natgillin/translations-raw huggingface dataset:
A clinical study performed in Latin America evaluated Rotarix in more than 20000 subjects.
8 Klinična študija, izvedena v Latinski Ameriki, je cepivo Rotarix ovrednotila pri več kot 20000 osebah.
Severe rotavirus gastro- enteritis (2nd year of life) Rotarix N=7175; Placebo N=7062 (§) Efficacy (%) [95% CI]
Hud rotavirusni gastroenteritis (drugo leto življenja) Rotarix N = 7. 175; Placebo N = 7. 062( §) Učinkovitost (%) 95% IZ
(§)ATP cohort for efficacy * Statistically significant (p < 0.05) # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group).
(§) kohorta po protokolu za učinkovitost * Statistično pomembno (p < 0, 05) # Število oseb na katerih temelji ocena učinkovitosti proti G4P[ 8] je zelo majhno (1 oseba v skupini, ki je prejela cepivo Rotarix in 2 osebi v skupini, ki je prejela placebo).
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] type during the first year of life.
Združena analiza petih študij * kaže, da je bila med prvim letom življenja učinkovitost proti hudemu rotavirusnemu gastroenteritisu (Vesikari ≥ 11), ki ga povzroča serotip G2P[ 4] rotavirusa 71, 4- odstotna (95% interval zaupanja:
17 * In these studies, the point estimates and confidence intervals were respectively:
20, 1; 91, 1). * Ocenjene vrednosti in intervali zaupanja iz teh študij:
Protective efficacy of the liquid formulation:
Učinkovitost zaščite tekoče oblike cepiva
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation.
Ker je imunski odziv, opažen po aplikaciji 2 odmerkov tekoče oblike cepiva Rotarix, primerljiv z imunskim odzivom po aplikaciji 2 odmerkov liofilizirane oblike cepiva, lahko domnevamo, da je učinkovitost zaščite tekoče oblike enaka učinkovitosti zaščite liofilizirane oblike.
The following table shows the percentage of subjects with serum anti-rotavirus IgA antibody titers ≥20U/ml (by ELISA) one to two months after the second dose of vaccine or placebo as observed in different studies with Rotarix lyophilised formulation.
9 V spodnji tabeli so prikazani odstotki oseb, pri katerih je bil en ali dva meseca po aplikaciji drugega odmerka cepiva ali placeba v različnih študijah liofilizirane oblike cepiva Rotarix dosežen titer serumskih protirotavirusnih IgA protiteles ≥ 20 E/ ml (ELISA).
% ≥ 20U/ml N [95% CI]
% ≥ 20 E/ ml [95% IZ]
2, 3 to 4
2 in 3 do 4
Latin
Latinska
months
mesec
America; 11 countries
Amerika; 11 držav
In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was comparable to the one elicited by Rotarix lyophilized formulation.
V treh primerjalnih nadzorovanih preskušanjih je bil imunski odziv po aplikaciji tekoče oblike cepiva Rotarix primerljiv z imunskim odzivom po aplikaciji liofilizirane oblike cepiva Rotarix.
Sucrose Di-sodium Adipate Dulbecco’s Modified Eagle Medium (DMEM)
saharoza dinatrijev adipat Dulbekov spremenjeni nujni medij (DMEM – » Dulbecco’ s Modified Eagle Medium «) voda za injekcije
The vaccine should be used immediately after opening.
3 leta Cepivo je treba uporabiti takoj po odprtju vsebnika.
1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1, 5, 10 or 25.
Velikosti pakiranja po 1, 5, 10 ali 25.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Pred aplikacijo morate preveriti videz cepiva glede morebitne prisotnosti kakršnihkoli tujih delcev in/ ali neobičajnega fizikalnega videza.
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral applicator.
Ne injicirajte!
19 Oral applicator Tip-Cap
Zaščitni pokrovček peroralnega aplikatorja
not inject.
injicirajte.
20 1.
12 1.
Method of administration
13 Način uporabe
21 Rotarix is for oral use only.
Cepivo Rotarix je namenjeno izključno za peroralno uporabo.
22 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.
14 Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
23 • Clinical trials for the lyophilised formulation
• Klinična preskušanja liofilizirane oblike cepiva
24 Intussusception within 31 days after administration of:
Invaginacija v 31 dneh po
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
17 V spodnji tabeli je prikazana učinkovitost zaščite cepiva med prvim in drugim letom življenja po aplikaciji dveh odmerkov cepiva Rotarix:
1st year of life
Drugo leto življenja Prvo leto življenja Rotarix N=2. 554; Rotarix N=2. 572; Placebo N=1. 294 (§) Placebo N=1. 302 (§) Učinkovitost cepiva (%) proti rotavirusnemu gastroenteritisu katerekoli jakosti in proti hudemu rotavirusnemu gastroenteritisu [95% IZ]
Rotarix N=2554;
Hud †
Severe† Any sev
Katerakoli jakost
G9P[8]
Sevi s P[ 8]
Strains with P[8] genotype Circulating rotavirus strains
rotavirusov
A clinical study performed in Latin America evaluated Rotarix in more than 20000 subjects.
18 Klinična študija, izvedena v Latinski Ameriki, je cepivo Rotarix ovrednotila pri več kot 20000 osebah.
26 * In these studies, the point estimates and confidence intervals were respectively:
20, 1; 91, 1). * Ocenjene vrednosti in intervali zaupanja iz teh študij:
The following table shows the percentage of subjects with serum anti-rotavirus IgA antibody titers ≥20U/ml (by ELISA) one to two months after the second dose of vaccine or placebo as observed in different studies with Rotarix lyophilised formulation.
19 V spodnji tabeli so prikazani odstotki oseb, pri katerih je bil en ali dva meseca po aplikaciji drugega odmerka cepiva ali placeba v različnih študijah liofilizirane oblike cepiva Rotarix dosežen titer serumskih protirotavirusnih IgA protiteles ≥ 20 E/ ml (ELISA).
3.5
3 in 4 mesec
3, 4 months
Češka
1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a tip seal and a tube cap (polypropylene) in pack sizes of 1, 10 or 50.
Velikosti pakiranja po 1, 10 ali 50.
Pull off the cap from the top of the tube.
S tube odstranite zaporko.
Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.
Zaporko obrnite in jo pokončno namestite na zataljeno konico tube kot je prikazano na sliki.
Twist the cap to remove the tip seal (do not snap it off) leaving a hole through which the vaccine can be expelled.
Zaporko zavrtite in tako odstranite zataljeno konico (pazite, da je ne odlomite), da ostane luknjica skozi katero boste iztisnili cepivo.
Ensure that the tip seal has been properly removed.
Prepričajte se, da ste zataljeno konico pravilno odstranili.
A hole should be clearly visible at the tip of the tube and the tip seal should be inside the top of the tube cap.
Luknjica na konici tube mora biti jasno vidna, zataljena konica pa mora ostati znotraj vrhnjega dela zaporke.
In the event that the tip seal is accidentally pushed into the tube, discard the vaccine.
Če zataljeno konico tube po nesreči potisnete v tubo, cepivo zavrzite.
This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine.
To je le previdnostni ukrep, saj je malo verjetno, da bi zataljeno konico pri aplikaciji cepiva iztisnili iz tube.
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the tube by gently squeezing the tube several times.
Celotno vsebino tube iztisnite v otrokova usta (npr. na notranjo stran lica) tako, da večkrat nežno pritisnete na tubo.
(A residual drop may remain in the tip of the tube).
(Po aplikaciji lahko v konici tube ostane kapljica).
Tip seal
Zaporka tube
Pull off the cap from the top of the tube.
Zataljena konica Tuba
Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.
S tube odstranite zaporko. namestite na zataljeno konico tube kot je prikazano na sliki.
Tube tip
21 Konica tube
Tip seal
Zataljena konica tube
29 ANNEX II
22 DODATEK II
30 A.
23 A.
Rue de l’ Institut 89 1330 Rixensart Belgium
Rue de l’ Institut 89, 1330 Rixensart Belgija
Rue de l’Institut 89 1330 Rixensart Belgium
Rue de l’ Institut 89, 1330 Rixensart Belgija
The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila vzpostaviti sistem farmakovigilance, kot je opisan v različici 3 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, in ga vzdrževati ves čas trženja zdravila.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, ki so podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4 načrta za obvladovanje tveganja (RMP) v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet z zdravilom in vse naknadne dopolnitve načrta za obvladovanje tveganja v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja mora biti posodobljen načrt za obvladovanje tveganja predložen sočasno z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted
24 Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti:
- When new information is received that may impact on the current Safety Specification,
- če se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance
Pharmacovigilance Plan or risk minimisation activities
ali aktivnosti za zmanjševanje tveganja.
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem
reached
tveganja).
32 ANNEX III
25 DODATEK III
33 A.
26 A.
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING GLASS CONTAINER WITH ORAL APPLICATOR AND TRANSFER ADAPTER, PACK SIZE OF 1, 5, 10 OR 25
27 PODATKI NA ZUNANJI OVOJNINI STEKLENIČKA Z PERORALNIM APLIKATORJEM IN NASTAVKOM ZA PRENOS, VELIKOST PAKIRANJA 1, 5, 10 ALI 25
Powder and solvent for oral suspension
Prašek in vehikel za peroralno suspenzijo 1 steklen vsebnik: prašek 1 peroralni aplikator: vehikel 1 nastavek za prenos 1 odmerek (1 ml)
1 glass container: powder 1 oral applicator: solvent 1 transfer adapter 1 dose (1 ml) 5 glass containers: powder 5 oral applicators: solvent 5 transfer adapters 5 x 1 dose (1 ml)
5 steklenih vsebnikov: prašek 5 peroralnih aplikatorjev: vehikel 5 nastavkov za prenos 5 x 1 odmerek (1 ml)
Oral use Do not inject!
Ne injicirajte!
35 Shake before use Read the package leaflet before use
28 Pred uporabo pretresite Pred uporabo preberite priloženo navodilo
Rue de l’Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Belgija
EU/1/05/330/001 – pack of 1 (glass container + oral applicator + transfer adapter) EU/1/05/330/002 – pack of 5 (glass container + oral applicator + transfer adapter) EU/1/05/330/003 – pack of 10 (glass container + oral applicator + transfer adapter) EU/1/05/330/004 – pack of 25 (glass container + oral applicator + transfer adapter)
EU/ 1/ 05/ 330/ 001 – pakiranje po 1 (steklenička + peroralni aplikator + nastavek za prenos) EU/ 1/ 05/ 330/ 002 – pakiranje po 5 (steklenička + peroralni aplikator + nastavek za prenos) EU/ 1/ 05/ 330/ 003 – pakiranje po 10 (steklenička + peroralni aplikator + nastavek za prenos) EU/ 1/ 05/ 330/ 004 – pakiranje po 25 (steklenička + peroralni aplikator + nastavek za prenos)
36 15.
29 15.
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER
30 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PERORALNI APLIKATOR Z VEHIKLOM ZA REKONSTITUCIJO S PRAŠKOM
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT
31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH STEKLENIČKA S PRAŠKOM, KI SE GA REKONSTITUIRA Z VEHIKLOM
Rotarix Powder for oral suspension Rotavirus vaccine, live Oral use
Rotarix Prašek za peroralno suspenzijo Cepivo proti rotavirusom, živo Peroralna uporaba
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PERORALNI APLIKATOR Z VEHIKLOM ZA REKONSTITUCIJO S PRAŠKOM
Solvent for Rotarix Oral use
Vehikel za Rotarix Peroralna uporaba
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25
33 PODATKI NA ZUNANJI OVOJNINI NAPOLNJENI PERORALNI APLIKATOR, VELIKOST PAKIRANJA 1, 5, 10 ALI 25
1 dose (1.5 ml) contains:
1 odmerek (1, 5 ml) vsebuje:
Human rotavirus RIX4414 strain (live, attenuated)
ne manj kot 106. 0 CCID50 Humani rotavirus, sev RIX4414 (živ, atenuiran)
Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Peroralna suspenzija v napolnjenem peroralnem aplikatorju 1 napolnjen peroralni aplikator 1 odmerek (1, 5 ml)
5 pre-filled oral applicators 5 x 1 dose (1.5 ml)
5 napolnjenih peroralnih aplikatorjev 5 x 1 odmerek (1, 5 ml)
10 pre-filled oral applicators 10 x 1 dose (1.5 ml)
10 napolnjenih peroralnih aplikatorjev 10 x 1 odmerek (1, 5 ml)
25 pre-filled oral applicators 25 x 1 dose (1.5 ml)
25 napolnjenih peroralnih aplikatorjev 25 x 1 odmerek (1, 5 ml)
41 Ready to use No reconstitution required
Rekonstitucija ni potrebna.
EU/0/00/000/000 – pack of 1 pre-filled oral applicator EU/0/00/000/000 – pack of 5 pre-filled oral applicators EU/0/00/000/000 – pack of 10 pre-filled oral applicators EU/0/00/000/000 – pack of 25 pre-filled oral applicators
EU/ 0/ 00/ 000/ 000 – pakiranje z 1 napolnjenim peroralnim aplikatorjem EU/ 0/ 00/ 000/ 000 – pakiranje s 5 napolnjenimi peroralnimi aplikatorji EU/ 0/ 00/ 000/ 000 – pakiranje s 10 napolnjenimi peroralnimi aplikatorji EU/ 0/ 00/ 000/ 000 – pakiranje s 25 napolnjenimi peroralnimi aplikatorji
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUBE, PACK SIZES OF 1, 10 OR 50
35 PODATKI NA ZUNANJI OVOJNINI TUBA, VELIKOST PAKIRANJA 1, 5 ALI 50
Oral suspension 1 tube 1 dose (1.5 ml)
Peroralna suspenzija 1 tuba 1 odmerek (1, 5 ml)
10 tubes 10 x 1 dose (1.5 ml)
10 tub 10 x 1 odmerek (1, 5 ml)
50 tubes 50 x 1 dose (1.5 ml)
50 tub 50 x 1 odmerek (1, 5 ml)
43 FOR ORAL USE ONLY
LE ZA PERORALNO UPORABO
EU/0/00/000/000 – pack of 1 tube EU/0/00/000/000 – pack of 10 tubes EU/0/00/000/000 – pack of 50 tubes
EU/ 0/ 00/ 000/ 000 – pakiranje z 1 tubo EU/ 0/ 00/ 000/ 000 – pakiranje z 10 tubami EU/ 0/ 00/ 000/ 000 – pakiranje s 50 tubami
44 16.
37 16.
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS PRE-FILLED ORAL APPLICATOR
38 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU NAPOLNJENI PERORALNI APLIKATOR
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED ORAL APPLICATOR
39 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENI PERORALNI APLIKATOR
Rotarix Oral suspension Rotavirus vaccine, live Oral use
Rotarix Peroralna suspenzija Cepivo proti rotavirusom, živo Peroralna uporaba
1 dose (1.5 ml)
1 odmerek (1, 5 ml)
47 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE
40 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH TUBA
48 B.
41 B.
Read all of this leaflet carefully before your child receives this vaccine.
Preden bo vaš otrok prejel cepivo natančno preberite navodilo.
Do not pass it on to others.
- Cepivo je bilo predpisano vašemu otroku osebno in ga ne smete dajati drugim.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Če kateri koli neželeni učinek postane resen ali če opazite kateri koli neželeni učinek, ki ni omenjen v
What Rotarix is and what it is used for 2.
Kaj je cepivo Rotarix in za kaj ga uporabljamo 2.
Before your child receives Rotarix 3.
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Rotarix 3.
How Rotarix is given 4.
Kako se cepivo Rotarix uporablja 4.
How to store Rotarix 6.
Shranjevanje cepiva Rotarix 6.
WHAT ROTARIX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO ROTARIX IN ZA KAJ GA UPORABLJAMO
BEFORE YOUR CHILD RECEIVES ROTARIX
KAJ MORATE VEDETI, PREDEN BO VAŠ OTROK PREJEL CEPIVO ROTARIX
Rotarix should not be given: • if your child has previously had any allergic reaction to rotavirus vaccines or any component contained in Rotarix.
Vaš otrok cepiva Rotarix ne sme prejeti: • če je predhodno imel kakršno koli alergijsko reakcijo na cepiva proti rotavirusom ali katero koli sestavino cepiva Rotarix.
The active substances and other ingredients in Rotarix are listed at the end of the leaflet.
Zdravilne učinkovine in druge sestavine cepiva Rotarix so navedene na koncu tega navodila.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment). • if your child was born with a malformation of the gut that could lead to intussusception. • if your child has any disease which reduces his/her resistance to infection. • if your child has a severe infection with a high temperature.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in otekanje obraza ali jezika. • če je predhodno imel invaginacijo črevesja (črevesno zaporo pri kateri se en del črevesja uviha v drugega). • če se je rodil z nepravilnostjo črevesja, ki bi lahko povzročila invaginacijo. • če ima katero koli bolezen, ki zmanjšuje odpornost na okužbe. • če ima hujšo okužbo s povišano telesno temperaturo.
It might be necessary to postpone the vaccination until recovery.
Cepljenje bo morda treba odložiti dokler ne bo ozdravel.
A minor infection such as a cold should not be a problem, but talk to your doctor first. • if your child has diarrhoea or is vomiting.
Blažja okužba, kot je npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem vseeno pogovorite z zdravnikom. • če ima drisko ali bruha.
50 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
V tem primeru ni znano kakšen nivo zaščite se lahko doseže s cepivom.
Using other vaccines Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Uporaba drugih cepiv Obvestite svojega zdravnika, če vaš otrok jemlje ali je pred kratkim jemal katero koli zdravilo, tudi če ste ga dobili brez recepta, ali če je bil pred kratkim cepljen s katerim koli cepivom.
Using Rotarix with food and drink There are no restrictions on your child’s consumption of food or liquids, either before or after vaccination.
Uporaba cepiva Rotarix skupaj s hrano in pijačo Otrok lahko pred in po cepljenju brez omejitev uživa tako hrano kot tekočine.
Breast-feeding Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Dojenje Dokazi, pridobljeni med kliničnimi preskušanji kažejo, da dojenje ne zmanjša zaščite pred rotavirusnim gastroenteritisom, ki se jo doseže s cepivom Rotarix.
Important information about some of the ingredients of Rotarix If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before using this vaccine.
Pomembne informacije o nekaterih sestavinah cepiva Rotarix Če veste, da vaš otrok ne prenaša določenih sladkorjev o tem obvestite zdravnika, preden otrok prejme cepivo.
HOW ROTARIX IS GIVEN
KAKO SE CEPIVO ROTARIX UPORABLJA
Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses.
Med obema odmerkoma mora miniti vsaj 4 tedne.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age.
Oba odmerka cepiva mora prejeti preden dopolni 24 tednov, najbolje pa je, da ju prejme že pred dopolnjenim 16 tednom starosti.
When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.
Če je otrok prejel prvi odmerek cepiva Rotarix priporočamo, da prejme tudi drugi odmerek cepiva Rotarix (in ne drugo cepivo proti rotavirusom).
51 Like all medicines, Rotarix can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Rotarix neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
Side effects that occurred during clinical trials with Rotarix were as follows:
44 Med kliničnim preskušanjem cepiva Rotarix so se pojavili naslednji neželeni učinki:
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
♦ Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri 1 na 10 odmerkov cepiva ali več):
♦ Common (These may occur with up to 1 in 10 doses of the vaccine): • fever, tiredness • diarrhoea, vomiting, regurgitation of food, flatulence, abdominal pain
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 10 odmerkov cepiva):
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): • crying • sleep disorder, sleepiness • constipation
♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 100 odmerkov cepiva):
♦ Rare (These may occur with up to 1 in 1,000 doses of the vaccine): • infection of the upper respiratory system, hoarseness, runny nose • inflammation of the skin, rash • muscle cramp
♦ Redki (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 1. 000 odmerkov cepiva):
HOW TO STORE ROTARIX
SHRANJEVANJE CEPIVA ROTARIX
Do not use Rotarix after the expiry date which is stated on the carton.
Cepiva Rotarix ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
After reconstitution, the vaccine contained in the oral applicator should be administered promptly.
Po rekonstituciji je treba cepivo v peroralnem aplikatorju nemudoma aplicirati.
What Rotarix contains
Kaj vsebuje cepivo Rotarix
- The active substances are:
- Zdravilna učinkovina je:
- The other ingredients in Rotarix are:
- Pomožne snovi cepiva Rotarix so: