qanastek/EMEA-V3 huggingface dataset:
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR-145)
A/ Solomon Islands/ 3/ 2006 (H1N1) like strain (A/ Solomon Islands/ 3/ 2006, IVR- 145)
15 micrograms HA**
15 – il mikrogramma HA **
A/ Wisconsin/ 67/ 2005 (H3N2) like strain
A/ Wisconsin/ 67/ 2005 (H3N2) like strain
15
15 – il mikrograma HA **
micrograms HA** per 0.5 ml dose
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) 15 – il mikrogramma HA ** F’ kull doża ta ’ 0. 5 ml …………………………………………………………………………………. * ippropagati fiċ- ċelluli Madin Darby Canine Kidney (MDCK) ** haemagglutinin
The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2007/ 2008 season.
It- tilqima hi konformi mar- rakkomandazzjoni tal- WHO (emisferu tat- tramuntana) u mad- deċiżjoni ta ’ l- UE għall- istaġun 2007/ 2008.
Suspension for injection in pre-filled syringe Clear to slightly opalescent.
Ta ’ kulur minn ċar sa ftit opalexxenti.
Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.
Profilassi ta ’ l- influwenza għall- adulti, speċjalment f’ dawk li jkollhom riskju akbar ta ’ komplikazzjonijiet assoċjati.
The use of Optaflu should be based on official recommendations.
L- użu ta ’ Optaflu għandu jkun ibbażat fuq ir- rakkomandazzjonijiet uffiċjali.
0.5 ml.
0. 5 ml
Immunisation should be carried out by intramuscular (into the deltoid muscle) injection.
It- tilqima għandha tingħata permezz ta ’ injezzjoni ġol- muskoli (ġol- muskolu tad- deltoid).
Children and adolescents (< 18 years of age):
Tfal u adolexxenti (< 18- il sena):
Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see section 5.1).
Optaflu mhux irrakkomandat għall- użu fit- tfal u adolexxenti taħt it- 18- il sena, peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
Hypersensitivity to the active substances or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi, jew għal xi sustanzi mhux attivi.
Immunisation shall be postponed in patients with febrile illness or acute infection.
It- tilqima għandha tiġi posposta f’ pazjenti bid- deni jew b’ infezzjoni akuta.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal m’ hemm bżonn għall- vaċċini kollha li jistgħu jiġu injettati, il- kura u s- superviżjoni medika adattata għandhom dejjem ikunu disponibbli fil- pront f’ każ ta ’ avveniment anafilattiku rari wara l - għoti tat- tilqima.
Optaflu should under no circumstances be administered intravascularly.
Optaflu m’ għandu taħt l- ebda ċirkustanza jingħata b’ mod intravaskulari.
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Ir- respons ta ’ l- antikorpi f’ pazjenti b’ immunosuppressjoni endoġena jew iatroġenika tista ’ tkun insuffiċjenti.
Optaflu may be given at the same time as other vaccines.
Optaflu jista ’ jingħata fl- istess ħin ma ’ vaċċini oħrajn.
Immunisation should be carried out on separate limbs.
It- tilqima għandha tingħata f’ dirgħajn/ riġlejn differenti.
It should be noted that adverse reactions may be intensified.
Wieħed għandu jkun jaf li r- reazzjonijiet avversi jistgħu jintensifikaw.
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Ir- respons immunoloġiku jista ’ jitnaqqas jekk il- pazjent ikun qed jieħu kura immunosuppressanti.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV-1, Hepatitis C and especially HTLV-1 have been observed.
Wara t- tilqima ta ’ l- influwenza, kienu osservati riżultati pożittivi foloz fit- testijiet seroloġiċi li jużaw il- metodu ELISA biex jiskopru l- antikorpi kontra l- HIV- 1, Epatite Ċ u speċjalment HTLV- 1.
The Western Blot technique disproves the results.
It - teknika Western Blot tgiddeb ir- riżultati.
The transient false positive reactions may be due to the IgM response to the vaccine.
Ir- reazzjonijiet pożittivi foloz li jgħaddu malajr jistgħu jkunu minħabba r- respons ta ’ l- IgM għat- tilqima.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or in clinical trials.
Is- sigurtà ta ’ Optaflu fit- tqala u t- treddigħ ma kinitx evalwata fi studji ta ’ qabel l- użu kliniku jew fil - provi kliniċi.
In general data from influenza vaccinations in pregnant women do not indicate adverse fetal and maternal outcomes attributable to the vaccine.
B’ mod ġenerali, informazzjoni mit- tilqim ta ’ l- influwenza f’ nisa tqal, ma tindikax riżultati avversi fil - fetu u fl- omm, attribwiti mat- tilqima.
The use of Optaflu may be considered from the second trimester of pregnancy.
L- użu ta ’ Optaflu jista ’ jkun ikkunsidrat mit- tieni trimestru tat - tqala.
For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Għal nisa tqal b’ kundizzjonijiet mediċi fejn l- influwenza żżidilhom r- riskju ta ’ komplikazzjonijiet, l- għoti tat- tilqima hu rakkomandat, irrispettivament mill- istadju li fih tkun it- tqala tagħhom.
Optaflu may be used during lactation.
Optaflu jista ’ jintuża matul it- treddigħ.
The vaccine is unlikely to produce an effect on the ability to drive and use machines.
It- tilqima mhix mistennija li tipproduċi effett fuq il- ħila biex issuq jew tħaddem magni.
Adverse reactions from clinical trials:
Reazzjonijiet avversi mill- provi kliniċi:
The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program.
Is- sigurtà ta ’ Optaflu kienet evalwata f’ sitt provi kliniċi randomized, ikkontrollati b’ mod attiv li twettqu bħala parti mill- programm ta ’ l- iżvilupp.
Overall 3439 single doses of Optaflu were administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older).
B’ kollox, 3439 dożi waħidhom ta ’ Optaflu ngħataw lil 2366 pazjent adult li kellhom 18 - 60 sena u 1073 pazjent anzjan (li kellhom 61 sena jew iktar).
Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.
L - evalwazzjonijiet dwar is- sigurtà u r- reattoġeniċita twettqu fl- individwi kollha matul l- ewwel 3 ġimgħat wara t- tilqima u SAEs (Serious Adverse Events - Avvenimenti Avversi Serji) inġabru għal madwar 3100 pazjent li ngħataw it- tilqima matul is- sitt xhur ta ’ wara, fejn baqgħu jiġu segwiti.
So far there are no data from post-marketing experiences with Optaflu.
S’ issa m’ hemm l- ebda informazzjoni mill- esperjenza ta ’ wara t- tqegħid fis- suq b’ Optaflu.
In adults, the following undesirable effects have been observed during clinical trials with Optaflu:
Fl- adulti, ir - reazzjonijiet avversi li ġejjin kienu osservati matul il- provi kliniċi b’ Optaflu:
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1000 to < 1/ 100); rare (≥ 1/ 10000 to < 1/ 1000); very rare (< 1/ 10000), not known (cannot be estimated from the available data).
Komuni ħafna (≥ 1/ 10); komuni (≥ 1/ 100 sa < 1/ 10); mhux komuni (≥ 1/ 1, 000 sa < 1/ 100); rari (≥ 1/ 10, 000 sa < 1/ 1, 000); rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data
3 Frequency in adults (18-60 years of age)
3 disponibbli).
Organ class Blood and lymphatic system disorders
Frekwenza fl- adulti (fl- eta ta ’ 18- 60 sena)
Very common ≥ 1/ 10
Komuni ħafna ≥ 1/ 10
Common ≥ 1/ 100 to < 1/ 10
Komuni ≥ 1/ 100 sa < 1/ 10
Uncommon ≥ 1/ 1000 to < 1/ 100
Mhux Komuni ≥ 1/ 1000 sa < 1/ 100
Rare ≥ 1/ 10,000 to < 1/ 1000
Rari ≥ 1/ 10, 000 sa < 1/ 1000
Very rare < 1/ 10,000 Transient thrombocytopenia
Rari ħafna < 1 / 10, 000
Headache*
Uġigħ ta ’ ras *
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome
Disturbi newroloġiċi, bħal enċefalomajelite, nevrite u s - sindrome ta ’ Guillain Barré
Sweating*
Għaraq *
Generalised skin reactions including pruritus, urticaria or non-specific rash
Reazzjonijiet tal- ġilda ġeneralizzati li jinkludu ħakk, urtikarja jew raxx mhux speċifiku
Myalgia*, arthralgia*
Mijalġja *, artralġja *
Vasculitis, possibly associated with transient renal involvement
Vaskulite, possibbilment marbuta ma ’ involviment tal - kliewi li jgħaddi malajr
General disorders and administration site disorders
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata
Erythema*, pain* Malaise*,
Eritema *, uġigħ * Telqa *,
Swelling*, ecchymosis*, induration* Fever*,
Nefħa *, ekkimożi *, ebusija *
Local lymphadeno- pathy
Limfadenopatija lokali Deni ta ’ aktar
fatigue*
għeja * kbira *
shivering* Gastrointestinal disorders such as abdominal pain, diarrhoea or dyspepsia*
Deni *, tertir *
Fever greater than 39.0°C
minn 39. 0°C
Allergic reactions, in very rare cases leading to shock
Reazzjonijiet allerġiċi, li f’ każijiet rari ħafna jwasslu għal xokk
* These reactions usually disappeared within 1-2 days without treatment.
* Dawn ir- reazzjonijiet normalment għebu fi żmien minn jum sa jumejn mingħajr kura.
In the elderly frequencies were similar, exept for headache and pain which were classified as ‘ common’.
4 Fl- anzjani, il- frekwenzi kienu simili, minbarra l- uġigħ ta ’ ras u uġigħ li kienu kklassifikati bħala ‘ komuni ’.
The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).
Ir- rati ta ’ l- inċidenza għal uġigħ moderat u sever wara t- tilqima b’ Optaflu huma simili għal dawk ta ’ tilqim ta ’ l- influwenza derivat mill- bajd; madankollu, b’ Optaflu kienet osservata żieda żgħira fir- riskju għall- uġigħ fis- sit ta ’ l- injezzjoni li jkun ħafif u li jdum ftit, fis- sotto- grupp ta ’ pazjenti anzjani li ngħataw it- tilqima (8% mqabbla ma ’ 6% bit- tilqima ta ’ l- influwenza derivata mill- bajd).
With egg-derived influenza vaccines neuralgia, paraesthesia and febrile convulsions have been observed rarely.
Bit- tilqim ta ’ l- influwenza derivat mill- bajd, in- nevralġija, parestesija u konvulżjonijiet tad- deni kienu osservati b’ mod rari.
Overdosage is unlikely to have any untoward effect.
Doża eċċessiva mhux mistenni li jkollha xi effett negattiv.
Influenza vaccine, ATC-Code:
Tilqima ta ’ l- influwenza, Kodiċi ATC:
Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.
Is- seroprotezzjoni ġeneralment tinkiseb fi żmien 3 ġimgħat, kif wera l- istudju kliniku V58P4 importanti ħafna ta ’ fażi III għall- popolazzjoni adulta u anzjana.
In this comparative trial against an egg-derived influenza vaccine the seroprotection rate*, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
F’ din il- prova komparattiva kontra tilqima ta ’ l- influwenza derivata mill- bajd, ir- rata tas - seroprotezzjoni *, is- serokonverżjoni jew ir- rata taż- żieda sinifikanti ** u l- proporzjon medju ġeometriku (GMR) għall- antikorp anti- HA (imkejjel minn HI) kienu evalwati skond kriterji definiti minn qabel.
Data for adults were as follows (values in brackets show the 95% confidence intervals):
L- informazzjoni għall- adulti kienet kif ġej (il- figuri fil- parentesi juru l- intervalli tal- kunfidenza 95%):
Seroprotection rate
Rata ta ’ seroprotezzjoni
83% (80, 86)
(80, 86) 78%
Seroconversion/ Significant increase rate GMR
(59, 67)
63% 58% (59, 67) (54, 62) 7.62 4.86
(54, 62)
78% (75, 81) 9.97
(75, 81)
* Seroprotection = HI titers ≥ 40
* Seroprotezzjoni = HI titers ≥ 40
(6.86, 8.46)
(6. 86, 8. 46)
(4.43, 5.33)
(4. 43, 5. 33)
(9.12, 11)
(9. 12, 11)
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥ 40; Significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer
** Serokonverżjoni = titer HI negattiv qabel it- tilqima u titer HI ta ’ wara t- tilqima ≥ 40; żieda sinifikanti = titer HI pożittiv qabel it- tilqima u żieda mill- anqas 4 darbiet aktar fit- titer HI ta ’ wara t - tilqima.
Data for elderly were as follows (values in brackets show the 95% confidence intervals):
L- informazzjoni għall- anzjani kienet kif ġej (il- figuri fil- parentesi juru l- intervalli tal- kunfidenza 95%):
672
N=672
(72, 79)
(72, 79) 48%
(96, 98)
(96, 98) 65%
(81, 87)
(81, 87) 76%
Seroconversion/ Significant increase rate GMR
fir- rata
48% (44, 52) 4.62
(44, 52)
65% (61, 68) 5.91
(61, 68)
76% (72, 79) 9.63
(72, 79)
(4.2, 5.08)
(4. 2, 5. 08)
(5.35, 6.53)
(5. 35, 6. 53)
(8.77, 11)
(8. 77, 11)
** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥ 40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.
** Serokonverżjoni = titer HI negattiv qabel it- tilqima u titer HI pożittiv wara t- tilqima ≥ 40, żieda sinifikanti = titer HI ta ’ qabel it- tilqima pożittiv u żieda mill- anqas 4 darbiet aktar fit- titer HI ta ’ wara t- tilqima.
No differences were observed between the cell-culture and the comparator egg-derived vaccine.
L- ebda differenzi ma kienu osservati bejn il- koltura taċ- ċelluli u t- tilqima derivata mill- bajd li ntużat bħala komparatur.
Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers.
Fuq il- firxa tat- tliet razez ta ’ l- influwenza, għat- tilqima derivata mill- bajd, ir- rati tas- seroprotezzjoni varjaw bejn 85% u 98%, is- serokonverżjoni jew iż- żieda sinifikanti fir- rata varjaw bejn 62% u 73%, u l- GMRs varjaw bejn 5. 52 u 8. 76 darbiet aktar mit- titers HI tal- linja bażi.
The persistence of postvaccination antibodies to strains included in the vaccine is usually 6-12 months, as shown by studies performed during the clinical development of this vaccine.
Il- persistenza ta ’ l- antikorpi ta ’ wara t- tilqima għal razez inklużi fit- tilqima normalment iddum sa 6 - 12- il xahar, kif urew studji li twettqu matul l- l- iżvilupp kliniku ta ’ din it- tilqima.
Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group.
Optaflu ma kienx studjat fil- popolazzjoni pedjatrika u għalhekk, l- informazzjoni fuq ir- respons immuni mhix disponibbli għal dan il- grupp ta ’ età.
5 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on animal studies that are appropriate for the safety assessment of vaccines.
Informazzjoni li mhiex klinika ma ’ turi l- ebda periklu speċjali għall- bnedmin, magħmula fuq studji fuq l- annimali li huma adattati għall- evalwazzjoni tas- sigurtà tat- tilqim.
Optaflu was well tolerated and immunogenic in mice and ferrets.
Optaflu kien ittollerat tajjeb u kien immunoġeniku fil- ġrieden u fl- inmsa.
In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated.
Fi studju dwar l- effett tossiku minn dożi ripetuti fil- fniek ma kien hemm l- ebda evidenza ta ’ tossiċità sistemika u t- tilqima kienet ittollerata tajjeb lokalment.
Genotoxicity, carcinogenic potential, and toxicity to reproduction were not assessed because these studies are not appropriate for a vaccine.
L - effett tossiku fuq il- ġeni, ir- riskju ta ’ kanċer, l- effett tossiku fuq is- sistema riproduttiva ma kienux evalwati minħabba li dawn l- istudji mhumiex adattati għal tilqima.
Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Disodium phosphate dihydrate, Potassium dihydrogen phosphate, Water for injections.
Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Disodium phosphate dihydrate, Potassium dihydrogen phosphate Ilma għall- injezzjonijiet.
6.4 Special precautions for storage
6 6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original carton in order to protect from light.
Aħżen fil- kartuna oriġinali sabiex tilqa ’ mid- dawl.
0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber).
Suspensjoni ta ’ 0. 5 ml f’ siringi mimlija għal- lest (ħġieġ ta ’ tip I) b’ tapp bil- planġer (lastku bromobutyl).
Pack sizes of 1, 10 or 20 (2 × 10), each with or without needle are available.
Pakketti tad- daqsijiet ta ’ 1, 10 jew 20 (2 × 10), kull siringa hija disponibbli bil- labra jew mingħajrha.
The vaccine should be allowed to reach room temperature before use.
It- tilqima għandha titħalla tilħaq it- temperatura tal- kamra qabel l- użu.
Unused vaccine and other waste material should be disposed of in compliance with local rules for the disposal of products of this nature.
Tilqim mhux użat u materjal ieħor għar- rimi għandu jintrema kif jitolbu l- liġijiet lokali għar- rimi ta ’ prodotti ta ’ dan it- tip.
KG Emil-von-Behring-Strasse 76 D-35041 Marburg GERMANY
KG Emil- von- Behring- Strasse 76 D- 35041 Marburg IL- ĠERMANJA
01 June 2007
01 ta Ġunju 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott mediċinali tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
KG Emil-von-Behring-Strasse 76 D-35041 Marburg Germany
KG Emil- von- Behring- Strasse 76 D- 35041 Marburg Il- Ġermanja
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq irid jiżgura li jkun hemm sistema ta ’ farmakoviġilanza li tkun taħdem qabel ma ’ l- prodott jitpoġġa fuq is- suq.
Risk Management plan
Pjan dwar l- Immaniġġar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq iwiegħed li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- pjan tal- Farmakoviġilanza.
An updated Risk management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use.
Pjan dwar l- Immaniġġar tar- Riskju aġġornat għandu jkun ipprovdut skond il- Linja Gwida tas- CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskji għal prodotti mediċinali għall- użu uman.
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box: syringe with needle
Kaxxa: siringa bil- labra
Optaflu suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) (2007/ 2008 season)
Optaflu suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest Tilqima ta ’ l- influwenza (antiġen tal- wiċċ, inattivata, ippreparata f’ kolturi taċ- ċelluli) (Staġun 2007/ 2008)
15
15 – il mikrogramma HA **
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004)
15 micrograms HA** per 0.5 ml dose
15 – il mikrogramma HA ** F’ kull doża ta ’ 0. 5 ml
* propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin
* ippropagati fiċ- ċelluli Madin Darby Canine Kidney (MDCK) ** haemagglutinin
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall- injezzjonijiet.
Suspension for injection 1 x pre-filled syringe (0.5 ml) with needle 10 x pre-filled syringes (0.5 ml) with needle 2 x 10 pre-filled syringes (0.5 ml) with needle
Suspensjoni għall- injezzjoni siringa 1 mimlija għal- lest (0. 5 ml) bil- labra 10 siringi mimlijin għal- lest (0. 5 ml) bil- labra 2 x 10 siringi mimlijin għal- lest (0. 5 ml) bil- labra
For intramuscular injection
Għal Injezzjoni ġol- muskoli
12 Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not inject intravascularly!
Tinjettax b’ mod intravaskulari!
Exp.:
JIS
Batch:
Lott
Justification for not using Braille accepted.
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
13 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Box: syringe without needle
Kaxxa: siringa mingħajr labra
1 x pre-filled syringe (0.5 ml) without needle 10 x pre-filled syringes (0.5 ml) without needle 2 x 10 pre-filled syringes (0.5 ml) without needle
siringa 1 mimlija għal- lest (0. 5 ml) mingħajr labra 10 siringi mimlijin għal- lest (0. 5 ml) mingħajr labra 2 x 10 siringi mimlijin għal- lest (0. 5 ml) mingħajr labra
15 Justification for not using Braille accepted.
STRUZZJONIJIET DWAR L- UŻU
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Prefilled syringe
Siringa mimlija għal- lest
Optaflu (2007/ 2008 season)
Optaflu (Staġun 2007/ 2008)
i. m. injection
Injezzjoni ġol- muskoli
Optaflu suspension for injection in a pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Optaflu suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest Tilqima ta ’ l- influwenza (antiġen tal- wiċċ, inattivata, ippreparata f’ kulturi taċ- ċelluli)
What Optaflu is and what it is used for 2.
X’ inhu Optaflu u għalxiex jintuża 2.
Before you use Optaflu 3.
Qabel ma tuża Optaflu 3.
How to use Optaflu 4.
Kif għandek tuża Optaflu 4.
How to store Optaflu 6.
Kif taħżen Optaflu 6.
WHAT OPTAFLU IS AND WHAT IT IS USED FOR
X’ INHU OPTAFLU U GĦALXIEX JINTUŻA
Optaflu is a vaccine against flu (influenza).
Optaflu hu tilqima kontra l- influwenza.
Due to the kind of manufacturing Optaflu is free of chicken/ egg protein.
Minħabba t- tip ta ’ manifattura, Optaflu hu ħieles mill- proteina tat- tiġieġ/ bajd.
For manufacturing the vaccine the influenza virus was killed and prepared in a special way that the vaccine only contains influenza virus surface proteins (influenza virus surface antigens).
Biex tiġi mmanifatturata t- tilqima, il- virus ta ’ l- influwenza nqatel u kien ippreparat b’ mod speċjali sabiex t- tilqima jkun fiha biss il- proteini tal- wiċċ tal- virus ta ’ l- influwenza (antiġeni tal- wiċċ tal- virus ta ’ l- influwenza).
These proteins stimulate your immune system so that it can develop a protection against flu.
Dawn il- proteini jistimulaw is- sistema immuni tiegħek biex tkun tista ’ tiżviluppa protezzjoni kontra l- influwenza.
Optaflu is used to prevent flu in adults, especially in those who run an increased risk of experiencing associated complications in case they fall ill with flu.
Optaflu jintuża għall- prevenzjoni ta ’ l- influwenza fl- adulti, speċjalment f’ dawk li jkollhom riskju akbar ta ’ komplikazzjonijiet assoċjati f’ każ li jimirdu bl- influwenza.
BEFORE YOU USE OPTAFLU
QABEL MA TUŻA OPTAFLU
You must NOT use Optaflu • if you are allergic (hypersensitive) to influenza vaccine or any of the other ingredients of Optaflu • if you have an acute illness associated with fever • if you have an acute infection.
M’ GĦANDEKX tuża Optaflu • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għat- tilqima ta ’ l- influwenza jew sustanzi oħra ta ’ Optaflu • jekk ikollok xi marda akuta bid- deni • jekk ikollok infezzjoni akuta.
Take special care with Optaflu BEFORE receiving the vaccine • you should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e. g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see Section 2, “ Taking other medicines”). • your doctor or nurse will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration.
Oqgħod attent ħafna b’ Optaflu QABEL ma tingħata t- tilqima • għandek tgħid lit- tabib tiegħek jekk is- sistema immuni tiegħek hi difettuża, jew jekk qed tieħu kura li taffettwa s- sistema immuni, eż. b’ mediċina kontra l- kanċer (kimoterapija) jew mediċini li fihom il- kortikosterojdi (ara Sezzjoni 2, “ Meta tieħu mediċini oħra ”). • it- tabib jew in- ners tiegħek ser jiżguraw li kura medika u superviżjoni adattata jkunu disponibbli fil- pront f’ każ ta ’ reazzjoni anafilattika rari (reazzjoni allerġika severa ħafna b’ sintomi bħal diffikultà biex tieħu n- nifs, sturdament, polz dgħajjef u mgħaġġel u raxx tal - ġilda) wara li tieħu t- tilqima.
This reaction may occur with Optaflu as with all vaccines that are injected.
Din ir- reazzjoni tista ’ sseħħ b’ Optaflu kif jista ’ jiġri bit- tilqim kollu li jiġi injettat.
WHILE receiving the vaccine • your doctor or nurse will take care not to inject Optaflu into a blood vessel.
WAQT li tkun qed tingħata t- tilqima • it- tabib jew ners tiegħek ser joqogħdu attenti li ma jinjettawx Optaflu f’ xi vina jew arterja.
19 • Optaflu is not recommended for use in children below 18 years of age since there is no information available.
20 Tfal u adolexxenti • Optaflu mhux rakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena għax m’ hemm l- ebda informazzjoni disponibbli.
Taking other medicines Special care should be taken if you are receiving Optaflu and any of the following medicines at the same time: • medicines against cancer (chemotherapy), corticosteroid medicines (such as cortisone) or other medicines affecting the immune system.
Meta tieħu mediċini oħra Għandha tittieħed attenzjoni speċjali jekk inti qed tuża Optaflu u kwalunkwe waħda minn dawn il - mediċini li ġejjin fl- istess ħin: • mediċini kontra l- kanċer (kimoterapija), mediċini li fihom il- kortikosterojdi (bħal cortisone) jew mediċini oħrajn li jaffettwaw is- sistema immuni.
Tell your doctor if you are being treated with such medicines.
Għid lit- tabib tiegħek jekk qed tiġi kkurat b’ mediċini bħal dawn.
The immune response of your body may be weakened.
Ir- respons immuni ta ’ ġismek jista ’ jiddgħajjef.
Therefore the vaccine may work less effectively. • other vaccines.
Għalhekk it- tilqima tista ’ taħdem b’ mod inqas effettiv. • vaċċini oħrajn.
In this case the vaccines should be injected into separate limbs.
F’ dan il- każ il- vaċċini għandhom jiġu injettati f’ dirgħajn/ riġlejn differenti.
Note that the side effects of the vaccines may be intensified.
Wieħed għandu jkun jaf li l- effetti sekondarji tat- tilqim jistgħu jintensifikaw.
The safety of Optaflu in pregnant and breast-feeding women has not been determined.
Is- sigurtà ta ’ Optaflu f’ nisa tqal u nisa li qed ireddgħu ma kinitx stabbilita.
The limited data from influenza vaccinations in pregnant women do not indicate that there are negative effects for the unborn child.
L- informazzjoni limitata mit- tilqim ta ’ l- influwenza f’ nisa tqal ma tindikax li hemm xi effetti negattivi għat- tarbija mhix imwielda.
The use of this vaccine may be considered from the second trimester of pregnancy.
L- użu ta ’ din it- tilqima jista ’ jkun ikkunsidrat mit- tieni trimestru tat- tqala.
For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy.
Għal nisa tqal b’ kundizzjonijiet mediċi fejn l- influwenza żżidilhom r- riskju ta ’ komplikazzjonijiet, l- għoti tat- tilqima hu rakkomandat, irrispettivament mill- istadju li fih tkun it- tqala tagħhom.
Optaflu may be used during breast feeding.
Optaflu jista ’ jintuża matul it- treddigħ.
Therefore your doctor will decide whether you should receive Optaflu if you are pregnant or breast- feeding.
Għalhekk it- tabib tiegħek ser jiddeċiedi jekk għandekx tuża Optaflu jekk inti tqila jew qed tredda ’.
Important information about some of the ingredients of Optaflu This medicine contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially ‘ sodium-free’.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Optaflu Din il- mediċina fiha anqas minn 1 mmol sodium (23 mg) f’ kull doża, jiġifieri essenzjalment ‘ ħielsa mis- sodium ’.
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i. e. essentially ‘ potassium- free’.
Din il- mediċina fiha anqas minn 1 mmol (39 mg) ta ’ potassium f’ kull doża, jiġifieri essenzjalment ‘ ħielsa mill- potassium ’.
HOW TO USE OPTAFLU
KIF GĦANDEK TUŻA OPTAFLU
Optaflu is applied to you by your doctor or nurse.
Optaflu jingħatalek mit- tabib jew min- ners tiegħek.
Usual dose for persons of 18 years and older:
Id- doża normali għal persuni ta ’ 18- il sena jew aktar:
0.5 ml of Optaflu suspension.
0. 5 ml ta ’ suspensjoni ta ’ Optaflu.
Optaflu is injected into the muscle on the top of the upper arm (deltoid muscle).
Optaflu jiġi njettat ġol- muskolu fin- naħa ta ’ fuq tad- driegħ (ġol- muskolu tad- deltoid).
Optaflu should under no circumstances be injected into a blood vessel.
Optaflu m’ għandu taħt l- ebda ċirkustanza jingħata ġol- vini/ arterji.
Like all medicines, Optaflu can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Optaflu jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following undesirable effects have been observed during clinical trials:
L- effetti mhux mixtieqa li ġejjin kienu osservati waqt il- provi kliniċi:
Very common Common Uncommon Rare Very rare
21 Komuni ħafna Komuni
in more than 1 in 10 vaccinees in more than 1 in 100 vaccinees, but less than 1 in 10 vaccinees in more than 1 in 1,000 vaccinees, but less than 1 in 100 vaccinees in more than 1 in 10,000 vaccinees, but less than 1 in 1,000 vaccinees in less than 1 in 10,000 vaccinees, including isolated reports
f’ iktar minn 1 minn kull 10 individwi li ngħataw it- tilqima f’ iktar minn 1 minn kull 100 individwu li ngħataw it- tilqima, iżda f’ inqas minn 1 minn kull 10 individwi li ngħataw it- tilqima
20 Very serious side effects Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:
Effetti sekondarji serji ħafna Għid lit- tabib tiegħek immedjatament jew mur fis- sezzjoni ta ’ l- emerġenza ta ’ l- eqreb sptar jekk ikollok dan l- effett sekondarju li ġej – jista ’ jkollok bżonn attenzjoni medika urġenti jew li tiddaħħal l - isptar:
Very rare: • difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction) Rare: • numbness and tingling sensation • painful disorders of the nerves, e. g. attacks of extreme pain in the face, throat or ear fits (convulsions) (only observed with egg-derived influenza vaccines)
Rari ħafna: • diffikultà biex tieħu n- nifs, sturdament, polz dgħajjef u mgħaġġel u raxx tal- ġilda li huma sintomi ta ’ reazzjoni anafilattika (reazzjoni allerġika severa ħafna) Rari: • tnemnim u sensazzjoni ta ’ tingiż • disturbi bl- uġigħ tan- nervituri, eż. attakki ta ’ uġigħ estrem fil- wiċċ, fil- gerżuma jew fil- widnejn aċċessjonijiet (konvulżjonijiet) (osservati biss b’ tilqim ta ’ l- influwenza derivat mill- bajd)
Also, tell your doctor immediately if you experience any of the following side effects – you may need medical attention:
Flimkien ma ’ dan, għid lit- tabib tiegħek immedjatament jekk ikollok kwalunkwe wieħed minn dawn l - effetti sekondarji li ġejjin – jista ’ jkollok bżonn attenzjoni medika:
Very rare: • skin rashes, fever, joint pain or kidney problems which are symptoms of an inflammation of the blood vessels • fever, headache, vomiting and drowsiness progressing to coma or fits (convulsions) which are symptoms of an inflammation of the brain and spinal cord • weakness beginning in the legs and progressing to the arms with numbness and tingling sensation which are symptoms of an inflammation of the nerves
Rari ħafna: • raxx tal- ġilda, deni, uġigħ fil- ġogi jew problemi tal- kliewi li huma sintomi ta ’ infjammazzjoni tal- vini jew arterji • deni, uġigħ ta ’ ras, rimettar u ngħas li jiżviluppa f’ koma jew aċċessjonijiet (konvulżjonijiet) li huma sintomi ta ’ infjammazzjoni tal- moħħ u tas- sinsla • dgħjufija li tibda fir- riġlejn u tinfirex lejn id- dirgħajn bi tnemnim u b’ sensazzjoni ta ’ tingiż li huma sintomi ta ’ infjammazzjoni tan- nervituri
Serious side effects Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:
Effetti sekondarji serji Għid lit- tabib tiegħek immedjatament jekk ikollok kwalunkwe wieħed minn dawn l- effetti sekondarji li ġejjin – jista ’ jkollok bżonn attenzjoni medika:
Very Rare: • bleeding or bruising which are symptoms of a low platelet count in the blood
Rari ħafna: • ħruġ ta ’ demm jew tbenġil li huma sintomi ta ’ għadd baxx tal- plejtlets fid- demm
These reactions are usually mild and only last a few days.
Effetti sekondarji ħfief Komuni ħafna: • sintomi bħal ta ’ l- influwenza bħal uġigħ ta ’ ras, sensazzjoni ta ’ skonfort, għeja • uġigħ, ħmura Dawn ir- reazzjonijiet normalment ikunu ħfief u jdumu biss ftit jiem.
Pain and headache were common in the elderly.
L- uġigħ u l- uġigħ ta ’ ras kienu komuni fl- anzjani.
Common: • sweating, joint and muscle pain, chills, hardening or swelling at the site of the injection, bruising, fever, shivering • gastrointestinal disorders such as abdominal pain, diarrhoea or disturbance of the digestive tract These reactions are usually mild and only last a few days.
Komuni: • għaraq, uġigħ fil- ġogi u fil- muskoli, tertir ta ’ bard, ebusija jew nefħa fis- sit ta ’ l- injezzjoni, tbenġil, deni, tertir • disturbi gastro- intestinali bħal uġigħ ta ’ żaqq, dijarea jew disturbi fl- apparat diġestiv Dawn ir- reazzjonijiet normalment ikunu ħfief u jdumu biss ftit jiem.
Uncommon: • generalised skin reactions such as itching, bumps on the skin or non-specific rash
Mhux komuni: • reazzjonijiet ġeneralizzati tal- ġilda bħal ħakk, ħotob fuq il- ġilda jew raxx mhux speċifiku
Rare: • swelling and pain of local lymphnodes • Fever greater than 39.0 °C
22 Rari: • nefħa u uġigħ fin- nodi tal- limfi lokali • Deni ta ’ aktar minn 39. 0°C
HOW TO STORE OPTAFLU
KIF TAĦŻEN OPTAFLU
Do not use Optaflu after the expiry date which is stated on the label and carton.
Tużax Optaflu wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa.
The expiry date refers to the last day of that month.
Id- data ta’ skadenza tirreferi għal l- aħħar ġurnata ta’ dak ix- xahar.
Storage conditions of the unopened product: • Store in a refrigerator (2 °C to 8 °C). • Do not freeze. • Keep the pre-filled syringe in the carton in order to protect from light.
Kundizzjonijiet tal- ħażna għall- prodott mhux miftuħ: • Aħżen fi friġġ (2°C sa 8°C) • Tagħmlux fil- friża. • Żomm is- siringa mimlija għal- lest fil- kaxxa biex tilqa ’ mid- dawl.
Preparation of the product before use:
Kif tipprepara l- prodott qabel l- użu:
Your doctor or nurse will take care that Optaflu should be allowed to reach room temperature before use and is shaken before use.
It- tabib jew in- ners tiegħek ser joqogħdu attenti biex Optaflu jitħalla jilħaq it- temperatura tal- kamra qabel l- użu u jitħawwad qabel l- użu.
Ask you pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Optaflu contains The active substances are influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:
X’ fih Optaflu Is- sustanzi attivi huma antiġeni tal- wiċċ tal- virus ta ’ l- influwenza (haemagglutinin u neuraminidase) *, inattivati, tar- razez li ġejjin:
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) ……………………………………
B/ Malaysia/ 2506/ 2004 like strain (B/ Malaysia/ 2506/ 2004) ……………………………………
* produced in Madin Darby Canine Kidney (MDCK) cells (this is influenza virus is grown) ** haemagglutinin
* magħmul f’ ċelluli Madin Darby Canine Kidney (MDCK) (din hi koltura ta ’ ċelluli speċjali li fiha jitkabbar l- virus ta ’ l- influwenza) ** haemagglutinin
The other ingredients are: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Is- sustanzi l- oħra huma: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate u ilma għall- injezzjonijiet.
What Optaflu looks like and contents of the pack Optaflu is a suspension for injection in a pre-filled syringe (ready-to-use syringe).
23 Id- dehra ta ’ Optaflu u d- daqs tal- pakkett Optaflu hu suspensjoni għall- injezzjoni f’ siringa mimlija għal- lest (siringa li tkun lesta għall- użu).
Optaflu is a clear to slightly opalescent suspension.
Optaflu hu suspensjoni minn ċara sa ftit opalexxenti.
A single syringe contains 0.5 ml of suspension for injection.
Siringa waħda fiha 0. 5 ml ta ’ suspensjoni għall- injezzjoni.
Pack sizes of 1, 10 or 20 (2 x 10), each with or without needle are available.
Pakketti tad- daqsijiet ta ’ 1, 10 jew 20 (2 x 10), siringa, kull waħda hi disponibbli bil- labra jew mingħajrha.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
KG Emil-von-Behring-Strasse 76 D-35041 Marburg
KG Emil- von- Behring- Strasse 76 D- 35041 Marburg IL- ĠERMANJA
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f’ xx/ yyy
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - mediċini (EMEA): http: // www. emea. europa. eu /
What is OptiMARK?
X’ inhu OptiMARK?
OptiMARK is a solution for injection that contains the active substance gadoversetamide.
OptiMARK hu soluzzjoni għall- injezzjoni li fiha s- sustanza attiva gadoversetamide.
It is available in a pre-filled syringe and in a vial (500 micromoles per millilitre).
Jiġi f’ siringa mimlija għal- lest u fi fjala (500 micromoles kull millilitru).
What is OptiMARK used for?
Għal x’ hiex jintuża OptiMARK?
OptiMARK is for diagnostic use.
OptiMARK hu għal użu dijanjostiku.
It is used in patients who are undergoing magnetic resonance imaging (MRI), a special type of scan where images of the internal organs are taken.
Jintuża f’ pazjenti li tkun se ssirilhom immaġni b’ reżonanza manjetika (MRI), tip speċjali ta ’ sken fejn jittieħdu immaġni ta ’ l- organi interni.
OptiMARK is used to obtain a clearer scan in patients who have, or are thought to have abnormalities in the brain, spine or liver.
OptiMARK jintuża biex jinkiseb sken iktar ċar f’ pazjenti li jkollhom, jew li jkun maħsub li għandhom anormalitajiet fil - moħħ, fis- sinsla jew fil- fwied.
How is OptiMARK used?
Kif jintuża OptiMARK?
OptiMARK should only be given by a doctor who has experience in using MRI.
OptiMARK għandu jingħata biss minn tabib li jkollu esperjenza fl- użu ta ’ l- MRI.
It is given as an intravenous injection (into a vein) of 100 micromoles per kilogram body weight.
Jingħata bħala injezzjoni intravenuża (fil- vina) ta ’ 100 micromole għal kull kilogramma li jiżen il- pazjent.
OptiMARK allows images to be taken for up to an hour, although the best time to take a scan after injection depends on the location and type of abnormality that is being examined.
OptiMARK jippermetti li jittieħdu immaġni għal perjodu twil sa siegħa, għalkemm l- aħjar ħin li fih għandu jittieħed l- isken wara l- injezzjoni jiddependi mill- post u t- tip ta ’ anormalità li tkun qed tiġi eżaminata.
When looking at certain abnormalities in the brain, OptiMARK may need to be used at a higher dose, or the dose may need to be repeated.
Meta wieħed iħares lejn ċerti anormalitajiet fil- moħħ, OptiMARK jista ’ jkollu jintuża f’ doża ikbar, jew inkella jkun hemm bżonn li tiġi ripetuta d- doża.
OptiMARK is not recommended for use in children below 2 years of age, because of a lack of information on safety and effectiveness in this group.
OptiMARK mhux rakkomandat sabiex jintuża fi tfal ta ’ inqas minn sentejn, minħabba nuqqas ta ’ tagħrif fuq is- sigurtà u l- effettività f’ dan il- grupp.
How does OptiMARK work?
Kif jaħdem OptiMARK?
The active substance in OptiMARK, gadoversetamide, contains gadolinium, a ‘ rare earth’ metal element.
Is- sustanza attiva f’ OptiMARK, gadoversetamide, fiha l- gadolinju, element metalliku rari (‘ rare earth ’).
Gadolinium is used as a ‘ contrast enhancer’ to help obtain better images with MRI scans.
Il- gadolinju jintuża biex ‘ isaħħaħ il- kuntrast ’ ħalli jgħin fil- kisba ta ’ immaġni aħjar bl- iskens ta ’ l- MRI.
MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
L- MRI hu metodu ta ’ teħid ta ’ immaġni li jiddependi fuq kampijiet manjetiċi żgħar ħafna prodotti mill- molekuli ta ’ l- ilma fil- ġisem.
Once injected, gadolinium interacts with the water molecules.
Ladarba jiġi injettat, il- gadolinju u l- molekuli ta ’ l- ilma jkollhom effett fuq xulxin.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
Minħabba din l- azzjoni reċiproka, il- molekuli ta ’ l- ilma jagħtu sinjal iktar b’ saħħtu, u dan jgħin biex tinkiseb stampa iktar luminuża.
In OptiMARK, the gadolinium is bound to another chemical in a ‘ chelate ’ (a type of chemical) so that the metal is not released in the body but stays ‘ trapped’ in the chelate until it is eliminated from the body in the urine.
F’ OptiMARK, il- gadolinju jkun magħqud ma ’ kimika oħra f ’ ‘ chelate ’ (tip ta ’ kimika) sabiex il- metall ma jiġix rilaxxat fil- ġisem iżda jibqa ‘ maqbud ’ fil- chelate sakemm jiġi eliminat mill- ġisem fl- awrina.
(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 studies in 403 patients).
(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 Kif ġie studjat OptiMARK?
In all studies, the effects of OptiMARK were compared with those of gadopentetate dimeglumine (another contrast agent containing gadolinium).
Fl- istudji kollha, l- effetti ta ’ OptiMARK tqabblu ma ’ dawk ta ’ gadopentetate dimeglumine (aġent ieħor tat- tisħiħ tal- kuntrast li fih il- gadolinju).
The main measure of effectiveness was the difference in the ability to see the abnormalities on MRI scans taken with and without the contrast agent.
Il- mezz ewlieni tal- kejl ta ’ l- effettività kienet id- differenza fl- abilità li juri l- anormalitajiet fuq l- iskens ta ’ l- MRI meħuda bl- aġent tal- kuntrast jew mingħajru.
Each scan’ s clarity was scored on a four-point scale.
Iċ- ċarezza ta ’ kull sken ingħatat punteġġ fuq skala b’ erba ’ punti.
The scans were analysed by three radiologists (specialised physicians) who did not know what treatment the patient had received beforehand, to make sure the findings were as accurate as possible.
L- iskens ġew analizzati minn tliet radjoloġisti (tobba speċjalizzati) li ma kinux jafu minn qabel xi trattament kien qed jingħata lill- pazjent, biex ikun żgurat li s- sejbiet ikunu preċiżi kemm jista ’ jkun.
What benefit has OptiMARK shown during the studies?
X’ inhuma l- benefiċċji ta ’ OptiMARK li ntwerew matul dawn l- istudji?
In all studies, OptiMARK was as effective as the comparator contrast agent in improving the ability to see abnormalities on the scans.
Fl- istudji kollha, OptiMARK kien effettiv daqs l- aġent tal- kuntrast li tqabbel miegħu fit- titjib ta ’ l - abilità li juri l- anormalitajiet fuq l- iskens.
Both medicines were associated with similar improvements in the score given to the scans.
Iż- żewġ mediċini kienu assoċjati ma ’ titjib simili fil- punteġġ mogħti lill- iskens.
In the two studies of brain and spine abnormalities taken together, scans taken with OptiMARK had a score increase of 0.63 points on average (from a ‘ baseline ’ of 1.58 points without OptiMARK).
Fiż- żewġ studji ta ’ l- anormalitajiet tal- moħħ u tas- sinsla meħudin flimkien, l- iskens meħuda b’ OptiMARK kellhom żieda medja ta ’ 0. 63 punti fil- punteġġ (minn bażi ta ’ 1. 58 punti mingħajr OptiMARK).
This compared with a very similar increase of 0.66 points with the comparator contrast agent, from a baseline of 1.60 points.
Dan qabel ma ’ żieda simili ħafna ta ’ 0. 66 punti ma ’ l- aġent tal- kuntrast tat - tqabbil, minn bażi ta ’ 1. 60 punti.
In the studies of liver abnormalities, both medicines increased the score by an average of 0.38 points from a baseline of 1.82 points.
Fl- istudji ta ’ l- anormalitajiet tal- fwied, iż- żewġ mediċini żiedu l - punteġġ b’ medja ta ’ 0. 38 punti minn bażi ta ’ 1. 82 punti.
What is the risk associated with OptiMARK?
X’ riskju hu assoċjat ma ’ OptiMARK?
The most common side effects with OptiMARK (seen in between 1 and 10 patients in 100) are dizziness, headaches, dysgeusia (taste disturbances) and feeling hot.
L- iktar effetti sekondarji komuni ta ’ OptiMARK (li dehru f’ bejn pazjent wieħed u għaxra minn kull mija) huma l- isturdament, uġigħ ta ’ ras, disturbi fit- togħma (dysgeusia), u sħana.
For the full list of all side effects reported with OptiMARK, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti sekondarji rrappurtati ma ’ OptiMARK, ara l- Fuljett ta ’ Tagħrif.
OptiMARK should not be used in people who may be hypersensitive (allergic) to gadoversetamide, any of the other ingredients or other medicines containing gadolinium.
OptiMARK m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal gadoversetamide u għal xi sustanzi jew mediċini oħra li jkun fihom il- gadolinju.
It should also not be used in patients who have severe problems with their kidneys or in liver transplant patients, due to a risk of a condition called nephrogenic systemic fibrosis (NSF), which causes thickening of the skin and connective tissues.
Lanqas m’ għandu jingħata lil pazjenti li jbagħtu minn problemi serji fil- kliewi jew f’ pazjenti bi trapjant tal- fwied, minħabba f ’ riskju ta ’ kondizzjoni magħrufa bħala fibrożi sistemika nefroġenika (nephrogenic systemic fibrosis - NSF), li twassal għal ħxuna tal- ġilda u tat- tessuti konnettivi.
Why has OptiMARK been approved?
Għaliex ġie approvat OptiMARK?
The Committee for Medicinal Products for Human Use (CHMP) decided that OptiMARK’ s benefits are greater than its risks for use with MRI of the central nervous system and liver.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ OptiMARK’ s huma ikbar mir- riskji tiegħu meta jintuża ma ’ MRI tas- sistema nervuża ċentrali u tal - fwied.
The Committee recommended that OptiMARK be given marketing authorisation.
Il- Kumitat irrakkomanda li OptiMARK jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about OptiMARK:
Tagħrif ieħor dwar OptiMARK:
The European Commission granted a marketing authorisation valid throughout the European Union for OptiMARK to Tyco Healthcare Deutschland GmbH on 23 July 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal OptiMARK lil Tyco Healthcare Deutschland GmbH fi 23 ta ’ Lulju 2007.
The full EPAR for OptiMARK can be found here.
L- EPAR sħiħ għal OptiMARK jista ’ jinstab minn hawn.
This summary was last updated in 06-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 06- 2007.
Solution for Injection
soluzzjoni għall - injezzjoni
Pre-filled syringe
siringa mimlija għal - lest
1 pre-filled syringe
siringa 1 mimlija għal- lest
Optimark 500 micromol/ ml solution for injection in a pre-filled syringe
Optimark 500 mikromol/ ml soluzzjoni għall- injezzjoni, f’ siringa mimlija għal- lest