FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you are taking any of the following as they may interact with TRADEMARK: - medicine to thin the blood (anti-coagulants, aspirin or other salicylates) - water tablets (diuretics) used for heart failure or blood pressure - lithium which is used to treat depression and similar conditions - methotrexate - cyclosporin make sure that your doctor or pharmacist knows that you are taking these medicines before taking TRADEMARK.
Maltese: - Jekk qed tieħu xi waħda minn dawn il-mediċini li ġejjin, għax jistgħu jinteraġixxu ma' TRADEMARK: - mediċina li traqqaq id-demm (anti-koagulanti, aspirina jew salicylates oħrajn) - pilloli tal-ilma (dijuretiċi) li jintużaw għal insuffiċjenza tal-qalb jew għall-pressjoni tad-demm - lithium li jintuża għall-kura tad-dipressjoni u kundizzjonijiet simili - methotrexate - cyclosporin aċċerta ruħek li t-tabib jew l-ispiżjar tiegħek ikunu jafu li int qed tieħu dawn il-mediċini qabel ma tieħu TRADEMARK.
English: In patients with renal or cardiac impairment, caution is required since the use of Nimesulide 100mg Tablets/granules may result in deterioration of renal function.
Maltese: F'pazjenti b'indeboliment renali jew kardijaku, l-attenzjoni hi meħtieġa għax l-użu ta' Nimesulide 100 mg Pilloli/granijiet jista' jirriżulta f'deterjorament tal-funzjoni renali.
English: 100mg bid after meal.
Maltese: 100 mg darbtejn kuljum wara l-ikel.
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Nimesulide 100mg Tablets/granules should be considered (see section 4.6).
Maltese: F'nisa li jkollhom diffikultajiet biex joħorġu tqal li jkunu qed ikollhom investigazzjoni dwar l-infertilità, it-twaqqif ta' Nimesulide 100 mg Pilloli/granijiet għandu jkun ikkunsidrat (ara sezzjoni 4.6).
English: Known hypersensitivity to nimesulide or to any of the excipients of the products.
Maltese: Sensittività eċċessiva magħrufa għal nimesulide jew għal xi sustanzi mhux attivi tal-prodotti.
English: History of hepatotoxic reactions to nimesulide
Maltese: X'INHU TRADEMARK U GĦALXIEX JINTUŻA
English: Simultaneous use of different NSAIDs is not recommended.
Maltese: L-użu fl-istess ħin ta' NSAIDs differenti mhuwiex rakkomandat.
English: HOW TO TAKE TRADEMARK
Maltese: Oqgħod attent ħafna bi TRADEMARK
English: The maximum duration of a treatment course with nimesulide is 15 days.
Maltese: It-tul massimu tal-kors tal-kura b'nimesulide hu ta' 15-il jum.
English: - If you are planning a pregnancy, you should inform your doctor since TRADEMARK may decrease fertility.
Maltese: - Jekk qed tippjana li toħroġ tqila, għandek tinforma lit-tabib tiegħek, għax TRADEMARK jista' jnaqqas il-fertilità.
English: Elderly: In elderly patients there is no need to reduce the daily dosage (see section 5.2).
Maltese: F'pazjenti anzjani m'hemm l-ebda ħtieġa li tnaqqas id-dożaġġ ta' kuljum (ara sezzjoni 5.2).
English: Urticaria, pruritus*
Maltese: Urtikarja, ħakk*
English: Uncommon Myalgia* Rare
Maltese: Mhux komuni Majalġja* Rari
English: Uncommon Rash Rare
Maltese: Mhux komuni Raxx Rari
English: 0.025 milligrams Al3+
Maltese: 0.025 milligrammi A13+
English: Hepatitis B surface antigen3,4
Maltese: Antiġen tas-superfiċje ta' l-epatite B 3,4
English: Hypoaesthesia*, paraesthesia*, dizziness
Maltese: Ipoestesija*, parasteżija*, ngħas
English: In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
Maltese: F'żewġ provi kliniċi fit-tul, il-peristenza tal-antikorpi anti-HAV u anti-HBs intweriet li baqgħet sa 10 snin fi tfal li għandhom bejn 12-15-il sena u sa 5 snin fi tfal li għandhom bejn 1-11-il sena.
English: GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
Maltese: Latvija GlaxoSmithKline Latvia SIA Tel: + 371 67312687 lv-epasts@gsk.com
English: 0.2 milligrams Al3+
Maltese: 0.2 milligrammi A13+
English: The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
Maltese: Ir-reazzjonijiet avversi rrappurtati b'mod komuni ġejjin mill-amministrazzjoni ta' Twinrix Paediatric huma uġigħ u ħmura li jseħħu f'kull doża b'frekwenza ta' 28.5% u 11.5% rispettivament.
English: Hypotension*
Maltese: Artralġja*
English: The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Maltese: Doża ta' 0.5 ml (360 ELISA Units/10μg HbsAg) hija rakkomandata għal trabi, tfal u adoloxxenti ta'
English: • Second dose:
Maltese: • It-tieni doża:
English: 0.2 milligrams Al3+ - The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
Maltese: 0.2 milligrammi A13+ - L-ingredjenti l-oħra f'Twinrix Paediatric huma: sodium chloride, ilma għall-injezzjonijiet.
English: years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 97% had anti-HBs antibody ≥10 mIU/ml.
Maltese: 97% kellhom antikorpi anti-HBs ta' ≥10 mIU/ml.
English: The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Maltese: Il-proporzjon ta' individwi li laħqu livell ta' anti-HBs ta' ≥ 10 mIU/ml kien ta' 98.3% għal tilqim mogħti flimkien u 100% għal Twinrix mogħtija waħedha.
English: 50 x 1 dose (0.5 ml)
Maltese: 50 x doża 1(0.5 ml)
English: Very rare: System Organ Class
Maltese: Sistema tal-Klassi tal-Organi
English: EU/1/97/029/009 - pack of 1 with 2 needles EU/1/97/029/010 - pack of 10 with 20 needles
Maltese: EU/1/97/029/009 - pakkett ta' 1 b'2 labriet EU/1/97/029/010 - pakkett ta' 10 b'20 labra
English: (meningitis)
Maltese: (antibijotiku)
English: Twinrix Paediatric is a combined vaccine formulated by pooling bulk preparations of the purified, inactivated hepatitis A (HA) virus and purified hepatitis B surface antigen (HBsAg), separately adsorbed onto aluminium hydroxide and aluminium phosphate.
Maltese: Twinrix Paediatric huwa vaċċin kombinat ifformulat billi jinġemaw preparazzjonijiet fuq skala kbira tal- virus tal-epatite A (HA) ippurifikat u inattivat u l-antiġenu ta' barra tal-epatite B ippurifikat (HbsAg), separatament adsorbiti fuq aluminium hyroxide u aluminium phosphate.
English: 10 x 1 dose (0.5 ml)
Maltese: 10 x doża 1 (0.5 ml)
English: Pharmaco-therapeutic group: Hepatitis vaccines, ATC code: J07BC20.
Maltese: Kategorija farmakoterapewtika: vaċċini tal-epatite, ATC Kodiċi ATC:
English: Specific humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Maltese: Antikorpi speċifiċi kontra l-epatite B ġew osservati f' madwar 67% tas-suġġetti wara l-ewwel doża u 100% wara t-tielet doża.
English: Pack sizes of 1, 10 and 50 with or without needles.
Maltese: Daqs tal-pakketti ta' 1, 10 u 50 bi jew mingħajr labar.
English: Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Maltese: Twinrix Paediatric jista'jingħata flimkien mat-tilqima tal-Papillomavirus Uman (HPV).
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Maltese: 3Manifatturat fuq ċelluli tal-ħmira (Saccharomyces cerevisiae)b'teknoloġija rikombinanti tad-DNA 4Adsorbit fuq aluminium phosphate
English: EU/1/97/029/001 - pack of 1 without needle EU/1/97/029/002 - pack of 10 without needle EU/1/97/029/008 - pack of 50 without needle EU/1/97/029/006 - pack of 1 with 1 needle EU/1/97/029/007 - pack of 10 with 10 needles
Maltese: EU/1/97/029/002 - pakkett ta' 10 mingħajr labra EU/1/97/029/008 - pakkett ta' 50 mingħajr labra EU/1/97/029/006 - pakkett ta' 1 b'labra1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 February 1997
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 1996
English: How Twinrix Paediatric is given
Maltese: Twinrix Paediatric.
English: 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Maltese: In-natura tal-kontenitur u dak li hemm ġo fih 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ ta' tip I) b'tapp tal-planġer (lastiku butyl).
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Maltese: Il-livelli tal-antikorpi anti-HBs u anti-HAV osservati wara kors primarju ta' vaċċinazzjoni bil-vaċċin kombinat huma flistess meddata' dawk wara t-tilqima bil-vaċċini individwali.
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Maltese: 2Adsorbit fuq aluminium hydroxide idratat
English: Twinrix Paediatric, Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Maltese: Twinrix Paediatric, suspensjoni għall-injezzjoni Vaċċin (adsorbit) tal-epatite A (inattivat) u epatite B (rDNA) (HAB).
English: 12-15 years, all subjects followed up retained ≥15 mIU/ml anti-HAV antibody and 85% had anti-HBs antibody ≥10 mIU/ml.
Maltese: HAV u 85% kellhom antikorpi anti-HBs ta' ≥10 mIU/ml.
English: Meningitis
Maltese: Treddigħ
English: Vasculitis
Maltese: Hrvatska
English: Other medicines and Twinrix Paediatric
Maltese: Kif taħżen Twinrix Paediatric
English: Uncommon Upper respiratory tract infection*
Maltese: Mhux komuni Infezzjoni fil-parti ta' fuq tal-apparat respiratorju*
English: Rare:
Maltese: Rari ħafna
English: Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Maltese: Nefħa fis-sit tal-injezzjoni, reazzjoni fis sit tal-injezzjoni (bħal tbenġil), għeja, tħossok ma tiflaħx, deni (≥ 37.5°C)
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Maltese: Waqt li mhux mistenni li l antiġen tas-superfiċje ta' l-epatite B rekombinanti jkollu effetti avversi fuq it-tqala jew fuq il-fetu, hu rakkomandat li t-tilqim jiġi pospost għal wara l-ħlas, sakemm ma jkunx hemm bżonn urġenti li tipproteġi l-omm kontra infezzjoni ta' l-epatite B.
English: • Official batch release
Maltese: • Pressjoni baxxa
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Maltese: jinħtieġux doża ta' rinforz billi fl-assenza ta' antikorpi evidenti jista' jkun li l-protezzjoni tiġiassigurata bil-memorja immunoloġika.
English: • Feeling of pins and needles (paraesthesia)
Maltese: • Tnemnim (paraestesija)
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Maltese: Rari (dawn jistgħu jseħħu f'sa 1 minn kull 1,000 doża tal-vaċċin)
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Maltese: Rari ħafna (dawn jistgħu jseħħu f'sa 1 minn kull 10,000 doża tal-vaċċin)
English: Posology - Dosage
Maltese: Il-Belġju
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Maltese: Il-virus jinstab fil-fluwidi tal-ġisem bħal demm, semen, tisfija tal-vaġina, jew saliva (bżiq) ta' nies infettati.
English: 1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
Maltese: siringa 1 mimlija għal-lest + 2 labriet doża 1(0.5 ml)
English: 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Maltese: siringa 1 mimlija għal-lest + labra 1 doża 1(0.5 ml)
English: 0.025 milligrams Al3+ Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Maltese: 3Manifatturat fuq ċelluli tal-ħmira (Saccharomyces cerevisiae)b'teknoloġija rikombinanti tad-DNA
English: Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens.
Maltese: Twinrix Paediatric fl-istess ħin ma' Cervarix (tilqima HPV) ma wera l-ebda interferenza ta' rilevanza klinika fir-rispons tal-antikorpi għall-antiġens tal-HPV u tal-epatite A.
English: Influenza like illness*, chills*
Maltese: Sintomi bħal tal-influwenza*, tkexkix ta' bard*
English: Twinrix Paediatric confers immunity against HAV and HBV infection by inducing specific anti-HA and anti-HBs antibodies.
Maltese: Twinrix Paediatric tagħti immunita' kontra l-infezzjoni ta' HAV u HBV billi tinduċi antikorpi speċifiċi kontra HAV u HBs.
English: Abnormal liver function tests * refers to adverse reactions observed in clinical trials performed with the adult formulation
Maltese: * jirreferi għal effetti mhux mixtieqa li ġew osservati fi provi kliniċi li saru bil-preparazzjoni għall adulti Rappurtar ta' reazzjonijiet avversi suspettati
English: How to store Twinrix Paediatric Contents of the pack and other information
Maltese: Kif jidher Twinrix Adult u l-kontenut tal-pakkett:
English: Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Maltese: Sinjali ta' reazzjonijiet allergiċi serji jistgħu jkunu tipi ta' raxx li jistgħu jkunu b'ħakk jew bil-blisters, nefħa ta' l-għajnejn u tal-wiċċ, diffikultà biex tieħu n-nifs u biex tibla, pressjoni li titbaxxa f'salt u tintilef minn sensik.
English: Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Maltese: Twinrix Paediatric jinsab f'pakketti ta' 1, 10 jew 50 bil-labar jew mingħajrhom.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal xi wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: EXPIRY DATE EXP: MM/YYYY
Maltese: Fuljett ta' taghrif: Informazzjoni ghall-utent
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Maltese: GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
English: AntiHBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected.
Maltese: Konċentrazzjonijiet ġeometriċi medji tal-antikorpi anti-HBs kienu aktar baxxi meta t-tilqimiet ingħataw flimkien, iżda s-sinifikat kliniku ta' din l-osservazzjoni mhuwiex magħruf minħabba li r-rati ta' seroprotezzjoni ma kinux affettwati.
English: 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 50 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Maltese: Fl-10 sena mill-bidu ta' skeda ta' għoti ta' Twinrix Paediatric fix-xhur 0, 1, u 6 fi tfal li għandhom bejn 12-15-il sena, l-individwi kollha li ġew segwiti żammew livell ta' ≥15 mIU/ml ta' antikorp anti
English: The safety profile presented below is based on data from approximately 800 subjects.
Maltese: • int qatt kellek xi problemi relatati mas-saħħa wara xi tilqima.
English: • Swelling of the face, mouth or throat (angioneurotic oedema)
Maltese: • Mard tan-nervituri ta' l-għajnejn (newrite ottika)
English: 10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
Maltese: 10 siringi mimlijin għal-lest + 20 labra
English: • Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Maltese: • Sintomi bħal tal-influwenza bħal deni ogħli, mard tal-gerżuma, mnieħer inixxi, sogħlau tkexkix ta'
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Maltese: Doża 1 (0.5 ml):
English: The kinetics of decline of anti-HAV and anti-HBs antibodies were shown to be similar to those of the monovalent vaccines.
Maltese: immunita' baxxa, livelli adekwati tal-antikorpi anti-HAV u anti-HBs jistgħu ma jintlaħqux wara l ewwel kors primarju ta' tilqim.
English: Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
Maltese: Twinrix Paediatric huwa indikat għall-użu fit-trabi, tfal u adoloxxenti ta' eta` minn sena sa u jinkludi 15 il-sena li ma jkollhomx l-immunita' relevanti u li huma fir-riskju ta' infezzjoni mill-epatite A kif ukoll mill-epatite B.
English: • Swollen glands in the neck armpit or groin (lymphadenopathy)
Maltese: • Nefħa tal-wiċċ, ħalq jew tal-gerżuma (edema anġjonewrotika)
English: • Infection around the brain which may give severe headache with stiff neck and sensitivity to light
Maltese: • Uġigħ, tingiż u sensazzjoni ta' ħruqimmedjatfis-sittal-injezzjoni Rappurtar tal-effetti sekondarji
English: The full EPAR for Zoledronic acid Actavis 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: Zoledronic acid Actavis is a ‘generic medicine'.
Maltese: Zoledronic acid Actavis huwa ‘mediċina ġenerika'.
English: The usual dose of Zoledronic acid Actavis is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali ta' Zometa acid Actavis hija ta' infużjoni waħda ta' 4 mg tul mill-inqas 15-il minuta.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Actavis.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zoledronic acid Actavis.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Actavis on 20 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid Actavis fl-20 ta' April 2012.
English: The active substance in Zoledronic acid Actavis, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid Actavis, l-aċidu żoledroniku, hija bisfosfonat.
English: Zoledronic acid Actavis zoledronic acid
Maltese: Tagħrif ieħor dwar Zoledronic acid Actavis
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi fratturi (ksur fl-għadam), kompressjoni fl-ispina tad-dahar (meta lispina tad-dahar tkun kompressa mill-għadam), disturbi fl-għadam li jeħtieġu r-radjuterapija (kura birradjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fid-demm).
English: What is Zoledronic acid Actavis?
Maltese: X'inhu Zoledronic acid Actavis?
English: It is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Maltese: Huwa disponibbli bħala konċentrat li jitħallat f'soluzzjoni għall-infużjoni (dripp) fil-vina.
English: In addition, the company that markets Zoledronic acid Actavis will provide a card to inform patients about the risk of osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) and to instruct them to contact their doctor if they experience symptoms.
Maltese: Barra minn hekk, il-kumpanija li tawtorizza Zoledronic acid Actavis għat-tqegħid fis-suq ser tipprovdi kard biex tinforma lill-pazjenti bir-riskji tal-osteonekrożi fix-xedaq (ħsara lill-għadam tax-xedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew laxkament fis-snien) u biex ittihom struzzjonijiet biex jikkuntattjaw lit-tabib tagħhom jekk ikollhom is-sintomi.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Actavis has been shown to be comparable to Zometa.
Maltese: Is-CHMP ikkonkluda li skont ir-rekwiżiti tal-UE, Zoledronic acid Actavis wera li jista' jitqabbel ma' Zometa.
English: This means that Zoledronic acid Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Maltese: Dan ifisser li Zoledronic acid Actavis huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Zometa.
English: Because Zoledronic acid Actavis is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Zoledronic acid Actavis huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu li huma listess bħal dawk tal-mediċina ta' referenza.
English: A risk management plan has been developed to ensure that Zoledronic acid Actavis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoledronic acid Actavis jintuża bl-aktar mod sigur possibbli.
English: What are the benefits and risks of Zoledronic acid Actavis?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic acid Actavis?
English: {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Maltese: {Isem u indirizz} {tel} {fax} {e-mail}
English: Mitoxantrone is 78 % bound to plasma proteins.
Maltese: Mitoxantrone huwa 78 % marbut mal-proteini tal-plasma.
English: Oncology
Maltese: Onkoloġija
English: Oedema Extravasation* Dysgeusia
Maltese: Ekstravażazzjoni* Disgweżja
English: Extravasation*
Maltese: Ekstravażazzjoni*
English: Amenorrhoea*
Maltese: Amenorrea*
English: 4.3 Contraindications
Maltese: .2 Inkompatibbiltajiet
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <Mhux applikabbli>
English: Multiple Sclerosis
Maltese: Sklerożi Multipla
English: - Metabolic disturbances (tumour lysis syndrome).
Maltese: - Disturbi metaboliċi (sindrome tal-liżi tat-tumur)
English: Cardiac function
Maltese: Funzjoni kardijaka
English: In men, no data are available.
Maltese: Fl-irġiel, m'hemm l-ebda data disponibbli.
English: In the several studies in multiple sclerosis the effective cumulative dose ranged from 36 mg/m to 120 mg/m2.
Maltese: F'bosta studji fi sklerożi multipla, id-doża kumulattiva effettiva varjat minn 36 mg/m2 sa 120 mg/m2.
English: Novantrone contains the active substance mitoxantrone.
Maltese: Novantrone fih is-sustanza attiva mitoxantrone.
English: for 5 days given as a continuous 24-hour infusion on Days 1 to 5.
Maltese: għal 5 ijiem mogħti bħala infużjoni għal 24 siegħa kontinwi fuq Jiem 1 sa 5.
English: The fraction bound is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.
Maltese: Il-frazzjoni mwaħħla hija indipendenti millkonċentrazzjoni u mhijiex affettwata mill-preżenza ta' phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, eparina, jew aspirina.
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Maltese: Il-frekwenzi huma ddefiniti skont ilkonvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Mitoxantrone has been demonstrated to be a substrate for the BCRP transporter protein in vitro.
Maltese: Mitoxantrone ntwera li huwa substrat għall-proteina trasportatriċi BCRP in vitro.
English: Mitoxantrone, a synthetic anthracenedione derivative, is an established cytotoxic, antineoplastic agent.
Maltese: Mitoxantrone, derivattiv anthracenedione sintetiku, huwa sustanza ċitotossika, antineoplastika stabbilita.
English: • if you use Novantrone in high doses (>14 mg/m2 per day x 3 days).
Maltese: • Jekk tuża Novantrone f'dożi għoljin (>14 mg/m2 kull jum x 3 ijiem).
English: Haematological parameters should be regularly monitored (see section 4.4).
Maltese: Il-parametri ematoloġiċi għandhom jiġu mmonitorjati b'mod regolari (ara sezzjoni 4.4).
English: Infection (including fatal outcome)
Maltese: Infezzjoni (inkluż riżultat fatali) Infezzjoni (inkluż riżultat fatali)