FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.9 Amounts to be administered and administration route In-hive use.
Maltese: Ammont li jingħata u l-metodu ta' amministrazzjoni Użu fid-doqqajs.
English: Spring
Maltese: UŻU
English: The pharmacokinetics of formic acid in bees is not known.
Maltese: kombinazzjoni Kodiċi ATC veterinarja:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed bee-hive dispersion for honey bees Formic acid / oxalic acid dihydrate
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Keep the bottle tightly closed.
Maltese: Dispersjoni tad-doqqajs.
English: 5.1 Pharmacodynamic properties
Maltese: Kwalitajiet farmakodinamiċi
English: To be trickled onto bees in occupied bee-spaces of the brood chamber.
Maltese: Li għandu jitqattar fuq in-naħal fi spazji okkupati tan-naħal tal-kamra tad-duqqajs.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT VarroMed bee-hive dispersion
Maltese: Tużax il-prodott mediċinali veterinarju jekk tinnota deskrizzjoni ta' sinjali viżibbli ta' deterjorazzjoni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 15 ml Sachet
Maltese: JMISS MAL-PRODOTT Qartas ta' 15 ml
English: Oxalic acid dihydrate
Maltese: EFFETTI MHUX MIXTIEQA
English: − People with known sensitivity to formic acid or oxalic acid should administer the veterinary medicinal product with caution.
Maltese: − Persuni li huma sensittivi għall-aċidu formiku jew għall-aċidu ossaliku għandhom jamministraw il-prodott mediċinali veterinarju b'kawtela.
English: Vereinigtes Königreich/Royaume-Uni, Verenigd Kononkrijk
Maltese: Vereinigtes Königreich/Royaume-Uni, Verenigd
English: • Hyperparathyroidism/Osteitis fibrosa cystica
Maltese: • Iperparatirojdiżmu/Osteitis fibrosa cystica
English: An increased relative risk of thromboembolic events (RR 1.67, 95% CI: 1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Maltese: Żieda relattiva fir-riskju ta' avvenimenti tromboemboliċi (RR 1.67, 95% CI: 1.35, 2.06, 35 prova u 6769 pazjent) kienet osservata f'pazjenti kkurati b'erythropoietin uman rikombinanti.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI: 0.99, 1.18; 42 trials and 8167 patients).
Maltese: Meta-analiżi ta' dejta dwar is-sopravivenza totali, ipproduċiet hazard ratio point estimate ta' 1.08 favur il-kontrolli (95% CI: 0.99, 1,18; 42 prova u 8167 pazjent).
English: България / Česká Republika/ Danmark/ Eesti/ Ελλάδα/ Ireland/ Ísland/ Κύπρος/ Latvija/ Lietuva/ Magyarország/ Malta/ Nederland/ Norge/ Österreich/Polska/ România/ Slovenija/ Slovenská Republika/ Suomi/ Sverige/United Kingdom
Maltese: България/ Česká Republika/ Danmark/ Eesti/ Ελλάδα/ Ireland/ Ísland/ Κύπρος/ Latvija/
English: Date of last renewal: 18 March 2007
Maltese: Data ta' l-aħħar tiġdid: 18 ta' Marzu, 2007
English: Berkshire SL1 4DX United Kingdom
Maltese: Berkshire SL1 4DX Renju Unit
English: Polycythaemia Thrombocytosis
Maltese: Poliċitemija Tromboċitosi
English: The elimination half-life ranges from 4.7 to 13.2 hours in patients.
Maltese: Il-half-life ta' leliminazzjoni tvarja minn 4.7 sa 13.2 sigħat fil-pazjenti.
English: Other:
Maltese: Tqala:
English: Nervous system disorders:
Maltese: Disturbi tas-sistema nervuża:
English: The bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Maltese: Il-bijodisponibilità ta' epoetin delta mogħti taħt il-ġilda hi bejn 26% u 36%.
English: Convulsions have been rarely reported (less than 1 every 1000 patients).
Maltese: Konvulżjonijiet kienu rarament irrappurtati (inqas minn 1 minn kull 1000 pazjent).
English: Epoetin delta
Maltese: IU/ml) ta' epoetin delta.
English: Dynepo contains less than 1mmol of sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
Maltese: Dynepo fih inqas minn 1 mmol ta' sodium (23 mg) f'kull doża, i.e. hu essenzjalment “sodium-free”.
English: A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Maltese: Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil-kanċer li kienu qed jipparteċipaw f'57 prova klinika.
English: Store in a refrigerator (2 C - 8 C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 and water for injections.
Maltese: Sustanzi mhux attivi: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 u ilma għal injezzjonijiet.
English: The manufacturer is Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O.
Maltese: Il-manifattur hu Shire Human Genetic Therapies AB, Åldermansgatan 2, P.O. Box 1117, SE-221 04
English: Dynepo therapy is usually a long-term treatment.
Maltese: It-terapija b'Dynepo hi normalment kura fit-tul.
English: Half life is approximately 50% shorter in healthy subjects.
Maltese: Il-half life hi madwar 50% iqsar f'persuni b'saħħithom.
English: Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients.
Maltese: Dynepo hu indikat għall-kura ta' anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (CRF) f'pazjenti adulti.
English: • Malignant diseases including multiple myeloma and myelodysplastic syndrome
Maltese: • Mard malinn li jinkludi mjeloma multipla u s-sindrome mjelodisplastiku
English: The marketing authorisation holder for Dynepo is Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, United Kingdom
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq għal Dynepo hu Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, Renju
English: Before you take Dynepo).
Maltese: Qabel ma tuża Dynepo).
English: Store in a refrigerator (2oC to 8oC).
Maltese: Aħżen fi friġġ (2oC to 8oC).
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMEA): http://www.emea.europa.eu/.
English: Deutschland Shire Deutschland GmbH Siegburger Str. 229b 50679 Köln
Maltese: Shire Deutschland GmbH & Co.KG Siegburger Str. 126
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/l) to 12g/dL (7.5mmol/l).
Maltese: Il-varjabilità ta' l-emoglobina għandha tkun indirizzata permezz ta' l-immaniġġjar tad-doża, b'konsiderazzjoni għall-medda tal-mira ta' lemoglobina ta' 10 g/dL (6.2 mmol/l) sa 12 g/dL (7.5 mmol/l).
English: Epoetin delta is produced in human cells (HT-1080) by gene-activation technology.
Maltese: Epoetin delta hu prodott fiċ-ċelluli tal-bniedem (HT-1080) bit-teknoloġija ta' l-attivazzjoni tal-ġeni.
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Maltese: Fl-erba' studji kkontrollati bil-plaċebo, ilproporzjonijiet tal-periklu għas-sopravivenza totali varjaw bejn 1.25 u 2.47 favur il-kontrolli.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 March 2002
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 18 ta' Marzu 2002
English: - The other ingredients of Dynepo are sodium phosphate monobasic (monohydrate), sodium phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride and water for injections
Maltese: - Is-sustanzi l-oħra ta' Dynepo huma sodium phosphate monobasic (monohydrate), sodium phosphate dibasic (heptahydrate), polysorbate 20, sodium chloride u ilma għal injezzjonijiet.
English: Survival and tumour progression have been examined in five large controlled studies of epoetin alfa, beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebocontrolled studies and one was an open-label study.
Maltese: Is-sopravivenza u l-progressjoni tat-tumur kienu eżaminati f'ħames studji kbar ikkontrollati ta' epoetin alfa, beta u darbepoetin alfa, li kienu jinvolvu total ta' 2,833 pazjent, li erba' minnhom kienu studji double-blind u kkontrollati bil-plaċebo, u wieħed kien studju open-label.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2oC - 8oC)
Maltese: Aħżen fi friġġ (2oC - 8oC)
English: Dynepo is not indicated for the management of anaemia associated with cancer.
Maltese: Dynepo mhuwiex indikat għall-immaniġġjar ta' anemija marbuta mal-kanċer.
English: Transferrin saturation should be at least 20 %, and ferritin should be at least 100 ng/ml.
Maltese: Is-saturazzjoni ta' transferrin għandha tkun millinqas 20%, u dik ta' ferritin għandha tkun mill-inqas 100 ng/ml.
English: Pharmacotherapeutic group: Antianaemic - ATC code: B03XA..
Maltese: Antianemiku - Kodiċi ATC:
English: Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe Dynepo 2,000 IU/0.5ml solution for injection in a pre-filled syringe Dynepo 3,000 IU/0.3ml solution for injection in a pre-filled syringe Dynepo 4,000 IU/0.4ml solution for injection in a pre-filled syringe Dynepo 5,000 IU/0.5 ml solution for injection in a pre-filled syringe Dynepo 6,000 IU/0.3 ml solution for injection in a pre-filled syringe Dynepo 8,000 IU/0.4 ml solution for injection in a pre-filled syringe Dynepo 10,000 IU/0.5ml solution for injection in a pre-filled syringe Epoetin delta
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Dynepo 3,000 IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Dynepo 4,000
English: Following intravenous doses, volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/kg.
Maltese: Wara dożi ġol-vina, il-volum taddistribuzzjoni joqrob dak tal-volum totali tad-demm u jvarja minn 0.063 sa 0.097 l/kg.
English: The haemoglobin level should then be monitored at regular intervals.
Maltese: Il-livelli ta' l-emoglobina għandhom imbagħad ikunu mmonitorjati f'intervalli regolari.
English: The target haemoglobin concentration in two studies was >13 g/dL; in the remaining three studies it was 12-14 g/dL.
Maltese: Il-konċentrazzjoni tal-mira ta' lemoglobina fiż-żewġ studji kienet ta' >13 g/dL; fit-tliet studji l-oħrajn kienet ta' 12-14 g/dL.
English: Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from precursors of the stem cell compartment.
Maltese: Erythropoietin hu glikoproteina li tistimula l-formazzjoni ta' eritroċiti mill-prekursuri talkompartiment taċ-ċelluli staminali.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjoni ma prodotti oħra mediċinali u forom oħra ta` interazzjoni.
English: Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician's evaluation of the individual patient's clinical course and condition is necessary.
Maltese: Sintomi ta' anemija u kundizzjonijiet jew mard b'konsegwenza tagħha jistgħu jvarjaw ma' l-età, sess, u l-gravità totali tal-marda; hemm bżonn ta' evalwazzjoni ta' tabib tal-kors kliniku u tal-kundizzjoni tal-pazjent individwali.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Maltese: Dawn listudji wrew mortalità eċċessiva konsistenti li kienet statistikament sinifikanti, u li ma kinitx spjegabbli, f'pazjenti li kellhom anemija assoċjata ma' diversi kanċers komuni, li rċivew erythropoietin uman rikombinanti, meta mqabbla mal-kontrolli.
English: Other side effects that occur less frequently (in 0.1% to 1% of patients) include itching, pain, reaction at the site of injection (such as soreness and bleeding), flu-syndrome, diarrhoea, nausea.
Maltese: Effetti sekondarji oħrajn li jseħħu inqas ta' spiss (f'0.1% sa 1% tal-pazjenti) jinkludu ħakk, uġigħ, reazzjoni fis-sit ta' l-injezzjoni (bħal uġigħ u ħruġ ta' demm), sindrome ta' l-influwenza, dijarea, dardir.
English: INFORMATION IN BRAILLE Dynepo 6000
Maltese: Dynepo 6,000
English: - 4,000 IU in 0.4 ml
Maltese: IU/0.4 ml
English: Your first dose will be given under medical supervision as rarely, an allergic-type reaction may occur.
Maltese: L-ewwel doża tiegħek ser tingħata taħt superviżjoni medika, għax għalkemm rari jista` jkun hemm allerġija.
English: A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
Maltese: Żieda fl-emoglobina ta' iktar minn 2 g/dL (1.25 mmol/l) fuq perjodu ta' erba' ġimgħat għandha tkun evitata.
English: This is the most common cause of an incomplete response to an erythropoietin therapy.
Maltese: Din hi l-iktar kawża komuni ta' rispons inkomplet għat-terapija eritropojetika.
English: 28008 Madrid
Maltese: 50679 Köln
English: INFORMATION IN BRAILLE Dynepo 5000
Maltese: Dynepo 5,000
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dL (7.5 mmol/l).
Maltese: Fi provi kliniċi, kienet osservata żieda fir-riskju ta' mewt u avvenimenti kardjovaskulari serji meta ngħataw mediċini li jistimulaw l-erythropoiesis (ESAs) biex jinkiseb livell ta' emoglobina ta' iktar minn 12 g/dL (7.5 mmol/l).
English: Dynepo 8,000 IU/0.4 ml injection
Maltese: U MNEJN GĦANDU JINGĦATA Dynepo 8,000 IU/0.4 ml
English: • Vitamin deficiencies, i.e., folic acid or vitamin B12 deficiencies
Maltese: • Emoglobinopatiji bħal talessimja jew sickle cell anaemia • Defiċjenzi tal-vitamini, i.e., defiċjenzi tal-folic acid jew ta' vitamina
English: Increases in serum chemistry values including creatinine and potassium have been observed (see section
Maltese: Żidiet fil-valuri tal-kimika fis-serum li jinkludu l-krejatinina u l-potassium kienu osservati (ara sezzjoni
English: Sodium chloride
Maltese: Pressjoni għolja
English: INFORMATION IN BRAILLE Dynepo 10000
Maltese: Dynepo 10,000
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: IU/ml) tas-sustanza attiva
English: - The active substance is epoetin delta, 0.5 ml of the solution containing 1,000 IU (International Units) (2,000 IU/ml), 0.5 ml of the solution containing 2,000 IU (4,000 IU/ml), 0.3 ml of the solution containing 3,000 IU (10,000 IU/ml), 0.4ml of the solution containing 4,000 IU (10,000 IU/ml), 0.5 ml of the solution containing 5,000 IU (10,000 IU/ml), 0.3 ml of the solution containing 6,000 IU (20,000 IU/ml), 0.4 ml of the solution containing 8,000 IU (20,000 IU/ml), or 0.5 ml of the solution containing 10,000 IU/ml (20,000 IU/ml) of epoetin
Maltese: IU/ml), 0.3 ml ta' soluzzjoni fih 6,000 IU (20,000 IU/ml), 0.4 ml ta' soluzzjoni fih 8,000 IU (20,000
English: Patients with homozygous sickle cell disease and renal failure should where possible be maintained at a total haemoglobin concentration between 7 and 9 g/dl.
Maltese: Pazjenti li għandhom il-homozygous sickle cell disease u kollass tal-kliewi għandhom, fejn ikun possibbli, jinżammu f'konċentrazzjoni totali ta' l-emoglobina bejn 7 u 9 g/dl.
English: After administration of epoetin delta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Feincorporation rate.
Maltese: Wara l-għoti ta' epoetin delta, in-numru ta' eritroċiti, il-valuri talHb u l-għadd tar-reticuloċiti jiżdiedu, kif tagħmel ukoll ir-rata ta' l-inkorporazzjoni 59Fe.
English: How do I inject Dynepo myself?
Maltese: Kif għandi nipprepara l-injezzjoni tiegħi b'Dynepo?
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Maltese: Flistudju open-label ma kien hemm l-ebda differenza fis-sopravivenza totali bejn pazjenti kkurati b'erythropoietin uman rikombinanti u l-kontrolli.
English: The 5 day period must end before the expiry date stated on the carton and label of the syringe after ‘EXP'.
Maltese: Il-perjodu ta' 5 ijiem irid jintemm qabel id-data ta' skadenza li hemm fuq il-kaxxa tal-kartun u fuq it-tikketta tas-siringa wara ‘JIS'.
English: 28008 Madrid, Espanha Tel. : +34 91 550 06 91
Maltese: Shire Pharmaceuticals Iberica, S.L. Paseo Pintor Rosales, 40 Bajo Izda. 28008 Madrid, Espanha Tel. : +34 91 550 06 91
English: The frequency of adverse events that were experienced during Dynepo therapy is tabulated below.
Maltese: Il-frekwenza ta' avvenimenti avversi li seħħew matul it-terapija b'Dynepo huma elenkati hawn taħt.
English: - headache
Maltese: FEJN MA
English: Pain Injection site reaction (e.g. pain, haemorrhage) Flu-syndrome
Maltese: Uġigħ Reazzjoni fis-sit ta' linjezzjoni (eż. uġigħ, emorraġija) Sindrome ta' influwenza
English: INFORMATION IN BRAILLE Dynepo 4000
Maltese: Dynepo 4,000
English: - 3,000 IU in 0.3 ml
Maltese: IU/0.3 ml
English: Body System
Maltese: Sistema tal-Ġisem
English: If transferrin saturation falls below 20 %, or if ferritin falls below 100 ng/ml, iron should be administered.
Maltese: Jekk is-saturazzjoni ta' transferrin taqa' taħt 20%, jew jekk ferritin jaqa' taħt 100 ng/ml, għandu jingħata l-ħadid.
English: Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta.
Maltese: - Is-sustanza attiva hi epoetin delta, 0.5 ml ta' soluzzjoni fih 1,000 IU (Unitajiet Internazzjonali) (2,000
English: The most frequent side effects observed (in 1% to 10% of patients) with Dynepo are: - increase in blood pressure.
Maltese: L-iktar effetti sekondarji frekwenti li kienu osservati (f'1% sa 10% tal-pazjenti) b'Dynepo huma:
English: A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dL (7.5mmol/l) are observed, are described below (see Dose Management section below).
Maltese: Livell sostnut ta' emoglobina ta' iktar minn 12 g/dL (7.5 mmol/l) għandu jkun evitat; gwida għal aġġustament adattat fid-doża għal meta lvaluri ta' l-emoglobina li jaqbżu 12 g/dL (7.5 mmol/l) ikunu osservati, huma deskritti hawn taħt (ara ssezzjoni Immaniġġjar tad-Doża hawn taħt).
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in Section 4.2.
Maltese: F'pazjenti b'insuffiċjenza kronika renali, il-konċentrazzjoni tal-manteniment ta' l-emoglobina m'għandhiex taqbeż il-limitu ta' fuq tal-konċentrazzjoni ta' l-emoglobina fil-mira rakkomandata f'sezzjoni 4.2.
English: Epoetin delta IV/SC
Maltese: TWISSIJA/IET SPEĊJALI
English: Keep the syringes in the outer carton to protect from light.
Maltese: Ħalli s-siringa timxi 'l fuq sakemm il-labra kollha tkun protetta.
English: Solution for injection, 0.3ml of epoetin delta in a pre-filled syringe: pack size of 6
Maltese: Soluzzjoni għall-injezzjoni, 0.3ml ta' epoetin delta f'siringa mimlija għal-lest: daqs tal-pakkett ta' 6
English: Dynepo 1,000 IU/0.5 ml injection
Maltese: U MNEJN GĦANDU JINGĦATA Dynepo 1,000 IU/0.5 ml
English: Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Maltese: Attenzjoni partikulari għandha tingħata lill-uġigħ ta' ras qisu emigranja, li jiġi għall-għarrieda, għax dan ikun possibbilment sinjal ta' twissija.
English: Solution for injection, 0.5ml of epoetin delta in a pre-filled syringe: pack size of 6
Maltese: Soluzzjoni għall-injezzjoni, 0.5ml ta' epoetin delta f'siringa mimlija għal-lest: daqs tal-pakkett ta' 6
English: Laboratory monitoring
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Aluminium intoxication
Maltese: GĦAMLA KWALITATTIVA
English: - 5,000 IU in 0.5 ml
Maltese: IU/0.5 ml
English: Dose should be increased by 25 % - 50 % if: - Haemoglobin falls below < 10 g/dl and - The rate of increase of haemoglobin is below 0.7 g/dl in any 4 week period.
Maltese: Id-doża għandha tiżdied b'25% - 50% jekk: - Ir-rata taż-żieda ta' emoglobina tkun inqas minn 0.7 g/dl fi kwalunkwe perjodu ta' 4 ġimgħat.
English: Dynepo 3,000 IU/0.3 ml injection
Maltese: U MNEJN GĦANDU JINGĦATA Dynepo 3,000 IU/0.3 ml
English: Blood and lymphatic system disorders:
Maltese: Disturbi tad-demm u tassistema limfatika:
English: Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/dl.
Maltese: Esperjenza klinika bl-epoetins tissuġġerixxi li l-pressjoni għolja tad-demm u r-riskju ta' trombożi jistgħu jitnaqqsu billi jsir titraġġ tad-doża biex il-livelli ta' l-emoglobina jinżammu bejn 10 sa 12 g/dl.
English: Tel. : +44 1256 894 894
Maltese: Tel/Tlf/Tηλ/ Sími/Puh: +44 1256 894 894
English: Peak serum concentrations for subcutaneously administered epoetin delta occur between 8 and 36 hours following injection.
Maltese: Konċentrazzjonijiet massimi fis-serum għal epoetin delta mogħti taħt il-ġilda jseħħu bejn 8 u 36 siegħa wara l-injezzjoni.
English: Dynepo 6,000 IU/0.3 ml injection
Maltese: Dynepo 6,000 IU/0.
English: The half-life of subcutaneously administered epoetin delta is prolonged compared to intravenous administration and ranges from 27 to 33 hours in patients.
Maltese: Il-half-life ta' epoetin delta mogħti taħt il-ġilda titwal meta mqabbla ma' l-għoti ġolvina u tvarja minn 27 sa 33 siegħa fil-pazjenti.
English: Sweden
Maltese: Deutschland
English: NAME OF THE MEDICINAL PRODUCT Dynepo 3,000 IU/0.3 ml solution for injection in a prefilled syringe Epoetin delta
Maltese: Dynepo 3,000 IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin delta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml (10,000 IU/ml)
Maltese: IU/ml), 0.5 ml ta' soluzzjoni fih 5,000 IU (10,000
English: Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Maltese: Dynepo għandu jingħata minn taħt il-ġilda jew ġol-vina biex iżid l-emoglobina għal mhux iktar minn 12 g/dL (7.5 mmol/l).
English: The usual starting dose is 50 IU/kg three times a week if administered intravenously or 50 IU/kg twice a week if administered subcutaneously.
Maltese: Id-doża għandha titnaqqas b'25% - 50% jew il-kura titwaqqaf temporanjament u mbagħad tinbeda
English: Your doctor will manage your dosage so that haemoglobin concentrations will not consistently be above 12 g/dl which may be associated with a higher risk of cardiovascular events (e.g. heart attacks).
Maltese: It-tabib tiegħek ser jimmaniġġja d-dożaġġ tiegħek b'tali mod li l-konċentrazzjonijiet ta' l-emoglobina ma jkunux iktar minn 12 g/dl b'mod konsistenti, li jista' jkun assoċjat ma' riskju ogħla ta' avvenimenti kardjovaskulari (eż. attakki tal-qalb).
English: LOT
Maltese: FOLJI
English: NAME OF THE MEDICINAL PRODUCT Dynepo 8,000 IU/0.4 ml solution for injection in a prefilled syringe Epoetin delta
Maltese: Dynepo 8,000 IU/0.4 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Epoetin delta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 ml (4,000 IU/ml)
Maltese: IU/ml), 0.5 ml ta' soluzzjoni fih 2,000 IU (4,000
English: Serum chemistry values including creatinine and potassium should be monitored regularly during Dynepo therapy.
Maltese: Il-valuri tal-kimika tas-serum, li jinkludu kreatinina u potassium, għandhom jiġu mmonitorjati regolarment matul it-terapija b'Dynepo.
English: Hold the syringe assembly by the sides of the device and gently remove the plastic cover and rubber guard from the needle without twisting.
Maltese: Protezzjoni tal-labra tal-lastiku naturali riġidu u polystyrene, lasta tal-planġer talpolystyrene u protezzjoni tas-sigurtà tal-labra.