qanastek/EMEA-V3 huggingface dataset:
7, 36) reduction for recurrent AOM (5 episodes in six months or 6 episodes in one year).
7, 36) għal AOM rikorrenti (5 episodji f’ sitt xhur jew 6 episodji f’ sena).
Tympanostomy tube placement was reduced by 24% (95% CI:
Il - frekwenza tat- tqegħid ta ’ tubu tat- timpanostomija tnaqqset b’ 24% (95% CI:
12, 35) in the per-protocol analysis and by 23% (95% CI:
12, 35) fl- analiżi skont il - protokoll u 23% (95% CI:
11, 34) in the intent-to-treat analysis.
11, 34) fl- analiżi intent- to- treat.
Effectiveness
Effettività
The effectiveness of Prevenar against IPD (i. e. comprising the protection afforded by vaccination and from herd immunity due to reduced transmission of vaccine serotypes in the population) has been evaluated in national immunisation programmes that employ three-dose or two-dose infant series, each with booster doses.
L- effettività ta ’ Prevenar kontra IPD (i. e. li kienet tinkludi l- protezzjoni mogħtija mit- tilqima u mill - immunità tal - ’ merħla ’ minħabba t- trasmissjoni mnaqqsa tas- serotipi tat- tilqima fil- popolazzjoni) kienet evalwata fi programmi nazzjonali ta ’ immunizzazzjoni li jużaw serje tat- trabi bi tliet dożi jew b’ żewġ dożi, kull waħda b’ dożi booster.
In the USA, generalised vaccination with Prevenar using a four-dose series in infants and a catch-up programme for children up to 5 years of age was introduced in 2000.
Fl- Istati Uniti tal- Amerika, tilqim ġeneralizzat bi Prevenar bl- użu ta ’ serje b’ erba ’ dożi fit- trabi u programm catch- up għal tfal sa 5 snin kien introdott fis- sena 2000.
Vaccine effectiveness against IPD caused by vaccine serotypes was evaluated in 3- to 59-month old children within the first four years of the implementation of the programme.
L- effettività tat- tilqima kontra IPD ikkawżata minn serotipi tat- tilqima kienet evalwata fi tfal li kellhom minn 3 sa 59 xahar, fl- ewwel erba ’ snin tal- programm ta ’ implimentazzjoni.
When compared with no vaccination, point estimates for the effectiveness of 2-, 3-, or 4-doses given on an infant schedule were similar:
Meta mqabbel mal- ebda t- tilqima, point estimates għall- effettività ta ’ 2, 3, jew 4 dożi mogħtija fuq skeda tat- trabi kienu simili:
96% (95% CI 88-99); 95% (95% CI 88-99); and 100% (95% CI 94-100), respectively.
96% (95% CI 88- 99); 95% (95% CI 88- 99); u 100% (95% CI 94- 100), rispettivament.
8 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/ 99).
Fl- Istati Uniti tal- Amerika fl- istess perjodu ta ’ żmien, kien hemm tnaqqis ta ’ 94% fit- tip ta ’ tilqima IPD f’ individwi li kellhom inqas minn 5 snin, meta mqabbla mal- linja bażi ta ’ qabel it- tilqima (1998/ 99).
In parallel, there was a 62% reduction in vaccine type IPD in individuals over 5 years of age.
Fl- istess żmien kien hemm tnaqqis ta ’ 62% fit- tip ta ’ tilqima IPD f’ individwi li kellhom iktar minn 5 snin.
This indirect or herd effect is due to a reduction in transmission of vaccine serotypes from immunised young children to the rest of the population and coincides with decreased nasopharyngeal carriage of vaccine serotypes.
Dan l- effett indirett jew ‘ tal - merħla ’ hu minħabba tnaqqis fit- trasmissjoni tas- serotipi tat- tilqima minn tfal żgħar li kienu mlaqqma mill- bqija tal- popolazzjoni u jikkoinċidi mat- tnaqqis tal- carriage nażofarinġeali tas- serotipi tat - tilqima.
In Quebec, Canada Prevenar was introduced at 2, 4 and 12 months of age with a single dose catch-up programme in children up to 5 years of age.
Fi Quebec, Canada Prevenar kien introdott f’ età ta ’ 2, 4 u 12- il xahar bi programm ta ’ doża waħda catch- up fi tfal li kellhom sa 5 snin.
In the first two years of the programme, with over 90% coverage, the observed effectiveness against IPD caused by vaccine serotypes was 93% (95% CI 75-98) for the 2 dose infant series and 100% (95% CI 91-100) for the completed schedule.
Fl- ewwel sentejn tal- programm, b’ kopertura ta ’ iktar minn 90%, l - effettività osservata kontra l- IPD ikkawżata minn serotipi tat- tilqima kienet ta ’ 93% (95% CI 75- 98) għas- serje ta ’ 2 dożi lit- trabi, u 100% (95% CI 91- 100) għall- iskeda kompluta.
Preliminary data from England and Wales reported less than 1 year following introduction of routine immunisation at 2, 4 and 13 months with a single dose catch-up programme for children 13 to 23 months of age have suggested that effectiveness of this schedule might be lower against serotype 6B than against the other serotypes in the vaccine.
Dejta preliminari mill- Ingilterra u Wales irrappurtata inqas minn sena wara l- introduzzjoni ta ’ immunizzazzjoni ta ’ rutina fl- età ta ’ 2, 4 u 13- il xahar, bi programm ta ’ doża waħda catch- up għal tfal li kellhom minn 13 sa 23 xahar, issuġġeriet li l- effettività ta ’ din l- iskeda tista ’ tkun iktar baxxa kontra serotip 6B milli kontra s- serotipi oħrajn fit- tilqima.
The effectiveness of a two-dose primary series has not been established against pneumonia or acute otitis media.
L- effettività ta ’ serje primarja b’ żewġ dożi ma kinitx stabbilita kontra l- pnewmonja jew infjammazzjoni akuta fil- parti tan- nofs tal- widna.
Additional immunogenicity data
Dejta addizzjonali dwar l- immunoġeniċità
The immunogenicity of Prevenar has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease.
L- immunoġeniċità ta ’ Prevenar kienet investigata fi studju open- label, multiċentriku f’ 49 tarbija bil - marda taċ- ċelluli sickle.
Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months) and 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
It- tfal kienu mlaqqma bi Prevenar (3 dożi b’ intervall ta ’ xahar bejniethom mill- età ta ’ xahrejn) u 46 minn dawn it- tfal irċivew ukoll tilqima tal- polysaccharide pnewmokokkali bi 23 valent fl- età ta ’ 15- 18- il xahar.
After primary immunisation, 95.6% of the subjects had antibody levels of at least 0.35 µg/ ml for all seven serotypes found in Prevenar.
Wara l- immunizzazzjoni primarja, 95. 6% tat- tfal kellhom livelli ta ’ antikorpi ta ’ mill- anqas 0. 35 µg/ ml għas- seba ’ serotipi kollha li jinsabu fi Prevenar.
A significant increase was seen in the concentrations of antibodies against the seven serotypes after the polysaccharide vaccination, suggesting that immunological memory was well established.
Żieda sinifikanti kienet osservata fil- konċentrazzjonijiet ta ’ antikorpi kontra s- seba ’ serotipi wara t- tilqima bil - polysaccharide, li tissuġġerixxi li l- memorja immunoloġika kienet stabbilita sew.
Evaluation of pharmacokinetic properties is not available for vaccines.
Evalwazzjoni ta ’ proprjetajiet farmakokinetiċi mhijiex disponibbli għat- tilqim.
A repeated dose intramuscular toxicity study (13 weeks, 5 injections, one every three weeks) of pneumococcal conjugate vaccine in rabbits revealed no evidence of any significant local or systemic toxic effects.
Studju dwar it- tossiċità ta ’ dożi ripetuti mogħtija ġol- muskoli (13- il ġimgħa, 5 injezzjonijiet, waħda kull tliet ġimgħat) tat- tilqima tal- konjugat pnewmokokkali fil- fniek, ma żvela l- ebda evidenza ta ’ kwalunkwe effetti tossiċi sinifikanti lokali jew sistemiċi.
Repeated dose subcutaneous toxicity studies (13 weeks, 7 injections of the clinical dose, one every other week, followed by a 4-week recovery period) of Prevenar in rats and monkeys revealed no evidence of any significant local or systemic toxic effects.
9 Studju dwar it- tossiċità ta ’ dożi ripetuti mogħtija taħt il- ġilda (13- il ġimgħa, 7 injezzjonijiet tad- doża klinika, waħda kull ġimagħtejn, segwiti minn perjodu ta ’ rkupru ta ’ 4 ġimgħat) ta ’ Prevenar fil- firien u x- xadini, ma żvela l- ebda evidenza ta ’ kwalunkwe effetti tossiċi sinifikanti lokali jew sistemiċi.
9 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
0.5 ml suspension for injection in vial (Type I glass) with a grey butyl rubber stopper - pack size of 1 and 10 vials without syringe/ needles.
0. 5 ml suspensjoni għall- injezzjoni f’ kunjett (ħġieġ ta ’ Tip I) b’ tapp griż tal- lastku tal- butyl - daqs tal - pakkett ta ’ 1 u 10 kunjetti mingħajr siringi/ labar.
Pack size of 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Daqs tal- pakkett ta ’ kunjett 1 b’ siringa u 2 labar (1 biex tiġbed, 1 għall- injezzjoni).
Upon storage, a white deposit and clear supernatant can be observed.
Meta jinħażen, depożitu abjad u supernatant ċar jista ’ jkun osservat.
The vaccine should be well shaken to obtain a homogeneous white suspension and be inspected visually for any particulate matter and/ or variation of physical aspect prior to administration.
It- tilqima għandha titħawwad tajjeb biex tinkiseb suspensjoni bajda omoġenja, u tkun eżaminata viżwalment għal kwalunkwe frak u/ jew varjazzjoni tal- aspett fiżiku, qabel ma tingħata.
Do not use if the content appears otherwise.
Tużahiex jekk il- kontenut ma jkunx hekk.
Rue du Bosquet, 15 B-1348 Louvain-la-Neuve Belgium
Rue du Bosquet, 15 B- 1348 Louvain- la- Neuve Il- Belġju
MARKETING AUTHORISATION NUMBER(S)
DATA TAL- EWWEL AWTORIZZAZZJONI/ TIĠDID TAL- AWTORIZZAZZJONI
02/ 02/ 2001 Date of last renewal:
02/ 02/ 2001 Data tal- aħħar tiġdid:
Prevenar suspension for injection in pre-filled syringe Pneumococcal saccharide conjugated vaccine, adsorbed
Prevenar suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest Tilqima konjugata saccharide pnewmokokkali, adsorbita
* Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
* Konjugat - għall- proteina carrier CRM197 u adsorbit fuq aluminium phosphate (0. 5 mg)
Suspension for injection in pre-filled syringe.
Suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest.
11 Infants aged 2 - 6 months:
Trabi ta ’ bejn 2 - 6 xhur:
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
12 Alternattivament, meta Prevenar jingħata bħala parti minn programm ta ’ rutina ta ’ immunizzazzjoni lit- trabi, tista ’ tkun ikkunsidrata skeda b’ żewġ dożi.
12 Limited data have demonstrated that Prevenar (three dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Dejta limitata wriet li Prevenar (serje primarja bi tliet dożi) jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il- marda taċ- ċelluli sickle, bi profil tas- sigurtà simili għal dak osservat fi gruppi li mhux qegħdin f’ riskju għoli (ara sezzjoni 5. 1).
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e. g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome).
13 pnewmokokkali invażiv (eż. tfal b’ disfunzjoni konġenitali oħra jew b’ disfunzjoni miksuba tal- milsa, li huma infettati bl- HIV, li għandhom malinn, u li għandhom sindrome nefrotiku).
Prevenar can be administered simultaneously with other paediatric vaccines in accordance with the recommended immunisation schedules.
/ Prevenar jista ’ jingħata fl- istess ħin ma ’ tilqim pedjatriku ieħor skont l- iskedi rakkomandati tal - immunizzazzjoni.
13 Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/ Hib(PRP-T)/ IPV/ HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
14 Dejta dwar l- għoti fl- istess ħin ta ’ Prevenar ma ’ Infanrix hexa (tilqima DTaP/ Hib( PRP- T) / IPV/ HepB) ma wriet l- ebda interferenza klinikament rilevanti fir- rispons tal- antikorpi għal kull wieħed mill - antiġeni individwali, meta mogħtija bħala tilqima primarja ta ’ 3 dożi.
No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exception being a higher rate of transient tenderness (36.5%) and tenderness that interfered with limb movement (18.5%) were seen with the booster dose.
Ma kienet osservata l- ebda żieda konsistenti fir- reazzjonijiet lokali jew sistemiċi meta ngħataw dożi ripetuti matul is- serje primarja jew bid- doża booster, bl- eċċezzjonijiet ikunu rata ogħla ta ’ sensittività temporanja (36. 5%) u sensittività li interferixxiet mal- moviment tar- riġlejn jew tad- dirgħajn (18. 5%) li kienu osservati bid- doża booster.
Redness was reported in 40.0% of children, and induration was reported in 32.2% of subjects.
Fi studju li sar wara li nħarġet il- liċenzja għal dan il - prodott, li kien jinvolvi 115 tifel u tifla li kellhom bejn sentejn u 5 snin, is- sensittività kienet irrappurtata f’ 39. 1% tat- tfal; fi 15. 7% tat- tfal, is- sensittività interferixxiet mal- moviment tar- riġlejn jew tad- dirgħajn Il- ħmura kienet irrappurtata f’ 40. 0% tat- tfal, u l- ebusija kienet irrappurtata fi 32. 2% tat- tfal.
Fever of > 39 °C was reported in 3.3% of children compared to 1.2% in the control group.
15 b’ temperatura ta ’ > 39°C kien irrappurtat fi 3. 3% tat- tfal meta mqabbel ma ’ 1. 2% fil- grupp tal - kontroll.
14 Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups.
L- effetti mhux mixtieqa rrappurtati fil- provi kliniċi jew mill- esperjenza ta ’ wara l- bejgħ tal- prodott huma elenkati fit- tabella li ġejja skont is- sistema tal- ġisem u skont il- frekwenza, u dan japplika għall - gruppi kollha tal- età.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżla skont is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Hypersensitivity reactions such as, anaphylactic/ anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
Reazzjonijiet ta ’ sensittività eċċessiva bħal reazzjonijiet anafilattiċi/ anafillattojdi li jinkludu xokk, edema anġjonewrotika, bronkospażmu, qtugħ ta ’ nifs, edema tal- wiċċ.
Injection site reactions (e. g. erythema, induration/ swelling, pain/ tenderness); fever ≥ 38 °C, irritability, crying, drowsiness, restless sleep.
Reazzjonijiet fis- sit tal- injezzjoni (eż. eritema, ebusija/ nefħa, uġigħ/ sensittività); deni ≥ 38°C, irritabilità, biki, ngħas, irqad bla kwiet.
15 antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Intwera wkoll li Prevenar jikkaġuna antikorpi funzjonali (kif imkejla permezz ta ’ opsonofagoċitosi) għas- serotipi kollha tat- tilqima wara s - serje primarja.
Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥ 0.35 μ g/ mL (the reference antibody concentration recommended by WHO) 2 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
Il- biċċa l- kbira tad- dejta indikat li porzjonijiet iżgħar ta ’ trabi laħqu konċentrazzjonijiet ta ’ antikorpi ta ’ ≥0. 35 μg/ ml (ir- referenza tal- konċentrazzjoni tal - antikorp rakkomandata mill- WHO) 2 kontra serotipi 6B u 23F wara serje primarja b’ żewġ dożi mqabbla direttament jew indirettament ma ’ serje primarja bi tliet dożi.
Efficacy against invasive disease was assessed in a large-scale randomised, double-blind, clinical trial in a multiethnic population in Northern California (Kaiser Permanente trial).
Iktar minn
More than 37,816 infants were immunised with either Prevenar or a control vaccine (meningococcal conjugate group C vaccine), at 2, 4, 6 and 12-15 months of age.
17 37, 816 tarbija ngħataw tilqima jew bi Prevenar, jew b’ tilqima tal- kontroll (tilqima ta ’ grupp Ċ konjugat meningokokkali), wara 2, 4, 6 u 12- 15- il xahar.
85, 100) in the per protocol (fully immunised) population (40 cases).
85, 100) fil- popolazzjoni skont il - protokoll (imlaqqma b’ mod sħiħ) (40 każ).
16 Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
L- effettività (ma saret l- ebda konferma mikrobijoloġika tad- dijanjosi) kontra l- pnewmonja mhux batteremika kienet evalwata wkoll.
The effect of the vaccine in the per-protocol analysis was a 9% reduction (95% CI:
L- effett tat- tilqima fl- analiżi skont il- protokoll kien tnaqqis ta ’ 9% (95% CI:
7,36) reduction for recurrent AOM (5 episodes in six months or 6 episodes in one year).
Il -
Tympanostomy tube placement was reduced by 24% (95% CI:
18 frekwenza tat- tqegħid ta ’ tubu tat- timpanostomija tnaqqset b’ 24% (95% CI:
17 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/ 99).
Fl- Istati Uniti tal- Amerika fl- istess perjodu ta ’ żmien, kien hemm tnaqqis ta ’ 94% fit- tip ta ’ tilqima IPD f’ individwi li kellhom inqas minn 5 snin, meta mqabbla mal- linja bażi ta ’ qabel it- tilqima (1998/ 99).
Repeated dose subcutaneous toxicity studies (13 weeks, 7 injections of the clinical dose, one every other week, followed by a 4-week recovery period) of Prevenar in rats and monkeys revealed no evidence of any significant local or systemic toxic effects.
19 Studju dwar it- tossiċità ta ’ dożi ripetuti mogħtija taħt il- ġilda (13- il ġimgħa, 7 injezzjonijiet tad- doża klinika, waħda kull ġimagħtejn, segwiti minn perjodu ta ’ rkupru ta ’ 4 ġimgħat) ta ’ Prevenar fil- firien u x- xadini, ma żvela l- ebda evidenza ta ’ kwalunkwe effetti tossiċi sinifikanti lokali jew sistemiċi.
18 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
0.5 ml suspension for injection in pre-filled syringe (Type I glass) with a plunger rod (polypropylene) - pack size of 1 and 10 with or without needle, and multi pack of 5 packs of 10 pre-filled syringes without needle.
0. 5 ml suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest (ħġieġ ta ’ Tip I) b’ lasta tal- planġer (polypropylene) - daqs tal- pakkett ta ’ 1 u 10 bi jew mingħajr labra, u pakkett multiplu ta ’ 5 pakketti ta ’ 10 siringi mimlijin għal- lest mingħajr labra.
20 ANNEX II
21 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZI BIJOLOĠIĊI ATTIVI U DETENTUR TAL - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park NC 27330, Sanford, USA
CRM197, Saccharides Attivati, u Konjugati Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park NC 27330, Sanford, Stati Uniti tal- Amerika
Pneumococcal Polysaccharides Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 401 North Middletown Road NY 10965, Pearl River, USA
Polysaccharides Pnewmokokkali Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 401 North Middletown Road NY 10965, Pearl River, Stati Uniti tal- Amerika
• CONDITIONS AND RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TAL- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, submitted on November 22, 2006 and 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.
Id- Detentur tal- Awtorizzazzjoni tal- Manifattura jrid jiżgura li s- sistema ta ’ farmakoviġilanza, sottomessa fit- 22 ta ’ Novembru, 2006, u ppreżentata f’ Modulu 1. 8. 1. tal- Applikazzjoni għall - Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem meta l- prodott jibda jinbiegħ.
The marketing Authorisation holder will continue to submit periodic safety update reports on a 2- year cycle.
Id- detentur tal- Awtorizzazzjoni għat- tqegħid fis- suq: ser ikompli jissottometti rapporti perjodiċi dwar l- aġġornament tas- sigurtà fuq ċiklu ta ’ sentejn.
Official batch release: in accordance with Article 114 of Council 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: skont Artiklu 114 tad- Direttiva tal- Kunsill 2001/ 83/ KE kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju tal- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
22 Official Medicines Control Laboratory (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321 F - 69007 Lyon France
Laboratorju Uffiċjali tal- Kontroll tal- Mediċini (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321 F - 69007 Lyon Franza
25 Prevenar- single-dose vial x 1 pack
25 Prevenar - Pakkett b’ kunjett 1 b’ doża waħda
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON TEXT
KLIEM FUQ IL- KAXXA TA ’ BARRA
Each 0.5 ml dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg).
Kull doża ta ’ 0. 5 ml fiha 2 mikrogrammi ta ’ saccharide għas- serotipi 4, 9V, 14, 18C, 19F, u 23F, u 4 mikrogrammi ta ’ serotip 6B f’ kull doża (total ta ’ 16- il mikrogramma ta ’ saccharide) konjugat għal CRM197 proteina carrier u adsorbit fuq aluminju phosphate (0. 5 mg).
Also contains sodium chloride and water for injections.
Fih ukoll sodium chloride u ilma għall- injezzjonijiet.
1 single-dose (0.5 ml) vial.
Kunjett 1 b’ doża waħda (0. 5 ml).
Shake well before use.
Ħawwad tajjeb qabel l- użu.
Do not inject intravenously.
Tinjettax ġol- vini.
VIAL TEXT
KLIEM FUQ IL- KUNJETT
Prevenar suspension for injection Pneumococcal saccharide conjugated vaccine, adsorbed Intramuscular use.
Prevenar suspensjoni għall- injezzjoni Tilqima konjugata saccharide pnewmokokkali, adsorbita Użu għal ġol- muskoli.
1 dose (0.5 ml)
1 doża (0. 5 ml)
28 Prevenar- single-dose vial x 10 pack
28 Prevenar - Pakkett b’ 10 kunjetti b’ doża waħda
10 single-dose (0.5 ml) vials.
10 kunjetti b’ doża waħda (0. 5 ml).
30 Prevenar- single-dose pre-filled syringe without needle x 1 pack
30 Prevenar - doża waħda - siringa mimlija għal- lest mingħajr labra x 1 pakkett
1 single-dose (0.5 ml) pre-filled syringe without needle.
Siringa 1 mimlija għal- lest b’ doża waħda (0. 5 ml) mingħajr labra.
PRE-FILLED SYRINGE TEXT
KLIEM FUQ IS- SIRINGA MIMLIJA GĦAL- LEST
Intramuscular use.
Prevenar suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest Tilqima konjugata saccharide pnewmokokkali, adsorbita Użu għal ġol- muskoli.
METHOD OF ADMINISTRATION Shake well before use.
METODU TA ’ KIF GĦANDU JINGĦATA
33 Prevenar - single-dose pre-filled syringes without needle x 10 pack
33 Prevenar - pakkett ta ’ 10 siringi mimlijin għal- lest b’ doża waħda mingħajr labra
10 single-dose (0.5 ml) pre-filled syringes without needle.
10 siringi mimlijin għal- lest b’ doża waħda (0. 5 ml) mingħajr labra.
35 Prevenar- single-dose vial x 1 pack with syringe/ needles
35 Prevenar - doża waħda kunjett x 1 pakkett bis- siringi/ labar
1 separate syringe.
Siringa 1 separata.
2 separate needles.
2 labar separati.
37 Prevenar- single-dose pre-filled syringe with separate needle x 1 pack
37 Prevenar - dożi waħda - siringa mimlija b’ labra separata x 1 pakkett
1 single-dose (0.5 ml) pre-filled syringe with separate needle.
Siringa 1 mimlija għal- lest b’ doża waħda (0. 5 ml) b’ labra separata.
39 Prevenar - single-dose pre-filled syringes with separate needle x 10 pack
39 Prevenar - pakkett ta ’ 10 siringi mimlijin għal- lest b’ doża waħda b’ labra separata
10 single-dose (0.5 ml) pre-filled syringes with separate needle.
10 siringi mimlijin għal- lest b’ doża waħda (0. 5 ml) b’ labra separata.
41 Prevenar - single-dose pre-filled syringes without needle x 10: pack for multi pack presentation 5 x 10 without blue box
41 Prevenar - siringi mimlijin għal- lest b’ doża waħda mingħajr labra x 10: pakkett għal preżentazzjoni ta ’ pakkett multiplu 5 x 10
Component of a multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes without needle.
Komponent ta ’ pakkett multiplu b’ 5 pakketti, li kull wieħed ikun fih 10 siringi mimlijin għal- lest b’ doża waħda (0. 5 ml) mingħajr labra.
43 Prevenar – Outer wrapper label to be applied on the transparent foil for multi pack presentation 5 x 10, including the blue box
43 Prevenar – Tikketta tar- wrapper ta ’ barra biex titwaħħal fuq il- fojl trasparenti għal preżentazzjoni ta ’ pakkett multiplu 5 x 10, li jinkludi l- kaxxa l- blu
LABEL TEXT
KLIEM FUQ IT- TIKKETTA
Multipack comprising 5 packs, each containing 10 single-dose (0.5 ml) pre-filled syringes without needle.
Komponent ta ’ pakkett multiplu b’ 5 pakketti, li kull wieħed ikun fih 10 siringi mimlijin għal- lest b’ doża waħda (0. 5 ml) mingħajr labra.
Read all of this leaflet carefully before your child receives this vaccine.
Aqra sew dan il- fuljett kollu qabel it- tifel/ tifla tiegħek tingħata din it- tilqima.
- If you have any further questions, ask your doctor or your pharmacist.
- Jekk ikollok iktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
What Prevenar is and what it is used for 2.
X’ inhu Prevenar u għalxiex jintuż 2.
Before you use Prevenar 3.
Qabel ma tuża Prevenar 3.
How to use Prevenar 4.
Kif għandek tuża Prevenar 4.
How to store Prevenar 6.
Kif taħżen Prevenar 6.
WHAT PREVENAR IS AND WHAT IT IS USED FOR
X’ INHU PREVENAR U GĦALXIEX JINTUŻA
Prevenar is a pneumococcal vaccine.
Prevenar hu tilqima pnewmokokkali.
Prevenar helps protect your child against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Prevenar jgħin biex jipproteġi lit- tifel/ tifla tiegħek kontra mard bħal: meninġite, sepsis jew batteremija (batterji fiċ- ċirkolazzjoni tad- demm), pnewmonja u infezzjoni fil- widnejn ikkawżata minn seba ’ tipi tal- batterju Streptococcus pneumoniae.
The vaccine works by helping the body to make its own antibodies, which protect your child against these diseases.
It- tilqima taħdem billi tgħin lill- ġisem biex jipproduċi l- antikorpi tiegħu stess, li jipproteġu lit - tifel/ tifla tiegħek kontra dan il- mard.
BEFORE YOU USE PREVENAR
QABEL MA TUŻA PREVENAR
Do not use Prevenar:
Tużax Prevenar: jekk it- tifel/ tifla tiegħek hu/ hi hu allerġiku/ a (ibati/ tbati minn sensittività eċċessiva) għas -
diphtheria toxoid.
sustanzi attivi, għal xi sustanzi oħrajn, jew għat- toxoid tad- difterite.
Take special care with Prevenar:
Oqgħod attent ħafna bi Prevenar:
- if your child has any present or past medical problems after any dose of Prevenar.
- jekk it- tifel/ tifla tiegħek għandu/ għandha problemi mediċi, jew kellu/ kellha problemi fil- passat,
- if your child has any bleeding problems.
- jekk it- tifel/ tifla tiegħek għandu/ għandha kwalunkwe problemi ta ’ ħruġ ta ’ demm.
- if your child is sick with a high fever.
- jekk it- tifel/ tifla tiegħek hu/ hi marid/ a b’ deni qawwi.
Prevenar will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Prevenar ser jipproteġi biss kontra infezzjonijiet tal- widnejn ikkawżati mit- tipi ta ’ Streptococcus pneumoniae li għalihom it- tilqima kienet żviluppata.
It will not protect against other infectious agents that can cause ear infections.
Mhux ser jipproteġi kontra organiżmi infettivi oħrajn li jistgħu jikkawżaw infezzjonijiet tal- widnejn.
Using other medicines/ vaccines:
Meta tuża mediċini/ tilqim ieħor:
Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines including medicines obtained without prescription or has recently received any other vaccine.
Jekk jogħġbok għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qed jieħu/ tieħu jew ħax/ ħaditx dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk dan l - aħħar saritlu/ saritilha xi tilqima.
HOW TO USE PREVENAR
KIF GĦANDEK TUŻA PREVENAR
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine.
It- tabib jew infermiera ser jinjettaw id- doża rakkomandata (0. 5 ml) tat- tilqima.
Prevenar can be given at the same time as other childhood vaccines; in this case different injection sites should be used.
47 Prevenar jista ’ jingħata fl- istess ħin mat- tilqim li jingħata lit- tfal; f’ dan il- każ, siti differenti tal - injezzjoni għandhom jintużaw.
Prevenar should not be mixed with any other vaccines in the same syringe.
Prevenar m’ għandux jitħallat ma ’ kwalunkwe tilqim ieħor fl- istess siringa.
Prevenar will be injected into your child's muscle.
Prevenar ser ikun injettat ġol- muskoli tat- tifel/ tifla tiegħek.
Typically, your child should receive four doses of the vaccine.
Normalment, it- tifel/ tifla tiegħek għandu/ għandha jirċievi/ tirċievi erba ’ dożi tat- tilqima.
According to official recommendations in your country, an alternative schedule may be used by your health-care provider.
Skont rakkomandazzjonijiet uffiċjali f’ pajjiżek, tista ’ tintuża skeda alternattiva mill- fornitur tal- kura tas - saħħa tiegħek.
Each dose will be given on a separate occasion.
Kull doża ser tingħata f’ okkażjoni separata.
It is important to follow the instructions from the doctor/ nurse so that your child completes the course of injections.
Hu importanti li ssegwi l- istruzzjonijiet tat- tabib/ infermiera sabiex it- tifel/ tifla tiegħek itemm/ ittemm il- kors tal- injezzjonijiet.
If you forget to go back to the doctor or nurse at the scheduled time, ask the doctor or nurse for advice.
Jekk tinsa tmur għand it- tabib jew infermiera fiż- żmien skedat, staqsi lit- tabib jew lill- infermiera għal parir.
Like all vaccines, Prevenar can cause side effects, although not everybody gets them.
Bħal kull tilqima oħra, Prevenar jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The meaning of the terms used to describe the frequency of side effects is as follows:
It- tifsira tat- termini użati biex jiddeskrivu l- frekwenza tal- effetti sekondarji hi kif ġej:
Very Common: side effects which may occur in more than 1 of 10 patients.
Komuni ħafna: effetti sekondarji li jistgħu jseħħu f’ iktar minn 1 minn kull 10 pazjenti.
Common: side effects which may occur in less than 1 of 10 patients.
Komuni: effetti sekondarji li jistgħu jseħħu f’ inqas minn 1 minn kull 10 pazjenti.
Uncommon: side effects which may occur in less than 1 of 100 patients.
Mhux komuni: effetti sekondarji li jistgħu jseħħu f’ inqas minn 1 minn kull 100 pazjent.
Rare: side effects which may occur in less than 1 of 1000 patients.
Rari: effetti sekondarji li jistgħu jseħħu f’ inqas minn 1 minn kull 1000 pazjent.
Very Rare: side effects which may occur in less than 1 of 10,000 patients.
Rari ħafna: effetti sekondarji li jistgħu jseħħu f’ inqas minn 1 minn kull 10, 000 pazjent.
• Blood and lymphatic system disorders
• Disturbi tad- demm u tas- sistema limfatika
enlarged lymph nodes (lymphadenopathy) in the region of the injection site
għoqod kbar tal- limfa (limfadenopatija) fiż- żona tas- sit tal- injezzjoni
• Nervous System Reactions
• Reazzjonijiet tas- sistema nervuza
Rare: seizures, seizures associated with fever
Rari: puplesiji, puplesiji assoċjati ma ’ deni.
• Gastrointestinal Reactions
• Reazzjonijiet gastrointestinali
decreased appetite, vomiting, diarrhoea
nuqqas t’ aptit, rimettar, dijarea
• Skin Reactions
• Reazzjonijiet tal- ġilda
rash/ hives (urticaria) erythema multiforme
raxx/ urtikarja eritema multiforme
• Injection Site Reactions and General Reactions
• Reazzjonijiet fis- sit tal- injezzjoni u reazzjonijiet ġenerali
pain, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher, irritability, crying, drowsiness, restless sleep
uġigħ, sensittività, ħmura, nefħa, jew ebusija fis- sit tal- injezzjoni; deni ta ’ 38°C jew ogħla, irritabilità, biki, ngħas, irqad bla kwiet
redness, swelling, or hardness at the injection site greater than 2.4 cm; tenderness at the injection site interfering with movement; fever of 39 °C or higher
ħmura, nefħa, jew ebusija fis- sit tal- injezzjoni akbar minn 2. 4 ċm; sensittività fis- sit tal- injezzjoni li tinterferixxi mal- moviment; deni ta ’ 39°C jew ogħla
48
48 • Reazzjonijiet fis- sistema immuni
Rare: severe hypersensitivity/ allergic reactions, which may include swelling of the face and/ or lips, difficulty in breathing, and/ or shock (cardiovascular collapse)
Rari: reazzjonijiet ta ’ sensittività eċċessiva/ allerġiċi severi, li jistgħu jinkludu nefħa fil - wiċċ u/ jew xufftejn, diffikultà biex tieħu n- nifs, u/ jew xokk (kollass kardjovaskulari)
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 prematuri ħafna (wara 28 ġimgħa jew aktar ta ’ tqala), jistgħu jseħħu intervalli bejn kull nifs għal 2- 3 ijiem wara t- tilqima.
Please speak with your doctor or pharmacist should you have any questions or concerns.
Jekk jogħġbok tkellem mat- tabib jew mal- ispiżjar tiegħek jew għandek xi mistoqsijiet jew problemi.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE PREVENAR
KIF TAĦŻEN PREVENAR
Do not use Prevenar after the expiry date stated on the carton and label.
Tużax Prevenar wara d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta.
FURTHER INFORMATION
X’ fih Prevenar
What Prevenar contains
Is- sustanzi attivi Kull doża ta ’ 0. 5 ml fiha:
aluminium phosphate (0.5 mg)
* Konjugat għall- proteina carrier CRM197 u adsorbit fuq aluminium phosphate (0. 5 mg)
The other ingredients are sodium chloride and water for injections.
Is- sustanzi l- oħra huma sodium chloride u ilma għall- injezzjonijiet.
What Prevenar looks like and contents of the pack
Id- dehra ta ’ Prevenar u l- kontenuti tal- pakkett
The vaccine is a suspension for injection and provided in a single-dose vial (0.5 ml).
It- tilqima hi suspensjoni għall- injezzjoni pprovduta f’ siringa mimlija għal- lest li jkun fiha doża waħda (0. 5 ml).
Pack sizes of 1 and 10 vials without syringe/ needles.
Daqs tal- pakkett ta ’ 1 u 10 kunjetti mingħajr siringi/ labar.
49 Marketing Authorization Holder and Manufacturer
49 Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Manufacturing Authorisation Holder responsible for batch release:
Detentur tal- Awtorizzazzjoni tal- Manifattura responsabbli għall- ħruġ tal- lott:
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH-UK United Kingdom
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH- UK Ir- Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ελλάδα Wyeth Hellas Α .Ε .Β .Ε.
Polska Ελλάδα Wyeth Sp. z o. o.
Polska Wyeth Sp. z o. o.
Wyeth Hellas Α. Ε. Β. Ε.
Tel: +48 22 457 1000 Fax: + 48 22 457 1001
Tel: +48 22 457 1000 Τηλ: + 30 2 10 99 81 600 Fax: + 48 22 457 1001 Φαξ: + 30 2 10 99 21 994
Tel: + 34 91 334 65 65 Fax: + 34 91 663 65 53
50 Portugal España Wyeth Lederle Portugal (Farma), Lda.
Ireland Wyeth Vaccines Tel: + 353 1 449 3500 Fax: + 353 1 679 3773
Wyeth Vaccines Tel: + 353 1 449 3500 Fax: + 353 1 679 3773
Slovenská Republika Wyeth Whitehall Export GmbH, organizač ná zlož ka Tel: +42 1 2 654 128 16 Fax: +42 1 2 654 128 17
Wyeth Whitehall Export GmbH, organizačná zložka Tel: +42 1 2 654 128 16 Fax: +42 1 2 654 128 17
Prevenar is for intramuscular use only.
Prevenar hu għall- użu ġol- muskoli biss.
Do not administer intravenously.
Tagħtihx minn ġol- vina.
51 This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Din it- tilqima m’ għandhiex tingħata lil trabi jew lil tfal li għandhom it- tromboċitopenja jew kwalunkwe disturb tal- koagulazzjoni li minħabba fih l- injezzjoni ġol- muskoli tkun kontraindikata, ħlief jekk il- benefiċċju potenzjali jiżboq b’ mod ċar ir- riskju tal- għoti.
Infants age 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
L - ewwel doża normalment tingħata meta t- tarbija jkollha xahrejn, b’ intervall ta ’ mill- anqas xahar bejn id- dożi.
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
Alternattivament, meta Prevenar jingħata bħala parti minn programm ta ’ rutina ta ’ immunizzazzjoni lit- trabi, tista ’ tkun ikkunsidrata skeda b’ żewġ dożi.
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.
L- ewwel doża tista ’ tingħata mill- età ta ’ xahrejn, bit- tieni doża li tingħata mill- inqas xahrejn wara, u t- tielet doża (booster) li tingħata fl- età ta ’ 11- 15- il xahar.
Children aged 24 months - 5 years: one single dose.
Tfal li għandhom bejn 24 xahar – 5 snin: doża waħda.
Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine or other micro-organisms that cause invasive disease or otitis media.
Prevenar mhux ser jipproteġi kontra serotipi oħrajn ta ’ Streptococcus pneumoniae ħlief dawk inklużi fit- tilqima, jew kontra mikro- organiżmi oħrajn li jikkawżaw mard invażiv jew infjammazzjoni fil- parti tan- nofs tal- widna.
A higher rate of local reactions has been observed in children older than 24 months of age compared with infants.
Rata ogħla ta ’ reazzjonijiet lokali kienet osservata fi tfal li kellhom iktar minn 24 xahar, meta mqabbla mat- trabi.
Different injectable vaccines should always be given at different injection sites.
Tilqim differenti li jista ’ jiġi injettat għandu dejjem jingħata f’ siti differenti tal- injezzjoni.
Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.
Dejta limitata wriet li Prevenar jikkaġuna rispons immuni aċċettabbli fi trabi li għandhom il- marda taċ- ċelluli sickle, bi profil tas- sigurtà simili għal dak osservat fi gruppi li mhux qegħdin f’ riskju għoli.
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e. g. children with another congenital or acquired splenic dysfunction, HIV- infected, malignancy, nephrotic syndrome).
Dejta dwar is- sigurtà u l- immunoġeniċità għadhom mhumiex disponibbli għal tfal fi gruppi oħrajn speċifiċi li qegħdin f’ riskju għoli għal mard pnewmokokkali invażiv (eż. tfal b’ disfunzjoni konġenitali oħra jew b’ disfunzjoni miksuba tal- milsa, li huma infettati bl- HIV, li għandhom malinn, u li għandhom sindrome nefrotiku).
Children below 2 years old (including those at high-risk) should receive the appropriate-for-age Prevenar vaccination series.
Tfal ta ’ taħt is- sentejn (inklużi dawk li qegħdin f’ riskju għoli) għandhom jirċievu s- serje ta ’ tilqim ta ’ Prevenar li hi adattata għall- età tagħhom.
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
L- użu ta ’ tilqima konjugata pnewmokokkali ma tissostitwixxix l- użu ta ’ tilqim tal- polysaccharide pnewmokokkali li fih 23 valent fit- tfal ta ’ ≥ 24 xahar b’ kundizzjonijiet (bħal marda taċ- ċelluli sickle, asplenja, infezzjoni bl- HIV, mard kroniku jew li huma immunokompromessi) li jpoġġuhom f’ riskju ogħla għal mard invażiv minħabba Streptococcus pneumoniae.
The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23- valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
L - intervall bejn it- tilqima tal- konjugat pnewmokokkali (Prevenar) u t- tilqima tal- polysaccharide pnewmokokkali li fiha 23 valent, m’ għandux ikun ta ’ inqas minn 8 ġimgħat.
There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed
M’ hemm l- ebda informazzjoni disponibbli li tindika jekk l- għoti ta ’ tilqima tal- polysaccharide pnewmokokkali li fiha 23 valent lil tfal li ma jkunux tlaqqmu, jew lil tfal li jkunu diġà tlaqqmu bi Prevenar, jistax jirriżulta f’ rispons eċċessiv għal dożi addizzjonali ta ’ Prevenar.
Prophylactic antipyretic medication is recommended:
52 Mediċina profilattika kontra d- deni hi rakkomandata:
- for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis because
- għat- tfal kollha li jkunu qed jirċievu Prevenar fl- istess ħin ma ’ tilqim li jkun fih whole cell
of higher rate of febrile reactions
pertussis minħabba r- rata ogħla rata ta ’ reazzjonijiet bid- deni
Antipyretic treatment should be initiated whenever warranted or when the temperature rises above 39°C.
Il- kura kontra d- deni għandha tinbeda kull meta jkun meħtieġ jew meta t- temperatura titla ’ iktar minn 39°C.
As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low.
Minħabba li l- infjammazzjoni fil- parti tan - nofs tal- widna hi kkawżata minn ħafna organiżmi li mhumiex serotipi pnewmokokkali rappreżentati fit- tilqima, il- protezzjoni kontra l- infjammazzjonijiet kollha fil- parti tan- nofs tal- widna hi mistennija li tkun baxxa.
53 PACKAGE LEAFLET:
53 FULJETT TA ’ TAGĦRIF:
What Prevenar is and what it is used for 2.
X’ inhu Prevenar u għalxiex jintuża 2.
Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines including medicines obtained without prescription or has recently received any other vaccine
Jekk jogħġbok għid lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek jekk it- tifel/ tifla tiegħek qed jieħu/ tieħu jew ħax/ ħaditx dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk dan l - aħħar saritlu/ saritilha xi tilqima.
Prevenar can be given at the same time as other childhood vaccines; in this case different injection sites should be used.
Prevenar jista ’ jingħata fl- istess ħin mat- tilqim li jingħata lit- tfal; f’ dan il- każ, siti differenti tal - injezzjoni għandhom jintużaw.
Prevenar should not be mixed with any other vaccines in the same syringe.
54 Prevenar m’ għandux jitħallat ma ’ kwalunkwe tilqim ieħor fl- istess siringa.
Rare: injection site hypersensitivity reactions like rash/ hives (urticaria) or itching at the injection site; hypotonic hyporesponsive episode (collapse or shock-like state)
reazzjonijiet ta ’ sensittività eċċessiva fis- sit tal- injezzjoni bħal raxx/ urtikarja jew ħakk fis- sit tal- injezzjoni; episodju iporisponsiv ipotoniku (kollass jew tkun fi stat fiżiku bħal dak ta ’ xokk)
• Immune System Reactions:
• Reazzjonijiet fis- sistema immuni
Rare: severe hypersensitivity/ allergic reactions, which may include swelling of the face and/ or lips, difficulty in breathing, and/ or shock (cardiovascular collapse)
reazzjonijiet ta ’ sensittività eċċessiva/ allerġiċi severi, li jistgħu jinkludu nefħa fil - Rari: wiċċ u/ jew xufftejn, diffikultà biex tieħu n- nifs, u/ jew xokk (kollass kardjovaskulari)
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.
55 Fi trabi li twieldu prematuri ħafna (wara 28 ġimgħa jew aktar ta ’ tqala), jistgħu jseħħu intervalli bejn kull nifs għal 2- 3 ijiem wara t- tilqima.
The vaccine is a suspension for injection and provided in a single-dose pre-filled syringe (0.5 ml).
It- tilqima hi suspensjoni għall- injezzjoni pprovduta f’ siringa mimlija għal- lest li jkun fiha doża waħda (0. 5 ml).
Pack sizes of 1 and 10 with or without needle.
Daqs tal- pakkett ta ’ 1 u 10 bi jew mingħajr labra.
Multipack presentation of 5 packs of 10 pre-filled syringes without needles.
Preżentazzjoni ta ’ pakkett multiplu f’ 5 pakketti ta ’ 10 siringi mimlijin għal- lest mingħajr labar.
56 Marketing Authorisation Holder and Manufacturer
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH-UK United Kingdom
56 Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH- UK Ir- Renju Unit
Ireland Wyeth Vaccines Tel: + 353 1 449 3500 Fax: + 353 1 679 3773
57 Slovenská Republika Ireland Wyeth Whitehall Export GmbH, organizačná Wyeth Vaccines zložka Tel: + 353 1 449 3500 Tel: +42 1 2 654 128 16 Fax: + 353 1 679 3773 Fax: +42 1 2 654 128 17
58 This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
Din it- tilqima m’ għandhiex tingħata lil trabi jew lil tfal li għandhom it- tromboċitopenja jew kwalunkwe disturb tal- koagulazzjoni li minħabba fih l- injezzjoni ġol- muskoli tkun kontraindikata, ħlief jekk il- benefiċċju potenzjali jiżboq b’ mod ċar ir- riskju tal- għoti.
Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
L - ewwel doża normalment tingħata meta t- tarbija jkollha xahrejn, b’ intervall ta ’ mill- anqas xahar bejn id- dożi.
Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
58 Trabi ta ’ bejn 7 - 11- il xahar: żewġ dożi, kull waħda ta ’ 0. 5 ml, b’ intervall ta ’ mill- anqas xahar bejn id- dożi.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
59 Tfal b’ indeboliment fir- rispons immuni, kemm jekk dan iseħħ minħabba l- użu ta ’ terapija immunosoppressiva, difett ġenetiku, infezzjoni bl- HIV, jew kawżi oħrajn, jista ’ jkollhom tnaqqis fir - rispons tal- antikorpi għall- immunizzazzjoni attiva.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk trid aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l - Fuljett ta ’ Tagħrif (parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Prezista?
X’ inhu Prezista?
Prezista is a medicine that contains the active substance darunavir.
Prezista huwa mediċina li fiha s- sustanza attiva darunavir.
It is available as oval tablets (orange:
Huwa disponibbli f' pilloli ovali (oranġjo: