FrancophonIA/ELRC3.0 huggingface dataset:
English: Tolucombi is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Maltese: Tolucombi huwa mediċina li fiha żewġ sustanzi attivi, it-telmisartan u l-idroklorotijażide.
English: Why is Tolucombi approved?
Maltese: Għal xiex ġie approvat Tolucombi?
English: Tolucombi telmisartan / hydrochlorothiazide
Maltese: Sommarju tal-EPAR għall-pubbliku telmisartan / idroklorotijażide
English: Therefore, the CHMP's view was that, as for MicardisPlus, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' MicardisPlus, il-benefiċċji huma akbar mir-riskji identifikati.
English: How has Tolucombi been studied?
Maltese: Kif ġie studjat Tolucombi?
English: Because Tolucombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Tolucombi huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: A risk management plan has been developed to ensure that Tolucombi is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Tolucombi jintuża bl-aktar mod sigur possibbli.
English: Other information about Tolucombi
Maltese: Kif jintuża Tolucombi?
English: The Committee recommended that Tolucombi be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Tolucombi ikun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tolucombi has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Tolucombi għandu kwalità komparabbli u li huwa bijoekwivalenti għal MicardisPlus.
English: 08409 Vilnius Lithuania
Maltese: LT-08409 Vilnius
English: Teva UK Limited Tel: +44 1977 628500
Maltese: United Kingdom Teva UK Limited Tel: +44 1977 628500
English: UAB Teva Baltics filiāle Latvijā
Maltese: UAB Teva Baltics Eesti filiaal
English: Tevagrastim contains sorbitol (E420).
Maltese: Tevagrastim fih sorbitol (E420).
English: Name and address of the manufacturer of the biological active substance UAB Teva Baltics
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva UAB Teva Baltics
English: Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Maltese: Teva Pharma Belgium N.V./S.A./AG
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Maltese: Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta'glucose 50 mg/mL (5%), Tevagrastim huwa kompatibbli mal-ħġieġ u varji tipi ta' plastik, fosthom il-PVC, polyolefin (co-polymer ta' polypropylene u polyethylene) u polypropylene.
English: Tevagrastim contains sorbitol
Maltese: Tevagrastim fih sorbitol
English: Teva Santé Tél: +33 1 55 91 78 00
Maltese: Tél: +33 1 55 91 78 00
English: Tevagrastim contains sodium
Maltese: Tevagrastim fih sodium
English: Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Maltese: Riskju relattiv (95% CI) ta' GvHD u TRM wara l-kura b'G-CSF wara trapjant tal-mudullun
English: Cutaneous vasculitisa Sweets syndrome (acute febrile neutrophilic dermatosis)
Maltese: Vaskulite tal-ġildaa Sindrome ta' Sweets (dermatosi newtrofilika akuta biddeni)
English: Date of first authorisation: 15 September 2008.
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Settembru 2008
English: MedDRA system organ class
Maltese: Klassi tassistemi u tal-organi
English: Tevagrastim is a biosimilar medicinal product.
Maltese: Tevagrastim hu prodott mediċinali bijoloġiku simili.
English: Tevagrastim should not be diluted with sodium chloride solution.
Maltese: Tevagrastim m'għandux jiġi dilwit ma' soluzzjoni ta' sodium chloride.
English: Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Maltese: Tevagrastim huwa indikat għall-mobilizzazzjoni taċ-ċelluli proġenitriċi tad-demm periferali(PBPC).
English: Teva Denmark A/S Tlf: +45 44 98 55 11
Maltese: Tlf: +45 44 98 55 11
English: TEVA GmbH Tel: +49 731 402 08
Maltese: Tel: +49 731 402 08
English: Filgrastim should be diluted in 20 mL of 5% glucose solution for infusion (see section 6.6).
Maltese: Filgrastim għandu jiġi dilwit f'20 mL ta' soluzzjoni għall-infużjoni ta' 5% glucose (ara sezzjoni 6.6).
English: UAB Teva Baltics Eesti filiaal Tel: +372 661 0801
Maltese: UAB Teva Baltics filiāle Latvijā Tel: +371 673 23 666
English: Fertility Filgrastim did not affect reproductive performance or fertility in male or female rats (see section 5.3).
Maltese: Fertilità Filgrastim ma affettwax il-prestazzjoni riproduttiva jew il-fertilità f'firien irġiel jew nisa (ara sezzjoni 5.3).
English: Tevagrastim 30 MIU/0.5 mL: Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 mL solution.
Maltese: Tevagrastim 30 MIU/0.5 mL: Kull siringa mimlija għal-lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f'0.5 mL soluzzjoni.
English: 30 months.
Maltese: > 60 sena.
English: Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Tevagrastim 48 MIU/0.8 mL solution for injection/infusion
Maltese: Tevagrastim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni Tevagrastim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni/infużjoni
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution for infusion given over 30 minutes (see section 6.6).
Maltese: Filgrastim jista' jingħata bħala injezzjoni taħt il-ġilda ta' kuljum jew bħala infużjoni fil-vini ta' kuljum dilwita f'soluzzjoni għall-infużjoni ta' 5% glucose mogħtija fuq 30 minuta (ara sezzjoni 6.6).
English: Tevagrastim 48 MIU/0.8 mL solution for injection/infusion Filgrastim
Maltese: Tevagrastim 48 MIU/0.8 mL soluzzjoni għall-injezzjoni/infużjoni Filgrastim
English: ANNEX II
Maltese: II - IV
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Tevagrastim was comparable to that of the reference product after subcutaneous and intravenous administration.
Maltese: Studji randomised, single-blind, b'doża waħda u crossover li saru fuq 196 voluntiera b'saħħithom urew li l-profil farmakokinetiku ta'Tevagrastim kien komparabbli ma' dak tal-prodott ta' referenza kemm wara amministrazzjoni taħt il-ġilda kif ukoll ġol-vina.
English: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: TEVA GmbH Graf-Arco-Straße 3
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Maltese: Irrakkomandazzjoni ta' produzzjonijiet minimi ta' ≥ 2.0 x 106 CD34+ ċelluli/kg hija bbażata fuq esperjenzi ppublikati li rriżultaw f'rikostituzzjoni ematoloġika adegwata.
English: If required, Tevagrastim may be diluted in glucose 50 mg/mL (5 %) solution for infusion.
Maltese: Jekk ikun hemm bżonn, Tevagrastim jista' jiġi dilwit f'soluzzjoni għal infużjoni ta' glucose 50 mg/mL (5%).
English: Component of a multipack, cannot be sold separately.
Maltese: Parti minm pakkett multiplu, ma jistax jinbiegħ separatament.
English: This medicine contains 50 mg sorbitol in each mL.
Maltese: Din il-mediċina fiha 50 mg sorbitol f'kull mL.
English: UAB Teva Baltics Tel: +370 5 266 0203
Maltese: Tel: +370 5 266 0203
English: Tevagrastim 30 MIU/0.5 mL solution for injection/infusion Filgrastim
Maltese: Tevagrastim 30 MIU/0.5 mL soluzzjoni għall-injezzjoni/infużjoni Filgrastim
English: Diarrhoeaa, e Vomitinga,e Nauseaa
Maltese: Dijareaa, e Rimettara, e
English: The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Maltese: Is-sigurtà u l-effikaċja ta' filgrastim ma ġewx investigati f'donaturi normali ta' < 16-il sena jew
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see section 4.4 and 5.1).
Maltese: Kien hemm rapporti ta' GvHD u mwiet f'pazjenti li kienu qed jirċievu G-CSF wara trapjant alloġeniku tal-mudullun (ara sezzjonijiet 4.4 u 5.1).
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 terapija mijelosoppressiva estensiva ħafna ma jkollhomx mobilizzazzjoni suffiċjenti ta' PBPC biex jaslu għall-għadd minimu rakkomandat (≥ 2.0 x 106 CD34+ ċelluli/kg) jew biex l-irkuprar tal-plejtlits jaċċelera bl-istess grad.
English: Acute respiratory distress syndromea Respiratory failurea Pulmonary oedemaa Pulmonary haemorrhag e
Maltese: Sindrome ta' diffikultà respiratorja akutaa
English: The efficacy and safety of Tevagrastim 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: Other medicines and Tevagrastim
Maltese: Mediċini oħra u Tevagrastim
English: 1 pre-filled syringe with 0.5 mL with a needle safety guard 5 pre-filled syringes with 0.5 mL with a needle safety guard 10 pre-filled syringes with 0.5 mL with a needle safety guard
Maltese: 1 siringa mimlija għal-lest b'0.5 mL bi protezzjoni tas-sigurtà tal-labra 5 siringa mimlija għal-lest b'0.5 mL bi protezzjoni tas-sigurtà tal-labra 10 siringa mimlija għal-lest b'0.5 mL bi protezzjoni tas-sigurtà tal-labra
English: Transformation to leukaemia or myelodysplastic syndrome
Maltese: Trasformazzjoni għal lewkimja jew sindrome mijelodisplastiku
English: b. Tabulated summary of adverse reactions
Maltese: b. Sommarju ta' reazzjonijiet avversi f'tabella
English: Solution for injection/infusion Multipack: 10 (2 packs of 5) pre-filled syringes containing 0.8 mL.
Maltese: Pakkett multiplu: 10 (2 pakketti ta' 5) siringi mimlija għal-lest b'0.8 mL.
English: Injury, poisoning and procedural complicatio ns
Maltese: Korriment, avvelename nt u komplikazz jonijiet ta' xi proċedura
English: - sickle cell anaemia, as this medicine may cause sickle cell crisis- osteoporosis (bone disease).
Maltese: - anemija taċ-ċelluli sickle, għax din il-mediċina tista' tikkawża kriżi taċ-ċelluli sickle.
English: EU/1/08/445/007 2 x 5 pre-filled syringes
Maltese: EU/1/08/445/007 2 x 5 siringi mimlija għal-lest
English: EU/1/08/445/001 EU/1/08/445/002 EU/1/08/445/003 EU/1/08/445/004 EU/1/08/445/009 EU/1/08/445/010 EU/1/08/445/011
Maltese: EU/1/08/445/009 EU/1/08/445/010 EU/1/08/445/011 EU/1/08/445/005
English: EU/1/08/445/003 2 x 5 pre-filled syringes
Maltese: EU/1/08/445/003 2 x 5 siringi mimlija għal-lest
English: Tevagrastim 48 MIU/0.8 mL: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL solution.
Maltese: Kull siringa mimlija għal-lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f'0.8 mL soluzzjoni
English: 1 pre-filled syringe with 0.8 mL with a needle safety guard 5 pre-filled syringes with 0.8 mL with a needle safety guard 10 pre-filled syringes with 0.8 mL with a needle safety guard
Maltese: 1 siringa mimlija għal-lest b'0.8 mL bi protezzjoni tas-sigurtà tal-labra 5 siringi mimlija għal-lest b'0.8 mL bi protezzjoni tas-sigurtà tal-labra 10 siringi mimlija għal-lest b'0.8 mL bi protezzjoni tas-sigurtà tal-labra
English: Elderly
Maltese: Dardira
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji , toraċiċi u medjastinal i
English: • upper respiratory tract infection
Maltese: Insuffiċjenz a respiratorjaa
English: Tevagrastim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Maltese: Tevagrastim, 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: EU/1/08/445/012 1 pre-filled syringe with a needle safety guard EU/1/08/445/013 5 pre-filled syringe with a needle safety guard EU/1/08/445/014 10 pre-filled syringe with a needle safety guard
Maltese: EU/1/08/445/012 1 siringa mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra EU/1/08/445/013 5 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra EU/1/08/445/014 10 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra
English: Cases of Sweets syndrome (acute febrile neutrophilic dermatosis) have been reported in patients treated with filgrastim.
Maltese: Sindrome ta' Sweets Ġew irrapportati każijiet tas-sindrome ta' Sweets (dermatożi akuta newtrofilika bid-deni) f'pazjenti ttrattati b'filgrastim.
English: Dysuria Haematuria
Maltese: Disurja Ematurja
English: Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or PBPC mobilization e Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy c. Description of selected adverse reactions
Maltese: c Jinkludi uġigħ fl-għadam, uġigħ fid-dahar, artralġja, mijalġja, uġigħ fl-estremitajiet, uġigħ muskoluskeletriku, uġigħ muskoluskeletriku fis-sider, uġigħ fl-għonq d Il-każijiet ġew osservati fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti li kienu għaddejjin minn trapjant tal-mudullun jew mobilizzazzjoni ta' PBPC e Avvenimenti avversi b'inċidenza ogħla f'pazjenti fuq filgrastim meta mqabbel ma' plaċebo u assoċjati mal-konsegwenzi tat-tumur malinn sottostanti jew kimoterapija ċitotossika c.
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5 % of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Maltese: Għadd taċ-ċelluli bojod ta' 100 x 109/L jew aktar ġew osservati f'inqas minn 5 % tal-pazjenti bilkanċer li ngħataw filgrastim b'dożi akbar minn 0.3 MIU/kg/jum (3 μg/kg/jum).
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is
Maltese: Filgrastim għall-mobilizzazzjoni ta' PBPC wara kimoterapija majelosoppressiva:
English: No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
Maltese: Ma kienu osservati l-ebda differenzi globali fis-sigurtà u l-effikaċja f'individwi li kellhom aktar minn 65 sena meta mqabbla ma' adulti iżgħar (> 18-il sena) li kienu qed jirċievu kimoterapija ċitotossika, u l-esperjenza klinika ma identifikatx differenzi fir-risponsi bejn pazjenti adulti anzjani u pazjenti adulti iżgħar.
English: Decreased appetitee Blood lactate dehydrogen ase increased
Maltese: lactate dehydrogen ase fiddemm
English: 4.8 Undesirable effects a.Summary of the safety profile
Maltese: .8 Effetti mhux mixtieqa a.
English: Intravenous (80 µg/kg/day) administration of filgrastim to rabbits during the period of organogenesis was maternally toxic and increased spontaneous abortion, post-implantation loss, and decreased mean live litter size and foetal weight were observed.
Maltese: (80 μg/kg/jum) ta' filgrastim lill-fniek waqt il-perjodu ta' organoġenesi kien tossiku għall-omm u kienu osservati żieda fl-abort spontanju, fit-telf wara l-impjantazzjoni u tnaqqis fid-daqs medju talboton ħaj u fil-piż tal-fetu.
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: Analiżi statistika tar-relazzjoni bejn in-numru ta' ċelluli CD34+ infużi mill-ġdid u r-rata ta' rkupru talplejtlits wara kimoterapija ta' doża għolja jindika relazzjoni kumplessa iżda kontinwa.
English: Tevagrastim is supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes with injection needle and with or without a needle safety guard.
Maltese: Tevagrastim jiġi f'pakketti ta' 1, 5 jew 10 siringi mimlijin għal-lest jew f'pakkett multiplu ta'10 (2 pakketti ta' 5) b'labra tal-injezzjoni bi jew mingħajr protezzjoni tas-sigurtà tal-labra.
English: EU/1/08/445/009 1 pre-filled syringe with a needle safety guard EU/1/08/445/010 5 pre-filled syringe with a needle safety guard EU/1/08/445/01110 pre-filled syringe with a needle safety guard
Maltese: EU/1/08/445/009 1 siringa mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra EU/1/08/445/010 5 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra EU/1/08/445/011 10 siringi mimlija għal-lest bi protezzjoni tas-sigurtà tal-labra
English: Dyspnoea Cougha Oropharyng eal
Maltese: Newtropenja idjopatika jew ċiklika
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini
English: In view of the possible risk of microbial contamination, Tevagrastim syringes are for single use only.
Maltese: Minħabba r-riskju potenzjali ta' kontaminazzjoni bil-mikrobi, is-siringi ta' Tevagrastim iridu jintużaw darba biss.
English: In cancer patients, the pharmacokinetic profile of Tevagrastim and the reference product was comparable after single and repeated subcutaneous administration.
Maltese: F'pazjenti b'kanċer, il-profil farmacokinetiku ta' Tevagrastim u dak tal-prodott ta' referenza kienu komparabbli wara amministrazzjoni taħt il-ġilda ta' doża waħda jew dożi ripetuti.
English: • high uric acid levels in the blood, which may cause gout (hyperuricaemia) (blood uric acid
Maltese: • livelli għoljin ta' aċidu uriku fid-demm, li jistgħu jikkawżaw gotta (iperurikemija) (żieda ta'
English: Capillary leak syndromea Aortitis
Maltese: Sindrome ta' tnixxija talkapillaria Aortite
English: Accidental exposure to freezing temperatures does not adversely affect the stability of Tevagrastim.
Maltese: L-esposizzjoni bi żball għal temperatura ta' friża ma jeffettwax ħażin l-istabilita` ta' Tevagrastim.
English: Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Maltese: Il-fattur li jistimula l-kolonji ta' granuloċiti (Granulocyte-colony stimulating factor) jista' jippromwovi it-tkabbir ta' ċelluli majelojdi in vitro u effetti simili jistgħu jidhru wkoll f'xi ċelluli mhux majelojdi in vitro.
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 Tevagrastim 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'Tevagrastim huwa indikat biex jiżdied l-għadd ta' newtrofili u sabiex l-inċidenza u t-tul ta' ġrajjiet avversi relatati ma' infezzjonijiet jonqsu.
English: EU/1/08/445/005 EU/1/08/445/006 EU/1/08/445/007 EU/1/08/445/008 EU/1/08/445/012 EU/1/08/445/013 EU/1/08/445/014
Maltese: EU/1/08/445/001 EU/1/08/445/002 EU/1/08/445/003 EU/1/08/445/004
English: There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Maltese: M'hemmx evidenza li pazjenti b'infezzjoni ta' HIV ikkurati b'filgrastim ikollhom żieda firreplikazzjoni ta' HIV.
English: Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 mL (60 MIU/mL, 600 microgram/mL).
Maltese: Kull siringa mimlija għal-lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f'0.8 mL (60
English: Contents of the pack and other information What Tevagrastim contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Tevagrastim
English: Permanently discontinue Tevagrastim in patients with clinically significant hypersensitivity.
Maltese: Waqqaf Tevagrastim għal kollox f'pazjenti b'sensittività eċċessiva li hija klinikament sinifikanti.
English: How to store Tevagrastim
Maltese: X'fih Tevagrastim
English: For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μg) per mL, human serum albumin (HSA) should be added to a final concentration of 2 mg/mL.
Maltese: MIU (15 μg)/mL, din trid tiġi miżjuda bl-albumina tas serum umana (HSA) sabiex il-konċentrazzjoni finali tkun 2 mg/mL.
English: Acute grade II-IV GvHD
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà
English: - osteoporosis (bone disease).
Maltese: - osteoporożi (marda tal-għadam).
English: Hypertensio n
Maltese: ANNESS III
English: Solution for injection/infusion 1 pre-filled syringe with 0.5 mL 5 pre-filled syringes with 0.5 mL 10 pre-filled syringes with 0.5 mL
Maltese: 1 siringa mimlija għal-lest b'0.5 mL 5 siringa mimlija għal-lest b'0.5 mL 10 siringa mimlija għal-lest b'0.5 mL
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2)
English: Fatiguea Mucosal inflammatio na
Maltese: Effett tal-kimoterapija fuq eritroċiti u tromboċiti
English: Pseudogout (chondrocalcinosis pyrophosphate)
Maltese: (Chondroca lcinosis
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk filgrastim/metaboliti jiġux eliminat mill-ħalib tas-sider tal-bniedem.
English: Paina,e
Maltese: A./AG,
English: EU/1/08/445/001 1 pre-filled syringe EU/1/08/445/002 5 pre-filled syringes EU/1/08/445/004 10 pre-filled syringes
Maltese: EU/1/08/445/001 1 siringa mimlija għal-lest EU/1/08/445/002 5 siringi mimlija għal-lest EU/1/08/445/004 10 siringi mimlija għal-lest
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 tal-għadd ta' newtrofili jinżamm bejn 1.5 x 109/L u 10 x 109/L.
English: Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5 mL solution for injection/ infusion.
Maltese: Kull siringa mimlija għal-lest fiha 30 MIU (300 µg) filgrastim f'0.5 mL ta' soluzzjoni għallinjezzjoni/infużjoni.
English: • abnormal x-rays of the lungs (lung infiltration)
Maltese: • infjammazzjoni tal-pulmun (marda tal-interstizju tal-pulmun) • x-rays tal-pulmun mhux normali (infiltrazzjoni tal-pulmun)