natgillin/translations-raw huggingface dataset:
Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
7 Poremećaji mokrenja (urgencija, polakizurija, nokturija, smanjen protok urina, napinjanje pri mokrenju).
- 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).
- visok krvni tlak, - povišeni lipidi u krvi, povišena laktat-dehidrogenaza, povišene bijele krvne stanice, povišena kreatin-fosfokinaza, snižena razina kalija, povišen antigen specifičan za prostatu (PSA),
Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Jedna bočica lijeka TOOKAD 366 mg sadrži 366 mg padeliporfina (u obliku kalijeve soli).
• The approaches (including VTP with TOOKAD) for the treatment of his prostate cancer and the potential benefits, risks and uncertainties of VTP with TOOKAD: o To state that information beyond two years after the TOOKAD -VTP procedure is limited and consequently, data on the long-term efficacy and safety of TOOKADVTP are currently not available o Information on the efficacy/safety of any subsequent treatments required, such as radical prostatectomy, is currently lacking
Vodič za liječnike o lijeku TOOKAD trebaju sadržavati sljedeće ključne elemente: • Pristupe (uključujući VTP s lijekom TOOKAD) liječenju raka prostate i moguće koristi, rizike i dvojbe oko VTP terapije lijekom TOOKAD; o informaciju da su podaci nakon dvije godine od TOOKAD-VTP postupka ograničeni i posljedično, podaci o dugoročnoj djelotvornosti i sigurnosti TOOKAD-VTP terapije trenutačno nisu dostupni.
In healthy human male subjects, the mean volume of distribution ranged from 0.064-0.279 L/kg, for posologies from 1.25 to 15 mg/kg of padeliporfin di-potassium indicating distribution into extracellular fluid.
0,279 l/kg, za doziranja od 1,25 to 15 mg/kg padeliporfindikalija, što upućuje na distribuciju u izvanstaničnu tekućinu.
Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Tablica 6.: PCM301 - Učinak na erektilnu funkciju (IIEF) - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
There is minimal renal excretion of TOOKAD so no adjustment in dose is required in patients with renal impairment.
U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze zbog minimalnog izlučivanja lijeka TOOKAD putem bubrega.
An injection filter of 0.22 µm and an opaque tubing should be used to administer the medicinal product to the patient.
Za primjenu lijeka bolesniku potrebno je koristiti injekcijski filtar od 0,22 µm i neprozirne cjevčice.
Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Jedna kutija lijeka TOOKAD 183 mg prašak za otopinu za injekciju sadrži smeđu staklenu bočicu s plavim zatvaračem.
Photosensitisers
Fotoosjetljivost
Patients on a controlled potassium diet
Bolesnici na dijeti s ograničenim unosom kalija
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1228/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1228/002
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 u stopi neuspjeha liječenja povezanog s opaženom progresijom bolesti od raka prostate niskog do umjerenog ili višeg rizika.
There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF (medicines used to prevent new blood vessel growth) therapy.
U bolesnika koji su primili intraokularnu anti-VEGF terapiju (lijekovi za sprječavanje rasta novih krvnih žila) može postojati dodatni rizik fotoosjetljivosti očiju.
Each mL of the resulting solution will contain 9.15 mg of padeliporfin.
Jedan ml dobivene otopine sadržava 9,15 mg padeliporfina.
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
- Gleason zbrojem ≤ 6, na temelju biopsijskih strategija visoke rezolucije, - PSA ≤ 10 ng/ml, - 3 cilindra pozitivna na rak, dobivena biopsijom širokom iglom (engl. core biopsy) s najvećom duljinom od 5 mm u bilo kojem od cilindara ili 1 - 2 cilindra pozitivna na rak pri čemu u bilo kojem od cilindara ≥ 50 % sačinjava rak ili gustoćom PSA ≥ 0,15 ng/ml/cm3.
Back pain
Bol u leđima5
Range: min, max Estimated prostate volume (cc) Mean (SD)
Ukupan broj pozitivnih cilindara Srednja vrijednost (SD) Raspon: min, maks Procijenjen volumen prostate (cm3) Srednja vrijednost (SD) Raspon: min, maks PSA (ng/ml)
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.
Ovi lijekovi (npr. acenokumarol, varfarin) trebaju se prestati uzimati barem 10 dana prije VTP terapije s lijekom TOOKAD.
Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
6 Dizurija (bol u mjehuru, spazam mjehura, hipertonični mjehur, uretralni spazam, bol u urinarnom sustavu).
Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Tablica 3.: PCM301 - Koprimarne mjere ishoda djelotvornosti - cijela prostata i liječeni režanj(evi)* - ITT populacija i bolesnici koji ispunjavaju kriterije indikacije
Very common Perineal pain Male sexual dysfunction
Perinealna bol9 Seksualna disfunkcija muškaraca10
TOOKAD-VTP arm
TOOKAD-VTP skupina
Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Jedna bočica sadrži 366 mg padeliporfina (u obliku dikalijeve soli).
Number of subjects who initiated a radical treatment after progression, n (%)
Broj ispitanika koji su započeli s radikalnim liječenjem nakon progresije,
Dysuria
Doza
No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Ostali razlozid, n (%) Pozitivan nalaz biopsije, n
Hepatotoxicity
Hepatotoksičnost4
Planning of optical fibre positioning should be performed at the beginning of the procedure using the treatment guidance software.
U početku postupka potrebno je uporabom terapijskog vodiča u obliku programske podrške izvršiti planiranje smještanja optičkih vlakana.
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.
International Prostate Symptoms Score, IPSS) pokazao je umjeren rast 7 dana nakon VTP terapije, i u ITT populaciji i u bolesnika koji ispunjavaju kriterije indikacije.
Hepatic impairment
Afektivni poremećaj
Although they were excluded from the clinical trials, there is a potential risk of increased stenosis post the TOOKAD-VTP procedure in patients with pre-existing stenosis (see section 4.8).
TOOKAD-VTP postupka u bolesnika s od prije postojećim stenozama (vidjeti dio 4.8).
- You experience involuntary passing of urine after the VTP procedure.
- ako Vam se javi nekontrolirano mokrenje nakon VTP terapije;
What TOOKAD is and what it is used for What you need to know before TOOKAD is used How TOOKAD is used
Što morate znati prije primjene lijeka TOOKAD TOOKAD se ne smije primjenjivati:
Rectal haemorrhage (anal haemorrhage).
3 Rektalna hemoragija (analna hemoragija).
Post-procedural urine leak Procedural pain Post-procedural discharge Fall
Istjecanje urina nakon postupka Bol tijekom postupka Iscjedak nakon postupka Pad
Sciatica
Astenija
Genital haemorrhage Penile swelling Prostatic haemorrhage Testicular swelling
Hemoragija prostate Oticanje testisa
Common side effects (may affect up to 1 in 10 people) - Anorectal discomfort (discomfort near the anus and just inside the anus), haemorrhoids (piles),
- Anorektalna nelagoda (nelagoda u području anusa i neposredno unutar anusa), hemoroidi,
There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy.
U bolesnika koji su primili intraokularnu anti-VEGF terapiju postoji dodatni rizik fotoosjetljivosti očiju.
Problem associated with the urethra
Poteškoće u vezi s mokraćnom cijevi
Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
39 (50,0)j gPrilagođen omjer hazarda (95 % CI) = 0,34 (0,24; 0,46) ; p vrijednost ≤ 0,001 hPrilagođen omjer hazarda (95 % CI) = 0,31 (0,20; 0,50) ; p vrijednosti ≤ 0,001 iPrilagođen omjer hazarda (95 % CI) = 0,17 (0,12; 0,27) ; p vrijednost ≤ 0,001 jPrilagođen omjer hazarda (95 % CI) = 0,11 (0,05; 0,25) ; p vrijednost ≤ 0,001
Abnormal clotting
Abnormalno zgrušavanje
Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.
uključujući transuretralnu resekciju prostate (TURP) zbog benigne hipertrofije prostate.
NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
TOOKAD 183 mg prašak za otopinu za injekciju padeliporfin
The use of medicinal products that are substrates of OATP1B1 or OATP1B3 (repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide) for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.
Uporabu lijekova koji su supstrati za OATP1B1 ili OATP1B3 (repaglinid, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin,
NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
TOOKAD 366 mg prašak za otopinu za injekciju padeliporfin
Swirl the vial gently for 2 minutes.
Nježno kružiti bočicom 2 minute kako bi se prašak otopio.
Haemorrhoids Anorectal discomfort Abdominal pain Rectal haemorrhage
Abdominalna bol Rektalna hemoragija3
Very common side effects (may affect more than 1 in 10 people) - Problems with or pain on passing urine (including pain or discomfort on passing urine, bladder pain, the need to pass urine urgently or more frequently or at night; involuntary passing of urine), - Sexual problems (including difficulty in getting or maintaining an erection, ejaculation failure, loss of desire or pain on intercourse), - Blood in the urine (haematuria), - Perineal injury including bruising in the skin, bruising near where the needles are put into the prostate, pain and tenderness, - Genital pain and discomfort (inflammation of the testicles or the epididymis, pain due to inflammation or fibrosis of the prostate).
proktalgija (bol u području anusa), - problemi s crijevima (uključujući proljev ili povremeno ispuštanje stolice), - općenita bol i bol u mišićima i kostima (bol u mišićima/kostima, bol na završecima udova, bol u leđima ili krvarenje u zglobovima),
Uncommon side effects (may affect up to 1 in 100 people) - Dizziness, fall, - Headache, - Sensory disturbance, formication (sensation like crawling insects on or under the skin), - Eye irritation, photophobia (intolerance to light), - Dyspnoea exertional (excessive shortness of breath during or after exercise), - Mood disorder, - Weight decreased.
- nadražaj oka, fotofobija (nepodnošenje svjetlosti), - dispneja pri naprezanju (nedostatak zraka tijekom ili nakon vježbanja),
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin
Uputa o lijeku: Informacije za korisnika TOOKAD 183 mg prašak za otopinu za injekciju TOOKAD 366 mg prašak za otopinu za injekciju padeliporfin
Adjusted Hazard Ratio (95% CI) = 0.17 (0.12 ; 0.27) ; p value ≤ 0.001
58 (28,2)g 121 (58,5)g 27 (33,8)h
Table 2: PCM301 - Baseline characteristics by arm for the Intention-To-Treat (ITT) population and patients meeting the indication criteria
Tablica 2.: PCM301 - Početne značajke po skupinama za populaciju s namjerom liječenja (ITT)
Pregnancy and breast-feeding TOOKAD is not indicated for the treatment of women.
TOOKAD nije namijenjen za liječenje žena.
Tumour localisation
Prijavljivanje nuspojava
You can help by reporting any side effects you may get.
Prijavom svih sumnji na nuspojavu i vi možete pomoći.
- You feel any abnormal pain after the VTP procedure.
- ako osjećate bilo kakvu abnormalnu bol nakon VTP terapije; - ako ste već imali problema sa suženjem mokraćne cijevi ili protokom urina;
Each vial contains 183 mg of padeliporfin (as di-potassium salt).
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 183 mg padeliporfina (u obliku dikalijeve soli).
Possible side effects can occur with TOOKAD and VTP procedure.
Primjenom VTP terapije i lijeka TOOKAD može doći do nuspojava.
Erythema
Eritem
This appearance is normal
Takav izgled je normalan
(cases/controls)
(slučajevi/kontrole)
Ask your pharmacist how to throw away medicines your child no longer uses.
Pitajte svog ljekarnika kako baciti lijekove koje Vaše dijete više ne koristi.
America; 11 countries
Latinska Amerika; 11 država
• If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
• Ako se membrana nije probušila, pogledajte ponovno dio B i ponovite korake 2, 3 i 4.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Manja infekcija, poput prehlade, ne bi smjela predstavljati problem, ali najprije razgovarajte s liječnikom.
(7) NA: Not available.
(7) ND: nije dostupno.
not less than 106.0 CCID50
ne manje od 106,0 CCID50
South Africa, Malawi
Južna Afrika, Malawi
The presence of a minor infection is not a contra-indication for immunisation.
Prisustvo manje infekcije nije kontraindikacija za imunizaciju.
Impact on hospitalisation§
Utjecaj na hospitalizaciju§
What to do if the membrane has not been pierced
Što treba učiniti ako se membrana nije probušila?
*Produced on Vero cells
*proizveden na Vero stanicama
* Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
*Budući da su ovi događaji prijavljeni spontano, nije moguće pouzdano utvrditi njihovu učestalost.
Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls.
Procjena učinkovitosti cjepiva se temelji na 41 potpuno cjepljenom slučaju i 175 potpuno cijepljenih kontrola.
(5) Vaccine effectiveness was calculated using neighborhood controls.
(5) učinkovitost cjepiva se izračunala koristeći susjedne kontrole.
It might be necessary to postpone the vaccination until recovery.
Može biti potrebno odgoditi cijepljenje do oporavka.
Not known*
nije poznato*
As always, please take care to wash your hands thoroughly after changing soiled nappies.
Kao i uvijek, molimo temeljito perite ruke svaki put nakon promjene isprljanih dječjih pelena.
When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Kad su ti uzorci testirani na prisutnost živog soja virusa, samo ih je 17% bilo pozitivno.
Rotarix with food and drink
Rotarix s hranom i pićem
• he/she has not been gaining weight and growing as expected.
• do sada nije dobivalo na težini ili nije raslo prema očekivanju.
50 tubes
50 tuba
If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C.
Ako se ne primijeni odmah, vrijeme čuvanja do primjene ne smije biti duže od 24 sata na temperaturi od 2 do 25°C.
All m: months yrs: years
Svi m: mjeseci god: godina
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.
Obavijestite svog liječnika ako Vaše dijete uzima, nedavno je uzelo ili bi moglo uzeti bilo koje druge lijekove, ili ako je nedavno primilo neko drugo cjepivo.
- This vaccine has been prescribed for your child only.
Ovo cjepivo propisano je samo Vašem djetetu.
Impact on mortality§
Utjecaj na mortalitet§
If you notice anything abnormal, do not use the vaccine.
Ako primijetite nešto neobično, nemojte primijeniti cjepivo.
There is limited evidence of a smaller increased risk following the second dose.
Postoje malobrojni dokazi o malom povećanju rizika nakon primjene druge doze.
Your child will receive two doses of the vaccine.
Vaše dijete će primiti dvije doze cjepiva.
10, 14 weeks and 6, 10, 14 weeks (Pooled)
10, 14 tjedana i 6, 10, 14 tjedana (zbirno)
(1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given.
(1) Dan je broj potpuno cijepljenih (2 doze) i necijepljenih slučajeva i kontrola.
Natural fluctuations of the incidence of the disease may also influence the observed temporal effect.
Prirodne promjene incidencije bolesti mogu utjecati na zapaženi vremenski učinak.
These data should be interpreted with caution.
Ove podatke treba interpretirati s oprezom.
If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Ako se rekonstituirano cjepivo ne primijeni u roku od 24 sata, treba ga baciti.
2°C to 8°C
2°C - 8°C
Some cases of overdose have been reported.
Prijavljeno je nekoliko slučajeva predoziranja.
The use of Rotarix should be based on official recommendations.
Primjena cjepiva Rotarix mora se temeljiti na službenim preporukama.
These data should be interpreted with caution
Ove podatke treba interpretirati s oprezom
• Very rare: hives (urticaria)
• vrlo rijetko: koprivnjača (urtikarija)
Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).
Kliničke studije iz kojih su dobiveni podaci o djelotvornosti provedene su u Europi, Srednjoj i Južnoj Americi, Africi i Aziji (vidjeti dio 5.1).
All of these strains are circulating worldwide.
Svi ovi sojevi cirkuliraju u cijelom svijetu.
Safety in infants with human immunodeficiency (HIV) infection
Sigurnost primjene u dojenčadi s infekcijom virusom humane imunodeficijencije (HIV-om)
C Check the tube has opened correctly 1.
C Provjerite je li tuba ispravno otvorena 1.
2, 3 to 4 months
2, 3 do 4 mjeseca
No cases of intussusception were reported.
Nije bilo prijavljenih slučajeva intususcepcije.
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
S obzirom da je korist od cijepljenja u toj skupini dojenčadi visoka, cijepljenje se ne bi smjelo izostaviti ili odgađati.
Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients.
Ozbiljni štetni događaji primijećeni su u 5,1% onih koji su primili Rotarix, u usporedbi s 6,8% onih koji su primili placebo.
Oral suspension 1 tube
Oralna suspenzija 1 tuba
- Infants who have known or suspected immunodeficiency
- Dojenčad kod koje se zna ili sumnja na imunodeficijenciju
• There should be a hole at the top of the tube.
• Na vrhu tube mora biti rupa.
These strains are circulating worldwide.
Ovi sojevi cirkuliraju u cijelom svijetu.
Other medicines and Rotarix
Drugi lijekovi i Rotarix
A protective immune response may not be elicited in all vaccinees (see section 5.1).
Zaštitni imunološki odgovor možda se neće postići u svih cijepljenih osoba (vidjeti dio 5.1).
Contact a doctor/health care professional right away if your child experiences one of these symptoms.
Odmah kontaktirajte liječnika ili drugog zdravstvenog djelatnika ukoliko Vaše dijete ima jedan od ovih simptoma.
Schedule Studies conducted in
Studije provedene u
OTHER SPECIAL WARNING(S), IF NECESSARY
DRUGO(A) POSEBNO UPOZORENJE(A), AKO JE POTREBNO
• Check the tube has not been damaged nor is already open.
• Provjerite da tuba nije oštećena ili već otvorena.
- Pre-filled oral applicator: 3 years
Napunjeni oralni aplikator: 3 godine
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.
Slična ispitivanja u Armeniji, Australiji, Brazilu, Kanadi, Salvadoru i Zambiji su pokazala smanjenje od 45% do 93% između 2 i 4 godine nakon uvođenja cjepiva.
The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy.
Incidencija teških RV gastroenteritisa povezanih s pojedinim genotipovima je bila premala da bi dozvoljavala izračun djelotvornosti.
Immune response
Imunološki odgovor
Rotarix should under no circumstances be injected.
Rotarix se ni pod kojim okolnostima ne smije injicirati.
Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
Kliničke studije provedene su u Europi, Latinskoj Americi, Africi i Aziji kako bi se procijenila zaštitna djelotvornost cjepiva Rotarix protiv bilo kojeg oblika i teškog rotavirusnog gastroenteritisa.
2, 3 months France,
2, 3 mjeseca Francuska,
Check the membrane has been pierced
Provjerite je li membrana probušena
NA(7)
ND(7)
• 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.
• ima bilo kakvu bolest ili uzima lijekove koji smanjuju djetetovu otpornost na infekcije ili ako je djetetova majka tijekom trudnoće uzimala bilo koji lijek koji može oslabiti imunološki sustav.
Rotarix is not intended for use in adults.
Rotarix nije namijenjen primjeni u odraslih.
However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.
Međutim, neka djeca se teško razbole uz jako povraćanje, proljev i po život opasan gubitak tekućine koji zahtijeva bolničko liječenje.
No increase in the incidence or severity of these events was seen with the second dose.
Nije zabilježena povećana incidencija ili težina tih događaja nakon druge doze.
The vaccination course consists of two doses.
Ciklus cijepljenja sastoji se od dvije doze.
What Rotarix looks like and contents of the pack
Kako Rotarix izgleda i sadržaj pakiranja
When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Kad osoba primi cjepivo, imunološki sustav (prirodna obrana organizma) će stvoriti protutijela protiv najčešćih tipova rotavirusa.
• 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).
• ako je Vaše dijete prethodno imalo alergijsku reakciju na cjepiva protiv rotavirusa ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.).
In order to address the presence of porcine circovirus type 1(PCV-1) in Rotarix, the MAH commits to:
U cilju rješavanja prisutnosti svinjskog cirkovirusa tipa 1 (PCV-1) u cjepivu Rotarix, nositelj odobrenja se obvezuje da će: