FrancophonIA/ELRC3.0 huggingface dataset:
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: CONDITIONS OF THE MARKETING AUTHORISATION
Maltese: KUNDIZZJONIJIET TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: The protocol and the timelines of the DUS should be provided to the RMS within one month of the commission decision concluding this referral procedure.
Maltese: Il-protokoll u l-iskedi taż-żmien tad-DUS għandhom jiġu pprovduti lill-RMS fi żmien xahar mid-deċiżjoni tal-kummissjoni li tikkonkludi din il-proċedura ta' riferiment.
English: Sildenafil ratiopahrm EMA/432244/2013
Maltese: Sildenafil ratiopharmEMA/432227/2013
English: The full EPAR for Sildenafil ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Sildenafil ratiopharm jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Sildenafil ratiopharm is a ‘generic medicine'.
Maltese: Sildenafil ratiopharm huwa ‘mediċina ġenerika'.
English: Sildenafil ratiopahrm sildenafil
Maltese: Sildenafil ratiopharm sildenafil
English: The active ingredient in Sildenafil ratiopharm, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva f'Sildenaphil ratiopharm, is-sildenafil, tappartieni lill-grupp ta' mediċini msejħa inibituri tal-fosfodjesterażi tat-tip5 (PDE5).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil ratiopharm on 23 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Sildenafil ratiopharm valida flUnjoni Ewropea kollha fit-23 ta' Diċembru 2009.
English: Sildenafil ratiopharm is a medicine that contains the active substance sildenafil.
Maltese: Sildenafil ratiopharm huwa mediċina li fiha s-sustanza attiva sildenafil.
English: This is a summary of the European public assessment report (EPAR) for sildenafil.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sildenafil ratiopharm.
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil ratiopharm has been shown to have comparable quality and to be bioequivalent to Viagra.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Sildenafil ratiopharm għandu kwalità kumparabbli u li huwa bijoekwivalenti għal Viagra.
English: Because Sildenafil ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Maltese: Billi Sildenafil ratiopharm huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testijiet li jistabbilixxu l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Viagra.
English: liver function or severely reduced kidney function should start treatment with the 25-mg dose.
Maltese: funzjoni tal-fwied jew tnaqqis gravi fil-funzjoni tal-kliewi għandhom jibdew it-trattament b'25 mg.
English: This means that Sildenafil ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Maltese: Dan ifisser li Sildenafil ratiopharm huwa simili għal 'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Viagra.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: Din tikkawża r-rilassament tal-muskolu fit-tessut li qisu sponża tal-pene (il-korpora kavernoża).
English: Sildenafil ratiopharm is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a sufficiently hard penis (erection) for satisfactory sexual activity.
Maltese: Sildenafil ratiopharm jintuża fit-trattament ta' rġiel adulti b'disfunzjoni erettili (xi drabi tissejjaħ impotenza) meta ma jkunx jista' jkollhom jew ma jkunux jistgħu jżommu l-pene iebes biżżejjed (erezzjoni) għal attività sesswali sodisfaċenti.
English: Because Sildenafil ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Sildenafil ratiopharm huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusin bħala l-istess bħal dawk tal-mediċina ta' referenza.
English: By blocking the breakdown of cGMP, Sildenafil ratiopharm restores erectile function.
Maltese: Għaliex ġie approvat Sildenafil ratiopharm?
English: If Sildenafil ratiopharm is taken with food, the onset of activity may be delayed compared with taking Sildenafil ratiopharm without food.
Maltese: Il-Kumitat irrakkomanda li Sildenafil ratiopharm jingħata awtorizzazzjoni għal tqegħid fis-suq.
English: This allows blood to flow into the corpora, producing the erection.
Maltese: Dan jippermetti li d-demm jimxi fil-korpora, u b'hekk tiġi prodotta erezzjoni.
English: Take special care with Abseamed:
Maltese: Tużax Abseamed:
English: Abseamed contains sodium
Maltese: Abseamed fih sodium
English: Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Maltese: KG, Kuhloweg 37, D-58638 Iserlohn, Il-Ġermanja
English: Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37
Maltese: Medice Arzneimittel Pütter GmbH & Co
English: (subcutaneously) yourself.
Maltese: (b'mod subkutaneju).
English: Other medicines and Abseamed
Maltese: Mediċini oħra u Abseamed
English: INFORMATION IN BRAILLE Abseamed 8,000 IU/0.8 mL
Maltese: Abseamed 8,000 IU/0.8 mL
English: INFORMATION IN BRAILLE Abseamed 7,000 IU/0.7 mL
Maltese: Abseamed 7,000 IU/0.7 mL
English: Kolodvorska 27
Maltese: KG Kuhloweg 37
English: How to store Abseamed
Maltese: X'fih Abseamed
English: Abseamed is not approved in the management of anaemia associated with hepatitis C.
Maltese: Abseamed mhuwiex approvat fl-immaniġġjar ta' anemija marbuta ma' epatite Ċ.
English: Abseamed is a biosimilar medicinal product.
Maltese: Abseamed hu prodott mediċinali bijosimili.
English: INFORMATION IN BRAILLE Abseamed 40,000 IU/1 mL
Maltese: Abseamed 40,000 IU/1 mL
English: INFORMATION IN BRAILLE Abseamed 3,000 IU/0.3 mL
Maltese: Abseamed 3,000 IU/0.3 mL
English: 1 pre-filled syringe of 0.75 mL 6 pre-filled syringes of 0.75 mL 1 pre-filled syringe of 0.75 mL with a needle safety guard 4 pre-filled syringes of 0.75 mL with a needle safety guard 6 pre-filled syringes of 0.75 mL with a needle safety guard
Maltese: 6 siringi mimlija għal-lest ta' 0.75 mL Siringa mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra 4 siringi mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.75 mL bi protezzjoni tas-sigurtà tal-labra
English: INFORMATION IN BRAILLE Abseamed 2,000 IU/1 mL
Maltese: Abseamed 2,000 IU/1 mL
English: Do not use Abseamed:
Maltese: Oqgħod attent ħafna bi Abseamed:
English: In patients with a poor haemoglobin response to Abseamed, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Maltese: F'pazjenti b'rispons batut tal-emoglobina għal Abseamed, għandhom jiġu kkunsidrati spegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.4 u 5.1).
English: INFORMATION IN BRAILLE Abseamed 1,000 IU/0.5 mL
Maltese: Abseamed 1,000 IU/0.5 mL
English: Abseamed is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Maltese: Abseamed huwa indikat fit-trattament tal-anemija sintomatika (konċentrazzjoni ta' emoglobina ta'
English: Do not administer Abseamed by intravenous infusion or in conjunction with other medicinal product solutions (please refer to section 6.6 for further information).
Maltese: Tagħtix Abseamed permezz ta' infużjoni ġol-vini jew flimkien ma' soluzzjonijiet oħrajn ta' prodotti mediċinali (jekk jogħġbok irreferi għal sezzjoni 6.6 għal informazzjoni addizzjonali).
English: If the haemoglobin exceeds 13 g/dL (8.1 mmol/L), discontinue therapy until it falls below 12 g/dL (7.5 mmol/L) and then reinstitute Abseamed therapy at a dose 25% below the previous dose.
Maltese: Jekk l-emoglobina taqbeż 13 g/dL (8.1 mmol/L), waqqaf it-terapija sakemm il-livell jinżel taħt 12 g/dL (7.5 mmol/L), u mbagħad erġa' ibda t-terapija b'Abseamed f'doża li tkun 25% taħt id-doża ta' qabel.
English: Abseamed is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy) for the treatment of anaemia and reduction of transfusion requirements.
Maltese: limfoma malinna jew majeloma multipla, u li jkunu f'riskju ta' trasfużjoni kif evalwat mill-istat ġenerali tal-pazjent (eż. status kardjovaskulari, anemija diġà eżistenti fil-bidu tal-kimoterapija) għal kura ta' anemija u tnaqqis tal-ħtiġijiet ta' trasfużjoni.
English: Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 40,000 IU of epoetin alfa* corresponding to 336.0 micrograms per mL
Maltese: Abseamed 40,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull mL ta' soluzzjoni fih 40,000 IU ta' epoetin alfa* li jikkorrispondu għal 336.0 mikrogrammi f'kull mL
English: 1 pre-filled syringe of 0.6 mL 6 pre-filled syringes of 0.6 mL 1 pre-filled syringe of 0.6 mL with a needle safety guard 6 pre-filled syringes of 0.6 mL with a needle safety guard
Maltese: 6 siringi mimlija għal-lest ta' 0.6 mL Siringa mimlija għal-lest ta' 0.6 mL bi protezzjoni tas-sigurtà tal-labra 6 siringi mimlija għal-lest ta' 0.6 mL bi protezzjoni tas-sigurtà tal-labra
English: Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 8,000 IU/0.8 mL injezzjoni Epoetin alfa
English: Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Informazzjoni għall-pazjent Abseamed 1,000 IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Abseamed 2,000 IU/1 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Abseamed 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Abseamed 4,000
English: Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Epoetin alfa
Maltese: IU/0.75 mL injezzjoni Epoetin alfa
English: Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 3,000 IU/0.3 mL injezzjoni Epoetin alfa
English: Side effects from an overdose of Abseamed are unlikely.
Maltese: Effetti sekondarji minn doża eċċessiva ta' Abseamed mhumiex mistennija.
English: Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 7,000 IU/0.7 mL injezzjoni Epoetin alfa
English: If Abseamed is injected under the skin (subcutaneously), the amount injected is not normally more than one millilitre (1 mL) in a single injection.
Maltese: Jekk Abseamed jiġi injettat taħt il-ġilda (b'mod subkutaneju), l-ammont injettat fi kwalunkwe post normalment ma jkunx iktar minn millilitru (1 mL) f'injezzjoni waħda.
English: EU/1/07/412/025 EU/1/07/412/026 EU/1/07/412/051 EU/1/07/412/055 EU/1/07/412/052
Maltese: EU/1/07/412/026 EU/1/07/412/051 EU/1/07/412/055
English: Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Abseamed 8,000 IU/0.8 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.8 mL ta' soluzzjoni għall-injezzjoni.
English: Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 40,000 IU/1 mL injezzjoni Epoetin alfa
English: Abseamed is prescribed to stimulate your bone marrow to produce more red blood cells.
Maltese: Abseamed huwa prodott sterili iżda mhux ippreservat u jintuża darba biss.
English: Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Maltese: ≤ 10 g/dL) f'adulti b'riskju baxx jew intermedju 1 ta' sindromi majelodisplastiċi primarji (MDS,
English: Abseamed contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 1,000 IU/0.5 mL injezzjoni Epoetin alfa
English: Abseamed is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Maltese: Abseamed hu wieħed minn gruppi ta' prodotti li jistimulaw il-produzzjoni ta' ċelluli tad-demm ħomor bħalma tagħmel erythropoietin proteina umana.
English: The effect of epoetin alfa (300 IU/kg or 100 IU/kg) on the exposure to allogeneic blood transfusion has been evaluated in a placebo-controlled, double-blind clinical trial in non-iron deficient adult patients scheduled for major elective orthopaedic hip or knee surgery.
Maltese: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi) Epoetin alfa juri effett relatat mad-doża fuq il-parametri ematoloġiċi li hu indipendenti mir-rotta talgħoti.
English: Abseamed should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Maltese: Abseamed għandu jingħata sabiex iżid l-emoglobina għal livell ta' mhux iktar minn 11 g/dL (6.8 mmol/L).
English: Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Each syringe contains 0.7 mL of solution for injection.
Maltese: Abseamed 7,000 IU/0.7 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.7 mL ta' soluzzjoni għall-injezzjoni.
English: Mildly anaemic patients (haematocrit of 33 to 39%) requiring predeposit of ≥ 4 units of blood should be treated with Abseamed 600 IU/kg intravenously, 2 times per week for 3 weeks prior to surgery.
Maltese: Kura ta' pazjenti kirurġiċi adulti fi programm ta' predonazzjoni awtologa Pazjenti li għandhom anemija ħafifa (ematokrit ta' 33 sa 39%) li jeħtieġu predepożitu ta' ≥ 4 unitajiet ta' demm, għandhom jiġu kkurati b'Abseamed b'doża ta' 600
English: If signs and symptoms suggestive of these reactions appear, Abseamed should be withdrawn immediately and an alternative treatment considered.
Maltese: Jekk jitfaċċaw sinjali u sintomi li jissuġġerixxu dawn ir-reazzjonijiet, Abseamed għandu jitwaqqaf minnufih u jiġi kkunsidrat trattament alternattiv.
English: • If you do not respond adequately to Abseamed, your doctor will check your dose and will inform you if you need to change doses of Abseamed.
Maltese: • ma tistax tieħu mediċini li jraqqu d-demm Abseamed jista' ma jkunx adattat għalik.
English: Package leaflet: Information for the patient Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Abseamed 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Abseamed 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Abseamed 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Abseamed 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Abseamed 10,000 IU/1 mL solution for injection in a pre-filled syringe Abseamed 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Abseamed 30,000 IU/0.75 mL solution for injection in a pre-filled syringe Abseamed 40,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Maltese: Studju ta' 7 trabi tat-twelid li twieldu qabel iż-żmien b'piż baxx ħafna meta twieldu, u 10 adulti f'saħħithom li ngħataw eritropoetin i.v., issuġġerixxa li l-volum tad-distribuzzjoni kien madwar 1.5 sa darbtejn ogħla fi trabi tat-twelid li twieldu qabel iż-żmien milli f'adulti f'saħħithom, u t-tneħħija kienet madwar 3 darbiet ogħla fi trabi tat-twelid li twieldu qabel iż-żmien milli f'adulti f'saħħithom.
English: Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe
Maltese: Abseamed 2,000 IU/1 mL injezzjoni Epoetin alfa
English: Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each syringe contains 0.3 mL of solution for injection.
Maltese: Abseamed 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 0.3 mL ta' soluzzjoni għall-injezzjoni.
English: When treatment starts, Abseamed is usually injected by a medical professional or a nurse.
Maltese: Meta tibda l-kura, Abseamed normalment jiġi injettat minn staff mediku jew mill-infermiera.
English: EU/1/07/412/015 EU/1/07/412/016 EU/1/07/412/045 EU/1/07/412/046
Maltese: EU/1/07/412/016 EU/1/07/412/045
English: In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40,000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Maltese: Kura ta' pazjenti adulti b'anemija kkawżata mill-kimoterapija Sintomi ta' anemija u l-konsegwenzi tagħha jistgħu jvarjaw skont l-età, is-sess, u l-gravità totali tal marda; hemm bżonn ta' evalwazzjoni ta' tabib tal-kors kliniku u tal-kundizzjoni tal-pazjent individwali.
English: If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Abseamed dose by about 25 to 50%.
Maltese: Jekk il-konċentrazzjoni tal-emoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell tal-konċentrazzjoni tal-emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Abseamed b'madwar 25 sa 50%.
English: Major elective orthopaedic surgery
Maltese: Jekk tinsa tuża Abseamed
English: Abseamed 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Abseamed 5,000 IU/0.5 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Maltese: Abseamed 3,000 IU/0.3 mL soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per mL
Maltese: Kull mL ta' soluzzjoni fih 2,000 IU ta' epoetin alfa* li jikkorrispondu għal 16.8 mikrogrammi f'kull mL
English: If the haemoglobin level reaches 15 g/dL (9.38 mmol/L), or higher, during the preoperative period, administration of Abseamed should be stopped and further dosages should not be administered.
Maltese: Jekk il-livell tal-emoglobina jilħaq il-15 g/dL (9.38 mmol/L), jew ogħla, matul il-perjodu ta' qabel l operazzjoni, l-għoti ta' Abseamed għandu jitwaqqaf u ma għandhomx jingħataw aktar dożaġġi.
English: If the haemoglobin is rising by more than 2 g/dL (1.25 mmol/L) per month, or if the sustained haemoglobin exceeds 12 g/dL (7.5 mmol/L) reduce the Abseamed dose by 25%.
Maltese: Jekk lemoglobina tkun qed tiżdied b'iktar minn 2 g/dL (1.25 mmol/L) kull xahar, jew jekk il-livell sostnut ta' emoglobina jaqbeż 12 g/dL (7.5 mmol/L), naqqas id-doża ta' Abseamed b'25%.
English: • The starting dose is 450 IU per kilogram bodyweight once a week.
Maltese: • Id-doża tal-bidu hija ta' 450 IU għal kull kilogramma ta' piż tal-ġisem darba fil-ġimgħa.
English: The use of Abseamed in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Maltese: L-użu ta' Abseamed f'pazjenti skedati għal operazzjoni ortopedika mhux obbligatorja maġġuri u li ma jkunux qegħdin jipparteċipaw fi programm ta' predonazzjoni tad-demm awtologu, huwa kontra indikat f'pazjenti b'mard koronarju, mard tal-arterji periferali, mard tal-karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b'infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
English: A randomised, double-blind, placebo-controlled, multicentre study evaluated the efficacy and safety of epoetin alfa in adult anaemic subjects with low- or intermediate-1-risk MDS.
Maltese: Studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bil-plaċebo u multiċentriku evalwa l-effikaċja u s-sigurtà tal-epoetin alfa f'individwi adulti anemiċi b'riskju baxx jew intermedju ta' MDS.
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dL or 6.2 to 8.1 mmol/L) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 mL).
Maltese: u 8.1 mmol/L) li ma jkollhomx programm ta' predonazzjoni awtologu disponibbli u li jkun mistenni li jkun hemm telf moderat ta' demm (900 sa 1,800 mL).
English: Pharmacokinetic data in neonates is limited.
Maltese: u wieħed kien studju open-label.
English: 1081 CN Amsterdam The Netherlands
Maltese: 1081 CN Amsterdam In-Netherlands
English: Phenytoin and dexamethasone
Maltese: Phenytoin u dexamethasone
English: Table 1
Maltese: Tabella 1.
English: Pneumonitis.
Maltese: Pneumonite.
English: - The active substance is carmustine.
Maltese: - Is-sustanza attiva hija carmustine.
English: Leucocytes/mm3
Maltese: Lewkoċiti/mm3
English: Pulmonary toxicity has been observed in up to 30% of patients.
Maltese: It-tossiċità pulmonari ġiet osservata f'sa 30 % tal-pazjenti.
English: Pulmonary fibrosis (with fatal outcome), pulmonary infiltration
Maltese: Fibrożi pulmonari (b'riżultati fatali), infiltrazzjoni pulmonari
English: The half-life α is 1-4 minutes and the half-life β is 18-69 minutes.
Maltese: Il-half life α hija bejn minuta u erba' minuti u l-half life β hija ta' bejn 18-il minuta u 69 minuta.
English: Carmustine Obvius contains ethanol (alcohol)
Maltese: Carmustine Obvius fih ethanol (alkoħol)
English: Common Anorexia, constipation, diarrhoea, stomatitis.
Maltese: Anoressija, stitikezza, dijarea, stomatite.
English: Solvent for Carmustine Obvius ethanol anhydrous IV
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal Carmustine Obvius ethanol anhydrous IV
English: Emetogenic potential.
Maltese: Potenzjal emetoġeniku.