FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event that hypotension does occur, symptomatic treatment, e.g. fluid therapy, should be provided.
Maltese: F'każ li sseħħ pressjoni baxxa, kura sintomatika, eż. terapija bil-fluwidu, għandha tiġi pprovduta.
English: If SBP is below the target or if there are concurrent signs of hypotension, please refer to section 4.5.
Maltese: Jekk l-SBP tkun taħt il-mira jew jekk hemm sinjali attwali ta' pressjoni baxxa, jekk jogħġbok irreferi għas-sezzjoni 4.5.
English: Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq u l-manifattur responsabbli għall-ħrug tal-lott Boehringer Ingelheim Vetmedica GmbH
English: Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN; nitrogen containing waste products in the blood).
Maltese: L-għoti tal-prodott f'doża eċċessiva (3 sa 5 darbiet tad-doża rakkomandata għal 6 xhur) irriżulta fi tnaqqis notevoli fil-pressjoni tad-demm, tnaqqis fl-għadd taċ-ċelluli tad-demm ħomor (effetti attribwibbli għall-attività farmakoloġika tal-prodott) u żidiet fin-Nitroġenu fl-Urea fid-Demm (BUNBlood Urea Nitrogen); nitroġenu li jkun fih prodotti mhux bżonnjużi fid-demm).
English: The following mild and transient gastrointestinal signs have rarely been observed in a clinical study (in order of decreasing frequency): mild and intermittent regurgitation, vomiting, diarrhoea or soft faeces.
Maltese: Is-sinjali gastrointestinali ħfief u temporanji li ġejjin ġew osservati b'mod rari fi studju fuq l-annimali (f'ordni ta' frekwenza dejjem tonqos): rigurġitazzjoni ħafifa u intermittenti, rimettar, dijarea jew ippurgar artab.
English: As determined by AUC, food consumption does not affect the overall extent of absorption of telmisartan.
Maltese: Kif stabbilit mill-AUC, il-konsum tal-ikel ma jaffettwax il-grad globali ta' assorbiment ta' telmisartan.
English: Due to the mode of action of the veterinary medicinal product, transient hypotension (low blood pressure) may occur.
Maltese: Minħabba l-mod ta' azzjoni tal-prodott veterinarju mediċinali, tista' sseħħ pressjoni baxxa temporanja.
English: Symptomatic treatment, e.g. fluid therapy, should be provided in case of any clinical signs of hypotension.
Maltese: Kura sintomatika, eż. terapija bil-fluwidu, għandha tiġi pprovduta f'każ ta' kwalunkwe sinjali kliniċi ta' pressjoni baxxa.
English: After administration of up to 5 times the recommended dose for 6 months to young adult healthy cats, adverse reactions observed were consistent with those mentioned in section 4.6.
Maltese: Wara l-għoti sa 5 darbiet tad-doża rakkomandata għal 6 xhur lil qtates adulti żgħar f'saħħithom, irreazzjonijiet avversi osservati kienu konsistenti ma' dawk imsemmija f'sezzjoni 4.6.
English: Mild and transient gastrointestinal signs such as vomiting and diarrhoea associated with product administration have been observed commonly in a clinical study.
Maltese: Sinjali gastrointestinali ħfief u temporanji bħal rimettar u dijarea assoċjati mal-għoti tal-prodott ġew osservati b'mod komuni fi studju kliniku.
English: In a further clinical trial in cats with hypertension a reduction in mean systolic blood pressure was achieved with a dose of 2 mg/kg.
Maltese: Fi prova klinika oħra fi qtates bi pressjoni għolja, inkiseb tnaqqis fil-pressjoni sistolika medja tad-demm b'doża ta' 2 mg/kg.
English: Semintra 10 mg/ml oral solution for cats
Maltese: VETERINARJU Semintra 10 mg/ml soluzzjoni orali għall-qtates
English: Reduction of proteinuria associated with chronic kidney disease (CKD) in cats.
Maltese: Tnaqqis ta' proteinurija assoċjata ma' mard kroniku tal-kliewi (CKD) fil-qtates.
English: Administration of the product at overdose (up to 2.5 times the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Maltese: L-għoti tal-prodott f'doża eċċessiva (sa 2.5 darbiet id-doża rakkomandata għal 6 xhur) irriżulta fi tnaqqis notevoli fil-pressjoni tad-demm, tnaqqis fl-għadd taċ-ċelluli tad-demm ħomor (effetti attribwibbli għall-attività farmakoloġika tal-prodott) u żidiet fin-Nitroġenu fl-Urea fid-Demm (BUNBlood Urea Nitrogen).
English: Semintra 4 mg/ml oral solution for cats
Maltese: VETERINARJU Semintra 4 mg/ml soluzzjoni orali għall-qtates
English: Administration of the product at overdose (3 to 5 times of the recommended dose for 6 months) resulted in marked reductions in blood pressure, decreases in red blood cell count (effects attributable to the pharmacological activity of the product) and increases in Blood Urea Nitrogen (BUN).
Maltese: L-għoti tal-prodott f'doża eċċessiva (3 sa 5 darbiet tad-doża rakkomandata għal 6 xhur) irriżulta fi tnaqqis notevoli fil-pressjoni tad-demm, tnaqqis fl-għadd taċ-ċelluli tad-demm ħomor (effetti attribwibbli għall-attività farmakoloġika tal-prodott) u żidiet fin-Nitroġenu fl-Urea fid-Demm (BUNBlood Urea Nitrogen).
English: No pharmacological activity has been shown for the conjugate.
Maltese: L-ebda attività farmakoloġika ma ntweriet għall-konjugat.
English: Telmisartan is an orally active and specific angiotensin II receptor (subtype AT1) antagonist which causes a dose-dependent decrease in mean arterial blood pressure in mammalian species including the cat.
Maltese: Telmisartan hu attiv oralment u antagonist speċifiku ta' riċettur ta' angiotensin II (sottotip AT1) li jikkawża tnaqqis li jiddependi mid-doża fil-pressjoni arterjali tad-demm medja fi speċi ta' mammiferi li jinkludu l-qtates.
English: The safety and efficacy of telmisartan has not been tested in cats under the age of 6 months.
Maltese: Is-sigurtà u l-effikaċja ta' telmisartan ma ġietx ittestjata fi qtates li għandhom inqas minn 6 xhur.
English: Semintra 10 mg/ml oral solution for cats Telmisartan
Maltese: VETERINARJU Semintra 10 mg/ml soluzzjoni orali għall-qtates Telmisartan
English: Telmisartan is an orally active and specific angiotensin II receptor (subtype AT1) antagonist which causes a dose-dependent decrease in mean arterial blood pressure in mammalian species, including the cat.
Maltese: Telmisartan hu attiv oralment u antagonist speċifiku ta' riċettur ta' angiotensin II (sottotip AT1) li jikkawża tnaqqis li jiddependi mid-doża fil-pressjoni arterjali tad-demm medja fi speċi ta' mammiferi, li jinkludu l-qtates.
English: Semintra 4 mg/ml oral solution for cats Telmisartan
Maltese: VETERINARJU Semintra 4 mg/ml soluzzjoni orali għall-qtates Telmisartan
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: Telmisartan selectively binds to the AT1 receptor and does not show affinity for other receptors, including AT2 or other less characterised AT receptors.
Maltese: Telmisartan jeħel b'mod selettiv mar-riċettur ta' AT1 u ma jurix affinità għal riċetturi oħrajn, li jinkludu AT2 u riċetturi AT oħrajn inqas karatterizzati.
English: If the SBP increases over the course of the disease the daily dose may be increased again up to 2 mg/kg.
Maltese: Jekk l-SBP tiżdied matul il-kors tal-marda d-doża ta' kuljum tista' terġa' tiżdied sa 2 mg/kg.
English: Semintra 4 mg/ml oral solution for cats telmisartan
Maltese: Semintra 4 mg/ml soluzzjoni orali għall-qtates telmisartan
English: If SBP is below the target or if there are concurrent signs of hypotension, please refer to the “Special warnings” section.
Maltese: Jekk l-SBP tkun taħt il-mira jew jekk hemm sinjali attwali ta' pressjoni baxxa, jekk jogħġbok irreferi għas-sezzjoni ‘Twissijiet speċjali'.
English: 1 measuring syringe.
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni orali.
English: Immune Tolerance Induction (ITI)
Maltese: Induzzjoni ta' Tolleranza Immuni (ITI)
English: MedDRA Standard System Organ Class
Maltese: Standard MedDRA Sistema talklassifika talorgani
English: Imed Poland sp. z.o.o.
Maltese: Imed Poland sp. z.o.o. Tel.
English: Apply a tourniquet.
Maltese: 13. Applika turnikett.
English: Antibodies (Inhibitors)
Maltese: Antikorpi (Inibituri)
English: Clearance: 3 ml/h/kg
Maltese: 3 ml/h/kg
English: Factor VIII level required (%) (IU/dl)
Maltese: meħtieġ (%) (IU/dl)
English: Overall, 9 out of 60 (15%) developed inhibitors.
Maltese: 60 (15%) żviluppaw inibituri.
English: Overall list of possible side effects:
Maltese: Lista sħiħa ta' effetti sekondarji possibbli:
English: Solvent Water for injections, sterilised.
Maltese: Solvent Ilma għall-injezzjonijiet, sterilizzat.
English: 100 % (1 IU/ml) 60 % (0.6 IU/ml) 40 % (0.4 IU/ml)
Maltese: 100 % (1 IU/ml) 3.0 60% (0.6
English: Inhibitor Formation to FVIII (reported in PUPs and MTPs)*
Maltese: FVIII (irrappurtata f'PUPs u MTPs)*
English: Marketing Authorisation Holder Bayer Pharma AG 13342 Berlin Germany
Maltese: Bayer Pharma AG 13342 Berlin
English: Concentrations of rFVIII solution 100 IU/ml 200 IU/ml 400 IU/ml
Maltese: IU/ml 200 IU/ml 400 IU/ml
English: Marketing Studies)*
Maltese: Suq)*
English: Possible side effects
Maltese: IU Effetti sekondarji possibbli
English: Infusion rate for 75 kg patient ml/h
Maltese: Rata ta' infużjoni għal pazjent ta' 75 kg/ f'ml/h
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5
Maltese: IU meħtieġa = piż tal-ġisem (kg) × żjieda mixtieqa ta' fattur VIII (% tan-normal) × 0.5
English: A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Maltese: Saret evalwazzjoni retrospettiva fuq 40 pazjent, u 39 pazjent ġew inklużi fi studju kliniku prospettiv li nbeda mill-investigatur.
English: LIST OF EXCIPIENTS Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
Maltese: Glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, sucrose.
English: Continuous Infusion
Maltese: Infużjoni Kontinwa
English: Continuous infusion
Maltese: Infużjoni kontinwa
English: PUPs = previously untreated patients PTPs = previously treated patients MTPs = minimally treated patients * see section below
Maltese: PTPs = pazjenti li ġew ikkurati fil-passat MTPs = pazjenti kkurati minimament
English: Infusion rate IU/h/kg
Maltese: IU/h/kg
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Maltese: Ħamsa minn 37 (14%) pazjent PUP u 4 minn 23 (17%) pazjent MTP ikkurati b'Helixate NexGen żviluppaw inibituri fi żmien 20 jum ta' esponiment.
English: Date of latest renewal: 06 August 2010
Maltese: Data tal-aħħar tigdid: 06 ta' Awwissu 2010
English: Helixate NexGen contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Maltese: Helixate NexGen fih livelli baxxi ta' polysorbate-80 bħala sustanza mhux attiva li hu magħruf li jżid ir-rata ta' estrazzjoni ta' di-(2-ethylhexyl)phthalate (DEHP) minn materjali magħmula minn polyvinyl chloride (PVC).
English: The specific activity of Helixate NexGen is approximately 4000 IU/mg protein.
Maltese: L-attività speċifika ta' Helixate NexGen hija madwar 4000 IU/mg ta' proteina.
English: I.
Maltese: A.
English: Ελλάδα
Maltese: Tqegħid fis
English: • one vial with powder (10 ml clear glass type 1 vial with latex-free grey halogenobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett bit-trab (10 ml, ħġieġ trasparenti tip 1 kunjett magħluq b'għatu griż mmarkat li ma fihx latex tal-lastku tal-halogenobutyl u ssiġillat bl-aluminju).
English: Helixate NexGen can be infused by continuous infusion.
Maltese: Infużjoni kontinwa Helixate NexGen jista' jingħata permezz ta' infużjoni kontinwa.
English: For continuous infusion, clinical and in vitro stability has been demonstrated using ambulatory pumps with a PVC reservoir.
Maltese: Għall-infużjoni kontinwa, stabbilità klinika u in vitro ġiet murija permezz ta' pompi ambulatorji b'riżervwar tal-PVC.
English: For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Maltese: Għal kalkulazzjoni ta' ml/siegħa, immultiplika r-rata tal-infużjoni f'IU/h/kg b'kg/bw/konċentrazzjoni tas-soluzzjoni (IU) ml.
English: Filtering is achieved by using the Mix2Vial adapter.
Maltese: Il-filtrazzjoni ssir permezz tal-adattatur Mix2vial.
English: This product is indicated for adults, adolescents and children of all ages.
Maltese: Dan il-prodott hu indikat għal adulti, adolexxenti u tfal ta' kull età.
English: Degree of haemorrhage/ Type of surgical procedure
Maltese: Qawwa tal-emorraġija/ Tip ta' proċedura kirurġika
English: Data show that Helixate NexGen has been used to induce immune tolerance.
Maltese: Id-dejta turi li Helixate NexGen intuża biex jinduċi tolleranza immuni.
English: Additional pharmacokinetic parameters for Helixate NexGen for bolus injection are: mean residence time [MRT (0-48)] of about 22 hours and clearance of about 160 ml/h.Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 ml/h corresponding to 3.0 ml/h/kg (range 1.6-4.6 ml/h/kg).
Maltese: Tneħħija medja fil-linja bażi għal 14-il pazjent adult li kellhom interventi kirurġiċi maġġuri b'infużjoni kontinwa hija ta' 188 ml/siegħa li tikkorrispondi għal 3.0 ml/h/kg (firxa 1.6-4.6 ml/h/kg).
English: The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).
Maltese: Mega standard tal-FDA li ġie kkalibrat fuq standard tal-WHO u mkejjel f'Unitajiet Internazzjonali (IU).
English: CSL Behring ΜΕΠΕ, Τηλ: +30-210 7255 660
Maltese: Τηλ: +30-210 7255 660
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 ml syringe - 2 alcohol swabs for single use
Maltese: - tagħmir tal-filter 1 li jitrasferixxi 20/20 - sett 1 għat-titqib tal-vina - siringa ta' 5 ml li tintrema wara li tintuża
English: The active substance is human coagulation factor VIII (octocog alfa) produced by recombinant DNA technology.
Maltese: Is-sustanza attiva hi l-Fattur VIII rikombinanti tal-koagulazzjoni umana (octocog alfa) magħmul minn teknoloġija ta' DNA rikombinanti.
English: This medicine should be injected intravenously over several minutes.
Maltese: Din il-mediċina għandha tingħata permezz ta' injezzjoni fil-vina fuq medda ta' diversi minuti.
English: Inhibitor development in previously untreated and treated patients (PUPs / PTPs) has been reported (see section 4.4).
Maltese: Kien irrappurtat żvilupp ta' inibitur f'pazjenti li ma kinux ikkurati qabel u f'pazjenti kkurati minn qabel (PUPs/PTPs - previously untreated patients/previously treated patients) (ara sezzjoni 4.4).
English: Infusion rate (in IU/kg/h) = Clearance (in ml/h/kg) × desired factor VIII level (in IU/ml)
Maltese: Rata tal-infużjoni (f'IU/kg/h) = Tneħħija (f'ml/h/kg) × il-livell ta' fattur VIII mixtieq (f'IU/ml).
English: The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose (see end of section 2).
Maltese: Is-sustanzi l-oħra huma glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, u sucrose (ara fit-tmiem ta' sezzjoni 2).
English: In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated paediatric patients (MTPs, defined as having ≤4 exposure days) with residual FVIII:C < 2 IU/dl.
Maltese: Fi studji kliniċi, Helixate NexGen intuża fil-kura ta' episodji ta' fsada f'37 pazjent li ma kinux ikkurati qabel (PUPs - previously untreated patients) u fi 23 pazjent pedjatriku kkurati b'mod minimu (MTPs - minimally treated patients, imfissra bħala li kellhom esponiment ta' ≤4 ijiem)
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed with recombinant factor VIII products and may in some cases progress to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjoedima, ħruq u tingiż fis-sit tal-infużjoni, tertir ta' bard, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, nuqqas ta' kwiet, takikardija, għafis tas-sider, tnemnim, rimettar, tħarħir) ġew osservati ma' prodotti ta' fattur rikombinanti VIII u f'xi każijiet jistgħu jiżviluppaw f'anafilassi severa (li tinkludi xokk).
English: 1 vial with 2.5 ml water for injections.
Maltese: Kunjett wieħed b' 2,5 ml ilma għall-injezzjoni.
English: • hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)
Maltese: jistgħu jaffettwaw sa persuna 1 li qed tużah minn kull 1,000 • reazzjonijiet ta' sensittività eċċessiva li jinkludu reazzjoni allerġika severa għal għarrieda (li jistgħu jinkludu ħorriqija, dardir, urtikarja, anġjoedima, tertir ta' bard, fwawar, uġigħ ta' ras, letarġija, tħarħir jew diffikultà biex tieħu nifs, irrekwitezza, takikardija, tnemnim jew xokk anafilattiku, eż. għafsa fis-sider/tħossok ma tiflaħx, sturdament u dardir u pressjoni tad-demm kemmxejn baxxa , li tista' tagħmlek dgħajjef waqt li tkun bil-wieqfa)
English: One ml of Helixate NexGen 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Maltese: IU fih madwar 100 IU (250 IU / 2,5 ml) ta' fattur VIII talkoagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Maltese: IgG, li jaġixxu kontra l-attività pro-koagulanti ta' fattur VIII, u jiġu mkejla f'Unitajiet Bethesda (BU) għal kull ml ta' plażma bl-użu tal-analiżi modifikata.
English: EXP (End of the 12 month period, if stored at room temperature): ........... Do not use after this date.
Maltese: EXP EXP (Fi tmiem perijodu ta' 12-il xahar jekk maħżun f'temperatura ambjentali): ...........
English: In one observational study, the incidence of inhibitor development in previously untreated patients with severe haemophilia A was 64/183 (37.7%) with Helixate NexGen (followed up to 75 exposure days).
Maltese: Fi studju wieħed ta' osservazzjoni, l-inċidenza ta' żvilupp ta' inibitur f'pazjenti li ma kinux ikkurati qabel li għandhom emofilija A severa kienet ta' 64/183 (37.7%) b'Helixate NexGen (segwiti sa 75 jum ta' esponiment).
English: 1 vial with 5.0 ml water for injections.
Maltese: Kunjett wieħed b' 5,0 ml ilma għall-injezzjoni.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
Maltese: Fi studji kliniċi bi 73 pazjent ikkurati minn qabel (PTP - previously treated patient, imfisser bħala li kellu ≥100 jum ta' esponiment), segwiti għal aktar minn 4 snin, ma kien osservat l-ebda inibitur de novo.
English: Expected factor VIII rise (% of normal) = 2 × administered IU body weight (kg)
Maltese: II. Żjieda mistennija ta' fattur VIII (% tan-normal)= 2 × IU li jingħata piż tal-ġisem (kg)
English: INFORMATION IN BRAILLE Helixate NexGen 250
Maltese: INFORMAZZJONI BIL-BRAILLE Helixate NexGen 250
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Maltese: Fil-każ ta' interventi kirurġiċi maġġuri, monitoraġġ preċiż tat-terapija ta' sostituzzjoni permezz ta' analiżi tal-koagulazzjoni (attività ta' fattur VIII fil-plażma) huwa indispensabbli.
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting.
Maltese: Waqt li l-kunjett tal prodott ikun wieqaf, waħħal is-siringa mal-Luer Lock talMix2Vial.
English: INFORMATION IN BRAILLE Helixate NexGen 3000
Maltese: INFORMAZZJONI BIL-BRAILLE Helixate NexGen 3000
English: Example for calculation of infusion rate for continuous infusion after initial bolus injection
Maltese: Eżempju għal kalkulazzjoni ta' rata ta' infużjoni għal infużjoni kontinwa wara injezzjoni bolus inizjali
English: Example: for a 75 kg patient with a clearance of 3 ml/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Maltese: Eżempju: għal pazjent ta' 75 kg b'rata ta' tneħħija ta' 3 ml/h/kg, ir-rata inizjali ta' infużjoni għandha tkun ta' 3 IU/h/kg biex jintlaħaq livell ta' FVIII ta' 100%.
English: INFORMATION IN BRAILLE Helixate NexGen 1000
Maltese: INFORMAZZJONI BIL-BRAILLE Helixate NexGen 1000
English: Helixate NexGen is used for treatment and prophylaxis of bleeding adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Maltese: Helixate NexGen huwa intiż għal kura u l-profilassi ta' fsada f'adulti, adolexxenti u tfal ta' kull età li għandhom l-emofilja A (nuqqas konġenitali tal-fattur VIII).
English: INFORMATION IN BRAILLE Helixate NexGen 500
Maltese: INFORMAZZJONI BIL-BRAILLE Helixate NexGen 500
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa (600 IU/ml after reconstitution).
Maltese: 3000 IU octocog alfa (600
English: • nausea this can constitute an early warning for hypersensitivity and anaphylactic reactions.
Maltese: • dardir jista' jkun li din tkun indikazzjoni bikrija tas-sensittività eċċessiva u reazzjonijiet anafilattiċi.
English: Each vial contains nominally 3000 IU human coagulation factor VIII (INN: octocog alfa).
Maltese: Kull kunjett nominalment fih 3000 IU ta' fattur VIII tal-koagulazzjoni umana (INN: octocog alfa).
English: One ml of Helixate NexGen 1000 IU contains approximately 400 IU (1000 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Maltese: IU fih madwar 400 IU (1000 IU / 2,5 ml) ta' fattur VIII talkoagulazzjoni umana (INN: octocog alfa) wara r-rikostituzzjoni.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Maltese: Irrepeti l-infużjoni kull 12 - 24 siegħa għal 3 - 4 ijiem jew aktar, sakemm jitfejjaq l-uġigħ u d diżabilità.
English: • one vial with solvent (6 ml clear glass type 1 vial with latex-free grey chlorobutyl rubber blend stopper and aluminium seal)
Maltese: • kunjett wieħed bis-solvent (6 ml, ħġieġ trasparenti tip 1 kunjett magħluq b'għatu griż ta'
English: The safety and efficacy of Helixate NexGen in children of all ages have been established.
Maltese: Is-sigurtà u l-effikaċja ta' Helixate NexGen fit-tfal ta' kull età ġew determinati.
English: INFORMATION IN BRAILLE Helixate NexGen 2000
Maltese: INFORMAZZJONI BIL-BRAILLE Helixate NexGen 2000
English: A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR