FrancophonIA/ELRC3.0 huggingface dataset:
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal antifracture phase III studies carried-out inpostmenopausal women, was observed.
Maltese: Fuq 12-il xahar, ġiet osservata żieda statistikament sinifikanti fil-BMD lumbari medju, il-kriterji medji tal-effikaċja (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0.001), simili għal dik osservata fl-istudji ta' fażi
English: Adverse reactionsare listed below using 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: III huma dawn li ġejjin bl-użu ta' din il-konvenzjoni (frekwenza versus plaċebo): 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-data disponibbli).
English: These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
Maltese: Dawn il-mediċini jinkludu: sustanzi antiinflammatorji mhux sterojdi (inkluż acetylsalicylic acid), anilides (bħal paracetamol), mediċini li jimblukkaw ir-riċetturi H2 u l-pompa protonika, dijuretiċi, digoxin u glikosidi tal-qalb, nitrati organiċi u mediċini oħra li jwessgħu lvini f'mard tal-qalb, imblokkaturi tal-kanal tal-kalċju, imblokkaturi beta, mediċini li jimpedixxu l-ACE, mediċini li jaħdmu kontra l-angiotensin II, mediċini li jgħinu selettivament il-beta-2 adrenoriċetturi, antikoagulanti li jittieħdu mill-ħalq, mediċini li jimpedixxu t-twaħħil tal-plejtlits, statins, fibrates u derivattivi tal-benzodiazepines.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Aspartame (E951)
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Aspartame (E951) Maltodextrin
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Maltese: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Franza Przedsiebiorstwo Farmaceutyczne ANPHARM
English: and TROPOS enrolled 1,556 patients over 80 years at inclusion (23.1% of the study population).
Maltese: Flimkien f'SOTI u TROPOS ħadu sehem 1,556 pazjent ta' aktar minn 80 sena fil-bidu tal-istudju (23.1% tal-popolazzjoni fl-istudju).
English: Table 1: Incidence of patients with vertebral fracture and relative risk reduction
Maltese: Tabella 1: L-inċidenza ta' pazjenti bi ksur fis-sinsla u t-tnaqqis fir-riskju relattiv Studju
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases - Other drugs affecting bone structure and mineralisation, ATC code: M05BX03.
Maltese: Mediċini għall-kura ta' mard fl-għadam- Mediċini oħrajn li jaħdmu fuq l-istruttura u l-mineralizzazzjoni tal-għadam, Kodiċi ATC: M05BX03.
English: NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension Strontium ranelate
Maltese: PROTELOS 2 g granijiet għal sospensjoni orali Strontium ranelate
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and 5.2).
Maltese: Strontium renalate mhuwiex irrakkomandat f'pazjenti b'indeboliment sever tal-kliewi (eliminazzjoni talkreatinina inqas minn 30 ml/min) (ara sezzjonijiet 4.4 u 5.2).
English: Other medicines and PROTELOS:
Maltese: Mediċini oħra u PROTELOS:
English: However, it is recommended to drink the suspension immediately after preparation (see section 4.2) 6.4 Special precautions for storage
Maltese: Madankollu huwa rrakkommandat li s-sospensjoni tinxtorob immedjatamet wara li titħejja (ara sezzjoni 4.2) 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of PROTELOS.
Maltese: Reazzjonijiet tal-ġilda li huma ta' theddida għas-saħħa (is-sindromu ta' Stevens-Johnson (SJS), nekroliżi epidermali tossika (TEN) u raxx minħabba xi mediċina b'eosinofilja u sintomi sistemiċi (DRESS)) ġew irrapportati bl-użu ta' PROTELOS.
English: The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Maltese: L-effikaċja ta' PROTELOS intweriet fi rġiel b'osteoporożi fi studju kkontrollat bi plaċebo, double-blind ta' sentejn b'analiżi ewlenija wara sena f'243 pazjent (popolazzjoni b'intenzjoni li tiġi kkurata, 161 pazjent ingħataw strontium ranelate) b'riskju għoli ta' ksur (età medja ta' 72.7 sena; valur tal-punteġġ BMD T lumbari medju ta' -2.6; 28% tal-ksur vertebrali prevalenti).
English: In each Member State where PROTELOS is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Maltese: F'kull Stat Membru fejn PROTELOS jiġi kkummerċjalizzat, id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH) għandu jaqbel mal-Awtorità Kompetenti Nazzjonali fuq il-programm edukattiv finali.
English: NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension
Maltese: IL-PRODOTT MEDIĊINALI PROTELOS 2 g granijiet għal sospensjoni orali
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Maltese: o Jekk ikun hemm preżenti sinjali jew sintomi tas-Sindromu ta' Stevens-Johnson (SJS), Nekroliżi Epidermali Tossika (TEN) jew Raxx dovut għall-Mediċina b'Esinofilja jew Sintomi Sistemiċi (DRESS) (eż. raxx, deni, esinofilja u invovliment sistemiku, eż. adenopatija, epatite, nefropatija interstizjali, mard tal-pulmun interstizjali), il-kura bi PROTELOS għandha titwaqqaf minnufih.
English: Where possible, screening for HLA-A*33:03 and HLA-B*58:01 alleles could be considered before starting treatment with PROTELOS in patients of Han Chinese origin.
Maltese: Fejn ikun possibbli, għandu jiġi kkunsidrat l-iskrinjar għall-alleli HLA-A*33:03 u HLA-B*58:01 qabel il-bidu tal-kura bi PROTELOS f'pazjenti ta' oriġini Ċiniża Han.
English: Package leaflet: Information for the patient PROTELOS 2 g granules for oral suspension Strontium ranelate
Maltese: TAL-PRODOTT MEDIĊINALI PROTELOS 2 g granijiet għal sospensjoni orali Strontium ranelate
English: Together, SOTI
Maltese: Jekk tieqaf tieħu PROTELOS
English: In phase III studies, which demonstrated the anti-fracture efficacy of PROTELOS treatment, measured mean BMD increased from baseline with PROTELOS by approximately 4% per year at the lumbar spine and 2% per year at the femoral neck, reaching 13% to 15% and 5% to 6% respectively after 3 years, depending on the study.
Maltese: III, li wrew l-effett kontra l-ksur bil-kura bi PROTELOS, il-medja mkejla ta' BMD mill-bażi żdiedet bejn wieħed u ieħor b'4% kull sena fil-lumbari tal-ispina tad-dahar bi PROTELOS u b'2% kull sena fl-għonq tal-femur, u tilħaq 13% sa 15% u 5% sa 6% rispettivament wara 3 snin skont l-istudju.
English: In this group, over 3 years of treatment, PROTELOS reduced the risk of hip fracture by 36% relative to the placebo group (table 2).
Maltese: F'dan il-grupp, tul 3 snin ta' kura, PROTELOS naqqas ir-riskju ta' ksur tal-ġenb b'36% meta mqabbel mal-grupp bi plaċebo.
English: The anti-fracture studies program of PROTELOS was made up of two placebo-controlled phase III studies: SOTI study and TROPOS study.
Maltese: III ikkontrollati bi plaċebo: Studju SOTI u studju TROPOS.
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Maltese: F'pazjenti ta' aktar minn 80 sena meta daħlu fl-istudju, analiżi miġbura flimkien tal-istudji SOTI u TROPOS uriet li PROTELOS naqqas ir-riskju relattiv li wieħed isofri minn ksur ġdid tas-sinsla b'32% fuq 3 snin (inċidenza ta' 19.1% bi strontium ranelate vs. 26.
English: PROTELOS reduced the relative risk of new vertebral fracture by 41% over 3 years in the SOTI study (table 1).
Maltese: PROTELOS naqqas ir-riskju relattiv ta' ksur ġdid fis-sinsla b'41% tul tliet snin fl-istudju SOTI (tabella 1).
English: PROTELOS has been studied in clinical trials involving nearly 8,000 participants.
Maltese: PROTELOS ġie studjat fi studji kliniċi li kien fihom kważi 8,000 parteċipant.
English: * In Asian countries reported as rare # For adverse reaction not observed in clinical trials, the upper limit of the 95% confidence interval is not higher than 3/X with X representing the total sample size summed up across all relevant clinical trials and studies.
Maltese: Għal reazzjoni avversa mhux osservata fil-provi kliniċi, il-limitu ta' fuq tal-intervall ta' fiduċja ta' 95% mhuwiex ogħla minn 3/X b'X tirrappreżenta d-daqs tal-kampjun totali magħdud flimkien mill-provi kliniċi u mill-istudji relevanti kollha.
English: EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
Maltese: EU/1/04/288/006 100 qartas
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Maltese: F'analiżi posterjuri ta' pazjenti mill-istudji SOTI u TROPOS miġbura flimkien b'bażi lumbari tal-ispina u/jew tal-għonq tal-femur BMD fil-wisa' osteopenika u mingħajr ksur prevelanti iżda mill-inqas b'fattur ta' riskju addizjonali għall-ksur (N = 176), PROTELOS naqqas ir-riskju li jkun hemm l-ewwel ksur tassinsla b'72% tul 3 snin (inċidenza ta' ksur tas-sinsla 3.6% bi strontium ranelate vs.
English: The safety and efficacy of PROTELOS in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' PROTELOS fit-tfal ta' inqas minn 18-il sena ma ġewx determinati s'issa.
English: You should stop taking PROTELOS if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Maltese: Għandek tieqaf tieħu PROTELOS jekk ikollok bżonn tieħu tetracyclines bħal doxycycline jew quinolones bħal ciprofloxacin mill-ħalq (żewġ tipi ta' antibijotiċi).
English: PROTELOS contains aspartame, a source of phenylalanine, which may be harmful for people with phenylketonuria.
Maltese: Eċċipjenti PROTELOS għandu aspartame, sors ta' phenylalanine, li jista' jkun ta' ħsara f'nies b'phenylketonuria.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/004 56 sachets
Maltese: EU/1/04/288/005 84 qartas
English: • The contraindications to the treatment with PROTELOS.
Maltese: • Il-kontraindikazzjonijiet għall-kura bi PROTELOS.
English: • PROTELOS should only be used with caution in: o Patients with significant risk factors for cardiovascular events such as hypertension, hyperlipidaemia, diabetes mellitus or smoking.
Maltese: • PROTELOS għandu jintuża biss b'kawtela f': o Pazjenti b'fatturi ta' riskju sinifikanti għal episodji kardjovaskulari bħal pressjoni għolja, iperlipidemija, diabetes mellitus jew tipjip.
English: PROTELOS is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE.
Maltese: PROTELOS huwa kontraindikat f'pazjenti bi storja fil-passat ta' avvenimenti tromboemboliċi fil-vini (ara sezzjoni 4.3) u għandu jintuża bil-galbu f'pazjenti b'riskju ta' VTE.
English: If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Maltese: Jekk ikun hemm sintomi jew sinjali ta' SJS jew TEN (eż. raxx tal-ġilda progressiv spiss b'nuffati jew leżjonijiet mukożali) jew DRESS (eż. raxx, deni, esinofilja u involviment sistemiku (eż. adenopatija, epatite, nefropatija interstizjali, marda tal-pulmun interstizjali), il-kura bi PROTELOS għandha titwaqqaf minnufih.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where PROTELOS is marketed, all physicians who are expected to prescribe PROTELOS are provided with the following educational package:
Maltese: Il-MAH għandu jiżgura li, wara diskussjoni u ftehim mal-Awtorità Nazzjonali Kompetenti f'kull Stat Membru fejn PROTELOS jiġi kkummerċjalizzat, it-tobba kollha li huma mistennija li jagħtu PROTELOS jiġu pprovduti bil-pakkett edukattiv li ġej:
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Maltese: Reazzjonijiet tal-ġilda li jistgħu jkunu ta' theddida għas-saħħa (is-sindromu ta' Stevens-Johnson, nekroliżi epidermali tossika u reazzjonijiet severi dovuti ta' ipersensittività (DRESS)) ġew irrapportati bl-użu ta' PROTELOS.
English: The highest risk for occurrence of SJS or TEN is within the first weeks of treatment and usually around 3-6 weeks for DRESS.
Maltese: L-ogħla riskju li jitfaċċaw SJS jew TEN huwa fi żmien l-ewwel ġimgħat ta' kura u normalment madwar 3-6 ġimgħat għal DRESS.
English: How to take PROTELOS
Maltese: Twissijiet u prekawzjonijiet
English: Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Maltese: Minħabba li jiġi assorbit bil-mod, PROTELOS għandu jingħata qabel ir-raqda ta' billejl, preferibbilment mill-inqas sagħtejn wara l-ikel (ara sezzjonijiet 4.5 u
English: PROTELOS
Maltese: BŻONN
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/003
Maltese: EU/1/04/288/006
English: PROTELOS is a medicine used to treat severe osteoporosis: - in postmenopausal women, - in adult men, at high risk of fracture, for whom other alternative treatments are not possible.
Maltese: PROTELOS huwa mediċina li tintuża biex tikkura l-osteoporożi severa: - f'nisa wara l-menopawsa, - f'irġiel adulti, b'riskju ogħla ta' ksur li għalihom, kuri alternattivi mhumiex possibbli.
English: - Current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1. - Avvenimenti tromboemboliċi fil-vini (VTE) attwali jew preċedenti, inklużi trombożi profonda talvini u emboliżmu pulmonari.
English: No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTELOS in the target population were found during clinical trials.
Maltese: Matul il-provi kliniċi, ma nstabet l-ebda evidenza ta' interazzjonijiet kliniċi jew ta' żieda relevanti fillivelli ta' strontium fid-demm ma' prodotti mediċinali mistennija li jingħataw b'mod komuni ma' PROTELOS fil-popolazzjoni fil-mira.
English: • PROTELOS is contraindicated and must not be used in patients with : o Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Maltese: • PROTELOS huwa kontraindikat u m'għandux jintuża f'pazjenti bi : o Storja stabbilita, attwali jew preċedenti ta' mard iskemiku tal-qalb, mard arterjali periferali u/jew mard ċerebrovaskulari.
English: In vitro, strontium ranelate: - increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture.
Maltese: Ħafna nies b'osteoporożi ma jkollhomx sintomi u inti tista' lanqas biss tinduna li jkollok l-osteoporożi.
English: In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Maltese: Fin-nuqqas ta' tagħrif dwar is-sigurtà fl-għadam f'pazjenti b'indeboliment sever tal-kliewi fuq kura bi strontium ranelate, PROTELOS mhuwiex irrakkomandat f'pazjenti b'eliminazzjoni tal-kreatinina ta' inqas minn 30 ml/min (ara sezzjoni 5.2).
English: Pack of 1 vial.
Maltese: Pakkett ta' 1 kunjett.
English: 35041 Marburg (Stadtteil Michelbach) Germany
Maltese: 35041 Marburg (Stadtteil Michelbach)
English: 1 vial 0.5 g 1 vial 1 g 1 vial 2 g
Maltese: Trab siġillant 1 kunjett 0.5 g 1 kunjett 1 g 1 kunjett 2 g
English: Martin House, Gloucester Crescent, Wigston, Leicester, Leicestershire, LE18 4YL, United Kingdom
Maltese: Martin House, Gloucester Crescent, Wigston, Leicester, Leicestershire, LE18 4YL, Ir-Renju Unit
English: Ireland
Maltese: L- Irlanda
English: Store between + 2 °C to + 25 °C.
Maltese: Aħżen f'temperatura bejn + 2°C sa + 25°C.
English: This leaflet was last approved in 12/2016.
Maltese: Dan il-fuljett kien rivedut l-aħħar f' 12/2016.
English: Date of first authorisation: 19 March 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Marzu, 2015
English: Intravascular application
Maltese: Applikazzjoni intravaskulari
English: Raplixa is indicated in adults over 18 years of age.
Maltese: Raplixa hu indikat fl-adulti ta' aktar minn 18-il sena.
English: Human Fibrinogen
Maltese: Fibrinogen Uman
English: College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland
Maltese: College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, L- Irlanda
English: Trehalose Calcium chloride Albumin
Maltese: Calcium chloride Albumina
English: Human Thrombin
Maltese: Thrombin Uman
English: • Use of the correct pressure (not exceed 1.5 bars or 22 psi) and distance from tissue not closer than
Maltese: • L-użu ta' pressjoni korretta (taqbiżx 1.5 bars jew 22 psi) u d-distanza mit-tessut mhux eqreb
English: Clinical studies with Raplixa demonstrating haemostasis were conducted in patients undergoing spinal (n=146), vascular (n=137), liver (n=158) and soft tissue surgery (n=125).
Maltese: Studji kliniċi b'Raplixa li juri l-emostasi twettqu f'pazjenti li kienet qed issirilhom operazzjoni tassinsla (n=146), operazzjoni vaskulari (n=137), operazzjoni tal-fwied (n=158) u operazzjoni tat-tessut artab (n=125).
English: Function
Maltese: Funzjoni
English: Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Maltese: Injezzjoni intravaskulari mhux intenzjonata tista' twassal għal avveniment tromboemboliku u koagulazzjoni intravaskulari mifruxa (DIC), u hemm ukoll riskju ta' reazzjoni anafilattika (ara sezzjoni 4.4).
English: 0.5 g, 1 g, 2 g of powder per vial (Type I glass) with a rubber stopper and aluminium/ plastic tear-off.
Maltese: 0.5 g, 1 g, 2 g ta' trab f'kull kunjett (ħġieġ ta' Tip I) b'tapp tal-lastku u tear-off tal-aluminju/plastik.
English: Human plasma
Maltese: Plażma umana
English: Table 1: Composition of Raplixa (per gram powder) Component
Maltese: Tabella 1: Kompożizzjoni ta' Raplixa (għal kull gramma ta' trab) Komponent
English: Excipients: Trehalose, Calcium chloride, Human Albumin, Sodium chloride, Sodium citrate, L-arginine-hydrochloride
Maltese: Trehalose, Calcium chloride, Albumina Umana, Sodium chloride, Sodium citrate, L-arginine-hydrochloride
English: Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland
Maltese: Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, L-Irlanda
English: Sterile
Maltese: Sterili
English: 2 g human fibrinogen 79 mg/g human thrombin 726 IU/g
Maltese: 2 g fibrinogen uman 79 mg/g thrombin uman 726 IU/g
English: Clinical studies in the EU were done with the CE marked Spongostan gelatin sponge.
Maltese: Studji kliniċi fl-UE twettqu bi sponża tal-ġelatina Spongostan immarkata b'CE.
English: Raplixa sealant powder Human fibrinogen/Human thrombin
Maltese: Raplixa trab siġillant Fibrinogen uman/Thrombin uman
English: The pressure should be within the range recommended by ProFibrix.
Maltese: Il-pressjoni għandha tkun fil-medda rakkomandata minn ProFibrix.
English: Human fibrinogen 79 mg/g Human thrombin 726 IU/g
Maltese: Fibrinogen uman 79 mg/g Thrombin uman 726 IU/g
English: Raplixa must be used in combination with an approved gelatin sponge (see section 5.1).
Maltese: Raplixa jrid jintuża flimkien ma' sponża tal-ġelatina approvata (ara sezzjoni 5.1).
English: Raplixa is supplied in three different presentations 0.5 grams (39.5 mg human fibrinogen and 363 IU human thrombin), 1 gram (79 mg human fibrinogen and 726 IU human thrombin) and 2 grams (158 mg human fibrinogen and 1452 IU human thrombin).
Maltese: Raplixa hu fornut fi tliet preżentazzjonijiet differenti: 0.5 gramma (39.5 mg ta' fibrinogen uman u 363 IU ta' thrombin uman), 1 gramma (79 mg ta' fibrinogen uman u 726
English: Maximum amount of Raplixa recommended is 3 gram.
Maltese: L-ammont massimu rakkomandat ta' Raplixa hu ta' 3 grammi.
English: Name and address of the manufacturers of the biological active substances CSL Behring GmbH
Maltese: Isem u indirizz tal-manifattur tas-sustanzi bijoloġiċi attivi CSL Behring GmbH
English: - The other ingredients are trehalose, calcium chloride, albumin, sodium chloride, sodium citrate,
Maltese: - Is-sustanzi l-oħra huma trehalose, calcium chloride, albumina, sodium chloride, sodium citrate,
English: Intravascular administration is contraindicated.
Maltese: L-għoti intravaskulari hu kontraindikat.
English: Store Raplixa powder vials at 2 °C to 25 °C.
Maltese: Aħżen il-kunjetti bit-trab ta' Raplixa f'temperatura ta' 2°C sa 25°C.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Maltese: Antikorpi kontra l-komponenti ta' siġillanti tal-fibrin/prodotti emostatiċi jistgħu jseħħu b'mod rari.
English: • The Summary of Product Characteristics (SmPC)
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott (SmPC)
English: The measures taken are considered effective for enveloped viruses such human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
Maltese: Il-miżuri meħuda huma kkunsidrati effettivi għal viruses enveloped bħal virus tal-immunodefiċjenza umana (HIV), il-virus tal-epatite B (HBV) u l-virus tal-epatite Ċ (HCV).
English: Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section 6.6 for pressure and distance).
Maltese: Id-distanza tal-isprej mit-tessut u l-pressjoni għandhom ikunu filmeded rakkomandati mill-manifattur (ara t-tabella f'sezzjoni 6.6 għall-pressjoni u d-distanza).
English: • Itch
Maltese: • Ħakk