FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Maltese: Ir-reviżjoni saret mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għal mistoqsijiet dwar mediċini għall-użu mill-bniedem, li adotta l-opinjoni tal-Aġenzija.
English: For younger children, the use of age-appropriate formulations is recommended.
Maltese: Għal tfal iżgħar, huwa rakkomandat li jintużaw formulazzjonijiet xierqa skont l-età.
English: This summary was last updated in 11-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2016.
English: The full EPAR for Crixivan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public indinavir
Maltese: Sommarju tal-EPAR għall-pubbliku indinavir
English: The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered sense of taste and abdominal pain (stomach ache).
Maltese: L-effetti sekondarju l-aktar komuni bl-użu ta' Crixivan (li dehru f'aktar minn pazjent 1 minn 10) huma żidiet fid-daqs taċ-ċelloli ħomor tad-demm, tnaqqis fin-newtrofili (tip ta' ċelloli bojod tad-demm), uġigħ ta' ras, sturdament, nawżja (tħossok ma tiflaħx), remettar, dijarrea, ħruq ta' stonku, waqtiet ta' livelli għoljin tal-bilirubin li ma jikkawżawx sintomi, żieda fil-livelli tal-enzimi tal-fwied (alanina u transamini aspartati), raxx, ġilda xotta, demm fl-awrina, proteina fl-awrina, kristalli fl-awrina, dgħjufija jew għeja, bidla fis-sens tat-togħma u wġigħ addominali (uġigħ ta' stonku).
English: Other information about Crixivan
Maltese: Informazzjoni oħra dwar Crixivan
English: The active substance in Crixivan, indinavir, is a protease inhibitor.
Maltese: Is-sustanza attiva fi Crixivan, l-indinavir, hija inibitur tal-proteażi.
English: This is a summary of the European public assessment report (EPAR) for Crixivan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Crixivan.
English: Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Crixivan huwa mediċina antivirali li tintuża biex tikkura individwi infettati bil-virus talimmunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tal-immunodefiċjenza akkwiżita (AIDS).
English: The standard dose is 800 mg every eight hours, but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine).
Maltese: Id-doża standard hija 800 mg kull tmien sigħat, iżda Crixivan jista' jittieħed ukoll f'doża ta' 400 mg darbtejn kuljum jekk kull doża tittieħed ma' 100 mg ritonavir (mediċina antivirali oħra).
English: In one study, 90% of those taking Crixivan in combination with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment, compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and lamivudine without Crixivan.
Maltese: Fi studju minnhom, 90% ta' dawk li kienu qed jieħdu Crixivan flimkien ma' zidovudina u lamivudina kellhom tagħbijiet virali taħt il-500 kopja/ml wara 24 ġimgħa, meta mqabbla ma' 43% ta' dawk li kienu qed jieħdu Crixivan biss u 0% ta' dawk li kienu qed jieħdu zidovudin u lamivudina mingħajr Crixivan.
English: It blocks an enzyme called protease, which is involved in the reproduction of HIV.
Maltese: Din timblokka enzima li tissejjaħ proteażi, li hija involuta fir-riproduzzjoni tal-HIV.
English: Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.
Maltese: Crixivan jintuża flimkien ma' mediċini antivirali oħra u fih is-sustanza attiva indinavir.
English: Why is Crixivan been approved?
Maltese: Għaliex ġie approvat Crixivan?
English: For the full list of side effects reported with Crixivan, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bi Crixivan, ara l-fuljett ta' tagħrif.
English: Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two hours after a meal with water or a light low-fat meal.
Maltese: Crixivan jiġi bħala kapsuli (200 u 400 mg) u jittieħed mill-ħalq siegħa qabel l-ikel jew sagħtejn wara mal-ilma jew ma' ikla ħafifa bi ftit xaħam.
English: What are the risks associated with Crixivan?
Maltese: X'inhuma r-riskji assoċjati ma' Crixivan?
English: Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster'.
Maltese: Xi kultant, Ritonavir, inibitur tal-proteażi ieħor, jintuża flimkien ma' Crixivan bħala "booster".
English: By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.
Maltese: Peress li timblokka din l-enzima, l-indinavir twaqqaf lill-virus milli jirriproduċi normalment u għaldaqstant l-infezzjoni tinxtered aktar bil-mod.
English: Studies have shown that Crixivan in combination with other antiviral medicines is effective at reducing the level of HIV in the blood (viral load).
Maltese: Studji wrew li Crixivan flimkien ma' mediċini antivirali oħra huwa effettiv fit-tnaqqis tal-livell ta' HIV fid-demm (tagħbija virali).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan on 4 October 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida fl-Unjoni Ewropea kollha għal Crixivan fl-4 ta' Ottubru 1996.
English: What measures are being taken to ensure the safe and effective use of Crixivan?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Crixivan?
English: The CHMP decided that Crixivan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Crixivan huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Crixivan ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.
Maltese: Crixivan ma għandux jittieħed ma' ċerti mediċini oħra minħabba l-possibbiltà ta' interazzjonijiet perikolużi.
English: To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).
Maltese: Il-pazjenti għandhom jixorbu ħafna likwidi (tal-inqas 1.5 litri kuljum għall-adulti) ħalli jevitaw ir-riskju li jiżviluppawlhom ġebel fil-kliewi .
English: How is Crixivan used?
Maltese: Kif jintuża Crixivan?
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
English: Further information on Waylivra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/waylivra.
Maltese: ema.europa.eu/medicines/human/EPAR/waylivra.
English: Waylivra contains the active substance volanesorsen.
Maltese: Waylivra fih is-sustanza attiva volanesorsen.
English: Other information about Waylivra
Maltese: Informazzjoni oħra dwar Waylivra
English: The active substance in Waylivra, volanesorsen, is an ‘antisense oligonucleotide,' a very short piece of synthetic RNA (a type of genetic material).
Maltese: Is-sustanza attiva f'Waylira, volanesorsen, hija ‘antisense oligonukleotide,' biċċa qasira ħafna ta' RNA sintetiku (tip ta' materjal ġenetiku).
English: FCS is rare, and Waylivra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 February 2014.
Maltese: L-FCS hija rari, u Waylivra ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-19 ta' Frar 2014.
English: After 3 months, patients given Waylivra had an average 77% reduction in the level of triglycerides compared with an average 18% reduction in patients given placebo (a dummy treatment).
Maltese: Wara 3 xhur, il-pazjenti li ngħataw Waylivra kellhom medja ta' tnaqqis ta' 77 % fil-livell ta' trigliċeridi meta mqabbla ma' tnaqqis medju ta' 18 % fil-pazjenti li ngħataw il-plaċebo (kura finta).
English: What information is still awaited for Waylivra?
Maltese: Liema informazzjoni għadha mistennija għal Waylivra?
English: It has been designed to block the production of a protein that slows down the breakdown of fats called apolipoprotein C-III.
Maltese: Is-sustanza attiva tfasslet biex timblokka l-produzzjoni ta' proteina li tnaqqas il-veloċità ta' xaħmijiet imsejħa apolipoproteina C-III.
English: What are the risks associated with Waylivra?
Maltese: X'inhuma r-riskji assoċjati ma' Waylivra?
English: The most common side effects with Waylivra are reduced platelet levels (which may affect 4 in 10 people) and reactions at the site of the injection such as pain, swelling, itching, or bruising (which may affect 8 in 10 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Waylira huma livelli baxxi ta' pjastrini (li jistgħu jaffettwaw 4 minn kull 10) u reazzjonijiet fis-sit tal-injezzjoni bħal uġigħ, nefħa, ħakk, jew tbenġil (li jistgħu jaffettwaw 8 minn kull 10).
English: Waylivra was effective in reducing triglycerides in the blood in a study of 67 patients with FCS.
Maltese: Waylivra kienet effettiva fit-tnaqqis tat-trigliċeridi fid-demm fi studju ta' 67 pazjent b'FCS.
English: Waylivra effectively reduces triglyceride levels and is expected to reduce the risk of pancreatitis in patients with FCS.
Maltese: Waylivra effettivament inaqqas il-livelli ta' trigliċeridi u hu mistenni jnaqqas ir-riskju ta' pankreatite f'pazjenti b'FCS.
English: The frequency of injections is adjusted again after 6 and 9 months depending on how well the medicine is working.
Maltese: Il-frekwenza tal-injezzjonijiet terġa' tiġi aġġustata wara 6 u 9 xhur skont kemm qed taħdem tajjeb il-mediċina.
English: As for all medicines, data on the use of Waylivra are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Waylivra hija ssorveljata kontinwament.
English: The company that markets Waylivra will provide educational materials for patients and healthcare professionals with information on the risk of thrombocytopenia and bleeding with treatment and the importance of regularly checking platelet levels in patients.
Maltese: Il-kumpanija li tikkummerċjalizza Waylivra se tipprovdi materjal edukattiv għall-pazjenti u lprofessjonisti fil-qasam tal-kura tas-saħħa b'informazzjoni dwar ir-riskju tat-tromboċitopenija u fsada b'kura u l-importanza li l-livelli tal-pjastrini fil-pazjenti jiġu ċċekkjati b'mod regolari.
English: Waylivra has been given ‘conditional authorisation'.
Maltese: Waylivra ngħata ‘awtorizzazzjoni kondizzjonali'.
English: Because Waylivra can reduce blood levels of platelets (components that help the blood to clot), patients' blood platelet levels should be checked regularly, in addition to regular checks of triglycerides to see how well the medicine is working.
Maltese: Peress li Waylivra jista' jnaqqas il-livelli tad-demm tal-pjastrini (komponenti li jgħinu biex id-demm jagħqad), il-livelli ta' pjastrini fid-demm għandhom jiġu kkontrollati regolarment, flimkien ma' kontrolli regolari tat-trigliċeridi biex wieħed jara kemm qed taħdem tajjeb il-mediċina.
English: Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood.
Maltese: Waylivra hija mediċina li tintuża fil-kura tas-sindrome ta' chiyomoniememia (FCS) familjali, kundizzjoni ġenetika li tagħti lok għal livelli għoljin ta' xaħmijiet imsejħa trigliċeridi fid-demm.
English: Why is Waylivra authorised in the EU?
Maltese: Għaliex Waylivra huwa awtorizzat fl-UE?
English: How is Waylivra used?
Maltese: Waylivra?
English: For the full list of side effects and restrictions with Waylivra, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Waylivra, ara l-fuljett ta' tagħrif.
English: Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).
Maltese: Ix-xaħam żejjed huwa mibni f'diversi partijiet tal-ġisem u jwassal għal sintomi inkluż uġigħ addominali (uġigħ fiż-żaqq), depożiti ta' xaħam taħt il-ġilda u pankreatite (infjammazzjoni tal-frixa).
English: Since Waylivra has been given conditional authorisation, the company that markets Waylivra will provide results of a study based on a registry of patients to investigate how blood checks and adjustments to frequency of injections are carried out in practice and how well they work to prevent thrombocytopenia and bleeding.
Maltese: Peress li Waylivra ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tikkummerċjalizza Waylivra ser tipprovdi riżultati ta' studju bbażat fuq reġistru ta' pazjenti biex tinvestiga kif il-verifiki tad-demm u laġġustamenti għall-frekwenza tal-injezzjonijiet jitwettqu fil-prattika u kemm jaħdmu tajjeb biex jipprevjenu tromboċitopenija u fsada.
English: By blocking the production of this protein, the medicine reduces the level of triglycerides in the blood and, as a result, fat accumulation in the body, which is expected to reduce the risk of pancreatitis.
Maltese: Billi timblokka l-produzzjoni ta' din ilproteina, il-mediċina tnaqqas il-livell ta' trigliċeridi fid-demm u, bħala riżultat, l-akkumulazzjoni ta' xaħam fil-ġisem, li hu mistenni jnaqqas ir-riskju ta' pankreatite.
English: Side effects reported with Waylivra are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Waylivra huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Waylivra work?
Maltese: Kif jintuża Waylivra?
English: Waylivra must not be used in patients who have long-term or unexplained thrombocytopenia (low blood platelet levels).
Maltese: Waylivra ma għandux jintuża f'pazjenti li għandhom tromboċitopenja mhux spjegata fit-tul (livelli baxxi ta' pjastrini fid-demm).
English: Mississauga, Ontario, Canada L5N 8H9
Maltese: Mississauga, Ontario, Il-Kanada L5N 8H9
English: • Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
Maltese: • Tneħħija: 0.665 ± 0.0493 l/h (Medja ± SE)
English: • Distribution half-life: 1.74 ± 1.28 h, elimination half-life: 10.16 ± 1.28 h.
Maltese: • half-life tad-distribuzzjoni: 1.74 ± 1.28 h, half-life ta' l-eliminazzjoni: 10.
English: • Mean residence time (MRT): 8.57 ± 1.24 h
Maltese: • Ħin medju tar-residenza (Mean residence time - MRT): 8.57 ± 1.24 h
English: Frequency category
Maltese: Kategorija ta' frekwenza
English: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, France
Maltese: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, Franza
English: The active substance is antithrombin alfa*: 1750 IU.
Maltese: Is-sustanza attiva hi antithrombin alfa*: 1750 IU.
English: Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Maltese: Antithrombin, 58 kD, 432 amino-acid glycoprotein, jagħmel parti mis-super-familja ta' serpin (inibitur ta' serine protease).
English: • Area under the curve: 587.88 ± 1.63 (% x h)
Maltese: 587.88 ± 1.63 (% x h)
English: Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Lulju 2006 Data tal-aħħar tiġdid: 15 ta' Lulju 2016
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen f'temperatura ta' 2°C - 8°C fil-friġġ.
English: Antithrombin contains two functionally important domains.
Maltese: L-antithrombin fih żewġ dominji li huma funzjonalment importanti.
English: This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
Maltese: Din il-mediċina fiha 38 mg (1.65 mmol) ta' sodium f'kull kunjett ta' 10 ml.
English: One International Unit (IU) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma.
Maltese: International Unit (IU) wieħed ta' attività ta' l-antithrombin hu ekwivalenti għall-kwantità ta' antithrombin f'1 ml ta' plażma umana normali.
English: Pharmacotherapeutic Group: Antithrombotic agents: heparin group; ATC code: B01AB02.
Maltese: Sustanzi antitrombotiċi: grupp ta' l-eparina; Kodiċi ATC:
English: Reporting of side effects
Maltese: Effetti sekondarji possibbli
English: One vial contains nominally 1750 IU antithrombin alfa*.
Maltese: Kunjett wieħed fih nominalment 1750 IU antithrombin alfa*.
English: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, The Netherlands.
Maltese: MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, L-Olanda
English: The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Maltese: Id-doża qawwija tal-bidu normali f'pazjenti kirurġiċi (50% attività AT fil-linja bażi, piż talġisem 75 kg) b'defiċjenza konġenitali ta' l-antithrombin f'sitwazzjonijiet ta' riskju kliniku hi ta' 20-25
English: Powder for solution for infusion (1750 IU)
Maltese: Trab għal soluzzjoni għall-infużjoni (1750 IU)
English: This medicinal product contains 1.65 mmol (or 37.9 mg) sodium per vial.
Maltese: Dan il-prodott mediċinali fih 1.65 mmol (jew 37.9 mg) ta' sodium f'kull kunjett.
English: Reconstitution/dilution
Maltese: Rikostituzzjoni/dilwizzjoni
English: Feeling hot
Maltese: FEJN MA
English: b)
Maltese: NUMRU(I)
English: One vial contains nominally 1750 IU* antithrombin alfa**.
Maltese: Kunjett wieħed fih nominalment 1750 IU* ta' antithrombin alfa**.
English: Adverse reactions are presented below by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati hawn taħt skont is-sistema ta' klassifika tal-organi u l-frekwenza assoluta.
English: In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Maltese: Fi prova klinika formali li fiha intużaw eżamijiet ultrasoniċi Duplex serjali, intwera li lantithrombin alfa kien effettiv fil-prevenzjoni ta' avvenimenti tromboemboliċi f'erbatax-il pazjent b'defiċjenza konġenitali ta' l-antithrombin f'sitwazzjonijiet ta' riskju kliniku għoli.
English: Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
Maltese: Il-parametri farmakokinetiċi tal-popolazzjoni għal ATryn miskuba mill-istess studju urew (medja ± SD):
English: After intravenous administration of ATryn (intravenous bolus dose of 50 IU/kg or 100 IU/kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/IU/kg body weight (mean ± SD).
Maltese: IU/kg jew 100 IU/kg ta' piż talġisem) lil pazjenti b'defiċjenza konġenitali ta' l-antithrombin mingħajr sintomi kliniċi ta' trombożi, u mingħajr l-użu ta' l-eparina, l-irkuprar inkrementali kien ta' 2.07 ± 1.54 %/IU/kg ta' piż tal-ġisem (medja ± SD).
English: Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for
Maltese: Soluzzjoni normali ta' 9 mg/ml (0.9%) ta' sodium chloride tista' tiżdied biex tintlaħaq
English: Compatibility with PVC infusion lines with in-line filters has been established.
Maltese: Il-kompatibilità ta' linji tal-infużjoni tal-PVC ma' filtri in-line ġiet stabbilita.
English: After reconstitution, 1 ml of solution contains
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni
English: Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ml) and levels in neonates are about
Maltese: L-attività normali ta' l-antithrombin fl-adulti hi ta' 80 - 120% (0.8-1.2 IU/ml) u l-livelli fittrabi huma madwar 40 - 60% (0.4-0.6
English: ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of adult patients with congenital antithrombin deficiency.
Maltese: ATryn hu indikat għall-profilassi ta' tromboemboliżmu fil-vini fl-operazzjonijiet ta' pazjenti adulti b'defiċjenza konġenitali ta' l-antithrombin.
English: ATryn contains antithrombin alfa which is similar to the naturally occurring human antithrombin.
Maltese: ATryn fih antithrombin alfa li hu simili għal antithrombin uman li jseħħ b'mod naturali.
English: The number of units of antithrombin alfa administered is expressed in International Units (IU), which is related to the current WHO standard for antithrombin concentrate.
Maltese: In-numru ta' unitajiet ta' antithrombin alfa li jingħataw huma espressi f'International Units (IU), li huma marbuta ma' l-istandard kurrenti tal-WHO għal konċentrat ta' l-antithrombin.
English: The most commonly reported adverse reactions observed in clinical trials are dizziness, headache, haemorrhage, nausea, venipuncture site haemorrhage, post procedural haemorrhage and wound secretion.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni rrappurtati li ġew osservati fil-provi kliniċi huma: sturdament, uġigħ ta' ras, emorraġija, dardir, emorraġija fis-sit tat-titqiba ġol-vina, emorraġija wara l-proċeduri u tnixxija mill-ferita.
English: Laboratoire Français du Fractionnement et des Biotechnologies, 3 Avenue des Tropiques, ZA de
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Laboratoire Français du Fractionnement et des Biotechnologies, 3 Avenue des Tropiques, ZA
English: Prior to launch of Atryn in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' ATryn f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra talprogramm, mal-Awtorità Kompetenti Nazzjonali.
English: The specific activity of ATryn is approximately 7 IU/mg protein.
Maltese: L-attività speċifika ta' ATryn hi ta' madwar 7 IU/mg ta' proteina.
English: Limited clinical data are available on the use of antithrombin alfa in pregnant women.
Maltese: Informazzjoni klinika limitata hi disponibbli fuq l-użu ta' antithrombin alfa f'nisa tqal.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan ilprodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.