FrancophonIA/ELRC3.0 huggingface dataset:
English: Strong complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Maltese: Reattività qawwija, kompluta, bażolaterali jew laterali fil membrana f'≥ 10 % taċ-ċelluli tat-tumur.
English: The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of 0.9 % sodium chloride solution.
Maltese: Il-ammont xieraq ta' soluzzjoni għandu jittella' mill-kunjett u jiżdied ma' borża tal-infużjoni li fiha 250 mL ta' soluzzjoni ta' 0.9 % Sodium chloride.
English: Table 4: Efficacy results from the non-comparative monotherapy and combination therapy studies Parameter
Maltese: Tabella 4: Riżultati tal-effikaċja minn studji mhux komparattivi ta' monoterapija u ta' terapija kombinata
English: The rate was highest in patients who were administered Herceptin concurrently with a taxane (2.0 %).
Maltese: Ir-rata kienet l-ogħla f'pazjenti li ngħataw Herceptin flimkien ma' taxane (2.0 %).
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm).
Maltese: Ir-rata ta' disfunzjoni kardijaka mingħajr sintomi żdiedet filgrupp ta' kura ta' sentejn (8.1 % kontra 4.6 % fil-grupp ta' kura ta' sena waħda).
English: Herceptin 600 mg solution for injection in vial Trastuzumab
Maltese: Herceptin 600 mg soluzzjoni għall-injezzjoni f'kunjett Trastuzumab
English: In the adjuvant treatment setting, Herceptin was investigated in 4 large multicentre, randomised, trials.
Maltese: Flambjent ta' trattament awżiljarju, Herceptin kien investigat f'4 provi kbar, b'aktar minn ċentru wieħed u randomised:
English: Hazard Ratio vs
Maltese: Reazzjoni avversa
English: The data suggest that beneficial effects were greater among those patients with higher levels of overexpression of HER2 (3+).
Maltese: Id-dejta tindika li effetti tajbin kienu akbar fost dawk il-pazjenti b'livelli ogħla ta' espressjoni żejda ta' HER2 (3+).
English: Neutralizing antitrastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the Herceptin intravenous arm and 3 of 47 in the Herceptin subcutaneous arm. 21.0 % of patients treated with Herceptin subcutaneous formulation developed antibodies against the excipient hyaluronidase (rHuPH20).
Maltese: 21.0 % tal-pazjenti kkurati bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin żviluppaw antikorpi kontra l-eċċipjent hyaluronidase (rHuPH20).
English: Signs and symptoms of cardiac dysfunction such as dyspnoea, orthopnoea, increased cough, pulmonary oedema, S3 gallop, or reduced ventricular ejection fraction, have been observed in patients treated with Herceptin (see section 4.4).
Maltese: Sinjali u sintomi ta' disfunzjoni kardijaka bħal qtugħ ta' nifs, qtugħ ta' nifs waqt li wieħed ikun mindud, żieda fis-sogħla, edima pulmonari, gallop S3, jew porzjon imbuttat 'il barra mill-ventriklu imnaqqsa, ikunu osservati f'pazjenti kkurati b'Herceptin (ara sezzjoni 4.4).
English: NSABP B-31 and NCCTG N9831.
Maltese: Fl-istudji NSABP B-31 u NCCTG N9831 Herceptin ingħata flimkien ma' paclitaxel, wara kimoterapija AC.
English: L-methionine
Maltese: • tbenġil
English: which was followed by - Paclitaxel 175 mg/m2 administered 3-weekly for 4 cycles,
Maltese: li kien segwit minn • Paclitaxel 175 mg/m mogħti darba kull 3 ġimgħat għal 4 ċikli,
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: Biopsy specimenstaining pattern
Maltese: Perjodu biex Trastuzumab jiġi eliminat kompletament
English: Acne
Maltese: AGC
English: Study MO22982 investigated switching between the Herceptin intravenous and Herceptin subcutaneous formulation with a primary objective to evaluate patient preference for either intravenous or the subcutaneous route of trastuzumab administration.
Maltese: Studju MO22982 investiga bidla bejn il-formulazzjoni ta' Herceptin għall-għoti fil-vini u Herceptin għall-għoti taħt il-ġilda bi skop primarju li tiġi evalwata l-preferenza tal-pazjenti għall-għoti ta' trastuzumab fil-vini jew taħt il-ġilda.
English: What Herceptin looks like and contents of the pack Herceptin is a solution for injection that is supplied in a glass vial with a butyl rubber stopper containing 5 mL (600 mg) of trastuzumab.
Maltese: Herceptin huwa soluzzjoni għall-injezzjoni li huwa disponibbli f'kunjett tal-ħġieġ b'tapp tal-lasktu butyl li fih 5 mL (600 mg) ta' trastuzumab.
English: Ataxia
Maltese: Ċiklu
English: Table 4 Efficacy Results from the Monotherapy and Combination Therapy Studies
Maltese: Tabella 4: Riżultati tal-Effikaċja mill-Istudji ta' Monoterapija u ta' Terapija Kombinata
English: The addition of Herceptin to paclitaxel chemotherapy also resulted in a 37 % decrease in the risk of death.
Maltese: Iż-żieda ta' Herceptin ma' kimoterapija b'paclitaxel irriżultat ukoll fi tnaqqis ta' 37 % fir-riskju ta' mewt.
English: - Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable).
Maltese: - Studju BO16348 kien maħsub biex iqqabbel kura b'Herceptin kull tliet ġimgħat għal sena u sentejn ma' osservazzjonijiet f'pazjenti b'EBC pożittiv għal HER2 wara kirurġija, kimoterapija stabbilita u radjuterapija (jekk applikabbli).
English: Always keep this medicine in the closed original pack at a temperature of 2ºC - 8 ºC in a refrigerator.
Maltese: Dejjem żomm din il-mediċina fil-pakkett oriġinali magħluq f'temperatura ta' 2ºC - 8 ºC fil-friġġ.
English: The extracellular domain of the receptor (ECD, p105) can be shed into the blood stream and measured in serum samples.
Maltese: Id-dominju ekstraċellulari tar-riċettur (ECD, p105 - extracellular domain, p105) jista' jmur fid-demm u jitkejjel f'kampjuni tas-serum.
English: An absolute benefit of 13 percentage points in favour of the Herceptin arm was estimated in terms of 3-year event-free survival rate (65 % versus.
Maltese: Benefiċċju assolut ta' 13-il punt perċentwali favur il-grupp ta' Herceptin kien stmat f'termini ta' rata ta' sopravivenza mingħajr avveniment ta' 3 snin (65 % kontra 52%).
English: Children and adolescents Herceptin is not recommended for anyone under the age of 18 years.
Maltese: Tfal u adolexxenti Herceptin mhux rakkomandat għall-persuni b'età inqas minn 18-il sena.
English: Roche a/s
Maltese: Roche (Hellas) A.E.
English: In the neoadjuvant-adjuvant treatment setting, study MO16432, a multicentre randomised trial, was designed to investigate the clinical efficacy of concurrent administration of Herceptin with neoadjuvant chemotherapy including both an anthracycline and a taxane, followed by adjuvant Herceptin, up to a total treatment duration of 1 year.
Maltese: Fl-ambjent ta' trattament neoawżiljarju-awżiljarju, l-istudju MO16432, prova randomized b'aktar minn ċentru wieħed, kienet maħsuba biex tinvestiga l-effikaċja klinika ta' għoti ta' Herceptin flimkien ma' kimoterapija neoawżiljarja inkluż kemm anthracycline kif ukoll taxane, segwit minn Herceptin awżiljarju, sa tul ta' kura totali ta' sena.
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in Section 4.4.
Maltese: Dettalji ta' miżuri ta' minimizzazzjoni tar-riskji li huma konsistenti mal-Pjan tal-Ġestjoni tar-Riskju tal-UE huma ppreżentati fis-Sezzjoni 4.4.
English: One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Maltese: Kunjett ta' 15 mL magħmul minn ħġieġ ċar tip I b'tapp tal-gomma butyl laminat b'kisja ta' fluororesin li fih 150 mg ta' trastuzumab.
English: New injections should be given at least 2.5 cm away from an old site.
Maltese: Injezzjonijiet ġodda għandhom jingħataw mill-inqas 2.5 ċm bogħod minn sit antik.
English: Table 16 Population Predicted PK Parameter Values at Steady State for Herceptin IV Dosing
Maltese: Tabella 16 Valuri Mbassra tal-Parametru PK tal-Popolazzjoni fi Stat Fiss għal Korsijiet ta' Dożaġg ta' Herceptin IV f'Pazjenti b'MBC, EBC u AGC
English: Herceptin is not genotoxic.
Maltese: Dawn ġeneralment huma temporanji.
English: The final OS results from the joint analysis of studies NSABP B-31 and NCCTG N9831 are summarized in Table 7:
Maltese: Ir-riżultati finali ta' OS mill-analiżi konġunta tal-istudji NSABP B-31 u NCCTG N9831 huma miġbura fil-qosor f'Tabella 7 taħt:
English: Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group (> 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment.
Maltese: Minħabba l-impatt sinifikanti tal-piż tal-ġisem fuq it-tneħħija ta' trastuzumab u l-użu ta' doża fissa għall-għoti taħt il-ġilda id-differenza fl-esponiment bejn għoti taħt il-ġilda u fil-vini kienet dipendenti fuq il-piż tal-ġisem: f'pazjenti b'piż tal-ġisem < 51 kg, l-AUC medja ta' trastuzumab fi stat fiss kienet madwar 80% ogħla wara kura taħt il-ġilda milli wara kura filvini filwaqt li fil-grupp tal-ogħla BW (> 90 kg) l-AUC kienet 20% inqas wara kura taħt il-ġilda milli wara kura fil-vini.
English: In vitro, trastuzumab-mediated
Maltese: Marda tal-interstizju tal-pulmun
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without Herceptin.
Maltese: Pazjenti li qabel kienu rċevew kimoterapija awżiljarja bbażata fuq anthracycline kienu kkurati b'paclitaxel (175 mg/m mogħti bħala infużjoni fuq medda ta' 3 sigħat) bi jew mingħajr Herceptin.
English: Subsequent Herceptin maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
Maltese: 6 mg/kg, rispettivament) għandhom jingħataw 7 ijiem jew 21 jum wara skont il-programmi ta' darba fil-ġimgħa jew ta' darba kull tliet ġimgħat, rispettivament.
English: Roche Diagnostics GmbH
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Caution is recommended with Herceptin subcutaneous formulation as severe pulmonary events have been reported with the use of the intravenous formulation in the post-marketing setting (see section 4.8).
Maltese: Kawtela hija rakkomandata bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin peress li avvenimenti pulmonari severi kienu rrappurtati bl-użu tal-formulazzjoni għall-għoti fil-vini fl-ambjent ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: In this leaflet:
Maltese: Tabella 7:
English: Although serious ARRs, including dyspnoea, hypotension, wheezing, bronchospasm, tachycardia, reduced oxygen saturation and respiratory distress, were not reported in the clinical trial with the Herceptin subcutaneous formulation, caution should be exercised as these have been associated with the intravenous formulation.
Maltese: Għalkemm ARRs serji, inkluż qtugħ ta' nifs, pressjoni baxxa, tħarħir, bronkospażmu, takikardija, saturazzjoni mnaqqsa ta' ossiġnu u distress respiratorju, ma kinux irrappurtati fil-prova klinika bilformulazzjoni għall-għoti taħt il-ġilda ta' Herceptin, għandu jkun hemm attenzjoni peress li dawn ġew assoċjati mal-formulazzjoni għall-għoti fil-vini.
English: Uncommon side effects of Herceptin: may affect up to 1 in 100 people
Maltese: Effetti sekondarji mhux komuni ta' Herceptin: jistgħu jaffettwaw sa persuna waħda minn kull 100
English: Tumour cell cluster with a faint ⁄
Maltese: Kull kartuna fiha kunjett wieħed.
English: Paclitaxel2 N=77
Maltese: N=77
English: Patients treated with Herceptin are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction.
Maltese: Pazjenti kkurati b'Herceptin huma f'riskju akbar għall-iżvilupp ta' CHF (New York Heart Association [NYHA] Klassi
English: The safety profile of Herceptin subcutaneous formulation (evaluated in 298 and 297 patients treated with the intravenous and subcutaneous formulations respectively) from the pivotal trial in EBC was overall similar to the known safety profile of the intravenous formulation.
Maltese: Il-profil ta' sigurtà ta' formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin (evalwat f'298 u 297 pazjent ikkurati bil-formulazzjoni għall-għoti fil-vini u bil-formulazzjoni għall-għoti taħt il-ġilda rispettivament) mill-prova pivitali f'EBC globalment kien simili għall-profil ta' sigurtà magħruf talformulazzjoni għall-għoti fil-vini.
English: 1Muscle tightness
Maltese: Punteġġ Dehra tat-tbajja
English: In the pivotal trial BO22227, there were more than twice as many patients reporting all grade hypertension with the Herceptin subcutaneous formulation (4.7 % versus 9.8 % in the intravenous and subcutaneous formulations respectively), with a greater proportion of patients with severe events (NCI
Maltese: BO22227, kien hemm aktar mid-dopju pazjenti li rrappurtaw pressjoni għolja ta' kull grad bil-formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin (4.7 % kontra 9.8 % fil-formulazzjonijiet għall-għoti fil-vini u għall-għoti taħt il-ġilda rispettivament), bi proporzjon akbar ta' pazjenti b'avvenimenti severi (NCI CTCAE grad ≥3) <1 % kontra 2.0 % bil-formulazzjonijiet għall-għoti filvini u għall-għoti taħt il-ġilda rispettivament.
English: In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin (intravenous formulation) was administered after anthracyclinecontaining chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin (intravenous formulation) was administered concurrently with taxanes than when administered sequentially to taxanes.
Maltese: F'pazjenti b'EBC kienet osservata żieda fl-inċidenza ta' avvenimenti kardijaċi sintomatiċi u mhux sintomatiċi meta Herceptin (formulazzjoni għall-għoti fil-vini) ingħata wara kimoterapija li fiha anthracycline meta mqabbel ma' għoti flimkien ma' kors ta' docetaxel u carboplatin li ma fihx anthracycline u kienet aktar evidenti meta Herceptin (formulazzjoni għall-għoti fil-vini) ingħata flimkien ma' taxanes milli meta ingħatat wara taxanes.
English: Common side effects of Herceptin: may affect up to 1 in 10 people
Maltese: Effetti sekondarji komuni ta' Herceptin: jistgħu jaffettwaw sa persuna waħda minn kull 10:
English: Hazard Ratio (95 % CI)
Maltese: Proporzjon ta' Periklu (CI ta' 95 %)
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fi friġġ (2ºC - 8ºC)
English: Progression free survival was doubled in the Herceptin plus anastrozole arm compared to anastrozole (4.8 months versus 2.4 months).
Maltese: Is-sopravivenza mingħajr progressjoni irduppjat fil-grupp ta' Herceptin flimkien ma' anastrozole meta mqabbel ma' anastrozole (4.8 xhur kontra 2.4 xhur).
English: Herceptin Subcutaneous
Maltese: Herceptin fil-vini
English: However, capecitabine itself showed higher concentrations and a longer half-life when combined with Herceptin.
Maltese: Madankollu, capecitabine innifsu wera konċentrazzjonijiet ogħla u half-life itwal meta kkombinat ma' Herceptin.
English: Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting.
Maltese: Herceptin u anthracyclines m'għandhomx jingħataw fl-istess waqt f'sitwazzjoni ta' kura awżiljarja.
English: Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).
Maltese: Huwa meħtieġ ittestjar għal HER2 qabel tinbeda t-terapija (ara sezzjonijiet 4.4 u 5.1).
English: The difference in serious adverse event rates between formulations was mainly due to infections with or without neutropenia (4.4 % versus 8.1 %) and cardiac disorders (0.7 % versus 1.7 %);
Maltese: Id-differenza fir-rati ta' avvenimenti avversi serji bejn il-formulazzjonijiet fil-biċċa l-kbira kienet minħabba infezzjonijiet bi jew bla newtropenija (4.4 % kontra 8.1 %) u disturbi kardijaċi (0.7 % kontra
English: • the other is given as a subcutaneous injection over 2 to 5 minutes.
Maltese: • l-ieħor jingħata bħala injezzjoni taħt il-ġilda fuq medda ta' 2 sa 5 minuti.
English: • you suffer from breathlessness., especially if you are currently using a taxane.
Maltese: • tbati minn qtugħ ta' nifs, speċjalment jekk bħalissa qed tuża taxane.
English: Combination treatment with Herceptin and anastrozole Herceptin has been studied in combination with anastrozole for first line treatment of MBC in HER2 overexpressing, hormone-receptor (i.e. estrogen-receptor (ER) and/or progesterone-receptor (PR)) positive postmenopausal patients.
Maltese: Herceptin kien studjat f'kombinazzjoni ma' anastrozole għall-kura preferita ta' MBC f'pazjenti wara lmenopawża li kienu posittivi għall-espressjoni żejda ta' HER2, għar-riċettur tal-ormon (jiġifieri riċettur ta' estrogen (ER - estrogen-receptor) u/jew riċettur ta' progesterone (PR - progesteronereceptor)).
English: The efficacy results from the BCIRG 006 are summarized in Tables 8 and 9.
Maltese: Ir-riżultati tal-effikaċja minn BCIRG 006 huma miġbura fil-qosor f'Tabelli 8 u 9.
English: Hazard Ratio versus
Maltese: Proporzjoni ta' Periklu kontra
English: Weekly dosing in metatstatic breast cancer The efficacy results from the monotherapy and combination therapy studies are summarised in Table
Maltese: Riżultati tal-Effikaċja mill-Istudji Mhux Komparattivi ta' Monoterapija u ta' Terapija Kombinata
English: After aseptic reconstitution with sterile water for injection, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C.
Maltese: Wara r-rikostituzzjoni asettika b'ilma għall-injezzjoni sterili, l-istabbiltà kimika u fiżika tas-soluzzjoni rikostitwita ġiet murija għal 48 siegħa f'temperatura ta' 2°C - 8°C.
English: In the pivotal trial (BO22227) Herceptin subcutaneous formulation was administered in the neoadjuvant/adjuvant setting in patients with early breast cancer.
Maltese: Fil-prova pivitali (BO22227) formulazzjoni għall-għoti taħt il-ġilda ta' Herceptin ingħatat f'ambjent neoawżiljarju/awżiljarju lill-pazjenti b'kanċer bikri tas-sider.
English: The majority of patients with cardiac symptoms and evidence of a clinical benefit of Herceptin treatment continued on therapy without additional clinical cardiac events.
Maltese: Il-maġġoranza tal-pazjenti b'sintomi kardijaċi u b'evidenza ta' benefiċċju kliniku ta' kura b'Herceptin komplew fuq it-terapija mingħajr aktar avvenimenti kardijaċi kliniċi.
English: Clinically significant interactions between Herceptin and the concomitant medicinal products used in clinical trials have not been observed.
Maltese: Ma kienux osservati interazzjonijiet klinikament sinifikanti bejn Herceptin u l-prodotti mediċinali mogħtija fl-istess waqt użati fil-provi kliniċi.
English: No reactivity or membranous reactivity in < 10 % of tumour cells
Maltese: L-ebda reattività jew reattività fil-membrana f'< 10 % taċċelluli tat-tumur
English: For instructions on use and handling of Herceptin subcutaneous formulation refer to section 6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni tal-formulazzjoni għall-għoti fil-vini ta' Herceptin qabel lamministrazzjoni, ara sezzjoni 6.6.
English: Early breast cancer (adjuvant setting)
Maltese: - ċikli addizzjonali ta' Herceptin awżiljarju (biex titkompla sena ta' kura)
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Herceptin, or longer if a continuous decrease of LVEF is observed.
Maltese: F'pazjenti li jirċievu kimoterapija li fiha anthracycline huwa rakkomandat aktar monitoraġġ, u dan għandu jseħħ kull sena sa 5 snin wara l-aħħar għoti ta' Herceptin, jew aktar jekk jiġi osservat tnaqqis kontinwu ta' LVEF.
English: Adjuvant treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: • bumpy rash
Maltese: L-istudji NSABP
English: The efficacy results from the joint analysis of the NSABP B-31 and NCCTG 9831 trials at the time of the definitive analysis of DFS* are summarized in Table 7.
Maltese: Ir-riżultati tal-effikaċja mill-analiżi konġunta tal-provi NSABP B-31 u NCCTG 9831 fil-ħin tal-analiżi definittiva ta' DFS* huma miġbura fil-qosor f'Tabella 7.
English: Herceptin plus paclitaxel2
Maltese: paclitaxel2
English: Herceptin subcutaneous formulation was locally and systemically well tolerated.
Maltese: Il-formulazzjoni għallgħoti taħt il-ġilda ta' Herceptin kienet ittollerata tajjeb lokalment u b'mod sistemiku.
English: Most patients who developed CHF or asymptomatic cardiac dysfunction in pivotal trials improved with standard CHF treatment consisting of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and a beta-blocker.
Maltese: Jekk tiżviluppa insuffiċjenza sintomatika tal-qalb waqt terapija b'Herceptin, għandha tiġi kkurata bi prodotti mediċinali standard għal CHF. Il-biċca l-kbira tal-pazjenti li żviluppaw CHF jew disfunzjoni kardijaka bla sintomi fil-provi pivitali marru għall-aħjar b'kura standard għal CHF li tikkonsisti minn inibitur tal-enzima li tittrasforma lill-angiotensin (ACE - angiotensin-converting enzyme) jew imblokkatur tar-riċettur ta' angiotensin (ARB - angiotensin receptor blocker) u imblokkatur tarriċetturi beta.
English: Reproductive toxicology studies with rHuPH20 revealed embryofetal toxicity in mice at high systemic exposure, but did not show teratogenic potential.
Maltese: L-aktar reazzjoni severa frekwenti kienet sensittività eċċessiva għall-mediċina.
English: carboplatin and trastuzumab; CI = confidence interval
Maltese: Nisa li jistgħu joħorġu tqal / Kontraċezzjoni
English: +Hypoxia
Maltese: Kimo +
English: Data from study JP16003, a single-arm study of Herceptin (4 mg/kg IV loading dose and 2 mg/kg IV
Maltese: Id-doża ogħla tal-bidu rakkomandata ta' Herceptin hija ta' 4 mg/kg ta' piż tal-ġisem.
English: Invented name StrengthPharmaceutical form
Maltese: Qawwa Għamla farmaċewtika
English: Further information on Nobivac LeuFel can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Nobivac LeuFel tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Nobivac LeuFel received a marketing authorisation valid throughout the EU for Nobivac LeuFel on 6 November 2017.
Maltese: Nobivac LeuFel irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-6 ta' Novembru 2017.
English: In a second study, kittens aged 8 to 9 weeks were given an initial vaccination course of a combination vaccine consisting of one dose of Feligen RCP (against feline rhinotracheitis virus, feline calici virus and feline panleucopaenia virus) with one dose of Nobivac LeuFel.
Maltese: Fit-tieni studju, frieħ ta' 8 sa 9 ġimgħat ingħataw kors ta' tilqim inizjali ta' vaċċin ta' kombinazzjoni li kien jikkonsisti minn doża waħda ta' Feligen RCP (kontra l-virus rinotrakeite tal-qtates, virus calici tal-qtates u virus panlewkopenija tal-qtates) b'doża waħda ta' Nobivac LeuFel.
English: Nobivac LeuFel (feline leukaemia inactivated vaccine)
Maltese: Nobivac LeuFel (tilqima inattivata kontra l-lewkimja tal-qtates)
English: Other information about Nobivac LeuFel
Maltese: Informazzjoni oħra dwar Nobivac LeuFel
English: Nobivac LeuFel contains small amounts of a protein from the outer layer of the virus called ‘envelope p45 protein'.
Maltese: Nobivac LeuFel fih ammonti żgħar ta' proteina mis-saff ta' barra tal-virus li tissejjaħ "proteina envelopp p45".