FrancophonIA/ELRC3.0 huggingface dataset:
English: Immediate systemic hypersensitivity-like reactions were commonly observed after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Maltese: Rejazzjonijiet sistemiċi immedjati bħal ta' ipersensittività kienu osservati spiss wara l-vaċċinazzjoni, li jwasslu għall-sintomi newroloġiċi minuri bħal tregħid u/jew eċċitazzjoni, li normalment jgħaddu fi ftit minuti mingħajr bżonn ta' trattament.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes {20, 50, 100, 200 and 500 ml}
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxi tal-kartun {20, 50, 100, 200 and 500 ml}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs
Maltese: VETERINARJU Porcilis PCV emulsjoni għall-injezzjoni għal ħnieżer
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/08/091/001
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fil-friġġ (20C - 80C)
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units (as determined in the in vivo potency test in chickens)
Maltese: Subunit tal-antiġen ta' Circovirus tal- ħnieżer tip 2 ORF2: tal-anqas 4.5 log2 ELISA units kif miksub minn testijiet ta' potenza in vivo fil-flieles.
English: In some piglets depression and a reduced feed intake for up to 5 days were uncommonly observed.
Maltese: F'xi qżieqeż dipressjoni unuqqas ta' ikel kienu osservati mhux komuni, sa 5 tijiem.
English: Opalescent white, with brown resuspendable sediment.
Maltese: Abjad opalaxxenti, b'sediment kannella li jista' jerġa' jiġi sospiż fl-emulsjoni.
English: Excipients.
Maltese: Vaċċinazzjoni
English: Light liquid paraffin
Maltese: KONTENUT BĦALA
English: Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Maltese: Qabel tuża t-tilqima, ħalliha tilħaq it-temperatura tal-kamra (15-25°C) u ħawwad sew qabel l-użu.
English: Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar Kaxxi tal-kartun li fihom, 1 jew 10 fjali PET ta' 20, 50, 100, 200 jew 500 ml.
English: Pigs
Maltese: FIL
English: Transient local reactions at the injection site were very commonly observed after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Maltese: Waral-vaċċinazzjoni, rejazzjonijiet lokalizzati li jgħaddu, kienu osservati ħafna drabi fil-post talinjezzjoni b'mod komuni taħt forma ta' nefħa iebsa, sħuna u xi drabi li tkun tuġgħa (dijametru sa 10cm).
English: Vaccination
Maltese: VETERINARJU
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International BV
Maltese: Intervet International B.V.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials {20 and 50 ml}
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L-IPPAKKJAR EWLIENI TA' PAKKETTI ŻGĦAR {kunjetti 20, 50ml}
English: In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed.
Maltese: F'xi annimali individwali,żieda fit-temperatura rettali sa 2.5
English: Read the package leaflet before use
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitpoġġew fis-suq
English: 4.2 Indications for use, specifying the target species For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
Maltese: Għal-immunizzazzjoni attiva tal-ħnieżer biex jitnaqqas l-ammont ta' virus fid-demm u tessut limfatiku, u biex jitnaqqsu l-imwiet u t-telf ta' piż assoċjat mal-infezzjoni bil-PCV2 waqt iż-żmien tassimna.
English: For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
Maltese: Għal immunizzazzjoni attiva tal-ħnieżer biex jitnaqqas l-ammont ta' virus fid-demm u tessut limfatiku u biex jitnaqqsu l-imwiet u t-telf ta' piż assoċjati mal-infezzjoni bil-PCV2 waqt iż-żmien tas-simna.
English: 0.5 mg/ml Oral suspension Dogs amber glass bottle (type III), 2 polypropylene dosing syringes.
Maltese: Klieb Użu orali flixkun tal-ħġieġ ta' lewn safrani (tip III) 2 siringa tad-dożaġġ polypropylene siringa tad-dożaġġ polypropylene ta' lewn safrani.
English: Content Package size Withdrawal period
Maltese: Kontenut Daqs talpakket
English: 150 ml 1 bottle plus dosing syringe
Maltese: Qawwa Għamla Farmaċewtika
English: EMEA-number Invented Name Strength Pharmaceutical Form
Maltese: Numru ta' l-UE Isem kummerċjali
English: Medicinal product no longer authorised
Maltese: Suspensjoni orali
English: This summary was last updated in 12-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 12-2017.
English: The full EPAR for Nplate 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: Nplate contains the active substance romiplostim.
Maltese: Nplate fih is-sustanza attiva romiplostim.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Nplate jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Nplate
Maltese: Informazzjoni oħra dwar Nplate
English: A platelet count below 30 million per millilitre puts patients at risk of bleeding while the normal count is 150 to 400 million per millilitre.
Maltese: Għadd ta' pjastrini taħt it30 miljun għal kull millilitru jpoġġi lill-pazjenti f'riskju ta' fsada filwaqt li l-għadd normali huwa bejn 150 u 400 miljun għal kull millilitru.
English: This is a summary of the European public assessment report (EPAR) for Nplate.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nplate.
English: Why is Nplate approved?
Maltese: Għaliex ġie approvat Nplate?
English: The active substance in Nplate, romiplostim, stimulates the production of platelets.
Maltese: Is-sustanza attiva f'Nplate, romiplostim, tistimula l-produzzjoni tal-pjastrini.
English: What are the risks associated with Nplate?
Maltese: X'inhuma r-riskji assoċjati ma' Nplate?
English: Because the number of patients with ITP is low, the disease is considered ‘rare', and Nplate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn ITP huwa baxx, il-marda hija kkunsidrata ‘rari', u Nplate ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-27 ta' Mejju 2005.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nplate on 4 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nplate fl-4 ta' Frar 2009.
English: The most common side effects in children include infections of the nose and throat, runny nose, cough, fever, mouth and throat pain, abdominal (belly) pain, diarrhoea, rash and bruising.
Maltese: L-effetti sekondarji l-aktar komuni fit-tfal jinkludu infezzjonijiet tal-imnieħer u tal-griżmejn, imnieħer iqattar, sogħla, deni, uġigħ fil-ħalq u filgriżmejn, uġigħ addominali (ta' żaqq), dijarea, raxx u tbenġil.
English: Platelet count rose above the threshold in 61% of patients who received Nplate (25 out of 41) compared with 5% receiving placebo (1 out of 21).
Maltese: L-għadd ta' pjastrini żdied ‘il fuq mil-limitu f'61% tal-pazjenti li rċivew Nplate (25 minn 41) meta mqabbel ma' 5% li rċivew il-plaċebo (1 minn 21).
English: Nplate is used in patients from 1 year of age with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient's immune system destroys platelets (components in the blood that help it to clot).
Maltese: Nplate jintuża f'pazjenti mill-età ta' sena b'purpura tromboċitopenika immuni (ITP, immune thrombocytopenic purpura) fit-tul, marda li fiha s-sistema immuni tal-pazjent teqred il-pjastrini (komponenti fid-demm li jgħinuh jagħqad).
English: Platelet count rose above the threshold in 52% of patients who received Nplate (22 out of 42) compared with 10% receiving placebo (2 out of
Maltese: L-għadd ta' pjastrini żdied ‘il fuq mil-limitu fi 52 % tal-pazjenti li rċivew Nplate (22 minn 42) meta mqabbel ma' 10 % li rċivew ilplaċebo (2 minn 20).
English: In the body, a hormone called ‘thrombopoietin' normally stimulates the production of platelets in the bone marrow.
Maltese: Fil-ġisem, ormon imsejjaħ “trombopoietina” jistimula l-produzzjoni ta' pjastrini fil-mudullun.
English: Long-term studies involving over 1,000 patients, some treated for longer than 5 years, confirmed that Nplate remained effective both in patients whose spleen had been removed and those who had their spleen.
Maltese: Studji fit-tul li involvew aktar minn 1,000 pazjent, xi wħud li ġew ikkurati għal aktar minn 5 snin, ikkonfermaw li Nplate baqa' effettiv kemm f'pazjenti li tneħħitilhom il-milsa tagħhom kif ukoll f'dawk li kellhom il-milsa tagħhom.
English: Patients were treated for 24 weeks and the main measure of effectiveness was the increase in platelet count above a threshold of 50 million platelets per millilitre of blood during at least 6 of the last 8 weeks of treatment.
Maltese: Il-pazjenti ġew ikkurati għal 24 ġimgħa u l-kejl ewlieni tal-effikaċja kien iż-żieda fl-għadd tal-pjastrini għal aktar minn limitu ta' 50 miljun pjastrina għal kull millilitru ta' demm waqt tal-inqas 6 mill-aħħar 8 ġimgħat tal-kura.
English: The study in children involved 62 patients aged 1 to less than 18 years whose ITP had been treated previously (including some whose spleen had been removed).
Maltese: It-tieni studju involva 62 pazjent li l-ITP tagħhom kienet ġiet ikkurata preċedentement (iżda li ma tneħħitilhomx il-milsa).
English: The most common side effects with Nplate in adults (seen in more than 1 patient in 10) include headache, infections of the nose and throat and allergic (hypersensitivity) reactions such as rash, itching and rapid swelling under the skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Nplate fl-adulti (li dehru f'aktar minn pazjent 1 minn kull 10) jinkludu wġigħ ta' ras, infezzjonijiet tal-imnieħer u tal-griżmejn u reazzjonijiet allerġiċi (ta' sensittività eċċessiva) bħal raxx, ħakk u nefħa f'daqqa taħt il-ġilda.
English: Adults whose platelet levels are stable may inject the medicine themselves after they have been properly trained.
Maltese: L-adulti li l-livelli tal-pjastrini tagħhom ikunu stabbli jistgħu jinjettaw il-mediċini waħidhom wara li jkunu tħarrġu sew.
English: For the full list of side effects reported with Nplate, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Nplate, ara l-fuljett ta' tagħrif.
English: Platelet count rose above the threshold in 38% of patients who received Nplate (16 out of 42) compared with none of the 21 patients receiving placebo.
Maltese: L-għadd ta' pjastrini żdied ‘il fuq mil-limitu fi 38 % tal-pazjenti li rċivew Nplate (16 minn 42) meta mqabbel mal-ebda wieħed mill-21 pazjent li rċivew il-plaċebo.
English: How does Nplate work?
Maltese: Kif jintuża Nplate?
English: Romiplostim has been designed to attach to and stimulate the same targets (receptors) as thrombopoietin.
Maltese: Romiplostim tfassal biex jeħel ma' u jistimula l-istess miri (riċetturi) bħat-trombopoietina.
English: Nplate must not be used in people who are hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Maltese: Nplate m'għandux jintuża f'persuni li huma sensittivi ħafna (allerġiċi) għal romiplostim, kwalunkwe waħda mis-sustanzi mhux attivi l-oħra, jew proteini prodotti minn Escherichia coli (batterju).
English: By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, thereby increasing blood platelet counts and reducing the risk of bleeding.
Maltese: Billi jimita l-azzjoni tat-trombopoietina, romiplostim jistimula l-produzzjoni tal-pjastrini, u b'hekk iżid l-għadd ta' pjastrini fid-demm u jnaqqas ir-riskju ta' fsada.
English: All studies compared Nplate with placebo (a dummy treatment).
Maltese: L-istudji kollha qabblu Nplate mal-plaċebo (kura finta).
English: Treatment should be stopped if the platelet count does not rise enough to reduce the risk of bleeding after 4 weeks of treatment with the maximum dose of Nplate.
Maltese: Il-kura għandha titwaqqaf jekk l-għadd ta' pjastrini ma jiżdiedx biżżejjed biex inaqqas ir-riskju ta' fsada wara 4 ġimgħat ta' kura bid-doża massima ta' Nplate.
English: Two main studies in adults and a third one in children found Nplate effective for the treatment of longstanding ITP.
Maltese: Żewġ studji ewlenin fl-adulti u t-tielet wieħed fit-tfal sabu li Nplate kien effettiv għal-kura ta' ITP fit-tul.
English: What measures are being taken to ensure the safe and effective use of Nplate?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Nplate?
English: Further information on Tegsedi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Tegsedi tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: hATTR is rare, and Tegsedi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 March 2014.
Maltese: hATTR hija rari, u Tegsedi ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis26 ta' Marzu 2014.
English: The medicine is available as a solution for injection under the skin in pre-filled syringes (284 mg).
Maltese: Il-mediċina tiġi bħala soluzzjoni għal injezzjoni taħt il-ġilda f'siringi mimlijin għal-lest (284 mg).
English: The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Maltese: Il-proteina mkissra tifforma depożiti amilojdi f'tessuti u organi madwar il-ġisem, inkluż madwar in-nervituri, fejn tinterferixxi mal-funzjonijiet normali tagħhom.
English: The most common side effects with Tegsedi (which may affect more than 1 in 10 people) are reactions at the site of injection, nausea (feeling sick), low level of red blood cells, headache, fever, peripheral oedema (swelling, especially of the ankles and feet), chills, vomiting and low blood platelet counts which can lead to bleeding and bruising.
Maltese: L-effetti sekondarji l-aktar komuni b'Tegsedi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni, nawsja (tħossok ma tiflaħx), livell baxx ta' ċelloli tad-demm ħomor, uġigħ ta' ras, deni, edema periferika (nefħa, speċjalment tal-għekiesi u s-saqajn), bard, remettar u għadd baxx ta' pjastrini tad-demm li jistgħu jwasslu għal fsada u tbenġil.
English: The active substance in Tegsedi, inotersen, is an ‘antisense oligonucleotide', a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Maltese: Is-sustanza attiva f'Tegsedi, l-inotersen, hija “antisens oligonukleotid”, biċċa qasira ħafna ta' materjal ġenetiku sintetiku li ġiet iddisinjata biex teħel mal-materjal ġenetiku taċ-ċellula responsabbli millproduzzjoni ta' transtiretin u timblokkah.
English: Other information about Tegsedi
Maltese: Kif jintuża Tegsedi?
English: Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves.
Maltese: Tegsedi huwa mediċina li tintuża biex tikkura l-ħsara fin-nervituri kkawżata minn amilojdosi transtiretin ereditarja (hATTR, hereditary transthyretin amyloidosis), marda li fiha l-proteini msejħa amilojdi jinġemgħu fit-tessuti ta' madwar il-ġisem inkluż madwar in-nervituri.
English: In one main study involving 173 hATTR patients with stage 1 or 2 nerve damage, Tegsedi was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Maltese: Fi studju ewlieni wieħed li involva 173 pazjent bl-hATTR bi ħsara fin-nervituri fl-istadju 1 jew 2, Tegsedi ntwera li kien iktar effettiv mill-plaċebo (kura finta) biex inaqqas il-ħsara fin-nervituri kkawżata mill-marda.
English: Quality of life, measured by the Norfolk QoL-DN score, worsened by around 4 points in patients treated with Tegsedi, compared with around 13 points in those on placebo.
Maltese: Ilkwalità tal-ħajja, imkejla mill-punteġġ Norfolk QoL-DN, marret għall-agħar b'madwar 4 punti filpazjenti kkurati b'Tegsedi, meta mqabbla ma' madwar 13-il punt f'dawk li kienu qed jieħdu plaċebo.
English: As for all medicines, data on the use of Tegsedi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Tegsedi hija ssorveljata kontinwament.
English: The main measures of effectiveness were the changes in the patients' nerve damage and quality of life, as measured using standard scales called ‘mNIS+7' and ‘Norfolk QoL-DN' respectively.
Maltese: Il-kejl ewlieni tal-effikaċja kienu l-bidliet fil-ħsara fin-nervituri u fil-kwalità talħajja tal-pazjenti, kif imkejla bl-użu ta' skali standard imsejħa ‘mNIS+7' u ‘Norfolk QoL-DN' rispettivament.
English: After 15 months of treatment, the mNIS+7 score, used for assessing nerve damage, worsened by a lesser extent with Tegsedi (around 11 points) than with placebo (around 25 points).
Maltese: Wara 15-il xahar ta' kura, il-punteġġ mNIS+7, użat għall-valutazzjoni tal-ħsara finnervituri, mar inqas għall-agħar b'Tegsedi (madwar 11-il punt) milli bi plaċebo (madwar 25 punt).
English: How does Tegsedi work?
Maltese: Kif jaħdem Tegsedi?
English: In light of the unmet medical need, the safety profile of Tegsedi was considered acceptable and the risks to be manageable with specific monitoring, dose reduction and stopping rules.
Maltese: Fid-dawl tal-ħtieġa medika mhux issodisfata, il-profil tassigurtà ta' Tegsedi tqies bħala aċċettabbli u r-riskji jistgħu jiġu mmaniġġati b'regoli ta' monitoraġġ, ta' tnaqqis fid-doża u ta' twaqqif speċifiċi.
English: In patients with hATTR, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Maltese: F'pazjenti b'hATTR, proteina msejħa transtiretin li tiċċirkola fid-demm hija difettuża u tinkiser faċilment.
English: Tegsedi must not be used by patients with low platelet counts (less than 100x109/l), and by patients with severe kidney or liver problems.
Maltese: Tegsedi ma għandux jintuża minn pazjenti b'għadd baxx ta' pjastrini (inqas minn 100x109/l), u minn pazjenti bi problemi serji fil-kliewi jew fil-fwied.
English: This reduces production of transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Maltese: Dan inaqqas il-produzzjoni ta' transtiretin, u b'hekk inaqqas il-formazzjoni ta' amilojdi u jtaffi s-sintomi ta' amilojdosi hATTR.
English: What are the risks associated with Tegsedi?
Maltese: X'inhu Tegsedi u għal xiex jintuża?
English: Tegsedi was shown to be effective in the treatment of stage 1 or stage 2 nerve damage in patients with hATTR; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Maltese: Tegsedi ntwera li huwa effettiv fil-kura tal-ħsara fin-nervituri fl-istadju 1 jew fl-istadju 2 f'pazjenti b'hATTR; id-data disponibbli ma kinitx biżżejjed biex wieħed jassumi effett ta' benefiċċju fil-pazjenti flistadju 3 (dawk li qegħdin f'siġġu tar-roti).
English: Debrecen H-4042
Maltese: Debrecen H-4042 L-Ungerija
English: Date of latest renewal: 11 September 2014
Maltese: Data tal-aħħar tiġdid: 11 Settembru 2014
English: Tablet film coat Hypromellose 3cP Hypromellose 6cP Titanium dioxide Macrogol 400
Maltese: Hypromellose 3cP Hypromellose 6cP Titanium dioxide Macrogol 400
English: Teva Pharma - Produtos Farmacêuticos, Lda
Maltese: Teva Pharma - Produtos Farmacêuticos,
English: Tablet core: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate.
Maltese: Microcrystalline cellulose, sodium starch glycollate, magnesium stearate.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: Eastbourne, East Sussex BN22 9AG UK
English: Tablet film coat: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, iron oxide yellow (E172), iron oxide black (E172)
Maltese: Il-kisi tar-rita tal-pillola: Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80, iron oxide yellow (E172) u iron oxide black (E172).
English: 2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17)
Maltese: PENTA 13 2 sa 12-il sena (N=19) PENTA 15 3 sa 36 xahar (N=17)
English: 30 to<50
Maltese: 30 sa <50
English: The observed half-life of elimination is 5 to 7 hours.
Maltese: eliminazzjoni hu ta' bejn 5 sa 7 sigħat.
English: 5 to <15
Maltese: 5 sa <15
English: Microcrystalline cellulose Sodium starch glycolate (Type A) Magnesium Stearate
Maltese: Sodium starch glycolate (Tip A) Magnesium Stearate
English: - The active substance is lamivudine.
Maltese: - Is-sustanza attiva hi lamivudine.
English: UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Maltese: Teva Baltics Eesti filiaal Tel: +372 6610801
English: -4.8% (95% CI -11.5% to +1.9%), p=0.16 Week 48
Maltese: -4.8% (95% CI -11.5% to +1.9%), p=0.16
English: -1.6% (95% CI -8.4% to +5.2%), p=0.65 Week 96
Maltese: -1.6% (95% CI -8.4% to +5.2%), p=0.65
English: Frequencies are defined as 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).
Maltese: Il-frekwenzi huma mfissra hekk: 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) u rari ħafna (<1/10,000).
English: Teva Pharmaceuticals Ireland Tel: +353 19630330
Maltese: L-Irlanda Tel: +353 19630330
English: Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05.
Maltese: Kategorija farmakoterapewtika: analogu nukleoside, Kodiċi ATC:
English: It is metabolised intracellularly to the active moiety, lamivudine 5'-triphosphate.
Maltese: Huwa jiġi metabolizzat fiċ-ċelluli, għas-sustanza attiva, lamivudine 5'- trifosfat (TP).
English: Rare: Pancreatitis, elevations in serum amylase.
Maltese: Pankreatite, livelli ogħla ta' amylase fis-serum.
English: Very rare: Peripheral neuropathy (or paraesthesia).
Maltese: Rari ħafna: Newtopatija periferali (jew paraestesija).
English: From intravenous studies, the mean volume of distribution is 1.3 l/kg.
Maltese: Distribuzzjoni Studji ta' ġol-vini juru li l-volum medju ta' distribuzzjoni hu 1.3 L/kg.
English: In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 10.31 (6.26, 17.0) µg•h/mL in the once-daily dosing and 9.24 (4.66, 18.3) µg•h/mL in the twice-daily dosing.
Maltese: Fi studju PENTA 15, il-medja ġeometrika ta' AUC ta' lamivudine fil-plażma (0-24) (95% CI) talerba' individwi li għandhom inqas minn 12-il xahar li jeqilbu minn reġimen ta' dożaġġ ta' darbtejn kuljum għal wieħed ta' darba kuljum (ara sezzjoni 5.1) hija 10.31 (6.26, 17.0) µg•h/mL fid-dożaġġ ta' darba kuljum u 9.24 (4.66, 18.3) µg•h/mL) fid-dożaġġ ta' darbtejn kuljum.
English: Absorption differences have been observed between adult and paediatric populations (see “Special populations”).
Maltese: Ġew osservati differenzi fl-assorbiment bejn il-popolazzjoni tal-adulti u dik pedjatrika (ara Popolazzjonijiet speċjali).
English: mannitol, lactitol or maltitol), if taken regularly.
Maltese: mannitol, lactitol jew maltitol), jekk jittieħdu regolarment.