FrancophonIA/ELRC3.0 huggingface dataset:
English: Abdominal pain Dyspepsia
Maltese: Uġigħ addominali Dispepsja
English: This section describes the clinical experience with the H5N1 vaccine.
Maltese: Din is-sezzjoni tiddeskrivi l-esperjenza klinika b'vaċċin kontra l-H5N1.
English: Immune response against A/Vietnam/1203/2004 (H5N1) The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in two clinical studies in subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Maltese: L-immunoġeniċità tar-razza tal-vaċċin A/Vjetnam/1203/2004 ġiet evalwata fi tliet studji kliniċi fuq persuni adulti ta' bejn 18 - 59 sena (N=961) u f'żewġ studji kliniċi li saru fuq individwi anzjani ta' 60 sena u aktar (N=391) billi kienet segwita skeda ta' 0, 21 ġurnata.
English: 1 pre-filled syringe (0.5 ml)
Maltese: Siringa mimlija lesta (0.5 ml)
English: MN assay
Maltese: Assaġġ MN
English: The vaccine contains 10 doses of 0.5 ml.
Maltese: Il-vaċċin fih 10 dożi ta' 0.5 ml.
English: Ferrets vaccinated with the 7.5 µg dose of the A/Vietnam/1203/2004 vaccine demonstrated a high rate of seroconversion.
Maltese: L-inmsa imlaqqma bid-doża ta' 7.5 µg tal-vaċċin A/Vjetnam/1203/2004 urew rata għolja ta' serokonverżjoni.
English: Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Maltese: Studji fuq l-annimali b'vaċċini kontra razez H5N1 (A/Vjetnam/1203/2004 u A/Indoneżja/05/2005) ma jurux effetti ħżiena diretti jew indiretti fir-rigward tal-fertilità, fuq it-tqala, fuq l-iżvilupp tal-embriju/fetu, ħlas jew żvilupp ta' wara t-twelid (ara sezzjoni 5.3).
English: Uncommon (affects 1 to 10 users in 1,000):
Maltese: Mhux komuni (jaffettwaw minn 1 sa 10 utenti minnkull 1,000):
English: Neurological disorders, such as encephalomyelitis, neuritis, and Guillain Barré syndrome.
Maltese: Disturbi newroloġiċi, bħal enċefalomajlite, nevrite u s-sindrome ta' Guillain Barré.
English: • hardness, redness, swelling or bruising at the injection site b) The following side effects have been reported in clinical studies in children aged 3 to 8 years.
Maltese: • ebusija, ħmura, nefħa jew tbenġil fis-sit tal-injezzjoni b) Ġew irrappurtati dawn l-effetti sekondarji fl-istudji kliniċi fi tfal ta' età minn 3 sa 8 snin.
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Maltese: Vaċċin booster eterologu b'7.5 µg b'razza ta' vaċċin A/Indoneżja/05/2005 b'formulazzjoni non-adjuvanted ingħata wara 12-il xahar wara l-ewwel tilqima b'żewġ dożi tar-razza tal-vaċċin A/Vjetnam/1203/2004 fi tfal u adolexxenti ta' età minn 9 sa 17-il sena (N=196), tfal ta' età minn 3 sa 8 snin (N=79) u trabi u adolexxenti ta' età minn 6 xhur sa 35 xahar (N=25).
English: Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions.
Maltese: Il-provi kliniċi saru b'dan il-vaċċin kontra H5N1 (ara sezzjoni 5.1 għal aktar informazzjoni fuq il-vaċċini kontra H5N1) f'madwar 3,700 individwu (li varjaw fi gruppi ta' età minn 18 sa 59 sena u 60 sena u aktar), u fi gruppi f'riskju speċjali li kien fihom madwar 300 persuna kull wieħed, li kienu jikkonsistu minn individwi b'sistema immunokompromessa u pazjenti b'kundizzjonijiet ta' mard kroniku.
English: The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more severe.
Maltese: Is-sintomi tal-influwenza pandemika huma bħal dawk ta' influwenza ordinarja iżda normalment ikunu iktar severi.
English: Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency to provide immediate protection.
Maltese: L-immunoglobulina m'għandhiex tingħata ma' VEPACEL ħlief jekk tkun meħtieġa waqt emerġenza medika biex tipprovdi protezzjoni immedjata.
English: Pregnancy, breast-feeding
Maltese: Uġigħ fl-addome
English: NERVOUS SYSTEM DISORDERS
Maltese: FIS-SISTEMA NERVUŻA
English: - The other ingredients are Trometamol
Maltese: - Is-sustanzi l-oħra huma Trometamol
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Maltese: L-immunizzazzjoni għandha ssir permezz ta' injezzjoni ġol-muskoli fil-muskolu deltojde jew fil-koxxa anterolaterali, skont il-massa tal-muskoli.
English: * MN titer ≥ 20
Maltese: Booster wara 12 xahar * tajter MN ≥20
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems)
Maltese: • vaskulite (infjammazzjoni tal-vini/arterji tad-demm) li tista' tikkawża raxxijiet tal-ġilda, uġigħ fil-ġogi u problemi fil-kliewi)
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor***
Maltese: Ir-rata ta' seronewtralizzazzjoni* * Tajter MN ≥20
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years:
Maltese: Trabi, tfal u adolexxenti ta' età minn 6 xhur sa 17-il sena u adulti mill-età ta' 18-il sena: Doża waħda ta' 0.5 ml se tingħata.
English: One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) without needles.
Maltese: Pakkett wieħed b'siringa 1 b'doża waħda mimlija għal-lest (ħġieġ ta' tip I) li fiha 0.5 ml ta' suspensjoni għall-injezzjoni, b'tapp planġer bla latex (lastku tal-halogen-butyl) bil-labar.
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Maltese: Minn sorveljanza ta' wara t-tqegħid fis-suq b'vaċċin kontra H1N1, virijon sħiħ, derivat minn ċelluli Vero, ġew irrappurtati r-reazzjonijiet avversi li ġejjin (il-frekwenza ta' dawn ir-reazzjonijiet avversi mhijiex magħrufa (ma tistax tittieħed stima mid-data disponibbli):
English: Pandemic and Pre-pandemic vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Maltese: Vaċċini Pandemiċi u Prepandemiċi fihom antiġeni tal-influwenza li huma differenti minn dawk fil-viruses tal-influwenza li qed jiċċirkolaw bħalissa.
English: This indication is based on immunogenicity data from subjects from the age of 6 months onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1).
Maltese: Din l-indikazzjoni hi bbażata fuq dejta ta' immunoġeniċità minn individwi mill-età ta' 6 xhur 'il fuq wara l-għoti ta' żewġ dożi tal-vaċċin ippreparati b'razez ta' sottotip H5N1 (ara sezzjoni 5.1).
English: Seroneutralisation rate* Tested against
Maltese: Ir-rata ta' seronewtralizzazzjoni* Ittestjati kontra
English: Cross-reactive immune response against related H5N1 strains In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above (N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows:
Maltese: Fi studju fuq persuni adulti li kellhom minn 18 sa 59 sena (N=265) u fuq persuni aktar anzjani li kellhom 60 sena jew aktar (N=270) wara tilqima bil-vaċċin bir-razza A/Vjetnam/1203/2004, ir-rata ta' individwi b'antikorpi newtralizzanti inkroċjati kif imkejla mill-MN (tajter ≥20) kienet kif ġej:
English: Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been reported following use of a similar vaccine for H1N1 influenza during a pandemic period.
Maltese: Reazzjonijiet allerġiċi, li tinkludi reazzjonijiet allerġiċi li huma ta' theddida għall-ħajja (anafilassi), ġew irrappurtati wara l-użu ta' vaċċin simili kontra l-influwenza H1N1 waqt perjodu pandemiku.
English: Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
Maltese: Reazzjonijiet ta' sensittività eċċessiva, li jinkludu anafilassi, ġew irrappurtati wara l-użu ta' vaċċin simili kontra l-influwenza minn H1N1, virjon sħiħ, derivat minn ċelluli Vero, mogħti waqt perjodu pandemiku.
English: The most frequently occurring side effect was injection- site pain, which was usually mild.
Maltese: L-aktar effett sekondarju frekwenti kien uġigħ fis-sit tal-injezzjoni, li normalment kien wieħed ħafif.
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered in a time frame of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older people aged 60 years and above.
Maltese: Vaċċin booster eterologu b'7.5 µg b'razza ta' vaċċin A/Indoneżja/05/2005 b'formulazzjoni non-adjuvanted ingħata f'intervall ta' żmien ta' 12 sa 24 xahar wara l-vaċċin priming b'żewġ dożi tal-vaċċin tar-razza A/Vjetnam/1203/2004 fi tliet studji kliniċi f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni aktar anzjani li kellhom 60 sena jew aktar.
English: After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older people aged 60 years and above were as follows:
Maltese: Wara l-ewwel tilqima, ir-rata ta' individwi b'tajters ta' antikorpi li jinnewtralizzaw ta' ≥20, rata ta' serokonverżjoni u fattur tas-serokonverżjoni kif imkejla mill-assaġġ tal-mikronewtralizzazzjoni (MN) f'persuni adulti li kellhom minn 18 sa 59 sena u f'persuni aktar anzjani li kellhom 60 sena jew iżjed kienu kif ġej:
English: Uncommon: generalised skin reactions
Maltese: Mhux komuni: reazzjonijiet ġeneralizzati tal-ġilda
English: • injection-site reaction such as irritation, itching, bruising or stiff arm
Maltese: • reazzjoni fis-sit tal-injezzjoni bħal irritazzjoni, ħakk, tbenġil jew ebusija fid-driegħ
English: After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Maltese: Wara t-tilqima, ir-rata ta' persuni b'tajters ta' antikorpi li jinnewtralizzaw ta' ≥20, ir-rata ta' serokonverżjoni u l-fattur ta' serokonverżjoni kif imkejla mill-assaġġ tal-MN, fi trabi, tfal u adolexxenti ta' età minn 6 xhur sa 17-il sena kienu kif ġej:
English: No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of age.
Maltese: Ebda data hija disponibbli dwar is-sigurtà u l-effikaċja ta' VEPACEL fi tfal iżgħar minn 6 xhur.
English: Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Maltese: Fi prova klinika, il-vaċċin H5N1 ingħata lil 36 trabi u tfal ta' età minn 6 sa 35 xahar.
English: 20 multidose vials (10 doses of 0.5 ml per vial)
Maltese: Kunjett b'ħafna dożi (10 dożi ta' 0.5 ml)
English: Rare (affects 1 to 10 users in 10,000):
Maltese: Rari (jaffettwaw minn 1 utent sa 10 minn kull 10,000):
English: Seroneutralisation rate* Immunocompromised subjects Patients with chronic disease conditions Tested against
Maltese: Ir-rata ta' seronewtralizzazzjoni* Persuni immunokompromessi
English: b) Tabulated list of adverse reactions Adverse reactions are listed according to the following frequency:
Maltese: Ir-reazzjonijiet avversi huma elenkati skont din il-frekwenza li ġejja:
English: The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.
Maltese: Ir-reazzjonijiet avversi osservati fi prova f'klinika pedjatrika bil-vaċċin H5N1 huma elenkati hawn taħt.
English: • Injection site hemorrhage
Maltese: • Emorraġija fis-sit tal-injezzjoni
English: There are no post-marketing surveillance data available for VEPACEL.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: - if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Maltese: - jekk kellek kwalunkwe reazzjoni allerġika għal kwalukwe wieħed mill-ingredjenti tal-vaċċin (ara sezzjoni 6 fl-aħħar tal-fuljett) jew residwi f'ammonti żgħar ħafna (formaldehyde, benzonase, sucrose, trypsin, proteina ta' ċelluli ospitu Vero).
English: 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.
Maltese: Waqt sitwazzjoni pandemika, il-frekwenza tas-sottomissjoni tar-rapporti perjodiċi ta' aġġornament dwar is-sigurtà speċifikati f'Artiklu 24 tar-Regolament (KE) Nru 726/2004 mhux se tkun adegwata għall-monitoraġġ tas-sigurtà ta' vaċċin pandemiku li għalih livelli għoljin ta' espożizzjoni huma mistennija fi żmien qasir.
English: The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials.
Maltese: Is-sigurtà ta' VEPACEL waqt it-tqala u t-treddigħ ma ġietx evalwata fil-provi kliniċi.
English: NAME OF THE MEDICINAL PRODUCT VEPACEL
Maltese: TAL-PRODOTT MEDIĊINALI VEPACEL
English: Influenza virus (whole virion, inactivated) containing antigen of strain : A/Vietnam/1203/2004 (H5N1)
Maltese: Rispons immunitarju kontra A/Vjetnam/1203/2004 (H5N1)
English: Package leaflet: Information for the user VEPACEL suspension for injection Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Maltese: Informazzjoni għall-utent VEPACEL suspensjoni għal injezzjoni Vaċċin kontra l-influwenza prepandemika (H5N1) (virijon sħiħ, inattivat, ippreparat f'koltura taċ-ċelluli)
English: - if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet - section 6) or to any substances that may be present in trace (very low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein.
Maltese: - jekk fil-passat kellek reazzjoni allerġika severa għal xi wieħed mill-ingredjenti ta' VEPACEL (dawn huma elenkati fl-aħħar tal-fuljett - sezzjoni 6) jew għal kwalunkwe sustanzi li jistgħu jkunu preżenti f'ammonti żgħar ħafna (baxxi ħafna): formaldehyde, benzonase, sucrose, trypsin, proteina ta' ċelluli ospitu Vero.
English: • Injection site eyrthema
Maltese: • skonfort fis-sider
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Pre-filled syringe (0.5ml)
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 1 mimlija għal-siringa (0.5 ml)
English: Oropharyngeal pain Cough
Maltese: Popolazzjoni pedjatrika oħra
English: Hyperhidrosis Pruritis Rash
Maltese: FIS-SISTEMA NERVUŻA Uġigħ ta' ras Sturdament
English: • Official batch release
Maltese: • mard qisu influwenza
English: Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Maltese: Ir-rati tas-seronewtralizzazzjoni (tajter MN ta' ≥20) wara 21 jum wara l-vaċċin booster bid-doża ta' 7.5 minn tilqima tar-razza A/Indoneżja/05/2005, ittestjati kontra kemm razez omologi kif ukoll eterologi, kienu kif ġej:
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Maltese: Ir-rati tas-seronewtralizzazzjoni (tajter MN ta' ≥20) wara 21 jum wara l-vaċċin booster bid-doża ta' 7.5 µg wara 12 sa 24 xahar minn tilqima tar-razza A/Indoneżja/05/2005, ittestjati kontra kemm razez omologi kif ukoll eterologi, kienu kif ġej:
English: 1 pack of a pre-filled syringe containing a single dose of 0.5 ml suspension for injection with a latex-free plunger (halogeno-butyl-rubber) without needles.
Maltese: 1 pakkett ta 'siringa mimlija għal-lest li jkun fih doża waħda ta' 0.5 ml suspensjoni għall-injezzjoni bi planġer mingħajr latex (halogen-butyl-gomma) mingħajr labar.
English: A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain vaccine was also evaluated in adults aged 18 to 59 years.
Maltese: Vaċċin booster b'7.5 µg b'razza ta' vaċċin A/Indoneżja/05/2005 bil-formulazzjoni non-adjuvanted mogħti wara 12-il wahar wara doża waħda tal-vaċċin priming bil-vaċċin tar-razza A/Vjetnam/1203/2004 ġie evalwat ukoll f'persuni adulti li kellhom minn 18 sa 59.
English: The side effects are generally similar to those related to the flu vaccine.
Maltese: L-effetti sekondarji huma ġeneralment simili għal dawk relatati mal-vaċċin tal-influwenza.
English: • cough
Maltese: • biki
English: NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in pre-filled syringe Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Maltese: VEPACEL suspensjoni għal injezzjoni f'reċipjent b'ħafna dożi Vaċċin kontra l-influwenza prepandemika (H5N1) (virijon sħiħ, inattivat, ippreparat f'koltura taċ-ċelluli)
English: • vomiting
Maltese: • mejt
English: Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated.
Maltese: Sittax-il nemes inqasmu f'żewġ gruppi u ngħataw tilqima f'jum 0 u 21 b'7.5 µg tal-vaċċin A/Vjetnam/1203/2004 jew ingħataw tilqima finta.
English: 21 Days after
Maltese: 21 Jum wara
English: Intramuscular use.
Maltese: GASTRO-INTESTINALI
English: The suspension is clear to opalescent.
Maltese: Is-sospensjoni hija ċara għal opalexxenti.
English: • Infants, children, and adolescents
Maltese: • Trabi, tfal u adolexxenti
English: If vaccination is considered necessary, facilities for resuscitation should be immediately available in case of need (see section 4.4).
Maltese: Jekk it-tilqima tiġi kkunsidrata li hi meħtieġa, faċilitajiet għar-risuxxitazzjoni iridu jkunu disponibbli f'każ li jkunu meħtieġa (ara sezzjoni 4.4).
English: • runny nose and sore throat
Maltese: • tħossok imdardar • rimettar
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Maltese: It-tieni doża ta' 0.5 ml għandha tingħata wara intervall ta' mill-inqas tliet ġimgħat.
English: Heterologous Booster Vaccinations
Maltese: Tilqim b'Booster Eterologu
English: Heterologous booster vaccinations
Maltese: Tilqim b'booster eterologu
English: Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
Maltese: Studji mhux kliniċi wrew bidliet żgħar fl-enzimi tal-fwied u fil-livelli tal-kalċju fi studju dwar l-effett tossiku minn dożi ripetuti fil-firien.
English: • ear pain
Maltese: FL-GĦAJNEJN
English: Vomiting Diarrhoea
Maltese: TAL-PRODOTT MEDIĊINALI
English: Common Common Common Uncommon
Maltese: Komuni Komuni Ħafna
English: VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials.
Maltese: VEPACEL huwa ppreżentat bħala sospensjoni għall-injezzjoni f'kunjett b'ħafna dożi (10 dożi ta ' 0.5 ml f'kull kunjett) fid-daqs tal-pakkett ta' 20 kunjetti.
English: Strength Pharmaceutical form Route of administration
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15 1831 Diegem
Maltese: Omrix Biopharmaceuticals NV Leonardo Da Vincilaan 15 1831 Diegem
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 September 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29 ta' Settembru, 2013
English: Human fibrinogen (8.1 mg/cm2) Human thrombin (40 IU/ cm2)
Maltese: - Fibrinoġen uman (8.1 mg/cm2) - Trombin Uman (40
English: Telephone: +32 2 746 30 00 Telefax: + 32 2 746 30 01
Maltese: Telefown: + 32 2 746 30 00 Feks: + 32 2 746 30 01
English: UNIQUE IDENTIFIER-2DBARCODE 2D barcode carrying the unique identifier included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż.
English: Telefax: +972-3-5316590
Maltese: Feks: +972-3-5316590
English: Component 2 Human Thrombin
Maltese: Komponent 2: Trombina Umana
English: Table 1 Summary of Adverse Reactions to EVARREST MedDRA System Organ Class Preferred Term
Maltese: Tabella 1 Sommarju tar-Reazzjonijiet Avversi għal EVARREST Klassi tal-Organi tas-Sistema
English: EVARREST contains the components of fibrin sealant.
Maltese: EVARREST™ fih il-komponenti tas-siġillant ta' fibrin.
English: Intravascular administration is contraindicated.
Maltese: L-għoti intravaskulari huwa kontraindikat.
English: Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) 20 mg/cm2 Arginine hydrochloride
Maltese: Matriċi Komposta (Polyglactin lactin 910 u ċelluloża riġenerat ossidizzat) 20 mg/cm2 Arginine hydrochloride
English: ● Intra-abdominal haemorrhage Localised intra-abdominal fluid collection
Maltese: Ġabra lokalizzata ta' fluwidu intraddominali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/868/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/868/001
English: Most adverse reactions were reported as single events: intra-abdominal haemorrhage, abdominal distension, anaemia, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, deep vein thrombosis, localized intra-abdominal fluid collection, operative haemorrhage, ischaemic bowel and pulmonary embolism, except blood fibrinogen increased (3 events, 0.8%), anastomotic haemorrhage (3 events, 0.8%), and post procedural haemorrhage (2 events, 0.5%)
Maltese: Il-biċċa l-kbira tar-reazzjonijiet avversi ġew irrappurtati bħala avvenimenti waħidhom: emorraġija intraaddominali, distensjoni addominali, anemija, tnixxija mill-ispazju toraċiku, effużjoni plewrali, axxess addominali, axxite, trombożi tal-vini profondi, akkumulazzjoni lokalizzata ta' fluwidu intraaddominali, emorraġija operattiva, emboliżmu iskemiku fl-imsaren u filpulmun, ħlief żieda ta' fibrinogen fid-demm (3 avvenimenti, 0.8 %), emorraġija anastomotika (3 avvenimenti, 0.8 %), u emorraġija wara proċedura (2 avvenimenti, 0.5 %).
English: In the integrated analyses, 381 patients were treated with EVARREST and 272 patients were treated with control treatment.
Maltese: Fl-analiżi integrat, 381 pazjent ġew trattati b'EVARREST u 272 pazjent ġew trattati bi trattament ta' kontroll.
English: Human Fibrinogen:
Maltese: Fibrinoġen Uman:
English: Anti-thrombin antibodies
Maltese: Antikorpi anti-thrombin
English: The use of EVARREST is restricted to experienced surgeons.
Maltese: L-użu ta' EVARREST huwa ristrett għal kirurgi esperti.
English: Carton (10.2 cm x 10.2 cm, 5.1 cm x 10.2 cm) and Foil Sachet (10.2 cm x 10.2 cm)
Maltese: Kartuna (10,2 cm x 10,2 cm, 5,1 cm x 10,2 cm u Qartas tal-Fojl (10,2 cm x 10,2 cm)
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandha tkun implimentata kura medika standard għal xokk.
English: Composite Matrix (Polyglactin 910 and oxidised regenerated cellulose) Arginine hydrochloride
Maltese: Matriċi Komposta (Polyglactin 910 u ċelluloża riġenerat ossidizzat) Arginine hydrochloride