FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance, benzodiazepines or to any of the excipients listed in section Myasthenia gravis
Maltese: Sensittività eċċessiva għas-sustanza attiva, benzodiazepines jew għal kwalunkwe wieћed milleċċipjenti elenkati fis-sezzjoni 6.1
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 7.5 mg /1.5 ml
Maltese: Tikketta tat-Tubu tal-Plastik ta' 7.5 mg/1.5 ml
English: Published clinical studies show that oromucosal midazolam was administered to approx 443 children with seizures.
Maltese: Studji kliniċi ppubblikati juru li midazolam mogħti mill-mukuża tal-ħalq ingħata lil madwar 443 tifel u tifla li kellhom aċċessjonijiet.
English: 5 years to < 10 years
Maltese: 5 snin sa < 10 snin
English: The elimination half-life in cirrhotic patients may be longer and the clearance lower as compared to those in healthy volunteers (see section 4.4).
Maltese: Il-half-life tal-eliminazzjoni f'pazjenti ċirrotiċi tista' tkun itwal u t-tneħħija tkun iktar baxxa meta mqabbla ma' dawk f'voluntiera b'saħħithom (ara sezzjoni 4.4).
English: • A disease of the nerves and muscles causing muscle weakness (myasthenia gravis)
Maltese: • Marda tan-nervaturi u tal-muskoli li tikkawża dgħufija fil-muskoli (myasthenia gravis)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 2.5 mg /0.5 ml
Maltese: Tikketta tat-Tubu tal-Plastik ta' 2.5 mg/0.5 ml
English: In a population pharmacokinetic study, the metabolite levels are shown to be higher in younger than older paediatric patients and thus likely to be of more importance in children than in adults.
Maltese: Fi studju farmakokinetiku dwar il-popolazzjoni, intwera li l-livelli tal-metaboliti kienu ogħla f'pazjenti pedjatriċi iżgħar milli minn dawk akbar, u għaldaqstant x'aktarx li jkunu ta' importanza akbar fit-tfal milli f'persuni adulti.
English: Respiratory depression occurs at a rate of up to 5%, although this is a known complication of convulsive seizures as well as being related to midazolam use.
Maltese: Tnaqqis respiratorju jseħħ f'rata ta' sa 5%, għalkemm din hi kumplikazzjoni magħrufa ta' aċċessjonijiet konvulżivi kif ukoll li hi marbuta mal-użu ta' midazolam.
English: Alcohol (including alcohol-containing medicinal products may markedly enhance the sedative effect of midazolam.
Maltese: L-alkoħol (li jinkludi prodotti mediċinali li fihom l-alkoħol) jista' jżid b'mod notevoli l-effett sedattiv ta' midazolam.
English: BUCCOLAM contains a medicine called midazolam.
Maltese: BUCCOLAM fih mediċina msejħa midazolam.
English: An increased risk for falls and fractures has been recorded in elderly benzodiazepine users.
Maltese: Żieda fir-riskju ta' waqgħat u ksur ġiet osservata f'utenti anzjani ta' benzodiazepine.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 10 mg /2 ml
Maltese: Tikketta tat-Tubu tal-Plastik ta' 10 mg/2 ml
English: The other ingredients are sodium chloride, water for injections, hydrochloric acid and sodium hydroxide (for pH adjustment).
Maltese: Is-sustanzi l-oħra huma sodium chloride, ilma għall-injezzjonijiet, hydrochloric acid u sodium hydroxide (għal aġġustament tal-pH).
English: Antiepileptics
Maltese: Mediċini antiepilettiċi
English: The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables midazolam to form the hydrochloride salt with acids.
Maltese: In-nitroġenu bażiku f'pożizzjoni 2 tas-sistema taċ-ċirku ta' imidazobenzodiazepine jippermetti lil midazolam biex jifforma l-hydrochloride salt mal-aċidi.
English: BUCCOLAM 10 mg oromucosal solution EU/1/11/709/004
Maltese: BUCCOLAM 10 mg soluzzjoni għall-mukuża tal-ħalq EU/1/11/709/004
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Plastic Tube Label 5 mg /1 ml
Maltese: Tikketta tat-Tubu tal-Plastik ta' 5 mg/1 ml
English: Maximum plasma concentration is reached within 30 minutes in children.
Maltese: Il-konċentrazzjoni massima filplażma tintlaħaq fi żmien 30 minuta fit-tfal.
English: • Difficulty co-ordinating muscles
Maltese: • Diffikultà biex tikkoordina l-muskoli
English: Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Maltese: Doża eċċessiva ta' benzodiazepines normalment tidher minn gradi ta' tnaqqis tas-sistema nervuża ċentrali li jvarjaw minn ngħas għal koma.
English: Less than 1% of the dose is recovered in urine as unchanged medicinal product..
Maltese: Inqas minn 1% tad-doza tiġi rkuprata flawrina bħala prodott mediċinali mhux mibdul.
English: BUCCOLAM 7.5 mg oromucosal solution midazolam
Maltese: BUCCOLAM 7.5 mg soluzzjoni għall-mukuża tal-ħalq midazolam
English: BUCCOLAM is used to stop a sudden, prolonged, convulsive, seizure in infants, toddlers, children and adolescents (from 3 months to less than 18 years of age).
Maltese: BUCCOLAM jintuża biex iwaqqaf aċcessjoni għal għarrieda, konvulżiva u fit-tul fi trabi, tfal żgħar, tfal u adolexxenti (minn 3 xhur sa inqas minn 18-il sena).
English: Children younger than 3 months: BUCCOLAM should not be given to children younger than 3 months since there is not enough information in this age group.
Maltese: BUCCOLAM m'għandux jingħata lil trabi li jkollhom inqas minn 3 xhur għax m'hemmx biżżejjed informazzjoni f'dan il-grupp ta' età.
English: • antihistamines (to treat allergies).
Maltese: • antistamini (għall-kura tal-allerġiji).
English: Co-administration with protease inhibitors (e.g. Saquinavir and other HIV protease inhibitors) may cause a large increase in the concentration of midazolam.
Maltese: L-għoti flimkien mal-inibituri tal-protease (eż: Saquinavir u inibituri oħra tal-protease tal-HIV) jista' jikkawża żieda kbira fil-konċentrazzjoni ta' midazolam.
English: BUCCOLAM 7.5 mg oromucosal solution EU/1/11/709/003
Maltese: BUCCOLAM 7.5 mg soluzzjoni għall-mukuża tal-ħalq EU/1/11/709/003
English: Midazolam has an anticonvulsant effect.
Maltese: Midazolam għandu effett kontra l-konvulżjonijiet.
English: The safety and efficacy of midazolam in children aged 0 to 3 months has not been established.
Maltese: Is-sigurtà u effikaċja ta' midazolam fi tfal minn età ta' 0 sa 3 xhur ma ġewx determinati s'issa.
English: BUCCOLAM 10 mg oromucosal solution midazolam
Maltese: BUCCOLAM 10 mg soluzzjoni għall-mukuża tal-ħalq midazolam
English: BATCH NUMBER
Maltese: Kulur tattikketta
English: The effects of BUCCOLAM may be reduced by medicines such as:
Maltese: L-effetti ta BUCCOLAM jistgħu jitnaqqsu minn mediċini bħal:
English: The effects of BUCCOLAM may be intensified by medicines such as:
Maltese: L-effetti ta' BUCCOLAM jista' jiġu intensifikati minn mediċini bħal:
English: 3 months to < 1 year Yellow
Maltese: 3 xhur sa <1 sena
English: BUCCOLAM 5 mg oromucosal solution EU/1/11/709/002
Maltese: BUCCOLAM 5 mg soluzzjoni għall-mukuża tal-ħalq EU/1/11/709/002
English: Additionally, in 2 of the studies, cessation of visible signs of seizures within 10 minutes without recurrence within 1 hour after administration was observed in 56% to 70% of children.
Maltese: Flimkien ma' dan, fi 2 mill-istudji, il-waqfien ta' sinjali viżibbli ta' aċċessjonijiet fi żmien 10 minuti mingħajr rikorrenza fi żmien siegħa wara l-għoti, ġie osservat f'56% sa 70% tat-tfal.
English: The administration of high doses of midazolam in the last trimester of pregnancy or during labour has been reported to produce maternal or foetal adverse reactions (risk of aspiration of fluids and stomach contents during labour in the mother, irregularities in the foetal heart rate, hypotonia, poor suckling, hypothermia and respiratory depression in the new-born infant).
Maltese: Ġie rrappurtat li l-għoti ta' dożi qawwija ta' midazolam fl-aħħar trimestru tat-tqala jew waqt il-ħlas jipproduċi reazzjonijiet avversi fl-omm jew fil-fetu (riskju ta' aspirazzjoni ta' fluwidi u l-kontenut talistonku waqt il-ħlas fl-omm, irregolaritajiet fit-taħbit tal-qalb tal-fetu, ipotonija, it-trabi jerdgħu b'mod batut, ipotermija u tnaqqis respiratorja fit-tarbija tat-twelid).
English: Medical history of alcohol or drug abuse
Maltese: Storja medika ta' abbuż tal-alkoħol jew tad-droga
English: Clarithromycin increased the plasma concentrations of intravenous midazolam by up to 2.5-fold associated with an increase in terminal half-life by 1.5 to 2-fold.
Maltese: Clarithromycin żied il-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġol-vini b'sa 2.5 darbiet assoċjati ma' żieda fil-half-life terminali b'1.5 darbiet sad-doppju.
English: Alcohol intake should be strongly avoided in case of midazolam administration (see section 4.4).
Maltese: Hu rakkomandat bil-qawwa li t-teħid tal-alkoħol għandu jiġi evitat f'każ ta' għoti ta' midazolam (ara sezzjoni 4.4).
English: Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
Maltese: Midazolam jista' jakkumula f'pazjenti b'insuffiċjenza kronika tal-kliewi jew indeboliment fil-funzjoni tal-fwied, filwaqt li f'pazjenti b'indeboliment filfunzjoni kardijaka jista' jikkawża tnaqqis fit-tneħħija ta' midazolam.
English: In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Maltese: F'każijiet ħfief, is-sintomi jinkludu ngħas, konfużjoni mentali u letarġija; f'każijiet iktar serji, is-sintomi jistgħu jinkludu atassija, ipotonija, pressjoni baxxa, tnaqqis respiratorju, b'mod rari koma u b'mod rari ħafna l-mewt.
English: The co-administration of midazolam with other sedative/hypnotic medicinal products and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression.
Maltese: L-għoti flimkien ta' midazolam ma' prodotti mediċinali sedattivi/ipnotiċi oħrajn u dawk li jnaqqsu lattività tas-CNS, li jinkludu l-alkoħol, x'aktarx li ser jirriżulta f'żieda fis-sedazzjoni u tnaqqis respiratorju.
English: Hepatic impairment reduces the clearance of midazolam with a subsequent increase in terminal halflife.
Maltese: Indeboliment tal-fwied inaqqas it-tneħħija ta' midazolam b'żieda sussegwenti fil-half-life terminali.
English: Atorvastatin showed a 1.4-fold increase in plasma concentrations of intravenous midazolam compared to control group.
Maltese: Atorvastatin wera żieda ta' 1.4 darbiet fil-konċentrazzjonijiet fil-plażma ta' midazolam meta mqabbel mal-grupp ta' kontroll.
English: Midazolam may cause inhibition of levodopa.
Maltese: Midazolam jista' jikkawża l-inibizzjoni ta' levodopa.
English: Midazolam is excreted in low quantities (0.6%) in human milk.
Maltese: Midazolam hu eliminat fi kwantitajiet baxxi (0.6%) fil-ħalib tas-sider tal-bniedem.
English: Metabolism of midazolam and other benzodiazepines is accelerated by xanthines.
Maltese: Il-metaboliżmu ta' midazolam u benzodiazepines oħrajn isir iktar mgħaġel b'xanthines.
English: Constipation**, dry mouth**
Maltese: Għeja kbira**, sulluzzu**
English: 4.5 Interaction with other medicinal products and other forms of interaction Midazolam is metabolized by CYP3A4.
Maltese: Midazolam jiġi metabolizzat minn CYP3A4.
English: Upon co-administration with ritonavirboosted lopinavir, the plasma concentrations of intravenous midazolam increased by 5.4-fold, associated with a similar increase in terminal half-life.
Maltese: Mal-għoti flimkien ma' lopinavir imsaħħaħ b'ritonavir, il-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġol-vini żdiedu b'5.4 darbiet, assoċjata ma' żieda simili fil-half-life terminali.
English: Pharmacokinetic interactions with CYP3A4 inhibitors or inducers are more pronounced for oral as compared to oromucosal or parenteral midazolam as CYP3A4 enzymes are also present in the upper gastro-intestinal tract.
Maltese: Inibituri u indutturi ta' CYP3A4 għandhom il-potenzjal li rispettivament iżidu jew inaqqsu l-konċentrazzjonijiet fil-plażma u sussegwentement, l-effetti ta' midazolam, u b'hekk ikunu meħtieġa aġġustamenti tad-doża skont il-bżonn.
English: NAME OF THE MEDICINAL PRODUCT BUCCOLAM 7.5 mg oromucosal solution midazolam
Maltese: TAL-PRODOTT MEDIĊINALI BUCCOLAM 7.5 mg soluzzjoni għall-mukuża tal-ħalq midazolam
English: BUCCOLAM is for oromucosal use.
Maltese: BUCCOLAM mhuwiex intenzjonat biex jintuża ġol-vini.
English: • Keep this leaflet.
Maltese: • Tnaqqis fl-attenzjoni
English: Various medicinal products
Maltese: Prodotti mediċinali varji
English: • Agitation, restlessness, hostility, rage or aggression, excitement, confusion, euphoria (an excessive feeling of happiness or excitement), or hallucinations (seeing and possibly hearing things that are not really there)
Maltese: • Aġitazzjoni, nuqqas ta' kwiet f'ġismek, ostilità, rabja kbira jew aggressjoni, eċċitament,
English: Management
Maltese: tikkontrolla)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Shire logo
Maltese: FIS-SUQ Logo ta' Shire
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - 2Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: - Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni; - 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: Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Siringa tal-ħalq ta' lewn safrani mimlija għal-lest (tal-polypropylene), bla labra, bi planġer (talpolypropylene) u għatu fit-tarf (tal-polyethylene ta' densità għolja) ippakkjata f'tubu tal-plastik protettiv b'għatu.
English: NAME OF THE MEDICINAL PRODUCT BUCCOLAM 5 mg oromucosal solution midazolam
Maltese: TAL-PRODOTT MEDIĊINALI BUCCOLAM 5 mg soluzzjoni għall-mukuża tal-ħalq midazolam
English: How to store BUCCOLAM
Maltese: Mediċini oħra u BUCCOLAM
English: Purple
Maltese: BUCCOLAM
English: The frequency of adverse reactions is classified as follows:
Maltese: Il-frekwenza tar-reazzjonijiet avversi hi kklassifikata kif ġej:
English: • Each 2.5 mg pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution.
Maltese: • Kull siringa tal-ħalq mimlija għal-lest ta' 2.5 mg fiha 2.5 mg ta' midazolam (bħala hydrochloride) f'soluzzjoni ta' 0.5 ml.
English: • Muscle spasms and muscle tremors (shaking of your muscles that you cannot control)
Maltese: • Spażmi tal-muskoli u rogħda fil-muskoli (rogħda fil-muskoli tiegħek li ma tkunx tista'
English: Each pre-filled oral syringe contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution BUCCOLAM 5 mg oromucosal solution
Maltese: Kull siringa tal-ħalq mimlija għal-lest (0.5 ml) fiha 2.5 mg ta' midazolam (bħala hydrochloride)
English: In a rat fertility study, animals dosed up to ten times the clinical dose, no adverse effects on fertility were observed.
Maltese: Fi studju dwar il-fertilità fil-firien, f'firien li ngħataw doża li kienet sa għaxar darbiet tad-doża klinika, ma kienu osservati l-ebda effetti avversi fuq il-fertilità.
English: • medicines used to treat blood pressure, e.g. diltiazem, verapamil
Maltese: • mediċini li jintużaw għall-kura tal-pressjoni tad-demm, eż. diltiazem, verapamil
English: BUCCOLAM 2.5 mg oromucosal solution midazolam
Maltese: BUCCOLAM 5 mg soluzzjoni għall-mukuża tal-ħalq midazolam
English: Animal studies do not indicate a teratogenic effect with respect to reproductive toxicity, but foetotoxicity has been observed in humans as with other benzodiazepines.
Maltese: Studji f'annimali ma jindikaw l-ebda effett teratoġeniku fuq is-sistema riproduttiva, iżda ġiet osservata fetotossiċità filbnedmin bħal fil-każ ta' benzodiazepines oħrajn.
English: BUCCOLAM 10 mg oromucosal solution For children aged 10 years to less than 18 years
Maltese: BUCCOLAM 10 mg soluzzjoni għall-mukuża tal-ħalq Għal tfal li għandhom minn 10 snin sa inqas minn 18-il sena
English: If the seizure has not stopped within 10 minutes after administration of midazolam, emergency medical assistance must be sought and the empty syringe given to the healthcare professional to provide information on the dose received by the patient.
Maltese: Jekk l-aċċessjoni ma tkunx waqfet fi żmien 10 minuti wara l-għoti ta' midazolam, għandha tintalab għajnuna medika urġenti, u s-siringa vojta tingħata lill-professjonist fil-qasam tal-kura tas-saħħa biex tipprovdi informazzjoni fuq id-doża li jkun irċieva l-pazjent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (1.5 ml) contains 7.5 mg midazolam (as hydrochloride)
Maltese: Kull siringa tal-ħalq mimlija għal-lest (1.5 ml) fiha 7.5 mg ta' midazolam (bħala hydrochloride)
English: • Each 7.5 mg pre-filled oral syringe contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution.
Maltese: • Kull siringa tal-ħalq mimlija għal-lest ta' 7.5 mg fiha 7.5 mg ta' midazolam (bħala hydrochloride) f'soluzzjoni ta' 1.5 ml
English: Midazolam is almost entirely eliminated by biotransformation.
Maltese: Midazolam hu lipofiliku ħafna u jinfirex b'mod estensiv.
English: Fentanyl may reduce midazolam clearance.
Maltese: Nawseja u rimettar Rari ħafna:
English: Keep the oral syringe in the protective plastic tube.
Maltese: Żomm is-siringa tal-ħalq fit-tubu protettiv tal-plastik.
English: In infants from 3 months to less than 6 months it should only be used in a hospital setting where monitoring is possible and resuscitation equipment is available.
Maltese: Trabi li jkollhom minm 3 xhur sa inqas minn 6 xhur għandhom jiġu kkurati biss fi sptar fejn ilmonitoraġġ ikun possibbli u tagħmir ta' risuxxitazzjoni jkun disponibbli.
English: Uncommon side effects (may affect up to 1 in 100 people): • Rash, hives (lumpy rash), itchiness
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna):
English: • some medicines used to treat HIV and AIDS, e.g. saquinavir, lopinavir/ritonavir combination
Maltese: • xi mediċini li jintużaw għall-kura tal-HIV u AIDS, eż. saquinavir, kumbinazzjoni ta'
English: Midazolam may cause potentiation of muscle relaxants, with increased CNS depressant effects.
Maltese: Midazolam jista' jikkawża żieda fil-qawwa ta' rilassanti tal-muskoli, b'żieda fl-effetti tat-tnaqqis tal-attività tas-CNS.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled, oral syringe (2 ml) contains 10 mg midazolam (as hydrochloride)
Maltese: Kull siringa tal-ħalq mimlija għal-lest (2 ml) fiha 10 mg ta' midazolam (bħala hydrochloride)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Plastic oral syringe 2.5 mg/0.5 ml
Maltese: Ż-ŻGĦAR EWLENIN Siringa tal-ħalq tal-plastik ta' 2.5 mg/0.5 ml
English: Uncommon: Pruritus, rash and urticarial
Maltese: Mhux komuni: Ħakk, raxx u urtikarja
English: • Each 10 mg pre-filled oral syringe contains 10 mg midazolam (as hydrochloride) in 2 ml solution.
Maltese: • Kull siringa tal-ħalq mimlija għal-lest ta' 10 mg fiha 10 mg ta' midazolam (bħala hydrochloride) f'soluzzjoni ta' 2 ml
English: Therefore, the clinical effects may be stronger and prolonged, hence careful monitoring of the clinical effects and vital signs is recommended following administration of midazolam in patients with hepatic impairment (see section 4.4).
Maltese: Għalhekk, l-effetti kliniċi jistgħu jkunu iktar qawwija u fit-tul, u għaldaqstant hu rakkomandat li jsir monitoraġġ b'attenzjoni tal-effetti kliniċi u tas-sinjali vitali wara l-għoti ta' midazolam f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.4).
English: Midazolam may interact with other hepatically metabolised medicinal products, e.g. phenytoin, causing potentiation.
Maltese: Midazolam jista' jinteraġixxi ma' prodotti mediċinali oħrajn li jiġu metabolizzati mill-fwied, eż. Phenytoin, u jikkawżaw żieda fil-qawwa tiegħu.
English: Obese
Maltese: LOTT
English: The mean half-life is greater in obese than in non-obese patients (5.9 versus 2.3 hours).
Maltese: Il-medja tal-half-life hi akbar f'pazjenti obeżi milli f'pazjenti li mhumiex obeżi (5.9 kontra 2.3 sigħat).
English: Therefore, the use of BUCCOLAM in the 3-6 month age group should be limited for use only under the supervision of a health care professional where resuscitation equipment is available and where respiratory function can be monitored and equipment for respiratory assistance, if needed, is available.
Maltese: Għalhekk, l-użu ta' BUCCOLAM fil-grupp ta' età ta' 3-6 xhur għandu jiġi limitat biss għall-użu taħt is-superviżjoni ta' professjonist fil-qasam tal-kura tas-saħħa fejn tagħmir tar-risuxitazzjoni ikun disponibbli u fejn il-funzjoni respiratorja tista' tiġi mmonitorjata u tagħmir għal għajnuna respiratorja jkun disponibbli jekk ikun hemm bżonn.
English: > 6 months to < 1 year
Maltese: >6 xhur sa <1 sena
English: • You give too much BUCCOLAM and there are signs of overdose which include: o Drowsiness, tiredness, fatigue o Confusion or feeling disorientated o Absence of knee reflex or a response to a pinch o Breathing difficulties (slow or shallow breathing) o Low blood pressure (giddiness and feeling faint) o Coma
Maltese: o Ngħas, għeja, għeja kbira o Konfużjoni jew tħossok diżorjentat o Assenza tar-rifless tal-irkoppa jew ta' rispons meta tinqaras o Diffikultajiet biex tieħu n-nifs (teħid tan-nifs bil-mod jew b'mod dgħajjef) o Pressjoni baxxa tad-demm (mejt jew ħass ħażin) o Koma
English: • Dry mouth
Maltese: Jintuża darba biss
English: The patient must not drink grapefruit juice while taking BUCCOLAM.
Maltese: Il-pazjent ma jridx jixrob alkoħol meta jkun qed jieħu BUCCOLAM.
English: EU/1/00/144/001 - Helixate NexGen 250 IU EU/1/00/144/002 - Helixate NexGen 500 IU EU/1/00/144/003 - Helixate NexGen 1000 IU EU/1/00/144/004 - Helixate NexGen 2000 IU EU/1/00/144/005 - Helixate NexGen 3000 IU
Maltese: EU/1/00/144/001 - Helixate NexGen 250 IU EU/1/00/144/002 - Helixate NexGen 500
English: Each vial of Helixate NexGen contains nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa.
Maltese: Kull kunjett ta' Helixate NexGen fih ammont nominali ta' 250, 500, 1000, 2000 jew 3000 IU octocog alfa.
English: Helixate NexGencontains the active substance human recombinant coagulation factor VIII (octocog alfa).
Maltese: Helixate NexGen fih is-sustanza attiva Fattur VIII rikombinanti tal-koagulazzjoni uman (octocog alfa).
English: Helixate NexGen 250 Helixate NexGen 500 Helixate NexGen 1000 Helixate NexGen 2000 Helixate NexGen 3000
Maltese: Helixate NexGen 250 Helixate NexGen 500
English: CSL Behring sp. z o.o.
Maltese: CSL Behring sp. z o.o. Tel.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fil-friġġ (2°C - 8°C).
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 (<1/10,000), not known (cannot be estimated from the available data).
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: 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 livell baxx 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: Helixate NexGen can be infused by continuous infusion.
Maltese: Helixate NexGen jista' jiġi infuż permezz ta' infużjoni kontinwa.