za obdobje po zdravljenju z zdravilom TOOKAD, daljše od dveh let, so omejeni,
TOOKADVTP arm N = 206
Krak TOOKADVTP N = 206
Hollow needles are used to insert the fibres into the right place in the prostate.
Za vstavitev vlaken na pravo mesto v prostati se uporabljajo votle igle.
TOOKADVTP arm N = 80
Krak TOOKADVTP N = 80
Prostatic abscess
občasni absces prostate
Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Ena viala zdravila TOOKAD 366 mg vsebuje 366 mg padeliporfina (v obliki kalijeve soli).
a a e e
PRILOGA I
You may need to stay overnight if you have not fully recovered from the general anaesthetic and depending on your condition.
Če še ne boste popolnoma okrevali od splošne anestezije in glede na vaše stanje, boste morali v bolnišnici morda ostati čez noč.
Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Preglednica 3: PCM301 - sočasni primarni opazovani dogodki učinkovitosti - celotna prostata in zdravljeni reženj (ali oba)* - populacija ITT in bolniki, ki izpolnjujejo merila indikacije
Effect on urinary morbidity (IPSS) and erectile function (IIEF) following TOOKAD-VTP As shown in Table 5, in PCM301 study, the International Prostate Symptoms Score (IPSS) showed, a moderate increase 7 days after the VTP procedure, in both the ITT population and in patients meeting the indication criteria.
Kot je prikazano v preglednici 5, je bilo v študiji PCM301 z mednarodnim vprašalnikom o ocenjevanju simptomov prostate (IPSS - International Prostate Symptoms Score) pri populaciji ITT in bolnikih, ki izpolnjujejo merila indikacije, dokazano zmerno povečanje 7 dni po postopku VTP.
Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Ena viala zdravila TOOKAD 183 mg vsebuje 183 mg padeliporfina (v obliki kalijeve soli).
TOOKAD should be used with caution in patients with severe hepatic impairment.
Pri bolnikih z resno okvaro jeter je treba zdravilo TOOKAD uporabljati zelo previdno.
The equipment should be carefully calibrated and use the treatment guidance software to reduce the risk of clinically significant extraprostatic necrosis.
Za zmanjševanje tveganja klinično pomembne ekstraprostatične nekroze je treba opremo pazljivo umerjati, uporabljati pa je treba tudi programsko opremo za usmerjanje zdravljenja.
However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided the precautions against light exposure are stricly followed.
naj bi bilo tveganje povečane fototoksičnosti po pričakovanjih nizko, če so strogo upoštevani previdnostni ukrepi izogibanja svetlobi.
Total number of positive cores Mean (SD)
Skupno število pozitivnih stebričkov
One patient had Grade 3 perineal pain that started 35 weeks after the VTP procedure, and lasted for about 35 weeks before resolving without sequelae.
ki so se pojavile 35 tednov po postopku VTP in so trajale 35 tednov, posledic pa ni bilo.
Anticoagulants (medicines that prevent the blood from clotting) These medicines (e.g. acenocoumarol, warfarin) should be stopped at least 10 days before the VTP procedure with TOOKAD.
Ta zdravila (npr. acenokumarol, varfarin) je treba prenehati jemati vsaj 10 dni pred postopkom VTP z zdravilom TOOKAD.
These medicines (e.g. acetylsalicylic acid) should be stopped at least 10 days before the VTP procedure with TOOKAD and re-started at least 3 days after the procedure.
Antitrombotiki (zdravila, ki zmanjšujejo agregacijo (lepljivost) trombocitov v krvi in strjevanje) Ta zdravila (npr. acetilsalicilna kislina) je treba prenehati jemati vsaj 10 dni pred postopkom VTP z zdravilom TOOKAD in jih znova začeti jemati vsaj 3 dni po postopku.
Each vial contains 183 mg of padeliporfin (as di-potassium salt).
Ena viala vsebuje 183 mg padeliporfina (v obliki dikalijeve soli).
Table 2: PCM301 - Baseline characteristics by arm for the Intention-To-Treat (ITT) population and patients meeting the indication criteria
Preglednica 2: PCM301 - izhodiščne značilnosti glede na krak za populacijo z namenom zdravljenja (ITT - Intention-To-Treat) in bolnike, ki izpolnjujejo merila indikacije
Injury, poisoning and procedural complications
Poškodbe, zastrupitve in zapleti pri posegih pogosti poškodbe presredka15
Follow-up post TOOKAD-VTP
Krak TOOKADVTP
This should be taken into consideration (see section 4.4).
6 mesecev (glejte poglavje 4.8).
The vial should rest in an upright position for 3 minutes without further shaking or moving.
Viala mora nato brez dodatnega stresanja in premikanja mirovati v pokončnem položaju 3 minute.
You may watch television at a distance of 2 metres and, from 6 hours after the procedure, you may use electronic devices such as smartphones, tablets and computers.
po 6 urah po postopku pa lahko uporabljate elektronske naprave, kot so pametni telefoni ter tablični in osebni računalniki.
Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Ena viala vsebuje 366 mg padeliporfina (v obliki dikalijeve soli).
Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Ena škatla zdravila TOOKAD 183 mg prašek za raztopino za injiciranje vsebuje stekleno vialo jantarjeve barve z modrim pokrovčkom.
Allow the vial to rest in a vertical position for 3 minutes without further shaking or moving.
Pustite, da viala brez dodatnega stresanja in premikanja 3 minute miruje v pokončnem položaju.
Haemorrhoids Anorectal discomfort Abdominal pain Rectal haemorrhage
Bolezni prebavil pogosti hemeroidi nelagoden občutek v anorektalnem predelu2
TOOKAD) for the treatment of the type of prostate cancer, potential benefits, risks and uncertainties of VTP with TOOKAD.
• informacije o morebitnih koristih, tveganjih in negotovostih postopka VTP z zdravilom
Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Preglednica 5: PCM301 - vpliv na obolevnost zaradi bolezni sečil (IPSS) - populacija ITT in bolniki, ki izpolnjujejo merila indikacije Populacija ITT
Some degree of erectile dysfunction is possible soon after the procedure and may last for more than 6 months (see section 4.8).
Določena stopnja erektilne disfunkcije se lahko pojavi kmalu po postopku in lahko traja več kot
Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Zdravila, ki lahko povzročajo preobčutljivost na svetlobo: - določeni antibiotiki, ki se uporabljajo za zdravljenje okužb (tetraciklini, sulfonamidi, kinoloni); - določena zdravila za zdravljenje psihiatričnih stanj (fenotiazini); - določena zdravila, ki se uporabljajo pri sladkorni bolezni tipa II (hipoglikemični sulfonamidi); - določena zdravila za visok krvni tlak, edeme, srčno popuščanje ali odpoved ledvic (tiazidni diuretiki);
* The treated lobe(s) in the AS arm was defined as the lobe(s) with disease at baseline.
* Zdravljeni reženj v kraku AS je bil v izhodišču opredeljen kot oboleli reženj (če sta bila zdravljena oba, sta bila v kraku AS kot obolela v izhodišču opredeljena oba).
QUALITATIVE AND QUANTITATIVE COMPOSITION TOOKAD 183 mg powder for solution for injection Each vial contains 183 mg of padeliporfin (as di-potassium salt).
TOOKAD 183 mg prašek za raztopino za injiciranje Ena viala vsebuje 183 mg padeliporfina (v obliki dikalijeve soli).
TOOKAD is prepared by reconstituting the powder for solution for injection with: - 20 mL of 5 % glucose solution for TOOKAD 183 mg,
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.
Post-procedural urine leak Procedural pain Post-procedural discharge Fall
občasni ponovljen kirurški postopek kontuzija uhajanje urina po postopku bolečina zaradi postopka izcedek po postopku padec
- 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).
- 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).
Genito-urinary tract infection (urinary tract infection, orchitis, epididymitis, cystitis).
1 Okužba spolovil in sečil (okužba sečil, orhitis, epididimitis, cistitis).
See section 4.5 for interactions with photosensitizing medicinal products.
Za medsebojno delovanje z zdravili, ki povzročajo preobčutljivost na svetlobo glejte poglavje 4.5.
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.
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.
Genital pain (penile pain, testicular pain, scrotal pain, non-infective orchitis, spermatic cord inflammation, genital contusion).
11 Bolečina v spolovilih (bolečina v penisu, bolečina v modniku, nenalezljivi orhitis, vnetje semenovoda, kontuzija spolovil).
The activated medicine then causes the death of the cancer cells.
Rakave celice nato zaradi aktiviranega zdravila odmrejo.
- Fever, pain and swelling in the area of the operation might occur after the procedure.
- Po postopku se lahko pojavijo povišana telesna temperatura, bolečina in otekanje.
Photosensitivity There is a risk of skin and eye photosensitivity with exposure to light post TOOKAD-VTP.
Če po zdravljenju s postopkom TOOKAD-VTP pride do izpostavitve svetlobi, obstaja tveganje preobčutljivosti kože in oči na svetlobo.
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.
Ker zdravilo povzroča preobčutljivost na svetlobo, je treba raztopino pripraviti v okolju s pridušeno svetlobo.
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.
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.
- You have abnormal blood clotting.
Preiskave pogosti nenormalno strjevanje krvi14
proctalgia (pain in the anal region), - Problems with bowels (including diarrhoea or occasional soiling),
- Težave s črevesjem (vključno z drisko ali občasnim uhajanjem blata).
Use in patients on a controlled potassium diet
Bolniki, ki so na dieti z nadzorovanim vnosom kalija To zdravilo vsebuje kalij.
Table 2 gives baseline characteristics by arm.
V preglednici 2 so predstavljene izhodiščne značilnosti glede na krak.
White blood cell count increased
krvavitev v prostati otekanje mod
There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
Pri bolnikih, ki so prejemali intraokularno zdravljenje proti vaskularnemu endotelijskemu rastnemu faktorju (VEGF), lahko obstaja dodatno tveganje preobčutljivosti oči na svetlobo.
• Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide.
• razlago postopka, kot tudi ustreznih rezultatov glede varnosti in učinkovitosti zdravila
Photosensitivity Strong light may cause skin reactions and eye discomfort while TOOKAD is in the blood stream.
Dokler je zdravilo TOOKAD v krvnem obtoku, lahko močna svetloba povzroča kožne reakcije in nelagodne občutke v očeh.
Number of subjects with
Število oseb s/z
Eye irritation Photophobia
Očesne bolezni občasni draženje očesa fotofobija
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.
- B: razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni od nizko prek zmerno do visoko tveganega raka prostate.
• Patient information guide • Physician guideline
• smernice za zdravnike.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni dispneja ob naporu
Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
6 Disurija (bolečina v mehurju, krči mehurja, hipertonični mehur, krči sečnice, bolečina v sečilih).
Antiplatelet agents (medicines that decrease platelet aggregation (stickiness) in the blood and reduce clotting)
Antikoagulanti (zdravila, ki preprečujejo strjevanje krvi)
See also under “Other medicines and TOOKAD” for photosensitizing medicines.
Zdravila, ki povzročajo preobčutljivost na svetlobo, si oglejte tudi v poglavju „Druga zdravila in zdravilo TOOKAD“.
NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
TOOKAD 366 mg prašek za raztopino za injiciranje padeliporfin
How TOOKAD is stored
Shranjevanje zdravila TOOKAD
NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
TOOKAD 183 mg prašek za raztopino za injiciranje padeliporfin
Adjusted Hazard Ratio (95% CI) = 0.31 (0.20 ; 0.50) ; p value ≤ 0.001
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
- You have a history of a narrowing of the urethra or urinary flow problems.
- po postopku VTP čutite kakršno koli nenormalno bolečino; - imate anamnezo zoženja sečnice ali težave s pretokom urina;
Rectal haemorrhage (anal haemorrhage).
- Hematospermija (prisotnost krvi v ejakulatu).
VTP procedure.
VTP.
Ureteric haemorrhage Urethral haemorrhage Urinary tract disorders
Bolezni ledvic in sečil zelo pogosti zastajanje urina hematurija disurija6 motnje uriniranja7
TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin
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.
Perineal injury, perineal pain and prostatitis
pogosti prostatitis bolečina v spolovilih11 bolečina v prostati12
Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%)
B: Razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni Število oseb, pri katerih je bolezen v 24. mesecu napredovala, n (%)
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priprava raztopine mora potekati v okolju s pridušeno svetlobo.
Perineal pain (pelvic pain).
- Učinkovina je padeliporfin.
Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity
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
The median time to onset of genito-urinary infections was 22.5 days (4-360).
Srednja vrednost časa do nastopa okužbe sečil in spolovil je znašala 22,5
PHARMACEUTICAL FORM Powder for solution for injection.
FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje Prašek je liofilizat temne barve.
Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
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
Haematoma Hypertension
Žilne bolezni pogosti hematom hipertenzija
In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'.
(39 mg) kalija, kar v bistvu pomeni, da je pravzaprav „brez kalija“.
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
- 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
How TOOKAD is stored Contents of the pack and other information
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TOOKAD
This appearance is normal
Takšen videz je normalen.
(cases/controls)
(primeri/kontrole)
America; 11 countries
Latinska Amerika; 11 držav
* Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
* Ker so bili ti dogodki poročani spontano, njihove pogostnosti ni mogoče zanesljivo oceniti.
Sustained efficacy up to 3 years of age in Asia
Dolgotrajna učinkovitost do 3. leta starosti v Aziji
Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract.
Bond et al. (2018) navaja nekatera neskladja s tem priporočilom v nedavnem abstraktu za konferenco.
not less than 106.0 CCID50
ne manj kot 106,0 CCID50
These data should be interpreted with caution.
Te podatke je treba interpretirati previdno.
There is limited evidence of a smaller increased risk following the second dose.
Malo je dokazov o manjšem povečanju tveganja po drugem odmerku.
(5) Vaccine effectiveness was calculated using neighborhood controls.
(5) Učinkovitost cepiva je bila izračunana z uporabo kontrol iz soseščine.
Impact on hospitalisation§
Vpliv na hospitalizacije§
10, 14 weeks and 6, 10, 14 weeks (Pooled)
10, 14 teden in 6, 10, 14 teden (združeno)
Date of latest renewal: 14 January 2016
Datum zadnjega podaljšanja: 14. januar 2016
Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls.
Ocena učinkovitosti cepiva temelji na 41 v celoti cepljenih primerih in 175 v celoti cepljenih kontrol.
50 tubes
50 tub
All of these strains are circulating worldwide.
Vsi ti sevi krožijo po celem svetu.
If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Če se rekonstituirano cepivo ne uporabi v 24 urah, ga je treba zavreči.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
Frequencies are reported as:
Pogostnost je navedena kot:
South Africa, Malawi
Južnoafriška republika, Malavi
*Produced on Vero cells
*Pridobljen na Vero celicah
These strains are circulating worldwide.
Ti sevi krožijo po celem svetu.
No point estimate was available for the remaining study.
Za preostale študije ocenjene vrednosti niso na voljo.
Impact on mortality§
Vpliv na umrljivost§
• You do not need to twist.
• Ni vam treba vrteti.
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.
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.
(1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given.
(1) Navedeno je število v celoti cepljenih (2 odmerka) in necepljenih primerov in kontrol.
Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).
Klinične študije, na katerih temeljijo podatki o učinkovitosti, so bile izvedene v Evropi, Centralni ter Južni Ameriki, Afriki in Aziji (glejte poglavje 5.1).
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children.
Okužba z rotavirusi je najpogostejši vzrok hude driske pri dojenčkih in mlajših otrocih.
When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Ko so te vzorce blata testirali na prisotnost živega vakcinalnega seva virusa, je bilo pozitivnih le 17 % vzorcev.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Blažja okužba, kot je npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem vseeno pogovorite z zdravnikom;
The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy.
Incidenca hudega RV gastroenteritisa, povezanega s posameznimi genotipi, je bila premajhna, da bi dopuščala izračun učinkovitosti.
• Turn the cap upside down (180°).
• Obrnite zaporko na glavo (180°).
• 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).
• če je predhodno imel kakršnokoli alergijsko reakcijo na cepiva proti rotavirusom ali katerokoli sestavino tega cepiva (navedeno v poglavju 6).
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.
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.
Some cases of overdose have been reported.
Poročali so o nekaj primerih prevelikega odmerjanja.
Natural fluctuations of the incidence of the disease may also influence the observed temporal effect.
Na opaženi časovni učinek lahko vpliva tudi naravno nihanje incidence bolezni.
g) Pull it from the connecting bar.
g) Povlecite jo od povezovalne ploščice.