FrancophonIA/ELRC3.0 huggingface dataset:
English: In plasma, FXIII circulates as a heterotetramer [A2B2] composed of 2 FXIII A-subunits and 2 FXIII Bsubunits held together by strong non-covalent interactions.
Maltese: Fil-plażma, FXIII jiċċirkola bħala eterotetramer [A2B2] magħmul minn 2 subunitajiet A ta' FXIII u 2 subunitajiet ta' FXIII B li jinżammu flimkien minn interazzjonijiet qawwija mhux kovalenti.
English: NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting.
Maltese: NovoThirteen fih is-sustanza attiva catridecacog, li hu identiku mal-fattur uman XIII ta' koagulazzjoni, enzima neċċessarja sabiex id-demm jikkoagula.
English: Safely dispose of the syringe, vial adapter, infusion set and vials.
Maltese: Armi s-siringa, l-adapter tal-kunjett, is-sett tal-infużjoni u l-kunjetti b'mod sigur.
English: If the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children (see section 4.2 ‘Posology and method of administration - Paediatric population').
Maltese: Id-dilwizzjoni tal-prodott rikostitwit b'sodium chloride 0.9 %, soluzzjoni għall-injezzjoni Jekk il-pazjent pedjatriku jiżen inqas minn 24 kg, in-NovoThirteen rikostitwit għandu jiġi dilwit b'6 ml ta' sodium chloride 0.9% sabiex ikun jista' jintuża fid-dożaġġ ta' tfal żgħar (ara sezzjoni 4.2 ‘Pożoloġija u metodu ta' kif għandu jingħata - Popolazzjoni pedjatrika').
English: Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.
Maltese: Injetta bil-mod is-6 ml ta' sodium chloride 0.9%, soluzzjoni għall-injezzjoni fil-kunjett tanNovoThirteen rikostitwit.
English: Non-neutralising antibodies have been seen in 4 of the 82 exposed patients with congenital FXIII deficiency.
Maltese: L-antikorpi li ma jinnewtralizzawx ġew ossevati f'4 mit-82 pazjent esposti b'defiċjenza konġenitali ta' FXIII.
English: The enzymatic activity resides with the FXIII A-subunit.
Maltese: L-attività enzimatika hija fissubunità A ta' FXIII.
English: After dilution proceed to step H.
Maltese: Wara d-dilwizzjoni mur għall-pass H.
English: The recommended dose is 35 IU/kg body weight (bw) once monthly (every 28 days ± 2 days), administered as an intravenous bolus injection.
Maltese: Id-doża rakkomandata hi ta' 35 UI/kg tal-piż tal-ġisem (bw) darba fix-xahar (kull 28 jum ± jumejn), mogħti bħala injezzjoni bolus ġol-vini.
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA): 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Maltese: Kunjett wieħed fih catridecacog (fattur XIII ta' koagulazzjoni rikombinanti) (rDNA): 2500
English: Inhibitor formation:
Maltese: Kategorija farmakoterapewtika:
English: To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.
Maltese: Sabiex issir id-dilwizzjoni ta' NovoThirteen rikostitwit hemm il-bżonn ta' dawn l-affarijiet li ġejjin: kunjett li fih sodium chloride 0.9%, soluzzjoni għall-injezzjoni, siringa ta' 10 ml u garżi żgħar imxarrbin bl-alkoħol.
English: • If you experience an allergic reaction to NovoThirteen.
Maltese: • Jekk ikollok reazzjoni allerġika għal NovoThirteen.
English: A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and death) at a lower dose level than when administering the individual compounds.
Maltese: Effett sinerġistiku potenzjali tal-kura kombinata b'NovoThirteen u rFVIIa f'mudell kardjovaskulari avvanzat f'xadini tar-razza cynomolgus irriżulta f'farmakoloġija esaġerata (trombożi u mewt) f'livell ta' doża iktar baxx milli meta l-prodotti ngħataw b'mod individwali.
English: NovoThirteen 2500 IU powder and solvent for solution for injection catridecacog (recombinant coagulation factor XIII)
Maltese: UI trab u solvent għal soluzzjoni għall-injezzjoni catridecacog (rDNA fattur XIII)
English: In case a dilution of the reconstituted NovoThirteen is needed proceed to the section ‘Dilution of the reconstituted product with sodium chloride 0.9%, solution for injection'.
Maltese: F'każ li jkun hemm bżonn ta' dilwizzjoni tan-NovoThirteen rikostitwit mur fis-sezzjoni ‘Iddilwizzjoni tal-prodott rikostitwit b'sodium chloride 0.9 %, soluzzjoni għall-injezzjoni'.
English: General instructions for dilution
Maltese: Istruzzjonijiet ġenerali għad-dilwizzjoni
English: • Appropriate diagnostic procedures to confirm FXIII A-subunit deficiency
Maltese: • Twissija u prekawzjonijiet dwar l-anafilassi
English: Patients should be informed of the early signs of hypersensitivity reactions (including hives, generalised urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrin ta' reazzjonijiet ta' sensittività eċċessiva (li jinkludu ħorriqija, urtikarja ġeneralizzata, tagħfis fis-sider, tħarħir, pressjoni baxxa) u anafilassi.
English: No effects on reproductive organs have been seen in non-clinical studies.
Maltese: Ma ġew osservati l-ebda effetti fuq l-organi riproduttivi fi studji mhux kliniċi.
English: However, if the paediatric patient weighs less than 24 kg, the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to handle the dosing of small children (see section 6.6 ‘Special precautions for disposal and other handling - Use in the paediatric population').
Maltese: Madankollu, jekk il-pazjent pedjatriku jiżen inqas minn 24 kg, in-NovoThirteen rikostitwit għandu jiġi dilwit iżjed b'6 ml ta' sodium chloride 0.9% soluzzjoni għall-injezzjoni sabiex ikun jista' jintuża fid-dożaġġ ta' tfal żgħar (ara sezzjoni 6.6 ‘Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor- L-użu fil-popolazzjoni pedjatrika')
English: Upon activation, the FXIII A-subunit dissociates from the FXIII B-subunit and thereby exposes the active site of the FXIII A-subunit.
Maltese: Meta s-subunità A ta' FXIII tkun imwaħħla mas-subunità B ta' FXIII
English: To reconstitute and administer this product the following tools are needed: a 10 ml syringe or a syringe of a convenient size according to injection volume, alcohol swabs, the included vial adapter and an infusion set (tubing, butterfly needle).
Maltese: Biex tirrikostitwixxi u tagħti dan il-prodott għandek bżonn dawn l-affarijiet li ġejjin: siringa ta' 10 ml jew siringa ta' daqs konvenjenti skont il-volum tal-injezzjoni, swabs bl-alkoħol, l-adapter tal-kunjett li hemm inkluż, u sett tal-infużjoni (tubing, labra tat-tip butterfly).
English: Once attached, remove the protective cap from the vial adapter.
Maltese: Ġaladarba twaħħlu, neħħi l-għatu protettiv minn fuq l-adapter tal-kunjett.
English: If you stop using NovoThirteen, you are not protected against bleeding.
Maltese: Jekk tieqaf tuża NovoThirteen, m'intix protett kontra tnixxija ta' demm.
English: One vial contains catridecacog (recombinant coagulation factor XIII) (rDNA) 2500 IU per 3 ml, after reconstitution corresponding to a concentration of 833 IU/ml.
Maltese: UI/3 ml, wara r-rikostituzzjoni, li jikkorrispondi għal konċentrazzjoni ta' 833 UI/ml ).
English: The FXIII B-subunit acts as a carrier molecule for the FXIII A-subunit in circulation, and is present in excess in plasma.
Maltese: Użu fit-tfal u fl-adolexxenti (li jiżnu iżjed minn 24 kg) Fit-tfal u fl-adolexxenti, NovoThirteen jista' jintuża bħal fl-adulti.
English: Considering that the posology and the FXIII concentration in NovoThirteen are different from those of the other FXIII containing products, careful attention should be paid to the calculation of the appropriate dose for the individual patient (see dose volume formula provided in section 4.2).
Maltese: Meta tikkonsidra li l-pożoloġija u l-konċentrazzjoni ta' FXIII f'NovoThirteen huma differenti minn dawk ta' prodotti oħra li fihom FXIII, wieħed għandu joqgħod attent sew għal kalkulazzjoni tad-doża xierqa għall-pazjent fuq bażi individwali ( ara l-formula tal-volum tad-doża mogħtija f'sezzjoni 4.2).
English: If the patient weighs less than 24 kg, the reconstituted NovoThirteen should be diluted with 6 ml of sodium chloride 0.9%, solution for injection (refer to the section Use in the paediatric population for further detailed instructions on the dilution step).
Maltese: Jekk il-pazjent jiżen inqas minn 24 kg, in-NovoThirteen rikostitwit għandu jiġi dilwit b'6 ml ta' sodium chloride 0.9%, soluzzjoni għall-injezzjoni (irreferi għas-sezzjoni
English: • Development of antibodies against factor XIII which have no influence on the effect of the drug.
Maltese: • Żvilupp ta' antikorpi kontra fattur XIII li m'għandhom ebda influwenza fuq l-effett tal mediċina.
English: For instructions on reconstitution of the medicinal product prior to administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: NovoThirteen is given as an injection into a vein.
Maltese: NovoThirteen jingħata bħala injezzjoni ġo vina.
English: In a pharmacokinetic trial 6 children (age 1 to less than 6 years old) with congenital FXIII A-subunit deficiency were exposed to one single i.v.
Maltese: F'studju farmakokinetiku, 6 itfal (minn età ta' sena sa 6 snin) b'defiċjenza konġenitali ta' subunità-A ta' FXIII ġew esposti għal doża waħda biss ta' NovoThirteen 35 UI/kg mogħti minn ġol-vini.
English: EXP After reconstitution, use the medicine immediately due to the risk of microbiological contamination.
Maltese: Wara r-rikostituzzjoni, uża il-mediċina immedjatament minħabba r-riskju ta' kontaminazzjoni mikrobijoloġika
English: dose of NovoThirteen 35 IU/kg.
Maltese: NovoThirteen 2500 UI
English: • How to recognise the potential side effects (thrombosis and embolism)
Maltese: • Kif tirrikonoxxi l-effetti sekondarji li jista' jkun hemm (trombożi u emboliżmu)
English: • A drop in the number of some types of white blood cells.
Maltese: • Tnaqqis fin-numru ta' xi tipi ta' ċelluli bojod tad-demm .
English: Both documents are to be used as part of an educational plan aiming to minimise risks of medication errors, risk of thromboembolic events due to increased levels of non-proteolytically activated rFXIII in connection with incorrect storage, and risk of off-label use for treatment of breakthrough bleeding.
Maltese: Iż-żewġ dokumenti għandhom jintużaw bħala parti minn pjan edukattiv li għandu l-għan li jnaqqas kemm jista' jkun ir-riskji ta' żbalji fil-medikazzjoni, ir-riskju ta' avvenimenti tromboemboliċi minħabba ż-żieda fil-livelli ta' rFXIII attivat mhux b'mod proteolitiku kkawżat minn ħażna mhux korretta u r-riskju tal-użu mhux skont it-tikketta fil-kura ta' fsada li sseħħ bejn trattament u ieħor.
English: Gently swirl the vial to mix the solution.
Maltese: Id-dilwizzjoni għandha ssir taħt kondizzjonijiet asettiċi.
English: Increased levels of activated NovoThirteen may increase the risk of thrombosis.
Maltese: Żieda fil-livelli ta' NovoThirteen attivat tista' żżid ir-riskju ta' trombożi.
English: One patient with pre-existing neutropenia experienced a mild aggravation of neutropenia and leucopenia during treatment with NovoThirteen.
Maltese: Pazjent wieħed li diġà kellu newtropenija kellu aggravament ħafif ta' newtropenija u lewkopenija waqt il-kura b'NovoThirteen.
English: Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Maltese: Skont il-konċentrazzjoni tas-soluzzjoni ta' NovoThirteen, il-volum tad-doża li għandu jiġi injettat (f'millilitri) jista' jiġi kkalkulat minn din il-formula:
English: Inhibitor formation to NovoThirteen therapy has not been detected in clinical trials.
Maltese: Ma ġietx osservata l-formazzjoni ta' inibitur għal terapija b'NovoThirteen fil-provi kliniċi.
English: Denmark tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
Maltese: Id-Danimarka tel fax +45 3326 8380 e-mail regulatory@bavarian-nordic.com
English: Healthy 9 HIV 131
Maltese: B'saħħtu 9 HIV 131
English: Day 7/141
Maltese: Jum 7/141
English: Day 281
Maltese: Jum 281
English: Booster Dose
Maltese: Doża Booster
English: 1 dose (0.5 ml)
Maltese: INDIVIDWALI 1 doża (0.5 mL)
English: Day 421
Maltese: Jum 421
English: For instructions on administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq l-amministrazzjoni, ara sezzjoni 6.6.
English: N Day 71
Maltese: N Jum 71
English: IMVANEX contains sodium
Maltese: IMVANEX fih sodium
English: Sinusitis Conjunctivitis Influenza
Maltese: Sinusite Konġuntivite Influwenza
English: Individuals with atopic dermatitis (AD)
Maltese: Individwi b'dermatite atopika (AD - atopic dermatitis)
English: Active immunisation against smallpox in adults (see sections 4.4 and 5.1).
Maltese: Tilqima attiva kontra l-ġidri fl-adulti (ara sezzjonijiet 4.4 u 5.1).
English: Thaw at room temperature.
Maltese: Ħollu fit-temperatura tal-kamra.
English: Healthy 200
Maltese: B'saħħtu 200
English: Hejreskovvej 10 A, Kvistgård, 3490, Denmark
Maltese: Hejreskovvej 10 A, Kvistgård, 3490, Id-Danmarka
English: Pack size of 20.
Maltese: Daqs tal-pakkett ta' 20.
English: Day 01
Maltese: Jum 01
English: 3 Per Protocol Analysis Set (PPS), 4 seropositivity rates, 5 no immunogenicity sample taken, 6 combined Groups 1-3.
Maltese: Sett ta' Analiżi ta' Immunoġeniċità IAS) 3 Sett ta' Analiżi Skont il-Protokoll (PPS - Per Protocol Analysis Set), 4 rati ta' seropożittività, 5 l-ebda kampjun ta' immunoġeneċità ma ttieħed, 6 Gruppi 1-3 kombinati.
English: IMVANEX suspension for injection Smallpox vaccine (Live Modified Vaccinia Virus Ankara)
Maltese: IMVANEX suspensjoni għall-injezzjoni Tilqima kontra l-ġidri (Vaccinia Virus Ankara Ħaj Modifikat)
English: Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl.
Maltese: Ġiet iġġenerata dejta f'individwi infettati bl-HIV b'għadd ta' CD4 ta' ≥ 100 ċelluli/µL u ≤ 750 ċelluli/µL.
English: 1 dose (0.5 ml) has a titre of no less than 5 x 107 Inf.U (Inf.U = infectious units)
Maltese: ATTIVA(I) 1 doża (0.5 mL) għandha titre ta' mhux inqas minn 5 x 107 Inf.U (Inf.U = unitajiet infettivi)
English: 0.5 ml suspension in a vial (Type I glass) with stopper (bromobutyl rubber).
Maltese: 0.5 mL ta' suspensjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (lastku tal-bromobutyl).
English: Day 141
Maltese: Jum 141
English: Date of first authorisation: 31 July 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Lulju 2013
English: IMVANEX is available in pack containing 20 vials.
Maltese: IMVANEX hu disponibbli f'pakkett li fih 20 kunjett.
English: • if you have atopic dermatitis (see section 4).
Maltese: • jekk għandek dermatite atopika (ara sezzjoni 4).
English: The following general symptoms were reported more frequently in individuals with AD compared to healthy individuals: headache (33.1% vs. 24.8%), myalgia (31.8% vs. 22.3%), chills (10.7% vs. 3.8 %), nausea (11.9% vs. 6.8%), and fatigue (21.4% vs. 14.4%).
Maltese: Is-sintomi ġenerali li ġejjin ġew irrappurtati b'mod iktar frekwenti f'individwi b'AD meta mqabbla ma' individwi b'saħħithom: uġigħ ta' ras (33.1% vs. 24.8%), majalġja (31.8% vs. 22.3%), tertir (10.7% vs. 3.8%), dardir (11.9% vs. 6.8%), u għeja (21.4% vs. 14.
English: Primary immunisation
Maltese: Immunoġeniċità
English: Adverse Reactions Reported in Completed Clinical Trials with IMVANEX (N = 7,082 subjects)
Maltese: Reazzjonijiet Avversi għall-Mediċina Rrappurtati fil-Provi Kliniċi li Tlestew b'IMVANEX (N = 7,082 individwu)
English: Modified Vaccinia Ankara - Bavarian Nordic Live virus1 no less than 5 x 107 Inf.U * *infectious units
Maltese: Virus tal-Vaccinia Ankara - Bavarjan Nordiku Ħaj Modifikat1 ta' mhux inqas minn 5 x 107 Inf.U * *unitajiet infettivi
English: Healthy 61
Maltese: B'saħħtu 61
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase and gentamicin).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 jew traċċi ta' residwi (proteina tat-tiġieġ, benzonase u gentamicin).
English: Bavarian Nordic A/S Hejreskovvej 10A,
Maltese: Hejreskovvej 10A,
English: • influenza,
Maltese: • influwenza,
English: Bavarian Nordic A/S Hejreskovvej 10a 3490 Kvistgaard Denmark
Maltese: Bavarian Nordic A/S Hejreskovvej 10a 3490
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The active substance is Modified Vaccinia Ankara - Bavarian Nordic Live virus1, no less than 5 x 107 Inf.U* *infectious units
Maltese: Is-sustanza attiva hi virus tal-Vaccinia Ankara - Bavarjan Nordiku Ħaj Modifikat1 ta' mhux inqas minn 5 x 107 Inf.U* *unitajiet infettivi
English: • loss of appetite,
Maltese: • telf ta' aptit,
English: How to store IMVANEX 6.
Maltese: Kif taħżen IMVANEX 6.
English: NA
Maltese: N
English: At day 13-15, the median maximum lesion area for subjects who were administered ACAM2000 was 75mm2 (95% CI 69.0, 85.0) and for those who received Imvanex it was 0.0 (95% CI 0.0, 2.0).
Maltese: F'jiem 13-15, l-erja massima medja tal-leżjoni għal individwi li ngħataw ACAM2000 kienet ta' 75mm2 (CI ta' 95% 69.0, 85.0) u għal dawk li rċivew IMVANEX kienet ta' 0.0
English: EU/1/13/855/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/855/001
English: ELISA = enzyme-linked immunosorbent assay; GMT= geometric mean titre; N = number of subjects in the specific study group; PRNT = plaque reduction neutralisation test; SCR = seroconversion rate.
Maltese: GMT (geometric mean titre) = titre medju ġeometriku; N = numru ta' individwi fil-grupp tal-istudju speċifiku; PRNT (plaque reduction neutralisation test) = test tannewtralizzazzjoni tat-tnaqqis tal-plakka; SCR = rata ta' serokonverżjoni.
English: In a non-placebo controlled clinical trial that compared the safety of IMVANEX in individuals with AD to healthy individuals, individuals with AD reported erythema (61.2%) and swelling (52.2%) at the injection site with a higher frequency than healthy individuals (49.3% and 40.8%, respectively).
Maltese: Fi prova klinika kkontrollata mhux bi plaċebo li qabblet is-sigurtà ta' IMVANEX f'individwi b'AD ma' individwi b'saħħithom, individwi b'AD irrappurtaw eritema (61.2%) u nefħa (52.2%) fis-sit tal-injezzjoni bi frekwenza ogħla minn individwi b'saħħithom (49.3% u 40.8%, rispettivament).
English: How to store IMVANEX
Maltese: X'fih IMVANEX
English: Imvanex induced a peak neutralizing antibody geometric mean titer (GMT) of 153.5 (n = 185; 95% CI 134.3, 175.6), which was noninferior to the GMT of 79.3 (n = 186; 95% CI 67.1, 93.8) obtained after scarification with ACAM2000.
Maltese: (n = 185; CI ta' 95% 134.3, 175.6), li ma kienx inferjuri għall-GMT ta' 79.3 (n = 186; CI ta' 95% 67.1, 93.8) miksub wara skarifikazzjoni b'ACAM2000.
English: The safety of IMVANEX has been assessed in 20 clinical trials in which 5,261 Vaccinia-naïve individuals received two doses of no less than 5 x 107 Inf.U four weeks apart while 534 Vaccinia- and IMVANEX-experienced individuals received a single booster dose.
Maltese: Is-sigurtà ta' IMVANEX ġiet evalwata f'20-il prova klinika li fihom 5,261 individwu li fil-passat qatt ma ngħataw Vaccinia, irċivew żewġ dożi ta' mhux inqas minn 5 x 107 Inf.U f'intevall ta' erba' ġimgħat filwaqt li 534 individwu li fil-passat ngħataw Vaccinia u IMVANEX, irċivew doża booster waħda.
English: 7% of the individuals with AD in clinical trials with IMVANEX experienced a flare-up or worsening of their skin condition during the course of the trial.
Maltese: 7% tal-individwi b'AD fil-provi kliniċi b'IMVANEX kellhom aggravament f'daqqa jew aggravament talkundizzjoni tal-ġilda tagħhom matul il-kors tal-prova.
English: Trometamol Sodium chloride Water for injections
Maltese: Sodium chloride Ilma għall-injezzjonijiet
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fillista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Very common (≥1/10)
Maltese: Komuni ħafna (≥ 1/10)
English: IMVANEX is provided as a suspension for injection in a vial (0.5 ml).
Maltese: IMVANEX hu pprovdut bħala suspensjoni għall-injezzjoni f'kunjett (0.5 mL).
English: IMVANEX is a vaccine used to prevent smallpox infection in adults.
Maltese: IMVANEX hu tilqima li tintuża għall-prevenzjoni ta' infezzjoni tal-ġidri fl-adulti.
English: • sinus infection,
Maltese: • infezzjoni fis-sinus,
English: Body temperature increased Pyrexia
Maltese: Żieda fittemperatura talġisem
English: SCR = Seroconversion rate; 2 Full Analysis Set (FAS) (for POX-MVA-013: Immunogenicity Analysis Set; IAS);
Maltese: 2 Analiżi tas-Sett Sħiħ (FAS) (għal POX-MVA-013:
English: 20 single dose vials.
Maltese: 20 kunjett b'doża waħda.
English: 2 doses of IMVANEX Licensed smallpox vaccine
Maltese: 2 dożi ta' IMVANEX Tilqima liċenzjata kontra l-ġidri
English: • bruising.
Maltese: • tbenġil.
English: • swollen lymph nodes,
Maltese: • tħossok imdardar,
English: This vaccine contains trace residues of gentamicin (see section 4.3).
Maltese: Din it-tilqima fiha traċċi ta' residwi ta' gentamicin (ara sezzjoni 4.3).
English: The first co-primary endpoint compared vaccinia-specific neutralizing antibody responses at the peak visits (Day 42 after first vaccination for Imvanex where the subjects received two doses according to the standard vaccination schedule and Day 28 for ACAM2000).
Maltese: L-ewwel punt finali ko-primarju qabbel risponsi ta' antikorpi newtralizzanti speċifiċi għal vaccinia fl-ogħla visti (Jum 42 wara l-ewwel tilqima għal IMVANEX fejn l-individwi rċivew żewġ dożi skont l-iskeda standard ta' tilqim u Jum 28 għal ACAM2000).
English: • rash, numbness, dryness, movement impairment, vesicles at the injection site,
Maltese: • raxx, tmewwit, nixfa, indeboliment fil-moviment, bżieżaq żgħar fis-sit tal-injezzjoni,
English: • sore throat, runny nose, cough,
Maltese: • uġigħ fil-griżmejn, imnieħer inixxi, sogħla,
English: Non-human primate (NHP) studies have demonstrated that vaccination with IMVANEX induced a comparable immune response and protective efficacy to traditional smallpox vaccines used to eradicate smallpox and protected NHP from severe disease associated with a lethal challenge of monkeypox virus.
Maltese: Studji fuq primati mhux umani (NHP - Non-human primate) urew li tilqima b'IMVANEX ikkawżat rispons immuni komparabbli u effikaċja protettiva għal tilqim tradizzjonali kontra l-ġidri li jintuża biex jeqred ilġidri u pproteġa NHP minn mard sever assoċjat ma' sfida letali tal-virus tal-ġidri tax-xadini.
English: • drowsiness,
Maltese: • emigranja,
English: Name and address of the manufacturer(s) of the biological active substance(s) Bavarian Nordic A/S
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) Bavarian
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection in the form of antibodies against the smallpox virus.
Maltese: Meta persuna tingħata t-tilqima, is-sistema immuni (is-sistema ta' difiża naturali tal-ġisem) se tipproduċi lprotezzjoni tagħha stess fil-forma ta' antikorpi kontra l-virus tal-ġidri.