qanastek/EMEA-V3 huggingface dataset:
Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including chronic diarrhoea) or growth retardation.
M’ hemmx dejta fuq is- sigurtà u l- effikaċja dwar trabi b’ mard gastrointestinali attiv (inkluż dijarea kronika) u dawk lura fl- iżvilupp fiżiku.
Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Amministrazzjoni ta ’ RotaTeq tista 'tiġi ikkunsidrata b’ kawtela f’ dawn it- trabi meta, fl- opinjoni tat- tabib, jekk il- vaċċin ma jingħatax dan ikun jinvolvi riskju ikbar.
The level of protection provided by RotaTeq is based on the completion of all 3 doses.
Il- livell ta ’ protezzjoni pprovdut minn RotaTeq huwa bbażat fuq li jittieħdu t- 3 dożi kollha.
As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
Bħal f’ kull vaċċin ieħor, vaċċinazzjoni b’ RotaTeq tista 'ma tirriżultax fi protezzjoni sħiħa fir- riċevituri kollha.
RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
RotaTeq ma jipproteġix kontra gastroenterite minħabba patoġeni oħra għajr rotavirus.
Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia.
Provi kliniċi ta ’ l- effikaċja kontra gastroenterite minħabba rotavirus saru fl- Ewropa, l- Istati Uniti, l- Amerika Latina u l- Asja.
During these trials, the most common circulating rotavirus serotype was G1P1[8], while rotavirus serotypes G2P[4], G3P1[8], G4P1[8], and G9P1[8] were identified less often.
Waqt dawn il- provi, l- iktar serotip komuni ta ’ rotavirus li jiċċirkola kien G1P1[ 8], waqt li s- serotipi ta ’ rotavirus G2P[ 4], G3P1[ 8], G4P1[ 8], u G9P1[ 8] ġew identifikati f’ inqas frekwenza.
The extent of protection that RotaTeq might provide against other rotavirus serotypes and in other populations is unknown.
L- ammont ta ’ protezzjoni li RotaTeq jista 'jagħti kontra serotipi oħra ta ’ rotavirus u f’ popolazzjonijiet oħra m’ huwiex magħruf.
No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.
L- ebda dejta klinika m’ hija disponibbli fuq l- użu ta ’ RotaTeq għall- profilassi wara esponiment.
RotaTeq contains sucrose.
RotaTeq fih sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall fructose, assorbiment ħażin ta 'glucose- galactose jew insuffiċjenza ta ’ sucrase- isomaltase ma jistgħux jieħdu dan il- vaċċin.
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.
Ir- riskju potenzjali ta ’ apneja 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 partikolarment għal dawk bi storja preċedenti ta ’ immaturità respiratorja.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l- benefiċċju tat- tilqima huwa wieħed kbir f’ dan il- grupp ta ’ trabi, it- tilqima ma għandhiex ma tingħatax jew tiddewwem biex tingħata.
Clinical studies that involved co-administration of RotaTeq with a range of other routine infant vaccines at 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Studji kliniċi li jinvolvu l- għoti ta ’ RotaTeq flimkien ma ’ firxa oħra ta ’ vaċċinazzjonijiet li s- soltu jingħataw lit- trabi f’ età ta ’ 2, 4 u 6 xhur urew li r- rispons immuni u l- profili tas- sigurtà tal- vaċċini mogħtija ma ġewx affettwati.
Therefore, RotaTeq can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTaP- HBV-IPV/ Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTaP), Haemophilus influenzae type b vaccine (Hib), inactivated or oral poliomyelitis vaccine (IPV or OPV; see below), hepatitis B vaccine (HBV) and pneumococcal conjugate vaccine.
Għalhekk, RotaTeq jista 'jingħata fl- istess waqt ma ’ kull vaċċini monovalenti jew ikkumbinat [inkluż vaċċinijiet hexavalent (DTaP- HBV- IPV/ Hib)]: diphteria- tetanus - acellular pertussis vaccine (DTaP), vaċċin tal- Haemophilus influenzae tat- tip b (Hib), vaċċin tal- polio mhux attivat jew orali kontra l- poljomelite (IPV jew OPV, ara hawn taħt), vaċċin ta ’ l- epatite B (HBV) u vaċċin konjugat tal- pneumococcus.
Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) does not affect the immune response to the poliovirus antigens.
L- għoti ta ’ RotaTeq flimkien ma ’ vaċċin orali tal- poljomelite (OPV) ma jaffettwax ir- rispons immuni għall- antiġens tal- virus tal- poljo.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected.
Għalkemm l- għoti ta ’ OPV ma ’ RotaTeq jista ’ jnaqqas xi ftit ir - rispons immuni għall- vaċċin tar- rotavirus, attwalment ma hemmx evidenza li l- protezzjoni klinika kontra gastroenterite akuta kkawżata minn rotavirus se tkun affettwata.
The immune response to RotaTeq is unaffected when OPV is administered two weeks after RotaTeq.
Ir- rispons immuni għal RotaTeq ma jiġix affettwat meta OPV jingħata ġimagħtejn wara RotaTeq.
RotaTeq is intended for use in infants only.
4 RotaTeq huwa intenzjonat sabiex jintuża fi trabi biss.
Thus human data on use during pregnancy or lactation are not available and animal reproduction studies have not been performed.
Għalhekk tagħrif fl- umani fuq l- użu waqt it - tqala u treddiegħ m’ huwiex disponibbli u ma sarux studji fuq ir- riproduzzjoni fl- annimali.
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.
F’ subsett ta ’ trabi min 3 provi kliniċi kkontrollati bi plaċebo (n=6, 130 riċevituri ta ’ RotaTeq u 5, 560 riċevituri tal- plaċebo), RotaTeq ġie evalwat għal effetti avversi kollha fi żmien 42 ġurnata mil vaċċinazzjoni kemm bl- użu u mingħajr użu flimkien ta ’ vaċċinijiet oħra pedjatriċi.
Overall, 47% of infants given RotaTeq experienced an adverse reaction compared with 45.8% of infants given placebo.
B’ kollox, 47% ta ’ trabi li ngħataw RotaTeq esperjenzaw reazzjoni negattiva meta mqabbla ma ’ 45. 8% ta ’ trabi li ngħataw il- plaċebo.
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%).
L- iktar reazzjonijiet avversi li ġew irrapportati, li seħħew bi frekwenza ikbar bil - vaċċin milli bil- plaċebo kienu deni (20. 9%), dijarea (17. 6%) u rimettar (10. 1%).
Adverse reactions more common in the vaccine group are listed below per system organ class and frequency.
Reazzjonijiet avversi l- iktar komuni fil- grupp tal- vaċċin huma mniżżla hawn taħt f’ ordni ta ’ klassi ta ’ l- organi u frekwenza.
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%.
Fuq bażi ta ’ dejta miġbura minn 3 provi klinici fejn 6, 130 tarbija rċevew RotaTeq u 5, 560 tarbija rċevew plaċebo, ir- reazzjonijiet avversi mniżżla seħħew f’ riċevituri ta ’ RotaTeq b’ inċidenzi eċċessivi ta ’ bejn 0. 2% u 2. 5% meta mqabbla ma ’ riċevituri tal- plaċebo.
Frequencies are reported as:
Il- frekwenzi huma rrapportati bħala:
Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000)
Komuni ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux komuni (≥ 1/ 1, 000, < 1/ 100); Rari (≥ 1/ 10, 000, < 1/ 1, 000)
Upper respiratory tract infection Uncommon:
Infezzjonijiet fin- naħa ta ’ fuq ta ’ l- apparat respiratorju Mhux komuni:
Nasopharyngitis
Nasofaringite
Diarrhoea, Vomiting Uncommon:
Disturbi gastro- intestinali Komuni ħafna: dijarea, rimettar Mhux komuni:
Abdominal pain upper
Uġigħ fin- naħa ta ’ fuq ta ’ l- addome.
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.
Reazzjonijiet avversi serji ġew ivvalutati fil- parteċipanti kollha (36, 150 riċevitur ta ’ RotaTeq u 35, 536 riċevitur tal- plaċebo) fi 3 provi kliniċi sa 42 jum wara kull doża.
The overall frequency of these serious adverse reactions was 0.1% among recipients of RotaTeq and 0.2% among placebo recipients.
Il- frekwenza totali ta ’ dawn ir - reazzjonijiet negattivi kienet ta ’ 0. 1% fost riċevituri ta ’ RotaTeq u 0. 2% fost riċevituri tal- plaċebo.
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).
Il- marda Kawasaki ġiet irrapportata f’ 5 riċevituri tal- vaċċin minn 36, 150 (< 0. 1%) u riċevitur tal - plaċebo minn 35, 536 (< 0. 1%) b’ riskju relattiv (RR) ta ’ 4. 9 [95% CI, 0. 6 – 239. 1] (mhux statistikament sinjifikanti).
Otitis media and bronchospasm were reported in significantly more vaccine than placebo recipients overall; however, among cases that were considered to be vaccine-related in the opinion of the study investigator, the incidence of otitis media (0.3%) and bronchospasm (< 0.1%) was the same for vaccine and placebo recipients.
Otite medja u spasmi tal- bronki ġew irrapportati b' mod sinjifikanti iktar f’ riċevituri tal- vaċċin milli f' riċevituri tal- plaċebo meta tqis kollox; madankollu, fost każijiet li kienu kkunsidrati bħala relatati mal- vaċċin fl- opinjoni ta ’ l- investigatur ta ’ l- istudju, l- inċidenza ta ’ otite medja (0. 3%) u spasmi fil - bronki (< 0. 1%) kienu l- istess f’ riċevituri tal- vaċċin u tal- plaċebo.
Haematochezia was reported as an adverse experience in 0.6% (39/ 6,130) of vaccine recipients and 0.6% (34/ 5,560) of placebo recipients within 42 days of any dose (the difference was not statistically significant).
Haematochezia ġiet irrapportata bħala esperjenza avversa f' 0. 6% (39/ 6, 130) tar- riċevituri tat- tilqima u f’ 0. 6% (34/ 5, 560) tar- riċevituri tal- plaċebo fi żmien 42 jum minn kwalunkwe doża (id- differenza ma kinitx statistikament sinjifikanti).
The 95% CI for the relative
Intussussezzjoni
5 risk were 0.4, 6.4.
5 Ir- riskju ta ’ intussussezzjoni ġie evalwat fi studju kliniku kkontrollat bi plaċebo fit- trabi.
There was no clustering of cases among recipients of RotaTeq at any time period after any dose.
Fl- ebda perjodu ta ’ ħin u wara l- ebda doża ma kienx hemm clustering ta ’ każijiet fost riċevituri ta ’ RotaTeq.
Post-marketing reports The following adverse experiences have been spontaneously reported with RotaTeq.
Rapporti ta ’ wara t- tqegħid fis- suq L- esperjenzi avversi li ġejjin ġew irrapportati b’ mod spontanju ma ’ RotaTeq.
Haematochezia Skin and subcutaneous tissue disorders:
Haematochezia Disturbi tal- ġilda u tat- tessuti ta ’ taħt il- ġilda:
Additional information on special populations:
Tagħrif addizzjonali dwar popolazzjonijiet speċjali:
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Apneja fi trabi prematuri ferm (≤ 28 ġimgħa ta ’ ġestazzjoni) (ara sezzjoni 4. 4)
4.9 Overdose
4. 9 Doża Eċċessiva
There are no data with regard to overdose.
M’ hemmx dejta rigward dożi eċċessivi.
Pharmacotherapeutic group: viral vaccines ATC code:
Kategorija farmakoterapewtika: vaċċini virali Kodiċi ATC:
Efficacy The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus Efficacy and Safety Trial (REST):
Effikaċja L- effikaċja protettiva ta ’ RotaTeq ġiet evalwata f’ żewġ modi fil- Rotavirus Efficacy and Safety Trial (Prova ta 'l- Effikaċja u tas- Sigurtà ta' Rotavirus REST):
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 serotypes (G1-G4) that occurred at least 14 days after the third dose of vaccine through the first full rotavirus season after vaccination.
F’ 5, 673 tarbija mlaqqma (2, 834 fil- grupp tal- vaċċin) l- effikaċja protettiva ġiet imkejla bħala tnaqqis fl- inċidenza ta 'gastroenterite minħabba r- rotavirus (RV) ikkawżata minn serotipi tal - vaċċin (G1- G4) li seħħet ta ’ l- inqas 14- il ġurnata wara t- tielet doża tal- vaċċin sa tmiem l- ewwel staġun sħiħ tar- rotavirus wara l- vaċċinazzjoni.
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.
Fi 68, 038 tarbija vaċċinati (34, 035 fil- grupp tal- vaċċin), l- effikaċja protettiva ġiet imkejla bħala tnaqqis fir- rata ta ’ ammissjoni l- isptar u żjarat fid- departiment ta ’ l- emerġenza għal gastroenterite minħabba RV 14- il ġurnata wara t- tielet doża.
6 The results of these analyses are presented in the following tables.
Ir- riżultati ta ’ dawn l- analiżi huma ppreżentati fit- tabella li ġejja.
Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95% CI]) Serotype Severe* disease
Tnaqqis fl- inċidenza ta ’ gastroenterite ta ’ RV għal staġun sħiħ wara l- vaċċinazzjoni (RotaTeq n=2, 834)% [95% CI] Serotip
Any
Mard
98.0%
98. 0%
74.0%
74. 0%
74.9%
74. 9% †
63.4%
63. 4%
82.7%
82. 7%
48.1%
48. 1%
65.4%
65. 4%
[88.3, 100.0 ]†
[66. 8, 79. 9]
[66.8, 79.9 ]† [67.3, 80.9 ]† [2.6, 88.2 ]†
[67. 3, 80. 9]
[< 0, 99.6]
[< 0, 91. 6]
[< 0, 91.6]
[< 0, 99. 3]
[< 0, 99.3]
100. 0] †
* 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
Tnaqqis fil- ammissjonijiet l- isptar/ żjarat fid- dipartiment ta ’ l- emerġenza għal gastroenterite minħabba RV sa sentejn wara l- vaċċinazzjoni (RotaTeq n=34, 035)% [95% CI]
Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years post- vaccination (RotaTeq n=34,035) (% [95% CI])
G1 -
G1-G4 G1
G4 G1
G4 G1 G2 G3 G4
G3 G4
94.5%
94. 5%
95.1%
95. 1%
87.6%
87. 6%
93.4%
93. 4%
89.1%
89. 1%
[91.2, 96.6]†
[91. 2, 96. 6] †
[91.6, 97.1]†
[91. 6, 97. 1] †
[< 0, 98.5]
[< 0, 98. 5]
[49.4, 99.1]† [52.0, 97.5]† [69.6, 100]†
[49. 4, 99. 1] † [52. 0, 97. 5] † [69. 6, 100] †
Statistically significant
* Sever huwa definit bħala punteġġ > 16/ 24 meta tuża sistema ta 'punteġġ kliniku validat fuq il- bażi ta' l- intensità u l- gravità tas- sintomi (deni, rimettar, dijarea u bidla fl- imġiba) † Statistikament sinjifikanti
The reduction in incidence of RV gastroenteritis caused by 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.
It- tnaqqis fl- inċidenza ta 'gastroenterite ta ’ RV minħabba G1- G4 waqt it- tieni staġun ta' rotavirus wara l- vaċċinazzjoni kien ta ’ 88. 0% [95% CI 49. 4, 98. 7] għall- mard gravi u 62. 6% [95% CI 44. 3, 75. 4] għal mard ta ’ kull livell ta ’ gravità.
Efficacy against G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases than for G1.
L- effikaċja kontra r- rotavirus ta ’ tip G2P[ 4], G3P[ 8], G4P[ 8] u G9P[ 8] kienet ibbażata fuq inqas każijiet milli għal G1.
The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine.
L- effikaċja osservata kontra G2P[ 4] x’ aktarx irriżultat mill- komponent G2 tal - vaċċin.
There was an extension of REST conducted in Finland only.
Kien hemm estensjoni ta ’ REST li saret fil- Finlandja biss.
This Finnish Extension Study (FES) included a subset of 20,736 subjects that had been enrolled previously in REST.
Din l- Estensjoni tal- Istudju Finlandiż (FES) kienet tinkludi sottosett ta ’ 20, 736 individwu li kienu ġew rekrutati qabel f’ REST.
The infants were followed for up to 3 years post-vaccination in the FES.
It- trabi kienu segwiti għal sa perijodu ta ’ 3 snin wara li ngħataw il- vaċċinazzjoni fil- FES.
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.
Fir- REST kien hemm 403 inkontri ta ’ kura medika (20 fil- grupp tal- vaċċin u 383 fil- grupp tal- plaċebo) li kienu assoċjati ma ’ gastroenterite G1- G4 u G9 skond il- popolazzjoni tal- protokoll.
The additional data from the FES increased the number by 136 encounters in total, including 9 in the vaccine group and 127 in the placebo group.
It- tagħrif addizzjonali mill- FES żied in- numru b’ 136 inkontru b’ kollox, li kienu jinkludu 9 mill- grupp tal- vaċċin u 127 mill- grupp tal- plaċebo.
Overall, 31% and 25% of the encounters in the respective groups occurred during the FES.
Globalment, 31% u 25% tal- inkontri fil- gruppi rispettivi seħħew waqt l- FES.
92.8, 97.2) for serotype G1, 81.9% (95% CI:
Skont it- tagħrif ikkombinat minn REST u FES, it- tnaqqis sa 3 snin wara l- għoti tal- vaċċin fir- rata ta ’ mawriet fl- isptar u fid- dipartiment tal- emerġenza għal gastroenterite minħabba RV kienu 94. 4% (95% CI; 91. 6, 96. 2) għal serotipi G1- G4, 95. 5% (95% CI; 92. 8, 97. 2), għal serotip G1, 81. 9% (95% CI:
16.1, 98.0) for serotype G2, 89.0% (95% CI:
16. 1, 98. 0), għal serotip G2, 89. 0% (95% CI:
53.3, 98.7) for serotype G3, 83.4% (95% CI:
53. 3, 98. 7), għal serotip G3, 83. 4% (95% CI:
51.2, 95.8) for serotype G4, and 94.2% (95% CI:
51. 2, 95. 8), għal serotip G4, u 94. 2% (95% CI:
62.2, 99.9) for serotype G9.
62. 2, 99. 9) għal serotip G9.
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).
Matul sena 3, ma kien hemm ebda kuntatti ta ’ kura medika għal gastroenterite dovuta għal RV fil- grupp tal- vaċċin (n=3, 112) u wieħed (tip ma setax jingħaraf) fil- grupp tal- plaċebo.
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.
Serje kompluta ta ’ 3 dożi ta ’ RotaTeq għandhom jingħataw (ara sezzjoni 4. 2) sabiex jintlaħaq il- livell u l- perijodu ta ’ protezzjoni kontra gastroenterite minn rotavirus li kienu osservati fl- istudji kliniċi.
However, post hoc analyses indicated that RotaTeq achieved some reduction in the numbers of cases of rotavirus gastroenteritis of sufficient severity to require hospitalisation or an emergency department visit before completion of all three doses (i.e. from approximately 14 days after administration of the first dose onwards).
Madankollu, analiżi post hoc indikaw li RotaTeq kiseb tnaqqis fl- għadd ta ’ każijiet ta ’ gastroenreite minn rotavirus ta qawwa suffiċjenti li kienu jeħtieġu żjara l- isptar jew lid- dipartiment tal- emerġenza wara li ngħataw it- tliet dożi kollha (i. e minn madwar 14- il jum wara l- għoti tal- ewwel doża ’ l quddiem).
7 In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Effikaċja fuq trabi prematuri F’ REST, RotaTeq ingħata lil madwar 1, 000 tarbija li twieldu f’ età ta ’ ġestazzjoni ta ’ 25 jew 36 ġimgħa.
The efficacy of RotaTeq was comparable between this subset of infants and infants born at term.
L- effikaċja ta ’ RotaTeq kienet komparabbli bejn dan is- subsett ta ’ trabi u trabi li twieldu f’ perjodu ta ’ ġestazzjoni normali.
Immunogenicity The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not completely understood.
Immunoġeniċità Il- mekkaniżmu immunoloġiku li bih RotaTeq jipproteġi kontra gastroenterite tar- rotavirus m’ huwiex magħruf għal kollox.
No immunological correlate of protection has currently been identified for rotavirus vaccines.
L- ebda korrelazzjoni immunoloġika tal- protezzjoni ma ġiet identifikata s’ issa għall- vaċċinijiet tar- rotavirus.
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.
Fi studji tat- III fażi bejn 92. 5% u 100% ta ’ riċevituri ta ’ RotaTeq laħqu żieda sinjifikanti f’ anti- rotavirus IgA fis- serum wara tlett dożi.
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 P1[8]).
Il- vaċċin joħloq rispons immuni (jiġifieri, l- apparenza ta ’ antikorp li jinnewtralizza s- serum) għall- 5 proteini tar- rotavirus uman espressi fuq ir- reassortants (G1, G2, G3, G4 u P1[ 8]).
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni ta ’ tagħrif farmakokinetiku m’ huwiex meħtieġ għall- vaċċini.
A single and repeated dose oral toxicity study in mice suggests no special hazard to humans.
7 Studju orali tat- tossiċità fil- ġrieden fejn dawn ingħataw doża waħda u dożi ripetuti jissuġġerixxi li m’ hemmx perikli speċjali għall- umani.
The dose administered to mice was approximately 2.79 x 108 infectious units per kg (about 14-fold the projected infant dose).
Id- doża mogħtija lil ġrieden kienet bejn wieħed u ieħor 2. 79 x 108 units ta ’ l- infezzjoni kull kg (qisu 14- il darba iktar mid- doża proġettata għat- trabi).
RotaTeq is unlikely to pose any environmental risk.
Mhux probabbli li RotaTeq jikkawża riskju ambjentali.
See section 6.6.
Ara sezzjoni 6. 6.
Sucrose Sodium citrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide Polysorbate 80 Culture media (containing inorganic salts, amino acids and vitamins) Purified water
Sucrose Sodium citrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide Polysorbate 80 Mezzi tal- kultura (li fihom imluħa mhux organiċi, aċidi amminiċi u vitamini) Ilma ppurifikat
RotaTeq should be administered promptly after removal from refrigeration.
RotaTeq għandu jingħata minnufih wara li jitneħħa mill- friġġ.
Store in a refrigerator (2 °C – 8 °C).
Aħżen fi friġġ (2 °C - 8 °C).
Keep the dosing tube in the outer carton in order to protect from light.
Żomm it- tubu tad- doża fil- kartuna ta ’ barra biex tilqa ’ mid- dawl.
8 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
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 in a pack of 10.
2 ml soluzzjoni f' tubu li jintgħafas mimli għal- lest (LDPE), b' għatu twist- off (HDPE) f' borża ta 'protezzjoni, pakkett ta' 1 jew f' pakkett ta '10.
The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Il- vaċċin għandu jingħata mill- ħalq mingħajr ma jitħallat ma 'vaċċini jew soluzzjonijiet oħra.
Do not dilute.
Tiddilwix.
To administer the vaccine:
9 Biex tagħti l- vaċċin:
Tear open the protective bag and remove the dosing tube.
Ċarrat il- borża ta 'protezzjoni u neħħi t- tubu tad- doża.
Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap.
Neħħi l- fluwidu mit- tarf ta 'l- għoti billi żżomm it- tubu vertikalment u taptap fuq l- għatu li jinfetaħ billi ddawwru.
Open the dosing tube in 2 easy motions:
Iftaħ it- tubu tad- doża f' żewġ movimenti faċli:
Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
Taqqab it- tarf ta 'l- għoti billi tissikka l- għatu favur l- arloġġ sakemm dan
Remove cap by turning it counterclockwise.
Neħħi l- għatu billi ddawwru kontra l- arloġġ.
Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Agħti d- doża billi ġentilment timbotta l- likwidu fil- ħalq tat- tifel/ tifla lejn il - ħaddejn minn ġewwa sakemm it- tubu tad- doża jitbattal.
(A residual drop may remain in the tip of the tube.)
(Tista 'tibqa' qatra fit - tarf tat- tubu.)
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Armi t- tubu vojt u l- kappa f' reċipjenti ta 'l- iskart bijoloġiku approvati skond ir - regolamenti lokali.
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 LYON France
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F- 69007 LYON Franza
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Name and address of the manufacturer of the biological active substance
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Name of Company:
12 A.
Address:
Indirizz:
Country:
Pajjiż:
Merck & Co., Inc Sumneytown Pike – PO Box 4 – West Point – Pennsylvania 19486 United States of America +1 215 652 5603
Merck & Co., Inc Sumneytown Pike – PO Box 4 – West Point – Pennsylvania 19486 Stati Uniti ta 'l- Amerika +1 215 652 5603
manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Name of Company:
Isem tal- Kumpanija:
Box 581, 2003 PC Haarlem the Netherlands +31 23 5153153 +31 23 5148000
Box 581, 2003 PC Haarlem L- Olanda +31 23 5153153 +31 23 5148000
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli għall ħruġ tal- lott konċernat.
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
RotaTeq – Pack size of 1 single-dose(2ml) Tube RotaTeq – Pack size of 10 single-dose(2ml) Tubes
RotaTeq – Pakkett ta 'doża singola (2 ml) Tubu RotaTeq – Pakkett ta' 10 dożi singoli (2 ml) Tubi
RotaTeq, oral solution Rotavirus vaccine (live, oral)
RotaTeq, soluzzjoni orali Vaċċin ta 'rotavirus (ћaj, orali)
G1 ≥ 2.2 x 106 IU1 G2 ≥ 2.8 x 106 IU1 G3 ≥ 2.2 x 106 IU1 G4 ≥ 2.0 x 106 IU1 P1[8] ≥ 2.3 x 106 IU1
Doża waћda ta ’ 2- ml fiha rotavirus ta 'serotip *: ≥ 2. 2 x 106 IU1 G1 ≥ 2. 8 x 106 IU1 G2 ≥ 2. 2 x 106 IU1 G3 ≥ 2. 0 x 106 IU1 G4 ≥ 2. 3 x 106 IU1 P1[ 8]
* human-bovine rotavirus reassortants (live), produced in Vero cell.
* human- bovine rotavirus reassortants (ћaj), prodott f’ ċelloli Vero.
1 Infectious Units
1 Unitajiet infettivi
Sucrose
Sucrose
2 ml oral solution in a tube pack size of 1 tube pack size of 10 tubes
2 ml soluzzjoni orali f' tubu pakkett ta 'tubu wieħed pakkett ta' 10 tubi
FOR ORAL USE ONLY Read the package leaflet before use
GĦAL UŻU ORALI BISS Aqra l- fuljett ta 'tagħrif qabel l- użu
Store in a refrigerator Keep the dosing tube in the outer carton in order to protect from light.
Aħżen fi friġġ Żomm it- tubu ta 'dożaġġ fil- kartuna ta ’ barra biex tilqa' mid- dawl.
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F- 69007 Lyon Franza
EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
EU/ 1/ 06/ 348/ 001 pakkett ta ’ tubu wieħed EU/ 1/ 06/ 348/ 002 pakkett ta ’ 10 tubi
INFORMATION IN BRAILLE
ISTRUZZJONIJIET DWAR L- UŻU
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag
INFORMAZZJONI BIL- BRAILLE
RotaTeq, oral solution Rotavirus vaccine, (live, oral)
RotaTeq, soluzzjoni orali Vaċċin Rotavirus, (ћaj, orali)
1 dose
1 doża
tube label
tikketta tat- tubu
RotaTeq Oral solution Oral use
RotaTeq Soluzzjoni orali Użu mill- ħalq
1 dose (2 ml)
1 doża (2 ml)
19 PACKAGE LEAFLET:
FULJETT TA 'TAGĦRIF
INFORMATION FOR THE USER
20 FULJETT TA 'TAGĦRIF:
RotaTeq, oral solution Rotavirus vaccine (live oral)
RotaTeq, soluzzjoni orali Vaċċin Rotavirus (ћaj, orali)
Read all of this leaflet before your child is vaccinated.
Aqra sew dan il- fuljett kollu qabel it- tifel/ tifla tiegħek jitlaqqam/ titlaqqam.
- If you have any further questions, ask your doctor/health care professional.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib/ professjonist tal- kura tas- saħħa tiegħek.
Do not pass it on to others.
M’ GHANDEKX TGHADDIHA lil persuni
please tell your doctor/health care professional.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib/ professjonist tal- kura tas- saħħa.
What RotaTeq is and what it is used for 2.
X' inhu RotaTeq u għalxiex jintuża 2.
Before your child receives RotaTeq 3.
Qabel ma t- tifel/ tifla tiegħek j/ tieħu RotaTeq 3.
How RotaTeq is given 4.
Kif għandek tieħu RotaTeq?
How to store RotaTeq 6.
Kif taħżen RotaTeq 6.
WHAT RotaTeq IS AND WHAT IT IS USED FOR
X’ INHU RotaTeq U GĦALXIEX JINTUŻA
Type of Medicine: vaccine against a virus
Tip ta ’ Mediċina: vaċċin kontra virus
RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.
RotaTeq huwa vaċċin orali li jgħin biex jipproteġi t- trabi u tfal żgħar kontra gastroenterite (dijarea u rimettar) minħabba infezzjoni b' rotavirus.
The vaccine contains five types of live rotavirus strains.
Il- vaċċin fih ħames tipi ta ’ razez ta 'rotavirus ħaj.
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.
Meta tarbija tingħata l- vaċċin, is- sistema immuni (id- difiża naturali tal- ġisem) tipproduċi antikorpi kontra t - tipi l- aktar komuni ta 'rotavirus.
These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Dawn l- antikorpi jipproteġu kontra gastroenterite kkawżat minn dawn it- tipi ta ’ rotavirus.
BEFORE YOUR CHILD RECEIVES RotaTeq
QABEL MA ’ T- TIFEL/ TIFLA TIEGĦEK J/ TIEĦU RotaTeq
Do not use RotaTeq if:
Tużax RotaTeq jekk:
- your child is allergic to any of the components of the vaccine (see section 6).
- it- tifel/ tifla tiegħek huwa/ hija allerġiku/ a għal xi komponent tal- vaċċin (ara sezzjoni 6).
- your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus
- it- tifel/ tifla tiegħek żviluppa/ t reazzjoni allerġika wara li rċieva/ rċiviet doża ta ’ RotaTeq jew xi
vaccine.
vaċċin ieħor ta 'rotavirus.
- your child has previously had intussusception (a bowel obstruction in which one segment of
- it- tifel/ tifla tiegħek ġieli kellu/ ha intussussezzjoni (ostruzzjoni fl- intestini fejn biċċa mill -
bowel becomes enfolded within another segment).
intestini tingħalaq bejn biċċa oħra).
- your child was born with a malformation of the gastrointestinal system that might predispose for
- it- tifel/ tifla tiegħek twieled/ twiedet b’ malformazzjoni tas- sistema gastrointestinali li tista ’ tagħti
intussusception.
lok għal intussusezzjoni.
- your child has any disease which reduces his/her resistance to infection.
- it- tifel/ tifla tiegħek għandu/ ha xi marda li tnaqqas ir- reżistenza tiegħu/ tagħha għall -
- your child has a severe infection with a high temperature.
- it- tifel/ tifla tiegħek għandu/ ha infezzjoni severa b’ deni għoli.
It might be necessary to postpone the
Jista 'jkun hemm bżonn li
vaccination until recovery.
tipposponi t- tilqima sakemm jirkupra/ tirkupra.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Infezzjoni minuri bħal riħ m’ għandhiex tkun problema, imma kellem lit- tabib tiegħek qabel.
- your child has diarrhoea or is vomiting.
- it- tifel/ tifla tiegħek għandu/ ha dijarea jew qiegħed/ qegħda tirremetti.
It might be necessary to postpone the vaccination until
Jista 'jkun hemm bżonn li
recovery.
tipposponi t- tilqima sakemm jirkupra/ tirkupra.
20 Take special care with RotaTeq:
21 Oqgħod attent ħafna b' RotaTeq:
Inform your doctor/health care professional if your child:
Informa lit- tabib/ professjonista tal- kura tas- saħħa tiegħek jekk it- tifel/ tifla tiegħek:
- has received a blood transfusion or immunoglobulins within the last 6 weeks.
- irċieva/ irċiviet trasfużjoni tad- demm jew immunoglobulini matul dawn l- aħħar 6 ġimgħat.
- has a close contact such as a household member who has a weakened immune system, e.g., a
- għandu/ għandha kuntatt mill- qrib ma 'membru fid- dar li għandu s- sistema ta' l- immunità
person with cancer or who is taking medicines that may weaken the immune system.
bagħtuta, ngħidu aħna ma 'persuna bil- kanċer jew li qed tieħu mediċini li jistgħu jdgħajfu s - sistema ta' l- immunità.
- has any disorder of the gastrointestinal system.
- ibati/ tbati minn disturb fis- sistema gastrointestinali.
- has not been gaining weight and growing as expected.
- mhux qed iżid/ iżżid piż u mhux qed jikber/ tikber kif mistenni.
As always, please take care to wash your hands thoroughly after changing soiled nappies.
Bħal dejjem, jekk jogħġbok oqgħod attent/ a li taħsel idejk sew wara li tbiddel ħrieqi maħmuġin.
Also see Important information about some of the ingredients of RotaTeq below.
Ara wkoll informazzjoni importanti fuq xi ingredjenti ta ’ RotaTeq li hawn hawn taħt.
As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.
Bħal tilqim ieħor, RotaTeq jista ’ ma jipproteġix għal kollox lit- tfal kollha li jiġu mlaqqma anke wara li jingħataw it- tliet dożi kollha.
If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may not be able to prevent the illness.
Jekk it- tifel/ tifla tiegħek diġà ġie/ ġiet infettat/ a b' rotavirus imma għadu/ ha ma maradx/ marditx meta dan/ din jieħu/ tieħu l- vaċċin, RotaTeq jista ’ ma jkunx kapaċi jipprevjeni l- marda.
RotaTeq does not protect against diarrhoea and vomiting due to causes other than rotavirus.
RotaTeq ma jipproteġix kontra dijarea u rimettar minħabba kawżi oħra għajr rotavirus.
Using other medicines and other vaccines:
Meta tuża mediċini u tilqim ieħor:
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 and pneumococcal conjugate vaccines.
RotaTeq jista ’ jingħata fl- istess ħin meta it- tifel/ tifla tiegħek jirċievi/ tirċievi t- tilqim l- ieħor normalment rakkommandat, bħal difterja, tetnu, pertussis (sogħla konvulżiva), Haemophilus influenzae tip b, poljomelite inattivat jew orali, epatite B u vaċċinijiet konjugati tal- pneumococcus.
Please tell your doctor/health care professional if your child is taking or has recently taken any other medicine, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib/ professjonista tal- kura tas- saħħa jekk it- tifel/ tifla tiegħek qed jieħu/ tieħu jew ħa/ ħadet dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Taking RotaTeq with food and drink:
Meta tieħu RotaTeq ma ’ l- ikel u max- xorb:
There are no restrictions on taking food or liquid, including breast milk, either before or after vaccination with RotaTeq.
M’ hemm l- ebda restrizzjoni fuq it- teħid ta ’ ikel jew xorb, inkluż ħalib tas- sider, qabel jew wara tilqima b’ RotaTeq.
Important information about some of the ingredients of RotaTeq:
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'RotaTeq:
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.
Jekk qalulek li t- tifel/ tifla tiegħek għandu/ għandha intolleranza għal xi tip ta ’ zokkor, informa lit- tabib/ professjonista tal kura tas- saħħa qabel jingħata l- vaċċin.
HOW RotaTeq IS GIVEN
KIF GĦANDEK TIEĦU RotaTeq
RotaTeq IS FOR OR AL USE ONLY.
RotaTeq HUWA GĦAL UŻU ORALI BISS.
A doctor or nurse will administer the recommended doses of RotaTeq to your child.
Tabib jew ners jagħti d- doża rakkomandata ta ’ RotaTeq lit- tifel/ tifla tiegħek.
The vaccine (2 ml of liquid per dose) will be given by gently squeezing the tube and delivering the vaccine into your child’s mouth.
Il- vaċċin (2ml ta ’ likwidu kull doża) jingħata billi jingħafas it- tubu bil- mod u l- vaċċin jintefa f’ ħalq it- tifel/ tifla tiegħek.
The vaccine can be given without regard to food, liquid, or breast milk.
Il- vaċċin jista ’ jingħata mingħajr rigward għall- ikel, likwidi jew ħalib ta ’ l- omm.
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
F’ kas li t- tifel/ tifla tiegħek jobżoq/ tobżoq jew itella '/ ittella ’ ħafna mid- doża tal- vaċċin, doża waħda ta ’ sostituzzjoni tista ’ tingħata fl- istess żjara għat- tilqima.
Under no circumstance should this vaccine be administered by injection.
Dan il- vaċċin taħt l- ebda ċirkostanza m’ għandu jingħata b 'injezzjoni.
The first dose of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months).
L- ewwel doża 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).
RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks.
RotaTeq jista ’ jingħata lil trabi li twieldu kmieni diment li t- tqala damet mill- inqas 25 ġimgħa.
These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.
Dawn it- trabi għandhom jirċievu l- ewwel doża tat- tilqima bejn 6 u 12- il ġimgħa wara t- twelid.
It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Huwa importanti li t- tifel/ tifla tiegħek jirċievi/ tirċievi t- tliet dożi tal- vaċċin għall -
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 26 weeks.
Huwa preferibbli li t- tliet dożi jingħataw sa l- età ta '20- 22 ġimgħa u għallinqas tliet dożi għandhom jingħataw sa l- età ta' 26 ġimgħa.
When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course.
Meta RotaTeq jingħata lit- tifel/ tifla tiegħek, huwa rrakkomandat li t- tifel/ tifla tiegħek jirċievi/ tirċievi RotaTeq (u mhux vaċċin ieħor ta 'rotavirus) biex itemm/ ittemm il- kors tal- vaċċinazzjoni.
If you forget an appointment for RotaTeq:
Jekk tinsa tieħu RotaTeq:
It is important that you follow the instructions of your doctor/health care professional regarding your child’s return visits for the follow-up doses.
Huwa importanti li ssegwi l- istruzzjonijiet tat- tabib/ professjonist tal- kura tas- saħħa dwar iż- żjarat ta 'ritorn tat- tifel/ tifla tiegħek għad- dożi li jkun imiss.
If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.
Jekk tinsa jew jekk ma tkunx tista 'tmur għand it- tabib/ professjonista tal- kura tas- saħħa fid- data stipulata, staqsih/ ha għal parir.
Like all medicines, RotaTeq can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, RotaTeq jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects were reported in clinical studies with the use of RotaTeq:
L- effetti sekondarji li ġejjin ġew rappurtati fi studji kliniċi bl- użu ta ’ RotaTeq:
Very common (occurs in more than 1 in 10 infants): fever, diarrhoea, vomiting.
Komuni ħafna (iseħħu f’ iktar minn 1 f ’ kull 10 trabi): deni, dijarea, rimettar.
Common (occurs in more than 1 in 100 infants): infections of the upper respiratory system.
Komuni (iseħħu f’ iktar minn 1 f’ kull 100 tarbija): infezzjonijiet tal- parti ta 'fuq ta ’ l- apparat respiratorju.
Uncommon (occurs in less than 1 in 100 infants): stomach pains, runny nose and sore throat, ear infection, rash.
Mhux komuni (iseħħu f’ inqas minn 1 f’ kull 100 tarbija): uġigħ fl- istonku, flissjoni u griżmejn misluħa, infezzjoni fil- widnejn, raxx.
Rare (occurs in less than 1 in 1000 infants): bronchospasm (wheezing or coughing).
Rari (iseħħu f’ inqas minn 1 f’ kull 1000 tarbija): spażmi fil- bronki (tħarħir jew sogħla).
Side effects that have been reported during marketed use include: blood in stool, hives.
Effetti sekondarji li ġew irrapportati matul l- użu meta kien fis- suq jinkludu: demm fl- ippurgar, urtikarja.
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Fi trabi li twieldu ħafna qabel iż- żmien (fi jew qabel 28 ġimgħa ta ’ gravidenza) jista ’ jkun hemm perijodu ta ’ żmien itwal min- normal għat- teħid tan- nifs 2- 3 ijiem wara l- vaċċinazzjoni.
Ask your doctor/health care professional if you want more information about side effects for RotaTeq.
Staqsi lit- tabib/ professjonista tal- kura tas- saħħa jekk trid iktar informazzjoni dwar l- effetti sekondarji ta ’ RotaTeq.
If any of the side effects gets serious, or if you noticed any side effects not listed in this leaflet, please tell your doctor/health care professional.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib/ professjonista tal- kura tas- saħħa.
If the condition persists or worsens, seek medical attention.
Jekk il- kundizzjoni tippersisti, jew tiggrava, fittex attenzjoni medika.
HOW TO STORE RotaTeq
KIF TAĦŻEN RotaTeq
Store in a refrigerator (2 °C to 8 °C).
Aħżen fi friġġ (2 °C - 8 °C).
Keep the dosing tube in the outer carton in order to protect from light.
Żomm it- tubu tad- doża fil- kartuna ta ’ barra biex tipproteġih mid- dawl.
Do not use any of the dosing tubes of RotaTeq after the expiry date which is stated on the label after EXP.
Tużax it- tubi ta 'doża ta ’ RotaTeq wara d- data ta' skadenza li tidher fuq it- tikketta wara JIS.
What RotaTeq contains
X' fih RotaTeq
The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains:
Is- sustanzi attivi f’ RotaTeq huma 5 razez ta ’ human- bovine reassortant rotavirus:
2.2 x 106 Infectious Units 2.8 x 106 Infectious Units 2.2 x 106 Infectious Units 2.0 x 106 Infectious Units 2.3 x 106 Infectious Units
2. 2 x 106 Units ta ’ l- infezzjoni G1 2. 8 x 106 Units ta ’ l- infezzjoni G2 2. 2 x 106 Units ta ’ l- infezzjoni G3 2. 0 x 106 Units ta ’ l- infezzjoni G4 2. 3 x 106 Units ta ’ l- infezzjoni P1[ 8]
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.
L- ingredjenti 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.
What RotaTeq looks like and contents of the pack
Id- dehra ta 'RotaTeq u l- kontenut tal- pakkett
This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint.
Dan il- vaċċin huwa miżmum f' tubu ta 'doża waħda u huwa likwidu ċar safrani li jista' jkollu sfumatura fir- roża.
RotaTeq is available in pack size of 1, 10.
RotaTeq huwa disponibbli f' pakkett ta '1 u f' pakkett ta' 10.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Sanofi Pasteur MSD SNC, 8, rue Jonas Salk, F-69007 Lyon, France
Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F - 69007 Lyon, Franza
Manufacturer Responsible for Batch Release:
Manifattur Responsabbli għall- Ħruġ tal- Lott:
Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Merck Sharp and Dohme, B. V., Waarderweg 39, 2031 BN, Haarlem, L- Olanda
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Merck Sharp & Dohme IDEA, Inc., org. sl., Tel: +420.233.010.111 Danmark:
Merck Sharp & Dohme IDEA, Inc., org. sl.. Tel.: +420. 233. 010. 111 Danmark:
Merck Sharp & Dohme (Middle East) Limited., Tel: +357 22866700 Nederland:
Merck Sharp & Dohme (Middle East) Limited.,, Tel: + 357 22866700 Nederland:
Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201 Slovenská republika:
Merck Sharp & Dohme inovativna zdravila d. o. o, Tel: +386. 1. 520. 4201 Slovenská republika:
This leaflet was last approved in:
Dan il- fuljett kien approvat l- aħħar f ':
The following information is intended for medical or health care professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
To administer the vaccine:
Biex tagħti l- vaċċin:
Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
Taqqab it- tarf ta 'l- għoti billi tissikka l- għatu favur l- arloġġ
Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Agħti d- doża billi ġentilment timbotta l- likwidu fil- ħalq tat- tifel/ tifla lejn il- ħaddejn minn ġewwa sakemm it- tubu tad- doża jitbattal.
(A residual drop may remain in the tip of the tube.)
(Tista 'tibqa' qatra fit- tarf tat- tubu.)
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Armi t- tubu vojt u l- kappa f' reċipjenti ta 'l- iskart bijoloġiku approvati skond ir- regolamenti lokali.
Any unused product or waste material should be disposed of in accordance with local requirements.
25 Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa 'wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
HOW RotaTeq IS GIVEN.
KIF GĦANDEK TIEĦU RotaTeq.
Savene 20 mg/ ml powder for concentrate and diluent for solution for infusion.
Savene 20 mg/ ml trab għall- konċentrat u dilwent għal soluzzjoni għall- infużjoni.
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of water for injections.
Kull ml fih 20 mg ta ’ dexrazoxane wara rikonstituzzjoni b’ 25 ml ta ’ ilma għall- injezzjonijiet.
Each vial contains 500 mg dexrazoxane (as hydrochloride).
Kull kunjett fih 500 mg dexrazoxane (bħala hydrochloride).
Excipients in the diluent:
Sustanzi mhux attivi fid- dilwent:
Potassium 98 mg/ 500 ml Sodium 1.61 g/ 500 ml
Potassju 98 mg/ 500 ml Sodju 1. 61 g/ 500 ml
Powder for concentrate and diluent for solution for infusion.
Trab għal konċentrat u dilwent għal soluzzjoni għall- infużjoni.
Savene powder:
Savene trab:
White to off-white powder.
Trab bajdani għal bajdani fl- isfar.
Savene diluent:
Savene dilwent:
7.4).
Dilwent isotoniku ċar (295 mOsml/ l, pH bejn wieħed u ieħor 7. 4).
Savene is indicated for the treatment of anthracycline extravasation.
Savene huwa indikat għat- trattament ta ’ ekstravażjoni minn anthracycline.
Savene must be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
Savene jrid jingħata taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu ta ’ aġenti kimoterapewtiċi għall - kanċer.
Savene should be given once daily for 3 consecutive days.
Savene għandu jingħata darba kuljum għal tlett ijiem konsekuttivi.
The recommended dose is:
Id- doża rakkomandata hija:
Day two:
1000 mg/ m2 L- ewwel ġurnata:
Day three:
1000 mg/ m2 It- tieni ġurnata:
1000 mg/ m2 1000 mg/ m2 500 mg/ m2
500 mg/ m2 It- tielet ġurnata:
There is no experience with dose reduction/ increase or modification of the schedule in the treatment of extravasation.
M’ hemmx esperjenza bit- tnaqqis/ żieda fid- doża jew modifikazzjoni ta ’ l- iskeda fit- trattament ta ’ ekstravażjoni.
For patients with a body surface area of more than 2 m2 the single dose should not exceed 2000 mg.
Fil- każ ta ’ pazjenti b’ erja tas- superfiċje tal- ġisem ta ’ aktar minn 2 m2 id- doża waħdanija m’ għandhiex taqbeż 2000 mg.