FrancophonIA/ELRC3.0 huggingface dataset:
English: The immune responses to PRP, PT and FHA antigens one month after 2 doses given at 2 and 4 months of age were similar to those observed one month after a 2-dose priming given at 3 and 5 months of age: anti-PRP
Maltese: u FHA Antiġeni xahar wara 2 dożi mogħtija f'2 u 4 xhur ta 'età kienu simili għal dawk osservati xahar wara induzzjoni 2- doża li ngħatat 3 u 5 xhur ta' età : titers anti-PRP ≥ 0.15 mg / ml kienu osservati 73.0 %
English: Hexyon suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Maltese: Hexyon, suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin ikkonjugat (adsorbit) ta' Difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA),
English: Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Maltese: • Infjammmazzjoni ta' diversi nervi li jikawżaw disturbi sensorji jew dgħjufija fir-riġlejn (poliradikulonewrite), paraliżi tal-wiċċ, disturbi fil-vista, il-vista titbaxxa jew tmur f'daqqa (newrite ottika), mard infjammattorju tal-moħħ u tas-sinsla (dimijelinazzjoni tas-sistema nervuża ċentrali,
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Maltese: 9 snin wara serje primarja li tikkonsisti minn doża waħda tal-vaċċin tal-epatite B mogħtija mat-twelid segwit minn serje infantili ta' 3 dożi fit-2,4 u 6 xahar ta' età mingħajr ma tingħata buster wara l-età ta' sena fejn 49.3% ta' dawk li ħadu l-vaċċin kellhom antikorpi ≥ 10 mIU/ml b'konċentrazzjonijiet medji ġeometriċi ta' 13.3 (95% CI: 8.82 - 20.0) mIU/ml.
English: Hexyon - Carton for pre-filled syringe with one separate needle.
Maltese: Hexyon - Kartuna għall kunjett.
English: Hexyon (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Maltese: X'inhu Hexyon u għal-xiex jintuża Hexyon (DTaP-IPV-HB-Hib) huwa vaċċin li jintuża biex jipproteġi kontra mard infettiv.
English: Anti-PRP (≥ 0.15 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Argentina, Mexico, Peru) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration <8 EU/ml, then the post-vaccination antibody concentration should be ≥ 8 EU/ml.
Maltese: †† 2, 3, 4 xhur mingħajr vaċċinazzjoni epatite B fit-twelid (il-Finlandja) ‡ 2, 4, 6 xhur mingħajr vaċċinazzjoni epatite B fit-twelid (Arġentina , il-Messiku , il-Peru) u bl-epatite B
English: Package leaflet: Information for the user Hexyon suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Maltese: Vaċċin ikkonjugat (adsorbit) ta' Difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA),
English: Anti-diphtheria (≥ 0.1 IU/ml) Anti-tetanus (≥ 0.1 IU/ml) Anti-PT (Seroconversion‡‡) (Vaccine response§) Anti-FHA (Seroconversion‡‡) (Vaccine response§)
Maltese: IU/ml) Antitetnu (≥ 0.1 IU/ml) Anti-PT
English: Very common Injection-site pain, injection-site erythema, injection-site swelling
Maltese: KONTENUT SKOND IL-PIŻ, VOLUM, JEW PARTI INDIVIDWALI
English: Package leaflet: Information for the user Hexyon suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Maltese: Vaċċin ikkonjugat (adsorbit) għal difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA),
English: EXPIRY DATE EXP: MM/YYYY
Maltese: Tużax Hexyon jekk it-tifel/tifla tiegħek:
English: With hepatitis B at birth
Maltese: epatite B.
English: When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexyon and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations.
Maltese: Meta it-tilqim ta' epatite B jingħata fit-twelid, wara t-tliet dożi primarji, Hexyon jew tilqim pentavalenti DTaP-IPV/Hib jista jingħata għal buster.
English: (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
Maltese: - Newropatija periferali (poliradikulonewrite, paraliżi tal-wiċċ), newrite ottika, demijelinazzjoni tassistema nervuża ċentrali (sklerożi multipla) kienu rrappurtati wara l-għoti tal-vaċċin b'antiġen ta'
English: • Common side effects (may affect up to 1 in 10 people) are: - abnormal crying (prolonged crying) - diarrhoea - injection site hardness (induration)
Maltese: • Reazzjonijiet mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100 persuna) huma: - reazzjoni allerġika
English: Shake before use.
Maltese: Mhux applikabbli.
English: Table 1: Seroprotection/Seroconversion rates* one month after a primary vaccination with 2 or 3 doses of Hexyon
Maltese: Tabella 1: Rati ta' Seroprotezzjoni/Serokonverżjoni* xahar wara tilqim b'żewg jew tlett dożi primarji ta' Hexyon
English: The safety and efficacy of Hexyon in infants less than 6 weeks of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Hexyonfit trabi inqas minn 6 ġimgħat ma ġewx stabbiliti.
English: Pack size of 1, 2 or 10.
Maltese: Pakketti ta' 1, 2 jew 10.
English: There is no antidote for desirudin.
Maltese: Ma jeżistix antidot kontra desirudin.
English: The active substance is desirudin (15mg/0.5ml powder).
Maltese: Is-sustanza attiva hi desirudin (15 mg/0.5 ml trab).
English: injection of 15mg desirudin.
Maltese: INDIVIDWALI 15 mg desirudin.
English: Desirudin has no profibrinolytic activity.
Maltese: Desirudin m'għandux attività profibrinolitika.
English: Boehringer Ingelheim RCV GmbH & Co KG (BI RCV) Dr. Boehringer Gasse 5 - 11
Maltese: KG (BI RCV) Dr. Boehringer Gasse 5 - 11
English: Pack sizes: 1 vial and 1 ampoule in one package 2 vials and 2 ampoules in one package 10 vials and 10 ampoules in one package
Maltese: Daqsijiet tal-pakketti: 1 kunjett u 1 ampulla f'pakkett wieħed 2 kunjetti u 2 ampulli f'pakkett wieħed 10 kunjetti u 10 ampulli f'pakkett wieħed
English: Solvent for parenteral use
Maltese: Solvent għall-użu parenterali
English: Dyspnoea Gastrointestinal disorders
Maltese: Disturbi gastro-intestinali
English: Administration is by subcutaneous injection, preferably at an abdominal site.
Maltese: Tittieħed b'injezzjoni subkutanja, preferibbilment f'post addominali.
English: EU/1/97/043/002 10 vials/10 ampoules of solvent EU/1/97/043/003 1 vial/1 ampoule of solvent
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/043/001 2 kunjetti / 2 ampulli ta' solvent EU/1/97/043/002 10 kunjetti / 10 ampulli ta' solvent EU/1/97/043/003 1 kunjett/1 ampulla tas-solvent
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 1997
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 9 ta' Lulju 1997
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5ml of water for injections with 3% (w/v) of mannitol
Maltese: INDIVIDWALI 0.5 ml ta' ilma għal injezzjonijiet ma' 3% (w/v) ta' mannitol
English: Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/kg, respectively (overall mean = 4.6 h).
Maltese: sigħat, korrispondenti għall-livelli ta' dożaġġi ta' 0.1, 0.3 u 0.5 mg/kg, rispettivament (medjan totali = 4.6h).
English: Nervous system disorders Uncommon:
Maltese: Disturbi fis-sistema nervuża:
English: The common name of the active substance in Revasc is desirudin.
Maltese: L-isem komuni tas-sustanza attiva f'Revasc hija desirudin.
English: Powder: magnesium chloride, sodium hydroxide Solvent: mannitol, water for injections
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Trab: magnesium chloride, sodium hydroxide Solvent: mannitol, ilma għall-injezzjoni
English: Cross-sensitivity to other hirudin products is possible.
Maltese: L-allerġija għal prodotti oħra ta'hirudin huwa possibli.
English: Instructions for the preparation of Revasc are provided in section 6.6.
Maltese: Struzzjonijiet għall-preparazzjoni ta' Revasc huma pprovduti f'sezzjoni 6.6.
English: Usual dosage
Maltese: Twissijiet
English: Uncommon side effects (likely to affect between 1 in 100 and 1 in 1,000 patients):
Maltese: Effetti sekondarji mhux komuni (li x'aktarx li ser jaffettwaw bejn 1 minn kull 100 u 1 minn kull 1,000 pazjent):
English: Desirudin is contraindicated in severe hepatic impairment (see section 4.3).
Maltese: Desirudin huwa kontra-indikat f'indeboliment serju tal-fwied (ara sezzjoni 4.3).
English: As with other anticoagulants desirudin should be used with caution in conjunction with medicinal products which affect platelet function these medicinal products include: acetylsalicylic acid and NSAIDs, ticlopidine and clopidogrel, glycoprotein IIb/IIIa antagonists (abciximab, eptifibatide,
Maltese: acetylsalicylic acid u NSAIDs, ticlopidine u clopidogrel, antagonisiti ta' glycoprotein IIb/IIIa (abciximab, eptifibatide, tirofiban) u iloprost.
English: (N=370) was half that in patients treated with a standard dose of unfractionated heparin (N=396) (p<0.0001); the rate of proximal deep venous thrombosis was only one fifth that observed with the heparin (p<0.0001).
Maltese: (N=370) kienet in-nofs f'dawk il-pazjenti ttrattati b'doża normali ta' heparin mhux frazzjonat (N=396) (p<0.0001).
English: Allergic reactions have been reported in the same proportion (1.6%) of patients treated with desirudin (N=2,367) or with unfractionated heparin (N=1,1 34) in clinical trials, regardless of causality.
Maltese: Reazzjonijiet allerġiċi kienu rrappurtati fl-istess proporzjon (1.6%) tal-pazjenti kkurati b'desirudin (N=2,367) jew b'eparina mhux frazzjonati (N=1,134) fi provi kliniċi, mingħajr ma jingħata kas tal-kawżalità.
English: In patients with mild or moderate renal impairment (creatinine clearance between 31 and 90 ml/min; see section 4.4) activated partial thromboplastin time (aPTT) should be monitored.
Maltese: F'pazjenti li għandhom indeboliment ħafif jew ta' grad moderat tal kliewi, (tneħħija tal-krejatinina ta' bejn 31 u 90 ml/min ; ara sezzjoni 4.4), il-ħin biex tkun attivata parzjalment it-tromboplastina (aPTT) irid ikun immoniterjat.
English: The total urinary excretion of unchanged desirudin amounts to 40-50 % of the administered dose.
Maltese: It-tneħħija totali fl'awrina ta' desirudin mhux mibdul jammonta għal 40 - 50% tad-doża mogħtija.
English: If co-administration cannot be avoided, close clinical and laboratory monitoring should be conducted (see section 4.4).
Maltese: Jekk dan ma jkunx possibli, għandu jsir kontroll mill-qrib, kemm kliniku kif ukoll permezz ta' testijiet tal-laboratorju (ara sezzjoni 4.4).
English: ** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
Maltese: ** korrispondenti għal madwar 270,000 unità antitrombina (ATU) jew 18,000 (ATU) kull mg ta'
English: In two controlled double blind clinical trials, the overall rate of thromboembolic events in patients treated with desirudin 15mg s.c. b.i.d.
Maltese: F'żewġ studji kliniċi double-blind ikkontrollati, ir-rata totali t'episodji trombo-emboliċi f' pazjenti ttrattati b'desirudin 15 mg SC b.i.d.
English: In the solvent the
Maltese: Solvent:
English: 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000).
Maltese: L-effetti li huma l-aktar serji għandhom jitniżżlu l-ewwel, segwiti minn dawk anqas serji: komuni (≥ 1/100 sa <1/10); mhux komuni (≥ 1/1,000 sa <1/100); rari (≥ 1/10,000 sa <1/1,000).
English: In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied account for most of the adverse experiences reported.
Maltese: F'studji kliniċi ikkontrollati u investigattivi, desirudin, mogħti 15 mg darbtejn kuljum, mqabbel ma' doża standardizzata ta' heparin mhux frazzjonata, in natura tat-tip t'operazzjoni kirurġika fuq il-ġog tal-koxxa u l-mod ta' kif jaħdmu ż-zewġ mediċini iddeterminaw il-maġġoranza ta' l-effetti avversi rapportati.
English: Anaphylaxis: Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Maltese: Revasc jista' jikkawża reazzjonijiet allerġiċi, inklużi l-anafilassi u xokk (ara sezzjoni 4.8).
English: What Revasc contains
Maltese: X'fih Revasc
English: Each vial contains 15mg desirudin with 18,000 ATU/mg corresponding to approximately 270,000
Maltese: Kull kunjett għandu 15 mg desirudin bi 18,000
English: You will be given the first injection within 5 to 15 minutes before the operation.
Maltese: Sejjer tingħata l-ewwel injezzjoni minn 5 sa 15-il minuta qabel l operazzjoni.
English: Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients):
Maltese: Effetti sekondarji komuni rappurtati (li x'aktarx li ser jaffettwaw bejn 1 minn kull 10 u 1 minn kull 100 pazjent):
English: Dizziness, insomnia, confusion Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Sturdament, nuqqas ta' rqad, konfużjoni Disturbi respiratorji, toraċiċi u medjastinali
English: Important information about some of the ingredients of Revasc This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodium
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) f'kull 0.5 ml, i.e. hu essenzjalment ‘ħieles mis-sodium'.
English: Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): Anti-hirudin antibodies have been detected upon re-exposure Isolated cases of fatal bleeding have been reported.
Maltese: Effetti sekondarji rari (li x'aktarx li ser jaffettwaw bejn 1 minn kull 1,000 u 1 minn kull 10,000 Antikorpi anti-hirudin kienu osservati ma' l-espożizzjoni mill-ġdid
English: The dose
Maltese: U KWANTITATTIVA
English: A slower terminal elimination phase follows with a dose-independent mean terminal elimination half life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Maltese: Sussegwentement hemm fażi ta' half-life ta' l-eliminazzjoni terminali, b'rata aktar baxxa, ta' bejn 2 sa 3 sigħat li hija indipendenti mid-doża wżata.
English: There is no experience with Revasc in children.
Maltese: Ilpazjenti għandhom ikunu nformati li ngħataw Revasc.
English: The effects of desirudin and unfractionated heparins on prolongation of aPTT have been shown to be additive (see section 4.4).
Maltese: Leffetti ta' desirudin u heparins mhux frazzjonati ntwerew li għandhom effett addizzjonali li jtawwal ilħin ta' aPTT (ara sezzjoni 4.4).
English: The other ingredients in the powder are magnesium chloride and sodium hydroxide.
Maltese: magnesium chloride sodium hydroxide
English: Desirudin should be used with caution in conditions with increased risks of haemorrhage such as major surgery, biopsy or puncture of a non-compressible vessel within the last month; a history of haemorrhagic stroke, intracranial or intraocular bleeding including diabetic (haemorrhagic) retinopathy; a cerebral ischaemic attack within the last 6 months, a known haemostatic disorder (congenital or acquired, e.g. haemophilia, liver disease) or a history of gastrointestinal or pulmonary
Maltese: Desirudin għandu jintuża b'kawtela f'sitwazzjonijiet fejn hemm riskji miżjudin t'emorraġija bħalloperazzjonijiet kirurġiċi maġġuri, biopsy, jew titqiba f'pajp tad-demm li ma jistax ikun ikkompressat, fl-aħħar xahar; storja ta' puplesija emorraġġika; ħruġ ta' demm fil-kranju jew fl-għajnejn, inkluż irretinopatija (emorraġika) fid-dijabete; attakk iskemiku ċerebrali fl-aħħar 6 xhur; marda emostatika magħrufa (mit-twelid jew akkwiżita, per eżempju l-emofilja, mard tal-fwied); jew storja t'emorraġija gastro-intestinali jew pulmonari fl-aħħar tliet xhur.
English: Metabolism and elimination
Maltese: Metaboliżmu u tneħħija
English: The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
Maltese: L-ewwel injezzjoni trid tinbeda minn 5 sa 15-il minuta qabel l-operazzjoni, iżda wara l-anasteżija reġjonali li tinblokka nnervaturi, jekk ser tintuża.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali wrew tossiċità riproduttiva (ara sezzjoni 5.3). Mhux magħruf ir-riskju potenzjali fuq in-nies.
English: NAME OF THE MEDICINAL PRODUCT Revasc 15mg/0.5ml powder and solvent for solution for injection
Maltese: Revasc 15 mg / 0.5 ml trab u solvent għal soluzzjoni għall-injezzjoni
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Revasc 15 mg/0.5 ml
Maltese: Revasc 15 mg / 0.5 ml
English: Skin and subcutaneous tissue disorders
Maltese: Indeboliment fil-fejqan tal-ferita
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 2 VIALS (15mg/vial) AND 2 AMPOULES
Maltese: FUQ IL-KAXXA TA' BARRA: GĦAL 2 KUNJETTI (15 mg / kunjett) U 2 AMPULLI
English: - medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol) - medicines which affect the function of platelets (particles in the blood involved in bloodclotting), e.g. acetylsalicylic acid, a substance present in many medicinal products used to relieve pain and lower fever, and other non-steroidal anti-inflammatory agents.
Maltese: - il-mediċini li jintużaw biex iwaqqfu d-demm milli jagħqad (warfarin, heparin u dicoumarol) - il-mediċini li jaffettwaw il-funzjoni tal-plejtlets (partiċelli fid-demm involuti fit-taqgħid tad demm), e.g. acetylsalicylic acid, sustanza li tinsab f'ħafna prodotti mediċinali wżati biex itaffu l uġigħ u jniżżlu d-deni, u sustanzi oħra mhux sterojdi użati kontra l-infjammazzjoni.
English: If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods.
Maltese: Jekk pazjent jinbidlulu l-antikoagulanti orali għal terapija b'desirudin, jew minn desirudin għal antikoagulanti orali, l-attività kontra l-koagulazzjoni tad-demm trid tibqa' tkun immoniterjata mill-qrib b'metodi xierqa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL: 0.5ml SOLVENT
Maltese: TIKKETTA TA' L-AMPULLA: 0.5 ml SOLVENT
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: FOR 1 VIAL (15mg/vial) AND 1 AMPOULE
Maltese: FUQ IL- KAXXA TA' BARRA: GĦAL KUNJETT 1 (15 mg / kunjett) U 1 AMPULLA
English: - Keep this leaflet.
Maltese: L-eliminazzjoni epatika ta'
English: Revasc is contraindicated in pregnancy (see section 4.3).
Maltese: Revasc m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: Total clearance of desirudin has been found to be in the same range following either SC or IV administration (ca 1.95-2.20ml/min/kg) and was dose-independent.
Maltese: (ca 1.95-2.20 ml/min/kg), u kienet indipendenti mid-doża wżata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg desirudin.
Maltese: Kull kunjett fih 15 mg ta' desirudin.
English: Do not use Revasc after the expiry date which is stated on the carton and the pack.
Maltese: Tużax Revasc wara d-data ta' skadenza li tidher fuq il-kartuna u l-pakkett.
English: Unusual tiredness or weakness (anaemia), nausea, oozing of fluid from wounds, low blood pressure, fever, inflammation of veins sometimes accompanied by a clot, lumps at injection sites, bruising, swelling of the legs caused by fluid retention, non-fatal allergic reactions.
Maltese: Għeja jew dgħjufija mhux tas-soltu (anemija), nawseja, tnixxija ta' fluwidu mill-feriti, pressjoni taddemm baxxa, deni, infjammazzjoni tal-vini li xi kultant tkun akkompanjata minn embolu, nefħa fis-sit ta' l-injezzjoni, tbenġil, nefħa tal-riġlejn ikkawżata miż-żamma tal-fluwidu, reazzjonijiet allerġiċi mhux fatali.
English: Blood and the lymphatic system disorders Common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni:
English: At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C. In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or
Maltese: Barra minn hekk, ma jurix effetti fuq enżimi serine proteases, bħall-enżimi diġestivi trypsin jew chymotrypsin, jew fuq l-attivar tal komplement, permezz tas-sistema klassika jew dik alternattiva.
English: Treatment with desirudin is then continued twice daily post-operatively for 9 to a maximum of 12 days or until the patient is fully mobile, whichever occurs first.
Maltese: It-trattament b'desirudin imbagħad irid jitkompla darbtejn kuljum wara l operazzjoni sa 9, għall-massimu ta' 12-il jum, jew sakemm il-pazjent ikun kompletament mobbli,
English: Following administration of single SC doses of 0.1-0.75 mg/kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h. Both Cmax and AUC values are dose
Maltese: SC ta' 0.1-0.75 mg/kg, il-konċentrazzjoni ta' desirudin fil-plażma jiżdiedu malajr biex jilħqu l-livell massimu (Cmax) f'ħin ta' bejn siegħa u 3 sigħat.
English: Anti-hirudin antibodies have been detected upon re-exposure to desirudin in
Maltese: Antikorpi anti-hirudin kienu osservati ma' l-espożizzjoni mill-ġdid għal desirudin fi provi kliniċi.
English: 15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass).
Maltese: (fluoropolymer) fuq in-naħa ta' ġewwa, fejn imiss mal-prodott u 0.5 ml ta' solvent f'ampulla (ħġieġ tat-Tip I).
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anticoagulant, ATC code: B01AE01
Maltese: livelli terapewtiċi fis-serum , m'għandux effett fuq l-enżimi l-oħra tas-sistema emostatika, bħassustanzi
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Maltese: Sistema ta' Farmakoviġilanza
English: Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/min corresponding to a serum creatinine > 2.5mg/dl or 221μmol/l; see section 4.3).
Maltese: creatinine t'anqas minn 30 ml/min, korrispondenti ma' livell ta' krejatinina fis-serum > 2.5 mg/dl jew