FrancophonIA/ELRC3.0 huggingface dataset:
English: • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Maltese: • partijiet minn Bordetella pertussis (B. pertussis, batterju li jikkawża sogħla konvulsiva);
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus;
Maltese: • tossojdi (tossini dgħajfa kimikament) mid-difterite u t-tetnu;
English: This is a summary of the European public assessment report (EPAR) for Infanrix hexa.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Infanrix hexa.
English: The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness.
Maltese: L-aktar effetti sekondarji komuni b'Infanrix hexa (li jidhru f'aktar minn 1 minn kull 10 dożi tal-vaċċin) huma nfiħ, uġigħ u ħmura fil-post tal-injezzjoni, nuqqas ta' aptit, deni ta' 38ºC jew aktar, għeja, biki anormali, irritabbiltà u nuqqas ta' mistrieħ.
English: Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years.
Maltese: Infanrix hexa ġie studjat f'disa' studji, li kienu jinvolvu total ta' madwar 5,000 tifel u tifla li kellhom bejn 6 ġimgħat u sentejn.
English: Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib.
Maltese: Infanrix hexa ntwera li kien effettiv biex jipproduċi livelli protettivi ta' antikorpi kontra d-defterite, ittetnu, il-pertussis, l-epatite B jew il-poljovirusijiet, u l-Hib.
English: How is Infanrix hexa used?
Maltese: Infanrix hexa?
English: What is the risk associated with Infanrix hexa?
Maltese: X'inhu r-riskju assoċjat ma' Infanrix hexa?
English: Why is Infanrix hexa approved?
Maltese: Għaliex ġie approvat Infanrix hexa?
English: The main measure of effectiveness was the production of protective antibodies.
Maltese: L-effikaċja tal-vaċċin ġiet imkejla prinċipalment permezz tal-produzzjoni ta' antikorpi protettivi.
English: Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances.
Maltese: Ir-riżultati tal-istudji li ttieħdu flimkien urew li kors ta' tilqim b'Infanrix hexa kien effikaċi fil-produzzjoni ta' livelli protettivi ta' antikorpi daqs l-għoti ta' vaċċini separati li fihom l-istess sustanzi attivi.
English: Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.
Maltese: Kien hemm bejn 95 u 100% mit-totalità tat-tfal li kellhom antikorpi għad-difterite, it-tetnu, il-pertussis, ilvirus tal-epatite B, il-poljovirusijiet, u l-Hib, xahar wara l-ewwel kors tal-vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Infanrix hexa valida fl-UE kollha fit-23 ta' Ottubru 2000.
English: An additional five studies looked at the effects of a booster vaccination with Infanrix hexa.
Maltese: Ħames studji addizzjonali eżaminaw l-effetti ta' vaċċin “booster” b'Infanrix hexa.
English: The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions.
Maltese: Infanrix hexa huwa vaċċin li jagħti protezzjoni kontra firxa ta' infezzjonijiet.
English: What measures are being taken to ensure the safe and effective use of Infanrix hexa?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Infanrix hexa?
English: Over 3,000 of the children received a course of vaccination with Infanrix hexa.
Maltese: Iktar minn 3,000 tifel u tifla rċevew kors tal-vaċċin b'Infanrix hexa.
English: These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.
Maltese: L-effetti ta' Infanrix hexa ġew imqabbla ma' dawk ta' vaċċini separati li fihom l-istess sustanzi attivi.
English: 5 x (1 x 10 ml) vials
Maltese: 5 x (1 x 10 ml) kunjetti
English: 1 vial
Maltese: x
English: EU number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration)
Maltese: Numru ta' l-EU Isem inventat Qawwa
English: l t o r d
Maltese: Mnejn jingħata
English: Do not touch the sides or the thread of the plunger rod.
Maltese: Qabel ma jiġi injettat (l-amministrazzjoni), irid jiġi rikostitwit mas- solvent li hemm fis-siringa.
English: Distribution, elimination and linearity
Maltese: Distribuzzjoni, eliminazzjoni u linearità
English: - Coagulopathy
Maltese: - Koagulopatija
English: The pharmacokinetic profiles indicated dose proportionality.
Maltese: Il-profili farmakokinetiċi jindikaw proporzjonalità fid-doża.
English: Rare (≥1/10,000 to <1/1,000) Frequency Not Known
Maltese: Rari (≥1/10,000 to <1/1,000) Frekwenza mhux magħrufa
English: - Disseminated intravascular coagulation (see section 4.4)
Maltese: - Koagulazzjoni intravaskulari disseminata (ara sezzjoni 4.4)
English: Factor VII deficiency
Maltese: Defiċjenza tal-fattur VII
English: MedDRA system organ class
Maltese: Sistema ta' klassifika talorgani MedDRA
English: Uncommon (≥1/1,000 to
Maltese: Mhux komuni (≥1/1,000
English: An observational registry (F7HAEM-3521) covered 133 subjects with Glanzmann's thrombasthenia treated with NovoSeven.
Maltese: Reġistru ta' pazjenti li kienu taħt osservazzjoni (F7HAEM-3521) inkluda 133 suġġett b'Glanzmann's thrombasthenia ttrattati b'NovoSeven.
English: Haemophilia A and B with inhibitors
Maltese: Emofilja A u B bl-inibituri
English: Invasive procedure/surgery
Maltese: Operazzjoni/proċedura invażiva
English: 6.2 Incompatibilities
Maltese: .2 Inkompatibbilatijiet
English: - Rash (including allergic dermatitis and rash erythematous)
Maltese: - Raxx (li jinkludi dermatite allerġika u raxx eritematożu)
English: Glanzmann's thrombasthenia
Maltese: Trombastenja ta‘ Glanzmann
English: - Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin
Maltese: - Żieda fl-alanine aminotransferase, flalkaline phosphatase, fillactate dehydrogenase and fil-prothrombin
English: Thromboembolic events - arterial and venous
Maltese: Avvenimenti tromboemboliċi - arterjali u fil-vini
English: - Store powder and solvent below 25°C.
Maltese: - Aħżen it-trab u s-solvent taħt 25°C.
English: • Inject slowly over 2 to 5 minutes.
Maltese: • Injetta bil-mod minn 2 sa 5 minuti.
English: Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in adults.
Maltese: Il-medja tal-volum tad-distribuzzjoni fl-istat fiss kienet ta' 196 ml/kg fil-pazjenti pedjatriċi kontra 159 ml/kg fl-adulti.
English: - Increased fibrin degradation products
Maltese: - Żieda fil-prodotti ta' degradazzjoni ta' fibrin
English: • 1 vial with NovoSeven powder
Maltese: • Kunjett 1 bi trab NovoSeven
English: * Lack of efficacy (therapeutic response decreased) has been reported.
Maltese: * Nuqqas ta' effikaċja (tnaqqis fir-rispons terapewtiku) ġiet irrapportata.
English: Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, histidine, water for injections
Maltese: Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, histidine, ilma għall-injezzjonijiet
English: • Store powder and solvent below 25°C.
Maltese: • Aħżen it-trab u s-solvent taħt 25ºC.
English: Compatibility with the product was demonstrated for the system consisting of a 50 ml syringe (polypropylene), a 2 m infusion tube (polyethylene) and an inline filter with a 5 micrometer pore size.
Maltese: Ġie muri kompatibbiltà mal-prodott għassistema li tikkonsisti minn siringa ta' 50 ml (polypropylene), tubu tal-infużjoni (polyethylene) ta' 2 m u in-line filter b'daqs ta' por ta' 5 mikrometri.
English: - Hypersensitivity (see sections 4.3 and 4.4)
Maltese: - Sensittività eċċessiva (ara sezzjonijiet 4.3 u
English: • The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
Maltese: • Is-sustanza attiva hi l-fattur VIIa tal-koagulazzjoni rikombinanti (eptacog alfa attivat).
English: ml Novo Nordisk A/S
Maltese: OĦRAJN Novo Nordisk A/S
English: NovoSeven was used in 157 surgical procedures, at a median dose of 92 µg/kg (up to 270 µg/kg).
Maltese: NovoSeven intuża f'157 episodju kirurġiku, b'doża medjana ta' 92 µg/kg (sa 270 mcg/kg).
English: In the same registry 3 out of 91 surgical patients experienced thromboembolic events.
Maltese: Fl-istess reġistru, 3 minn 91 pazjent fil-kirurġija kellhom avvenimenti tromboemboliċi.
English: The efficacy rates were 81% and 82%, respectively, in patients with positive or negative refractoriness to platelet transfusions, and 77% and 85%, respectively, in patients testing positive or negative for antibodies to platelets.
Maltese: Ir-rati ta' effikaċja kienu 81 % u 82 % rispettivament, f'pazjenti b'reżistenza pożittiva jew negattiva għat-trasfużjonijiet tal-plejtlits, u 77 % u 85 % rispettivament, f'pazjenti li ttestjaw pożittiv jew negattiv għall-antikorpi għall-plejtlits.
English: Each pack contains:
Maltese: U KONTENUT Kull pakkett fih:
English: • 1 vial adapter
Maltese: • Adapter 1 tal-kunjett
English: • Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene).
Maltese: • Iġbed madwar 5 ml ta' arja sterili ġos-siringa (polypropylene) ta' 50 ml.
English: • The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
Maltese: • Is-sustanzi l-oħra fit-trab huma sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium hydroxide.
English: Injecting the solution H
Maltese: L-injezzjoni tas-soluzzjoni H
English: • Take out the number of NovoSeven packages you need.
Maltese: • Oħroġ in-numru ta' pakketti ta' Novoseven li għandek bżonn.
English: Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006
Maltese: Data tal-aħħar tiġdid: 23 ta' Frar 2006
English: 1 KIU equals 1,000 IU (International Units).
Maltese: 1 KUI huwa daqs 1,000 UI (Unità Internazzjonali).
English: Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and B, acquired haemophilia, factor VII deficiency or Glanzmann's thrombasthenia have shown that adverse drug reactions are common (≥ 1/100 to < 1/10).
Maltese: Provi kliniċi li saru f'484 pazjent (li jinkludu 4297 episodju ta' trattament) b'emofilja A u B, emofilja akwiżita, defiċjenza ta' fattur VII jew trombastinja ta' Glanzmann urew li r-reazzjonijiet avversi tal mediċina huma komuni (≥ 1/100 sa < 1/10).
English: NovoSeven contains activated recombinant coagulation factor VII.
Maltese: NovoSeven fih il-fattur VII attivat tal-koagulazzjoni rikombinanti .
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH)
English: Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Maltese: Eptacog alfa (attivat) huwa l-fattur VIIa rikombinanti tal-koagulazzjoni (rFVIIa) b'massa molekulari ta' madwar 50,000 Dalton prodott fiċ-ċelluli tal-kliewi tal-frieħ tal-ħamster (Ċelluli BHK) permezz ta' teknoloġija ta' DNA rikombinanti.
English: Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports
Maltese: Tabella 1 Reazzjonijiet avversi minn provi kliniċi u minn rapporti spontanji (wara li l-prodott tqiegħed fis-suq)
English: Thromboembolic events may lead to cardiac arrest.
Maltese: Avvenimenti tromboemboliċi jistgħu jwasslu għall-arrest kardijaku.
English: If you have Glanzmann's thrombasthenia:
Maltese: Jekk għandek it-trombastenja ta' Glanzmann:
English: - Arterial thromboembolic events (myocardial infarction, cerebral infarction, cerebral ischaemia, cerebral artery occlusion, cerebrovascular accident, renal artery thrombosis,
Maltese: - Avvenimenti tromboemboliċi fl-arterji (infart mijokardiku, infart ċerebrali, iskemija ċerebrali, okklużjoni talarterja ċerebrali, inċident ċerebrovaskulari, trombożi tal-arterja renali, iskemija periferali, trombożi talarterji periferali u iskemija intestinali)
English: As the total number of treatment episodes in clinical trials is below 10,000, the lowest possible frequency of adverse drug reactions that can be assigned is rare (> 1/10,000 to < 1/1,000).
Maltese: Peress li l-ammont totali ta' episodji ta' trattament filprovi kliniċi huwa inqas minn 10,000, l-inqas frekwenza possibbli ta' reazzjonijiet avversi għallmediċina li tista' tiġi assenjata hija rari (> 1/10,000 sa < 1/1,000).
English: As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, huwa preferibbli li jiġi evitat l-użu ta' NovoSeven waqt it-tqala.
English: White lyophilised powder.
Maltese: Issoluzzjoni rikostitwita hija bla kulur.
English: In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment.
Maltese: F'kundizzjonijiet patoloġiċi li fihom il-fattur tat-tessut jista' jiġi espress b'mod aktar estensiv minn dak li huwa kkunsidrat bħala normali, jista' jkun hemm riskju potenzjali ta' l-iżvilupp ta' avvenimenti trombotiċi jew li jkun hemm Koagulazzjoni Intravaskulari Disseminata (Disseminated Intravascular Coagulation-DIC) meta tingħata l-kura ta' NovoSeven.
English: NovoSeven 5 mg (250 KIU)
Maltese: NovoSeven 5 mg (250
English: Administer the solution as an intravenous bolus injection over 2 - 5 minutes.
Maltese: Agħti s-soluzzjoni bħala injezzjoni bolus minn ġol-vini fuq perijodu ta' 2 - 5 minuti.
English: NovoSeven 8 mg (400 KIU)
Maltese: NovoSeven 8 mg (400
English: NovoSeven 2 mg (100 KIU)
Maltese: NovoSeven 2 mg (100 KUI)
English: Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII.
Maltese: Skont studju li mhuwiex kliniku (ara sezzjoni 5.3), it-teħid flimkien ta' rFVIIa u rFXIII mhuwiex irrakkomandat.
English: The pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Maltese: L-effett farmakodinamiku tal-fattur VIIa, joħloq żieda fil-formazzjoni lokali tal-fattur Xa, thrombin u fibrin.
English: NovoSeven 1 mg (50 KIU)
Maltese: NovoSeven 1 mg (50
English: Monitoring of treatment - laboratory tests
Maltese: Monitoraġġ tal-kura - testijiet fil-laboratorji
English: Other medicines and NovoSeven
Maltese: Mediċini oħra u NovoSeven
English: Pharmacokinetics of NovoSeven in patients with Glanzmann's thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
Maltese: Il-farmakokinetika ta' NovoSeven f'pazjenti bi trombastenja ta' Glanzmann ma ġietx investigata, iżda mistennija li tkun tixbaħ il-farmakokinetika li ġiet murija f'pazjenti b'emofilja A u B.
English: Inhibitory antibody formation
Maltese: Formazzjoni ta' antikorpi inibitorji
English: Each pack contains: 1 vial of powder 1 vial of solvent
Maltese: U KONTENUT Kull pakkett fih: kunjett 1 bit-trab kunjett 1 bis-solvent
English: Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/h×kg), whereas the mean terminal half-life was determined to 2.3 hours in both groups.
Maltese: Il-medja ta' tneħħija kienet madwar 50% ogħla fil-pazjenti pedjatrici meta mqabbla ma' dik ta' l-adulti (78 kontra 53 ml/siegħa x kg), waqt li l-medja tal-half-life terminali ġiet stabbilita għal 2.3 sigħat fiżżewġ gruppi.
English: Each NovoSeven pack contains:
Maltese: Jintuża f'ċerti gruppi ta' nies:
English: In an observational registry (F7HAEM-3578) covering subjects with congenital FVII deficiency, the median dose for long term prophylaxis against bleeding in 22 paediatric patients (below 12 years of age) with Factor VII deficiency and a severe clinical phenotype was 30 µg/kg (range 17 µg/kg to 200 µg/kg; the dose most often used was 30 µg/kg in 10 patients) with a median dose frequency of 3 doses per week (range 1 to 7; the dose frequency most often reported was 3 per week in 13 patients).
Maltese: F'reġistru ta' pazjenti li kienu taħt osservazzjoni (F7HAEM-3578) u li kien jinkludi individwi b'defiċjenza konġenitali tal-fattur FVII, id-doża medjana għall-profilassi fit-tul kontra l-fsada f'22 pazjent pedjatriku (taħt l-età ta' 12-il sena) b'defiċjenza tal-fattur VII u b'fenotip kliniku sever kienet ta' 30 µg/kg (marġni ta' 17 µg/kg sa 200 µg/kg; id-doża li ntużat l-aktar kienet ta' 30 µg/kg f'10 pazjenti) b'frekwenza medjana fid-doża ta' 3 dożi fil-ġimgħa (marġni ta' 1 sa 7; il-frekwenza fid-doża li ġiet l-aktar irrapportata kienet ta' 3 fil-ġimgħa f'13-il pazjent).
English: Serious bleeding episodes
Maltese: Episodji emorraġiċi serji
English: • 1 plunger rod
Maltese: • planġer 1
English: In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)).
Maltese: F'studji kliniċi f'pazjenti li huma nieqsa mill-fattur VII, il-formazzjoni ta' antikorpi kontra NovoSeven u FVII huwa l-uniku reazzjoni avvers għall-mediċina rrapportat (frekwenza: komuni (≥ 1/100 sa < 1/10).
English: You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters).
Maltese: Ikollok bżonn ukoll set t'amministrazzjoni (tubi u butterfly needle, biċċiet tat-tajjar bl-alcoħol sterile, garzi u stikek).
English: Solvent vial
Maltese: Kunjett tas-Solvent
English: Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII.
Maltese: Tużax NovoSeven fl-istess ħin ma' konċentrati ta' kumpless ta' prothrombin jew rFXIII.
English: Single dose pharmacokinetics of rFVIIa, 15 and 30 μg per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: Volume of distribution at steady state (280 - 290 ml/kg), half-life (2.82 - 3.11 h), total body clearance (70.8 - 79.1 ml/h×kg) and mean residence time (3.75 - 3.80 h).
Maltese: Volum tad-distribuzzjoni fl-istat fiss (280 - 290 ml/kg), ,l-half-life (2.82 - 3.11 h), it-tneħħija totali mill-ġisem (70.
English: Uncommon (may affect up to 1 in 100 treatment episodes)
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 episodju ta' trattament)
English: As recombinant coagulation factor VIIa NovoSeven may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins.
Maltese: Peress li NovoSeven, bħala fattur tal-koagulazzjoni rikombinanti VIIa jista' jkun fih traċċi ta' IgG talġrieden, IgG tal-bovini u proteini residwi oħrajn ta'kultura (proteini tas-serum tal-ħamster u talbovini), teżisti l-possibbilità remota li l-pazjenti kkurati bil-prodott jistgħu jiżviluppaw sensittività eċċessiva għal dawn il-proteini.
English: During in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours at 25°C in a 50 ml syringe (polypropylene).
Maltese: Waqt l-istudji in-vitro, ġie muri li waqt l-użu l-istabilità kimika u fiżika żżomm għal 24 siegħa f'temperatura ta' 25°C f'siringa (polypropylene) ta' 50 ml.
English: The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for each injection.
Maltese: Normalment id-doża hi ta' 90 mikrogramma (il-limiti tad-doża huma bejn 80 sa 120 mikrogramma) għal kull kilogramm li tiżen, għal kull injezzjoni.
English: • Allergic, hypersensitivity or anaphylactic reactions.
Maltese: • Reazzjonijiet allerġiċi, ta' sensittività eċċessiva jew anafilattiċi.
English: Rare (may affect up to 1 in 1,000 treatment episodes)
Maltese: Rari (jistgħu jaffettwaw sa 1 minn kull 1,000 episodju ta' trattament)
English: - Related laboratory findings, including elevated levels of Ddimmer and decreased levels of AT (see section
Maltese: - Sejbiet relatati ta' laboratorju li jinkludu livelli għoljin ta' Ddimer u tnaqqis fil-livelli ta' AT ( ara sezzjoni 4.4)
English: When NovoSeven is administered to patients outside approved indications, arterial thromboembolic events are common (≥ 1/100 to < 1/10).
Maltese: Meta NovoSeven jingħata lil pazjenti għal indikazzjonijiet li mhumiex dawk approvati, avvenimenti tromboemboliċi fl-arterji huma komuni ( ≥ 1/100 sa < 1/10).
English: LIST OF EXCIPIENTS
Maltese: Deskrizzjoni Ġenerali
English: Overleaf: NovoSeven user instructions
Maltese: Informazzjoni għall-utent
English: Dose interval
Maltese: Twissijiet u prekawzjonijiet
English: See overleaf for detailed instructions.
Maltese: Ara fuq in-naħa ta' wara għal istruzzjonijiet dettaljati.
English: • Ensure that a vial adapter is used irrespective of presentation.
Maltese: • Aċċerta ruħek li jintuża adapter tal-kunjett irrispettivament mill-presentazzjoni.
English: The most frequent adverse drug reactions are pyrexia and rash (uncommon: > 1/1,000 to < 1/100), and the most serious adverse drug reactions are thromboembolic events.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina rrappurtati b'mod frekwenti huma d-deni u r-raxx (mhux komuni: > 1/1,000 to < 1/100), u l-aktar reazzjonijiet avversi serji tal-mediċina huma l-avvenimenti tromboemboliċi.
English: The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours).
Maltese: Id-doża rakkomandata għall-kura ta' episodji ta' emorraġija u għall-prevenzjoni ta' l-emorraġija f'pazjenti li għaddejjin minn operazzjoni jew proċeduri invażivi hi ta' 90 µg (limiti fid-doża ta' 80120 µg) għal kull kilogramm ta' piż tal-ġisem f'intervalli ta' sagħtejn (1.5 - 2.5 sigħat).
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3.
English: The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown.
Maltese: Ir-riskju ta' xi interazzjoni potenzjali bejn NovoSeven u l-konċentrati ta' fatturi tal-koagulazzjoni m'huwiex magħruf.
English: The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, water for injections.
Maltese: Is-sustanzi fis-solvent huma histidine, hydrochloric acid, sodium hydroxide, ilma għall-injezzjonijiet.
English: Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequently (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.
Maltese: Avvenimenti tromboemboliċi fl-arterji (okklużjoni tal-arterja ċerebrali, inċident ċerebrovaskulari), avvenimenti trmoboemboliċi fil-vini (embolu fil-pulmun, trombożi tal-vini filfond), angina pectoris, tqalligħ, deni, raxx eritematożu u investigazzjoni ta' żieda fil-livelli ta' prodotti ta' degradazzjoni ta' fibrin.
English: There is no requirement for monitoring of NovoSeven therapy.
Maltese: M'hemmx bżonn ta' monitoraġġ tat-terapija b'NovoSeven.