FrancophonIA/ELRC3.0 huggingface dataset:
English: The median duration of exposure to Imlygic was 23 weeks (5.3 months).
Maltese: Id-durata medjana tal-espożizzjoni għal Imlygic kienet ta' 23 ġimgħa (5.3 xhur).
English: No clinical studies have been performed to evaluate the effects of talimogene laherparepvec on fertility (see section 5.3).
Maltese: Ma saru l-ebda studji kliniċi biex jevalwaw l-effetti ta' talimogene laherparepvec fuq il-fertilità (ara sezzjoni 5.3).
English: There were no impacts to male or female reproductive tissues following treatment of adult mice at doses up to 4 x 108 PFU/kg (60-fold higher, on a PFU/kg basis, compared to the maximum clinical dose).
Maltese: Ma kienx hemm impatti fuq it-tessuti riproduttivi tar-raġel jew tal-mara wara t-trattament fuq ġrieden adulti f'dożi sa 4 x 108 PFU/kg (60 darba aktar, fuq bażi ta' PFU/kg, imqabbla mad-doża klinika massima).
English: Recommended dosing schedule for Imlygic
Maltese: Espożizzjoni aċċidentali għal Imlygic
English: Dyspnoea, Oropharyngeal pain, Upper respiratory tract infection
Maltese: Dispnea, Uġigħ orofarinġali, Infezzjoni fil-parti respiratorja ta' fuq
English: Prior to launch of IMLYGIC in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational and controlled distribution programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' IMLYGIC f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv u ta' distribuzzjoni kkontrollata, li jinkludi media tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħrajn tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Infectious talimogene laherparepvec virus was detected at the site of injection in 7 (11%) patients at multiple time points in the study; no samples were positive for viral infectivity after cycle 2 or after the end of treatment.
Maltese: Il-virus ta' talimogene laherparepvec ġie osservat fis-sit tal-injezzjoni f'7 (11%) pazjenti f'punti ta' żmien multipli fl-istudju; l-ebda kampjun ma' kien pożittiv għal infettività virali wara t-tieni ċiklu jew wara t-tmiem tat-trattament.
English: NAME OF THE MEDICINAL PRODUCT Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Maltese: Imlygic 108 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni talimogene laherparepvec
English: • Treat all Imlygic spills with a virucidal agent and absorbent materials.
Maltese: • Ittratta t-titjir kollu ta' Imlygic b'aġent viruċidali u b'materjali assorbenti.
English: • Thawed Imlygic is stable when stored at temperatures of 2°C up to 25°C protected from light in its original vial, in a syringe, or in the original vial followed by a syringe.
Maltese: • Imlygic maħlul huwa stabbli meta jinħażen f'temperaturi ta' 2°C sa 25°C protett mid-dawl filkunjett oriġinali tiegħu, ġewwa siringa, jew fil-kunjett oriġinali segwit minn siringa.
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 dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Gently swirl.
Maltese: Il-pazjenti kollha
English: Patients who were HSV-1 seronegative at baseline were reported to have a greater incidence of pyrexia, chills, and influenza-like illness compared with those who were HSV-1 seropositive at baseline, especially within the period of the first 6 treatments (see section 4.8).
Maltese: Il-pazjenti li kienu b'HSV-1 seronegattivi fil-linja bażi ġie rrappurtat li kellhom aktar inċidenza ta' deni, sirdat, u mard simili għall-influwenza meta mqabbla ma' dawk li kienu b'HSV-1 seropożittivi fil-linja bażi, speċjalment fil-perjodu tal-ewwel 6 trattamenti (ara sezzjoni 4.8).
English: This medicine contains genetically modified organisms.
Maltese: Din il-mediċina fiha organiżmi ġenetikament modifikati.
English: Among the Imlygic-treated responders, 56 (72%) responses were still ongoing at the time of primary analysis.
Maltese: Fost dawk li rrispondew għat-trattament b'Imlygic, 56 (72%) rispons kienu għadhom għaddejjin waqt l-analiżi primarja.
English: Overall survival
Maltese: Sopravivenza globali
English: The educational programme is aimed to inform about important risks associated with IMLYGIC:
Maltese: Il-programm edukattiv huwa mmirat biex jinforma dwar riskji importanti assoċjati ma' IMLYGIC:
English: The recommended dosing schedule for Imlygic is shown in table 1.
Maltese: L-iskeda rakkomandata ta' dożaġġ ta' Imlygic hi murija f'tabella 1.
English: The vial cap is colour coded: 106 (1 million) PFU/mL is light green and 108 (100 million) PFU/mL is royal blue.
Maltese: L-għatu tal-kunjett hu mmarkat skont il-kulur: 106 (1 miljun) PFU/mL hu aħdar ċar u 108 (100 miljun) PFU/mL hu blu qawwi.
English: Pyrexia, chills, and influenza like illness, which can occur any time during Imlygic treatment, generally resolved within 72 hours.
Maltese: Id-deni, is-sirdat, u lmard simili għall-influwenza, li jista' jfeġġ fi kwalunkwe ħin waqt it-trattament b'Imlygic, ġeneralment jiġi riżolt fi 72 siegħa.
English: In an in vivo study of intracerebral injection, talimogene laherparepvec was 10,000-fold less neurovirulent as compared to the wild-type HSV-1 dose that results in death 50% of the time in mice.
Maltese: Fi studju in vivo ta' injezzjoni ġol-moħħ, talimogene laherparepvec kien 10,000 darba inqas newrovirulenti meta mqabbel mad-doża HSV-1 tat-tip selvaġġ li rriżultat f'mewt f'50% tad-drabi filġrieden.
English: All patients
Maltese: TA' EĊĊIPJENTI
English: Package leaflet: Information for the patient Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection talimogene laherparepvec
Maltese: Informazzjoni għall-pazjent Imlygic 106 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni Imlygic 108 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni talimogene laherparepvec
English: Thawed Imlygic may be stored prior to administration (see section 6.3).
Maltese: Imlygic maħlul jista' jinħażen qabel ma jingħata (ara sezzjoni 6.3).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi) Komuni
English: Acyclovir and other anti-viral agents may interfere with the effectiveness of Imlygic if administered systemically or topically directly to the injection site.
Maltese: Acyclovir u sustanzi antivirali oħra jistgħu jinterferixxu mal-effettività ta' Imlygic jekk jingħata b'mod sistemiku jew topiku direttament fis-sit tal-injezzjoni.
English: Of the enrolled patients, 22% had stage IV M1c disease and 53% of patients had received prior therapy for melanoma such as chemotherapy and cytokine-based immunotherapy in addition to surgery, adjuvant therapy or radiation.
Maltese: Il-maġġoranza tal-pazjenti, 98%, kienu Kawkażi. 57% tal-popolazzjoni talistudju kienu pazjenti rġiel u 70% tal-pazjenti kienu fi stat ta' prestazzjoni ECOG 0 fil-linja bażi. Millpazjenti, 22% kellhom marda fi stadju IV M1c u 53% tal-pazjenti kienu rċivew diġà terapija għallmelanoma bħal kimoterapija u immunoterapija bbażata fuq ċitokini b'żieda mal-kirurġija, terapija awżiljarja, jew radjazzjoni.
English: No clinical studies have been conducted to evaluate the effect of hepatic or renal impairment on the pharmacokinetics of talimogene laherparepvec.
Maltese: Ma sarux studji kliniċi li jevalwaw l-effett ta' indeboliment epatiku jew renali fuq il-farmakokinetika ta' talimogene laherparepvec.
English: Ear pain
Maltese: U LUŻU
English: GM-CSF was administered subcutaneously at 125 µg/m2 delivered daily for 14 days followed by a 14-day rest period in repeating intervals.
Maltese: GM-CSF ingħata taħt il-ġilda f'doża ta' 125 µg/m2 kuljum għal 14-il jum u mbagħad b'waqfa ta' 14-il jum f'intervalli ripetuti.
English: Imlygic injection volume
Maltese: L-injezzjoni anestetika tista'
English: Based on animal data, patients who are severely immunocompromised may be at an increased risk of disseminated herpetic infection and should not be treated with Imlygic (see sections 4.3 and 5.3).
Maltese: Permezz ta' studji fuq l-annimali, ilpazjenti li huma immunokompromessi b'mod sever jistgħu jkunu f'riskju ikbar ta' tixrid ta' infezzjoni erpetika u m'għandhomx jiġu ttrattati b'Imlygic (ara sezzjonijiet 4.3 u 5.3).
English: Imlygic 106 plaque forming units (PFU)/mL solution for injection Imlygic 108 plaque forming units (PFU)/mL solution for injection
Maltese: Imlygic 106 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni Imlygic 108 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni
English: Cellulitis and systemic bacterial infection have been reported.
Maltese: Iċ-ċellulite u l-infezzjoni batterjali sistemika ġew irrappurtati.
English: No data are available.
Maltese: Id-dejta mhix disponibbli.
English: Imlygic 108 plaque forming units (PFU)/mL solution for injection Each vial contains 1 mL deliverable volume of Imlygic at a nominal concentration of 1 x 108 (100 million) plaque forming units (PFU)/mL.
Maltese: Imlygic 106 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni Kull kunjett fih 1 mL volum li jista' jingħata ta' Imlygic f'konċentrazzjoni nominali ta' 1 x 106 (1 miljun) unità li tifforma plakka (plaque forming units, PFU)/mL Imlygic 108 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni Kull kunjett fih 1 mL volum li jista' jingħata ta' Imlygic f'konċentrazzjoni nominali ta' 1 x 108 (100 miljun) unità li tifforma plakka (PFU)/mL.
English: Viral activity was measured in samples that were positive for talimogene laherparepvec DNA from the injection site, occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions.
Maltese: L-ebda attività virali ma ġiet osservata f'kampjuni tal-infaxxaturi okklussivi, il-mukuża tal-ħalq, l-erja anoġenitali, u leżjonijiet erpetiċi ssuspettati.
English: Some people taking Imlygic have developed inflammation in the kidneys (glomerulonephritis), narrowing or blockage of blood vessels (vasculitis), swelling of the lungs (pneumonitis), worsening skin scaling (psoriasis), and areas of skin without any colour (vitiligo).
Maltese: Xi wħud li jieħdu Imlygic żviluppaw infjammazzjoni fil-kliewi (glomerulonefrite), tidjiq jew imblukkar tal-arterji tad-demm (vaskulite), nefħa fil-pulmun (pnewmonite), tqaxxir aggravat tal-ġilda (psorjażi), u nuqqas ta' lewn f'xi partijiet tal-ġisem (vitiligo).
English: Accidental exposure may lead to transmission of Imlygic and herpetic infection.
Maltese: Espożizzjoni aċċidentali tista' twassal għal trażmissjoni ta' Imlygic u għal infezzjoni erpetika.
English: Keratitis herpetic Ear and labyrinth disorders Common
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Komuni
English: Imlygic 108 plaque forming units (PFU)/mL solution for injection Semi-translucent to opaque liquid following thaw from its frozen state.
Maltese: Imlygic 108 unità li tifforma plakka (PFU)/mL soluzzjoni għall-injezzjoni Likwidu semitrasluċidu għal opak wara li jkun inħall mill-istat tal-friża tiegħu.
English: Doses up to 4 mL at a concentration of 108 PFU/mL every 2 weeks have been administered in clinical trials with no evidence of dose limiting toxicity.
Maltese: Dożi sa 4 mL f'konċentrazzjoni ta' 108 PFU/mL kull ġimagħtejn ingħataw fi provi kliniċi bl-ebda evidenza ta' tossiċità li tillimita d-doża.
English: Healthcare professionals and close contacts (e.g. household members, caregivers, sex partners or persons sharing the same bed) should avoid direct contact with injected lesions or body fluids of treated patients during the entirety of the treatment period and up to 30 days after the last treatment administration (see section 6.6).
Maltese: Ilprofessjonisti tal-kura tas-saħħa u dawk li jkunu f'kuntatt mill-qrib magħhom (eż. il-membri tad-dar, dawk li jagħtu l-kura, sħab sesswali jew persuni li jkunu fl-istess sodda magħhom) għandhom jevitaw kuntatt dirett ma' feriti injettati jew fluwidi mill-ġisem ta' pazjenti ttrattati matul il-perjodu sħiħ tattrattament u sa 30 jum wara l-aħħar trattament (ara sezzjoni 6.6).
English: The mean (SD) treatment duration for the intent-to-treat (ITT) population was 15.76 weeks (15.79) in the GM-CSF arm and 26.83 weeks (18.39) in the Imlygic arm.
Maltese: 76 ġimgħat (15.79) fil-każ ta' GM-CSF u 26.
English: Disseminated herpetic infection may also occur in immunocompromised patients (such as those with HIV/AIDS, leukaemia, lymphoma, common variable immunodeficiency, or who require chronic high-dose steroids or other immunosuppressive agents).
Maltese: It-tixrid ta' infezzjoni erpetika jista' jsir ukoll minn pazjenti immunokompromessi (bħal dawk bl-HIV/AIDS, lewkimja, limfoma, immunodefiċjenza komuni varjabbli, jew li jeħtieġu sterojdi kroniċi b'doża għolja jew sustanzi immunosoppressivi oħra).
English: • Shortness of breath (dyspnoea), upper respiratory infection
Maltese: • Qtugħ ta' nifs (dispnea), infezzjoni fil-parti respiratorja ta' fuq
English: • Muscle pain (myalgia), painful/swollen joints (arthralgia), limb pain
Maltese: • Uġigħ fil-muskoli (majalġja), Uġigħ/nefħa fil-ġogi (artralġja), uġigħ fir-riġlejn jew id-dirgħajn
English: Inform your healthcare professional if you have a history of blood cancer including multiple myeloma.
Maltese: Informa lill-professjonist tal-kura ta' saħħtek jekk għandek storja mgħoddija ta' kanċer tad-demm, inkluż mijeloma multipla.
English: Imlygic may cause autoimmune reactions (an over-reaction of the body's immune system).
Maltese: Imlygic jista' jikkawża reazzjonijiet immuni (reazzjoni żejda fis-sistema immunitarja tal-ġisem).
English: The vial cap is colour coded: 106 PFU/mL is light green and 108 PFU/mL is royal blue.
Maltese: L-għatu tal-kunjett hu mmarkat skont il-kulur: 106 PFU/mL hu aħdar ċar u 108 PFU/mL hu blu qawwi.
English: Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a foetus or neonate contracts the wild type herpes infection.
Maltese: Infezzjonijiet b'HSV-1 ta' tip selvaġġ ġew assoċjati ma' effetti avversi serji, li jinkludu insuffiċjenza multiorganika u mewt, jekk il-fetu jew it-tarbija tat-twelid jieħdu infezzjoni tal-erpete tat-tip selvaġġ.
English: • Trained HCPs and support personnel regarding safe and appropriate storage, handling, and administration of IMLYGIC, and clinical follow-up for patients treated with IMLYGIC;
Maltese: • HCPs mħarrġa u staff ta' appoġġ fir-rigward ta' ħażna sigura u adattata, immaniġġjar, u l-għoti ta' IMLYGIC, u follow-up kliniku għal pazjenti kkurati b'IMLYGIC;
English: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with Imlygic (see section 4.6).
Maltese: In-nisa b'potenzjal li jkollhom it-tfal għandhom ikunu mwissija biex jużaw metodu effettiv ta' kontraċezzjoni ħalli jipprevenu t-tqala waqt it-trattament b'Imlygic (ara sezzjoni 4.6).
English: Thawing Imlygic vials
Maltese: Kif jingħata Imlygic
English: This is a weakened form of herpes simplex virus type-1 (HSV-1), which is commonly called the cold sore virus.
Maltese: Din hi għamla dgħajfa ta' tip-1 ta' herpes simplex virus (HSV-1), li komunement jissejjaħ il-virus li jikkaġuna l-ponot.
English: Single-use vial permanently inserted into a clear copolyester plastic sleeve
Maltese: Kunjett li jintuża darba mdaħħal b'mod permanenti ġo tubu trasparenti magħmul minn kopoliester plastik
English: Healthcare professionals who are immunocompromised or pregnant should not administer Imlygic and should not come into direct contact with the Imlygic injection site(s) or body fluids of treated patients (see sections 4.3 and 4.4).
Maltese: Il-professjonisti tal-kura tas-saħħa li huma immunokompromessi jew tqal b'tarbija m'għandhomx jagħtu Imlygic u m'għandhomx jiġu f'kuntatt dirett mas-sit(i) tal-injezzjoni Imlygic jew ma' fluwidi tal-ġisem ta' pazjenti ttrattati (ara sezzjonijiet 4.3 u 4.4).
English: No pharmacokinetic studies using talimogene laherparepvec have been conducted in special populations.
Maltese: Ma sarux studji farmakokinetiċi bl-użu ta' talimogene laherparepvec f'popolazzjonijiet speċjali.
English: Dehydration
Maltese: Deidradazzjoni
English: No overall differences in safety or efficacy were observed between elderly (≥ 65 years old) and younger adult patients.
Maltese: Ma kinux osservati differenzi fis-sigurtà jew l-effikaċja ta' bejn l-anzjani (≥ 65 sena) u pazjenti adulti iżgħar.
English: These events were reported more frequently within the period of the first 6 treatments, particularly in patients who were HSV-1 negative at baseline.
Maltese: Dawn l-avvenimenti ġew irrappurtati aktar fil-perjodu tal-ewwel 6 trattamenti, partikolarment f'pazjenti li kienu b'HSV-1 negattiv fil-linja bażi.
English: Determining Imlygic dose volume (per lesion)
Maltese: Il-visti tattrattament sussegwenti kollha (inkluż ilbidu millġdid)
English: Imlygic is provided in single use vials of 1 mL each in two different concentrations:
Maltese: Imlygic hu pprovdut f'kunjetti li jintużaw darba ta' 1 mL, kull wieħed f'żewġ konċentrazzjonijiet differenti:
English: • Dispose of all materials that have come in contact with Imlygic (e.g. vial, syringe, needle, any cotton or gauze) in accordance with local institutional procedures.
Maltese: • Armi kull materjal li jkun intmess b'Imlygic (eż. il-kunjett, is-siringa, il-labra, kwalunkwe tajjara jew garża) skont il-proċeduri istituzzjonali lokali.
English: Talimogene laherparepvec was also quantified in selected patient samples in clinical studies using viral infectivity assays at the injection sites and in some cases of potential herpetic lesions.
Maltese: Talimogene laherparepvec kien ikkwantifikat ukoll f'kampjuni magħżula ta' pazjenti fi studji kliniċi bl-użu ta' assaġġi tal-infettività virali fis-siti tal-injezzjoni u f'xi każi ta' feriti erpetiċi potenzjali.
English: • The injection site may be treated with a topical anaesthetic agent.
Maltese: • Is-sit tal-injezzjoni jista' jitnaddaf b'sustanza topika anestetika.
English: Unopened vial
Maltese: Reazzjonijiet awtoimmuni
English: Adverse reactions were determined based on clinical trials in patients with melanoma treated with Imlygic compared to GM-CSF and post-marketing experience.
Maltese: Ġew determinati reazzjonijiet avversi abbażi ta' provi kliniċi f'pazjenti bil-melanoma ttrattati b'Imlygic imqabbla ma' GM-CSF, u esperjenza ta' wara t-tqegħid fis-suq.
English: • Patients with a history of hypersensitivity to talimogene laherparepvec or any of its excipients.
Maltese: • Pazjenti bi storja medika ta' sensittività eċċessiva għal talimogene laherparepvec jew għal kwalunkwe wieћed mill-eċċipjenti tiegħu.
English: The following activities should be avoided: Sexual intercourse without a latex condom Kissing if either party has an open mouth sore Common usage of cutlery, crockery, and drinking vessels Common usage of injection needles, razorblades and toothbrushes; o Adequate waste disposal and decontamination, following the recommendations for disposal of biohazardous waste.
Maltese: L-attivitajiet li ġejjin għandhom jiġu evitati: Kopulazzjoni sesswali mingħajr kondom tal-latex Bews, jekk xi ħadd miż-żewġ persuni jkollu ferita miftuħa fil-ħalq Użu komuni ta' pożati, platti/borom eċċ., u reċipjenti tax-xorb Użu komuni ta' labar tal-injezzjoni, xfafar u xkupilji tas-snien; o Rimi adegwat tal-iskart u dekontaminazzjoni, skont ir-rakkomandazzjonijiet għar-rimi ta' skart bijoperikoluż.
English: Pregnant women, neonates, and immunocompromised individuals should not be exposed to potentially contaminated materials.
Maltese: Nisa tqal, trabi tat-twelid, u individwi immunokompromessi m'għandhomx jiġu esposti għal materjali potenzjalment ikkontaminati.
English: Kaplan-Meier Percent Alive
Maltese: Perċentwal ta‘ Sopravivenza (Kaplan-Meier)
English: o the storage time in the syringe at ambient temperature up to 25°C cannot exceed 2 hours for 106 (1 million) PFU/mL and 4 hours for 108 (100 million) PFU/mL (see table 7).
Maltese: • Jekk taħżen Imlygic maħlul fil-kunjett oriġinali segwit minn siringa: o għandha tinżamm l-istess firxa ta' temperatura tul il-ħażna sal-għoti. o il-ħin tal-ħażna fis-siringa f'temperatura ambjentali sa 25°C ma tistax taqbeż 2 sigħat għal 106 (1 miljun) PFU/mL u 4 sigħat għal 108 (100 miljun) PFU/mL (ara tabella 7). o il-ħin massimu kumulattiv tal-ħażna (ħin ta' ħażna f'kunjett flimkien mal-ħin ta' ħażna f'siringa) ma jistax jaqbeż t-tul speċifikat f'tabella 8.
English: • In the event of an accidental occupational exposure to Imlygic (e.g. through a splash to the eyes or mucous membranes) during preparation or administration, flush with clean water for at least 15 minutes.
Maltese: • F'każ ta' espożizzjoni aċċidentali okkupazzjonali għal Imlygic (eż. b'titjir fl-għajnejn jew fir-riti mukużi) waqt il-preparazzjoni jew l-għoti, laħlaħ b'ilma nadif għal mill-inqas 15-il minuta.
English: The safety and efficacy of Imlygic monotherapy compared with subcutaneously administered GM-CSF were evaluated in a phase 3, multinational, open-label, and randomised clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable.
Maltese: Is-sigurtà u l-effikaċja tal-monoterapija b'Imlygic imqabbla mal-għoti taħt il-ġilda ta' GM-CSF ġew evalwati fi studju kliniku ta' fażi 3, multinazzjonali, bit-tikketta tingħaraf, u b'mod każwali fuq pazjenti bi stadju IIIB, IIIC, u IV ta' melanoma li ma kinitx meqjusa li tista' titneħħa b'operazzjoni.
English: • Pain, redness, bleeding, swelling, inflammation, secretion, discharge, and warmth at the injection site
Maltese: • Uġigħ, ħmura, dmija, nefħa, infjammazzjoni, tnixxija, rilaxx, u sħana fis-sit tal-injezzjoni
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Maltese: L-effett addittiv ta' prodotti li fihom is-sorbitol (jew il-fruttożju) amministrati fl-istess ħin u l-konsum fid-dieta ta' sorbitol (jew fruttożju) għandhom jitqiesu.
English: • Faster heart rate at rest (tachycardia)
Maltese: Tul ta' żmien tarrispons (rispons kontinwu fl-aħħar evalwazzjoni tattumur)
English: Overall, ninety eight per cent (98%) of these adverse reactions reported were mild or moderate in severity.
Maltese: Fuq kollox, tmienja u disgħin fil-mija (98%) ta' dawn ir-reazzjonijiet avversi rrappurtati kienu ħfief jew moderati fis-severità.
English: * See description of selected adverse reactions
Maltese: * Ara d-deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Patients with no prior herpes infection
Maltese: Ilma għall-injezzjonijiet
English: Wound complication, Wound secretion, Contusion, Procedural pain § Injection site reactions include: very common term of injection site pain, common terms of injection site erythema, injection site haemorrhage, injection site swelling, injection site reaction, injection site inflammation, secretion discharge, injection site discharge, uncommon term of injection site warmth.
Maltese: Uġigħ fid-dahar, Uġigħ fil-parti ta' bejn iż-żaqq u n-naħa ta' fuq tal-koxxa Disturbi ġenerali u kundizzjonijiet ta' mnejn ingħatat l-injezzjoni Komuni ħafna Mard li jixbah l-influwenza*, Deni, Sirdat, Għeja, Uġigħ, Reazzjonijiet fis-sit talinjezzjoni§
English: Weight decreased
Maltese: Tqala u treddigħ
English: 6.3 Shelf life
Maltese: 4.1 xhur
English: *Monensin 32.4 g (equivalent to 35.2 g monensin sodium).
Maltese: *Monensin 32.4 g (ekwivalenti għal 35.2 g ta' monensin sodium).
English: EU Number
Maltese: Numru ta' l-UE
English: Packaging Content
Maltese: Daqs talpakkett
English: Route of administration
Maltese: Mod ta' Amministrazzj oni
English: Withdrawal period intraruminal device
Maltese: Speċi li fuqhom għandu jintuża lprodott
English: Pack age size
Maltese: Ippakkja r
English: Ref.: EMEA/442332/2009 EMEA/H/C/552
Maltese: EMEA/442324/2009 EMEA/H/C/552