FrancophonIA/ELRC3.0 huggingface dataset:
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni tista' tinstab taħt il-buttuna ‘All documents' ('Id-dokumenti kollha).
English: Based on the review of the data and the company's response to the CHMP's lists of questions, the CHMP had some concerns and was of the provisional opinion that Joicela could not have been approved for the symptomatic treatment of osteoarthritis (swelling and pain in the joints) of the knee and hip in adults who are not carriers of DQA1*0102.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, isCHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Joicela ma setax jiġi approvat għall-kura tassintomi tal-osteoartrite (nefħa u uġigħ fil-ġogi) tal-irkoppa u l-ġenbejn f'adulti li mhumiex ġarriera ta' DQA1*0102.
English: The Committee was not convinced that screening patients for the DQA1*0102 gene variant sufficiently reduced this risk.
Maltese: Il-Kumitat ma kienx konvint li l-iskrinjar talpazjenti għall-varjant tal-ġene DQA1*0102 inaqqas dan ir-riskju b'mod sinifikanti.
English: How is Joicela expected to work?
Maltese: Kif inhu mistenni li jaħdem Joicela?
English: The effects of Joicela were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Joicela ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq ilbnedmin.
English: By reducing the production of prostaglandins, Joicela helps to reduce the symptoms of inflammation, such as pain, seen in osteoarthritis.
Maltese: Billi jnaqqas il-produzzjoni ta' prostaglandins, Joicela jgħin biex inaqqas is-sintomi ta' infjammazzjoni, bħall-uġigħ, li jidher fl-osteoartrite.
English: 27 January 2010
Maltese: 27 ta' Jannar 2010
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Maltese: 1 Artikolu 33(4) tad-Direttiva 2001/82/KE, kid emendat.
English: Opinion following an Article 33(4) referral for APPM Respipharm EMA/839689/2009
Maltese: Opinjoni skont l-Artikolu 33(4) riferiment għal APPM Respipharm EMA/66714/2010
English: The Committee appointed Dr Anna-Maria Brady as rapporteur and Dr Frédéric Descamps as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Anna-Maria Brady bħala rapporteur u lil Dr Frédéric Descamps bħala ko-rapporteur.
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Maltese: Kumitat għall-prodotti mediċinali għall-użu veterinarju (CVMP)
English: Respipharm
Maltese: II.
English: APPM Respipharm is a multi-component formaldehyde inactivated whole-cell bacterial vaccine containing three strains of Actinobacillus pleuropneumoniae (Serotypes 2, 9 and 11) and one strain of Pasteurella multocida (Serotype A).
Maltese: APPM Respipharm huwa vaċċin batteriku multi-komponenti ta' ċellola sħiħa diżattivat bil-formaldehyde li fih tliet razez tal-Actinobacillus pleuropneumoniae (Serotipi 2, 9 u 11) u razza waħda tal-Pasteurella multocida (Serotip A).
English: The product is indicated for use in pigs (sows and weaned piglets) from 6 weeks of age, intended to induce active immunisation of sows and piglets against pleuropneumonia caused by Actinobacillus pleuropneumoniae and against secondary infection by Pasteurella multocida.
Maltese: Il-prodott huwa indikat għall-użu fil-majjali (majjali nisa u ħnienes miftuma) mill-età ta' 6 ġimgħat, maħsub sabiex jinduċi l-immunizzazzjoni attiva tal-majjali nisa u l-ħnienes kontra l-plewropnewmonja kkawżata mill-Actinobacillus pleuropneumoniae u kontra l-infezzjoni sekondarja mill-Pasteurella multocida.
English: Written explanations were provided by the Marketing Authorisation Holder on 14 January 2009 and supplementary information was submitted on 22 April 2009.
Maltese: Id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq ipprovda spjegazzjonijiet bil-miktub fl-14 ta' Jannar 2009 u fit-22 ta' April 2009 ġiet ippreżentata informazzjoni supplimentari.
English: During its 15-17 September 2009 meeting, the CVMP appointed Dr Kristina Lehmann as rapporteur and Prof. Tibor Soós as co-rapporteur for the re-examination of the abovementioned opinion.
Maltese: Matul il-laqgħa tiegħu tal-15-17 ta' Settembru 2009, il-CVMP, ħatar lil Dr Kristina Lehmann bħala rapporteur u lill-Prof Tibor Soós bħala ko-rapporteur għar-rieżami tal-opinjoni hawn fuq imsemmija.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Slovakia and the Concerned Member States were Poland and Spain.
Maltese: L-applikazzjoni ġiet ippreżentata fil-qafas tal-Artikolu 32 tadDirettiva 2001/82/KE, kif emendata, fejn l-Istat Membru tar-Riferiment kien is-Slovakkja u l-Istati Membri Kkonċernati kienu l-Polonja u Spanja.
English: The Mutual Recognition Procedure started on 3 April 2008.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku bdiet fit-3 ta' April 2008.
English: Background information
Maltese: TAGĦRIF TA' SFOND
English: On 28 July 2009, Pharmagal Bio s.r.o.
Maltese: Ir-raġunijiet dettaljati għar-rieżami kienu ppreżentati minn Pharmagal Bio s.r.o. fl-14 ta' Settembru 2009.
English: The re-examination procedure started on 15 September 2009.
Maltese: Il-proċedura ta' rieżami bdiet fil-15 ta' Settembru 2009.
English: Due to concerns raised by Spain during the Mutual Recognition Procedure that APPM Respipharm may pose a potentially serious risk to human or animal health or to the environment with respect to quality and efficacy of the product, the Reference Member State, Slovakia, referred the matter to the Agency on 7 October 2008 under Article 33(4) of Directive 2001/82/EC.
Maltese: Minħabba t-tħassib imqajjem minn Spanja waqt il-Proċedura ta' Rikonoxximent Reċiproku li APPM Respipharm jista' jippreżenta riskju serju għas-saħħa tal-bniedem jew tal-annimali jew għall-ambjent fir-rigward tal-kwalità u l-effikaċja tal-prodott, l-Istat Membru tar-Riferiment, is-Slovakkja, irrefera lkwistjoni lill-Aġenzija fis-7 ta' Ottubru 2008 skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: The detailed grounds for the re-examination were submitted by Pharmagal Bio s.r.o.
Maltese: Il-konklużjonijiet xjentifiċi huma pprovduti fl-Anness
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that its opinion of 15 July 2009 should not be revised, and therefore adopted an opinion on 11 November 2009 recommending the suspension of the existing Marketing Authorisation and the refusal of the granting of the Marketing Authorisations for APPM Respipharm.
Maltese: Fuq il-bażi tal-evalwazzjoni tal-valutazzjoni tar-rapporteur tal-informazzjoni attwalment disponibbli, ilCVMP ħass li l-opinjoni tiegħu tal-15 ta' Lulju 2009 ma kellhiex tiġi riveduta, u għalhekk adotta opinjoni fil-11 ta' Novembru 2009 li rrakkomandat is-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq eżistenti u r-rifjut tal-għoti tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal APPM Respipharm.
English: The Marketing Authorisation Holder, Pharmagal Bio s.r.o., submitted an application via mutual recognition for APPM Respipharm, on the basis of the marketing authorisation granted by Slovakia.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, Pharmagal Bio s.r.o., ippreżenta applikazzjoni permezz ta' rikonoxximent reċiproku għal APPM Respipharm, fuq il-bażi tal-awtorizzazzjoni għattqegħid fis-suq mogħtija mis-Slovakkja.
English: Questions and answers
Maltese: Is-sustanza
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratio had been shown to have comparable quality and to be bioequivalent to Actos.
Maltese: Is-CHMP kkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li Pioglitazone ratio wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Actos.
English: What is Pioglitazone ratio?
Maltese: X'inhu Pioglitazone ratio?
English: Pioglitazone ratio is a medicine that contains the active substance pioglitazone.
Maltese: Pioglitazone ratio huwa mediċina li fiha s-sustanza attiva pijoglitażonu.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratio, for the treatment of type 2 diabetes.
Maltese: Fit-3 ta' Frar 2012, ratiopharm GmbH uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Pioglitazone ratio, għat-trattament tad-dijabete tat-tip 2.
English: Because Pioglitazone ratio is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Maltese: Peress li Pioglitazone ratio huwa mediċina ġenerika, l-istudji f'pazjenti ġew limitati għal testitjiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Actos.
English: Pioglitazone ratio, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Maltese: attiva f'Pioglitazone ratio, il-pijoglitażonu, tagħmel iċ-ċelloli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jibda jagħmel użu aħjar mill-insulina li jipproduċi.
English: This means that Pioglitazone ratio is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Maltese: Pioglitazone ratio ġie żviluppat bħala ‘mediċina ġenerika' Dan ifisser li Pioglitazone ratio huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Actos.
English: What was Pioglitazone ratio expected to be used for?
Maltese: Għal xiex kien mistenni jintuża Pioglitazone ratio?
English: Pioglitazone ratio was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Maltese: Pioglitazone ratio kellu jintuża waħdu f'pazjenti li ma jkunux jistgħu jieħdu l-metformina (mediċina antidijabetika oħra).
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratio for the treatment of type 2 diabetes.
Maltese: Għaldaqstant, fiż-żmien meta l-mediċina ġiet irtirata, is-CHMP kellu opinjoni favorevoli, u rrakkomanda li tingħata awtorizzazzjoni għat-tqegħid fissuq għal Pioglitazone ratio għall-kura tad-dijabete tat-tip 2.
English: The full EPAR for Zyclara 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: Zyclara is a ‘hybrid medicine'.
Maltese: Zyclara hija ‘mediċina ibrida'.
English: The active substance in Zyclara cream, imiquimod, is an immune response modifier.
Maltese: Is-sustanza attiva fil-krema Zyclara, imiquimod, hija modifikatur tar-reazzjoni immuni.
English: It contains the active substance imiquimod at 3.75% strength (100 mg cream contains 3.75 mg imiquimod).
Maltese: Dan fih is-sustanza attiva imiquimod b'qawwa ta' 3.75 % (100 mg krema fiha 3.75 mg imiquimod).
English: Other information about Zyclara
Maltese: Informazzjoni oħra dwar Zyclara
English: This is a summary of the European public assessment report (EPAR) for Zyclara.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zyclara.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Zyclara is available in a different strength.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda Zyclara jiġi f'qawwa differenti.
English: The reference medicine for Zyclara is Aldara, which contains imiquimod at 5% strength.
Maltese: Il-mediċina ta' referenza għal Zyclara hija Aldara, li fiha imiquimod b'qawwa ta' 5 %.
English: Why is Zyclara approved?
Maltese: Għaliex ġie approvat Zyclara?
English: What are the risks associated with Zyclara?
Maltese: X'inhuma r-riskji assoċjati ma' Zyclara?
English: When imiquimod is applied to the skin, it acts locally on the immune system to trigger the release of cytokines, including interferon.
Maltese: Meta imiquimod jiġi applikat fuq il-ġilda, dan jaġixxi lokalment fuq is-sistema immuni biex jattiva r-rilaxx taċ-ċitokini, inkluż interferon.
English: Zyclara is available as a 3.75% cream in individual sachets.
Maltese: Zyclara jiġi bħala krema ta' 3.75 % fi qratas individwali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zyclara on 23 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zyclara fit-23 ta' Awwissu 2012.
English: Most patients using Zyclara experience side effects on the skin where the medicine was applied (most commonly redness, scab formation, dryness and shedding of the skin).
Maltese: Ħafna mill-pazjenti li jużaw Zyclara jesperjenzaw effetti sekondarji fuq il-ġilda fejn il-mediċina ġiet applikata (bl-aktar komuni ħmura, l-iffurmar ta' qoxra, nixfa u taqa' l-ġilda).
English: Zyclara has been shown to be effective in clearing actinic keratosis from the skin in two main studies involving 479 patients with actinic keratosis on the face and scalp.
Maltese: Zyclara ntwera li huwa effettiv biex ineħħi l-keratożi aktinika mill-ġilda f'żewġ studji ewlenin li involvew 479 pazjent bil-keratożi aktinika fuq il-wiċċ u l-ġilda tal-qorriegħa.
English: Two doses of Zyclara (2.5% and 3.75%) were compared with placebo (a dummy treatment) in these studies, and the main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis after treatment.
Maltese: F'dawn l-istudji, żewġ dożi ta' Zyclara (2.5 % u 3.75 %) tqabblu mal-plaċebo (kura finta) u l-kejl ewlieni tal-effettività kien in-numru ta' pazjenti li l-ġilda tagħhom fieqet kompletament mill-keratożi aktinika wara l-kura.
English: If actinic keratosis is cleared after two 2-week courses but then it comes back, it can be treated again with one or two 2-week treatment courses provided these are given after a break of at least 12 weeks from the original treatment.
Maltese: Jekk il-keratożi aktinika titneħħa wara żewġ korsijiet ta' ġimagħtejn iżda terġa' titfaċċa, din tista' terġa' tiġi kkurata b'kors wieħed jew tnejn ta' kura ta' ġimagħtejn sakemm dawn jingħataw wara waqfa ta' mill-inqas 12-il ġimgħa mill-kura oriġinali.
English: Zyclara at a lower strength (2.5%) had a lower clearance rate than the 3.75% strength.
Maltese: Zyclara b'doża aktar baxxa (2.5 %) kellu rata ta' tneħħija aktar baxxa mill-qawwa ta' 3.75 %.
English: For the full list of side effects and restrictions with Zyclara, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet bi Zyclara, ara l-fuljett ta' tagħrif.
English: Zyclara is used to treat adults whose immune system (the body's natural defences) is working normally when other skin treatments for actinic keratosis cannot be used or are less appropriate.
Maltese: Zyclara jintuża biex jikkura adulti li s-sistema immuni tagħhom (id-difiżi naturali tal-ġisem) tkun qed taħdem b'mod normali meta kuri oħrajn talġilda għall-keratożi aktinika ma jkunux jistgħu jintużaw jew ikunu inqas xierqa.
English: If actinic keratosis does not improve enough with Zyclara, a different treatment should be tried.
Maltese: Jekk il-keratożi aktinika ma titjibx biżżejjed b'Zyclara, għandha tiġi ppruvata kura differenti.
English: Around 36% of patients treated with Zyclara 3.75% cream in the two studies had complete clearance compared with around 6% of patients treated with placebo.
Maltese: Madwar 36 % tal-pazjenti kkurati bi krema Zyclara b'qawwa ta' 3.75 % fiż-żewġ studji kellhom tneħħija kompleta meta mqabbla ma' madwar 6 % tal-pazjenti kkurati bil-plaċebo.
English: Actinic keratosis is a precancerous, abnormal skin growth that develops after too much exposure to sunlight.
Maltese: Keratożi aktinika hija tkabbir anormali fuq il-ġilda, prekanċeruż li jiżviluppa wara wisq esponiment għad-dawl tax-xemx.
English: Zyclara is a cream used to treat actinic keratosis on the face and balding parts of the scalp.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tiegħu fl-UE u l-kondizzjonijiet ta' użu tiegħu.
English: What measures are being taken to ensure the safe and effective use of Zyclara?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zyclara?
English: Aortitis [rare frequency] (see section 4.4).
Maltese: Aortite [frekwenza rari] (ara sezzjoni 4.4).
English: INFORMATION IN BRAILLE UDENYCA
Maltese: INFORMAZZJONI BIL-BRAILLE UDENYCA
English: (see Figure 1).
Maltese: (ara Figura 1).
English: 0.6 ml
Maltese: INDIVIDWALI 0.6 mL
English: Millmount Healthcare Limited Block 7, City North Business Campus, Stamullen Co. Meath, K32 YD60 Ireland
Maltese: Millmount Healthcare Limited Block 7, City North Business Campus, Stamullen Co.
English: Pegfilgrastim contains sorbitol.
Maltese: Pegfilgrastim fih sorbitol.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier will be included.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku se jkun inkluż.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta 'Settembru 2018
English: Pulmonary haemorrhage2
Maltese: Emorraġija Pulmonari2
English: The adverse reactions are ranked under heading of frequency 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) and not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma klassifikati taħt intestatura ta' frekwenza bl-użu talkonvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 to <1/10), mhux komuni (1/1,000 to <1/100), rari (1/10,000 to <1/1,000), rari ħafna (<1/10,000) u mhux magħruf (ma jistax jiġi previst mid-data disponibbli).
English: UDENYCA contains the active substance pegfilgrastim.
Maltese: UDENYCA fih is-sustanza attiva pegfilgrastim.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1303/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1303/001
English: FIGURE 12 B: Insert the needle into the pinched area of the skin at a 45 to 90 degree angle (see Figure 13)
Maltese: FIGURA 12 B: Daħħal il-labra fil-parti maqrusa tal-ġilda f'angolu ta' 45 sa 90 grad (ara Figura 13)
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see section 4.4).
Maltese: Kienu rrappurtati każijiet komuni ta' lewkoċitosi (Għadd ta' Ċelluli bojod tad-Demm [WBC - White Blood Count] > 100 x 109/L) (ara sezzjoni 4.4).
English: A: Place the sealed syringe tray on a flat, clean surface and allow it to sit at room temperature for at least 30 minutes (see Figure 3).
Maltese: A: Poġġi l-pjanċa ssiġillata tas-siringa fuq superfiċje ċatt u nadif u ħalliha toqgħod f'temperatura ambjentali mill-inqas 30 minuta (ara Figura 3).
English: OTHER ERA, GmbH - Germany
Maltese: OĦRAJN ERA, GMBH - IL-ĠERMANJA
English: Transient elevations in LFT's for ALT or AST1
Maltese: Żidiet temporanji fl-LFTs għal ALT jew AST1
English: FIGURE 16
Maltese: FIGURA 16
English: • coughing up blood (haemoptysis)
Maltese: • sogħla bid-demm (haemoptysis)
English: The youngest age group (0-5 years) had a higher mean exposure to pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg·hr/ml) than older children aged 6-11 years and 12-21 years (22.0 ± 13.1 μg hr/ml and 29.3 ± 23.2 μg·hr/ml, respectively) (see section 5.1).
Maltese: Il-grupp tal-iżgħar età (0-5 snin) kellu esponiment medju ogħla għal pegfilgrastim (AUC) (± Standard Deviation) (47.9 ± 22.5 μg ·siegħa/ml) minn tfal akbar b'età ta' 6-11-il sena u 12-21 sena (22.0 ± 13.1 μg ·hr/ml u 29.3 ± 23.2 μg ·siegħa/ml, rispettivament) (ara sezzjoni 5.1).
English: • bleeding from the lung (pulmonary haemorrhage)
Maltese: • Fsada mill-pulmun (emorraġija pulmonari)
English: polysorbate 20 and water for injections.
Maltese: polysorbate 20 u ilma għall-injezzjoni.
English: The concentration is 10 mg/ml based on protein content only**.
Maltese: Ilkonċentrazzjoni hija ta' 10 mg/ml ibbażata fuq kontenut ta' proteini biss**.
English: FIGURE 8
Maltese: FIGURA 8
English: The incidence of hospitalisations and IV anti-infective use associated with a clinical diagnosis of febrile neutropenia was lower in the pegfilgrastim group compared with placebo (1% versus 14%, p < 0.001; and 2% versus 10%, p < 0.001).
Maltese: IV kontra l-infezzjonijiet assoċjati ma' dijanjosi klinika ta' newtropenija bid-deni kienet aktar baxxa fil-grupp ta' pegfilgrastim meta mqabbla mal-grupp talplaċebo (1% versus 14%, p  0.001; u 2% versus 10%, p  0.001).
English: Severe skin reactions (Stevens-Johnson syndrome) have been reported with the use of UDENYCA.
Maltese: Reazzjonijiet severi tal-ġilda (sindrome ta' Stevens-Johnson) ġew irrappurtati bl-użu ta' UDENYCA.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTURTAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: FIGURE 2
Maltese: FIGURA 2
English: White blood cell (WBC) counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving pegfilgrastim.
Maltese: Għadd ta' ċelluli bojod tad-demm (WBC - white blood cell) ta' 100 x 109/l jew aktar ġew osservati f'inqas minn 1% tal-pazjenti li kienu qed jirċievu pegfilgrastim.
English: FIGURE 5
Maltese: FIGURA 5
English: Germany
Maltese: L-Irlanda
English: UDENYCA is for use in adults aged 18 and over.
Maltese: UDENYCA huwa għall-użu f'adulti minn 18-il sena 'l fuq.
English: FIGURE 14
Maltese: FIGURA 14
English: FIGURE 15
Maltese: FIGURA 15
English: Each pre--filled syringe contains 30 mg sorbitol
Maltese: Kull siringa mimlija għal-lest fiha 30 mg sorbitol
English: FIGURE 9
Maltese: FIGURA 9
English: FIGURE 13
Maltese: FIGURA 13
English: In a phase II (n = 37) multicentre, randomised, open-label study of paediatric sarcoma patients receiving 100 μg/kg pegfilgrastim following cycle 1 of vincristine, doxorubicin and cyclophosphamide (VAdriaC/IE) chemotherapy, a longer duration of severe neutropenia (neutrophils < 0.5 x 109) was observed in younger children aged 0-5 yrs (8.9 days) compared to older children aged 6-11 years and 12-21 years (6 days and 3.7 days, respectively) and adults.
Maltese: Fi studju b'aktar minn ċentru wieħed, randomised, open-label ta' fażi II (n = 37) fuq pazjenti pedjatriċi b'sarkoma li kienu qed jirċievu 100 μg/kg pegfilgrastim wara ċiklu 1 ta' kimoterapija ta' vincristine, doxorubicin u cyclophosphamide (VAdriaC/IE), kien osservat tul itwal ta' newtropenija severa (newtrofili < 0.5 x 109) fi tfal iżgħar b'età ta' 0-5 snin (8.9 ijiem) meta mqabbel ma' tfal akbar b'età ta' 6-11-il sena u 12-21 sena (6 ijiem u 3.7 ijiem, rispettivament) u ma' adulti.
English: What UDENYCA contains - The active substance is pegfilgrastim.
Maltese: X'fih UDENYCA - Is-sustanza attiva hi pegfilgrastim.
English: The pharmacokinetics of pegfilgrastim were studied in 37 paediatric patients with sarcoma, who received 100 μg/kg pegfilgrastim after the completion of VAdriaC/IE chemotherapy.
Maltese: Il-farmakokinetika ta' pegfilgrastim kienet studjata f'37 pazjent pedjatriku b'sarkoma, li rċevew 100 μg /kg pegfilgrastim wara li temmew kimoterapija VAdriaC/IE.
English: Pegfilgrastim contains less than 1 mmol (23 mg) sodium per 6 mg dose, that is to say, essentially 'sodium-free'.
Maltese: Pegfilgrastim fih anqas minn 1 mmol (23 mg) sodium f'kull doża ta' 6 mg, jiġifieri essenzjalment 'ħieles mis-sodium'.
English: FIGURE 7
Maltese: FIGURA 7