FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Jevtana (li dehru f'aktar minn pazjent 1 minn kull 10) huma l-anemija (għadd baxx taċ-ċelloli tad-demm ħomor), lewkopenja (għadd baxx taċ-ċelloli taddemm bojod), newtropenja (għadd baxx ta' newtrofili, tip ta' ċellola tad-demm bajda), tromboċitopenja (għadd baxx ta' pjastrini fid-demm) u dijarea.
English: Jevtana is a cancer medicine used to treat men with metastatic castration-resistant prostate cancer.
Maltese: Jevtana huwa mediċina kontra l-kanċer li tintuża biex tikkura rġiel b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni.
English: Jevtana prolonged overall survival (the average length of time the patients lived) in one main study involving 755 men with metastatic castration-resistant prostate cancer who had previously been treated with docetaxel.
Maltese: Jevtana tawwal is-sopravivenza ġenerali (it-tul ta' żmien medju li għexu l-pazjenti) fi studju ewlieni wieħed li involva 755 raġel b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni li preċedentement kienu ġew ikkurati b'docetaxel.
English: Jevtana is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Maltese: Jevtana jintuża f'kombinazzjoni mal-prednisone jew mal-prednisolone (mediċini antiinfjammatorji) f'pazjenti li fil-passat kienu rċevew kura bid-docetaxel (mediċina oħra kontra l-kanċer).
English: It must not be given to patients whose blood neutrophil count is below 1,500/mm3, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.
Maltese: Lanqas ma għandu jingħata lil pazjenti li lgħadd ta' newtrofili fid-demm tagħhom ikun taħt l-1,500/mm3, li jkollhom funzjoni mnaqqsa b'mod serju fil-fwied jew li jkunu għadhom kif irċevew jew waslu biex jirċievu l-vaċċin tad-deni l-isfar.
English: Jevtana is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein.
Maltese: Jevtana jiġi bħala konċentrat u solvent biex jitħallat f'soluzzjoni għal infużjoni (dripp) fil-vina.
English: The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.
Maltese: Is-sopravivenza ġenerali medja għal pazjenti kkurati b'Jevtana kienet ta' 15.1 xhur apparagun ma' 12.7 xhur għal pazjenti li ngħataw il-mitoxantrone.
English: What are the risks associated with Jevtana?
Maltese: X'inhuma r-riskji assoċjati ma' Jevtana?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the ability of Jevtana to prolong overall survival in castration-resistant metastatic prostate cancer patients was clinically important.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonsidra li l-abbiltà ta' Jevtana biex itawwal is-sopravivenza ġenerali f'pazjenti b'kanċer metastatiku tal-prostata reżistenti għall-kastrazzjoni kien klinikament importanti.
English: It is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height).
Maltese: Jevtana jingħata darba kull tliet ġimgħat bħala infużjoni li ddum siegħa, f'doża ta' 25 mg kull metru kwadru talerja tas-superfiċje tal-ġisem (ikkalkulata permezz tal-piż u t-tul tal-pazjent).
English: For more information, see the package leaflet.
Maltese: Għal aktar informazzjoni, ara l-fuljett ta' tagħrif.
English: * PD50- 50% protective dose in cattle as described in Ph. Eur.
Maltese: *PD50: 50% doża protettiva fil-baqar kif deskritta fil-monografu Ph.Eur. 0063.
English: O Taiwan 3/97, A24 Cruzeiro and A Turkey
Maltese: O Taiwan 3/97, A24 Cruzeiro &
English: O1 Manisa, O Taiwan 3/97 and A Turkey
Maltese: O1 Manisa, O Taiwan 3/97 &
English: A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Maltese: A24 Cruzeiro u A Turkey 14/98 ≥ 6 PD50*
English: A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Maltese: A22 Iraq u A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa and O1 BFS ≥ 6 PD50*
Maltese: O1 Manisa u O1 BFS ≥ 6 PD50*
English: A Turkey 14/98 and Asia 1 Shamir ≥ 6 PD50*
Maltese: A Turkey 14/98 u Asia 1 Shamir ≥ 6 PD50*
English: A24 Cruzeiro and Asia 1 Shamir ≥ 6 PD50*
Maltese: A24 Cruzeiro u Asia 1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A Turkey 14/98 ≥ 6 PD50*
English: O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A22 Iraq ≥ 6 PD50*
English: O1 Manisa and A22 Iraq ≥ 6 PD50*
Maltese: O1 Manisa u A22 Iraq ≥ 6 PD50*
English: A24 Cruzeiro, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Maltese: A24 Cruzeiro u A Turkey 14/98 u Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa and A24 Cruzeiro ≥ 6 PD50*
Maltese: O1 Manisa u A24 Cruzeiro ≥ 6 PD50*
English: O Taiwan 3/97, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A Turkey 14/98 u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and A22 Iraq ≥ 6 PD50*
Maltese: O1 BFS u A22 Iraq ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A Turkey 14/98 ≥ 6 PD50*
Maltese: O1 BFS u O Taiwan 3/97 u A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Maltese: O1 Manisa u A24 Cruzeiro u A Turkey 14/98 ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Maltese: O1 BFS u O Taiwan 3/97 u A22 Iraq ≥ 6 PD50*
English: A22 Iraq, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Maltese: A22 Iraq u A24 Cruzeiro u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 BFS u A22 Iraq u Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A22 Iraq ≥ 6 PD50*
Maltese: O1 Manisa u O Taiwan 3/97 u A22 Iraq ≥ 6 PD50*
English: O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Maltese: O Taiwan 3/97 u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A24 Cruzeiro and A Turkey 14/98 ≥ 6 PD50*
Maltese: O1 BFS u A24 Cruzeiro u A Turkey 14/98 ≥ 6 PD50*
English: O Taiwan 3/97, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A24 Cruzeiro u Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 Manisa u O Taiwan 3/97 u Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 Manisa u Asia1 Shamir ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and Asia1 Shamir ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A22 Iraq u Asia1 Shamir ≥ 6 PD50*
English: SAT2 Saudi Arabia ≥ 6 PD50*
Maltese: Għarabja Sawdita ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Maltese: O1 BFS u O Taiwan 3/97 u A24 Cruzeiro ≥ 6 PD50*
English: O Taiwan 3/97, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Maltese: O Taiwan 3/97 u A22 Iraq u A24 Cruzeiro ≥ 6 PD50*
English: O1 BFS, A22 Iraq and A24 Cruzeiro ≥ 6 PD50*
Maltese: O1 BFS u A22 Iraq u A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa, O Taiwan 3/97 and A24 Cruzeiro ≥ 6 PD50*
Maltese: O1 Manisa u O Taiwan 3/97 u A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 Manisa u A24 Cruzeiro u Asia1 Shamir ≥ 6 PD50*
English: O1 Manisa, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 Manisa u A Turkey 14/98 u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 BFS u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, O Taiwan 3/97 and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 BFS u O Taiwan 3/97 u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A Turkey 14/98 and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 BFS u A Turkey 14/98 u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS, A24 Cruzeiro and Asia1 Shamir ≥ 6 PD50*
Maltese: O1 BFS u A24 Cruzeiro u Asia1 Shamir ≥ 6 PD50*
English: O1 BFS and A24 Cruzeiro ≥ 6 PD50*
Maltese: O1 BFSu A24 Cruzeiro ≥ 6 PD50*
English: O1 Manisa and A Turkey ≥ 6 PD50*
Maltese: O1 Manisa u A Turkey 14/98 ≥ 6 PD50*
English: O1 Manisa, O1 BFS and O Taiwan 3/97 ≥ 6 PD50*
Maltese: O1 Manisa u O Taiwan 3/97 ≥ 6 PD50*
English: O1 BFS and O Taiwan ≥ 6 PD50*
Maltese: O1 BFS u O Taiwan 3/97 ≥ 6 PD50*
English: O1 BFS and A Turkey ≥ 6 PD50*
Maltese: O1 BFS u A Turkey 14/98 ≥ 6 PD50*
English: ≥ 6 PD50*
Maltese: Shamir ≥ 6 PD50*
English: O1 Manisa and O Taiwan ≥ 6 PD50*
Maltese: O1 Manisa ≥ 6 PD50*
English: Telephone: Telefax:
Maltese: Telefax:
English: 1 dose (2 ml)
Maltese: 1 doża (2 ml)
English: Effectiveness % [95%CI]
Maltese: Effikaċja % [CI ta' 95%]
English: * See section 4.4.
Maltese: * Ara sezzjoni 4.4.
English: Store in a refrigerator (2 °C to 8 °C).
Maltese: Aħżen fi friġġ (2 °C sa 8 °C).
English: EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
Maltese: EU/1/06/348/001 pakkett ta' tubu wieħed EU/1/06/348/002 pakkett ta' 10 tubi
English: Date of latest renewal: 18 May 2011
Maltese: Data tal-aħħar tiġdid: 18 ta' Mejju 2011
English: 402 cases 2,559 controls* Aged <8 years Received 3 doses
Maltese: 402 każijiet 2,559 kontroll* B'età <8 snin Irċivew 3 dożi
English: rotavirus type* P1A[8]
Maltese: rotavirus tip* P1A[8]
English: Statistically significant
Maltese: Statistikament sinifikanti
English: Infectious Units As lower confidence limit (p = 0.95)
Maltese: Unitajiet Infettivi Bћala limitu baxx ta' kunfidenza (p = 0.95)
English: Telephone:
Maltese: Telefon:
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Maltese: Manifattur Responsabbli għall-Ħruġ tal-Lott: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN, Haarlem, L-Olanda
English: Overall, 31 % and 25 % of the encounters in the respective groups occurred during the FES.
Maltese: Globalment, 31% u 25% tal-każijiet li ġew f'kuntatt magħhom fil-gruppi rispettivi seħħew waqt lFES.
English: * human-bovine rotavirus reassortants (live), produced in Vero cell.
Maltese: * human-bovine rotavirus reassortants (ћaj), prodott f'ċelluli Vero.
English: - has any disorder of the gastrointestinal system.
Maltese: - ibatu minn disturb fis-sistema gastrointestinali.
English: Infectious Units
Maltese: Unitajiet Infettivi
English: Intussusception α *
Maltese: Intussuxxezzjoni α *
English: 33,140 vaccinated 26,167 unvaccinated Aged ≥7 months Received 3 doses
Maltese: 33,140 imlaqqma 26,167 mhux imlaqqma B'età ta' ≥ 7 xhur Irċivew 3 dożi
English: Any severity (G1-G4)
Maltese: Kwalunkwe severità (G1-G4)
English: Excipient with known effect: This vaccine contains 1080 mg sucrose (see section 4.4).
Maltese: Din it-tilqima fiha 1080 mg ta' sucrose (ara sezzjoni 4.4).
English: See sections 4.2 and 5.1.
Maltese: Ara sezzjonijiet 4.2 u 5
English: *RV-negative acute gastroenteritis controls
Maltese: *Kontrolli b'gastroenterite akuta negattivi għal RV
English: RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Maltese: RotaTeq huwa indikat gћall-immunizzazzjoni attiva ta' trabi minn età ta' 6 ġimgћat sa 32 ġimgħa gћall-prevenzjoni ta' gastroenterite minћabba infezzjoni b'rotavirus (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: RotaTeq is available in pack size of 1, 10 dosing tubes.
Maltese: RotaTeq huwa disponibbli f'pakkett ta' 1, 10 tubi tad-dożaġġ.
English: Efficacy in premature infants
Maltese: Effikaċja fi trabi prematuri
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva gћas-sustanza attiva jew gћal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: 6 Infectious Units P1A[8] 2.3 x 10
Maltese: P1A[8] 2.3 x 10
English: There is limited evidence of a smaller increased risk following the second dose.
Maltese: Hemm evidenza limitata dwar żieda iżgħar fir-riskju wara t-tieni doża.
English: The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.
Maltese: Is-sustanzi l-oħra f'RotaTeq huma: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, mezzi tal-kultura (li fihom imluħa mhux organiċi, aċidi amminiċi u vitamini), u ilma ppurifikat.
English: 1,895 vaccinated with 3 doses
Maltese: 1,895 imlaqqma bi 3 dożi 2,102 mhux imlaqqma
English: RotaTeq - Pack size of 1 single-dose (2 ml) Tube RotaTeq - Pack size of 10 single-dose (2 ml) Tubes
Maltese: (2 ml) Tubu RotaTeq - Daqs tal-pakkett ta' 10 dożi waħidhom (2 ml) Tubi
English: Waarderweg 39, 2031 BN Haarlem, P.O.
Maltese: Waarderweg 39, 2031 BN Haarlem, P.O. Box 581, 2003 PC Haarlem
English: Outpatients due to RVGE
Maltese: Outpatients minħabba RVGE
English: Very Rare
Maltese: Rari ħafna
English: Cohort study (France)
Maltese: Studju ta' Koorti (Franza)
English: System Organ Class
Maltese: Klassi tas-sistemi u tal-organi
English: Oral Solution Pale yellow clear liquid that may have a pink tint
Maltese: Soluzzjoni Orali Likwidu trasparenti isfar ċar li jista jkollu sfumatura roża
English: Kawasaki disease was reported in 5 of 36,150 vaccine recipients (<0.1 %) and 1 of 35,536 placebo recipients (<0.1 %) with a relative risk (RR) of 4.9 [95 % CI, 0.6 - 239.1] (not statistically significant).
Maltese: Il-marda ta' Kawasaki ġiet irrappurtata f'5 persuni li rċivew it-tilqima minn 36,150 (<0.1%) u f'persuna waħda li rċeviet plaċebo minn 35,536 (<0.1%) b'riskju relattiv (RR) ta' 4.9 [95% CI, 0.6239.1] (mhux statistikament sinifikanti).
English: RotaTeq oral solution
Maltese: RotaTeq soluzzjoni orali
English: RotaTeq contains sucrose.
Maltese: RotaTeq fih sucrose.
English: The frequency category was estimated based on relevant clinical trials.
Maltese: Il-kategorija tal-frekwenza kienet stmata fuq bażi ta' provi kliniċi rilevanti.
English: α
Maltese: A.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta'eċċipjenti, ara sezzjoni 6.1.
English: For subjects with a predisposition for intussusception, see section 4.3.
Maltese: Għall-individwi bi predispożizzjoni għal intussuxxezzjoni, ara sezzjoni 4.3.
English: One dose (2 ml) contains:
Maltese: Doża waћda (2 ml) fiha:
English: (A residual drop may remain in the tip of the tube.)
Maltese: (Tista' tibqa' qatra fit-tarf tat-tubu.)
English: One dose (2 ml) contains rotavirus type*: G1
Maltese: Doża waћda (2 ml) fiha rotavirus tat-tip*: G1
English: The most commonly reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia (20.9 %), diarrhoea (17.6 %) and vomiting (10.1 %).
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati, li seħħew bi frekwenza ikbar bit-tilqima milli bil-plaċebo kienu deni (20.9 %), dijarea (17.6 %) u rimettar (10.1 %).
English: tube label
Maltese: tikketta tat-tubu
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Maltese: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Franza
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 LYON, France.
Maltese: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Franza.
English: The vaccine induces an immune response (i.e., appearance of serum neutralising antibody) to the five human-rotavirus proteins expressed on the reassortants (G1, G2, G3, G4 and P[8]).
Maltese: It-tilqima toħloq rispons immuni (i.e., l-apparenza ta' antikorp li jinnewtralizza fis-serum) għall-5 proteini tar-rotavirus uman espressi fuq ir-reassortants (G1, G2, G3, G4 u P[8]).
English: Overall, 47 % of infants given RotaTeq experienced an adverse reaction compared with 45.8 % of infants given placebo.
Maltese: B'kollox, 47 % ta' trabi li ngħataw RotaTeq esperjenzaw reazzjoni negattiva meta mqabbla ma' 45.8 % ta' trabi li ngħataw ilplaċebo.
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data)
Maltese: Rari (≥ 1/10,000, < 1/1,000), Rari ħafna (< 1/10,000), Mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli)
English: Address:
Maltese: Indirizz:
English: As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).
Maltese: Bħala prekawzjoni, il-professjonisti fil-qasam mediku għandhom jieħdu azzjoni fuq kwalunkwe sintomi li jindikaw intussuxxezzjoni (uġigħ qawwi fl-addome, rimettar persistenti, ippurgar bid-demm, nefħa fl-addome u/jew deni qawwi) peress li dejta minn studji ta' osservazzjoni jindikaw żieda firriskju ta' intussuxxezzjoni, l-aktar fi żmien 7 ijiem wara t-tilqima tar-rotavirus (ara sezzjoni 4.8).
English: Post-marketing adverse events (frequency cannot be estimated from the available data).
Maltese: Avvenimenti avversi ta' wara t-tqegħid fis-suq (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli).
English: In 5,673 vaccinated infants (2,834 in the vaccine group) protective efficacy was measured as a reduction in the incidence of rotavirus (RV) gastroenteritis caused by vaccine G genotypes (G1G4) that occurred at least 14 days after the third dose of vaccine through the first full rotavirus season after vaccination.
Maltese: F'5,673 tarbija mlaqqma (2,834 fil-grupp tat-tilqima) l-effikaċja protettiva ġiet imkejla bħala tnaqqis fl-inċidenza ta' gastroenterite minħabba r-rotavirus (RV) ikkawżata minn ġenotipi G tattilqima (G1-G4) li seħħet tal-inqas 14-il ġurnata wara t-tielet doża tat-tilqima sa tmiem l-ewwel staġun sħiħ tar-rotavirus wara t-tilqima.
English: Based upon combined data from REST and the FES, the reduction up to 3 years post-vaccination in the rate of hospitalisations and emergency department visits for RV gastroenteritis was 94.4 % (95 % CI: 91.6, 96.2) for genotypes G1-G4, 95.5 % (95 % CI: 92.8, 97.2) for genotype G1, 81.9 % (95 % CI: 16.1, 98.0) for genotype G2, 89.0 % (95 % CI: 53.3, 98.7) for genotype G3, 83.4 % (95 % CI: 51.2, 95.8) for genotype G4, and 94.2 % (95 % CI: 62.2, 99.9) for genotype G9.
Maltese: 9 % (95 % CI: 16.1, 98.0), għall-ġenotip G2, 89.0 % (95 % CI: 53.3, 98.7), għall-ġenotip G3, 83.4 % (95 % CI: 51.2, 95.8), għall-ġenotip G4, u 94.2 % (95 % CI: 62.2, 99.9) għall-ġenotip G9.
English: Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95 % CI]) Efficacy against any severity by rotavirus genotype
Maltese: Tnaqqis fl-inċidenza ta' gastroenterite minħabba RV għal staġun sħiħ wara t-tilqima (RotaTeq n=2,834) % [95 % CI] Effikaċja kontra kwalunkwe severità tal-mard skont il-ġenotip tarrotavirus
English: RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines.
Maltese: RotaTeq jista' jingħata fl-istess ħin meta ibnek/bintek jirċievu t-tilqim l-ieħor normalment rakkommandat, bħal difterite, tetnu, pertussis (sogħla konvulżiva), Haemophilus influenzae tip b, poljomelite inattivata jew orali, epatite B, tilqim konjugat tal-pneumococcus u tilqim konjugat talmeningococcus tal-grupp Ċ.
English: Hypersensitivity after previous administration of rotavirus vaccines.
Maltese: Sensittività eċċessiva wara għoti preċedenti ta' tilqim ta' rotavirus.
English: Post-marketing observational safety surveillance study In a large prospective post-marketing observational study in the US, the risk of Kawasaki disease was analysed among 85,150 infants receiving one or more doses of RotaTeq (17,433 person-years of follow-up).
Maltese: Studju ta' osservazzjoni ta' sorveljanza tas-sigurtà wara t-tqegħid fis-suq Fi studju prospettiv kbir ta' osservazzjoni ta' wara t-tqegħid fis-suq fl-Istati Uniti, ir-riskju tal-marda ta' Kawasaki kien analizzat fost 85,150 tarbija li rċivew doża waħda jew aktar ta' RotaTeq (17,433 sena ta' persuna segwita wara t-trattament).
English: Culture media (containing inorganic salts, amino acids and vitamins) Purified water
Maltese: Mezzi tal-koltura (li fihom imluħa mhux organiċi, aċidi amminiċi u vitamini)
English: Frequencies are reported as:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: No further doses are recommended after completion of the 3-dose vaccination course (see sections 4.4 and 5.1 regarding available information on persistence of protection).
Maltese: Mhuwiex rakkomandat li jittieћdu iktar dożi wara li jitlesta l-kors ta' tilqim ta' 3 dożi (ara sezzjonijiet 4.4 u 5.1 dwar informazzjoni disponibbli fuq il-persistenza tal-protezzjoni).
English: From 33 weeks to 18 years RotaTeq is not indicated in this subset of paediatric population.
Maltese: Minn 33 ġimgħa sa 18-il sena RotaTeq mhux indikat f'dan is-sottosett tal-popolazzjoni pedjatrika.
English: The reduction in incidence of RV gastroenteritis caused by genotypes G1-G4 during the second rotavirus season after vaccination was 88.0 % [95 % CI 49.4, 98.7] for severe disease and 62.6 % [95 % CI 44.3, 75.4] for disease of any severity.
Maltese: It-tnaqqis fl-inċidenza ta' gastroenterite ta' RV minħabba l-ġenotipi G1-G4 waqt it-tieni staġun ta' rotavirus wara t-tilqima kien ta' 88.0 % [95 % CI 49.4, 98.7] għal mard sever u 62.6 % [95 % CI 44.3, 75.4] għal mard ta' kull livell ta' severità.
English: The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine.
Maltese: L-effikaċja osservata kontra G2P[4] x'aktarx irriżultat mill-komponent G2 tattilqima.
English: The frequency category was estimated based on observational study data.
Maltese: Il-kategorija tal-frekwenza kienet stmata fuq bażi ta' dejta minn studju ta' osservazzjoni.
English: Adverse Reaction/Event
Maltese: Reazzjoni Avversa/Avveniment Avvers
English: The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus Efficacy and Safety Trial (REST):
Maltese: L-effikaċja protettiva ta' RotaTeq ġiet evalwata b'żewġ modi fil-Prova tal-Effikaċja u tas-Sigurtà ta' Rotavirus (REST - Rotavirus Efficacy and Safety Trial) ikkontrollata bi plaċebo:
English: Strain-specific - G1P[8] - G2P[4] - G3P[8] - G12P[8]
Maltese: Rikoverar fl-isptar u visti fl-ED minħabba RVGE Speċifiċi għar-razza - G1P[8] - G2P[4] - G3P[8] - G12P[8]
English: Case-control study (US)
Maltese: Studju ta' każijiet u kontrolli (lIstati Uniti)
English: Efficacy against genotypes G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases than for G1.
Maltese: L-effikaċja kontra r-rotavirus tal-ġenotipi G2P[4], G3P[8], G4P[8] u G9P[8] kienet ibbażata fuq inqas każijiet milli għal G1.
English: 2 ml oral solution in a tube pack size of 1 tube pack size of 10 tubes
Maltese: 2 ml soluzzjoni orali f'tubu daqs tal-pakkett ta' tubu wieħed daqs tal-pakkett ta' 10 tubi
English: In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of genotypes G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8].
Maltese: Fi provi kliniċi, intweriet effikaċja kontra gastroenterite kkawżata minn rotavirus tal-ġenotipi G1P[8], G2P[4], G3P[8], G4P[8], u G9P[8].
English: However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of between 32 and 36 weeks.
Maltese: Madankollu, 19 minn madwar 1,000 tarbija twieldu f'età ta' ġestazzjoni ta' 25 sa 28 ġimgħa, 55 twieldu f'età ta' ġestazzjoni ta' 29 sa 31 ġimgħa u l-bqija twieldu f'età ta' ġestazzjoni ta' bejn 32 u 36 ġimgħa.
English: Other medicines and RotaTeq:
Maltese: Mediċini oħra u RotaTeq:
English: The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains: G1 2.2 x 10
Maltese: Is-sustanzi attivi f'RotaTeq huma 5 razez ta' human-bovine reassortant rotavirus: