FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia.
Maltese: Provi kliniċi tal-effikaċja kontra gastroenterite minħabba rotavirus saru fl-Ewropa, l-Istati Uniti, l-Amerika Latina u l-Asja.
English: It is preferable that the vaccination course of three doses should be completed by the age of 20-22 weeks.
Maltese: Huwa ppreferut li l-kors ta' tilqim ta' tliet dożi jitlesta sal-età ta' 20-22 ġimgħa.
English: RotaTeq oral solution Rotavirus vaccine, live
Maltese: RotaTeq soluzzjoni orali Tilqima ta' rotavirus, ћaj
English: • Not known (frequency cannot be estimated from the available data): irritability
Maltese: • Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli): irritabilità
English: See section 6.6 for administration instructions.
Maltese: Ara sezzjoni 6.6 gћal istruzzjonijiet dwar kif għandu jingħata.
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose, assorbiment ħażin ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din ittilqima.
English: In addition, there was no statistically significant increased risk of this adverse event during the 0-30 day follow-up period compared with a concurrent control group of infants who received DTaP, but not RotaTeq (n=62,617, 12,339 person-years of follow-up).
Maltese: Flimkien ma' dan, ma kien hemm l-ebda żieda statistikament sinifikanti fir-riskju ta' dan ilkaż avvers waqt il-perjodu minn 0-30 jum fejn il-persuna ġiet segwita wara t-trattament meta mqabbel ma' grupp ta' kontroll ta' trabi li fl-istess ħin irċivew DTaP, iżda mhux RotaTeq (n=62,617, 12,339 sena ta' persuna segwita wara t-trattament).
English: Tel.: +48.22.549.51.00 msdpolska@merck.com
Maltese: MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com
English: * Severe defined as a score >16/24 using a validated clinical scoring system based on the intensity and duration of symptoms (fever, vomiting, diarrhoea and behavioural changes) Statistically significant
Maltese: * Sever huwa definit bħala punteġġ ta' > 16/24 meta tintuża sistema vvalidata ta' punteġġ kliniku bbażata fuq l-intensità u t-tul ta' żmien tas-sintomi (deni, rimettar, dijarea u bidla fl-imġiba)
English: Do not use RotaTeq if:
Maltese: Tużax RotaTeq jekk:
English: Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years post-vaccination (RotaTeq n=34,035) (% [95 % CI])
Maltese: Tnaqqis fin-numru ta' pazjenti rikoverati l-isptar/żjarat fid-dipartiment tal-emerġenza għal gastroenterite minħabba RV sa sentejn wara t-tilqima (RotaTeq n=34,035) % [95 % CI]
English: Serious adverse reactions were assessed in all participants (36,150 recipients of RotaTeq and 35,536 placebo recipients) of 3 clinical trials for up to 42 days after each dose.
Maltese: Reazzjonijiet avversi serji kienu stmati fil-parteċipanti kollha (36,150 persuna li rċivew RotaTeq u 35,536 persuna li rċivew plaċebo) ta' 3 provi kliniċi sa 42 jum wara kull doża.
English: 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.
Maltese: Ir-riskju potenzjali ta' apnea u l-ħtieġa għal monitoraġġ respiratorju għal 48-72 siegħa għandhom jiġu kkunsidrati meta tingħata s-serje ta' immunizzazzjoni primarja lil trabi prematuri ħafna (li twieldu ≤28 ġimgħa ta' ġestazzjoni) u partikularment għal dawk bi storja preċedenti ta' immaturità respiratorja.
English: In a combined post-hoc analysis of REST and another phase III study, the vaccine efficacy against G1, G2-, G3- and G4-serotype RVG cases (any severity) was 61.5 % [95 % CI: 14.2; 84.2] among infants who were >26 to ≤32 weeks of age at dose 3.
Maltese: III, l-effikaċja tat-tilqima kontra każijiet (kwalunkwe qawwa) ta' RVG tas-serotipi G1, G2, G3 u G4 kienet ta' 61.5 % [95 %CI: 14.2; 84.2] fost trabi li kellhom età ta' >26 sa ≤32 ġimgħa meta ngħataw it-3 doża.
English: Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8).
Maltese: Trabi li gћandhom, jew li hemm suspett li gћandhom immunodefiċjenza (ara sezzjonijiet 4.4 u 4.8).
English: Date of first authorisation: 27 June 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Ġunju 2006
English: When an infant is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Maltese: Meta tarbija tingħata t-tilqima, is-sistema immuni (id-difiża naturali tal-ġisem) tipproduċi antikorpi kontra t-tipi laktar komuni ta' rotavirus.
English: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 info@msd.fi
Maltese: +358 (0)9 804 650 info@msd.fi
English: G4 2.0 x 10
Maltese: 2.0 x 10
English:  2.0 x 10 6 IU
Maltese:  2.0 x 10 6
English: It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Maltese: Huwa importanti li ibnek/bintek jirċievu t-3 dożi kollha tat-tilqima għall-protezzjoni kontra rotavirus.
English: In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Maltese: Fi studju kliniku, RotaTeq ingħata lil madwar 1,000 tarbija li twieldu f'età ta' ġestazzjoni ta' 25 sa 36 ġimgħa.
English: Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants with severe combined immunodeficiency (SCID, see section 4.3).
Maltese: Każijiet ta' gastroenterite assoċjata mal-virus tat-tilqima ġew irrappurtati wara t-tqegħid fis-suq fi trabi b'immunodefiċjenza kkombinata severa (SCID, severe combined immunodeficiency ara sezzjoni 4.3).
English: In 68,038 vaccinated infants (34,035 in the vaccine group) protective efficacy was measured as a reduction in the rate of hospitalisations and emergency department visits for RV gastroenteritis from 14 days after the third dose.
Maltese: Fi 68,038 tarbija mlaqqma (34,035 fil-grupp tat-tilqima), l-effikaċja protettiva ġiet imkejla bħala tnaqqis fir-rata ta' pazjenti rikoverati l-isptar u żjarat fid-dipartiment tal-emerġenza għal gastroenterite minħabba RV minn 14-il ġurnata wara t-tielet doża.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Co-administration of RotaTeq with a group C meningococcal conjugate vaccine (MenCC, the vaccine studied was a tetanus toxoid conjugate) at 3 and 5 months of age (and mostly at the same time as DTaP-IPV-Hib vaccine), followed by a third dose of RotaTeq at approximately 6 months of age, demonstrated that the immune responses to RotaTeq and MenCC were unaffected.
Maltese: L-għoti ta' RotaTeq flimkien ma' tilqima konjugata tal-meningococcus tal-grupp Ċ (MenCC, ittilqima studjata kienet konjugat tat-tossojdi tat-tetnu) fl-età ta' 3 u 5 xhur (u l-aktar fl-istess żmien tattilqima DTaP-IPV-Hib), segwita mit-tielet doża ta' RotaTeq fl-età ta' madwar 6 xhur, wera li r-rispons immuni għal RotaTeq u MenCC ma ġiex affettwat.
English: Intussusception
Maltese: Intussuxxezzjoni
English: Upper respiratory tract infection
Maltese: Infezzjonijiet fin-naħa ta' fuq tal-apparat respiratorju
English: Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %.
Maltese: Ibbażat fuq dejta miġbura minn 3 provi klinici fejn 6,130 tarbija rċivew RotaTeq u 5,560 tarbija rċivew plaċebo, ir-reazzjonijiet avversi mniżżla seħħew f'persuni li rċivew RotaTeq b'inċidenzi eċċessivi ta' bejn 0.2 % u 2.5 % meta mqabbla ma' persuni li rċivew plaċebo.
English: RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
Maltese: Dawn l-antikorpi jipproteġu kontra gastroenterite kkawżata minn dawn ittipi ta' rotavirus.
English: No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large postmarketing observational safety surveillance study (see section 5.1).
Maltese: Kawasaki fost trabi li kienu qed jirċievu RotaTeq fi studju kbir ta' osservazzjoni ta' sorveljanza tassigurtà wara t-tqegħid fis-suq (ara sezzjoni 5.1).
English: Instructions
Maltese: LISTA
English: Rotavirus vaccine, live
Maltese: Tilqima tar-rotavirus, ћaj
English: During the 0-30 day follow-up period after vaccination, there were no statistically significant difference in the rate of Kawasaki disease compared with the expected background rate.
Maltese: Waqt il-perjodu minn 0-30 jum ta' segwitu wara t-tilqim, ma kien hemm l-ebda differenza statistikament sinifikanti fir-rata tal-marda ta' Kawasaki meta mqabbla mar-rata mistennija f'ambjent normali.
English: Package Leaflet: Information for the user RotaTeq oral solution Rotavirus vaccine, live
Maltese: Informazzjoni għall-utent RotaTeq soluzzjoni orali Tilqima ta' rotavirus, ћaj
English: The background incidence of intussusception in infants less than one year of age in these countries ranged from 25 to 101 per 100,000 infants per year.
Maltese: Linċidenza ta' intussuxxezzjoni f'ambjent normali fi trabi b'età inqas minn sena f'dawn il-pajjiżi kienet tvarja minn 25 sa 101 għal kull 100,000 tarbija kull sena.
English: During year 3, there were no health care contacts for RV gastroenteritis in the vaccine group (n=3,112) and one (non-typeable) in the placebo group (n=3,126).
Maltese: Matul sena 3, fil-qasam tal-kura tas-saħħa ma kien hemm l-ebda kuntatt ma' gastroenterite dovuta għal RV fil-grupp tat-tilqima (n=3,112) u każ wieħed (tip ma setax jingħaraf) fil-grupp tal-plaċebo (n=3,126).
English: In phase III studies between 92.5 % and 100 % of recipients of RotaTeq achieved a significant rise in serum anti-rotavirus IgA after a three-dose regimen.
Maltese: III, bejn 92.5 % u 100 % tal-persuni li rċivew RotaTeq kisbu żieda sinifikanti f'anti-rotavirus
English: It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 32 weeks.
Maltese: Huwa preferibbli li t-tliet dożi jingħataw sal-età ta' 20-22 ġimgħa u t-tliet dożi għandhom jingħataw sa mhux aktar tard mill-età ta' 32 ġimgħa.
English: G2 2.8 x 10
Maltese: 2.8 x 10
English: G3 2.2 x 10
Maltese:  2.2 x 10
English: 4.8 Undesirable effects a. Summary of the safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: rotavirus type* G1
Maltese: rotavirus tip* G1
English: In REST there were 403 healthcare encounters (20 in the vaccine group and 383 in the placebo group) associated with G1-G4 and G9 RV gastroenteritis in the per protocol population.
Maltese: F'REST il-qasam tal-kura tas-saħħa ġie f'kuntatt ma' 403 każijiet (20 fil-grupp tat-tilqima u 383 fil-grupp tal-plaċebo) li kienu assoċjati ma' gastroenterite b'RV G1-G4 u G9 skont ilpopolazzjoni tal-protokoll.
English: RV seasons
Maltese: Staġuni ta' RV
English: Hospitalization and Emergency Department (ED) visits due to RVGE
Maltese: Rikoverar fl-isptar u visti fidDipartiment tal-Emerġenza (ED - Emergency Department) minħabba RVGE
English: rotavirus type* G3
Maltese: rotavirus tip* G3
English: Co-administration of RotaTeq with vaccines containing one or more of the following antigens at approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected: - Diphtheria-tetanus-acellular pertussis vaccine (DTaP) - Haemophilus influenzae type b vaccine (Hib) - Inactivated poliomyelitis vaccine (IPV) - Hepatitis B vaccine (HBV) - Pneumococcal conjugate vaccine (PCV)
Maltese: - Tilqima tad-Diphteria-tetanus-acellular pertussis (DTaP) - Tilqima tal-Haemophilus influenzae tat-tip b (Hib) - Tilqima inattivata tal-poljomelite (IPV) - Tilqima tal-epatite B (HBV) - Tilqima konjugata tal-pneumococcus (PCV).
English: Discard the empty tube and cap in approved biological waste containers according to local regulations.
Maltese: Armi t-tubu vojt u l-għatu f'reċipjenti tal-iskart bijoloġiku approvati skont irregolamenti lokali.
English: No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.
Maltese: L-ebda dejta klinika mhija disponibbli fuq l-użu ta' RotaTeq għall-profilassi wara esponiment.
English: rotavirus type* G4
Maltese: rotavirus tip* G4
English: Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, with up to 6 additional cases per 100,000 infants within 7 days of vaccination.
Maltese: Dejta minn studji ta' osservazzjoni dwar is-sigurtà li saru f'diversi pajjiżi jindikaw li l-vaċċini tarrotavirus iżidu r-riskju ta' intussuxxezzjoni, b'sa 6 każijiet addizzjonali għal kull 100,000 tarbija fi żmien 7 ijiem mit-tilqima.
English: rotavirus type* G2
Maltese: rotavirus tip* G2
English: The first dose (2 ml) of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months).
Maltese: L-ewwel doża (2 ml) ta' RotaTeq tista' tingħata minn età ta' 6 ġimgħat u trid tingħata qabel l-età ta' 12-il ġimgħa (bejn wieħed u ieħor 3 xhur).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: No safety or efficacy data are available from clinical trials regarding administration of RotaTeq to immunocompromised infants, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing.
Maltese: M'hemm l-ebda dejta disponibbli minn provi kliniċi dwar is-sigurtà u l-effikaċja rigward l-għoti ta' RotaTeq lil trabi immunokompromessi, trabi infettati bl-HIV jew trabi li rċivew trasfużjoni tad-demm jew immunoglobulini fi żmien 42 ġurnata mid-dożaġġ.
English:  2.8 x 10 6 IU
Maltese:  2.8 x 10 6
English:  2.3 x 10 6 IU
Maltese:  2.3 x 10 6
English: How to use RotaTeq
Maltese: RotaTeq QATT
English: Effectiveness study data Post marketing studies demonstrating effectiveness to prevent RV gastroenteritis (RVGE)
Maltese: Studji ta' wara t-tqegħid fis-suq li juru l-effikaċja biex tiġi evitata gastroenterite kkawżata minn RV (RVGE - RV gastroenteritis)
English: Do not dilute.
Maltese: Ilma ppurifikat
English: In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Maltese: F'REST, RotaTeq ingħata lil madwar 1,000 tarbija li twieldu f'età ta' ġestazzjoni ta' 25 sa 36 ġimgħa.
English: 6 Infectious Units
Maltese: 6 Unitajiet tal-Infezzjoni
English: Country:
Maltese: Pajjiż:
English: Although concomitant administration of OPV slightly reduced the immune response to rotavirus vaccine, there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected.
Maltese: Għalkemm l-għoti ta' OPV ma' RotaTeq naqqas xi ftit ir-rispons immuni għat-tilqima tar-rotavirus, attwalment m'hemmx evidenza li l-protezzjoni klinika kontra gastroenterite akuta kkawżata minn rotavirus se tkun affettwata.
English: From 6 weeks to 32 weeks
Maltese: Minn 6 ġimgħat sa 32 ġimgħa
English: Angioedema
Maltese: FARMAĊEWTIKU
English: D. CONDITION OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not completely understood.
Maltese: Il-mekkaniżmu immunoloġiku li bih RotaTeq jipproteġi kontra gastroenterite tar-rotavirus mhuwiex mifhum għal kollox.
English: One chart-confirmed case was recorded among infants vaccinated with RotaTeq compared with one chart-confirmed case among concurrent DTaP controls (relative risk = 0.7, 95 % CI: 0.01-55.56).
Maltese: Każ wieħed ikkonfermat permezz ta' chart kien dokumentat fost trabi mlaqqmin b'RotaTeq meta mqabbel ma' każ wieħed ikkonfermat permezz ta' chart fost kontrolli li fl-istess ħin minflok ħadu DTaP (riskju relattiv = 0.7, 95 % CI: 0.
English: Co-administration resulted in an acceptable safety profile.
Maltese: L-għoti tagħhom flimkien irriżulta fi profil ta' sigurtà aċċettabbli.
English: RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3).
Maltese: RotaTeq huwa tilqima orali li tgħin biex tipproteġi lit-trabi u tfal żgħar kontra gastroenterite (dijarea u rimettar) ikkawżata minħabba infezzjoni b'rotavirus u tista' tingħata lit-trabi mill-età ta' 6 ġimgħat saletà ta' 32 ġimgħa (ara sezzjoni 3).
English: The overall frequency of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo recipients.
Maltese: Il-frekwenza globali ta' dawn ir-reazzjonijiet avversi serji kienet ta' 0.1 % fost il-persuni li rċivew RotaTeq u ta' 0.2% fost ilpersuni li rċivew plaċebo.
English: Uncommon Rash
Maltese: TAGĦRIF
English: Tel: +385 1 66 11 333 croatia_info@merck.com
Maltese: Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com
English: There should be intervals of at least 4 weeks between doses.
Maltese: Għandu jkun hemm intervalli ta' mill-inqas 4 ġimgћat bejn id-dożi.
English: Co-administration of RotaTeq with DTaP-IPV-HBV-Hib vaccine (Infanrix hexa) at approximately 2, 3, and 4 months of age demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected compared to separate administrations.
Maltese: L-għoti ta' RotaTeq flimkien mat-tilqima DTaP-IPV-HBV-Hib (Infanrix hexa) fl-età ta' madwar 2, 3 u 4 xhur wera li r-risponsi immuni u l-profili tas-sigurtà tat-tilqim mogħti fl-istess waqt ma ġewx affettwati meta mqabbla ma' għotjiet separati.
English: From birth to 6 weeks RotaTeq is not indicated in this subset of paediatric population.
Maltese: Mit-twelid sa 6 ġimgħat RotaTeq mhux indikat f'dan is-sottosett tal-popolazzjoni pedjatrika.
English: Uncommon Haematochezia †, Abdominal pain upper
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination with or without concomitant use of other paediatric vaccines.
Maltese: F'sottosett ta' trabi minn 3 provi kliniċi kkontrollati bi plaċebo (n=6,130 persuna li rċivew RotaTeq u 5,560 persuna li rċivew plaċebo), RotaTeq ġie evalwat għall-effetti avversi kollha fi żmien 42 ġurnata mit-tilqima kemm bl-użu u mingħajr użu flimkien ta' tilqim pedjatriku ieħor.
English: 2 ml solution in a pre-filled squeezable tube (LDPE), with a twist-off cap (HDPE) in a protective bag, pack size of 1 or 10 pre-filled squeezable tube(s).
Maltese: 2 ml soluzzjoni f'tubu li jingħafas mimli għal-lest (LDPE), b'għatu twist-off (HDPE) f'borża ta' protezzjoni, daqs tal-pakkett ta' tubu 1 jew ta' 10 tub(i) mimli(jin) għal-lest li jingħafas(su).
English: If you forget an appointment for RotaTeq:
Maltese: Jekk tinsa appuntament għal RotaTeq:
English: not less than 2.2 x 10 6 IU
Maltese: mhux inqas minn 2.2 x 10 6
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BH02.
Maltese: Tilqim, Tilqima Virali Kodiċi ATC:
English: Open the dosing tube in 2 easy motions:
Maltese: Biex tagħti t-tilqima:
English: During these trials, the most common circulating rotavirus genotype was G1P[8], while rotavirus genotypes G2P[4], G3P[8], G4P[8], and G9P[8] were identified less often.
Maltese: Waqt dawn il-provi, l-iktar ġenotip komuni ta' rotavirus li jiċċirkola kien G1P[8], waqt li l-ġenotipi ta' rotavirus G2P[4], G3P[8], G4P[8], u G9P[8] ġew identifikati inqas ta' spiss.
English: not less than 2.3 x 10 6 IU
Maltese: mhux inqas minn 2.3 x 10 6
English: UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com
Maltese: +370.5.2780.247 msd_lietuva@merck.com
English: not less than 2.8 x 10 6 IU
Maltese: mhux inqas minn 2.8 x 10 6
English: As no data exist regarding the interchangeability of RotaTeq with another rotavirus vaccine, it is recommended that infants who receive RotaTeq for the first immunisation against rotavirus should receive this same vaccine for the subsequent doses.
Maltese: Minћabba li m'hemm l-ebda dejta eżistenti dwar jekk tistax tibdel RotaTeq ma' xi tilqima oħra ta' rotavirus, huwa rrakkomandat li trabi li jirċievu RotaTeq gћall-ewwel immunizzazzjoni kontra rotavirus jirċievu din l-istess tilqima għad-dożi sussegwenti.
English: • Bronchospasm (rare, may affect up to 1 in 1000 infants).
Maltese: • Bronkospażmu (rari, jista' jaffettwa sa tarbija waħda minn kull 1,000).
English: In general, the adverse event profile reported with overdose was comparable to that observed with recommended doses of RotaTeq.
Maltese: B'mod ġenerali, il-profil ta' avvenimenti avversi rrappurtat b'doża eċċessiva kien kumparabbli ma' dak osservat bid-dożi rrakkomandati ta' RotaTeq.
English: If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.
Maltese: Jekk qalulek li ibnek/bintek għandhom intolleranza għal xi tip ta' zokkor, informa littabib/professjonist fil-kura tas-saħħa qabel jingħataw it-tilqima.
English: • Uncommon (may affect up to 1 in 100 infants): stomach pains (see also above for signs of a very rare side effect of intussusception), runny nose and sore throat, ear infection, rash, blood in stool
Maltese: • Mhux komuni (jistgħu jaffettwaw sa tarbija waħda minn kull 100): uġigħ fl-istonku (ara wkoll hawn fuq għal sinjali ta' effett sekondarju rari ta' intussuxxezzjoni), imnieħer inixxi, u griżmejn juġgħu, infezzjoni fil-widnejn, raxx, demm mal-ippurgar
English: not less than 2.0 x 10 6 IU
Maltese: mhux inqas minn 2.0 x 10 6
English: Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) did not affect the immune response to the poliovirus antigens.
Maltese: L-għoti ta' RotaTeq flimkien ma' tilqima orali tal-poljomelite (OPV) m'affettwax ir-rispons immuni għall-antiġeni tal-virus tal-poljo.
English: A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical studies.
Maltese: Serje kompluta ta' 3 dożi tat-tilqima ta' RotaTeq għandha tingħata (ara sezzjoni 4.2) sabiex jintlaħaq il-livell u t-tul ta' żmien ta' protezzjoni kontra gastroenterite minn rotavirus li kienet osservata flistudji kliniċi.
English: What RotaTeq looks like and contents of the pack
Maltese: Kif jidher RotaTeq u l-kontenut tal-pakkett
English: These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Maltese: RotaTeq ma jipproteġix kontra gastroenterite minħabba patoġeni oħra għajr rotavirus.