FrancophonIA/ELRC3.0 huggingface dataset:
English: The pre-filled syringe can be supplied with either a ceramic coated treatment (CCT) of the luer tip or with a plastic rigid tip cap (PRTC) luer lock adaptor.
Maltese: Is-siringa mimlija għal-lest tista' tkun fornuta jew bi trattament miksi biċ-ċeramika (CCT, ceramic coated treatment) tat-tapp luer jew bl-għatu tat-tapp tal-plastik riġidu (PRTC, plastic rigid tip cap).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OF 50 (5 X 10) (OUTER WRAPPER LABEL TO BE APPLIED ON TRANSPARENT FOIL, INCLUDING BLUE BOX)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA PAKKETT MULTIPLU TA' 50 (5 X 10) (TIKKETTA TAT-TGEŻWIRA TA' BARRA LI GĦANDHA TIĠI APPLIKATA FUQ FOJL TRASPARENTI, INKLUŻ
English: Pack sizes of 1 and 10 with or without needles and a multipack of 5 packs, each containing 10 vials and 10 pre-filled syringes, without needles.
Maltese: Daqsijiet tal-pakketti ta' 1 u 10 bil-labar jew mingħajr labar u pakkett multiplu ta' 5 pakketti, kull wieħed fih 10 kunjetti u 10 siringi mimlijin għal-lest, mingħajr labar.
English: Infanrix hexa should not be given:
Maltese: X'fih Infanrix hexa Is-sustanzi attivi huma:
English: Syringe barrel
Maltese: Tubu tas-siringa
English: Uncommon Upper respiratory tract infection
Maltese: Mhux komuni Infezzjoni fil-parti ta' fuq tal-apparat respiratorju
English: Needle protector
Maltese: Vaċċinazzjoni booster
English: 10 vials and 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Maltese: 10 kunjetti 10 siringi mimlija għal-lest + 20 labra
English: months N= 196 (2 studies)
Maltese: 2-3-4 xhur N= 196 (2 studji)
English: Anaphylactic reactions2, anaphylactoid reactions (including urticaria)2
Maltese: Reazzjonijiet anafilattiċi2, reazzjonijiet anafilattojdi (li jinkludu urtikarja)2,
English: When Infanrix hexa was co-administered with MenB and pneumococcal conjugate vaccines, inconsistent results were seen across studies for responses to inactivated poliovirus type 2, pneumococcal conjugate serotype 6B antigen and to the pertussis pertactin antigen but these data do not suggest clinically significant interference.
Maltese: poljovirus tip 2 mhux attivat u għall-antiġen pertussis pertactin iżda din id-dejta ma tissuġġerix interferenza klinikament sinifikanti.
English: Multipack comprising 5 packs, each containing 10 vials and 10 pre-filled syringes without needles 50 x 1 dose (0.5 ml)
Maltese: Siringa mimlija għal-lest: suspensjoni Pakkett multiplu li fih 5 pakketti, kull wieħed fih 10 kunjetti u 10 siringi mimlija għal-lest mingħajr labar 50 x 1 dose (0.5 ml)
English: The immunogenicity of Infanrix hexa was evaluated across three studies including approximately 300 preterm infants (born after a gestation period of 24 to 36 weeks) following a 3-dose primary vaccination course at 2, 4 and 6 months of age.
Maltese: L-immunoġeniċità ta' Infanrix hexa kienet evalwata fi tliet studji li jinkludu madwar 300 tarbija li twieldu qabel iż-żmien (li twieldu wara perjodu ta' ġestazzjoni ta' 24 sa 36 ġimgħa) wara kors ta' vaċċinazzjoni ta' 3 dożi f'2, 4 u 6 xhur ta' età.
English: GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00 info.lt@gsk.com
Maltese: +370 5 264 90 00 info.lt@gsk.com
English: Infanrix hexa is indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b.
Maltese: Infanrix hexa hija indikata għat-tilqim primarju u tilqim booster għal trabi u trabi li jkunu telqu jimxu kontra d-difterite, tetnu, pertussis (sogħla konvulsiva), epatite B, poljomelite u mard ieħor kkawżat minn Haemophilus influenzae tip b.
English: A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Infanrix hexa.
Maltese: Tfal (SIDS), fil-passat mediku tal-familja, ma jfissirx li l-użu ta' Infanrix hexa huwa kontraindikat.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Maltese: Ir-risponsi immuni ma kinux affettwati.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity after primary and booster vaccination with Infanrix hexa
Maltese: Persentaġġ ta' individwi b'titri ta' antikorpi indikattivi ta' seroprotezzjoni / seropożittività xahar wara vaċċinazzjoni primarja u booster b'Infanrix hexa
English: Collapse or shock-like state (hypotonichyporesponsive episode)2
Maltese: Kollass jew stat bħal f'xokk (episodju ipotoniku iporisponsiv)2
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with plunger stopper (butyl).
Maltese: Suspensjoni għall-injezzjoni f`siringa mimlija għal-lest (ħġieġ tat-tip I) (0.5 ml) b'tapp għall-planġer (butyl).
English: The vaccine may contain traces of formaldehyde, neomycin and polymyxin which are used during the manufacturing process (see section 4.3).
Maltese: 4propogati f'ċelloli VERO It-tilqima jista' jkun fiha traċċi ta' formalina, neomycin u polymyxin li jintużaw waqt il-proċess tal-manifattura (ara sezzjoni 4.3).
English: In a clinical study in which some of the vaccinees received a booster dose of Infanrix hexa concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine, fever ≥ 38.0°C was reported in 76.6% of children receiving MMRV vaccine and Infanrix hexa at the same time, as compared to 48% of children receiving Infanrix hexa alone and 74.7% of children receiving MMRV vaccine alone.
Maltese: Fi studju kliniku li fih xi wħud mill-persuni mlaqqmin rċevew doża booster ta' Infanrix hexa flimkien ma' vaċċin kontra l-ħosba-gattone-rubella-varicella (MMRV), deni ≥ 38.0°C kien irrapportat fi 76.6%
English: • Infanrix hexa will be given as an injection into a muscle.
Maltese: • Infanrix hexa tingħata bħala injezzjoni ġol-muskolu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hib for Infanrix hexa
Maltese: Hib għal Infanrix hexa
English: Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions (with or without fever) and HHE when comparing groups which reported use of Infanrix hexa with Prevenar 13 to those which reported use of Infanrix hexa alone.
Maltese: konvulżjonijiet (b'deni jew mingħajr deni) u HHE meta l-gruppi li rrapportaw l-użu ta' Infanrix hexa ma' Prevenar 13 tqabblu ma' dawk li rrapportaw l-użu ta' Infanrix hexa waħdu.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 2-dose primary and booster vaccination with Infanrix hexa
Maltese: Persentaġġ ta' individwi b'titri ta' antikorpi indikattivi ta' seroprotezzjoni/seropożittività xahar wara vaċċinazzjoni primarja ta' 2 dożi u booster b'Infanrix hexa
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine): bronchitis, rash, swollen glands in the neck, armpit or groin (lymphadenopathy), bleeding or bruising more easily than normal (thrombocytopenia), in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination, temporarily stopping breathing (apnoea), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), swelling of the whole injected limb, blisters.
Maltese: (limfadeneopatija), emorraġiji jew tbenġil aktar malajr mis-soltu (tromboċitopenija), fi trabi li jitwieldu ħafna qabel iż-żmien (fit-28 ġimgħa ta' tqala jew qabel) jista' jkun hemm perjodi itwal minnormal bejn nifs u ieħor għal 2-3 ijiem wara t-tilqima, waqfien temporanju ta' teħid tan-nifs (apnea), nefħa fil-wiċċ, fix-xufftejn, fil-ħalq, fl-ilsien jew fil-griżmejn li tista' tikkawża diffikultà biex wieħed jibla' jew biex jieħu n-nifs (anġjoedima), nefħa tad-driegħ/tal-riġel kollu injettat, infafet.
English: Percentage of subjects with antibody titres indicative of seroprotection / seropositivity one month after 3-dose primary and booster vaccination with Infanrix hexa
Maltese: Persentaġġ ta' individwi b'titri ta' antikorpi indikattivi ta' seroprotezzjoni/seropożittività xahar wara vaċċinazzjoni primarja ta' 3 dożi u booster b'Infanrix hexa
English: After a complete vaccination according to a 2-dose primary and booster schedule with Infanrix hexa, at least 97.9% of the subjects had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Maltese: Wara vaċċinazzjoni kompluta skont skeda ta' doża primarja ta' 2 dożi u booster b'Infanrix hexa, mill-inqas 97.9% tal-individwi kienu żviluppaw livelli ta' antikorpi seroprotettivi jew seropożittivi kontra kull wieħed mill-anitiġeni tal-vaċċin.
English: The active substances are: Diphtheria toxoid1
Maltese: Toxoid tad-Difterite1
English: Immunogenicity
Maltese: effikaċja
English: Polio can make the muscles unable to move (paralysis).
Maltese: Il-poljo tista' twaqqaf il-muskoli milli jiċċaqalqu (paraliżi).
English: However, as the immune response to pertussis antigens following Infanrix hexa administration is equivalent to that of Infanrix (DTPa), the protective efficacy of the two vaccines is expected to be equivalent.
Maltese: Madankollu, billi r-rispons immuni għal antiġeni ta' pertussis wara it-tehid ta' Infanrix hexa huma ekwivalenti għal dawk ta' Infanrix (DTPa), l-effikaċja protettiva taż-żewġ vaċċini hija mistennija li tkun l-istess.
English: Syringe
Maltese: Pajjiż
English: Data from one clinical study indicate that when Infanrix hexa is co-administered with MMRV vaccine, the rate of febrile reactions is higher compared to that occurring following the administration of Infanrix hexa alone and similar to that occurring following the administration of MMRV vaccine alone (see sections 4.4 and 4.8).
Maltese: Dejta klinika tindika li Infanrix hexa jista' jingħata għal trabi li jitwieldu qabel iż-żmien, madankollu, kif mistenni f'din il-popolazzjoni, ġie osservat rispons immunitarju aktar baxx għal xi antiġeni (ara sezzjoni 4.8 u sezzjoni 5.1).
English: According to different studies, immune response to the PRP antigen of Infanrix hexa after 2 doses given at 2 and 4 months of age will vary if co-administered with a tetanus toxoid conjugate vaccine.
Maltese: Skont studji differenti, ir-rispons immuni għall-antiġen PRP ta' Infanrix hexa wara 2 dożi mogħtija f'2 u 4 xhur ser ivarjaw jekk jingħata flimkien ma' vaċċin konjugat tat-toxoid tat-tetnu.
English: GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 9218 111
Maltese: Tel:+ 39 (0)45 9218 111
English: • As with all vaccines, Infanrix hexa may not fully protect all children who are vaccinated.
Maltese: • Bħal b'kull tilqim ieħor, Infanrix hexa jista' ma jipproteġix kompletament lit-tfal kollha li jitlaqqmu.
English: • if after previously having Infanrix hexa or another vaccine against whooping cough, your child had any problems, especially: - a high temperature (over 40°C) within 48 hours of vaccination - a collapse or “shock-like” state within 48 hours of vaccination - persistent crying lasting 3 hours or more within 48 hours of vaccination - fits with or without a high temperature within 3 days of vaccination
Maltese: - deni għoli ('l fuq minn 40° C) fi żmien 48 siegħa mit-tilqima - kollass jew stat qisu ta' xokk fi żmien 48 siegħa mit-tilqima - biki persistenti li jdum tlett sigħat jew aktar fi żmien 48 siegħa mit-tilqima - aċċessjonijiet b`deni għoli jew mingħajru fi żmien 3 ijiem mit-tilqima
English: After a 3-dose primary vaccination schedule, at least 95.7% of infants had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Maltese: Wara skeda ta' vaċċinazzjoni primarja ta' 3 dożi, tal-inqas 95.7% tat-trabi żviluppaw livelli ta' antikorpi seroprotettivi jew seropożittivi kontra kull wieħed mill-antiġeni tal-vaċċin.
English: - formaldehyde.
Maltese: Mediċini.
English: The other ingredients are:
Maltese: DATA TA' SKADENZA JIS:
English: In extremely rare cases the following side effects have been reported with hepatitis B vaccine: paralysis, numbness or weakness of the arms and legs (neuropathy), inflammation of some nerves, possibly with pins and needles or loss of feeling or normal movement (Guillain-Barré syndrome), swelling or infection of the brain (encephalopathy, encephalitis), infection around the brain (meningitis).
Maltese: paraliżi, tnemnim jew dgħjufija tal-idejn u s-saqajn (newropatija), infjammazzjoni ta' xi nervituri, possibbilment tniġġiż jew telf ta' sensazzjoni jew moviment normali (sindrome ta' Guillain-Barré),
English: In a follow-up study conducted in 74 children, approximately 2.5 to 3 years after the booster dose, 85.3% of the children were still seroprotected against hepatitis B and at least 95.7% were seroprotected against the three poliovirus types and PRP.
Maltese: 3% tat-tfal kienu għadhom seroprotetti kontra l-epatite B u tal-inqas 95.7% kienu seroprotetti kontra t-tliet tipi ta' poljovirus u PRP.
English: Due to an increased risk of fever, pain at the injection site, appetite lost and irritability when Infanrix hexa was co-administered with MenB vaccine and 7-valent pneumococcal conjugate vaccine, separate vaccinations can be considered when possible.
Maltese: Minħabba riskju ta' deni, uġigħ fis-sit tal-injezzjoni, telf ta' aptit u irritabilità meta Infanrix hexa ngħata flimkien mal-vaċċin MenB u vaċċin tal-konjugat pnewmokokkali 7-valenti, fejn possibbli,
English: 4propagated in VERO cells
Maltese: 4propogati f'ċelloli VERO
English: • Instructions for use of pre-filled syringe if supplied with a PRTC luer lock adaptor
Maltese: • Tużax din it-tilqima wara d-data ta' meta tiskadi li tidher fuq il-kartuna.
English: (polyribosylribitol phosphate) 2 conjugated to tetanus toxoid as carrier protein approximately 25 micrograms
Maltese: 2 konjugat ma' toxoid tat-tetnu bħala proteina ġarriera madwar 25 mikrogramma
English: The clinical protection of the pertussis component of Infanrix (DTPa), against WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) was demonstrated after 3-dose primary immunisation in the studies tabulated below:
Maltese: Effikaċja fil-protezzjoni kontra l-pertussis Il-protezzjoni klinika tal-komponent tal-pertussis ta' Infanrix (DTPa), kif deskritta mill-WHO (≥ 21
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1
Maltese: Wara r-rikostituzjoni, doża 1 (0.5 ml) ikun fiha:
English: Over a six year period starting in 2006, where Infanrix hexa was the principal Hib-containing vaccine in use with vaccination coverage exceeding 95%, Hib invasive disease continued to be well controlled, with four confirmed Hib cases reported in Italian children aged less than 5 years through passive surveillance.
Maltese: Fuq perjodu ta' sitt snin li beda fl-2006, fejn it-tilqima tal-Infanrix hexa kienet it-tilqima prinċipali użata li kien fiha l-Hib b'tilqim li kien jilħaq aktar minn 95%, mard invażiv bl-Hib kompla jiġi kkontrollat tajjeb, b'erba'
English: Full-term infants 3-dose
Maltese: Trabi li jitwieldu fiż-żmien 3 dożi
English: Immunogenicity in preterm infants
Maltese: Vaċċinazzjoni primarja
English: Household contact study (prospective blinded)
Maltese: Studju ta' persuni li jgħixu fl-istess dar ma' persuna marida bilpertussis (prospettiv, blinded)
English: After booster vaccination (post-dose 4), at least 98.4% of children had developed seroprotective or seropositive antibody levels against each of the vaccine antigens.
Maltese: Wara l-vaċċin booster (wara r-raba' doża), mill-inqas 98.4% tat-tfal kienu żviluppaw livelli ta' antikorpi seroprotettivi jew seropożittivi kontra kull wieħed mill-antiġeni tal-vaċċin.
English: The clinical relevance of these observations remains unknown.
Maltese: Ir-rilevanza klinika ta' dawn l-osservazzjonijiet tibqa' mhux magħrufa.
English: Oral Drops, Solution Oral Use
Maltese: Taqtir Orali, Soluzzjoni
English: United Kingdom Tel: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail: druginfo@unither.com
Maltese: Tel: +44 (0)1932 664884 Fax: +44 (0)1932 573800 E-mail: druginfo@unither.com
English: United Therapeutics Corporation 1040 Spring Street Silver Spring, Maryland 20910 USA
Maltese: Spring Street Silver Spring, Maryland 20910
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1022/001
Maltese: EU/1/15/1022/001
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Maltese: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100).
English: Day IL-21
Maltese: Jum IL-21
English: Respiratory dysfunction
Maltese: Disfunzjoni respiratorja
English: GM-CSF1
Maltese: Jum GM-CSF1
English: United Therapeutics Europe, Ltd. Unither House
Maltese: United Therapeutics Europe, Ltd.
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Originally reported terms have been coded to preferred terms (using the Medical Dictionary for Regulatory Activities [MedDRA]).
Maltese: Attivitajiet Regolatorji [Medical Dictionary for Regulatory Activities, MedDRA]).
English: Chertsey, Surrey KT16 9FG
Maltese: Curfew Bell Road Chertsey, Surrey KT16 9FG Ir-Renju Unit
English: The 5 year estimates of OS were 74 % for dinutuximab immunotherapy compared to 57 % for isotretinoin alone (log-rank test p = 0.030).
Maltese: istimi ta' 5 snin ta' OS kienu 74% għal immunoterapija b'dinutuximab meta mqabbla ma' 57% għal isotretinoin waħdu (log-rank test p = 0.030).
English: Stridor, laryngeal oedema
Maltese: Stridor, edema larinġeali
English: Systemic infection or sepsis Grade 3 or 4
Maltese: Infezzjoni sistemika jew sepsis Grad 3 jew 4
English: Adverse reactions reported in four clinical studies (ANBL0032, ANBL0931, CCG-0935A, and DIV-NB201) of dinutuximab in patients (N=984) with high-risk neuroblastoma are summarized in Table 5.
Maltese: Reazzjonijiet avversi rrappurtati fl-erba' studji kliniċi (ANBL0032, ANBL0931, CCG-0935A, u DIV-NB201) dwar dinutuximab f'pazjenti (N=984) b'newroblastoma ta' riskju għoli qed jintwerew fil-qosor f'Tabella 5.
English: In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8.
Maltese: Fil-provi kliniċi, dożi skedati ta' dinutuximab sa 120 mg/m2 (60 mg/m2/jum) ingħataw bi profil ta' reazzjonijiet avversi simili għal dak deskritt f'sezzjoni 4.8.
English: Bronchospasm, pulmonary oedema
Maltese: Bronkospażmu, edema pulmonari
English: Grade 1 or 2
Maltese: 2 u 4
English: • Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
Maltese: • Dewwem il-bidu tal-ewwel kors sakemm alanine aminotransferase (ALT) ikun ta' inqas minn 5 darbiet il-limitu ta' fuq tan-normal (ULN).
English: The terminal halflife was estimated at 10 (+ 6) days.
Maltese: Il-half-life terminali kienet stmata li hi ta' madwar 10 (+ 6) ijiem.
English: Grade 4(life-threatening) - < 120 mmol/L despite appropriate fluid management
Maltese: Grad 4 (ta' theddida għall-ħajja) - < 120 mmol/L minkejja mmaniġġjar adasttat tal-fluwidu
English: The mean (± standard deviation) maximum plasma concentration observed after the 4th infusion was 11.5 (± 2.3) mcg/mL.
Maltese: fil-plażma osservata wara r-4ba' infużjoni kienet ta' 11.5 (± 2.3) mcg/m.
English: Dinutuximab is a chimeric human/mouse monoclonal antibody produced in a murine myeloma cell line (Sp2/0) by recombinant DNA technology.
Maltese: Dinutuximab hu antikorp kimeriku monoklonali uman/tal-ġrieden prodott f'razza ta' ċelluli tal-majeloma murine (Sp2/0) minn teknoloġija ta' DNA rikombinanti.
English: 17.5 mg/5 mL
Maltese: 1 kunjett 17.5 mg/5 mL
English: Systemic infections
Maltese: Infezzjonijiet sistemiċi
English: Onset of symptoms
Maltese: Bidu tas-sintomi
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC16
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67 %), pain (66 %), hypersensitivity (56 %), pyrexia (53 %), urticaria (49 %), capillary leak syndrome (45 %), anaemia (45 %), hypokalaemia (41 %), platelet count decreased (40 %), hyponatraemia (37 %), alanine aminotransferase increased (35 %), decreased lymphocyte count (34%) and decreased neutrophil count (31%).
Maltese: urtikarja (49%), sindrome ta' tnixxija kapillari (45%), anemija (45%), ipokalemija (41%), tnaqqis fl-għadd tal-plejtlits (40%), iponatremija (37%), żieda f'alanine aminotransferase (35%), tnaqqis fl-għadd ta' limfoċiti (34%) u tnaqqis fl-għadd tan-newtrofili (31%).
English: Atrial fibrillation, ventricular arrhythmia
Maltese: Fibrillazzjoni atrijali, arritmija ventrikulari
English: Electrolyte abnormalities have been reported in patients who received Unituxin (see section 4.8).
Maltese: Anormalitajiet fl-elettroliti ġew irrappurtati f'pazjenti li rċivew Unituxin (ara sezzjoni 4.8).
English: It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Maltese: Jingħata flimkien ma' kombinazzjoni ta' fattur li jistimula kolonji tal-makrofagi tal-granuloċiti (granulocytemacrophage colony-stimulating factor, GM-CSF), interleukin-2 (IL-2), u isotretinoin.
English: • Delay course initiation until creatinine clearance or glomerular filtration rate (GFR) is at least 70 mL/min/1.73 m2 Systemic infection or sepsis
Maltese: • Dewwem il-bidu tal-kors sakemm it-tneħħija tal-kreatinina jew ir-rata ta' filtrazzjoni glomerulari (glomerular filtration rate, GFR) tkun ta' mill-inqas 70 mL/min/1.73 m2 Infezzjoni sistemika jew sepsis
English: Interleukin-2 (IL-2): 3 MIU/m 2/day administered by continuous intravenous infusion over 96 hours on Days 1-4
Maltese: Interleukin-2 (IL-2): 3 MIU/m2/jum mogħtija permezz ta' infużjoni kontinwa ġol-vini fuq perjodu ta' 96 f'Jiem 1-4 u 4.5
English: Uncommon photophobia, mydriasis
Maltese: fotofobija, midrijasi
English: - The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
Maltese: - Is-sustanzi l-oħra huma histidine, polysorbate 20 (E 432), sodium chloride u ilma għall-injezzjoni.
English: You will be given pain relieving medicines (such as paracetamol, ibuprofen and morphine) to help prevent and reduce the pain.
Maltese: Inti se tingħata mediċini li jtaffu l-uġigħ (bħal paracetamol, ibuprofen, morfina) li jgħinu biex jipprevjenu u jnaqqsu l-uġigħ.
English: Unituxin contains sodium
Maltese: Unituxin fih is-sodium
English: Grade 3 or 4 Onset of symptoms
Maltese: Grad 3 jew 4 Bidu tas-sintomi
English: Hypersensitivity (Grade 4) to the active substance or to any of the excipients listed in section 6.1 of the SmPC.
Maltese: Sensittività eċċessiva (Grad 4) għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1 tal-SmPC.
English: Gabapentin may be administered at the time of starting morphine premedication, at an oral dose of 10 mg/kg/day.
Maltese: Gabapentin jista' jingħata fil-ħin meta tinbeda l-premedikazzjoni bil-morfina, b'doża orali ta' 10 mg/kg/jum.
English: The complete dosing regimen is outlined in Table 1 and Table 2.
Maltese: Il-kors sħiħ tad-dożaġġ qed jiġi deskritt fil-qosor f'Tabella 1 u f'Tabella 2.
English: Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Maltese: Reazzjonijiet avversi addizzjonali karatteristiċi ta' rispons allerġiku ġew irrappurtati wkoll - li jinkludu reazzjoni anafilattika (18%) u bronkospażmu (4%).
English: What Unituxin contains - The active substance is dinutuximab.
Maltese: X'fih Unituxin - Is-sustanza attiva hi dinutuximab.
English: Table 6: Courses 1, 3, and 5 dosing schedule for Unituxin, GM-CSF and isotretinoin
Maltese: Tabella 1: Skeda ta' dożaġġ għal Korsijiet 1, 3, u 5 għal Unituxin, GM-CSF u isotretinoin