FrancophonIA/ELRC3.0 huggingface dataset:
English: How Zoledronic acid Mylan is given - Zoledronic acid Mylan is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Maltese: Kif jingħata Zoledronic acid Mylan - Zoledronic acid Mylan jingħata bħala dripp (infużjoni) ġo vina li mill-anqas għandu jdum 15-il minuta u għandu jingħata bħala soluzzjoni waħda minn ġol-vina f'linja ta' infużjoni separata.
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Maltese: Iż-żmien ta' meta tibda huwa ≤ 3 ijiem wara l-infużjoni ta' zoledronic acid, u r-reazzjoni hija wkoll magħrufa bit-termini ta' sintomi “li jixbhu l-influwenza” jew “ta' wara d-doża”.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva b'zoledronic acid (ara 5.3).
English: The proportion of patients with at least one SRE (excluding hypercalcaemia) was 29.8% in the zoledronic acid-treated group versus 49.6% in the placebo group (p=0.003).
Maltese: Il-proporzjon ta' pazjenti b'almenu SRE wieħed (bl-esklużjoni ta' iperkalċimija) kienet ta' 29.8% fil-grupp ikkurat b'zoledronic acid kontra 49.
English: The active substance in Zoledronic acid Mylan is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Maltese: Is-sustanza attiva f'Zoledronic acid Mylan hija zoledronic acid li jagħmel parti minn grupp ta' sustanzi li jissejħu bisfosfonati.
English: In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Maltese: Fi provi kliniċi fuq pazjenti b'żieda fil-livell tal-kalċju fid-demm minħabba tumuri (TIH), il-profil ta' sigurtà fost it-tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien l-istess mil-lat ta' tipi u severità.
English: To avoid potential incompatibilities, Zoledronic acid Mylan concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Maltese: Biex wieħed jevita inkompatibbiltajiet potenzjali, is-soluzzjoni konċentrata ta' Zoledronic acid Mylan għandha tiġi ddilwita b soluzzjoni ghall-injezzjoni ta' 9mg/ml (0.9%) ta' sodium chloride jew b'5% w/v soluzzjoni ta' glucose.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/786/001
English: Zoledronic acid does not inhibit human P450 enzymes in vitro, shows no biotransformation and in animal studies < 3% of the administered dose was recovered in the faeces, suggesting no relevant role of liver function in the pharmacokinetics of zoledronic acid.
Maltese: Zoledronic acid ma jimpedixxix l-enzimi tal-bniedem P450 in vitro, ma jurix bijotrasformazzjoni, u fi studji li saru fuq annimali, < 3% tad-doża mogħtija nstabet fl-ippurgar li jissuġġerixxi li l-funzjoni tal-fwied ftit li xejn għandha rwol rilevanti fil-farmakokinetiċi ta' zoledronic acid.
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Maltese: Zoledronic acid jista' jerġa jingħata meta l-kreatinina fis-serum terġa lura għal 10% tal-linja bażi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING (WITHOUT BLUE BOX) BOX OF 1 VIAL AS PART OF A MULTIPACK COMPRISING 4 VIALS
Maltese: KAXXA TA' KUNJETT 1 BĦALA PARTI MINN PAKKETT MULTIPLU LI JINKLUDI 4 KUNJETTI
English: Instructions for preparing reduced doses of Zoledronic acid Mylan: Withdraw the appropriate volume of the liquid concentrate, as follows: - 4.4 ml for 3.5 mg dose
Maltese: Istruzzjonijiet biex tipprepara dożi mnaqqsa ta' Zoledronic acid Mylan Iġbed volum xieraq tas-soluzzjoni rikostitwita (4 mg/5 ml) kif meħtieġ: - 4.4 ml għal doża ta' 3.5 mg
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Mylan via the domestic sewage system.
Maltese: Il-professjonisti tal-kura tas-saħħa huma rrakkomandati li ma jarmux Zoledronic acid Mylan mhux użata fis-sistema domestika tad-dranaġġ.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/786/004
English: While being treated with Zoledronic acid Mylan, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Maltese: Waqt it-trattament b'Zoledronic acid Mylan, għandek iżżomm iġjene tajba fil-ħalq (inkluż billi taħsel snienek regolarment) u tagħmel check-ups tas-snien regolari.
English: How to store Zoledronic acid Mylan
Maltese: X'għandek tkun taf qabel ma tingħata Zoledronic acid Mylan
English: - Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Maltese: - Fi studji li saru fuq il-boroż tal-polyolefin (mimlijin minn qabel b'soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride jew 5% w/v ta' soluzzjoni tal-glukosju ma deherx li kien hemm xi inkompatibbiltà b'Zoledronic acid Mylan.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Maltese: Żieda fil-ħin tal-infużjoni minn 5 għal 15-il minuta, ikkawżat tnaqqis ta' 30% fil- konċentrazzjoni ta' zoledronic acid fi tmiem l-infużjoni, iżda ma kellha l-ebda effett fuq l-erja taħt il-kurva ta' konċentrazzjoni fil-plażma kontra l-ħin.
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Maltese: Rari (tista' taffettwa sa persuna 1 minn kull 1,000):
English: General disorders and administration site conditions Very common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: How Zoledronic acid Mylan is used
Maltese: Doża ta' zoledronic acid rrakkomandata*
English: Special precautions for disposal and other handling Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Maltese: Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor Qabel l-għoti, 5 ml konċentrat minn kunjett wieħed jew il-volum ta' konċentrat miġbud kif meħtieġ għandu jiġi dilwit aktar b'100 ml ta' soluzzjoni għall-infużjoni li ma jkunx fiha kalċju (soluzzjoni ta' sodium chloride 9mg/ml (0.9%) għall-injezzjoni jew 5% w/v soluzzjoni ta' glucose).
English: - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Maltese: - Biex tipprepara soluzzjoni għall-infużjoni ta' 4 mg ta' zoledronic acid, żid il-konċentrat ta' (5 ml) ma' 100 ml ta' soluzzjoni għall-infużjoni ħielsa mill-calcium jew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Maltese: - Uġigħ ta' ras u sindrome bħal tal-influwenza b'deni, għeja, debbulizza, ngħas, tkexkix ta' bard u uġigħ fl-għadam, fil-ġogi u/jew fil-muskoli.
English: Limited pharmacokinetic data in children with severe osteogenesis imperfecta suggest that zoledronic acid pharmacokinetics in children aged 3 to 17 years are similar to those in adults at a similar mg/kg dose level.
Maltese: Dejta farmakokinetika limitata fi tfal b'osteoġenesi imperfetta severa tissuġġerixxi li l-farmakokinetika ta' zoledronic acid fit-tfal mill-età ta' bejn it-3 snin u s-17-il sena tixbah lil dik fl-adulti f'livell ta' doża jixxiebah f'mg/kg.
English: The primary endpoint of the study was the percent change from baseline in lumbar spine bone mineral density (BMD) after 12 months of treatment.
Maltese: Il-punt aħħari ewlieni tal-istudju kien il-perċentwali ta' bidla mil-linja bażi fid-densità minerali tal-għadam (BMD) fil-parti lumbari tas-sinsla wara 12-il xahar ta' kura.
English: Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
Maltese: Blister (OPA/Alu /PVCAlu)
English: MA (EU) number (Invented) name
Maltese: Numru MA (UE) Isem (ivvintat)
English: Immediate Packaging Pack size
Maltese: Imballaġġ Primarju Daqs tal-pakkett
English: Preferred Term
Maltese: Terminu preferut
English: Component 2 Human thrombin
Maltese: Komponent 2 Trombina umana
English: Jerusalem 9777605, Israel
Maltese: Jerusalem 9777605, L-Iżrael
English: 800 - 1,200 IU 1,600 - 2,400 IU 4,000 - 6,000 IU
Maltese: 800 - 1,200 IU 1,600 - 2,400
English: MedDRA System Organ Class
Maltese: Sistema tal-klassifika tal-organi ta' MedDRA
English: POB 888, Kiryat Ono 5510801 Israel
Maltese: Kiryat Ono 5510801
English: Component 2: Human thrombin 800-1200 IU/ml
Maltese: Komponent 2: Trombina umana 800-1200 IU/ml
English: Omrix Pressure Regulator
Maltese: Regolatur talPressjoni Omrix
English: Human thrombin vial Calcium chloride Human albumin Mannitol
Maltese: Kunjett tat-trombina umana Calcium chloride Human albumin Mannitol
English: Intravascular administration is contraindicated.
Maltese: Għoti intravaskulari huwa kontraindikat.
English: Oedema peripheral
Maltese: Edema periferika
English: Human fibrinogen vial Arginine hydrochloride Glycine
Maltese: Kunjett li fih il-fibrinoġen uman Arginine hydrochloride Glycine
English: Human Fibrinogen:
Maltese: Fibrinogen tal-Bniedem:
English: At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Maltese: Fis-Cmax, il-konċentrazzjoni tal-plażma rrappreżentat biss 1-2 % tad-doża applikata.
English: For laparoscopy, see section 4.4.
Maltese: Għal laparoskopija, ara sezzjoni 4.4).
English: Adverse reactions - vascular surgery
Maltese: Reazzjonijiet avversi - kirurġija vaskulari
English: Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Maltese: Minn dawn, 2 kienu tfal ta' etajiet 2 u 5 snin u 2 kienu adolexxenti ta' 16-il sena.
English: • Pressure regulators do not exceed the maximum pressure of 1.7 bars for spraying EVICEL, and contain labels stating the recommended pressure and distance.
Maltese: • Ir-regolaturi tal-pressjoni ma jaqbżux il-pressjoni massima ta' 1.7 bars għall-isprejjar ta' EVICEL, u jkun fihom tikketti li jiddikjaraw il-pressjoni u d-distanza rakkomandata.
English: Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL, 72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra-abdominal surgery.
Maltese: Studji kliniċi li juru emostażi u appoġġ tas-sutura saru f'total ta' 147 pazjent (75 b'EVICEL, 72 bil-kontroll) sottoposti minn kirurġija vaskulari bi trapjanti PTFE u f'total ta' 135 pazjent (66 b'EVICEL, 69 bil-kontroll) sottoposti għal kirurġija retroperitoneali u intraddominali.
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours.
Maltese: Il-komponenti fibrinoġen u trombina huma stabbli f'temperatura ambjentali sa 24 siegħa.
English: • In accordance with the European Commission decision on the procedure EMEA/H/C/000898/A20/0018 to mitigate the risk of potentially life threatening air/gas embolism when the product is sprayed at higher than recommended pressures and/or in close proximity to the tissue surface, the MAH shall ensure that: - When EVICEL is sprayed using pressurized gas, the gas should be carbon dioxide because the greater solubility of carbon dioxide in blood reduces the risk of embolism.
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji Skont id-deċiżjoni tal-Kummissjoni Ewropea dwar il-proċedura EMEA/H/C/000898/A20/0018 sabiex jiġi mmitigat ir-riskju ta' emboliżmu tal-arja/tal-gass potenzjalment ta' theddida għall-ħajja meta l-prodott jiġi sprejjat bi pressjonijiet ogħla minn dawk rakkomandati u/jew qrib il-wiċċ tat-tessut, l-MAH għandu jiżgura li: - Meta EVICEL jiġi sprejjat permezz ta' gass taħt pressjoni, il-gass għandu jkun diossidu tal-karbonju minħabba li s-solubilità akbar tad-diossidu tal-karbonju fid-demm tnaqqas ir-riskju ta' emboliżmu.
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: 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: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-miżuri meħudin jistgħu jkunu ta' valur illimitat kontra virusijiet mhux envelopati bħal parvovirus B19.
English: Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30
Maltese: Kategorija farmakoterapewtika: emostatiċi lokali, kombinazzjonijiet, Kodiċi ATC:
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella ppreżentata hawn taħt hija skont is-sistema tal-klassifikazzjoni tal-organi MedDRA (SOC u Livell ta' Terminu Preferut).
English: Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06 t'Ottubru 2008
English: 10 - 15 cm (4 - 6 in)
Maltese: 10 - 15 ċm (4 - 6 pulzieri)
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: L-injezzjoni intravaskulari aċċidentali tista' twassal għal episodji tromboemboliċi jew koagulazzjoni intravaskulari disseminata (DIC), u barra dan jeżisti r-riskju ta' reazzjoni anafilattika (ara sezzjoni 4.4)
English: Sodium chloride Sodium citrate Calcium chloride Water for injections
Maltese: Sodium chloride Sodium citrate
English: EVICEL is a fibrin sealant.
Maltese: EVICEL huwa siġillant li fih il-fibrina.
English: EVICEL solutions for sealant human fibrinogen:
Maltese: EVICEL soluzzjonijiet ta' siġillant fibrinoġen uman:
English: • EVICEL should not be used in endoscopic surgery.
Maltese: • EVICEL m'għandux jintuża f'kirurġija endoskopika.
English: Abdominal abscess
Maltese: Axxess addominali
English: Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.
Maltese: Fibrinoġen Uman: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, ilma għall-injezzjonijiet.
English: Laparoscopic procedures
Maltese: Proċeduri ta' Laparoskopija
English: Component 1: Human clottable protein 50 - 90 mg/ml
Maltese: Komponent 1: proteina umana li tgħaqqad 50 - 90 mg/ml
English: Each contains 1 ml, 2 ml or 5 ml solution of human fibrinogen and human thrombin, respectively.
Maltese: Kull wieħed fih 1 ml, 2 ml jew 5 ml soluzzjoni ta' fibrinoġen uman u trombina umana rispettivament.
English: Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, and water for injections.
Maltese: Komponent 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, u ilma għall-injezzjonijiet.
English: Distance from target tissue
Maltese: Distanza rakkomandata mit-tessut filmira
English: Human Fibrinogen and Human Thrombin: Omrix Biopharmaceuticals Ltd.
Maltese: Fibrinogen tal-Bniedem u Trombina tal-Bniedem: Omrix Biopharmaceuticals
English: Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included in the controlled study of EVICEL, 4 patients treated with EVICEL were aged 16 years or younger.
Maltese: Minn 135 pazjent sottoposti għal kirurġija retroperitoneali u intraddominali li kienu inklużi fl-istudju kkontrollat ta' EVICEL, 4 pazjenti ttrattati b'EVICEL kienu ta' età ta' 16-il sena jew iżgħar.
English: No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ml.
Maltese: L-ebda effett tossikoloġiku minħabba reaġenti deterġenti solventi (TnBP u Triton X100) użati fil-proċedura ta' inattivazzjoni tal-virus ma huma mistennija peress li livelli reżidwi huma inqas minn 5 µg/ml.
English: After thawing, store unopened vials in the outer carton at 2°C -8°C for up to 30 days starting on:
Maltese: Wara t-taħlil, aħżen kunjetti mhux miftuħin fil-kartuna ta' barra f'2 C-8°C sa 30 jum li jibdew nhar:
English: Component 2: calcium chloride, human albumin, mannitol, sodium acetate, and water for injections.
Maltese: Komponent 2: calcium chloride, human albumin, mannitol, sodium acetate, u ilma għall-injezzjonijiet.
English: At 30 days post-operatively the incidence of SSIs was similar between the two treatment groups.
Maltese: Għal 30 jum wara l-operazzjoni, l-inċidenza ta' SSIs kienet simili bejn iżżewġ gruppi ta' kura.
English: Common Common Common
Maltese: Komuni Komuni Komuni Komuni
English: Adverse reactions - neurosurgery
Maltese: Reazzjonijiet avversi - newrokirurġija
English: Post-operative CSF leakage occurred within 30 days from treatment in 4/89 (4.5%) subjects treated with EVICEL (two cases of CSF leakage with impaired wound healing and two cases of rhinorrhoea) and in 1/50 (2.0%) subjects treated with additional sutures.
Maltese: Tnixxija ta' CSF wara l-operazzjoni seħħet fi żmien 30 jum mill-kura f'4/89 (4.5%) individwu kkurat b'EVICEL (żewġ każijiet ta' tnixxija ta' CSF b'indeboliment fil-fejqan tal-feriti u żewġ każijiet ta' ħruġ ta' likwidu mill-imnieħer) u 1/50 (2.0%) individwu kkurat b'suturi addizzjonali.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar il-preparazzjoni tal-prodott mediċinali qabel l-għoti, ara sezzjoni 6.6.
English: Human clottable protein containing mainly fibrinogen and fibronectin *
Maltese: Proteina umana li tagħqad li fiha prinċipalment fibrinoġen u fibronektina *
English: Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.
Maltese: Trombina Umana: calcium chloride, human albumin, mannitol, sodium acetate, ilma għall-injezzjonijiet.
English: EVICEL solutions for sealant human fibrinogen, human thrombin
Maltese: EVICEL soluzzjonijiet ta' siġillant fibrinoġen uman, trombina umana
English: Incision site haemorrhage Vascular graft occlusion Wound
Maltese: Emorraġija fil-punt ta' inċiżjoni Okklużjoni vaskulari tat-trapjant (graft) Ferita
English: EVICEL is available in the following pack sizes: 2 x 1 ml, 2 x 2 ml, and 2 x 5 ml.
Maltese: 2 x 1 ml, 2 x 2 ml, u 2 x 5 ml.
English: Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Maltese: Analiżi ta' fluwidu ċerebrospinali ma weriex sinjali maġġuri ta' infjammazzjoni.
English: Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Maltese: Il-konverżjoni ta' fibrinoġen f'fibrina sseħħ bil-qsim ta' fibrinoġen f'monomeri ta' fibrina u fibrinopeptidi.
English: In controlled clinical trials in vascular surgery, the individual dosage used was up to 4 ml; for suture line sealing in dura mater closure, doses of up to 8 ml were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 ml.
Maltese: Fi provi kliniċi kkontrollati f'kirurġija vaskulari, id-dożaġġ individwali użat kien sa 4 ml; għall-issiġillar ta' linja ta' suturi fl-għeluq tad-dura mater, intużaw dożi ta' sa 8 ml, filwaqt li f'kirurġija retroperitoneali u intraddominali, id-dożaġġ individwali użat kien sa 10 ml.
English: No major macroscopic signs of local intolerance and no treatment-related macroscopic findings were observed.
Maltese: Ma kienu osservati l-ebda sinjali makroskopiċi maġġuri ta' intolleranza lokali u l-ebda riżultat makroskopiku relatati mat-trattament.
English: 35 cm rigid tip 45 cm flexible tip
Maltese: 35 ċm tarf riġidu 45 ċm tarf flessibbli
English: Fibrin sealants in general may, in rare cases (up to 1 patient in 1,000 people), cause an allergic reaction.
Maltese: Siġillanti li fihom il-fibrina in ġenerali jistgħu, f'każjiet rari (sa pazjent 1 minn kull 1,000 persuna), jikkaġunaw reazzjoni allerġika.
English: Spray distance from tissue and CO2 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 tas-CO2 għandhom ikunu fil-firxa rakkomandata mill-manifattur (ara t-tabella fis-sezzjoni 6.6 għall-pressjoni u ddistanza).
English: EVICEL solutions for sealant
Maltese: EVICEL soluzzjonijiet ta' siġillanti
English: EVICEL solutions for sealant human thrombin:
Maltese: EVICEL soluzzjonijiet ta' siġillant trombina umana:
English: Post procedural haematoma Post-operative wound complication
Maltese: Ematoma post-proċedurali Kumplikazzjoni tal-ferita post-operatorja
English: • EVICEL must not be applied intravascularly.
Maltese: • EVICEL m'għandux jiġi applikat intravaskularment.
English: Other medicines and EVICEL
Maltese: Mediċini oħra u EVICEL
English: The application device should be stored at room temperature, separately from the fibrinogen and thrombin.
Maltese: L-apparat tal-applikazzjoni għandu jinħażen f'temperatura ambjentali, separatament mill-fibrinoġen u ttrombina.
English: CSF rhinorrhoea
Maltese: TA' KIF JINGĦATA
English: Omrix Biopharmaceuticals Ltd Pharmacovigilance Department Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Israel Tel: +972-3-5316512
Maltese: Omrix Biopharmaceuticals Ltd Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat
English: EVICEL solutions for sealant human fibrinogen human thrombin
Maltese: EVICEL soluzzjonijiet ta' siġillant fibrinoġen uman trombina umana
English: Solutions for sealant.
Maltese: Soluzzjonijiet ta' siġillant.
English: Adverse reactions in vascular surgery study Infections and infestations
Maltese: Reazzjonijiet avversi fl-istudju dwar il-kirurġija vaskulari Infezzjonijiet u infestazzjonijiet
English: • sealing in transphenoidal and otoneurosurgical procedures
Maltese: • issiġillar fi proċeduri transfenojdali u otonewrokirurġiċi.
English: After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Maltese: Wara applikazzjoni lokali, l-assorbiment ta' trombina għal ġewwa l-plażma jsir bil-mod u jikkonsisti prinċipalment minn prodotti ta' degradazzjoni ta' trombina li huma eliminati.
English: There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Maltese: Hemm ukoll possibbilità teorika li int tista' tiżviluppa antikorpi għall-proteini b'EVICEL, li jistgħu potenzjalment jinterferixxu mat-tgħaqid tad-demm.
English: Sodium acetate Water for injections
Maltese: Sodium acetate Ilma għall-injezzjonijiet
English: All concentrations of the combination of TnBP and Triton X-100 also tested negative in assays performed to determine mammalian cell mutagenicity, chromosomal aberrations and micronuclei induction.
Maltese: Il-konċentrazzjonijiet kollha tal--kombinazzjoni ta' TnBP u Triton X-100 ukoll ittestjaw negattivi f'assaġġi magħmulin biex jiddeterminaw mutaġeniċità ta' ċelloli mammiferi, aberrazzjonijiet kromożomiċi u induzjoni ta' mikronukleji.