qanastek/EMEA-V3 huggingface dataset:
Infections and infestations Rare: upper respiratory tract infection General disorders and administration site conditions Common: fever, fatigue
Infezzjonijiet u infestazzjonijiet Rari: infezzjoni ta ’ l- apparat respiratorju ta ’ fuq
Psychiatric disorders Very common: irritability Uncommon: sleep disorder, crying
Disturbi psikjatriċi Komuni ħafna: irritabilità Mhux komuni: biki, nuqqas ta ’ rqad tajjeb
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63225 subjects were enrolled.
Ir- riskju ta ’ intussuxezzjoni ġie valutat fi prova kbira dwar sigurtà li saret fl- Amerika Latina u l - Finlandja fejn ġew irreġistrati 63225 persuni.
This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table below.
Din il- prova ma wriet ebda evidenza ta ’ riskju ikbar ta ’ intussuxezzjoni fil- grupp ta ’ Rotarix meta mqabbel mall- grupp tal- plaċebo fit- tabella t’ hawn taħt.
Intussusception within 31 days after administration of:
5 Intussuxezzjoni fi żmien 31 jum wara li tittieħed:
Placebo N=31552
Plaċebo N=31552
Relative risk (95% CI*)
Riskju relattiv (95% CI *)
0.50 (0.07; 3.80)
L- ewwel doża It- tieni doża * CI: intervall ta ’ konfidenza
0.99 (0.31; 3.21)
0. 50 (0. 07; 3. 80) 0. 99 (0. 31; 3. 21)
• Post marketing surveillance:
• Tagħrif ta ’ wara t- tqegħid fis- suq:
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Disturbi respiratorji, toraċiċi u medjastinali Waqfien tan- nifs għal xi ħin fit- trabi mwieldin ħafna qabel iż- żmien (≤ 28 ġimgħa ta ’ tqala) (ara sezzjoni 4. 4)
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code:
Kategorija farmakoterapewtika: vaċċini kontra d- dijareja minn rotavirus, Kodiċi ATC:
J07BH01
JO7BH01
Protective efficacy
Effikaċja protettiva
Clinical studies have been conducted in Europe and Latin America to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
Twettqu studji kliniċi fl- Ewropa u fl- Amerika Latina biex tiġi evalwata l- effikaċja protettiva ta ’ Rotarix kontra kull tip ta ’ gastro- enterite severi minn rotavirus.
A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4000 subjects.
Studju kliniku li twettaq fl- Ewropa għamel evalwazzjoni ta ’ Rotarix meta mogħtija skond skedi Ewropej differenti (2, 3 xhur; 2, 4 xhur; 3, 4 xhur; 3, 5 xhur) f’ 4000 suġġetti.
Severity of gastro- enteritis was defined according to the Vesikari 20-point scale which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment.
Is- severità tal- gastro - enterite ġiet imfissra skond l- iskala Vesikari ta ’ 20 punt li tevalwa l- istampa klinika sħiħa ta ’ gastro - enterite bir- rotavirus billi tikkalkula s- severità u t- tul ta ’ ħin ta ’ dijareja u remettar, is- severità tad- deni u d- deidrazzjoni kif ukoll il- bżonn ta ’ trattament.
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
Wara żewġ dożi ta ’ Rotarix, l- effikaċja protettiva tal- vaċċin osservata matul l- ewwel u t- tieni sena ta ’ ħajja u fis- sentejn sħaħ, hija ppreżentata fit- tabella li ġejja:
Placebo N=1302 (§)
L- ewwel sena ta ’ ħajja Rotarix N=2572; Plaċebo N=1302 (§)
Placebo N=1294 (§)
It- tieni sena ta ’ ħajja Rotarix N=2554; Plaċebo N=1294 (§)
Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Effikaċja tal- vaċċin (%) kontra kull gastro- enterite bir- rotavirus u kontra gastro - enterite severi bir- rotavirus [95% CI]
Type
Severi †
Any severity
Severi †
Severe† Any se
Tip
Any severity Severe† Any severity
Kull tip ta ’ severità
Severe†
Kull tip ta ’ severità
95.6*
95. 6 *
96.4*
96. 4 *
82.7*
82. 7 *
96.5*
96. 5 *
[87.9; 98.8]
[87. 9; 98. 8]
[85.7; 99.6]
[85. 7; 99. 6]
[67.8; 91.3]
[67. 8; 91. 3]
[86.2; 99.6]
[86. 2; 99. 6]
62.0 [< 0.0; 94.4]
62. 0 [< 0. 0; 94. 4]
74.7 [< 0.0; 99.6]
74. 7 [< 0. 0; 99. 6]
57.1* [< 0.0; 82.6]
57. 1 * [< 0. 0; 82. 6]
89.9* [9.4; 99.8]
89. 9 * [9. 4; 99. 8]
89.9* [9.5; 99.8]
89. 9 * [9. 5; 99. 8]
100* [44.8; 100]
100 * [44. 8; 100]
79.7* [< 0.0; 98.1]
79. 7 * [< 0. 0; 98. 1]
83.1 [< 0.0; 99.7]
83. 1 [< 0. 0; 99. 7]
88.3* [57.5; 97.9]
88. 3 * [57. 5; 97. 9]
100* [64.9; 100]
100 * [64. 9; 100]
69.6 [< 0.0; 95.3]
69. 6 [< 0. 0; 95. 3]
87.3* [< 0.0; 99.7]
87. 3 * [< 0. 0; 99. 7]
75.6* [51.1; 88.5]
75. 6 * [51. 1; 88. 5]
94.7* [77.9; 99.4]
94. 7 * [77. 9; 99. 4]
70.5* [50.7; 82.8]
70. 5 * [50. 7; 82. 8]
76.8* [50.8; 89.7]
76. 8 * [50. 8; 89. 7]
Strains with P[8]
Razez bil- ġenotip
88.2*
88. 2 *
75.7*
75. 7 *
87.5*
87. 5 *
genotype
P[ 8]
[80.8; 93.0]
[80. 8; 93. 0]
[90.6; 99.1]
[90. 6; 99. 1]
[65.0; 83.4]
[65. 0; 83. 4]
[77.8; 93.4]
[77. 8; 93. 4]
Circulating
Razez tar- rotavirus
87.1*
87. 1 *
95.8*
95. 8 *
71.9*
71. 9 *
85.6*
85. 6 *
rotavirus strains
fiċ- ċirkolazzjoni
[79.6; 92.1]
[79. 6; 92. 1]
[89.6; 98.7]
[89. 6; 98. 7]
[61.2; 79.8]
[61. 2; 79. 8]
[75.8; 91.9]
[75. 8; 91. 9]
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention [95% CI]
Effikaċja tal- vaċċin (%) kontra gastro- enterite bir- rotavirus li teħtieġ attenzjoni medika [95% CI] Razez tar- rotavirus
91.8*
91. 8 *
76.2*
76. 2 *
[84; 96.3]
[84; 96. 3]
[63.0; 85.0]
[63. 0; 85. 0]
Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis [95% CI]
Effikaċja tal- vaċċin (%) kontra l- bżonn ta ’ kura fl- isptar minħabba gastro - enterite bir- rotavirus [95% CI] Razez tar- rotavirus
[81.8;100]
[81. 8; 100]
[65.6;99.1]
[65. 6; 99. 1]
Severe gastro-enteritis defined as a score ≥11 on the Vesikari scale (§) ATP cohort for efficacy * Statistically significant (p < 0.05)
Gastro- enterite severi definita bħala qari ta ’ ≥11 fuq l- iskala Vesikari (§) Grupp ta ’ suġġetti ATP għal effikaċja * Statistikament sinifikanti (p < 0. 05)
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI:
L- effikaċja tal- vaċċin matul l- ewwel sena ta ’ ħajja żdiedet progressivament maż- żieda fis- severità tal - marda u din laħqet 100% (95% CI:
84.7;100) for Vesikari scores ≥17.
84. 7; 100) għal qari Vesikari ≥17.
A clinical study performed in Latin America evaluated Rotarix in more than 20000 subjects.
Fi studju kliniku ta ’ Rotarix li twettaq fl- Amerika Latina ġie evalwat f’ iktar minn 20000 suġġetti.
Severity of gastro-enteritis was defined according to WHO criteria.
Is - severità tal- gastro- enterite ġiet imfissra skond kriterji tal- WHO.
The protective vaccine efficacy against severe rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the type specific vaccine efficacy after two doses of Rotarix are presented in the table below:
L- effikaċja protettiva tal- vaċċin kontra gastro- enterite bir- rotavirus severi li kienet tinħtieġ trattament fi sptar u/ jew terapija ta ’ reidrazzjoni ġo faċilità medika u l- effikaċja tal- vaċċin skond it- tip speċifiku wara żewġ dożi ta ’ Rotarix jidhru fit- tabella t’ hawn taħt:
Type
7 Gastro- enterite severi bir - Tip Gastro- enterite severi bir - rotavirus (it- tieni sena ta ’ rotavirus (l- ewwel sena ta ’ ħajja) ħajja) Rotarix N=7175; Rotarix N=9009; Plaċebo N=7062 (§) Plaċebo N=8858( §)
Severe rotavirus gastro- enteritis (1st year of life) Rotarix N=9009; Placebo N=8858(§) Efficacy (%) [95% CI]
Effikaċja (%) [95% CI]
Severe rotavirus gastro- enteritis (2nd year of life) Rotarix N=7175; Placebo N=7062 (§) Efficacy (%) [95% CI]
Effikaċja (%) [95% CI]
All RVGE
RVGE kollha
84.7* [71.7;92.4]
84. 7 * [71. 7; 92. 4]
79.0* [66.4;87.4]
79. 0 * [66. 4; 87. 4]
91.8* [74.1;98.4]
91. 8 * [74. 1; 98. 4]
72.4* [34.5;89.9]
72. 4 * [34. 5; 89. 9]
87.7* [8.3;99.7]
87. 7 * [8. 3; 99. 7]
71.9 [< 0.0;97.1]
71. 9 [< 0. 0; 97. 1]
50.8# [< 0.0;99.2]
50. 8 # [< 0. 0; 99. 2]
63.1* [0.7;88.2]
63. 1 * [0. 7; 88. 2]
90.6* [61.7;98.9]
90. 6 * [61. 7; 98. 9]
87.7* [72.9;95.3]
87. 7 * [72. 9; 95. 3]
Strains with P[8] genotype
Razez bil- ġenotip P[ 8]
90.9* [79.2;96.8]
90. 9 * [79. 2; 96. 8]
79.5* [67.0;87.9]
79. 5 * [67. 0; 87. 9]
(§) ATP cohort for efficacy * Statistically significant (p < 0.05) # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group).
(§) Grupp ta ’ suġġetti ATP għall- effikaċja * Statistikament sinifikanti (p < 0. 05) # In- numri ta ’ każi, li fuqhom kienu bbażati l- istimi ta ’ l- effikaċja kontra G4P[ 8], kienu żgħar ħafna (każ wieħed fil- grupp Rotarix u żewġ każi fil- grupp bi plaċebo).
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] type during the first year of life. * In these studies, the point estimates and confidence intervals were respectively:
Analiżi miġbura flimkien ta ’ ħames studji dwar l- effikaċja *, irriżultat f’ effikaċja ta ’ 71. 4% (95% CI: 20. 1; 91. 1) kontra gastro- enterite severi bir- rotavirus (qari Vesikari ≥11) kawżata mit- tip G2P[ 4] ta ’ rotavirus matul l- ewwel sena ta ’ ħajja. * F’ dawn l- istudji, l- istima tal- point u l- intervalli tal- kunfidenza kienu rispettivament:
100% (95% CI: - 1858.0;100), 100% (95% CI:
100% (95% CI: - 1858. 0; 100), 100% (95% CI:
21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
21. 1; 100), 45. 4% (95% CI: - 81. 5; 86. 6), 74. 7 (95% CI: - 386. 2; 99. 6).
No point estimate was available for the remaining study.
Ebda stima tal- point ma kien disponibbli għall- kumplament ta ’ l- istudju.
Immune response
Rispons immunitarju
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood.
Il- mekkaniżmu immunoloġiku li bih Rotarix jipproteġi kontra l- gastro- enterite bir- rotavirus għadu mhux mifhum biżżejjed.
A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
8 Skeda
Studies conducted in
Studji mwettqa fi
% ≥ 20U/ml [95% CI]
% ≥ 20U/ ml [95% CI [
2, 3 months
2, 3 xhur
France, Germany
Franza,
82.8 [77.5;87.4]
82. 8
8.7 [4.4;15.0]
Ġermanja
2, 4 months
[77. 5; 87. 4]
Spain
Spanja
85.5 [79.6;90.2]
85. 5
12.4 [6. 3;21.0]
[79. 6; 90. 2]
3, 5 months
3, 5 xhur
Finland, Italy
Finlandja, l -
94.4 [90.0;97.3]
94. 4
3.5 [1.0;8.7]
[90. 0; 97. 3]
3, 4 months
3, 4 xhur
Czech Republic
Repubblika
84.6 [78.5;89.5]
84. 6
2.2 [0.3;7.8]
[78. 5; 89. 5]
2, 3 to 4 months
2, 3 sa 4
Latin America; 11 countries
Amerika
77.9% [73.8;81.6]
77. 9%
15.1% [11.7;19.0]
Latina; 11- il pajjiż
Evaluation of pharmacokinetic properties is not required for vaccines.
Evalwazzjoni ta ’ tagħrif farmakokinetiku mhix meħtieġa għal vaċċini.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Informazzjoni li mhijiex klinika bażata fuq studji konvenzjonali dwar l- effett tossiku minn dożi ripetuti ma turi l- ebda periklu speċjali għall- bniedem.
Powder Sucrose Dextran Sorbitol Amino acids Dulbecco’s Modified Eagle Medium (DMEM)
Trab Sukrosju Dextran Sorbitol Amino aċidi Dulbecco’ s Modified Eagle Medium (DMEM)
Solvent Calcium carbonate Xanthan gum Sterile water
Solvent Karbonat tal- kalċju Gomma tax- xanthan Ilma sterili
After reconstitution:
Wara rikostituzzjoni:
8 After the reconstitution, the vaccine should be administered immediately.
Wara rikostituzzjoni, il- vaċċin għandu jingħata immedjatament.
However, experimental data have shown that the reconstituted vaccine is stable when stored for 24 hours at ambient temperature (18-25°C).
Madankollu, tagħrif esperimentali wera li l- vaċċin rikostitwit ikun stabbli meta jinżamm għal 24 siegħa f’ temperatura ambjentali (18- 25°C).
These data are not recommendations for storage.
Dan it- tagħrif mhuwiex rakkomandazzjoni dwar kif għandu jinħażen.
Store in the original package, in order to protect from light.
Aħżen fil- pakkett oriġinali, biex tipproteġih mid- dawl.
In case of temporary storage of the powder and the solvent outside the refrigerator, experimental data have shown that the powder as well as the solvent are stable when stored at temperatures up to 37°C for 1 week.
Fil- każ ta ’ ħażna għal ftit żmien tat- trab u s- solvent mhux fil- friġġ, tagħrif esperimentali wera li t- trab kif ukoll is- solvent ikunu stabbli meta jinħażnu f’ temperaturi sa 37°C għal ġimgħa waħda.
These data are not recommendations for storage.
Dan it - tagħrif mhuwiex rakkomandazzjoni dwar kif għandu jinħażen.
For storage conditions of the reconstituted product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott rikostitwit, ara sezzjoni 6. 3.
1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl) 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl).
Doża waħda ta ’ trab f’ kontenitur tal- ħġieġ (ħġieġ tat- tip I) b’ tapp (rubber butyl) 1 ml ta ’ solvent f’ applikatur tal- ħalq (ħġieġ tat- tip I) b’ tapp planġer u għatu protettiv (rubber butyl).
Transfer adapter for reconstitution (1/dose) in the following pack sizes:
Transfer adapter għar- rikostituzzjoni (doża waħda) fid- daqsijiet ta ’ pakketti li ġejjin:
- pack size of 1 glass container of powder plus 1 oral applicator of solvent
- daqs ta ’ pakkett ta ’ kontenitur wieħed tal- ħġieġ għat- trab flimkien ma ’ applikatur tal- ħalq tas -
- pack size of 5 glass containers of powder plus 5 oral applicators of solvent
- daqs ta ’ pakkett ta ’ 5 kontenituri tal- ħġieġ għat- trab flimkien ma ’ 5 applikaturi tal- ħalq tas- solvent
- pack size of 10 glass containers of powder plus 10 oral applicators of solvent
- daqs ta ’ pakkett ta ’ 10 kontenituri tal- ħġieġ għat- trab flimkien ma ’ 10 applikaturi tal- ħalq tas -
- pack size of 25 glass containers of powder plus 25 oral applicators of solvent
- daqs ta ’ pakkett ta ’ 25 kontenitur tal- ħġieġ għat- trab flimkien ma ’ 25 applikaturi tal- ħalq tas -
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent.
Depożitu abjad u sustanza ċara f’ wiċċ l- ilma tkun tidher meta jinħażen l- applikatur tal- ħalq li jkun fih is- solvent.
The solvent should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
Is- solvent għandu jiġi spezzjonat viżwalment qabel u wara li jitħawwad għal xi frak żgħir li ma jiffurmax parti minnu u/ jew xi dehra fiżika mhux normali qabel ma jiġi rikostitwit.
The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Il- vaċċin rikostitwit ikun ftit iktar imdardar mis- solvent u jkollu kulur abjad ħalib.
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Il- vaċċin rikostitwit għandu ukoll jkun spezzjonat viżwalment għal xi frak żgħir li ma jiffurmax parti minnu u/ jew xi dehra fiżika mhux normali qabel ma jingħata.
In the event of either being observed, discard the vaccine.
Jekk ikun jidher xi wieħed minn dawn, armi l- vaċċin.
Instructions for reconstitution and administration of the vaccine:
Struzzjonijiet dwar ir- rikostituzzjoni u l- għoti tal- vaċċin:
Remove the plastic cover from the glass container containing the powder.
Neħħi l- għatu tal- plastik mill- kontenitur tal- ħġieġ li jkun fih it- trab.
Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed.
Waħħal it- transfer adapter mal- kontenitur tal- ħġieġ billi timbuttah ’ l isfel sakemm it- transfer adapter jidħol f’ postu u jissikka tajjeb.
Shake the oral applicator containing the solvent vigorously.
Ħawwad sew l- applikatur tal- ħalq li jkun fih is- solvent.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit.
Is- suspensjoni li tkun tħawwdet tidher bħala likwidu mdardar b’ depożitu abjad li jibda joqgħod bil- mod il mod.
Remove the protective tip cap from the oral applicator.
Neħħi t- tapp protettiv mill- applikatur tal- ħalq.
Connect the oral applicator into the transfer adapter by pushing it firmly on this device.
Waħħal l- applikatur tal- ħalq mat- transfer adapter billi tagħfsu sew fuq dan.
Transfer the entire content of the oral applicator into the glass container containing the powder.
Ittrasferixxi l- kontenut kollu ta ’ l- applikatur tal- ħalq fil- kontenitur bit- trab.
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Waqt li l- applikatur tal- ħalq għadu mwaħħal, ħawwad il- kontenitur tal- ħġieġ u ara li s - suspensjoni tkun tħawwdet kompletament mat- trab.
The reconstituted vaccine will appear more turbid than the solvent alone.
Il- vaċċin rikostitwit ikun jidher iktar imdardar mis- solvent waħdu.
This appearance is normal.
Din id- dehra hi normali.
Withdraw the entire mixture back into the oral applicator.
Erga ’ oħroġ it- taħlita kollha għal ġo l- applikatur tal- ħalq.
Remove the oral applicator from the transfer adapter.
Aqla ’ l- applikatur tal- ħalq mit- transfer adapter.
This vaccine is for oral administration only.
Dan il- vaċċin għandu jingħata mill- ħalq biss.
The child should be seated in a reclining position.
It- tarbija għandha tkun bilqiegħda mitfugħa lura.
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek).
Agħtiha l- kontenut kollu ta ’ l- applikatur tal- ħalq minn ġo ħalqha (billi tagħtiha l- kontenut kollu ta ’ l- applikatur tal- ħalq fuq il- ġewwieni ta ’ ħaddejha).
Do not inject.
M’ għandekx tinjetta.
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
Jekk il- vaċċin rikostitwit ser jinħażen għal xi żmien qabel jingħata, erġa ’ qiegħed it- tapp protettiv fuq l- applikatur tal- ħalq.
The oral applicator containing the reconstituted vaccine should be shaken gently again before oral administration.
L- applikatur tal- ħalq li jkun fih il- vaċċin rikostitwit għandu jitħawwad bil- mod qabel ma jingħata mill- ħalq.
Do not inject.
M’ għandekx tinjettah.
Transfer adapter
Transfer adapter
Glass container
Kontenitur tal- ħġieġ
Oral applicator
Applikatur tal- ħalq
Oral applicator Tip-Cap
Ħawwad sew l- applikatur tal -
Remove the plastic cover from the glass container containing the powder
Neħħi l- għatu tal- plastik mill -
Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed
Waħħal it- transfer adapter mal -
3.
Is -
Shake the oral applicator containing the solvent vigorously.
kontenitur tal- ħġieġ li jkun fih it- trab
The shaken suspension will appear as a turbid liquid with a slow settling white deposit
suspensjoni li tkun tħawwdet tidher bħal likwidu mdardar b’ depożitu abjad li jibda joqgħod bil- mod. id
4.
Waqt li l- applikatur tal- ħalq għadu 4.
Remove the protective tip cap from the oral applicator
Neħħi t- tapp protettiv mill - applikatur tal- ħalq
Connect the oral applicator into the transfer adapter by pushing it firmly on this device
Waħħal l- applikatur tal- ħalq mat- transfer adapter billi timbuttah
Transfer the entire content of the oral applicator into the glass container containing the powder
Ittrasferixxi l- kontenut kollu ta ’ l - applikatur tal- ħalq fil- kontenitur
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
mwaħħal, ħawwad il- kontenitur tal- ħġieġ u ara li s- suspensjoni tkun tħawwdet
This appearance is normal
sew lejn dan
Withdraw the entire mixture back into the oral applicator
tal- ħġieġ li jkun fih it- trab
Remove the oral applicator from the transfer adapter
Il- vaċċin rikostitwit ikun jidher iktar imdardar mis - solvent waħdu.
This vaccine is for oral administration only.
Aqla ’ l- applikatur tal- ħalq mit - transfer adapter
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek)
Agħtiha l- kontenut kollu ta ’ l - applikatur tal- ħalq minn ġo ħalqha (billi tagħtiha l- kontenut kollu ta ’ l - applikatur tal- ħalq fuq il- ġewwieni ta ’ ħaddejha)
not inject.
M’ għandekx tinjetta
Rue de l'Institut 89 B-1330 Rixensart, Belgium
Rue de l' Institut 89 B- 1330 Rixensart, Il- Belġju
21 February 2006
21 ta ’ Frar 2006
Rotarix oral suspension in pre-filled oral applicator Rotavirus vaccine, live
Rotarix suspensjoni orali f’ applikatur tal- ħalq mimli lest Vaċċin ta ’ Rotavirus, ħaj
1 dose (1.5ml) contains:
Doża waħda (1. 5 ml) ikun fiha:
*Produced on Vero cells
Sustanza mhux attiva:
This product contains sucrose 1073 mg (see section 4.4).
Dan il- prodott fih 1073 mg sukrosju (ara sezzjoni 4. 4).
Oral suspension.
Suspensjoni orali.
Rotarix is a clear and colourless liquid.
Rotarix huwa likwidu ċar u bla kulur.
Method of administration
13 Metodu ta ’ kif jingħata
12 Rotarix is for oral use only.
Rotarix għandu jitteħed mill- ħalq biss
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Frak antiġen virali skopert b’ ELISA instab f’ 50% ta ’ ħmieġ solidu wara l- ewwel doża ta ’ Rotarix fil- forma lajofiliżżata u f’ 4% ta ’ ħmieġ solidu wara t- tieni doża.
In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.
F’ żewġ provi komparattivi kkontrollati, it- tneħħija tal- vaċċin wara tilqim b’ Rotarix fil- forma likwida kienet komparabbli għal dik osservata wara tilqim b’ Rotarix fil- forma lajofiliżżata.
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child’s nappies).
Persuni li jkunu f’ kuntatt ma ’ min ħa l- vaċċin riċentement għandhom josservaw l- iġjene personali (e. g ħasil ta ’ l- idejn wara bdil ta ’ ħrieqi tat- trabi).
13 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 ’ waqfien tan- nifs għal xi ħin u l- bżonn ta ’ monitoraġġ respiratorju għal 48- 72 siegħa, għandhom jiġu kkunsidrati meta l- kors ta ’ tilqim primarju jingħata lit- trabi mwieldin ħafna
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Minħabba li l- vaċċinazzjoni f' dan il- grupp ta 'trabi hija ta ’ ġid kbir, t- tilqim m’ għandux jinżamm lura jew jiġi pospost.
The vaccine contains sucrose as an excipient.
Il- vaċċin fih sukrosju bħala sustanza mhux attiva.
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 ’ nuqqas ta ’ tolleranza għal fruttosju, malassorbiment ta ’ glukosju- galattosju jew nuqqas ta ’ sucrase- isomaltase m’ għandomx jieħdu dan il- vaċċin.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Rotarix jista ’ jingħata flimkien ma ’ kull wieħed minn dawn il- vaċċini monovalenti jew kombinati li ġejjin [inklużi vaċċini eżavalenti (DTPa- HBV- IPV/ Hib)]: vaċċin għad- difterja- tetanu- sogħla konvulsiva b’ ċellula sħiħa (DTPw), vaċċin għad- difterja- tetnu- sogħla konvulsiva bla ċelluli (DTPa), vaċċin tip b Haemophilus influenzae (Hib), vaċċin tal- poljo inattivat (IPV), vaċċin ta ’ l- epatite B (HBV), vaċċin ta ’ pneumococcal conjugate u vaċċin ta ’ meningococcal serogroup C conjugate.
There are no restrictions on the infant’s consumption of food or liquid, either before or after vaccination.
M’ hemmx restrizzjonijiet fuq il- konsum ta ’ ikel jew likwidi minn trabi, la qabel u lanqas wara l - vaċċinazzjoni.
14 • Clinical trials for the lyophilised formulation
• Provi kliniċi għal forma lajofiliżżata:
In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix lyophilised formulation were administered to approximately 40200 infants.
F’ total ta ’ ħdax- il prova klinika kontrollati bi plaċebo, madwar 77800 dożi ta ’ Rotarix fil- forma lajofiliżżata ngħataw lil madwar 40200 trabi.
In two clinical trials (Finland), Rotarix lyophilised formulation was administered alone (administration of routine paediatric vaccines was staggered).
F’ żewġ provi kliniċi (Finlandja), Rotarix fil- forma lajofiliżżata ngħata waħdu (l- għoti ta ’ vaċċini pedjatriċi ta ’ rutina kien jitqassam fuq perijodi).
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix lyophilised formulation was co-administered with routine paediatric vaccines (see section 4.5).
Fid- disa ’ provi li kien baqa ’ (Ewropa, Canada, Stati Uniti ta ’ l- Amerika, Amerika Latina, Singapore, Afrika t’ Isfel), Rotarix fil- forma lajofiliżżata ngħata flimkien ma ’ vaċċini pedjatriċi ta ’ rutina (ara sezzjoni 4. 5).
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)
Infections and infestations Rare: upper respiratory tract infection
Infezzjonijiet u infestazzjonijiet Rari: infezzjoni ta ’ l- apparat respiratorju ta ’ fuq
General disorders and administration site conditions Common: fever, fatigue
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni: deni, għeja
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63225 subjects were enrolled.
16 Ir- riskju ta ’ intussuxezzjoni ġie valutat fi prova kbira dwar sigurtà li saret fl- Amerika Latina u l - Finlandja fejn ġew irreġistrati 63225 persuni.
15 Intussusception within 31 days after administration of:
Intussuxezzjoni fi żmien 31 jum wara li tittieħed:
First dose Second dose *CI: confidence interval
L- ewwel doża It- tieni doża * CI: intervall ta ’ konfidenza
0.50 (0.07;3.80) 0.99 (0.31;3.21)
0. 50 (0. 07; 3. 80) 0. 99 (0. 31; 3. 21)
• Post marketing surveillance for the lyophilised formulation:
• Tagħrif ta ’ wara t- tqegħid fis- suq għal forma lajofiliżżata:
• Clinical trials for the liquid formulation
• Provi kliniċi għal forma likwida
In a total of four clinical trials, approximately 3800 doses of Rotarix liquid formulation were administered to approximately 1930 infants.
F’ total ta ’ erbgħa provi kliniċi, ngħataw bejn wieħed u ieħor 3800 dożi ta ’ Rotarix fil- forma likwida lil 1930 tarbija.
Those trials have shown that the safety and reactogenicity profile of the liquid formulation is comparable to the lyophilised formulation.
Dawk il- provi wrew li l- profil ta’ sigurtà u reactoġeniċità tal- forma likwida huwa komparabbli ma ’ dik tal- forma lajofiliżżata.
Protective efficacy of the lyophilised formulation
Effikaċja protettiva tal- forma lajofiliżżata
Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
17 It- tieni sena ta ’ ħajja L- ewwel sena ta ’ ħajja Rotarix N=2554; Rotarix N=2572; Plaċebo N=1294 (§) Plaċebo N=1302 (§) Effikaċja tal- vaċċin (%) kontra kull gastro- enterite bir- rotavirus u kontra gastro - enterite severi bir- rotavirus [95% CI]
Severe† Any sev
Tip
[87.9;98.8]
[87. 9; 98. 8]
[85.7;99.6]
[85. 7; 99. 6]
[67.8;91.3]
[67. 8; 91. 3]
[86.2;99.6]
[86. 2; 99. 6]
62.0 [< 0.0;94.4]
62. 0 [< 0. 0; 94. 4]
74.7 [< 0.0;99.6]
74. 7 [< 0. 0; 99. 6]
57.1* [< 0.0;82.6]
57. 1 * [< 0. 0; 82. 6]
89.9* [9.4;99.8]
89. 9 * [9. 4; 99. 8]
89.9* [9.5;99.8]
89. 9 * [9. 5; 99. 8]
100* [44.8;100]
100 * [44. 8; 100]
79.7* [< 0.0;98.1]
79. 7 * [< 0. 0; 98. 1]
83.1 [< 0.0;99.7]
83. 1 [< 0. 0; 99. 7]
88.3*
88. 3 * [57. 5; 97. 9]
100*
100 * [64. 9; 100]
69.6
69. 6 [< 0. 0; 95. 3]
87.3*
87. 3 * [< 0. 0; 99. 7]
[57.5;97.9]
75. 6 * [51. 1; 88. 5]
[64.9;100]
94. 7 * [77. 9; 99. 4]
[< 0.0 ;95.3]
70. 5 * [50. 7; 82. 8]
[< 0.0;99.7]
76. 8 * [50. 8; 89. 7]
G9P[8]
88. 2 *
75.6*
96. 5 *
94.7*
75. 7 *
70.5*
87. 5 *
76.8*
P[ 8]
[51.1;88.5]
[80. 8; 93. 0]
[77.9;99.4]
[90. 6; 99. 1]
[50.7;82.8]
[65. 0; 83. 4]
[50.8;89.7]
[77. 8; 93. 4]
Strains with P[8] genotype Circulating rotavirus strains
Razez tar- rotavirus
88.2* [80.8;93.0] 87.1* [79.6;92.1]
fiċ- ċirkolazzjoni
96.5* [90.6;99.1] 95.8* [89.6;98.7]
[89. 6; 98. 7]
75.7* [65.0;83.4] 71.9* [61.2;79.8]
[61. 2; 79. 8]
87.5* [77.8;93.4] 85.6* [75.8;91.9]
[75. 8; 91. 9]
[84;96.3]
[84; 96. 3]
[63.0;85.0]
[63. 0; 85. 0]
Type
18 Gastro- enterite severi bir - Tip Gastro- enterite severi bir - rotavirus (it- tieni sena ta ’ rotavirus (l- ewwel sena ta ’ ħajja) ħajja) Rotarix N=7175; Rotarix N=9009; Plaċebo N=7062 (§) Plaċebo N=8858( §)
(§)ATP cohort for efficacy * Statistically significant (p < 0.05) # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group).
(§) Grupp ta ’ suġġetti ATP għall- effikaċja * Statistikament sinifikanti (p < 0. 05) # In- numri ta ’ każi, li fuqhom kienu bbażati l- istimi ta ’ l- effikaċja kontra G4P[ 8], kienu żgħar ħafna (każ wieħed fil- grupp Rotarix u żewġ każi fil- grupp bi plaċebo).
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] type during the first year of life.
Analiżi miġbura flimkien ta ’ ħames studji dwar l- effikaċja *, irriżultat f’ effikaċja ta ’ 71. 4% (95% CI: 20. 1; 91. 1) kontra gastro- enterite severi bir- rotavirus (qari Vesikari ≥11) kawżata mit- tip G2P[ 4] ta ’ rotavirus matul l- ewwel sena ta ’ ħajja. * F’ dawn l- istudji, l- istima tal- point u l- intervalli tal- kunfidenza kienu rispettivament:
Protective efficacy of the liquid formulation:
Effikaċja protettiva tal- forma likwida:
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation.
Peress li r- rispons immunitarju osservat wara 2 dożi ta ’ Rotarix fil- forma likwida kienet komparabbli għar- rispons osservat wara 2 dożi ta ’ Rotarix fil- forma lajofiliżżata, l- livell ta ’ effikaċja tal- vaċċin osservat bil- forma lajofiliżżata jista ’ jiġi estrapolat għal forma likwida.
A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
Għadha ma ġietx stabbilita relazzjoni bejn rispons ta ’ anti- korpi għall - vaċċinazzjoni bir- rotavirus u protezzjoni kontra l- gastro- enterite bir- rotavirus.
The following table shows the percentage of subjects with serum anti-rotavirus IgA antibody titers ≥20U/ml (by ELISA) one to two months after the second dose of vaccine or placebo as observed in different studies with Rotarix lyophilised formulation.
It- tabella li ġejja turi l- perċentwal ta ’ suġġetti b’ titer tas- serum b’ antikorpi anti- rotavirus IgA≥ 20U/ ml (by ELISA) xahar jew tnejn wara t- tieni doża tal- vaċċin jew plaċebo skond kif osservat fi studji differenti b’ Rotarix fil- forma lajofiliżżata.
Schedule
19 Skeda
% ≥ 20U/ml N [95% CI]
% ≥ 20U/ ml [95% CI [
France,
Franza,
82.8
82. 8
[4.4;15.0]
Ġermanja
12.4 [6.3;21.0]
[79. 6; 90. 2]
94.4
94. 4
[90.0;97. 3]
[90. 0; 97. 3]
[1.0;8.7]
[1. 0; 8. 7]
2, 3 to 4
2, 3 sa 4
Latin
Amerika
77.9%
77. 9%
15.1%
15. 1%
months
xhur
America; 11 countries
Latina; 11- il pajjiż
[73.8;81.6]
[73. 8; 81. 6]
[11.7;19.0]
[11. 7; 19. 0]
In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was comparable to the one elicited by Rotarix lyophilized formulation.
F’ tlett provi kliniċi komparattivi, Rotarix fil- forma likwida qanqal rispons immunitarju komparabbli għal dik minn Rotarix fil- forma lajofiliżżata
Sucrose Di-sodium Adipate Dulbecco’s Modified Eagle Medium (DMEM)
Sukrosju Di- sodium Adipate Dulbecco’ s Modified Eagle Medium (DMEM) Ilma sterili
The vaccine should be used immediately after opening.
3 snin Wara li jinfetaħ, il- vaċċin għandu jintuża immedjatament.
1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl) in pack sizes of 1, 5, 10 or 25.
1. 5 ml ta ’ suspensjoni orali f’ applikatur tal- ħalq mimli lest (ħġieġ tat- tip I) b’ tapp planġer (rubber butyl) u għatu ‘ tip cap ’ protettiv (rubber butyl) f’ pakketti ta ’ 1, 5, 10 u 25.
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Il- vaċċin huwa ppreżentat bħala likwidu ċar u bla kulur, bla ebda partiċelli visibli, li jingħata mill - ħalq.
The vaccine is ready to use (no reconstitution or dilution is required).
Il- vaċċin huwa lest għall- użu (m’ għandux bżonn jiġi rikostitwit jew dilwit).
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.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Il- vaċċin għandu jkun spezzjonat viżwalment għal xi frak żgħir li ma jiffurmax parti minnu u/ jew xi dehra fiżika mhux normali.
Instructions for administration of the vaccine:
Struzzjonijiet għall- għoti tal- vaċċin:
Remove the protective tip cap from the oral applicator.
Neħħi l- għatu protettiv tip- cap mill- applikatur tal- ħalq.
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral applicator.
Agħti mill- ħalq (jiġifieri ġo ħalq it- tarbija, fuq il- ġewwieni ta ’ ħaddejha) il- kontenut kollu ta ’ l - applikatur tal- ħalq M’ għandekx tinjetta.
19 Oral applicator Tip-Cap
Applikatur tal - ħalq Tip- Cap
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral applicator.
Agħti mill- ħalq (jiġifieri ġo ħalq it- tarbija, fuq il - ġewwieni ta ’ ħaddejha) il - kontenut kollu ta ’ l- applikatur tal - ħalq
Discard the empty oral applicator and tip cap in approved biological waste containers according to local regulations.
Armi l- applikatur tal- ħalq vojt u l- għatu tip cap ġo kontenitur approvat għall- iskart bijoloġiku kif jitolbu l- liġijiet lokali.
Rotarix oral suspension Rotavirus vaccine, live
Rotarix suspensjoni orali Vaċċin ta ’ Rotavirus, ħaj
Method of administration
23 Metodu ta ’ kif jingħata
21 Rotarix is for oral use only.
Rotarix għandu jitteħed mill- ħalq biss
22 The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Ir- riskju potenzjali ta ’ waqfien tan- nifs għal xi ħin u l- bżonn ta ’ monitoraġġ respiratorju għal 48- 72 siegħa, għandhom jiġu kkunsidrati meta l- kors ta ’ tilqim primarju jingħata lit- trabi mwieldin ħafna
4.8 Undesirable effects
25 4. 8 Effetti mhux mixtieqa
23 • Clinical trials for the lyophilised formulation
• Provi kliniċi għal forma lajofiliżżata:
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63225 subjects were enrolled.
26 Ir- riskju ta ’ intussuxezzjoni ġie valutat fi prova kbira dwar sigurtà li saret fl- Amerika Latina u l - Finlandja fejn ġew irreġistrati 63225 persuni.
24 Intussusception within 31 days after administration of:
Intussuxezzjoni fi żmien 31 jum wara li tittieħed:
1st year of life
27 It- tieni sena ta ’ ħajja L- ewwel sena ta ’ ħajja Rotarix N=2554; Rotarix N=2572; Plaċebo N=1294 (§) Plaċebo N=1302 (§) Effikaċja tal- vaċċin (%) kontra kull gastro- enterite bir- rotavirus u kontra gastro - enterite severi bir- rotavirus [95% CI]
2nd year of life
Severi †
Rotarix N=2554;
Severi †
Any severity
Kull tip ta ’ severità
Severe† Any sev
Kull tip ta ’ severità
[< 0.0;95.3]
70. 5 * [50. 7; 82. 8]
Type
28 Gastro- enterite severi bir - Tip Gastro- enterite severi bir - rotavirus (it- tieni sena ta ’ rotavirus (l- ewwel sena ta ’ ħajja) ħajja) Rotarix N=7175; Rotarix N=9009; Plaċebo N=7062 (§) Plaċebo N=8858( §)
Schedule
29 Skeda
3.5
[90. 0; 97. 3]
1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a tip seal and a tube cap (polypropylene) in pack sizes of 1, 10 or 50.
1. 5 ml ta ’ suspensjoni orali f’ tubu li jingħafas (polyethylene) b’ siġill fit- tarf u tapp (polyethylene) għat- tubu f’ pakketti ta ’ 1, 10 jew 50.
Pull off the cap from the top of the tube.
Iġbed l- għatu mill- parti ta ’ fuq tat- tubu.
Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.
Dawwar l- għatu rasu l- isfel u erġa ’ poġġi l- għatu wieqaf fuq is- siġill tat- tarf kif muri fl- istampa.
Twist the cap to remove the tip seal (do not snap it off) leaving a hole through which the vaccine can be expelled.
Dawwar l- għatu biex tneħħi s- siġill tat- tarf (tqaċċtux) u hekk tkun qed tħalli toqba minn fejn jista 'joħroġ il- vaċċin.
Ensure that the tip seal has been properly removed.
Ara li s- siġill tat- tarf jitneħħa sew.
A hole should be clearly visible at the tip of the tube and the tip seal should be inside the top of the tube cap.
Għandha tidher sew toqba fil- parti ta ’ fuq tat- tubu w s- siġill tat- tarf għandu jkun ġewwa l- parti ta ’ fuq ta ’ l- għatu tat- tubu.
In the event that the tip seal is accidentally pushed into the tube, discard the vaccine.
Jekk biż- żball timbotta s- siġill tat - tarf ġewwa t- tubu, armi l- vaċċin.
This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine.
Din hija prekawzjoni biss, għaliex mhux probabbli li s- siġill tat - tarf joħroġ mit- tubu waqt li qed jingħata l- vaċċin.
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the tube by gently squeezing the tube several times.
Agħti mill- ħalq (jiġifieri ġo ħalq it- tarbija, fuq il- ġewwieni ta ’ ħaddejha) il- kontenut kollu tat - tubu billi tgħafas it- tubu bil- mod ħafna drabi.
(A residual drop may remain in the tip of the tube).
(Jista jkun li tibqa ’ qatra fil- parti ta ’ fuq tat- tubu).
28 Tube Cap
Għatu tat - tubu
Tip seal
Siġill tat- tarf Tubu
Turn the cap upside-down and replace the cap vertically over the tip seal as shown in the diagram.
Iġbed l- għatu mill- parti ta ’ fuq tat - poġġi l- għatu wieqaf fuq is - siġill tat- tarf tubu. kif muri fl- istampa.
Tube tip
31 Parti ta ’ fuq tat - tubu
Tip seal
Siġill tat - tarf
Twist the cap to remove the tip seal (do not snap it off) leaving a hole through which the vaccine can be expelled.
Dawwar l- għatu biex tneħħi s- siġill tat - tarf (tqaċċtux) u hekk tkun qed tħalli toqba minn fejn jista 'joħroġ il- vaċċin.
In the event that the tip seal is accidentally pushed into the tube, discard the vaccine.
Jekk biż- żball timbotta s- siġill tat- tarf ġewwa t- tubu, armi l- vaċċin.
This is just a precaution, since it is unlikely that the tip seal could be expelled from the tube while administering the vaccine.
Din hija prekawzjoni biss, għaliex mhux probabbli li s- siġill tat - tarf joħroġ mit- tubu waqt li qed jingħata l - vaċċin.
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the tube by gently squeezing the tube several times.
Agħti mill- ħalq (jiġifieri ġo ħalq it- tarbija, fuq il- ġewwieni ta ’ ħaddejha) il- kontenut kollu tat- tubu billi tgħafas it- tubu bil- mod ħafna drabi.
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Armi t- tubu vojt u l- għatu ġo kontenitur approvat għall- iskart bijoloġiku kif jitolbu l- liġijiet lokali.
29 ANNEX II
32 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manifattur tas- sustanza( i) bijoloġika( ċi) attiva( i)
Rue de l’Institut 89 1330 Rixensart Belgium
Rue de l’ Institut 89 1330 Rixensart Il- Belġju
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/ KE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3 ppreżentata fit - Taqsima 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġjar tar- Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza l- oħra dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 4 tal- Pjan ta ’ l- Immaniġġjar tar- Riskju (RMP) ppreżentata fit- Taqsima 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u f’ xi aġġornamenti sussegwenti oħra ta ’ l- RMP miftehmin mas- CHMP.
In addition, an updated RMP should be submitted
Barra minn hekk, RMP aġġornat għandu jkun sottomess
- When new information is received that may impact on the current Safety Specification,
- Meta tkun irċevuta informazzjoni ġdida li tistà tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’
Pharmacovigilance Plan or risk minimisation activities
Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju.
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- Fi żmien 60 ġurnata minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew tnaqqis
reached
ta ’ riskju)
- At the request of the EMEA
- Fuq talba ta ’ l- EMEA
32 ANNEX III
35 ANNESS III
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING GLASS CONTAINER WITH ORAL APPLICATOR AND TRANSFER ADAPTER, PACK SIZE OF 1, 5, 10 OR 25
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KONTENITUR TAL- ĦĠIEĠ B’ APPLIKATUR TAL- ĦALQ U TRANSFER ADAPTER, PAKKETTI TA ’ 1, 5, 10 JEW 25
Rotarix powder and solvent for oral suspension Rotavirus vaccine, live
Rotarix trab u solvent għal suspensjoni orali Vaċċin ta ’ rotavirus, ħaj
After reconstitution, 1 dose (1 ml) contains:
Wara rikostituzzjoni, doża waħda (1ml) jkun fiha:
Human rotavirus RIX4414 strain (live, attenuated)*
Razza ta ’ rotavirus uman RIX4414 (ħajja attenwata) * mhux inqas minn 106. 0 CCID50
*Produced on Vero cells
* Prodotta fuq ċelluli Vero
Powder: sucrose, sorbitol
Trab: sukrosju, sorbitol
See the package leaflet for further information
Għal aktar tagħrif ara l- fuljett tal- pakkett
Powder and solvent for oral suspension
Trab u solvent għal suspensjoni orali kontenitur tal- ħġieġ 1: trab applikatur tal- ħalq 1: solvent transfer adapter 1 doża waħda (1 ml)
1 glass container: powder 1 oral applicator: solvent 1 transfer adapter 1 dose (1 ml) 5 glass containers: powder 5 oral applicators: solvent 5 transfer adapters 5 x 1 dose (1 ml)
5 kontenituri tal- ħġieġ: trab 5 applikaturi tal- ħalq: solvent 5 transfer adapters 5 x doża waħda (1 ml)
10 glass containers: powder 10 oral applicators: solvent 10 transfer adapters 10 x 1 dose (1 ml)
10 kontenituri tal- ħġieġ: trab 10 applikaturi tal- ħalq: solvent 10 transfer adapters 10 x doża waħda (1 ml)
25 glass containers: powder 25 oral applicators: solvent 25 transfer adapters 25 x 1 dose (1 ml)
25 kontenituri tal- ħġieġ: trab 25 applikaturi tal- ħalq: solvent 25 transfer adapters 25 x doża waħda (1 ml)
Oral use Do not inject!
Użu orali Tinjettahx!
35 Shake before use Read the package leaflet before use
38 Ħawwad qabel tużah Aqra l- fuljett ta ’ tagħrif qabel l- użu.
EXP {MM/YYYY}
JIS {MM/ YYYY}
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Aħżen fi friġġ Tiffriżahx Aħżen fil- pakkett oriġinali biex ikun protett mid- dawl
Dispose of in accordance with local regulations
Armi skond kif mitlub mir- regolamenti lokali
Rue de l’Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Il- Belġju
EU/1/05/330/001 – pack of 1 (glass container + oral applicator + transfer adapter) EU/1/05/330/002 – pack of 5 (glass container + oral applicator + transfer adapter) EU/1/05/330/003 – pack of 10 (glass container + oral applicator + transfer adapter) EU/1/05/330/004 – pack of 25 (glass container + oral applicator + transfer adapter)
EU/ 1/ 05/ 330/ 001 – pakkett ta ’ 1 (kontenitur tal- ħġieġ + applikatur tal- ħalq + transfer adapter) EU/ 1/ 05/ 330/ 002 – pakkett ta ’ 5 (kontenitur tal- ħġieġ + applikatur tal- ħalq + transfer adapter) EU/ 1/ 05/ 330/ 003 – pakkett ta ’ 10 (kontenitur tal- ħġieġ + applikatur tal- ħalq + transfer adapter) EU/ 1/ 05/ 330/ 004 – pakkett ta ’ 25 (kontenitur tal- ħġieġ + applikatur tal- ħalq + transfer adapter)
Medicinal product subject to medical prescription
39 Prodott mediċinali jingħata bir- riċetta tat- tabib.
37 MINIMUM PARTICULARS TO APPEAR ON BLISTERS ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI APPLIKATUR TAL- ĦALQ B’ SOLVENT GĦAL RIKOSTITUZZJONI BIT- TRAB
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KONTENITUR TAL- ĦĠIEĠ BIT- TRAB BIEX JIĠI RIKOSTITWIT MAS- SOLVENT
Rotarix Powder for oral suspension Rotavirus vaccine, live Oral use
Rotarix Trab għal suspensjoni orali Vaċċin tar- rotavirus, ħaj Użu orali
1 dose
Doża waħda
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN APPLIKATUR GĦALL- ĦALQ B’ SOLVENT GĦAL RIKOSTITUZZJONI BIT- TRAB
Solvent for Rotarix Oral use
Solvent għal Rotarix Użu orali
1 dose (1 ml)
Doża waħda (1ml)
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA APPLIKATUR TAL- HALQ MIMLI LEST, PAKKETTI TA ’ 1, 5, 10 JEW 25
1 dose (1.5 ml) contains:
Doża waħda (1. 5 ml) jkun fiha:
Human rotavirus RIX4414 strain (live, attenuated)
mhux inqas minn 106. 0 CCID50 Razza ta ’ rotavirus uman RIX4414 (ħajja attenwata)
Sucrose
Sukrosju
Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Suspensjoni orali f’ applikatur tal- ħalq mimli lest applikatur tal- ħalq 1 mimli lest doża waħda (1. 5 ml)
5 pre-filled oral applicators 5 x 1 dose (1.5 ml)
5 applikaturi tal- ħalq mimlijin lesti 5 x doża waħda (1. 5 ml)
10 pre-filled oral applicators 10 x 1 dose (1.5 ml)
10 applikaturi tal- ħalq mimlijin lesti 10 x doża waħda (1. 5 ml)