FrancophonIA/ELRC3.0 huggingface dataset:
English: Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Maltese: Filgrastim ratiopharm huwa indikat għat-tnaqqis fid-dewmien ta' newtropenja u fl-inċidenza ta' newtropenja bid-deni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita kontra malinni (bleċċezzjoni ta' lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti, taħt kura majeloablativa u segwita bit-trapjant tal-mudullun, li huma meqjusa li għandhom riskju għola ta' newtropenja qawwija u mdewma.
English: Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in normal donors receiving filgrastim; these were
Maltese: Żjidiet ħfief, li reġgħu lura għan-normal, fl-alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) u uric acid kienu rrapportati f'donaturi b'saħħithom li rċievu filgrastim; dawn ma kellhomx effetti kliniċi assoċjati magħhom.
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/l prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/l.
Maltese: Jekk ikun hemm bżonn ta' iktar minn proċedura waħda ta' lewkafereżi, trid issir attenzjoni partikulari lejn donaturi li għandhom livell ta' plejtlits < 100 x 109/l qabel il-lewkafereżi; bħala regola ġenerali, afereżi m'għandiex issir jekk il-livell ta' plejtlits jkun < 75 x 109/l.
English: MARKETING AUTHORISATION HOLDER ratiopharm GmbH
Maltese: info@ratiopharm.de
English: Diarrhoea
Maltese: Epatomegalija
English: Anaemia, splenomegaly
Maltese: Reazzjoni allerġiku
English: Filgrastim ratiopharm containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Filgrastim ratiopharm, li fih r-metHuG-CSF (filgrastim), jikkawża żjieda sinifikanti fl-għadd ta' newtrofili fid-demm periferali fi żmien 24 siegħa, b'żjidiet minuri fil-monoċiti.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.8 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 ml solution for injection or
Maltese: Pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest b' 0.8 ml soluzzjoni għall-injezzjoni jew infużjoni jew pakkett multiplu li fih 10 (2 pakketti ta' 5) siringi mimlijin għal-lest b' 0.8 ml soluzzjoni għall-injezzjoni jew infużjoni
English: Exacerbation of rheumatoid arthritis has been observed in individual cases.
Maltese: Aggravament ta' artrite rewmatika kien osservat f' każijiet individwali.
English: In cancer patients, the pharmacokinetic profile of Filgrastim ratiopharm and the reference product was comparable after single and repeated subcutaneous administration.
Maltese: F'pazjenti b'kanċer, il-profil farmacokinetiku ta' Filgrastim ratiopharm u dak tal-prodott ta' referenza kienu komparabbli wara amministrazzjoni taħt il-ġilda ta' doża waħda jew dożi ripetuti.
English: There was a low frequency (approximately 3%) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
Maltese: Fi studji kliniċi, kien hemm frewkwenza baxxa (madwar 3%) ta' sindromi majelodisplastiċi (MDS) jew lewkimja f'pazjenti b' SCN ikkurati b'filgrastim.
English: Packs containing 1, 5 or 10 pre-filled syringes with 0.5 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 ml solution for injection or
Maltese: Pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest b' 0.5 ml soluzzjoni għall-injezzjoni jew infużjoni jew pakkett multiplu li fih 10 (2 pakketti ta' 5) siringi mimlijin għal-lest b' 0.5 ml soluzzjoni għall-injezzjoni jew infużjoni
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (Farmakoviġilanza jew minimizzazzjoni tar-riskju)
English: For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Maltese: Għal l-infużjoni, id-doża ta' filgrastim trid tkun miżjuda ma' 20ml soluzzjoni ta' glucose 50 mg/ml (5%) (ara sezzjoni 6.6 għall-istruzzjonijiet fuq id-dilwit).
English: Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.
Maltese: Effetti mhux mixtieqa inqas frekwenti jinkludu disturbi fis-sistema urinarja, bl-effett predominanti
English: Patients who have undergone very extensive prior myelosuppressive therapy may not show sufficient mobilisation of PBPC to achieve the recommended minimum yield (2.0 x 106 CD34+ cells/kg) or acceleration of platelet recovery to the same degree.
Maltese: Jista' jkun li pazjenti li għaddew minn kura majelosoppressiva estensiva ma jkollhomx mobilizzazzjoni suffiċjenti ta' PBPC biex jaslu għall-għadd minimu rakkomandat (2.0 x 106 CD34+
English: Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of 4 x 106 CD34+ cells/kg recipient body weight in the majority of the donors after two leukaphereses.
Maltese: Qabel trapjant alloġenejiku ta' ċelluli proġenitriċi tad-demm periferali, l-użu ta'filgrastim għall-mobilizzazzjoni ta' ċelluli proġenitriċi tad-demm periferali f'donaturi normali jippermetti li jinġabru 4 x 106 CD34+ celluli għal kull kg ta' piż tal-ġisem tar-riċevitur, fil-maġġoranza ta' donaturi,
English: Each ml of solution for injection or infusion contains 60 million international units [MIU] (600 µicrogram) of filgrastim.
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni jew infużjoni fiha 60 miljun international units [MIU] (600 mikrogrammi) ta' filgrastim.
English: If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ml (5%) solution for infusion.
Maltese: Jekk ikun hemm bżonn, Filgrastim ratiopharm jista' jiġi dilwit f'soluzzjoni għal infużjoni ta' glucose 50 mg/ml (5%).
English: The volume of distribution in blood is approximately 150 ml/kg.
Maltese: Il-volum ta' distribuzzjoni fid-demm hu madwar 150 ml/kg.
English: In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Maltese: F'pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl-Għadd Assolut ta' Newtrofili (ANC) ta' ≤ 0.5 x 109/l, u storja ta' infezzjonijiet qawwija jew li jirkadu, it-terapija fit-tul b'Filgrastim ratiopharm huwa indikat biex jiżdied l-għadd ta' newtrofili u sabiex l-inċidenza u t-tul ta' ġrajjiet avversi relatati ma' infezzjonijiet jonqsu.
English: Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Maltese: Filgrastim ratiopharm u mobilizzazzjoni ta' ċelluli proġenitriċi tad-demm periferali
English: Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Maltese: Effetti mhux mixtieqa rari tal-pulmun, fosthom pulmonite interstizjali, edema pulmonari, ġew irrapportati fejn ftit minnhom irriżultaw f' inkapaċità respiratorja jew sindromu tat-tbatija respiratorja fl-adulti (ARDS), li setgħu jkunu fatali (ara sezzjoni 4.4)
English: Transformation to leukaemia or myelodysplastic syndrome Special care should be taken in the diagnosis of severe chronic neutropenias to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia and myeloid leukaemia.
Maltese: Trasformazzjoni f'lewkimja jew sindromu majelodisplastiku Il-kawtela speċjali trid tiġi eżerċitata f'djanjożi ta' newtropenja qawwija u kronika biex din tiġi distinta minn disturbi ematopojetiċi oħra bħal anemija aplastika, sindromu majelodisplastiku u lewkimja majelojde.
English: Then, if ANC remains > 1.0 x 109/l for 3 more
Maltese: Imbagħad, jekk l-ANC jibqa' > 1.0 x 109/l għal 3
English: There were no relevant differences between Filgrastim ratiopharm and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Maltese: Ma kienx hemm differenzi rilevanti bejn Filgrastim ratiopharm u l-prodott ta' referenza fir-rigward ta' dewmien ta' newtropenja qawwija u l-inċidenza ta' newtropenja bid-deni.
English: You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “Important information about some of the ingredients of Filgrastim ratiopharm”.
Maltese: Tista' ssib informazzjoni dettaljata dwar l-ingredjent sorbitol (tip ta' zokkor) f'sezzjoni 2 taħt ittitlu “Tagħrif importanti dwar xi wħud mis-sustanzi ta' Filgrastim ratiopharm”.
English: Blood and lymphatic system disorders
Maltese: Abnormalitajiet fis-sistema urinarja
English: Filgrastim ratiopharm is useful in several different conditions which are:
Maltese: Filgrastim ratiopharm huwa ta' benefiċju f'ħafna kundizzjonijiet differenti li huma:
English: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml (60 MIU/ml, 600 microgram/ml).
Maltese: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 ml (60
English: Pharmacotherapeutic group: Colony stimulating factors, ATC code: L03AA02
Maltese: Fatturi li jistimolaw il-kolonji ta' granuloċiti, Kodiċi ATC:
English: The efficacy and safety of Filgrastim ratiopharm has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Maltese: III, randomised u kontrollati bi placebo, f'pazjenti b'kanċer tas-sider, kanċer tal-pulmun u Non-Hodgkin-Limfoma.
English: Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
Maltese: Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq il-ġeni u tolleranza lokali, ma turi l-ebda periklu speċjali għall-bnedmin.
English: The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Maltese: Minħabba varjazzjoni li hemm bejn pazjenti individwali u d-differenzi li hemm fl-analiżi ta' celluli CD34+ fil-laboratorju, il-paragun dirett bejn studji varji huwa diffiċli.
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika .
English: Transient thrombocytopenia (platelets < 100 x 109/l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
Maltese: Wara l-amministrazzjoni ta' filgrastim u proċedura ta' lewkafereżi, ġiet osservata tromboċitopenja transitorja (plejtlits < 100 x 109/l) f'35% tas-suġġeti li ġew studjati.
English: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 30 MIU/0.5 ml solution for injection or infusion
Maltese: Filgrastim ratiopharm 30 MIU/0.5ml soluzzjoni għall-injezzjoni jew infużjoni
English: Thrombocytopenia
Maltese: L-KITBA
English: NAME OF THE MEDICINAL PRODUCT Filgrastim ratiopharm 48 MIU/0.8 ml solution for injection or infusion
Maltese: Filgrastim ratiopharm 48 MIU/0.8ml soluzzjoni għall-injezzjoni jew infużjoni
English: Constipation, anorexia, diarrhoea, mucositis Elevated GGT
Maltese: Infiltrati pulmonari Tqalligħ/rimettar Stitikezza, anoressija, dijarreja, mukożite
English: Premature discontinuation of filgrastim therapy prior to the time of the expected neutrophil nadir is not recommended.
Maltese: Erġa iċċekkja li hemm id-doża preskritta ta'Filgrastim ratiopharm fis-siringa.
English: The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/min/kg.
Maltese: Il-half-life ta' eliminazzjoni ta' filgrastim hija ta' madwar 3.5 siegħa, b'rata ta' tneħħija ta' madwar 0.6 ml/min/kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Wrapper Label on Multipacks Wrapped in Transparent Foil - Including the Blue Box
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA It-tikketta ta' fuq il-kisja ta' barra fuq pakketti multipli miksijin filfojl trasparenti - inkluza l-kaxxa ċ-ċelesti
English: Malta ratiopharm GmbH, Il Ġermanja
Maltese: KIF TAĦŻEN Filgrastim ratiopharm
English: For the mobilisation of PBPC in normal donors prior to allogeneic peripheral blood progenitor cell
Maltese: Kawżi oħra ta' newtropenja transitorji bħal infezzjonijiet virali għandhom jiġu esklużi.
English: Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/l and 10 x 109/l.
Maltese: Sussegwentement id-doża tista' tiġi aġġustata għal individwu kull gimgħa jew gimgħatejn biex il-medju ta' l-għadd ta' newtrofili jinżamm bejn 1.5 x 109/l u 10 x 109/l.
English: Cough, sore throat
Maltese: UŻATI JEW SKART MINN DAWN
English: Long-term administration may be required to maintain the ANC > 2.0 x 109/l.
Maltese: Kura fit-tul tista' tkun meħtieġa sabiex l-ANC jinżamm > 2.0 x 109/l.
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60
Maltese: Is-sigurta' u l-effikaċja ta' filgrastim ma ġewx investigati f'donaturi b'saħħithom <16-il sena jew > 60 sena.
English: Anaemia and epistaxis have also been
Maltese: TWISSIJA(IET) SPEĊJALI
English: The recommended starting dose is 1.2 MIU (12 μg)/kg/day subcutaneously as a single dose or in
Maltese: Id-doża tal-bidu rakkomandata hi 1.2 MIU (12 μg)/kg/jum mogħtija taħt il-ġilda bħala doża waħda jew
English: Nausea/Vomiting
Maltese: Disturbi fil-milza
English: Your doctor will tell you why you are being treated with Filgrastim ratiopharm.
Maltese: Għat-trattament ta' newtropenja, ikun hemm bżonn ta' kura b'Filgrastim ratiopharm fittul.
English: The recommended starting dose of filgrastim is 0.1 MIU (1 μg)/kg/day given daily by subcutaneous injection with titration up to a maximum of 0.4 MIU (4 μg)/kg/day until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x109/l).
Maltese: MIU (4 μg)/kg/jum sakemm livell normali fl-għadd ta' newtrofili jintlħaq u jista' jinżamm (ANC > 2.0 x109/l).
English: Read
Maltese: N
English: Multipack comprising 2 packs, each containing 5 pre-filled syringes.
Maltese: Pakkett multiplu li fih 2 pakketti li kull wieħed minnhom fih 5 siringi mimlijin għal-lest.
English: In a small number of patients (< 10%), doses up to 1.0 MIU (10 μg)/kg/day were required to achieve
Maltese: F'numru żgħir ta' pazjenti (< 10%), kien hemm bżonn ta' dożi sa 1.0
English: Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 ml solution for injection or
Maltese: Kull siringa mimlija għal-lest fiha 48 MIU (480 µg) filgrastim f'0.8 ml soluzzjoni għall-injezzjoni jew
English: You should watch for a temperature of 37.8 °C or above, chills or other signs of infection, such as a rash, sore throat, diarrhoea, ear-ache, difficult or painful breathing or problems such as cough or wheezing.
Maltese: Oqogħod attent għal temperatura ta' 37.8 °C jew iktar, sirdat u sinjali oħrajn ta' infezzjoni bħal raxx, uġigħ fil-grieżem, dijarreja, uġigħ tal-widnejn, diffikulta' jew uġigħ biex tieħu nifs jew disturbi bħal sogħla jew tisfir ma-nifs.
English: Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Maltese: Studju tar-relazzjoni bejn in-numru ta' ċelluli CD34+ infużi mill-ġdid u r-rata ta' rkuprar tal-plejtlits wara kimoterapija b'doża għolja jindika relazzjoni statistikament kumpless iżda kontinwu.
English: Check the appearance of Filgrastim ratiopharm.
Maltese: Iċċekkja d-dehra ta' Filgrastim ratiopharm.
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MIU (5 μg)/kg/day given daily by subcutaneous injection from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Maltese: MIU (5 μg)/kg/jum mogħtija bħala injezzjoni taħt il-ġilda ta' kuljum mill-ewwel ġurnata wara t-tmiem tal-kimoterapija sakemm in-nadir mistenni jkun għadda u l-għadd ta' newtrofili jkun reġa' lura għan-normal.
English: Tel: +49 731 402 02
Maltese: GmbH, Il Ġermanja Tel: +49 731 402 02
English: Timing of leukapheresis: 1 or
Maltese: talanqas 1 minn kull 10 pazjenti
English: Filgrastim ratiopharm and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Maltese: Id-doża tal-bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta' piż tal-ġisem, kuljum.
English: Established cytotoxic chemotherapy
Maltese: L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Risks associated with increased doses of chemotherapy Special caution should be used when treating patients with high dose chemotherapy because improved tumour outcome has not been demonstrated and intensified doses of chemotherapeutic agents may lead to increased toxicities including cardiac, pulmonary, neurologic and dermatologic effects (please refer to the Summary of Product Characteristics of the specific chemotherapy agents used).
Maltese: Il-kawtela speċjali trid tiġi eżerċitata f'kura ta' pazjenti li qed jirċievu dożi għola ta' kimoterapija għax rispons aħjar tat-tumur ma ġiex stabbilit u dozi aktar qawwija ta' sustanzi kimoterapewtiċi jistgħu jwasslu għal tossiċita' żejda inkluż diturbi fil-qalb, fil-pulmun, fis-sistema nervuża u fil-ġilda (jekk jogħġbok irreferi għas-Summarju tal-Karatteristiċi tal-Prodott tas-sustanża kimoterapewtika speċifika
English: The recommended starting dose of filgrastim is 1.0 MIU (10 μg)/kg/day given as a 30 minute or 24 hour intravenous infusion or 1.0 MIU (10 μg)/kg/day given by continuous 24 hour subcutaneous infusion.
Maltese: MIU (10 μg)/kg/jum mogħtija bħala infużjoni ġol-vina fuq medda ta' 30 minuta jew 24 siegħa jew inkella 1.0
English: Tel: + 370 5 212 3295
Maltese: Lietuva ratiopharm atstovas Lietuvoje Tel: + 370 5 212 3295
English: Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Maltese: Effeti mhux mixtieqa rari tal-pulmun, b' mod partikulari pulmonite interstizjali, ġew rrapportati wara l-għoti tal-fattur li jistimola l-kolonji ta' granuloċiti.
English: Deutschland ratiopharm GmbH Tel: +49 731 402 02
Maltese: Κύπρος ratiopharm GmbH, Γερμανία Τηλ: +49 731 402 02
English: Important information about some of the ingredients of Filgrastim ratiopharm This medicine contains sorbitol (a type of sugar).
Maltese: Din il-mediċina fiha sorbitol (tip ta' zokkor).
English: You will normally receive your first dose of Filgrastim ratiopharm at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Maltese: Normalment, tirċievi l-ewwel doża tiegħek ta' Filgrastim ratiopharm millinqas 24 siegħa wara l-kimoterapija imma qabel 24 hours li tirċievi t-trasfużjoni tal-mudullun.
English: 0.65 ml (200 µg/ml) 4 pre-filled pens
Maltese: 0.65 ml (200 µg/ml) 4 Pinen mimlija għallest
English: 0.375 ml (40 µg/ml) 1 pre-filled pen
Maltese: 0.375 ml (40 µg/ml) 4 Pinen mimlija għallest
English: 0.375 ml (40 µg/ml) 4 pre-filled syringes with needle guard
Maltese: 0.375 ml (40 µg/ml) 4 siringi mimlija għallest
English: 0.375 ml (40 µg/ml) 4 pre-filled pens pre-filled syringe (glass) 0.65 ml (200 µg/ml) 1 pre-filled syringe pre-filled syringe (glass) 0.65 ml (200 µg/ml) 4 pre-filled syringes pre-filled syringe (glass) 0.65 ml (200 µg/ml) 1 pre-filled syringe (non-blister)
Maltese: 0.65 ml (200 µg/ml) 4 siringi mimlija għallest b'għatu ta' protezzjoni tal-labra
English: pre-filled syringe (glass) 0.375 ml (40 µg/ml) 1 pre-filled syringe pre-filled syringe (glass) 0.375 ml (40 µg/ml) 4 pre-filled syringes pre-filled syringe (glass) 0.375 ml (40 µg/ml) 1 pre-filled syringe (non-blister)
Maltese: 0.375 ml (40 µg/ml) 4 siringi mimlija għallest b'għatu ta' protezzjoni tal-labra
English: 0.65 ml (200 µg/ml) 4 pre-filled syringes with needle guard
Maltese: 0.65 ml (200 µg/ml) 4 siringi mimlija għallest
English: 0.65 ml (200 µg/ml) 1 pre-filled syringe with needle guard
Maltese: 0.65 ml (200 µg/ml) Siringa waħda mimlija għal-lest
English: 0.375 ml (40 µg/ml) 1 pre-filled syringe with needle guard
Maltese: 0.375 ml (40 µg/ml) Siringa waħda mimlija għal-lest
English: The full EPAR and risk management plan summary for Aripiprazole Mylan Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Aripiprazole Mylan Pharma jinstabu fissit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Aripiprazole Mylan Pharma is available as tablets (5, 10, 15 and 30 mg) and can only be obtained with a prescription.
Maltese: Aripiprazole Mylan Pharma jiġi bħala pilloli (5, 10, 15 u 30 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Maltese: • disturb bipolari tat-tip I, marda mentali li biha l-pazjenti jesperjenzaw episodji ta' manija (perjodi anomali ta' burdata tajba), alternati b'perjodi ta' burdata normali.
English: The active substance in Aripiprazole Mylan Pharma, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Aripiprazole Mylan Pharma, l-aripiprażol, hija mediċina antipsikotika.
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and is a ‘generic medicine'.
Maltese: Aripiprazole Mylan Pharma fih is-sustanza attiva l-aripiprażol u huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aripiprazole Pharmathen on 30 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Aripiprazole Pharmathen fit-30 ta' Ġunju 2015.
English: This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aripiprazole Mylan Pharma.
English: The name of the medicine was changed to Aripiprazole Mylan Pharma on 3 June 2016.
Maltese: L-isem tal-mediċina nbidel f'Aripiprazole Mylan Pharma fit--3 ta' Ġunju 2016.
English: Aripiprazole Mylan Pharma is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults who have responded to the medicine in the past.
Maltese: Aripiprazole Mylan Pharma jintuża f'adulti għall-kura ta' episodji ta' manija minn moderati għal severi u għall-prevenzjoni ta' episodji ta' manija ġodda f'adulti li rrispondew għall-mediċina fl-imgħoddi.