FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or nurse before receiving {invented name}: - if you have a history of medicine allergy - if you have systemic lupus erythematosus - if you have rheumatoid arthritis - if you have severe asthma, eczema or other allergies
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira, Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt.
English: {Invented name} should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Maltese: {Isem ivvintat} għandu jingħata biss meta staff imħarreġ biex jevalwa u jimmaniġġja rreazzjonijiet anafilattiċi jkun disponibbli immedjatament, f'ambjent fejn faċilitajiet kompleti ta' risuxxitazzjoni jistgħu jiġi assigurati.
English: [the wording below should be inserted in the relevant section]
Maltese: [il-kitba t'hawn taħt għandha tiddaħħal fis-sezzjoni rilevanti]
English: Your doctor or nurse will administer {invented name} by {route of administration defined in posology section of SmPC}; the {invented name} will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.
Maltese: M'għandekx tirċievi {isem ivvintat}: - jekk inti allerġiku (għandek sensittività eċċessiva) għall-prodott jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6). - jekk kellek reazzjonijiet ta' allerġiji serji (sensittività eċċessiva) għal preparazzjonijiet oħrajn ta' ħadid li jista' jiġi injettat.
English: Treatment with {invented name} should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Maltese: Anemija minn defiċjenza ta' ħadid li sseħħ fl-ewwel trimestru tat-tqala tista' tiġi kkurata f'ħafna każijiet permezz ta' kura orali tal-ħadid b'{isem ivvintat} għandu jiġi limitat għat-tieni u t-tielet trimestru jekk il-benefiċċju jiġi ġġudikat li jiżboq ir-riskju potenzjali kemm għall-omm kif ukoll għall-fetu.
English: The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira, Website: www.medicinesauthority.gov.mt, e-mail:
English: 1 vial + 1 pre-filled syringe + 2 needles
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 2 labar
English: MARKETING AUTHORISATION NUMBER EU/1/12/775/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/775/001
English: Store in a refrigerator (2°C-8°C).
Maltese: Aħżen fi friġġ (2°C-8°C)
English: Thromboembolic risk:
Maltese: Riskju tromboemboliku:
English: Pack size of 1.
Maltese: Id-daqs tal-pakkett u ta' 1.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 September 2012
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 03 Settembru 2012
English: Leucopenia and aggravated neutropenia
Maltese: Lewkopenija u newtropenija aggravata
English: OTHER Novo Nordisk A/S
Maltese: OĦRAJN Novo Nordisk A/S
English: Pharmacotherapeutic group: Antihaemorrhagics, Blood Coagulation factor, ATC code: B02BD11.
Maltese: Antiemorraġiċi, Fattur ta' Koagulazzjoni tad-Demm, Kodiċi ATC B02BD11.
English: • Contraindication of hypersensitivity
Maltese: • Il-kontra-indikazzjoni ta' sensittività eċċessiva
English: Frequency categories are defined according to the following convention: 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: Il-kategoriji tal-frekwenzi huma definiti skont din il-konvenzjoni: komuni ħafna (≥1/10), komuni (≥ 1/100, < 1/10), mhux komuni (≥ 1/1000, < 1/100), rari (≥ 1/10000, < 1/1000), rari ħafna (< 1/10000), mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: Also, on-demand treatment is followed in a noninterventional post-authorisation safety study (NN1841-3868).
Maltese: Barra minn hekk, il-kura fil-pront hija segwita f'studju ta' sigurtà ta' wara l-awtorizzazzjoni ta' u li sar mingħajr ebda intervent (NN1841-3868).
English: Dose volume in ml = 0.042 x subject bw (kg)
Maltese: Volum tad-doża f'ml = 0.042 x bw tal-persuna (kg)
English: NovoThirteen should be injected at a rate not higher than 2 ml/minute.
Maltese: NovoThirteen għandu jiġi injettat b'rata mhux ogħla minn 2 ml/minuta.
English: Common (≥ 1/100 to < 1/10) Common (≥ 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10) Komuni (≥ 1/100 sa < 1/10)
English: Nervous system disorders Common (≥ 1/100 to < 1/10)
Maltese: Disturbi fis-sistema nervuża Komuni (≥ 1/100 sa < 1/10)
English: It is structurally identical to the human FXIII A-subunit [A2].
Maltese: Hu strutturalment identiku għas-subunità-A ta' FXIII [A2] umana.
English: NovoThirteen (A-subunit) binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2] with a similar half-life to endogenous [A2B2].
Maltese: NovoThirteen (subunità A) teħel mas-subunità B ta' FXIIIl libera umana u dan jirriżulta f'heterotetramer [rA2B2] b'half-life simili għal dik ta' [A2B2] endoġenu
English: In clinical trials, NovoThirteen has been administered to 82 patients with congenital factor XIII Asubunit deficiency (3112 doses of NovoThirteen).
Maltese: Fil-provi kliniċi, NovoThirteen ingħata lil 82 pazjent b'defiċjenza konġenitali ta' subunità A ta' fattur XIII (3112 doża ta' NovoThirteen)
English: Powder: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid, sodium hydroxide Solvent: water for injections
Maltese: Sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid (għall-aġġustament talpH), sodium hydroxide (għall-aġġustament tal-pH)
English: 3 patients (14%) aged between 6 and 18 years experienced serious adverse reactions in comparison to 0 patients over 18 years that experienced serious adverse reactions.
Maltese: 3 pazjenti (14 %) b'etajiet bejn 6 u 18-il sena kellhom reazzjonijiet avversai serji meta mqabbla ma' 0 pazjenti 'l fuq minn 18-il sena li kellhom reazzjonijiet avversi serji.
English: FXIII is a pro-enzyme (pro-transglutaminase), which is activated by thrombin in the presence of Ca2+.
Maltese: FXIII hi proenzima (protransglutaminase), li tiġi attivata minn thrombin fil-preżenza ta' Ca2+.
English: There are no clinical data available on interaction between NovoThirteen and other medicinal products.
Maltese: M'hemm l-ebda dejta klinika disponibbli dwar l-interazzjoni bejn NovoThirteen u prodotti mediċinali oħrajn.
English: Non-neutralising antibodies Fibrin D-dimer increased
Maltese: Antikorpi li ma jinnewtralizzawx Żieda fil-fibrin D-dimer
English: This is in agreement with the elimination pharmacokinetics estimated from a clinical pharmacology trial in healthy subjects, which determined the half-life to be 11.8 days.
Maltese: Dan jaqbel mal-farmakokinetika tal-eliminazzjoni stmata minn studju kliniku farmakoloġiku f'persuni b'saħħithom, li stabbilixxa li l-half life hi ta' 11.8 jiem.
English: The risk to humans is not known.
Maltese: Ir-riskju għall-bnedmin mhuwiex magħruf.
English: All findings in the non-clinical safety programme have been related to expected exaggerated pharmacology (general thrombosis, ischaemic necrosis and ultimately mortality) of rFXIII and non-proteolytically activated recombinant FXIII at dose levels in excess (>48 fold) of the maximum recommended clinical dose of 35 IU/kg.
Maltese: Ir-riżultati kollha fil-programm tas-sigurtà mhux kliniku kienu relatati mal-farmakoloġija esaġerata mistennija (trombożi ġenerali, nekrożi iskemika u finalment il-mewt) ta' rFXIII u FXIII rikombinanti attivat b'mod mhux proteolitiku f'livelli ta' doża ta' iktar (>48 darba ogħla) mid-doża klinika massima rakkomandata ta' 35 UI/kg.
English: Dose volume in millilitres = 0.117 x body weight in kilograms.
Maltese: Volum tad-doża f'millilitri= 0.117 x piż tal-ġisem f'kilogrammi.
English: The half-life of NovoThirteen was assessed in the F13CD-1725 trial from a limited blood sampling scheme at 1 hour, 14 and 28 days post dose.
Maltese: Il-half-life ta' NovoThirteen ġie evalwat fil-prova F13CD-1725 minn skema limitata ta' kampjuni ta' demm meħuda wara siegħa, 14 u 28 ġurnata mid-doża.
English: The active substance is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Maltese: Is-sustanza attiva hija prodotta fiċ-ċelluli tal-ħmira (Saccharomyces cerevisiae) permezz tatteknoloġija rikombinanti tad-DNA.
English: The dose volume in millilitres should be calculated based on body weight for each patient using the following formula: Dose volume in ml = 0.042 x subject bw (kg) if bw > 24 kg or dose volume in ml = 0.117 x bw (kg) if bw < 24 kg).
Maltese: Il volum tad-doża f'millilitri għandu jiġi kkalkulat skont il-piż tal-ġisem għal kull pazjent bl-użu ta' din il-formula: volum ta' doża f'ml = 0.042 x suġġett bw (kg), jekk il-bw > 24 kg jew volum ta' doża f'ml = 0.117 x bw (kg) jekk il-bw < 24 kg).
English: The mean t½ of FXIII was approximately 15 days (range: 10 to 25 days).
Maltese: Il-medja tal-t½ ta' FXIII kien madwar 15-il ġurnata (marġni: 10 sa 25 ġurnata).
English: Powder (2500 IU) in a vial (glass type I) with rubber stopper (chlorobutyl) and 3.2 ml solvent in a vial (glass type I) with rubber stopper (bromobutyl) and a vial adapter for reconstitution.
Maltese: UI) f'kunjett (tal-ħġieġ ta' tip I) b'tapp tal-lastku (chlorobutyl) u 3.2 ml ta' solvent f'kunjett (tal-ħġieġ ta' tip I) b'tapp tal-lastku (bromobutyl) u adapter tal-kunjett għar-rikostituzzjoni.
English: Summary of the safety profile The most frequent adverse reaction is ‘headache' reported in 37% of patients.
Maltese: Sommarju tal-profil tas-sigurtà L-iktar reazzjoni frekwenti avversa tal-mediċina hi ‘uġigħ ta' ras' irrapportata f'37 % tal-pazjenti.
English: A pivotal prospective, open-label, single-arm phase 3 trial (F13CD-1725) including 41 patients with FXIII A-subunit deficiency was conducted to investigate the haemostatic efficacy of rFXIII in patients with congenital FXIII deficiency as reflected by the rate of bleeding episodes requiring treatment with a FXIII-containing product.
Maltese: Studju prospettiv importanti ħafna, open-label, b'fergħa waħda, ta' Fażi 3 (F13CD-1725) kien jinkludi 41 pazjent b'defiċjenza ta' subunità-A ta' FXIII, li sar biex jinvestiga l-effikaċja emostatika ta' rFXIII f'pazjenti b'defiċjenza konġenitali ta' FXIII kif riflessa mir-rata ta' episodji ta' tnixxija tad-demm li jeħtieġu kura bi prodott li fih FXIII.
English: 21 patients were between the age of 6 to less than 18 years old and 6 patients were less than 6 years old (total of 986 exposures of NovoThirteen in paediatric subjects (less than 18 years old).
Maltese: 21 pazjent kienu bejn l-età ta' 6 snin u inqas minn 18-il sena u 6 pazjenti kellhom inqas minn 6 snin (total ta' 986 espożizzjoni għal NovoThirteen f'suġġetti pedjatriċi (inqas minn 18-il sena)).
English: One patient was treated on demand in a phase 3b extension study (F13CD-3720).
Maltese: Pazjent wieħed ġie kkurat fil-pront f'studju ta' estensjoni ta' fażi 3b (F13CD3720).
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Novo Nordisk A/S
English: In the reported cases of NovoThirteen overdose up to 2.3 times, no clinical symptoms have been observed.
Maltese: Fil-każijiet irrappurtati ta' dożaġġ eċċessiv b'NovoThirteen sa 2.3 darbiet aktar, ma ġew osservati lebda sintomi kliniċi.
English: In this trial the mean volume of distribution at steady state was 47 ml/kg, mean residence time was 15.5 days and mean clearance was 0.13 ml/kg.
Maltese: F'dan l-istudju, ilmedja tal-volum tad-distribuzzjoni fl-istat stabbli kienet ta' 47 ml/kg, il-mean residence time kien ta' 15.5 jiem u l-mean clearance kienet ta' 0.13 ml/kg.
English: Congenital FXIII B-subunit deficiency
Maltese: Defiċjenza konġenitali ta' subunità-B ta' FXIII
English: • The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.
Maltese: • Is-sustanzi l-oħra huma għat-trab sodium chloride, sucrose u polysorbate 20, L-histidine, hydrochloric acid (għall-aġġustament fil-pH), sodium hydroxide (għall-aġġustament fil-pH) u għas-solvent ilma għall-injezzjonijiet.
English: NovoThirteen is a recombinant coagulation factor XIII A-subunit produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
Maltese: NovoThirteen hu subunità-A ta' fattur XIII ta' koagulazzjoni rikombinanti magħmul fiċ-ċelluli talħmira (Saccharomyces cerevisiae) permezz tat-teknoloġija rikombinanti tad-DNA.
English: The preparation should be administered as a slow bolus intravenous injection at a rate not higher than 2 ml/minute.
Maltese: Agħti l-preparazzjoni bħala injezzjoni bolus bil-mod ġol-vini b'rata mhux ogħla minn 2 ml/minuta.
English: Based on FXIII activity measured by the Berichrom assay in patients with congenital FXIII deficiency, a geometric mean half-life of 11.8 days was estimated.
Maltese: Skont l-attività ta' FXIII kif imkejla millanaliżi ta' Berichrom f'pazjenti b'defiċjenza konġenitali ta' FXIII, ġiet stmata half-life ġeometrika medja ta' 11.8 ġranet.
English: In the F13CD-1725 extension trial F13CD-3720, the age-adjusted rate of bleeds that required treatment with a FXIII-containing product was estimated to be 0.021 bleeds per subject year with a 95% CI of [0.0062; 0.073] (model-based estimate corresponding to a mean age of the trial population of 31.0 years).
Maltese: Fl-istudju F13CD-1725 u fl-istudju ta' estensjoni F13CD-3720, ir-rata aġġustata għall-età ta' tnixxija tad-demm li kienet teħtieġ kura bi prodott li kien fih FXIII kienet stmata li kienet ta' 0.021 ta' tnixxija tad-demm għal kull sena ta' suġġett b'95% CI ta' [0.
English: What is in this leaflet:
Maltese: Formazzjoni ta' inibitur:
English: Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.
Maltese: Iġbed b'attenzjoni eżattament 6 ml ta' sodium chloride 0.9%, soluzzjoni għall-injezzjoni fis-siringa ta' 10 ml.
English: NovoThirteen 2500 IU powder for injection catridecacog
Maltese: trab għall-injezzjoni catridecacog
English: Children above 6 years were investigated through the pivotal phase 3 trial (F13CD-1725) and the extension study (F13CD-3720) assessing the safety of monthly replacement therapy with NovoThirteen.
Maltese: Tfal 'il fuq minn 6 snin ġew investigati permezz tal-prova prinċipali ta' Fażi 3 (F13CD-1725) u listudju ta' estensjoni (F13CD-3720) li qed jevalwa s-sigurtà tat-terapija ta' sostituzzjoni ta' kull xahar b'NovoThirteen.
English: • Embolic and thrombotic events including the increased risk of vessel occlusion in patients at risk of thrombosis
Maltese: • Avvenimenti emboliċi u tromboemboliċi inkluż ir-riskju ta' okklużjoni ta' xi komponent tas sistema ċirkolatorja f'pazjenti f'riskju ta' trombożi
English: The crude bleeding rates in the two trials, F13CD-1725 and F13CD-3720, not adjusted for age, were 0.138 and 0.043 respectively, corresponding to a total of 13 bleeds over 223 subject-years and a pooled rate of 0.058.
Maltese: Ir-rati ta' tnixxija tad-demm mingħajr arranġamenti fiż-żewġ studji, F13CD-1725 u F13CD-3720, mhux aġġustati għall-età, kienu ta' 0.138 u 0.043 rispettivament, li tikkorrispondi għal total ta' 13-ittnixxija ta' demm fuq ammont ta' 223 suġġett għal kull sena ta' studju u rata kollettiva ta' 0.058.
English: In clinical studies, adverse reactions were more frequently reported in patients aged from 6 to less than 18 years old than in adults.
Maltese: F'studji kliniċi, ir-reazzjonijiet avversi ġew irrapportati b'mod iżjed frekwenti f'pazjenti b'etajiet minn 6 snin sa inqas minn 18 sena milli fl-adulti.
English: Monitoring NovoThirteen activity levels using a standard FXIII activity assay is recommended.
Maltese: Huwa rrakkomandat li l-livelli tal-attività ta' NovoThirteen jiġu ċċekkjati permezz ta' analiżi standard tal-attività FXIII.
English: There is limited information on overdose with NovoThirteen.
Maltese: Hemm informazzjoni limitata dwar dożaġġ eċċessiv b'NovoThirteen.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: The dosing scheme used was 35 IU/kg/month (every 28 days ± 2 days).
Maltese: L-iskeda ta' dożaġġ li ntużat kienet ta' 35 UI/kg/xahar (kull 28 jum ± 2 ijiem).
English: What NovoThirteen is
Maltese: Tużax NovoThirteen
English: There is limited clinical experience in administering NovoThirteen to elderly patients with congenital FXIII deficiency.
Maltese: Hemm esperjenza klinika limitata dwar l-għoti ta' NovoThirteen f'pazjenti anzjani b'defiċjenza konġenitali ta' FXIII.
English: Other medicines and NovoThirteen
Maltese: Mediċini oħra u NovoThirteen
English: Frequency descriptions of all adverse reactions identified from 82 patients with congenital FXIII deficiency exposed in clinical trials are presented in the below table by system organ class.
Maltese: Id-deskrizzjonijiet tal-frekwenza tar-reazzjonijiet avversi identifikati minn 82 pazjent b'defiċjenza konġenitali ta' XIII esposti fil-provi kliniċi qed jiġu ppreżentati fit-tabella hawn taħt skont il-klassi tas-sistema tal-organi.
English: When the FXIII Asubunit is bound to the FXIII B-subunit [A2B2], the half-life of the FXIII A-subunit [A2] is prolonged.
Maltese: [A2B2], il-half-life tas-subunità A ta' FXIII [A2] titwal.
English: The 6 patients below 6 years were investigated through a single dose pharmacokinetic phase 3b trial (F13CD-3760) and then, included in the long-term follow-up trial (F13CD-3835) assessing the safety and the efficacy of monthly replacement therapy with NovoThirteen.
Maltese: Is-6 pazjenti taħt is-6 snin ġew investigati permezz ta' prova farmakokinetika b'doża waħda ta' fażi 3b (F13CD-3760) u mbagħad, inklużi fil-prova sussegwenti li saret fit-tul (F13CD-3835) u li evalwat issigurtà u l-effikaċja tat-terapija ta' sostituzzjoni ta' kull xahar b'NovoThirteen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2500 IU
Maltese: IL-KONTENUT SKONT IL-PIŻ, VOLUM, JEW UNITÀ 2500
English: Twenty-one children between the age of 6 to less than 18 years old and six children less than 6 years old have been treated with NovoThirteen for a total of 986 exposures.
Maltese: Wieħed u għoxrin tifel u tifla bejn l-età ta' 6 snin sa inqas minn 18-il sena u sitt itfal inqas minn 6 snin ġew ikkurati b'NovoThirteen għal total ta' 986 espożizzjoni.
English: Powder and solvent for solution for injection 2500 IU powder in a vial, 3.2 ml solvent in a vial, 1 vial adapter
Maltese: 1 kunjett bi 3.2 ml ta' solvent, 1 adapter tal-kunjett għar-rikostituzzjoni
English: In the primary endpoint analysis covering the referred period, the age-adjusted rate (number per subject year) of treatment-requiring bleeds during the rFXIII treatment period was 0.048/year (95% CI: 0.009 - 0.250; model-based estimate corresponding to the mean age of 26.4 years for the 41 patients).
Maltese: 048/sena (95% CI: 0.009 - 0.250; stima bbażata fuq mudell li tikkorrispondi maletà medja ta' 26.4 snin tal-41 pazjent).
English: NovoThirteen has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.
Maltese: Ġie muri li NovoThirteen għandu l-istess propjetajiet farmakodinamiċi fil-plażma bħal FXIII endoġenu.
English: The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:
Maltese: Il-volum tad-doża għan-NovoThirteen rikostitwit li ġie dilwit b'6 ml sodium chloride 0.9%, soluzzjoni għall-injezzjoni jista' jiġi kkalkulat permezz ta' din il-formula:
English: Although expressed in the same unit (IU), the posology of NovoThirteen is different from the dosing schedule of the other FXIII containing products (see section 4.4).
Maltese: Għalkemm murija bl-istess mod ta' unitajiet (UI), il-pożoloġija ta' NovoThirteen hija differenti milliskeda ta' dożaġġ ta' prodotti oħra li fihom FXIII (ara sezzjoni 4.4).
English: FXIII B-subunit deficiency is associated with a much reduced half-life of the administered pharmacologically active A-subunit.
Maltese: Defiċjenza ta' subunità B ta' FXIII hi assoċjata ma' half-life mnaqqsa ħafna tas-subunità A li qiegħda tingħata u li hija farmakoloġikament attiva.
English: Dose volume in millilitres = 0.042 x your body weight in kilograms.
Maltese: Volum tad-doża f'millilitri = 0.042 x il-piż tal-ġisem tiegħek f'kilogrammi.
English: For more information see section ‘NovoThirteen user instructions - Instructions of how to dilute the reconstituted NovoThirteen'.
Maltese: Għal aktar informazzjoni ara s-sezzjoni ‘Istruzzjonijiet għal min qed juża NovoThirteen -Istruzzjonijiet dwar kif għandha ssir d-dilwizzjoni ta' NovoThirteen rikostitwit'.
English: The medicinal product contains less than 1 mmol sodium (23 mg) per injection, indicating that it is essentially ‘sodium free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) għal kull injezzjoni ,li juri li huwa prattikament ‘mingħajr sodium'.
English: No dose adjustment is required when NovoThirteen is used in paediatric patients and the dose of 35 IU/kg body weight should be used (see section 5.2 ‘Paediatric population').
Maltese: M'hemmx bżonn ta' aġġustament fid-doża meta NovoThirteen jintuża f'pazjenti pedjatriċi u għandha tintuża d-doża ta' 35 UI/kg ta' piż tal-ġisem (ara sezzjoni 5.2 ‘Popolazzjoni pedjatrika').
English: Based on the non-clinical study (see section 5.3) it is not recommended to combine NovoThirteen and recombinant activated FVII (rFVIIa).
Maltese: Skont l-istudju mhux kliniku (ara sezzjoni 5.3), mhuwiex rakkomandat li tikkombina NovoThirteen u FVII attivat irrikombinat (rFVIIa).
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: The four events of non-neutralising antibodies occurred in patients below the age of 18 (age 8, 8, 14 and 16).
Maltese: L-erba' avvenimenti ta' antikorpi li ma jinnewtralizzawx seħħew f'pazjenti li għandhom inqas min-18-il sena (etajiet ta' 8,8,14 u 16).
English: • The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
Maltese: • Is-sustanza attiva hi catridecacog (fattur XIII ta' koagulazzjoni rikombinanti: 2500
English: • The risks of off-label use within FXIII congenital deficiency
Maltese: • Ir-riskji ta' użu mhux skont it-tikketta fl-ambitu tad-defiċjenza konġenitali ta' FXIII
English: Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
Maltese: Neħħi l-karta protettiva mill-adapter tal-kunjett mingħajr ma toħroġ l-adapter tal-kunjett minn ġolgħatu protettiv.
English: NovoThirteen can be used for all age groups.
Maltese: NovoThirteen jista' jintuża f'kull grupp ta' età.
English: Side effects include:
Maltese: Effetti sekondarji fit tfal:
English: INFORMATION IN BRAILLE NovoThirteen
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Novo Nordisk A/S Hagedornsvej 1 DK-2820 Gentofte Denmark
Maltese: DK-2820 Gentofte Id-Danimarka
English: No effects on reproductive organs were noted in the repeated dose toxicity studies.
Maltese: Ma ġew osservati l-ebda effetti fuq l-organi riproduttivi fi studji dwar l-effett tossiku minn dożi ripetuti.