FrancophonIA/ELRC3.0 huggingface dataset:
English: Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Maltese: Uża siringa li tintrema wara l-użu ta' daqs adattat u adapter għall-kunjett, labra ta' trasferiment (20 - 26G) jew apparat xieraq ieħor.
English: Solvent for NovoSeven
Maltese: Solvent għal NovoSeven
English: If you have Factor VII deficiency: The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection.
Maltese: Normalment id-doża hi bejn 15 sa 30 mikrogramma għal kull kilogramm li tiżen, għal kull injezzjoni.
English: After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Maltese: Wara r-rikostituzzjoni, l-istabbilità kimika u fiżika ġiet ippruvata għal 6 sigħat f'temperatura ta' 25°C u għal 24 siegħa f'temperatura ta' 5°C.
English: Vial with NovoSeven powder
Maltese: Kunjett bi trab NovoSeven
English: • The NovoSeven powder vial and pre-filled syringe with solvent should be at room temperature at reconstitution.
Maltese: • Il-kunjetti bit-trab u s-solvent ta' NovoSeven għandhom ikunu f'temperatura tal-kamra waqt irrikostituzzjoni.
English: Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (212 years) and 5 adult patients in non-bleeding state.
Maltese: Permezz ta' studju ta' koagulazzjoni fuq il-fattur VIIa, il-karatteristiċi farmakokinetiċi ta' NovoSeven kienu investigati f'12-il pazjent pedjatriku (2 - 12-il sena) u 5 pazjenti adulti f'stat mhux emorraġiku.
English: • If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other ingredients in this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku/a għal eptacog alfa (is-sustanza attiva ta' NovoSeven) jew għal xi sustanza oħra ta' din il-mediċina ( elenkati fis-sezzjoni 6).
English: Powder and solvent for solution for injection Eptacog alfa (activated)
Maltese: KUI) trab u solvent għal soluzzjoni għall-injezzjoni eptacog alfa (attivat)
English: NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection
Maltese: KUI) trab u solvent għal soluzzjoni għall-injezzjoni NovoSeven 2 mg (100 KUI) trab u solvent għal soluzzjoni għall-injezzjoni NovoSeven 5 mg (250
English: Once attached, remove the protective cap. Take care not to touch the spike on the vial adapter.
Maltese: Neħħi l-karta protettiva minn mal-adapter għall-kunjett mingħajr ma tneħħilu l-għatu prottetiv.
English: Limited clinical experience in long term prophylaxis has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype (see section 5.1).
Maltese: Bħala profilassi fit-tul, l-esperjenza klinika li hemm fil-popolazzjoni pedjatrika taħt it-12-il sena b'fenotip kliniku sever hija limitata (ara sezzjoni 5.1).
English: - Therapeutic response decreased*
Maltese: - Tnaqqis fir-rispons terapewtiku*
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, hamster or bovine protein.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1 jew għall-proteini tal-ġrieden, tal-ħamster jew tal-bovini.
English: The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of clearance ranged from 33.3 to 37.2 ml/h×kg.
Maltese: Il-medja tal-volum tad-distribuzzjoni fiss kienet tvarja minn 130 sa 165 ml/kg, il-valuri medji ta' tneħħija kienu jvarjaw minn 33.3 sa 37.2 ml/siegħa x kg u l-medja tal-half-life terminali kienet tvarja minn 3.9 sa 6.0 sigħat.
English: In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days.
Maltese: F'operazzjoni maġġuri, id-doża għandha titkompla bejn kull sagħtejn u 4 sigħat għal 6 - 7 ijiem.
English: Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Eptacog alfa (attivat) 2 mg/kunjett (100 KUI/kunjett), 1 mg/ml wara r-rikostituzzjoni
English: Plunger rod: made of polypropylene.
Maltese: Planġer: magħmula mill-propylene.
English: Plastic cap Rubber stopper
Maltese: Għatu tal-plastik Tapp tal-gomma
English: The solvent is a histidine solution.
Maltese: Is-solvent huwa soluzzjoni tal-histidine.
English: • 1 plunger rod (placed under the syringe)
Maltese: • Planġer 1 (jinsab taħt is-siringa)
English: In vial
Maltese: U LUŻU
English: Administration through a needleless connector may require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe.
Maltese: Għat-teħid permezz ta' konnekter ta' mingħajr labra jista' jkun hemm il-bżonn li tiġbed il-prodott rikostitwit għal ġo siringa standard luerlock sterili tal-plastik ta' 10 ml.
English: • If you have Glanzmann's thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if platelets are not readily available.
Maltese: • Jekk għandek it-trombastenja ta' Glanzmann (disturb emorraġiku) u l-kondizzjoni tiegħek ma tistax tiġi kkurata b'mod effettiv b'trasfużjonijiet tal-plejtlets jew jekk il-plejtlits mhumiex disponibbli faċilment.
English: Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4).
Maltese: Pazjenti li huma nieqsa mill-fattur VII kkurati b'NovoSeven għandhom ikunu mmonitorjati għall-antikorpi ta' fattur VII. (ara Sezzjoni 4.4).
English: - 1 vial (12 ml) with white powder for solution for injection - 1 pre-filled syringe (10 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
Maltese: - Kunjett 1 (12 ml) bi trab abjad għal soluzzjoni għall-injezzjoni - Siringa 1 mimlija għal-lest (10 ml) bis-solvent għar-rikostituzzjoni - Planġer 1 - Adapter tal-kunjett 1, b'filtru integrat għall-frak b'daqs ta' pori ta' 25 mikrometri
English: Powder in vial and solvent in vial:
Maltese: Trab f'kunjett u solvent f'kunjett
English: • 1 pre-filled syringe with solvent
Maltese: • Siringa 1 mimlija għal-lest bis-solvent
English: - 1 vial (2 ml) with white powder for solution for injection - 1 pre-filled syringe (3 ml) with solvent for reconstitution - 1 plunger rod - 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer.
Maltese: - Kunjett 1 (2 ml) bi trab abjad għal soluzzjoni għall-injezzjoni - Siringa 1 mimlija għal-lest (3 ml) bis-solvent għar-rikostituzzjoni - Planġer 1 - Adapter tal-kunjett 1, b'filtru integrat għall-frak b'daqs ta' pori ta' 25 mikrometri
English: - Flushing - Angioedema
Maltese: - Ħmura fil-wiċċ - Anġjoedima
English: Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU).
Maltese: Il-pakkett ta' NovoSeven 5 mg (250 KUI)/ NovoSeven 8 mg (400
English: The pharmacokinetics were similar across sex and ethnic groups.
Maltese: Ma kien hemm ebda differenza fil-karatteristiċi farmakokinetiċi fil-gruppi mqassma skont is-sess u skont l-etniċità.
English: If devices other than those supplied by Novo Nordisk are used, ensure the use of an adequate filter with a pore size of 25 micrometer.
Maltese: Jekk jintuża apparat ieħor li ma jkunx provdut minn NovoNordisk, għandu jiġi aċċertat li jintuża filtru adegwat b'daqs ta' pori ta' 25 mikrometri.
English: After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated).
Maltese: Wara r-rikostituzzjoni, 1 ml tas-soluzzjoni fih 1 mg ta' eptacog alfa (attivat).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar ir-rikostituzzjoni tal-prodott mediċinali qabel ma jingħata, ara sezzjoni 6.6.
English: Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight (3 doses each) and/or placebo.
Maltese: Is-suġġetti kien mqassma skont is-sess u grupp etniku u rċievew dożi ta' 40, 80, u 160µg NovoSeven għal kull kg ta' piż tal-ġisem (3 dożi kull wieħed) u/ jew plaċebo.
English: • Remove the protective paper from the vial adapter.
Maltese: • Neħħi l-karta protettiva mill-adapter tal-kunjett.
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala treddigħ u fertilità
English: The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus and urticaria.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina rrappurtati b'mod frekwenti huma tnaqqis fir-rispons terapewtiku, deni, raxx, avvenimenti tromboemoliċi fil-vini, ħakk u urtikarja.
English: Thread
Maltese: Trab
English: NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection eptacog alfa (activated)
Maltese: NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall-injezzjoni li fih 5 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 250
English: - Headache
Maltese: Pożoloġija
English: Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.
Maltese: L-ogħla dożi possibbli ta' NovoSeven qabel ma jibdew l-effetti tossiċi ma ġewx investigati fi studji kliniċi.
English: The reconstituted solution has a pH of approximately 6.0.
Maltese: Is-soluzzjoni rikostitwita għandha pH ta' madwar 6.0.
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, għandha tiġi implimentata l-kura medika normali għal xokk.
English: Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger.
Maltese: Siringa mimlija għal-lest: kunjett tal-ħġieġ tat-Tip I ma' backstop tal-polypropylene u planġer talgomma tal-bromobutyl.
English: A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.
Maltese: Riskju teoretiku għall-iżvilupp ta' attivazzjoni sistemika tas-sistema tal-koagulazzjoni f'pazjenti li jbatu minn mard ieħor li jippredisponuhom għall-DIC, ma jistax jiġi eskluż għal kollox.
English: Intravenous use.
Maltese: Aħsel idejk.
English: • Fever.
Maltese: • Deni.
English: Store below 25°C Do not freeze
Maltese: Aħżen taħt 25ºC
English: • If the CVAD line needs to be flushed before or after NovoSeven injection, use sodium chloride 9 mg/ml solution for injection.
Maltese: • Jekk it-tubu tas-CVAD ikollu bżonn jitlaħlaħ qabel jew wara l-injezzjoni ta' NovoSeven, uża soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml.
English: Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh.
Maltese: It-tabib tiegħek jista' jirrakkomandalek doża waħda ta' 270 mikrogrammi għal kull kilogramm li tiżen.
English: NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).
Maltese: NovoSeven jiġi ppreżentat bħala trab u solvent għal soluzzjoni għall-injezzjoni li fih 8 mg eptacog alfa (attivat) kull kunjett (jikkorrispondi għal 400 KUI/kunjett).
English: The recommended dose range in adults and children for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μg per kg body weight every 4 - 6 hours until haemostasis is achieved.
Maltese: Il-marġni rrakkomandati tad-doża fl-adulti u fit-tfal għall-kura ta' episodji ta' emorraġija u għallprevenzjoni ta' fsada f'pazjenti li fuqhom saret operazzjoni jew proċeduri invażivi huma ta' 15-30 µg għal kull kilogramm ta' piż tal-ġisem kull 4 sa 6 sigħat sakemm tintlaħaq l-emostasi.
English: Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Eptacog alfa (attivat) 5 mg/kunjett (250
English: This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor.
Maltese: Dan jirriżulta fil-konverżjoni ta' prothrombin f'ammonti kbar ta' thrombin indipendentement mill-fattur tat-tessuti.
English: After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with solvent.
Maltese: Wara r-rikostituzzjoni, il-prodott fih 1 mg/ml eptacog alfa (attivat) meta jiġi rrikostitwit bis-solvent.
English: - Intracardiac thrombus including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial thrombophlebitis and intestinal ischaemia)
Maltese: Disturbi vaskulari - Avvenimenti tromboemboliċi filvini (trombożi tal-vini fil-fond, trombożi fissit tal-injezzjoni filvina, embolu filpulmun, avvenimenti tromboemboliċi talfwied li jinkludu trombożi tal-vina portali, trombożi talvina renali, tromboflebite, tromboflebite tassuperfiċji u iskemija intestinali)
English: Attach the vial adapter to the solvent vial.
Maltese: Waħħal l-adapter għall-kunjett mal-kunjett tas-solvent.
English: Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Eptacog alfa (attivat) 1 mg/kunjett (50
English: A higher risk of arterial thromboembolic adverse events (see table: Vascular disorders) (5.6% in patients treated with NovoSeven versus 3.0% in placebo-treated patients) has been shown in a meta-analysis of pooled data from placebo-controlled trials conducted outside current approved indications in various clinical settings, each of these having distinct patient characteristics and hence different underlying risk profiles.
Maltese: Disturbi vaskulari) (5.6% f'pazjenti kkurati b'NovoSeven kontra 3% f'pazjenti kkurati bi plaċebo).
English: The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 2-3 hours until bleeding is controlled.
Maltese: Normalment id-doża hi ta' 90 mikrogramma għal kull kilogramm li tiżen; tista' tirrepeti l-injezzjoni kull 2-3 sigħat sakemm il-fsada tiġi kkontrollata.
English: - Do not freeze.
Maltese: - Ħakk u urtikarja
English: Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor.
Maltese: Dożi farmakoloġiċi ta' NovoSeven jattivaw il-fattur X direttament fuq il-wiċċ tal-plejtlets attivati, li jkunu lokalizzati fis-sit tal-ferita, indipendentement mill-fattur tat-tessut.
English: • Push the plunger rod to inject all the solvent into the vial.
Maltese: • Żomm il-lasta tal-planġer imbuttat 'l isfel kompletament.
English: Syringe cap
Maltese: Lasta talplanġer
English: Do not store reconstituted NovoSeven in plastic syringes, unless as described in section 6.3.
Maltese: Taħżinx NovoSeven rikostitwit f'siringi tal-plastik, sakemm mhux kif deskritt f'sezzjoni 6.3.
English: NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Maltese: Il-kunjetti bit-trab u s-solvent ta' NovoSeven għandhom ikunu f'temperatura tal-kamra waqt ir-rikostituzzjoni.
English: - Nausea
Maltese: - Deni
English: 1 pre-filled syringe of solvent with separate plunger rod 1 vial adapter for reconstitution
Maltese: Kull pakkett fih: kunjett 1 bit-trab siringa 1 mimlija bil-lest bis-solvent bi planġer with separate plunger rod adapter 1 għall-kunjett għar-rikostituzzjoni
English: The reconstituted NovoSeven must be injected into your vein (intravenous injection).
Maltese: In-NovoSeven rikostitwit irid jiġi injettat fil-vina tiegħek (injezzjoni minn ġol-vini).
English: Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity.
Maltese: Sustanzi anti-fibrinolitiċi ġew irrappurtati li jnaqqsu l-ammont ta' demm li jintilef assoċjat ma' loperazzjonijiet f'pazjenti bl-emofilja, speċjalment f'operazzjonijiet ta' l-ortopedija u f'operazzjonijiet fejn ikun hemm ħafna attività fibrinolitika, bħall-kavità orali.
English: Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA eptacog alfa (attivat) 8 mg/kunjett (400
English: Acquired Haemophilia
Maltese: Emofilja akkwiżita
English: IX > 5 Bethesda Units (BU)
Maltese: • f'pazjenti li għandhom emofilja konġenitali b'inibituri għall-fatturi VIII jew IX tal koagulazzjoni > 5 Unitajiet Bethesda (UB)
English: Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/kg rFVIIa).
Maltese: Proporzjonalità fid-doża ġiet stabbilita fit-tfal għad-dozi ta' 90 u 180 µg għal kull kg ta' piż tal-ġisem li kienu taħt studju u li huwa skont dak li kien diġà instab għad-dożi aktar baxxi (17.5 - 70 µg/kg rFVIIa).
English: 90 µg/kg (range 28 to 450 µg/kg).
Maltese: Id-doża medjana għal kull infużjoni għat-trattament ta' 333 episodju ta' fsada kienet ta' 90 µg/kg (tvarja minn 28 µg/kg sa 450 µg/kg).
English: Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08
Maltese: Fatturi ta' koagulazzjoni tad-demm, Kodiċi ATC:
English: In syringe (50 ml polypropylene) in hospital settings only Reconstitution must take place in controlled and validated aseptic conditions by adequately trained staff.
Maltese: F'siringa (50 ml polypropylene) f'ambjent ta' sptar biss Ir-rikostituzzjoni għandha ssir taħt kondizzjonijiet asettiċi kkontrollati u validati minn ħaddiema mħarrġa adegwatament.
English: Mild to moderate bleeding episodes (including home therapy) Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds.
Maltese: Episodji emorraġiċi ħfief għal moderati (inkluża l-kura d-dar) Ġie muri li intervent bikri kien effikaċi fil-kura ta' emorraġiji ħfief għal moderati tal-ġogi, tal-muskoli u mukokutanji.
English: After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.
Maltese: Wara l-għoti ta' NovoSeven, l-prothrombin time (PT) u l-activated partial thromboplastin time (aPTT)
English: Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.
Maltese: Madankollu, l-esperjenza bl-għoti flistess ħin ta' sustanzi anti-fibrinolitiċi u l-kura b'rFVIIa, hi limitata.
English: - Pruritus and urticaria
Maltese: TWISSIJIET SPEĊJALI
English: NovoSeven 2 mg (100 KIU) EU/1/96/006/005
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/006/010
English: • Headache
Maltese: - Dardir
English: NovoSeven 1 mg (50 KIU) EU/1/96/006/004
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/006/004
English: NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA eptacog alfa (attivat) 5 mg/kunjett (250
English: Thrombosis has been reported in FVII deficient patients receiving NovoSeven during surgery but the risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown (see section 5.1).
Maltese: Ġiet irrapportata trombożi f'pazjenti b'nuqqas tal-Fattur VII li kienu qed jirċievu NovoSeven waqt kirurġija imma rriskju ta' trombożi f'pazjenti b'nuqqas tal-Fattur VII li huma kkurati b'NovoSeven mhux magħruf (ara sezzjoni 5.1).
English: The mean in vivo plasma recovery was approximately 20%.
Maltese: Il-medja tal-irkupru tal-plażma in vivo kienet ta' madwar 20%.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Maltese: • Meta tinjetta ġo CVAD jista' jkun hemm il-bżonn li tuża siringa sterili tal-plastik ta' 10 ml biex tiġbed is-soluzzjoni rrikostitwita.
English: Plunger rod
Maltese: Kunjett tat-Trab
English: Patients should be informed of the early signs of hypersensitivity reactions.
Maltese: Il-pazjenti għandhom jiġu infurmati x'inhuma s-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva.
English: Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin.
Maltese: It-thrombin iwassal għall-attivazzjoni tal-plejtlets u tal-fatturi V u VIII filpost fejn ikun hemm il-ferita u għall-formazzjoni tal-plagg emostatiku permezz tal-konverżjoni ta' fibrinogen għal fibrin.
English: Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Maltese: Sib sit adattat, u bil-mod injetta NovoSeven ġo vina fuq perjodu ta' 2-5 minuti mingħajr ma tneħħi l-labra mis-sit tal-injezzjoni.
English: If using a transfer needle, screw the transfer needle tightly onto the syringe.
Maltese: Jekk qiegħed tuża labra ta' trasferiment, invita sew il-labra ta' trasferiment fuq is-siringa.
English: EU/1/96/006/010
Maltese: EU/1/96/006/006 EU/1/96/006/010
English: Pooling of vials (hospital use only):
Maltese: Pooling ta' kunjetti (għall-użu ta' sptar biss):
English: Read all of this leaflet carefully before you are given this injection because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.
English: • Remove the empty solvent vial.
Maltese: • Aqla' l-kunjett vojt tas-solvent.
English: NovoSeven 8 mg (400 KIU) EU/1/96/006/007
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/006/007
English: NovoSeven 5 mg (250 KIU) EU/1/96/006/006
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/006/006
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi taddemm u tassistema limfatika
English: In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII deficiency.
Maltese: Hija limitata l-esperjenza fl-użu fl-istess ħin ta' NovoSeven u mediċini msejħa antifibrinolitiċi (bħal aminocaproic acid jew tranexamic acid) li jintużaw ukoll biex tiġi kkontrollata l-fsada.
English: Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Maltese: Genzyme Europe B.V. Paasheuvelweg 25 1105 BP Amsterdam L-Olanda
English: One gram of Renagel contains approximately 180 mg (5.1 mEq) chloride.
Maltese: Renagel fih bejn wieħed u ieħor 180 mg (5.1 mEq) ta' chloride.
English: Inflammatory Gastrointestinal Disorders
Maltese: Disturbi infjammatorji gastrointestinali
English: Name and address of the manufacturer responsible for batch release Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: Renagel does not contain calcium.
Maltese: Renagel ma fihx kalċju.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-rata ta' rapportaġġ hi kklassifikata bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf ( ma tistax tiġi stmata mit-tagħrif disponibbli).
English: Abdominal pain, intestinal obstruction, ileus/subileus, diverticulitis, intestinal perforation1, gastrointestinal hemorrhage*1, intestinal ulceration*1, gastrointestinal necrosis*1, colitis*1, intestinal mass*1
Maltese: ulċerazzjoni intestinali*1, nekrożi gastrointestinali*1, kolite*1, massa intestinali*1
English: Crystal deposit intestine*1
Maltese: kristalli flintestin*1