FrancophonIA/ELRC3.0 huggingface dataset:
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic medicinal products such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with medicinal products which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Maltese: prodotti mediċinali li jdgħajfu l-metaboliżmu tas-serotonin (inklużi l-Inibituri tal-Monoamine Oxidase [MAOIs]).
English: One dose of PecFent may include administration of 1 spray (100 microgram or 400 microgram doses) or 2 sprays (200 microgram or 800 microgram doses) of the same strength (either 100 microgram or 400 microgram strength).
Maltese: 400 mikrogramma) jew 2 sprejs (dożi ta' 200 mikrogramma jew 800 mikrogramma) tal-istess qawwa (jew qawwa ta' 100 mikrogramma jew qawwa ta' 400 mikrogramma).
English: Disposition of fentanyl following intranasal administration of PecFent has not been characterised in a mass balance study.
Maltese: Id-dispożizzjoni ta' fentanyl wara l-għoti intranażali ta' PecFent ma kinitx ikkaratterizzati fi studju dwar il-bilanċ tal-piż.
English: Fentanyl diffuses from the gel and is absorbed through the nasal mucosa; this gel-modulated absorption of fentanyl restrains the peak in plasma concentration (Cmax) whilst allowing the attainment of an early time to that peak (Tmax).
Maltese: Fentanyl jiġi diffuż mill-ġel u jiġi assorbit minn ġol-mukuża nażali; dan l-assorbiment ta' fentanyl immodulat mill-ġel, irażżan il-livell massimu ta' konċentrazzjoni fil-plażma (Cmax),
English: Insomnia Drug dependence (addiction) Drug abuse
Maltese: Dipendenza fuq id-drogi (vizzju)
English: Hyperhydrosis Urticaria
Maltese: Waqfien respiratorju
English: These include: o medicines for HIV infection (such as ritonavir, nelfinavir, amprenavir or fosamprenavir) o medicines for fungal infections (such as ketoconazole, itraconazole or fluconazole) o medicines for bacterial infections (such as troleandomycin, clarithromycin or erythromycin) o ‘aprepitant' - used to stop you feeling sick o ‘diltiazem' and ‘verapamil' - used for high blood pressure or heart problems.
Maltese: o mediċini għal infezzjonijiet fungali (bħal ketoconazole, itraconazole jew fluconazole) o mediċini għal infezzjonijiet batterjali (bħal troleandomycin, clarithromycin jew erythromycin)
English: The concomitant use of other central nervous system depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Maltese: L-użu fl-istess ħin ta' mediċini li jnaqqsu l-attività tas-sistema nervuża ċentrali, li jinkludu opjojdi oħrajn, sedattivi jew mediċini ipnotiċi, anestetiċi ġenerali, phenothiazines, trankwillanti, rilassanti talmuskoli skeletriċi, antistamini sedattivi u alkoħol jistgħu jipproduċu effetti addizzjonali li jnaqqsu l attività.
English: Anosmia
Maltese: Parosmija
English: When you see the number “8” in the counting window, there is still medicine in the bottle that you must empty.
Maltese: Meta tara n-numru “8” fil-counting window, xorta jkun għad fadal il-mediċina ġol-flixkun li inti trid tbattal.
English: • If you are an athlete, using PecFent may result in positive doping-tests.
Maltese: • Jekk inti atleta, l-użu ta' PecFent jista' jirriżulta f'testijiet tad-doping li jkollhom riżultat pożittiv.
English: Memory impairment Parosmia
Maltese: Burdata ewforika
English: It is subject to first pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Maltese: Hu suġġett għal metaboliżmu first pass fil-fwied u intestinali u lmetaboliti ma jikkontribwixxux għall-effett terapewtiċi ta' fentanyl.
English: Nasal spray, solution (nasal spray).
Maltese: sprej jew 2 sprejs (wieħed f'kull minfes).
English: The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated; however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Maltese: L-influwenza ta' indeboliment tal-fwied u tal-kliewi fuq il-farmakokinetika tal-prodott mediċinali ma kinitx evalwata; madankollu, meta li jingħata minn ġol-vina, intwera li t-tneħħija ta'
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Maltese: L-użu fl-istess ħin ta' mediċini li jnaqqsu l-attività tas-sistema nervuża ċentrali jista' jżid ir-riskju ta' tnaqqis respiratorju (ara sezzjoni 4.5).
English: Wipe the nozzle with a tissue and flush the tissue down the toilet.
Maltese: Imsaħ in-nozzle b'tissue u ifflaxxja t-tissue fit-tojlit.
English: A pharmacokinetic study was conducted to evaluate the absorption and tolerability of a single dose of PecFent in patients with pollen-induced seasonal allergic rhinitis, comparing the un-challenged, acutely challenged (rhinitic) and acutely challenged and then treated with oxymetazoline, states.
Maltese: Twettaq studju farmakokinetiku biex jevalwa l-assorbiment u t-tollerabilità ta' doża waħda ta' PecFent f'pazjenti li kellhom rinite allerġika staġjonali kkaġunata mill-polline, meta tqabblu l-istati unchallenged, l-istat challenged b'mod akut (riniktiku) u mbagħad ikkurat b'oxymetazoline.
English: • vaginal bleeding
Maltese: • infezzjoni fis-sider
English: There was no clinically significant effect of acute rhinitis on Cmax, Tmax or overall exposure to fentanyl, comparing the unchallenged with the acutely challenged states.
Maltese: Ma kien hemm kien l-ebda effett klinikament sinifikanti ta' rinite akuta fuq is-Cmax, it-Tmax jew lespożizzjoni totali għal fentanyl, meta tqabblu l-istati unchallenged mal-istati challenged b'mod akut.
English: The efficacy of a given dose should be assessed over the ensuing 30 minute period.
Maltese: L-effikaċja ta' doża mogħtija għandha tiġi evalwata fuq il-perjodu ta' 30 minuta ta' wara.
English: Arthralgia Muscle twitching
Maltese: .8 Effetti mhux mixtieqa
English: PecFent excipients
Maltese: TA' EĊĊIPJENTI
English: The variability of the pharmacokinetics of fentanyl was considerable following treatment with both PecFent and OTFC.
Maltese: Il-varjabilità tal-farmakokinetika ta' fentanyl kienet konsiderevoli wara lkura kemm b'PecFent kif ukoll b'OTFC.
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Maltese: Fentanyl hu lipofiliku ħafna u hu ddistribwit tajjeb lil hemm mis-sistema vaskulari, b'volum apparenti kbir ta' distribuzzjoni.
English: When you see the number “2” in the counting window, there is still medicine in the bottle that you must empty.
Maltese: Meta tara n-numru “2” fil-counting window, xorta jkun għad fadal il-mediċina ġol-flixkun li inti trid tbattal.
English: PecFent should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Maltese: PecFent għandu jingħata b'kawtela lil pazjenti b'indeboliment moderat jew sever tal-fwied jew tal kliewi (ara sezzjoni 4.4).
English: • PecFent nasal spray is only indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain
Maltese: PecFent hu indikat għall-immaniġġjar ta' wġigħ temporanju li jseħħ għal għarrieda (breakthrough pain - BTP) f'persuni adulti li diġà qed jirċievu terapija ta' manteniment bl-opjojdi għal uġigħ kroniku tal-kanċer.
English: Cyanosis
Maltese: MEDIĊINALI
English: Fertility There are no clinical data on the effects of fentanyl on fertility.
Maltese: M'hemm l-ebda dejta klinika dwar l-effett ta' fentanyl fuq il-fertilità.
English: • Patients should be prescribed an initial titration supply of one bottle (2 sprays or 8 sprays) of PecFent 100 micrograms/spray.
Maltese: • Il-pazjenti għandhom jingħataw riċetta ta' provvista ta' titrazzjoni inizjali ta' titrazzjoni provvista ta' flixkun wieħed (2 sprejs jew 8 sprejs) ta' PecFent 100 mikrogramma/sprej.
English: Bottle (clear Type I glass) with an attached metering pump incorporating an audible dose counter and a protective cap (solid white cap for the 2 spray and translucent cap for the 8 spray).
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Flixkun (ħġieġ ċar ta' Tip I) mgħammar b'metering pump li tinkorpora dose counter li jinstema' u għatu protettiv (għatu abjad solidu għaż-2 sprejs u għatu transluċidu għat-8 sprejs).
English: Therefore it is not possible to definitively separate the effects of PecFent alone.
Maltese: Għalhekk mhuwiex possibbli li wieħed jifred b'mod definittiv l-effetti ta' PecFent waħdu.
English: Initial dose
Maltese: Figura 1
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signficant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Sneezing
Maltese: Dispnea
English: • feeling dizzy
Maltese: • diffikultà biex titkellem
English: • feeling sleepy, headache
Maltese: • mejt, taqa', telqa
English: Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority.
Maltese: Qabel it-tnedija tal-prodott f'kull Stat Membru, id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq għandu jaqbel dwar il-materjal edukattiv mal-Awtorità Kompetenti nazzjonali.
English: This may occur within the recommended dose (see section 4.5).
Maltese: Dan jista' jseħħ fi ħdan id-doża rakkomandata (ara sezzjoni 4.5).
English: Due to physico-chemical properties of excipients included in the formulation, intravenous or intra-arterial injection must be avoided in particular.
Maltese: Minħabba lproprjetajiet fiżiko-kimiċi ta' eċċipjenti inklużi fil-formulazzjoni, injezzjoni ġol-vini jew intra-arterjali trid tiġi evitata b'mod partikulari.
English: • Drug dependence (addiction)
Maltese: • Dipendenza fuq id-drogi (vizzju)
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Maltese: Jekk isseħħ, għandha tiġi mmaniġġjata bl-użu ta' ventilazzjoni assistita, minn antagonist tal-opjojdi, u bħala alternattiva finali, minn sustanza ta' mblukkar newromuskolari.
English: Retching
Maltese: Rinite
English: Pneumonia Nasopharyngitis Pharyngitis Rhinitis
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Each spray contains 400 micrograms of fentanyl (as citrate)
Maltese: Kull ml ta' soluzzjoni fih 4,000 mikrogramma ta' fentanyl (bħala citrate)
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Evaluation of brain slides from the carciogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Maltese: Xi bidliet li jistgħu jiġu osservati jinkludu żieda tal-prolactin fis-serum, u tnaqqis ta' cortisol u testosterone fil plażma.
English: Lethargy
Maltese: Plaċebo
English: • nasal sprays to treat a stuffy nose (containing a decongestant such as oxymetazoline)
Maltese: • tibdil fiċ-ċelluli tad-demm (osservat mit-testijiet tal-laboratorju)
English: Abdominal pain Tongue disorder Mouth ulceration Dyspepsia
Maltese: mediċini għall-ansjetà jew mediċini għall-allerġiji (anti-istamini)
English: How to store PecFent
Maltese: X'fih PecFent
English: • you experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Maltese: • ikollok taħlita tas-sintomi li ġejjin: dardir, rimettar, anoressija, għeja, dgħufija, sturdament u pressjoni tad-demm baxxa.
English: Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones
Maltese: Din hi kundizzjoni li fiha lglandoli adrenali ma jipproduċux biżżejjed ormoni
English: • medicines that might make you sleepy such as sleeping tablets, tranquilisers, muscle relaxants, medicines for anxiety or medicines for allergies (anti-histamines)
Maltese: • mediċini li jistgħu jraqqduk, bħal pilloli tal-irqad, kalmanti, mediċini li jirilassaw il-muskoli,
English: Phenylethyl alcohol
Maltese: GĦAMLA FARMAĊEWTIKA
English: Don't use any other kind of nasal spray for at least 15 minutes after using PecFent.
Maltese: M'għandek tuża l-ebda tip ieħor ta' sprej nażali għal mill-inqas 15-il minuta wara li tuża PecFent.
English: AUC (hr*IU/ml) 22.3 (8.4 - 38.1) 21.2 (8.4 - 32.6) 23.3 (17.4 - 35.5) 33.5 (28.9 - 38.1) T1/2 (hr)
Maltese: AUC (hr*IU/ml) 22,3 (8,4 - 38,1) 21,2 (8,4 - 32,6) 23,3 (17,4 - 35,5) 33,5 (28,9 - 38,1)
English: See section 2, “Vihuma contains sodium”.
Maltese: Ara sezzjoni 2, "Vihuma fih sodium".
English: EU/1/16/1168/001 EU/1/16/1168/002 EU/1/16/1168/003 EU/1/16/1168/004 EU/1/16/1168/005 EU/1/16/1168/006 EU/1/16/1168/007
Maltese: EU/1/16/1168/001 EU/1/16/1168/002 EU/1/16/1168/003 EU/1/16/1168/004
English: Vihuma contains sodium
Maltese: Vihuma fih sodium
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Maltese: Thrombin imbagħad jikkonverti fibrinogen għal fibrin u jista' jifforma embolu.
English: Normal weight: BMI 18.5-25 kg/m2, Pre-adipose: BMI 25-30 kg/m2, Adipose: BMI > 30 kg/m2, SD = Standard deviation
Maltese: Piż Normali: BMI 18.5-25 kg/m2, Pre-adipose:
English: Octapharma AB Lars Forssells gata 23 112 75 Stockholm Sweden
Maltese: Octapharma AB Lars Forssells gata 23 112 75
English: A prospective open-label clinical study in PUPs with severe haemophilia A (<1% FVIII:C) is ongoing.
Maltese: Għadu għaddej studju kliniku open-label prospettiv f'PUPs b'emofilja A severa (<1% FVIII:C).
English: The immunogenicity of Vihuma was evaluated in clinical trials in 190 previously treated patients with severe haemophilia A (129 adult and 61 paediatric patients).
Maltese: L-immunoġeniċità ta' Vihuma kienet evalwata fi provi kliniċi f'190 pazjent b'emofilja A severa li kienu trattati qabel (129 adult u 61 pazjent pedjatriku).
English: Table 1 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: Tabella 1 preżentata hawn isfel hi skont is-sistema tal-klassifika tal-organi MedDRA (SOC u l-Livell ta' Terminu Preferut).
English: Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188
Maltese: Eċċipjenti: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188
English: Expected factor VIII rise (% of normal) = 2 x administered IU body weight (kg)
Maltese: Żieda ta' fattur VIII mistennija (% tan-normal) = 2 x IU amministrata piż tal-ġisem (kg)
English: Vihuma is produced by recombinant DNA technology in genetically modified human embryonic kidney (HEK) 293F cells.
Maltese: Vihuma hu prodott bit-teknoloġija rikombinanti tad-DNA f'ċelluli embrijoniċi tal-kliewi 293F (human embryonic cells, HEK) umani modifikati ġenetikament.
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life, IVR = Incremental in vivo recovery, CL = Clearance, SD = Standard deviation
Maltese: Erja taħt il-kurva (FVIII:C), T1/2 = Half-life terminali, IVR = (Incremental in vivo recovery) Irkupru inkrementali in vivo, CL = (Clearance) Tneħħija, SD = Devjazzjoni standard
English: Frequencies have been evaluated 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
Maltese: Il-frekwenzi ġew evalwati skont il-konvenzjoni li ġejja: 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 tittieħed stima mid-dejta disponibbli).
English: Frequency of adverse drug reactions (ADRs) in clinical trials MedDRA Standard System
Maltese: Frekwenza ta' reazzjonijiet avversi għall- mediċina (ADRs) fi provi kliniċi
English: The mean ± SD annualised bleeding rate was 1.2 ± 3.9 and the mean ± SD dose were 52.2 ± 12.2 IU/kg per injection and 99.7 ± 25.6 IU/kg per week.
Maltese: Ir-rata ta' emorraġija fis-sena medja ± SD kienet ta' 1.2 ± 3.9 u d-doża medja ± SD kienet ta' 52.2 ± 12.2 IU/kg kull injezzjoni u 99.7 ± 25.6
English: Adult and adolescent population 12 - 65 years of age
Maltese: Popolazzjoni ta' adulti u adolexxenti f'età ta' 12-65 sena Profilassi:
English: Inject the solution into the vein at a slow speed, not faster than 4 ml per minute.
Maltese: Injetta s-soluzzjoni ġol-vina b'veloċità baxxa, mhux aktar minn 4 ml kull minuta.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 (IU/kg per IU/dl)
Maltese: Unitajiet meħtieġa = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur VIII (%) (IU/dl) x 0.5
English: During clinical studies with Vihuma in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 129) with severe haemophilia A, a total of 12 adverse drug reactions (ADRs) (8 in adults, 4 in children) were reported in 8 patients (4 adults, 4 children).
Maltese: (2 sa 11-il sena, n=58) u adulti (n=74) trattati qabel b'emofilja A severa, total ta' 12-il reazzjoni avversa għall-mediċina (adverse drug reactions, ADRs) (8 f'adulti, 4 fit-tfal) kienu rapportati fi 8 pazjenti (4 adulti, 4 itfal).
English: Chromogenic assay
Maltese: Assaġġ kromoġeniku
English: The median consumption of Vihuma for prophylaxis per month was 521.9 IU/kg.
Maltese: Il-konsum medjan ta' Vihuma għal profilassi kull xahar kien ta' 521.9 IU/kg.
English: Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, L-Iżvezja
English: Excipient(s) with known effect 7.35 mg sodium per ml reconstituted solution (18.4 mg sodium per vial).
Maltese: 7.35 mg sodium kull ml ta' soluzzjoni rikostitwita (18.4 mg sodium f'kull kunjett).
English: Severe symptoms require prompt emergency treatment.
Maltese: Sintomi severi għandhom mnejn ikunu jeħtieġu trattament ta' emerġenza.
English: The amino acid sequence is comparable to the 90 + 80 kDa form of human plasma factor VIII (i.e. B-domain deleted).
Maltese: Is-sekwenza ta' aċidi amminiċi hi komparabbli mal-għamla 90 + 80 kDa tal-fattur VIII fil-plażma umana (i.e.
English: Chromogenic assay Mean ± SD
Maltese: Assaġġ kromoġeniku Medja ± SD
English: Currently available data are described in sections 4.8, 5.1 and 5.2.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8. 5.1 u 5
English: Uncommon* Uncommon (PTPs) # Very common (PUPs)#
Maltese: Mhux komuni* Mhux komuni (PTPs)#
English: Chromogenic assay Median (range)
Maltese: Assaġġ kromoġeniku Medjan (medda)
English: Simoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1440 amino acids.
Maltese: Simoctocog alfa (fattur VIII ta' koagulazzjoni (rDNA) uman huwa proteina purifikata umana li għandha 1440 aċidu amminiku.
English: INFORMATION IN BRAILLE Vihuma 2000
Maltese: INFORMAZZJONI BIL-BRAILLE Vihuma 2000
English: How to store Vihuma
Maltese: Tużax Vihuma
English: A higher median dose of Vihuma was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg).
Maltese: Doża medjana ogħla ta' Vihuma kienet meħtieġa sabiex jiġu trattati emorraġiji fi tfal (43.9 IU/kg) milli f'adulti (33.0 IU/kg), u doża medjana ogħla kienet meħtieġa sabiex jiġu trattati emorraġiji moderati sa maġġuri milli dawk minuri (78.2 IU/kg kontra 41.7 IU/kg).
English: Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Vihuma for prophylaxis was 468.7 IU/kg/month.
Maltese: Fi studju kliniku fi 32 pazjent adult b'emofilja A severa, il-konsum medjan ta' Vihuma għal profilassi kienet ta' 468.7 IU/kg/xahar.
English: - The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
Maltese: - Is-sustanzi l-oħra huma sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
English: In another clinical study, 22 adult patients were treated on demand.
Maltese: Fi studju kliniku ieħor, 22 pazjent adult kienu ttrattati fuq talba.
English: In total 986 bleeding episodes were treated with a median dose of 30.9 IU/kg.
Maltese: B'kollox 986 każ ta' emorraġija ġew ttrattati b'doża medjana ta' 30.9 IU/kg.
English: Younger children in general required higher median doses (6-12 years: 43.9 IU/kg; 2-5 years: 52.6 IU/kg).
Maltese: Tfal iżgħar b'mod ġenerali kienu jeħtieġu dożi medjani ogħla (6-12-il sena: 43.9 IU/kg; 2-5 snin: 52.6
English: These measures will help protect the environment.
Maltese: IU/mg ta' proteina.
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Maltese: F'pazjenti b'fatturi ta' riskju kardjovaskulari eżistenti, it-terapija ta' sostituzzjoni b'FVIII tista' żżid ir riskju kardjovaskulari.
English: Vihuma contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Maltese: Vihuma fih is-sustanza attiva fattur VIII ta' koagulazzjoni rikombinanti umana (simoctocog alfa).
English: This medicine contains less than 1 mmol sodium (23 mg) per vial.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) kull kunjett.
English: Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor VIII, ATC code: B02BD02.
Maltese: Mediċini kontra l-emorraġiji: fattur VIII ta' koagulazzjoni tad-demm, Kodiċi ATC:
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjonijiet tal-prodott mediċinali.
English: Each pack contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa in a type 1
Maltese: Kull pakkett ta' Vihuma fih: - Kunjett 1 ta' trab b'250, 500, 1000, 2000, 2500, 3000 jew 4000 IU simoctocog alfa
English: It is recommended that not more than 4 ml per minute be administered.
Maltese: Huwa rakkomandat li ma jingħatax aktar minn 4 ml kull minuta.
English: Paraesthesia Headache Dizziness
Maltese: Reazzjonijiet allerġiċi
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to Vihuma.
Maltese: Hemm probabilità rari li tista' tesperjenza reazzjoni anafilattika (reazzjoni allerġika, severa, li tiġi f'daqqa) għal Vihuma.
English: The median dose per prophylactic infusion was 37.8 IU/kg.
Maltese: Id-doża medjana għal kull infużjoni profilattika kienet ta' 37.8 IU/kg.