qanastek/EMEA-V3 huggingface dataset:
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4-
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinina (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet aktar fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- medja tat- titre ġeometriku (GMT) wara t- tilqim u GMT qabel it- tilqim.
Twenty-one days after administration of the second dose, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titres.
Wieħed u għoxrin ġurnata wara l- amministrazzjoni tat- tieni doża, 96. 0% ta ’ l- individwi kellhom żieda fit- titres ta ’ antikorp li jinnewtralizza s- serum ta ’ 4 darbiet aktar.
A neutralising antibody titre of at least 1:80 was achieved in 97.8% of subjects at day 42.
Ġiet milqugħa titre ta ’ antikorp li jinnewtralizza ta ’ mill- anqas 1: 80 f’ 97. 8% tas- suġġetti f’ jum 42.
In a dose finding study in subjects aged 18-60 years, 50 subjects received a dose of 3.75 micrograms HA/ AS03 in a volume of 1 ml at 0 and 21 days.
Fi studju biex tinstab id- doża, f’ individwi ta ’ età bejn it- 18- 60 sena, 50 individwu rċieva doża ta ’ 3. 75 mikrogramma HA/ AS03 f’ volum ta ’ 1 ml fil- ġranet 0 u 21.
The seroprotection rates, seroconversion rates and seroconversion factors for anti-haemagglutinin (anti-HA) antibody at day 42 (post dose 2) and day 180 (persistence) were as follows:
Ir- rati ta ’ seroprotezzjoni, rati ta ’ serokonverżjoni u l- fatturi ta ’ serokonverżjoni għall- antikorp kontra l- emagglutinina (anti- HA) f’ jum 42 (wara t- tieni doża) u jum 180 (persistenza) kienu kif ġej:
anti-HA antibody Seroprotection rate* † Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Antikorp anti- HA Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
Day 42 84% 82% 27.9
Ġurnata 42 84% 82% 27. 9
Day 180 54% 52% 4.4
Ġurnata 180 54% 52% 4. 4
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinina (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet aktar fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- medja tat- titre ġeometriku (GMT) wara t- tilqim u GMT qabel it- tilqim.
Cross-reactive immune response against variants of A/ Vietnam/ 1194/ 2004 (H5N1):
Rispons immuni cross- reactive kontra varjanti ta ’ A/ Vietnam/ 1194/ 2004 (H5N1):
Seroprotection rate* † Seroconversion rate† Seroconversion factor† * anti-HA ≥ 1:40
Rata ta ’ seroprotezzjoni * † Rata ta ’ serokonverżjoni † Fattur ta ’ serokonverżjoni † * anti- HA ≥1: 40
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre ta ’ inibizzjoni ta ’ l- emagglutinina (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet aktar fit- titre; fattur ta ’ serokonverżjoni: proporzjon ta ’ GMT wara t- tilqim u GMT qabel it- tilqim.
In the dose finding study the seroprotection rate, seroconversion rate and seroconversion factor against H5N1 drift variants 21 days after the second dose were as follows:
6 Fl- istudju biex tinstab id- doża, r- rata ta ’ seroprotezzjoni, ir- rata ta ’ serokonverżjoni, u l- fattur ta ’ serokonverżjoni kontra varjanti mibdula ta ’ H5N1, 21 ġurnata wara t- tieni doża kienu kif ġej:
35.0% 35.0% 3.4 6
35. 0% 35. 0% 3. 4
† seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥ 1:40; seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and have a 4- fold increase in titre; seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination GMT.
† rata ta ’ seroprotezzjoni: proporzjon ta ’ individwi b’ titre (HI) ≥ 1: 40; rata ta ’ serokonverżjoni: proporzjon ta ’ individwi li jew kienu seronegattivi qabel it- tilqim u għandhom titre protettiv ta ’ ≥ 1: 40 wara t- tilqim, jew kienu seropożittivi qabel it- tilqim u għandhom żieda ta ’ 4 darbiet fit- titre; fattur ta ’ serokonverżjoni: proporzjon tal- GMT wara t- tilqim u GMT qabel it- tilqim.
Twenty one days after the second dose, a 4-fold increase in serum neutralising antibody titres was obtained in 77.1% of subjects against the A/ Indonesia/ 5/ 2005 strain, in 75.0% of subjects against A/ Anhui/ 01/ 2005 and in 85.0% of subjects against A/ Turkey/ Turkey/ 1/ 2005.
Wieħed u għoxrin ġurnata wara t- tieni doża, żieda ta ’ 4 darbiet aktar fit- titres ta ’ l- antikorp li jinnewtralizza s- serum inkiseb f’ 77. 1% ta ’ l- individwi kontra r- razza A/ Indonesia/ 5/ 2005, f’ 75. 0% ta ’ l- individwi kontra A/ Anhui/ 01/ 2005 u f’ 85. 0% ta ’ l- individwi kontra A/ Turkey/ Turkey/ 1/ 2005.
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment.
Dożi ta ’ 15, 5, 1. 7 jew 0. 6 mikrogramma ta ’ HA ġew ittesjati fl- esperiment ta ’ sfida omologu, u dożi ta ’ 15, 7. 5, 3. 8 jew 1. 75 mikrogramma ta ’ HA ġew ittesjati fl- esperiment ta ’ sfida eterologu.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Informazzjoni li mhix klinka, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, effett tossiku fuq il- fertilità tal- mara, fuq l- embriju u l- fetu u wara t- twelid (sa tmiem il- perjodu ta ’ treddiegħ) ma turi l- ebda periklu speċjali għall - bnedmin.
Sodium chloride (NaCl) 7 Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Water for injections
Sodium chloride (NaCl) Disodium hydrogen phosphate (Na2HPO4) Potassium dihydrogen phosphate (KH2PO4) Potassium chloride (KCl) Ilma għall- injezzjonijiet
For adjuvants, see section 2.
Għal sustanzi supplimentari, ara sezzjoni 2.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ ((2°Ċ – 8°Ċ).
(butyl rubber).
(butyl rubber).
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml).
Il- volum wara li tħallat kunjett wieħed ta ’ suspensjoni (2. 5 ml) ma ’ kunjett wieħed ta ’ emulsjoni (2. 5ml) jikkorisspondi għal 10 dożi ta ’ vaċċin (5ml).
Pandemrix consists of two containers:
Pandemrix jikkonsisti f’ żewġ kontenituri:
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Kunjett A: kunjett wieħed b’ ħafna dożi li fih l- antiġen (suspensjoni), 8 Kunjett B: kunjett b’ ħafna dożi fih is- suppliment (emulsjoni).
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/ or abnormal physical appearance.
Qabel ma tħallat iż- żewġ komponenti, l- emulsjoni u s- suspensjoni għandhom jitħallew jilħqu t - temperatura tal- kamra, jitħawwdu, u jiġu spezzjonati viżwalment għal frak u/ jew dehra fiżika mhux normali.
The volume of Pandemrix (5 ml) after mixing corresponds to 10 doses of vaccine.
Il- volum ta ’ Pandemrix (5 ml) wara li jitħallat jikkorisspondi għal 10 dożi ta ’ vaċċin.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection.
Kull doża ta ’ vaċċin ta ’ 0. 5ml tinġibed ġo siringa għall- injezzjoni.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - HRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza bijoloġika attiva
KG Zirkustraße 40, D-01069 Dresden Germany
KG Zirkustraße 40, D- 01069 Dresden Ġermanja
Pandemrix can only be marketed when there is an official WHO/ EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pandemrix takes due account of the officially declared pandemic strain.
Pandemrix jista ’ jitqiegħed fis- suq biss meta jkun hemm dikjarazzjoni uffiċjali ta ’ influwenza pandemika mill- WHO/ EU, bil- kondizzjoni li d- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkunsidra sew it- tip ta ’ influwenza pandemika uffiċjalment dikjarata.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version V01 (dated June 2006) 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 V01 (bid- data ta ’ Ġunju 2006) ppreżentata fit- Taqsima 1. 8. 1. ta ’ Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis - Suq, qiegħda f’ postha u tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version RMPv3 (dated 31 January 2008) 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 RMPv03 (bid- data ta ’ 31 ta ’ Jannar 2008) tal- Pjan ta ’ l- Immaniġġjar tar- Riskju (RMP) ppreżentata fit- Taqsima 1. 8. 2. ta ’ 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 • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Barra minn hekk, RMP aġġornat għandu jkun sottomess
11 • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
11 • Meta tkun irċevuta informazzjoni ġdida li tistà tagħmel impatt fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ tnaqqis ta ’ riskju. • F’ 60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba ta ’ l- EMEA
PSUR submission during the influenza pandemic:
Sottomissjoni ta ’ PSUR meta Prepandrix tintuża waqt influwenza pandemika:
During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/ 2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
F’ sitwazzjoni pandemika, il- frekwenza tas- sottomissjoni ta ’ rapporti perjodikament aġġornati dwar sigurta` speċifikata fl- Artikolu 24 tar- Regolament (KE) Nru 726/ 2004 ma tkunx biżżejjed għas- sigurta` ta ’ monitoraġġ ta ’ vaċċin pandemiku li dwaru huma mistennija livelli għolja ta ’ esponiment fi żmien qasir.
In consequence, as soon as the pandemic is declared (Phase 6 of the WHO global Influenza preparedness plan) and the pandemic vaccine is used, the MAH shall submit periodic safety update reports with periodicity and format defined as follows:
Bħala konsegwenza, hekk kif l- influwenza pandemika tkun dikjarata (Fażi 6 tal- pjan tal- WHO dwar tħejjija għal Influwenza globali) u l- vaċċin pandemiku jkun ġie użat, l- MAH għandu jibgħat rapporti perjodikament aġġornati dwar sigurta` f’ perijodi u forma kif imfissra hawn taħt:
- The clock will start from the first Monday after shipment of the first batch of vaccine.
Il- ħin jibda għaddej mill- ewwel Tnejn tal- ġimgħa wara li jintbgħat l- ewwel lott tal - vaċċin.
- First data-lock point is 14 days later.
L- ewwel data- lock point ikun 14- il jum wara.
intervals.
Forma Ir- rapport għandu jnkludi fih it- Tabelli li ġejjin dwar l- informazzjoni globali bl- użu tal- mudelli miftehma:
Fatal and/ or life-threatening reactions – for each Preferred Term (PT), including the proportion of fatal reports 2.
Reazzjonijiet fatali u/ jew li jipperikolaw il- ħajja – għal kull Preferred Term (PT), inkluż il- proporzjon ta ’ rapporti fatali
All events occurring in the following age groups:
6- 23 xhur, 2- 8 snin, 8- 17- il sena, 18- 60 sena, > 60 sena.
A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Deskrizzjoni fil- qosor ta ’ kull ma jkun ġie rappurtat waqt il- perijodu, klassifikat skond it- tip ta ’ min jirrapporta (pazjent jew professjonijiet fil- kura tas- saħħa), serjeta` tal- każ, kemm kien mistenni, u jekk ikunx volontarju jew mitlub.
- Serious expected reactions will be reviewed by the MAH as part of their signal detection
Reazzjonijiet serji mistennija jiġu riveduti mill- MAH bħala parti mill- proċeduri importanti tagħhom dwar dak li jiskopru u jiffurmaw parti mir- rapport biss jekk tinqala ’ xi ħaġa ta ’ tħassib.
procedures and will only form part of the report if an issue of concern arises.
-
- All tables will be based on number of events (presented on PT level, sorted by System
Kull tabella tkun bażata fuq numru ta ’ affarijiet li jkunu ġraw (preżentati fuq livell ta ’ PT, u mqassma skond is- System Organ Class (SOC) u mhux fuq in- numru ta ’ każi.
- Tables 1 to 4 will be based on events reported from healthcare professionals only.
It- Tabelli 1 sa 4 ikunu bażati fuq dak li jkun ġie rappurtat biss minn professjonisti fil- kura tas- saħħa.
- In Tables 1 to 5, numbers will be provided for events received during the reporting period
Fit- Tabelli 1 sa 5, numri jingħataw għal kull ħaġa rappurtata waqt il- perijodu tar - rappurtar u skond kif jinġemgħu.
Product-specific data
It- tabelli kollha jkunu bażati fuq tagħrif ġeneriku u li ma jkunx speċifiku għall - prodott.
- No line listings are required – these can be provided in signal evaluation reports as
Ebda line listings ma huma meħtieġa – dawn jistgħu ikunu disponibbli f’ rapporti ta ’ evalwazzjoni tal- bidu skond il- bżonn.
12 A short summary shall also be provided with the periodic safety update reports, in which any area of concern should be highlighted, signal work-up prioritised (if the event of multiple signals) and appropriate timelines for submission of a full signal evaluation report provided.
Sommarju qasir għandu jingħata wkoll mar- rapporti perjodikament aġġornati dwar sigurta`, li fihom kull parti ta ’ tħassib għandha tkun enfasizzata, ix- xogħol tal- bidu jingħata prijorita` (jekk il- każ ikun ta ’ ħafna sinjali) u ħinijiet xierqa għandhom jingħataw għall- għoti ta ’ rapport sħiħ dwar l- evalwazzjoni ta ’ sinjali.
A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in: i) EU member states for the reporting period by batch number, ii) EU member states cumulatively and iii) the rest of the world
Stati Membri ta ’ l- EU dwar il- perijodu ta ’ rappurtar bin- numru tal- lott, Stati Membri ta ’ l- EU b’ mod kumulattiv u
Clinical
Skond u wara l - Kliniku
During the pandemic, the applicant will collect clinical safety and effectiveness data of the pandemic vaccine and submit this information to the CHMP for evaluation.
Waqt l- influwenza pandemika, l- applikant għandu jiġbor tagħrif dwar sigurta` u effettivita` klinika tal- vaċċin pandemiku u jibgħat din l- informazzjoni lis- CHMP għal evalwazzjoni.
Depending on and after implementation of vaccine when first pandemic will take place.
implimentazzjoni tal- vaċċin meta sseħħ l- ewwel influwenza pandemika.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Waqt l- influwenza pandemika, l- applikant għandu jwettaq studju ta ’ cohort prospettivv kif identifikat fil- pjan ta ’ Farmakoviġilanza.
Depending on and after implementation of vaccine when first pandemic will take place.
Skond u wara l - implimentazzjoni tal- vaċċin meta sseħħ l- ewwel influwenza pandemika.
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT LI FIH PAKKETT 1 TA ’ 50 KUNJETT TA ’ SUSPENSJONI U 2 PAKKETTI TA ’ 25 KUNJETT TA ’ EMULSJONI
Split influenza virus inactivated, containing antigen equivalent to:
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen ekwivalenti għal:
A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14)
3. 75 mikrogramma * Razza tixbaħ lil A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14)
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol polysorbate 80 (4.85 milligrams) * haemagglutinin
AS03 suppliment magħmul minn squalene (10. 68 milligramma), DL- α- tocopherol (11. 86 milligramma) u polysorbate 80 (4. 85 milligramma) * emagglutinina
50 vials: suspension 25 vials x 2: emulsion The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml)
50 kunjett: suspensjoni 25 kunjett x 2: emulsjoni Il- volum wara li jitħallat kunjett 1 ta ’ suspensjoni (2. 5ml) ma ’ kunjett 1 ta ’ emulsjoni (2. 5ml) jikkorrispondi għal 10 dożi ta ’ vaċċin (5ml)
Intramuscular use Shake before use 16 Read the package leaflet before use
Użu għal ġol- muskolu Ħawwad qabel l- użu 16 Aqra l- fuljett ta ’ tagħrif qabel l- użu
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ 50 KUNJETT TA ’ SUSPENSJONI
Pandemrix suspension for emulsion for injection Pandemic influenza vaccine (H5N1)
Pandemrix suspensjoni għal emulsjoni għall- injezzjoni Vaċċin għal influwenza pandemika (H5N1)
Split influenza virus, inactivated, containing antigen equivalent to A/ VietNam/ 1194/ 2004 (H5N1) like strain used (NIBRG-14) * haemagglutinin
Virus maqsum, mhux attivat ta ’ l- influwenza li jkun fih antiġen ekwivalenti għalrazza tixbaħ lil 3. 75 mikrogramma * A/ VietNam/ 1194/ 2004 (H5N1) użat (NIBRG- 14) * emagglutinina
Suspension to be exclusively mixed with emulsion before administration
Suspensjoni li għandha titħallat esklussivament ma ’ l- emulsjoni qabel tingħata
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ 25 KUNJETT TA ’ EMULSJONI
Emulsion for emulsion for injection for Pandemrix
Emulsjoni għal emulsjoni għall- injezzjoni għal Pandemrix
AS03 adjuvant composed of squalene (10.68 milligrams), DL-α -tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams)
AS03 suppliment magħmul minn squalene (10. 68 milligramma), DL- α- tocopherol (11. 86 milligramma) u polysorbate 80 (4. 85 milligramma)
Emulsion to be exclusively mixed with suspension before administration
Emulsjoni li għandha titħallat esklussivament mas- suspensjoni qabel tingħata
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KUNJETT TA ’ SUSPENSJONI
Vial A Pandemrix suspension for emulsion for injection
Kunjett A Pandemrix suspensjoni għal emulsjoni għall- injezzjoni
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KUNJETT TA ’ EMULSJONI
Vial B Emulsion for emulsion for injection for Pandemrix
Kunjett B Pandemrix Suspensjoni għal emulsjoni għall- injezzjoni
To be mixed with Vial A before administration
Għandu jitħallat ma ‘ Kunjett A qabel jingħata.
Pandemrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Pandemrix suspensjoni u emulsjoni għal emulsjoni għall- injezzjoni Vaċċin ta ’ l- influwanza pandemika (H5N1) (virion maqsum, inattivat, supplimentat)
What Pandemrix is and what it is used for 2.
X’ inhu Pandemrix u għalxiex jintuża 2.
Before you receive Pandemrix 3.
Qabel ma tieħu Pandemrix 3.
How Pandemrix is given 4.
Kif għandek tieħu Pandemrix 4.
How to store Pandemrix 6.
Kif taħżen Pandemrix 6.
WHAT PANDEMRIX IS AND WHAT IT IS USED FOR
X’ INHU PANDEMRIX U GĦALXIEX JINTUŻA
Pandemrix is a vaccine for use in adults aged 18 to 60 years to prevent pandemic influenza (flu).
Pandemrix huwa vaċċin għall- użu fl- adulti minn 18 sa 60 sena biex jilqa ’ kontra l- influwenza pandemika.
Pandemic flu is a type of influenza that occurs at intervals that vary from less than 10 years to many decades.
Influwenza pandemika hija tip ta ’ influwenza li tfaqqa ’ f’ intervalli li jvarjaw minn taħt għaxar snin għal ħafna akar perjodi ta ’ għaxar snin.
The symptoms of pandemic flu are similar to those of ordinary flu but are usually more severe.
Is- sintomi ta ’ l- influwenza pandemika huma simili għal dawk ta ’ l- influwenza normali imma ssoltu huma aktar severi.
None of the ingredients in the vaccine can cause flu.
L- ebda wieħed mill- ingredjenti ma jista ’ jikkawża l- influwenza.
As with all vaccines, Pandemrix may not fully protect all persons who are vaccinated.
Bħal vaċċini l- oħra kollha, Pandemrix jista ’ ma jipproteġix kompletament lill- persuni kollha li jkunu mlaqqma.
BEFORE YOU RECEIVE PANDEMRIX
QABEL MA TIEĦU PANDEMRIX
Pandemrix should not be given:
Tieħux Pandemrix:
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of Pandemrix (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate.
• jekk xi darba kellek reazzjoni allerġika f’ daqqa waħda li tkun ta ’ periklu għal- ħajja għal kwalunkwe ingredjent ta ’ Pandemrix (dawn huma mniżżla fl- aħħar ta ’ dan il- fuljett), jew għal xi wieħed mis- sustanzi li jista ’ jkun fih f’ ammonti żgħar ħafna bħal dawn li ġejjin: proteina tal - bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew sodium deoxycholate.
However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Madankollu, f’ sitwazzjoni ta ’ influwenza pandemika, jista ’ jkun jaqbel li tieħu l- vaċċin, basta li jkun hemm disponibbli kura medika xierqa immedjatament f’ każ ta ’ reazzjoni allerġika.
Take special care with Pandemrix:
Oqgħod attent ħafna b’ Pandemrix:
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and, chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
• jekk qatt kellek reazzjoni allerġika minbarra reazzjoni allerġika f’ daqqa waħda li tkun ta ’ periklu għall- ħajja għal kwalunkwe ingredjent li fih il- vaċċin, għal thiomersal, għal proteina tal - bajd u tat- tiġieġ, ovalbumin, formaldehyde, gentamycin sulphate (antibiotiku) jew għal sodium deoxycholate.
Further information). • if you have a severe infection with a high temperature (over 38°C).
Aktar informazzjoni) 26 • jekk għandek infezzjoni serja b’ deni għoli (’ l fuq minn 38°C).
A minor infection such
Jekk dan japplika għalik it- tilqim tiegħek ġeneralment jiġi pospost sakemm tkun qed tħossok aħjar.
26 as a cold should not be a problem, but your doctor will advise whether you can still be vaccinated with Pandemrix. • if you have problems with your immune system, since your response to the vaccine may then be poor. • if you are having a blood test to look for evidence of infection with certain viruses.
Infezzjoni ħafifa bħal riħ m’ għandiex tkun problema, iżda t- tabib tiegħek jagħtik parir jekk inti tistax xorta waħda titlaqqam b’ Pandemrix. • jekk għandek problema bis- sistema immuni, peress li minħabba f’ hekk ir- rispons tiegħek għal - vaċċin jista ’ ma jkunx biżżejjed. • jekk qed tagħmel xi test tad- demm biex issib evidenza ta ’ infezzjoni b’ ċerti tipi ta ’ virus.
In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
Fl - ewwel ftit ġimgħat wara t- tilqim b’ Pandemrix, ir- riżultati ta ’ dawn it- testijiet jistgħu ma jkunux tajba.
Tell the doctor requesting these tests that you have recently received Pandemrix.
Għid lit- tabib li qed jordnalek dawn it- testijiet li m’ ilekx li ħadt Pandemrix.
Using other medicines or vaccines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Meta tieħu mediċini jew vaċċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk tkun qed tieħu jew reċentement tkun ħadt xi mediċini oħra, inkluż mediċini mingħajr riċetta tat- tabib jew jekk reċentement tkun ħadt xi vaċċin ieħor.
Pandemrix is not intended to be given at the same time as other vaccines.
Pandemrix m’ huwiex maħsub biex jingħata fl- istess ħin ma ’ vaċċini oħra.
However, if this cannot be avoided, the other vaccine will be injected into the other arm.
Madankollu, jekk dan ma jistax jiġi evitat, il- vaċċini l- oħra għandhom jiġu injettati fid- driegħ l- ieħor.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Pandemrix can still be given but your response to the vaccine may be poor.
Jekk tieħu xi mediċini li jnaqqsu l- immunità għall- infezzjonijiet jew jekk tkun tieħu xi tip ta ’ kura oħra (bħal radjoterapija) li taffettwa s- sistema immuni, Pandemrix xorta jista ’ jingħata iżda l- effett tal - vaċċin jista ’ ma jkunx biżżejjed.
Pregnancy and breast-feeding There is no information on the use of Pandemrix in pregnant women.
Tqala u Treddigħ M’ hemmx informazzjoni dwar l- użu ta ’ Pandemrix f’ nisa tqal.
Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant.
It- tabib tiegħek għandu jagħmel stima tal- benefiċċji u r- riskji kieku kellu jagħtik il- vaċċin waqt li inti tqila.
Please tell your doctor if you are/ may be pregnant or intend to become pregnant.
Jekk jogħġbok għid lit- tabib tiegħek jekk inti / tista tkun tqila jew qed tagħmel ħsieb li ssir tqila.
Pandemrix may be given while you are breast-feeding.
Pandemrix jista ’ jingħata waqt li qed tredda ’.
Important information about some of the ingredients of Pandemrix Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Tagħrif importanti dwar xi wħud mill- ingredjenti ta ’ Pandemrix Thiomersal (preservattiv) huwa preżenti f’ dan il- prodott, u huwa possibbli li inti jista ’ jkollok reazzjoni allerġika.
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i. e. essentially sodium- and potassium-free.
Dan il- prodott mediċinali fih anqas minn 1mmol ta ’ sodium (23 mg) u anqas minn 1 mmol ta ’ potassium (39 mg) f’ kull doża, i. e. essenzjalment huwa mingħajr sodium u potassium.
HOW PANDEMRIX IS GIVEN
KIF GHANDEK TIEHU PANDEMRIX
You will receive two doses of Pandemrix.
Inti se tirċievi żewġ dożi ta ’ Pandemrix.
The second dose should be given after an interval of at least three weeks after the first dose.
It- tieni doża għandha tingħata wara intervall ta ’ mill- anqas tliet ġimgħat wara l- ewwel doża.
The doctor or nurse will give Pandemrix as an injection into your upper arm muscle.
It- tabib jew infermier jagħti Pandemrix bħala injezzjoni fil- muskolu tan- naħa ta ’ fuq tad- driegħ.
Like all medicines, Pandemrix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Pandemrix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
♦ Very common (these may occur with 1 in 10 doses or more of the vaccine): • Headache
27 ♦ Komuni ħafna (dawn jistgħu jseħħu b’ doża 1 minn 10 dożi jew aktar tal- vaċċin): • Uġigħ ta ’ ras • Għejja • Uġigħ, ħmura, nefħa jew għoqda iebsa fis- sit ta ’ l- injezzjoni • Deni • Uġigħ fil- muskoli, uġigħ fil- ġogi
♦ Common (these may occur with up to 1 in 10 doses of the vaccine): • Warmth, itching or bruising at the injection site • Increased sweating, shivering, flu-like symptoms • Swollen glands in the neck, armpit or groin
♦ Komuni (dawn jistgħu jseħħu b’ sa doża 1 minn 10 dożi tal- vaċċin): • Sħana, ħakk u tbenġil fis- sit ta ’ l- injezzjoni • Żieda fil- ħruġ ta ’ l- għaraq, tregħid, sintomi bħal ta ’ l- influwenza • Glandoli minfuħin fl- għonq, fl- abt jew fl- irqiq ta ’ bejn il- koxxa u ż- żaqq
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Tingling or numbness of the hands or feet • Sleepiness • Dizziness • Diarrhoea, vomiting, stomach pain, feeling sick • Itching, rash • Generally feeling unwell • Sleeplessness
♦ Mhux komuni (dawn jistgħu jseħħu b’ sa doża 1 minn 100 doża tal- vaċċin): • Tnemnim fl- idejn u fis- saqajn jew idejn u saqajn imtarrxin • Ngħas • Sturdament • Dijarea, rimettar, uġigħ fl- istonku, dardir • Ħakk, raxx • Tħossok ma tiflaħx b’ mod ġenerali • Nuqqas ta ’ rqad
These reactions usually disappear within 1-2 days without treatment.
Dawn ir- reazzjonijiet ġeneralment jgħaddu fi żmien ġurnata sa jumejn mingħajr kura.
♦ Uncommon (these may occur with up to 1 in 100 doses of the vaccine): • Generalised skin reactions including urticaria (hives)
♦ Mhux komuni (dawn jistgħu jseħħu b’ sa doża 1 minn 100 doża tal- vaċċin): • Reazzjonijiet mifruxa fil- ġilda li jinkludu l- urtikarja (ħorriqija)
♦ Rare (these may occur with up to 1 in 1,000 doses of the vaccine): • Severe stabbing or throbbing pain along one or more nerves • Fits • Low blood platelet count which can result in bleeding or bruising • Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death
♦ Rari (dawn jistgħu jseħħu b’ sa doża 1 minn 1, 000 doża tal- vaċċin): • Uġigħ qawwi donnu kkawżat minn xi arma bil- ponta jew tektik matul nerv wieħed jew aktar • Aċċessjonijiet • Għadd baxx ta ’ plejtlits fid- demm li jista ’ jwassal għal fsada jew tbenġil • Reazzjonijiet allerġiċi li jwasslu għal waqa ’ perikoluża fil- pressjoni, li jekk ma tiġix ikkurata tista ’ twassal għall- kollass, koma u mewt
♦ Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): • Narrowing or blockage of blood vessels with kidney problems • Temporary inflammation of the brain and nerves causing pain, weakness and paralysis that may spread across the body.
♦ Rari ħafna (dawn jistgħu jseħħu b’ sa doża 1 minn 10, 000 doża tal- vaċċin): • Djuq jew sadd ta ’ vini jew arterji fejn ikun hemm problemi bil- kliewi • Infjammazzjoni temporanja tal- moħħ u n- nervituri, li tikkawża uġigħ, djgħufija u paraliżi li tista ’ tinfirex mal- ġisem.
HOW TO STORE PANDEMRIX
KIF TAĦŻEN PANDEMRIX
28 After the vaccine is mixed:
28 Tagħmlux fi friża.
What Pandemrix contains
X’ fih Pandemrix
After mixing, one dose (0.5 ml) contains 3.75 micrograms of haemagglutinin from the following influenza virus strain:
Wara li titħallat, doża waħda (0. 5 ml) ikun fiha 3. 75 mikrogramma ta ’ emagglutinina mir- razza tal- virus ta ’ l- influwenza li ġej:
The emulsion vial contains an ‘adjuvant’ (AS03).
Il- kunjett ta ’ l- emulsjoni fih ‘ suppliment ’ (AS03) li jistimula rispons aħjar.
This compound contains squalene (10.68 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams).
Dan il- kompost fih squalene (10. 68 milligramma), DL- α- tocopherol (11. 86 milligramma) u polysorbate 80 (4. 85 milligramma).
Adjuvants are used to improve the body’s response to the vaccine.
Is- supplimenti jintużaw biex itejbu r- rispons tal- ġisem għal vaċċin.
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate(KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), water for injections
L- ingredjenti l- oħra huma: polysorbate 80, octoxynol 10, thiomersal, sodium chloride (NaCl), disodium hydrogen phosphate (Na2HPO4), potassium dihydrogen phosphate (KH2PO4), potassium chloride (KCl), magnesium chloride (MgCl2), ilma għall- injezzjonijiet
What Pandemrix looks like and contents of the pack
Id- dehra ta ’ Pandemrix u l- kontenuti tal- pakkett
One pack of Pandemrix consists of:
Pakkett wieħed ta ’ Pandemrix fih:
- one pack containing 50 vials of 2.5 ml suspension (antigen) for 10 doses
- pakkett wieħed li fih 50 kunjett ta ’ 2. 5 ml suspensjoni (antiġen) għal 10 dożi
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Rue de l’ Institut 89 B- 1330 Rixensart Il- Belġju
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- rappreżenttant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
България ГлаксоСмитКлайн ЕООД Тел.: + 359 2 953 10 34
България
Latvija GlaxoSmithKline Latvia SIA Tel: + 371 7312687
30 United Kingdom Latvija GlaxoSmithKline UK GlaxoSmithKline Latvia SIA Tel: + 44 (0) 808 100 9997 Tel: + 371 7312687 customercontactuk@ gsk. com lv- epasts@ gsk. com
Vial A: multidose vial containing the antigen (suspension), Vial B: multidose vial containing the adjuvant (emulsion).
Kunjett A: kunjett b’ ħafna dożi li fih l- antiġen (suspensjoni), Kunjett B: kunjett b’ ħafna dożi fih is- suppliment (emulsjoni).
Before mixing the two components, the emulsion and suspension should be allowed to reach room temperature, shaken and inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Qabel ma tħallat iż- żewġ komponenti, l- emulsjoni u s- suspensjoni għandhom jitħallew jilħqu t - temperatura tal- kamra, jitħawwdu, u jiġu spezzjonati viżwalment għal frak u/ jew dehra fiżika mhux normali.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott, jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
PANRETIN EPAR summary for the public
PANRETIN Sommarju ta ’ l- EPAR għall- pubbliku
What is Panretin?
X’ inhu Panretin?
Panretin is a gel containing the active substance alitretinoin (0.1%).
Panretin huwa ġell li fih is- sustanza attiva alitretinoin (0. 1%).
What is Panretin used for?
Għal x’ hiex jintuża Panretin?
Panretin gel is used to treat skin lesions (lumps or swellings) in patients with Kaposi’ s sarcoma, a type of skin cancer, in AIDS patients.
Panretin gel jintuża fit- trattament ta ’ leżjonijiet (tumuri jew nefħiet) f’ pazjenti b’ sarkoma ta ’ Kaposi, tip ta ’ kanċer tal- ġilda, fil- pazjenti bl- AIDS.
Panretin is used when: • the lesions are not ulcerated or lymphoedematous (the skin has not broken and the lesions are not swollen with fluid), and • they have not responded to the antiretroviral treatment the patient is already receiving, and • radiotherapy or chemotherapy is not appropriate, and • the patient does not need treatment for visceral (internal) Kaposi’ s sarcoma.
Panretin jintuża meta: • l- leżjonijiet tal- ġilda ma jkunux ulċerati jew limfedematużi (il- ġilda ma tkunx inkisret u l - leżjonijiet ma jkunux minfuħin bil- fluwidu), u • l- leżjonijiet ma jkunux irrispondew għat- trattament antiretrovirali li l- pazjent ikun qed jirċievi diġà, u • l- kimoterapija jew ir- radjuterapija ma tkunx adegwata, u • l- pazjent ma jkunx jeħtieġ trattament għal sarkoma ta ’ Kaposi vixxerali (interna).
How is Panretin used?
Kif jintuża Panretin?
Panretin treatment should be initiated and maintained by a doctor experienced in the treatment of patients with Kaposi’ s sarcoma.
It- trattament b’ Panretin għandu jinbeda u jiġi sorveljat minn tabib li għandu esperjenza fit- trattament ta ’ pazjenti b’ sarkoma ta ’ Kaposi.
Panretin is applied twice a day to the skin lesions, avoiding healthy skin, using enough gel to cover each lesion with a generous coating, then left to dry for three to five minutes before covering with clothing.
Għandu jintuża biżżejjed ġell biex kull leżjoni tingħata kisja ġeneruża u titħalla tinxef bejn tlieta u erba ’ minuti qabel ma titgħatta bl- ilbies.
Depending on each lesion’ s response to treatment, the number of applications can be increased to three or four times a day.
In- numru ta ’ applikazzjonijiet jista ’ jiżdied għal tlieta jew erba ’ darbiet kuljum u dan jiddependi fuq kemm kull leżjoni tirrispondi għat- trattament.
Panretin is usually applied for up to 12 weeks at first, and treatment continued after this period only on lesions which have responded to treatment.
Fil- bidu, Panretin jista ’ jiġi applikat għal mhux iktar minn 12- il ġimgħa, u wara dan il- perjodu it- trattament għandu jitkompla biss fuq leżjonijiet li jkunu rrispondew għat- trattament.
Panretin is used in male patients, and there is very little information about its use in female patients, since they rarely suffer from Kaposi’ s sarcoma.
Panretin jista ’ jintuża minn pazjenti rġiel, u ftit li xejn hemm tagħrif dwar l- użu tiegħu minn pazjenti nisa, il- għaliex in- nisa rari ħafna jbatu mis- sarkoma ta ’ Kaposi.
How does Panretin work?
Kif jaħdem Panretin?
The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group of retinoids, substances that are derived from vitamin A.
Is- sustanza attiva f’ Panretin, alitretinoin, hija aġent kontra l- kanċer li hu parti mill- grupp tar- retinojdi, sustanzi derivati mill- vitamina A.
The exact way alitretinoin works in Kaposi’ s sarcoma is unknown.
Mhux magħruf eżżatt kif jaħdem l- alitretinoin fis- sarkoma ta ’ Kaposi.
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Il- kejl 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Panretin has been examined in two 12-week studies in patients with Kaposi’ s sarcoma, involving a total of 402 patients, where the effectiveness of Panretin was compared to that of placebo (a dummy treatment, in this instance the gel without the active substance).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ewlieni ta ’ l- effettività kien ir- rispons globali għat- trattament, b’ ħarsa lejn ir- rispons tal- leżjonijiet trattati (leżjonijiet li jkopru arja iktar żgħira u leżjonijiet li huma iktar ċatti).
What benefit has Panretin shown during the studies?
X’ benefiċċji ta ’ Panretin ħarġu minn dawn l- istudji?
In both studies, Panretin was more effective than placebo, with an overall response to treatment of 35% and 37% in patient using Panretin compared with 18% and 7% in patients using placebo.
Fiż- żewġ studji, Panretin kien iktar effettiv mill- plaċebo, b’ rispons globali għat- trattament ta ’ 35% u 37% f’ pazjenti li kienu qed jużaw Panretin meta mqabbla ma ’ 18% u 7% f’ pazjenti li kienu qed jużaw il- plaċebo.
What is the risk associated with Panretin?
X’ inhuma r- riskji marbuta ma ’ Panretin?
The most common side effect with Panretin (seen in more than 1 patient in 10) are rash (redness, scaling, inflammation), pruritus (itching), skin disorders (cracking, scabbing, crusting, draining, oozing) and pain (burning, soreness).
L- iktar effetti sekondarji komuni ta ’ Panretin (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma raxx (ħmura, qxur fil- ġilda, infjammazzjoni), ħakk (pruritus), diżordnijiet fil- ġilda (qsim tal- ġilda, trobbija ta ’ qxur u skorċi fuq il- ġilda, ħruġ ta ’ likwidu mill- ġilda) u uġigħ (ħruq, irritazzjoni).
For the full list of all side effects reported with Panretin, see the Package Leaflet.
Għal - lista sħiħa ta ’ effetti sekondarji rrapurtati minħabba fl- użu tal- Panretin, ara l- Fuljett ta ’ Tagħrif li jiġi mal- pakkett.
Panretin should not be used in people who may be hypersensitive (allergic) to retinoids in general, alitretinoin, or any of the other ingredients.
Panretin m’ għandux jintuża minn persuni allerġiċi (iper sensittivi) għar- retinojdi b’ mod ġenerali, għal alitretinoin, jew għal kwalunkwe mill- ingredjenti l- oħra.
Panretin should also not be used in patients who are pregnant or breast-feeding.
Panretin m’ għandux wkoll jintuża minn pazjenti nisa tqal jew li jkunu qed ireddgħu.
Panretin should also not be used to treat lesions that are close to other skin disorders.
Panretin m’ għandux wkoll jintuża għat- trattament ta ’ leżjonijiet li jkunu qrib ta ’ diżordnijiet oħra tal- ġilda.
Why has Panretin been approved?
Għaliex ġie approvat Panretin?
The Committee for Medicinal products for Human Use (CHMP) decided that Panretin’ s benefits are greater than its risks for the treatment of cutaneous lesions in patients with AIDS- related Kaposi’ s sarcoma.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Panretin fit- trattament ta ’ leżjonijiet fil- ġilda f’ pazjenti b’ sarkoma ta ’ Kaposi relatata ma ’ l- AIDS huma ikbar mir- riskji tiegħu.
They recommended that Panretin be given marketing authorisation.
Huma rrakkomandaw li Panretin jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Panretin:
Aktar tagħrif dwar Panretin:
The European Commission granted a marketing authorisation valid throughout the European Union for Panretin on 11 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq, valida madwar l- Unjoni Ewropea kollha għal Panretin fil- 11 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 11 October 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil - 11 ta ’ Ottubru 2005.
The marketing authorisation holder is Eisai Ltd.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Eisai Ltd.
The full EPAR for Panretin is available here.
L- EPAR sħiħ dwar Panretin huwa disponibbli minn hawnhekk.
This summary was last updated in 04-2007.
Dan is- sommarju ġie aġġornat f’ 04- 2007.
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 teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek..
What is Parareg?
X’ inhu Parareg?
Parareg is a medicine containing the active substance cinacalcet.
Parareg huwa mediċina li fiha s- sustanza attiva cinacalcet.
What is Parareg used for?
Għal xiex jintuża Parareg?
Parareg is used in adults and elderly patients: • to treat secondary hyperparathyroidism.
Parareg jintuża f’ pazjenti adulti u anzjani: • biex jittratta iperparatirojdiżmu sekondarju.
This is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH). ‘ Secondary ’ means that the hyperparathyroidism is caused by another condition.
Din hi kundizzjoni fejn il- glandoli tal- paratirojde fl - għonq jipproduċu wisq ormon paratirojdu (PTH). ‘ Sekondarju ’ ifisser li l- iperparatirojdiżmu huwa kkawżat minn kundizzjoni oħra.
Parareg is used in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Parareg jintuża f' pazjenti b' mardiet serji tal- kliewi li jkollhom bżonn ta 'dijaliżi biex id- demm jitnaddfilhom mill- prodotti żejda.
How is Parareg used?
Kif jintuża Parareg?
PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Parareg.
Il- livelli tal- PTH għandhom jiġu ċċekkjati ta 'l- inqas 12 - il siegħa wara d- doża u bejn ġimgħa u erba' ġimgħat wara kull aġġustament tad- doża ta 'Parareg.
Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Parareg.
Il - livelli tal- kalċju fid- demm għandhom jitkejlu ta 'spiss, u fi żmien ġimgħa minn kull aġġustament tad - doża ta' Parareg.
Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
La tiġi stabbilita doża ta ’ manutenzjoni, il- livelli tal- kalċju għandhom jitkejlu kull xahar u l- livelli PTH għandhom jitkejlu bejn kull xahar sa tliet xhur.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Parareg for adults is 30 mg twice a day.
F’ pazjenti bil- karċinoma tal- paratirojde jew iperparatirojdiżmu primarju, id- doża inizjali rakkomandata ta 'Parareg għall- adulti hi ta' 30 mg darbtejn kuljum.
The dose of Parareg should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Id- doża ta 'Parareg għandha tiġi miżjuda bejn kull ġimagħtejn u erba' ġimgħat sa 90 mg tlieta jew erba 'darbiet kuljum kif meħtieġ biex jonqsu l- livelli tal- kalċju fid- demm għal- livelli normali.
Parareg is taken with food or shortly after a meal.
Parareg jittieħed ma 'l- ikel jew ftit wara l- ikel.
How does Parareg work?
Kif jaħdem Parareg?
The active substance in Parareg, cinacalcet, is a calcimimetic agent.
Is- sustanza attiva f’ Parareg, cinacalcet, hija aġent kalċimimetiku.
How has Parareg been studied?
Kif ġie studjat Parareg?
Parareg has been studied in three main studies involving 1,136 dialysis patients with serious kidney disease.
Parareg ġie studjat fi tliet studji ewlenin li fihom ħadu sehem 1, 136 pazjent b' mard serju tal- kliewi li kienu fuq dijaliżi.
Parareg was compared with placebo (a dummy treatment).
Parareg tqabbel ma 'plaċebo (trattament finta).
Parareg has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Parareg ġie studjat ukoll fi studju li kien jinvolvi 46 pazjent b’ iperkalċemija, li 29 minnhom kellhom karċinoma tal- paratirojde u 17 kellhom iperparatirojdiżmu primarju li ma setgħux ikollhom il- glandoli tal- paratirojde mneħħija jew li kirurġija għat- tneħħija ta ’ dawn il- glandoli ma kenitx effettiva.
A further three studies compared the effectiveness of Parareg and placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Minn dawn.
Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Parareg over a total of almost six years.
45 komplew għar- raba ’ studju fuq tul ta ’ żmien twil, b’ ħarsa lejn l- effikaċja ta ’ Parareg għal total ta ’ kważi sitt snin.
What benefit has Parareg shown during the studies?
X' benefiċċji wera Parareg f’ dawn l- istudji?