FrancophonIA/ELRC3.0 huggingface dataset:
English: A few patients who have experienced hypoglycaemic reactions after transfer from animal source insulin to human insulin have reported that early warning symptoms of hypoglycaemia were less pronounced or different from those experienced with their previous insulin.
Maltese: Ftit mill-pazjenti li esperjenzaw reazzjonijiet ipogliċemiċi wara trasferiment minn insulina li ġejja mill-annimali għal insulina umana rrapportaw li s-sintomi ta' twissija bikrija ta' l-ipogliċemija kienu inqas qawwija jew differenti minn dawk esperjenzati bl-insulina preċedenti tagħhom.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 1 mg inhalation powder pre-dispensed.
Maltese: TAL-PRODOTT MEDIĊINALI EXUBERA 1 mg trab għall-inalazzjoni magħmul għal-lest.
English: • Cardboard box containing 30 x 1 PVC/Aluminium perforated unit dose blisters (1 pouch)
Maltese: • Kaxxa tal-kartun fiha 30 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (pawċ 1)
English: A 1 mg blister of EXUBERA gives you about the same insulin dose as 3 IU of subcutaneously injected fast-acting insulin human.
Maltese: Bużżieqa ta' 1 mg ta' insulina inalata hija ekwivalenti għal madwar 3 IU ta' insulina umana li taħdem malajr injettata taħt il-ġilda.
English: NAME OF THE MEDICINAL PRODUCT EXUBERA 3 mg inhalation powder pre-dispensed.
Maltese: TAL-PRODOTT MEDIĊINALI EXUBERA 3 mg trab għall-inalazzjoni magħmul għal-lest.
English: IN H C o mp arato r
Maltese: Mod ta' kif jaħdem
English: Administration of salbutamol 30 minutes prior to EXUBERA in non-diabetic subjects with mildmoderate asthma resulted in an increase in insulin AUC and Cmax of between 25 and 51% compared to when EXUBERA was administered alone (see sections 4.2 and 4.5).
Maltese: Għoti ta' salbutamol 30 minuta qabel EXUBERA f'suġġetti mhux dijabetiċi b'ażżma ħafifa-moderata wassal għal żieda fl-AUC u s-Cmax ta' l-insulina ta' madwar 25% u 51% meta mqabbla ma' meta EXUBERA ngħatat waħidha.
English: If 3 mg blisters are unavailable, use only two 1 mg blisters as replacement.
Maltese: Jekk il-bżieżaq ta' 3 mg ma jkunux disponibbli, uża biss żewġ bżieżaq ta' 1 mg bħala sostitut għal waħda ta' 3 mg.
English: • A pack containing 270 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 270 x 1 ta' 1 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (9 pawċijiet) u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Blue Handle
Maltese: Żomm il-manku blu
English: Elderly
Maltese: Farinġite
English: EXUBERA is not recommended if you have breathing difficulties with congestive heart failure.
Maltese: Ftit hemm esperjenza b'EXUBERA f'pazjenti b'falliment konġestiv tal-qalb.
English: Uncommon side effects are inflammation of the throat (pharyngitis), nose bleed (epistaxis), airway constriction with difficulties breathing (bronchospasm), wheezing, voice alteration (dysphonia), throat pain (pharyngolaryngeal pain), tonsillar disorder, dry mouth and chest pain.
Maltese: Effetti sekondarji mhux komuni huma infjammazzjoni tal-ġriżmejn (farinġite), emorraġija millimnieħer (epistassi), egħluq tal-passaġġi ta' l-arja b'diffikultajiet fit-teħid tan-nifs (bronkospażmu), tħarħir, bidla fil-vuċi (disfonja), uġigħ fil-ġriżmejn (uġigħ faringolarinġejali), disturb fit-tunsilli, ħalq
English: • Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches)
Maltese: • Kaxxa tal-kartun fiha 60 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (2 pawċijiet)
English: • A pack containing 270 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 270 x 1 ta' 3 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (9 pawċijiet) u 6 Units tar-Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Severe (GOLD stage III or IV) Chronic obstructive pulmonary disease (COPD).
Maltese: Mard pulmonari kroniku u ostruttiv (COPD), qawwi (Stadji
English: The time to peak insulin concentration (Tmax) is generally half of that for subcutaneously administered fast-acting human insulin.
Maltese: Il-ħin biex tintlaħaq il-konċentrazzjoni massima ta' l-insulina (Tmax) huwa ġeneralment nofs dak ta' insulina umana li taħdem malajr mogħtija taħt il-ġilda.
English: • A pack containing 90 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 90 x 1 ta' 3 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (3 pawċijiet) u 2 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: In patients with a confirmed (i.e. at least two consecutive tests, 3 to 4 weeks apart) FEV1 decline of > 20% from baseline, EXUBERA therapy should be discontinued and the patient monitored as clinically indicated.
Maltese: F'pazjenti bi tnaqqis ta' FEV1 ta' > 20% mil-linja bażi kkonfermat (jiġifieri għallinqas żewġ testijiet konsekuttivi, 3 sa 4 ġimgħat 'il bogħod minn xulxin), it-terapija b'EXUBERA għandha titwaqqaf u lpazjent għandu jiġi sorveljat kif klinikament indikat.
English: In children (6-11 years) and adolescents (12-17 years) with type 1 diabetes, inhaled human insulin was absorbed more rapidly than fast-acting human insulin.
Maltese: Fi tfal (6-11-il sena) u adolexxenti (12-17-il sena) b'dijabete tip 1, l-insulina umana inalata kienet assorbita aktar malajr milli insulina li taħdem malajr.
English: • A pack containing 60 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 60 x 1 ta' 1 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (2 pawċijiet) u 2 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: The majority (> 95%) of dyspnoea was reported as mild to moderate.
Maltese: Il-maġġoranza (> 95%) ta' dawn ir-reazzjonijiet kienu rrapportati bħala ħfief għal moderati.
English: The efficacy and safety of inhaled human insulin in patients with baseline FEV1 < 70% predicted have not been established and the use of inhaled human insulin in this population is not recommended.
Maltese: L-effikaċja u s-sigurta ta' l-insulina umana inalata f'pazjenti bil-linja bażi mistennija FEV1 < 70% ma ġietx stabbilita, u l-użu ta' l-insulina umana inalata f'din il-popolazzjoni mhux rakkomandata.
English: If you stop therapy with EXUBERA, your lung function will usually return to your normal level.
Maltese: Jekk twaqqaf terapija b'EXUBERA, il-funzjoni tal-pulmun tiegħek ġeneralment tirritorna għal-livell normali tiegħek.
English: Human insulin lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects, increases the transport of glucose into cells as well as the formation of glycogen in the muscles and the liver, and improves pyruvate utilisation.
Maltese: L-insulina umana tbaxxi l-glukosju u tippromwovi effetti anaboliċi kif ukoll tnaqqas effetti kataboliċi, iżżid it-trasport ta' glukosju għal ġewwa ċ-ċelloli kif ukoll iżżid il-formazzjoni ta' glycogen filmuskoli u l-fwied, u ttejjeb l-użu ta' pyruvate.
English: • Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches)
Maltese: • Kaxxa tal-kartun fiha 90 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (3 pawċijiet)
English: One blister card contains 6 perforated unit dose blisters (PVC/Aluminium).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Bużżieqa waħda fiha 6 bżieżaq ipperforati (PVC/Aluminju) ta' doża waħda.
English: Box containing: 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Box containing: 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Box containing: 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Maltese: Kaxxa li fiha: 90 x 1 Bużżieqa ta' doża waħda perforata tal-PVC/Aluminju (3 pawċijiet), 1 inalatur ta' l-insulina, 1 ċejmber addizzjonali u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Three 1 mg blisters should not be substituted for one 3 mg blister (see section 2, “Take special care with EXUBERA” and section 3, “How to take EXUBERA”).
Maltese: Jekk tkun qed tieħu EXUBERA, tpejjipx (ara sezzjoni 2, “Tiħux EXUBERA”).
English: • OTHER CONDITIONS
Maltese: • KUNDIZZJONIJIET OĦRA
English: Table 1: Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient
Maltese: Tabella 1: Linji ta' Gwida Approssimattivi għal Dożi Inizjali ta' Qabel l-Ikel ta' EXUBERA (fuq il-bażi tal-piż tal-ġisem tal-pazjent).
English: • A kit containing 90 x 1 of 1 mg PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Maltese: • Kitt fih 90 x 1 of 1 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (3 pawċijiet), inalatur ta' l-insulina, ċejmber fuq ir-riħ u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I) U> DETENTUR(I) TA' L-AWTORIZZAZZJONI
English: An approximately 40% higher bioavailability of three 1 mg unit dose blisters compared to one 3 mg unit dose blister was observed in healthy subjects.
Maltese: Bijodisponibilità madwar 40% ogħla ta' tlett bżieżaq ta' doża waħda ta' 1 mg meta imqabbla ma' doża waħda ta' 3 mg kienet osservata f'suġġetti b'saħħithom.
English: EXUBERA 1 mg inhalation powder pre-dispensed EXUBERA 3 mg inhalation powder pre-dispensed
Maltese: Kull bużżieqa ta' doża waħda fiha 1 mg jew 3 mg tas- Is-sustanzi l-oħra huma: mannitol, glycine, sodium citrate (bħala dihydrate) u sodium
English: • A pack containing 60 x 1 of 3 mg PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Release Units (IRU)
Maltese: • Pakkett fih 60 x 1 ta' 3 mg bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (2 pawċijiet) u 2 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: Hypoglycaemia - As with all insulin therapy, the most common side effect with EXUBERA is hypoglycaemia (too low blood sugar).
Maltese: Trattament bl-insulina jista' jġiegħel lill-ġisem jipproduċi antikorpi għall-insulina (sustanzi li jorbtu ma' l-insulina).
English: Intrasubject variability of time to peak insulin concentrations was less for inhaled human insulin than for subcutaneous fast-acting human insulin in subjects with type 1 or 2 diabetes.
Maltese: Il-varjabilità fis-suġġetti tal-ħin biex tintlaħaq il-konċentrazzjoni massima ta' l-insulina kienet inqas għal insulina umana inalata milli għal insulina umana li taħdem malajr mogħtija taħt il-ġilda f'pazjenti b'dijabete ta' tip 1 jew 2.
English: Caution: please remember that artificial sweeteners and foods with artificial sweeteners (e.g. diet drinks) are of no help in hypoglycaemia.
Maltese: Attenzjoni: jekk jogħġbok ftakar li sweeteners artifiċjali u ikel bi sweeteners artifiċjali (eż. xarbiet tad-dieta) ma huma ta' ebda għajnuna f'ipogliċemija.
English: In clinical trials small but consistent treatment group differences in decline of pulmonary function (particularly Forced Expiratory Volume in one second (FEV1)) favouring comparator treated subjects have been observed.
Maltese: Fi provi kliniċi ġew osservati differenzi żgħar imma konsistenti fit-tnaqqis tal-funzjoni pulmonari filgrupp tat-trattament (b'mod partikolari Volum Espiratorju Sfurzat f'sekonda (FEV1)) li jiffavorixxu suġġetti ttrattati b'komparatur.
English: • Cardboard box containing 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and
Maltese: • Kaxxa tal-kartun fiha 60 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (2 pawċijiet) u
English: The cough tended to occur within seconds to minutes after insulin inhalation and was predominantly mild in severity.
Maltese: Is-sogħla kellha t-tendenza li tibda fi żmien sekondi sa minuti wara l-inalazzjoni ta' l-insulina u din kienet prinċipalment ħafifa fis-serjetà.
English: Renal impairment
Maltese: Reazzjonijiet oħra
English: Active smoking greatly enhances whereas passive exposure to tobacco smoke in non-smokers decreases the rate and extent of absorption of EXUBERA (see sections 4.3 and 5.2).
Maltese: Tipjip attiv iżid bil-bosta r-rata u l-firxa ta' assorbiment ta' EXUBERA filwaqt li espożizzjoni passiva għad-duħħan tat-tabakk f'dawk li ma jpejpux tnaqqas din ir-rata (ara sezzjonijiet 4.3 u 5.2).
English: Severe allergic reactions to insulin are very rare.
Maltese: Reazzjonijiet allerġiċi serji għall-insulina huma rari ħafna.
English: A 3 mg blister of EXUBERA gives you about the same insulin dose as 8 IU of subcutaneously injected fast-acting insulin human.
Maltese: Bużżieqa ta' 3 mg ta' EXUBERA tagħtik madwar listess doża ta' insulina daqs 3 8U ta' insulina umana li taħdem malajr injettata taħt il-ġilda.
English: Therefore three 1 mg unit dose blisters should not be substituted for one 3 mg unit dose blister (see sections 2, 4.4 and 5.2).
Maltese: Għaldaqstant, tliet bżieżaq ta' doża waħda ta' 1 mg m'għandhomx jiġu ssostitwiti b'bużżieqa ta' doża waħda ta' 3 mg (ara sezzjonijiet 2, 4.4 u 5.2).
English: An explanation for the differences in bioavailability appears to be the different energy to mass ratio between the 1 and 3 mg unit blisters since with less powder in the blister the inhaler is more efficient in breaking up or de-agglomerating the powder leading to a larger proportion of smaller aerodynamic particle sizes for the 1 mg blister
Maltese: L-ispjegazzjoni għad-differenzi filbijodisponibilità jidher li hija l-proporzjon differenti ta' l-enerġija kontra l-massa bejn bużżieqa waħda ta' 1 mg u bużżieqa ta' 3 mg minħabba li b'inqas trab fil-bużżieqa, l-inalatur huwa aktar effiċjenti fittkissir jew deagglomerazzjoni tat-trab li jwassal għal proporzjon akbar ta' partikuli erodinamiċi iżgħar għall-bużżieqa ta' 1 mg (ara sezzjonijiet 2 u 4.4).
English: Name and address of the manufacturer responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-hruġ tal-lott
English: Inhaled human insulin is delivered by the pulmonary route.
Maltese: L-insulina inalata hija imwassla permezz tar-rotta pulmonari.
English: Patients should then hold their breath for 5 seconds and exhale normally.
Maltese: Agħlaq ħalqek u żomm in-nifs għal 5 sekondi.
English: It is important to follow your doctor's instructions exactly.
Maltese: Ġorr miegħek xi informazzjoni li turi li inti dijabetiku.
English: Insulin Release Unit Chamber Release Button (not visible)
Maltese: TA' LINSULINA (Insulin Release Unit) (IRU) Ibdel il-Unit ta' Rilaxx ta' l-Insulina
English: • Cardboard box containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) and
Maltese: • Kaxxa tal-kartun fiha 90 x 1 bżieżaq ipperforati tal-PVC/Aluminju ta' doża waħda (3 pawċijiet) u
English: This means that it will start to lower your blood sugar 10-20 minutes after you take it, with a maximum effect at 2 hours and the effect will last for around 6 hours.
Maltese: Dan ifisser li hija tibda tbaxxilek iz-zokkor f'demmek 1020 minuta wara li teħodha, b'effett massimu wara sagħtejn u l-effett idum 6 sigħat.
English: • A kit containing 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU) Additional insulin inhaler, insulin release units and chamber packages are available.
Maltese: • Kitt fih 90 x 1 bżieżaq ipperforati tal-PVC/Aluminju b'doża waħda (3 pawċijiet), inalatur ta' l insulina, ċejmber fuq ir-riħ u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ Jiġu wkoll inalatur ta' l-insulina, Units ta' Rilaxx ta' l-insulina u pakketti taċ-ċejmbers addizjonali.
English: Ch ange Fro m B as eline Ser um Fre e In sulin C oncen tra tion ( uU/ml)
Maltese: Change From Baseline Serum Free Insulin Concentration (uU/ml)
English: Box containing: 60 x 1 PVC/Aluminium perforated unit dose blisters (2 pouches) and 2 spare Insulin Box containing: 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches) and 2 spare Insulin Box containing: 180 x 1 PVC/Aluminium perforated unit dose blisters (6 pouches) and 2 spare Insulin Box containing: 270 x 1 PVC/Aluminium perforated unit dose blisters (9 pouches) and 6 spare Insulin Box containing: 90 x 1 PVC/Aluminium perforated unit dose blisters (3 pouches), 1 insulin inhaler, 1 spare chamber and 6 spare Insulin Release Units (IRU)
Maltese: Kaxxa li fiha: 90 x 1 bużżieqa ta' doża waħda perforata tal-PVC/Aluminju (3 pawċijiet), 1 inalatur ta' l-insulina, 1 ċejmber addizzjonali u 6 Units ta' Rilaxx ta' l-Insulina (IRU) fuq ir-riħ
English: In clinical trials, insulin antibodies developed more frequently and mean levels of insulin antibodies were higher in patients who switched their subcutaneous human insulin to EXUBERA compared to subjects who remained on subcutaneous human insulin.
Maltese: F'pazjenti bid-dijabete mellitus, l-insulina umana inalata kellha varjiabilità ta' l-AUC fis-suġġetti komparabbli għal insulina umana li taħdem malajr mogħtija taħt il-ġilda.
English: In clinical trials in type 1 diabetes, patients using a regimen of EXUBERA in combination with longor intermediate-acting insulin had similar reductions in HbA1c compared with patients taking subcutaneous insulin alone.
Maltese: Fi provi kliniċi f'dijabete tip 1, pazjenti li jużaw reġimen ta' EXUBERA f'kombinazzjoni ta' insulina li taħdem b'mod intermedju jew fit-tul, kellhom tnaqqis simili fil-HbA1c meta mqabbel ma' pazjenti li qed jieħdu insulina taħt il-ġilda biss.
English: Smoking greatly increases the rate and extent of absorption of inhaled human insulin (Cmax about 3 to 5 times and AUC about 2 to 3 times higher) and therefore could increase the risk of hypoglycaemia
Maltese: It-tipjip iżid bil-bosta r-rata u l-firxa ta' assorbiment ta' l-insulina umana inalata (is-Cmax huwa madwar 3 sa 5 drabi u l-AUC huwa madwar 2 jew 3 drabi ogħla) u għalhekk jista' jżid ir-riskju ta' ipogliċemija (ara sezzjonijiet 4.3 u 4.5).
English: Do not substitute three 1 mg blisters for one 3 mg blister.
Maltese: Tissostitwixxix tliet bżieżaq ta' 1 mg b'waħda ta' 3 mg.
English: Bronchospasm may rarely occur.
Maltese: TAGĦTIHIEX lil persuni oħra.
English: • If you feel hypoglycaemia (low blood sugar) coming on. See the information at the end of section 4 “Possible side effects” of this leaflet for further advice.
Maltese: Għal tagħrif dwar it-trattament ta' l-ipogliċemija, ara l-aħħar ta' sezzjoni 4 “Effetti sekondarji li jista' jkollu”.
English: Mean Glucose Infusion Rate (GIR) Normalised to GIRmax for Each Subject Treatment When human insulin is inhaled, the onset of glucose lowering activity is within 10-20 minutes, the maximum effect is exerted approximately 2 hours after inhalation.
Maltese: Meta l-insulina umana hija inalata, il-bidu ta' l-attività li tbaxxi l-glukosju jseħħ fi żmien 10-20 minuta, l-effett massimu jseħħ madwar sagħtejn wara l-inalazzjoni.
English: --1 Live non-pathogenic Escherichia coli O8:K87* (F4ac):.......................1.3x108 to 9.0x108 CFU** Live non-pathogenic Escherichia coli O141:K94* (F18ac): ...............2.8x108 to 3.0x109 CFU**
Maltese: --1 Escherichia coli mhux patoġeniku ħaj O8:K87* (F4ac):.......................1.3x108 għal 9.0x108 CFU** Escherichia coli mhux patoġeniku ħaj O141:K94* (F18ac): ...............2.8x108 għal 3.0x109 CFU**
English: * not attenuated ** CFU - colony forming units
Maltese: * mhux attenwat ** CFU - unitajiet li jiffurmaw kolonja
English: EU (MA) Number Invented name
Maltese: Numru UE (MA) Isem ivvintat
English: Packaging Content Package size
Maltese: Ippakkjar Kontenu t
English: Target species
Maltese: Żero jiem
English: 4 vials Zero days
Maltese: Speċi fil-mira
English: Packaging Content (concentration)
Maltese: Il-pakkett Kontenut (konċentrazzjon i)
English: 1 vial
Maltese: Kunjett wieħed
English: 0.6 ml (20 mg/ml) 1 vial
Maltese: 7 kunjetti + 7 siringi sterili + 14-il swab tal-alkoħol
English: EU Number
Maltese: 1 kunjett
English: (Invented) name
Maltese: Numru ta' l-UE Isem (inventat)
English: Powder: 100 mg Solvent: 3 ml
Maltese: Trab: 100 mg Solvent: 3 ml
English: EU/1/18/1278/001 Carmustine Obvius 100 mg Powder and solvent for solution for infusion
Maltese: EU/1/18/1278/001 Carmustine Obvius
English: 1 vial + 1 ampoule
Maltese: Kunjett 1 + Ampolla 1
English: Intravenous use Powder: vial (glass) Solvent: ampoule (glass)
Maltese: Trab: kunjett (ħġieġ) Solvent: Ampolla (ħġieġ)
English: Dermatitis Alopecia
Maltese: Dermatite Alopeċja
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas sigurtà
English: Date of latest renewal: 22/05/2014
Maltese: Data tal-aħħar tiġdid: 22/05/2014
English: Κύπρος C.A.
Maltese: C.A.
English: OSSEOR contains aspartame (E951):
Maltese: OSSEOR fih aspartame (E951):
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/09/2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21/09/2004
English: Venous thromboembolism (VTE)
Maltese: Tromboemboliżmu tal-vini (VTE)
English: Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema)
Maltese: Reazzjonijiet ta' sensittività eċċessiva filġilda (raxx, prurite, urtikarja, anġjoedema)§
English: Its plasma clearance is about 12 ml/min (CV 22%) and its renal clearance about 7 ml/min (CV 28%).
Maltese: L-eliminazzjoni mill-plażma huwa ta' bejn wieħed u ieħor 12 ml/min (CV 22%) u l-eliminazzjoni talkliewi huwa ta' bejn wieħed u ieħor 7 ml/min (CV 28%).
English: Musculo-skeletal fraction > 3 times the upper limit of the normal range.
Maltese: a Ksur Muskoloskeletrali > 3 darbiet iktar mill-ogħla limitu tal-livell normali.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali u tat-tessuti konnettivi
English: Paper/polyethylene/aluminium/polyethylene sachets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Qartas tal-karti/polyethylene/aluminium/polyethylene
English: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysis* (see section
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs): is-sindromu ta' Stevens-Johnson u nekroliżi epidermali tossika* (ara sezzjoni 4.4))#
English: Papaellinas Ltd.Τηλ: +357 22741741
Maltese: Τηλ: +357 22741741
English: Over 12 months, a statistically significant increase in mean lumbar spine BMD, main efficacy criteria (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0,001), similar to that observed in the pivotal anti-fracture phase III studies carried-out in postmenopausal women, was observed.
Maltese: Fuq 12-il xahar, ġiet osservata żieda statistikament sinifikanti fil-BMD lumbari medju, il-kriterji medji tal-effikaċja (E (SE) = 5.32% (0.75); 95%CI = [3.86 ; 6.79]; p<0.001), simili għal dik osservata fl-istudji ta' fażi
English: SOTI involved 1,649 postmenopausal women with established osteoporosis (low lumbar BMD and prevalent vertebral fracture) and a mean age of 70 years.
Maltese: SOTI involva 1,649 mara ta' wara lmenopawsa b'osteoporożi stabbilit (BMD fil-lumbari baxx u prevelanza fi ksur tas-sinsla) u b'età medja ta' 70 sena.
English: In phase III studies, 85% of the patients had a creatinine clearance between 30 and 70 ml/min and 6% below 30 ml/min at inclusion, and the mean creatinine clearance was about 50 ml/min.
Maltese: III, 85% tal-pazjenti kellhom eliminazzjoni tal-kreatinina ta' bejn 30 u 70 ml/min u 6% b'inqas minn 30 ml/min fil-bidu tal-istudju u leliminazzjoni medja tal-kreatinina kienet ta' bejn wieħed u ieħor 50 ml/min.
English: LIST OF EXCIPIENTS Also contains aspartame (E 951).
Maltese: TA' EĊĊIPJENTI Fih ukoll aspartame (E 951).
English: Adverse reactions are listed below using the following convention : very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: III huma dawn li ġejjin bl-użu ta' din il-konvenzjoni (frekwenza versus plaċebo): komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1,10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).