natgillin/translations-raw huggingface dataset:
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Djelići virusnog antigena otkriveni ELISA testom nađeni su u 50% uzoraka stolica nakon prve doze liofiliziranog oblika cjepiva Rotarix i u 4% uzoraka stolica nakon druge doze.
PHARMACEUTICAL FORM AND CONTENTS Oral suspension
OBLIK I SADRŽAJ Oralna suspenzija
Rotarix is available in a pack of 1, 5, 10 or 25.
Rotarix je dostupan u pakiranju od 1, 5, 10 ili 25.
The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown.
Trenutno nije poznat opseg zaštite koju Rotarix može pružiti protiv drugih sojeva rotavirusa koji nisu cirkulirali u kliničkim studijama.
Human rotavirus RIX4414 strain (live, attenuated)*
Humani rotavirus soj RIX4414 (živi, atenuirani)*
• Hold the tube upright.
• Držite tubu uspravno.
QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1 ml) contains:
KVALITATIVNI I KVANTITATIVNI SASTAV Nakon rekonstitucije, 1 doza (1 ml) sadrži:
Bolivia
Bolivija
Rotarix is for oral use only.
Rotarix se primjenjuje isključivo peroralno.
Remove the protective tip cap from the oral applicator.
Skinite zaštitni zatvarač vrha s oralnog aplikatora.
In a clinical study conducted in preterm infants, born after at least 27 weeks of gestational age, the immunogenicity of Rotarix was assessed in a subset of 147 subjects and showed that Rotarix is immunogenic in this population; 85.7% (95% CI: 79.0;90.9) of subjects achieved serum anti-rotavirus IgA antibody titres ≥ 20U/ml (by ELISA) one month after the second dose of vaccine.
U kliničkoj studiji provedenoj u prijevremeno rođenoj dojenčadi, rođenoj s najmanje 27 tjedana gestacijske dobi, imunogenost cjepiva Rotarix je bila procjenjivana u podskupini od 147 ispitanika, te je pokazala da je Rotarix imunogeničan u ovoj populaciji; 85,7% (95% CI: 79,0; 90,9) ispitanika ostvarilo je titar IgA protutijela protiv rotavirusa u serumu ≥20 U/ml (ELISA) jedan mjesec nakon druge doze cjepiva.
The mixed vaccine will appear more turbid than the solvent alone.
Pomiješano cjepivo bit će mutnije od samog otapala.
Human rotavirus RIX4414 strain (live, attenuated)
Humani rotavirus soj RIX4414 (živi, atenuirani)
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).
Na temelju duljih razdoblja praćenja, ostaje nejasno utječu li cjepiva protiv rotavirusa na sveukupnu incidenciju intususcepcije (vidjeti dio 4.4).
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.
Da biste odvojili jednu od tuba za oralnu primjenu počevši od one s kraja trake: a) Uhvatite jezičak jedne od tuba za oralnu primjenu koja se nalazi na kraju trake.
Rotavirus vaccine, live
Cjepivo protiv rotavirusa, živo
• Once the tube is open check the liquid is clear,
• Nakon što je tuba otvorena provjerite je li tekućina bistra, bez ikakvih čestica u njoj.
Powder: dextran, sucrose, sorbitol (see also section 2, Rotarix contains sucrose and sorbitol), amino acids, Dulbecco's Modified Eagle Medium (DMEM) Solvent: calcium carbonate, xanthan gum, sterile water
Prašak: dekstran, saharoza, sorbitol (pogledajte također dio 2 “Rotarix sadrži saharozu i sorbitol“), aminokiseline, Dulbeccova modificirana Eagleova podloga (DMEM) Otapalo: kalcijev karbonat, ksantanska guma, sterilna voda
Date of first authorisation: 21 February 2006 Date of latest renewal: 14 January 2016
Datum posljednje obnove odobrenja: 14. siječnja 2016.
These data are considered sufficient to support the inclusion of urticaria in section 4.8 of the SmPC with the frequency very rare, as the SmPC guideline recommends to list in section 4.8 all adverse reactions for which, after a thorough assessment, a causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Naime, u smjernicama za izradu sažetka opisa svojstava lijeka preporučuje se da se u dio 4.8 uvrste sve nuspojave za koje se nakon detaljne ocjene utvrdi da je uzročna povezanost između lijeka i nuspojave barem razumno moguća.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rotarix
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Rotarix
If your child gets any of the side effects, talk to your doctor or pharmacist.
Ako Vaše dijete zadobije bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
2nd year of life Rotarix N=2,554 Placebo N=1,294 Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
2. godina života Rotarix N=2554 Placebo N=1294 Djelotvornost cjepiva (%) prema bilo kojem obliku i teškom rotavirusnom gastroenteritisu [95% CI]
< 5 yrs
<5 god
For instructions for the preparation or reconstitution of the medicinal product before administration, see section 6.6.
Za uputu o pripremi ili rekonstituciji lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
Check the liquid in the oral tubes is clear, colourless and free from any particles.
Provjerite je li tekućina u tubama za oralnu primjenu bistra i bezbojna, bez ikakvih čestica.
Intussusception (see section 4.4)
Immunodeficiency) (vidjeti dio 4.8).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2006
Datum prvog odobrenja: 21. veljače 2006.
EU/1/05/330/005 - pack of 1 pre-filled oral applicator EU/1/05/330/006 - pack of 5 pre-filled oral applicators EU/1/05/330/007 - pack of 10 pre-filled oral applicators EU/1/05/330/008 - pack of 25 pre-filled oral applicators
EU/1/05/330/005 - pakiranje s 1 napunjenim oralnim aplikatorom EU/1/05/330/006 - pakiranje s 5 napunjenih oralnih aplikatora EU/1/05/330/007 - pakiranje s 10 napunjenih oralnih aplikatora EU/1/05/330/008 - pakiranje s 25 napunjenih oralnih aplikatora
History of intussusception.
Anamneza intususcepcije.
Pre-filled oral applicator EU/1/05/330/005
Napunjen oralni aplikator EU/1/05/330/005
Strains with P[8] genotype † Severe rotavirus gastro-enteritis was defined as an episode of diarrhoea with or without vomiting that required hospitalization and/or re-hydration therapy in a medical facility (WHO criteria) * Not statistically significant (p ≥ 0.05).
† Teški rotavirusni gastroenteritis je bio definiran kao epizoda proljeva s ili bez povraćanja koja je zahtijevala hospitalizaciju i/ili rehidracijsku terapiju u medicinskoj ustanovi (SZO kriteriji) * Nije statistički značajno (p ≥ 0,05).
Sustained efficacy up to 3 years of age in Asia
Ove podatke treba interpretirati s oprezom Postojana djelotvornost do 3. godine života u Aziji
1st year of life Rotarix N=2,572 Placebo N=1,302
1. godina života Rotarix N=2572 Placebo N=1302
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility [95% CI] Circulating rotavirus strains
Djelotvornost cjepiva (%) protiv rotavirusnog gastroenteritisa koji zahtijeva hospitalizaciju i/ili rehidracijsku terapiju u medicinskoj ustanovi [95% CI]
Severe rotavirus gastroenteritis† (1st year of life) Rotarix N=9,009 Placebo N=8,858
Teški rotavirusni gastroenteritis† (1. godina života) Rotarix N=9009 Placebo N=8858
Do not use this vaccine after the expiry date which is stated on the carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake EXP.
The vaccine contains sucrose as an excipient.
Cjepivo sadrži saharozu kao pomoćnu tvar.
1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a membrane and a tube cap (polypropylene), in pack sizes of 1, 10 or 50.
1,5 ml oralne suspenzije u tubi za istiskivanje (polietilen) s membranom i zatvaračem tube (polipropilen) u veličinama pakiranja od 1, 10 ili 50.
• You may need to squeeze the oral tube a few times to get all of the vaccine out - it is okay if a drop stays in the oral tube.
• Možda ćete trebati stisnuti tubu za oralnu primjenu nekoliko puta kako bi izašao cjelokupan sadržaj.
f) Twist the separated oral tube.
f) Zakrenite odvojenu tubu za oralnu primjenu.
Discard the used oral tubes in approved biological waste containers according to local regulations.
Bacite upotrijebljene tube za oralnu primjenu u odobrene spremnike za biološki otpad sukladno nacionalnim propisima.
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
Ako se rekonstituirano cjepivo ne primjenjuje odmah, vratite zaštitni zatvarač na vrh oralnog aplikatora.
Squeezable tube EU/1/05/330/009 EU/1/05/330/010
Tuba za istiskivanje EU/1/05/330/009 EU/1/05/330/010 EU/1/05/330/011
Multi-monodose (5-single dose) squeezable tube presentation connected by a bar EU/1/05/330/012
Više jednodoznih tuba za istiskivanje (5 pojedinačnih doza) spojenih trakom EU/1/05/330/012
To position the child to receive the vaccine: • Seat the child leaning slightly backwards.
Da biste dijete stavili u položaj za primjenu cjepiva: • Smjestite dijete u polusjedeći položaj.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Rotarix se može dati u isto vrijeme kad Vaše dijete prima druga preporučena cjepiva, kao što su cjepiva protiv difterije, tetanusa i pertusisa (hripavca), Haemophilus influenzae tip b, poliomijelitisa (oralno ili inaktivirano), hepatitisa B te konjugirana cjepiva protiv pneumokoka i meningokoka serološke skupine C.
The following table shows the percentage of subjects initially seronegative for rotavirus (IgA antibody titres < 20 U/ml) (by ELISA) with serum anti-rotavirus IgA antibody titres ≥20U/ml one to two months after the second dose of vaccine or placebo as observed in different studies with Rotarix lyophilised formulation.
U sljedećoj tablici prikazan je postotak osoba koje su inicijalno bile seronegativne na rotavirus (titar IgA protutijela <20 U/ml) (ELISA), a koji su jedan do dva mjeseca nakon druge doze cjepiva ili placeba imali titar IgA protutijela protiv rotavirusa u serumu ≥20 U/ml, što je zabilježeno u različitim studijama.
How to store Rotarix
Kako čuvati Rotarix
Pre-filled oral applicator
Napunjen oralni aplikator
PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUBE, PACK SIZES OF 1, 10 OR 50
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU TUBA, VELIČINA PAKIRANJA OD 1, 10 ILI 50
Rotarix contains sucrose
Rotarix sadrži saharozu
Connect the oral applicator into the transfer adapter by pushing it firmly on this device
Spojite oralni aplikator u nastavak za prijenos i čvrsto ga utisnite
Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Oralna suspenzija u napunjenom oralnom aplikatoru 1 napunjeni oralni aplikator 1 doza (1,5 ml)
• Then lift off the cap.
• Nakon toga uklonite zatvarač.
Rotarix is supplied as clear and colourless liquid in a single dose pre-filled oral applicator (1.5 ml).
Rotarix je bistra i bezbojna tekućina u jednodoznom napunjenom oralnom aplikatoru (1,5 ml).
STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (1 ml) contains:
NAVOĐENJE DJELATNE(IH) TVARI Nakon rekonstitucije, 1 doza (1 ml) sadrži:
A What you need to do before giving Rotarix
Što trebate učiniti prije davanja cjepiva Rotarix
Powder and solvent for oral suspension
Prašak i otapalo za oralnu suspenziju
Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital control participants).
(4) učinkovitost cjepiva se izračunala koristeći bolničke kontrolne rotavirus-negativne sudionike (procjene za Tajvan su računate koristeći bolničke kontrolne rotavirus-negativne sudionike i bolničke kontrolne sudionike bez proljeva).
This vaccine is for oral administration only.
Ovo cjepivo je samo za oralnu primjenu.
Circulating rotavirus strains
Cirkulirajući sojevi rotavirusa
Remove the oral applicator from the transfer adapter
Skinite oralni aplikator s nastavka za prijenos
After reconstitution: The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Rekonstituirano cjepivo je nešto mutnije nego otapalo i mliječnobijele je boje.
Severe rotavirus gastroenteritis† (2nd year of life) Rotarix N=7,175 Placebo N=7,062
Teški rotavirusni gastroenteritis† (2. godina života) Rotarix N=7175 Placebo N=7062
B. Get the oral tube ready
Priprema tube za oralnu primjenu
Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day.
Poznato je da nakon cijepljenja dolazi do izlučivanja cjepnog virusa u stolici, s vršnim izlučivanjem oko 7-og dana.
There are no restrictions on the infant's consumption of food or liquid, either before or after vaccination.
Nema ograničenja u pogledu uzimanja hrane i pića ni prije niti poslije cijepljenja.
(2) GSK sponsored studies (3) Data from a post-hoc analysis (4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from
(2) studije koje je sponzorirao GSK (3) podaci iz post-hoc analize
In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Dodatno, pokazana je i djelotvornost prema manje čestim rotavirusnim genotipovima G8P[4](teški gastroenteritis) i G12P[6]
Efficacy (%) [95% CI ]
Djelotvornost (%) [95% CI]
Efficacy (%) [95% CI]
Djelotvornost (%) [95% CI ]
Rotarix oral suspension in pre-filled oral applicator Rotarix oral suspension in squeezable tube
Rotarix oralna suspenzija u napunjenom oralnom aplikatoru Rotarix oralna suspenzija u tubi za istiskivanje
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1.5 ml)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 doza (1,5 ml)
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastroenteritis up to 2 years of age is presented in the following table:
Zaštitna djelotvornost cjepiva opažena protiv teškog oblika rotavirusnog gastroenteritisa nakon dvije doze cjepiva Rotarix, do kraja 2. godine života prikazana je u sljedećoj tablici:
The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
Otapalo je mutna tekućina s bijelim talogom koji se polako taloži i bezbojnim supernatantom.
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).
Rotarix je bistra i bezbojna tekućina u jednodoznoj tubi za istiskivanje (1,5 ml).
• Hold the side of tube
• Uhvatite tubu sa strane.
Read the instructions before administration of the vaccine.
Prije primjene pročitati upute za primjenu cjepiva.
50 tubes 50 x 1 dose (1.5 ml)
50 tuba 50 x 1 doza (1,5 ml)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 single dose tubes
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 5 jednodoznih tuba
The protective vaccine efficacy (pooled doses) observed against any and severe rotavirus gastro-enteritis is presented in the following table:
Zaštitna djelotvornost (zbirne doze) opažena za bilo koji oblik, odnosno teški oblik rotavirusnog gastroenteritisa je prikazana u sljedećoj tablici:
All G1P[8] G2P[4]
Svi G1P[8] G2P[4]
• You may need to squeeze the tube a few times to get all of the vaccine out - it is okay if a drop remains in the tip of the tube.
• Možda ćete trebati stisnuti tubu nekoliko puta kako bi izašao cjelokupan sadržaj.
Rotarix is supplied as clear and colourless liquid in 5 single dose squeezable tubes (5 x 1.5 ml) connected by a bar.
Rotarix je bistra i bezbojna tekućina koja dolazi u 5 jednodoznih tuba za istiskivanje (5 x 1,5 ml) spojenih trakom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING GLASS CONTAINER WITH ORAL APPLICATOR AND TRANSFER ADAPTER, PACK SIZE OF 1, 5, 10 OR 25
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU STAKLENI SPREMNIK S ORALNIM APLIKATOROM I NASTAVKOM ZA PRIJENOS, VELIČINA PAKIRANJA OD 1, 5, 10 ILI 25
Repeatedly flick the top of the tube until it is clear of any liquid
Nekoliko puta kucnite vrh tube kako biste uklonili svu tekućinu s vrha tube.
In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6].
U opservacijskim ispitivanjima dokazana je učinkovitost cjepiva protiv teškog gastroenteritisa koji vodi do hospitalizacije, uzrokovanog čestim genotipovima rotavirusa G1P[8], G2P[4], G3P[8], G4P[8] i G9P[8], kao i manje čestim genotipovima rotavirusa G9P[4] i G9P[6].
• This vaccine is ready to use - do not mix it with anything else.
• Ovo je cjepivo spremno za primjenu - ne smije se ni sa čime miješati.
C. Give the vaccine orally immediately after opening
Cjepivo primijenite djetetu u usta odmah nakon otvaranja
In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo.
incidencija i težina događaja kao što su proljev, povraćanje, gubitak apetita, vrućica, razdražljivost i kašalj/curenje nosa, prikupljenih poticanim prijavljivanjem (prikupljene kroz 8 dana nakon cijepljenja), nije se značajnije razlikovala u skupini koja je primila Rotarix u usporedbi sa skupinom koja je primila placebo.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Primjenu cjepiva Rotarix mora se odgoditi u osoba koje imaju proljev ili povraćaju.
The vaccine should be used immediately after opening.
Nakon otvaranja cjepivo se mora odmah primijeniti.
Oral administration only
Samo za oralnu primjenu
Rotarix is available in a pack of 1, 10 or 50.
Rotarix je dostupan u pakiranju od 1, 10 ili 50 tuba.
Remove the protective tip cap from the oral applicator
Skinite zaštitni zatvarač s vrha oralnog aplikatora
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness.
Primjenu cjepiva Rotarix mora se odgoditi u osoba koje boluju od teže akutne bolesti praćene vrućicom.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE STAKLENI SPREMNIK S PRAŠKOM ZA REKONSTITUCIJU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NAPUNJENI ORALNI APLIKATOR, VELIČINA PAKIRANJA OD 1, 5, 10 ILI 25
† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
†Teški gastroenteritis je bio definiran rezultatom ≥11 na Vesikarijevoj ljestvici * Nije statistički značajno (p ≥ 0,05).
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Praznu tubu i zatvarač bacite u odobreni spremnik za biološki otpad sukladno nacionalnim propisima.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1 ml)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1 doza (1 ml)
To open the tube
Odvojite zatvarač od tube
Position the child to give the vaccine • Seat the child leaning slightly backwards.
Položaj djeteta kod primjene cjepiva • Smjestite dijete u polusjedeći položaj.
Discard the empty oral applicator and tip cap in approved biological waste containers according to local regulations.
Prazni oralni aplikator i zatvarač vrha bacite u odobrene spremnike za biološki otpad sukladno lokalnim propisima.
10 tubes 10 x 1 dose (1.5 ml)
10 tuba 10 x 1 doza (1,5 ml)
Strains with P[6] genotype
Sojevi s P[6] genotipom
• pack size of 25 glass containers of powder plus 25 oral applicators of solvent
• pakiranje s 25 staklenih spremnika s praškom i 25 oralnih aplikatora s otapalom
25 glass containers: powder 25 oral applicators: solvent 25 transfer adapters 25 x 1 dose (1 ml)
25 staklenih spremnika: prašak 25 oralnih aplikatora: otapalo 25 nastavaka za prijenos 25 x 1 doza (1 ml)
Squeezable tube
Tuba za istiskivanje
10 glass containers: powder 10 oral applicators: solvent 10 transfer adapters 10 x 1 dose (1 ml)
10 staklenih spremnika: prašak 10 oralnih aplikatora: otapalo 10 nastavaka za prijenos 10 x 1 doza (1 ml)
G1P[8] G2P[4] G3P[8] G4P[8] G9P[8]
G1P[8], G2P[4], G3P[8] i G9P[8].
< 4 yrs
<4 god
Powder and solvent for oral suspension.
OBLIK Prašak i otapalo za oralnu suspenziju.
Severe†
Severe Combined
Strains with P[4] genotype
Sojevi s P[4] genotipom
How Rotarix is given
Kako primjenjivati Rotarix
Strains with P[8] genotype
Sojevi s genotipom P[8]
1 glass container: powder 1 oral applicator: solvent 1 transfer adapter 1 dose (1 ml)
1 stakleni spremnik: prašak 1 oralni aplikator: otapalo 1 nastavak za prijenos 1 doza (1 ml)
The severe RV gastro-enteritis cases were due to RV strains G1P[8], G2P[4], G3P[8] and G9P[8].
Teški slučajevi RV gastroenteritisa bili su posljedica infekcije RV sojevima G1P[8], G2P[4], G3P[8] i G9P[8].
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED ORAL APPLICATOR
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENI ORALNI APLIKATOR
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Prilikom ciklusa primarne imunizacije znatno prijevremeno rođene dojenčadi (rođene ≤ 28. tjednu trudnoće), a osobito onih s anamnezom nezrelosti respiratornog sustava, mora se uzeti u obzir mogući rizik apneje te potreba za praćenjem respiratorne funkcije tijekom 48-72 sata.
5 glass containers: powder 5 oral applicators: solvent 5 transfer adapters 5 x 1 dose (1 ml)
5 staklenih spremnika: prašak 5 oralnih aplikatora: otapalo 5 nastavaka za prijenos 5 x 1 doza (1 ml)
During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group (N=4,222) versus 13 (0.3%) in the placebo group (N=4,185).
(N=4222) u odnosu na 13 (0,3%) u placebo skupini (N=4185).
< 2 yrs 6-11 m
< 2 god 6-11 m
MINIMUM PARTICULARS TO APPEAR ON BLISTERS PRE-FILLED ORAL APPLICATOR
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAPUNJENI ORALNI APLIKATOR
10 x 5 single dose tubes connected by a bar 1 dose (1.5 ml)
10 x 5 jednodoznih tuba spojenih trakom 1 doza (1,5 ml)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE TUBA
1st year of life
tjedana života.
The first dose may be administered from the age of 6 weeks.
Prvu dozu moguće je primijeniti od navršenih 6 tjedana života.
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
U kliničkim je ispitivanjima pokazana djelotvornost u protiv rotavirusnog gastroenteritisa uzrokovanog najčešćim genotipovima G1P[8], G2P[4], G3P[8], G4P[8] i G9P[8].
25 pre-filled oral applicators 25 x 1 dose (1.5 ml)
25 napunjenih oralnih aplikatora 25 x 1 doza (1,5 ml)
• pack size of 10 glass containers of powder plus 10 oral applicators of solvent
• pakiranje s 10 staklenih spremnika s praškom i 10 oralnih aplikatora s otapalom
6.6 Special precautions for disposal and other handling The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Cjepivo je bistra, bezbojna tekućina, bez vidljivih čestica, za oralnu primjenu.
• pack size of 1 glass container of powder plus 1 oral applicator of solvent
• pakiranje s 1 staklenim spremnikom s praškom i 1 oralnim aplikatorom s otapalom