FrancophonIA/ELRC3.0 huggingface dataset:
English: In another study, Insuman Comb 25 was compared with semi-synthetic human insulin in patients with type 1 and type 2 diabetes.
Maltese: Fi studju ieħor, Insuman Comb 25 tqabbel mal-insulina umana semisintetika f'pazjenti li kellhom dijabete tat-tip 1 u tat-tip 2.
English: Insuman contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystalline-protamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action.
Maltese: Insuman fih l-insulina f'diversi forom: fil-forma solubbli, li taġixxi malajr (fi żmien 30 minuta mill-injezzjoni) u fil-forma isofana u dik kristallina bil-protamina, li jiġu assorbiti b'mod iktar bil-mod matul il-jum u b'hekk jaġixxu iktar fit-tul.
English: • Insuman Comb, which is available in various combinations of fast- and intermediate-acting insulins.
Maltese: • Insuman Comb, li jiġi f'diversi kombinazzjonijiet ta' insulina li taħdem b'azzjoni immedjata u b'mod intermedju.
English: What is Insuman?
Maltese: X'inhu Insuman?
English: Insuman is used in patients with diabetes (type 1 and 2) who need treatment with insulin.
Maltese: Insuman jintuża fuq pazjenti bid-dijabete (tat-tip 1 u 2) li għandhom bżonn trattament bl-insulina.
English: These patients received Insuman Implantable as a continuous infusion into the peritoneal cavity.
Maltese: Dawn il-pazjenti rċevew Insuman Implantable bħala infużjoni kontinwa fil-kavità peritoneali.
English: Why has Insuman been approved?
Maltese: Għaliex ġie approvat Insuman?
English: In addition, Insuman Implantable was studied in adult patients with type 1 diabetes.
Maltese: Barra minn hekk, Insuman Implantable ġiet studjat f'pazjenti adulti li kellhom dijabete tat-tip 1.
English: What is the risk associated with Insuman?
Maltese: X'inhu r-riskju assoċjat ma' Insuman?
English: Insuman has been studied in three trials in 780 patients with either type 1 diabetes or type 2 diabetes.
Maltese: Insuman ġie studjat fi tliet provi f'780 pazjent li kellhom jew dijabete tat-tip 1 jew dijabete tat-tip 2.
English: Insuman Implantable is given only by infusion into the abdominal cavity using a pump (Medtronic MiniMed implantable pump) that is implanted under the skin of the abdomen.
Maltese: Insuman Implantable jingħata biss b'infużjoni fil-kavità addominali bl-użu ta' pompa (pompa impjantabbli Medtronic MiniMed) li tiġi impjantata taħt il-ġilda taż-żaqq.
English: Insuman led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin.
Maltese: Insuman wassal għal tnaqqis fil-livell ta' HbA1c, u dan jindika li l-livelli tal-glukożju fid-demm kienu ġew ikkontrollati għal livell simili għal dak li jidher bl-insulina umana semisintetika.
English: Insuman Rapid, Infusat, Basal and Comb are given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor's recommendations.
Maltese: Insuman Rapid, Infusat, Basal u Comb jingħataw permezz ta' injezzjoni taħt il-ġilda, ġeneralment filparti addominali (żaqq) jew fil-koxxa, skont ir-rakkomandazzjonijiet tat-tabib.
English: Insuman Infusat is specially prepared ready to be used as a continuous infusion under the skin using an external portable infusion pump.
Maltese: Insuman Infusat huwa ppreparat b'mod speċjali lest biex jintuża bħala infużjoni kontinwa taħt il-ġilda bl-użu ta' pompa esterna portabbli ta' infużjoni.
English: Insuman is a replacement insulin that is similar to the insulin made by the body.
Maltese: Insuman huwa insulina ta' sostituzzjoni simili għall-insulina li jagħmel il-ġisem.
English: In addition, Insuman Implantable must not be used any other way than as a continuous infusion using the Medtronic MiniMed Implantable Pump.
Maltese: Barra minn hekk, Insuman Implantable m'għandux jintuża b'mod ieħor ħlief bħala infużjoni kontinwa bl-użu tal-Pompa Implantabbli Medtronic MiniMed.
English: How has Insuman been studied?
Maltese: Kif ġie studjat Insuman?
English: The CHMP decided that Insuman's benefits are greater than its risks for the treatment of type 1 and type 2 diabetes.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Insuman huma akbar mir-riskji tiegħu għat-trattament tad-dijabete tat-tip 1 u t-tip 2.
English: Insuman may cause hypoglycaemia.
Maltese: Insuman jista' jikkawża ipogliċemija.
English: Insuman Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
Maltese: Insuman Rapid jista' jintuża wkoll għat-trattament ta' koma ipergliċemika (koma kkawżata minn eċċess ta' glukożju [zokkor] fid-demm) u ketoaċidożi (livelli għoljin ta' ketoni [aċidi] fid-demm), u sabiex jikkontrolla l-glukożju fid-demm qabel, matul jew wara operazzjoni.
English: It must also not be used in patients who are hypersensitive to titanium alloy, polysulfone or silicone material used in the components of the implanted pump.
Maltese: Lanqas m'għandu jintuża f'pazjenti li huma ipersensittivi għat-titanju jew derivanti tiegħu, il-polisulfon jew materjal tas-silikon użati fil-komponenti tal-pompa implantabbli.
English: Insuman Implantable is used in adult patients with type 1 diabetes that cannot be controlled with insulin given under the skin and who often have episodes of, otherwise unexplained, hyper- or hypoglycaemia (high or low blood glucose levels).
Maltese: Insuman Implantable jintuża fuq pazjenti adulti li jbatu mid-dijabete tat-tip 1 li ma tkunx tista' tiġi kkontrollata bl-insulina mogħtija taħt il-ġilda u li spiss ikollhom episodji ta' ipergliċemija jew ipogliċemija (livelli għoljin jew baxxi ta' glukożju fid-demm), li normalment huma inspjegabbli.
English: Important note:
Maltese: Nota importanti:
English: Frequency a
Maltese: Frekwenza a
English: ATC code: B02BD02.
Maltese: B02BD02.
English: Date of latest renewal: 20 December 2013
Maltese: Data tal-aħħar tiġdid: 20 ta' Diċembru 2013
English: Laboratory test abnormal
Maltese: Test tal-laboratorju abnormali
English: (IU/dL per IU/kg)a
Maltese: IU/kg)a
English: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Switzerland
Maltese: Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel L-Iżvizzera
English: Uncommon (PTPs)
Maltese: Mhux komuni (PTPs)
English: Adults (n=109)
Maltese: Adulti (n=109)
English: Glutathione (reduced)
Maltese: Glutathione (ridott).
English: Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Maltese: Baxter AG Industriestrasse 67 A-1221 Vienna L-Awstrija
English: Boulevard René Branquart 80 B-7860 Lessines Belgium
Maltese: Boulevard René Branquart 80 B-7860 Lessines Il-Belġju
English: Adolescents (n=33)
Maltese: Adolexxenti (n=33)
English: Retrospective chart review was done for 30 paediatric subjects on ITI (in study 060703).
Maltese: Saret evalwazzjoni retrospettiva taċ-chart għal 30 individwu pedjatriku fuq ITI (fi studju 060703).
English: (see section 4.2 for information on paediatric use).
Maltese: (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Octocog alfa (recombinant human coagulation factor VIII)
Maltese: Octocog alfa (fattur VIII tal-koagulazzjoni rikombinanti uman)
English: Parameter (mean ± standard deviation)
Maltese: Parametru (± devjazzjoni standard medja)
English: Each powder vial contains nominally 250, 500, 1000, 1500, 2000, or 3000 IU octocog alfa.
Maltese: Kull kunjett tat-trab fih nominament 250, 500, 1000, 1500, 2000 jew 3000 IU octocog alfa.
English: ADVATE contains sodium
Maltese: ADVATE fih sodium
English: Table 2 Frequency of adverse drug reactions (ADRs) in clinical trials and from spontaneous reports MedDRA Standard System Organ Class
Maltese: Tabella 2 Frekwenza ta' reazzjonijiet avversi għal mediċina (ADRs) fi provi kliniċi u minn rapporti spontanji Sistema tal-Klassifika ta' l-Organi
English: The specific activity of ADVATE is approximately 4,000-10,000 IU/mg protein.
Maltese: L-attività speċifika: madwar 4,000-10,000 IU/mg proteina.
English: (See Section 4 “Possible side effects”).
Maltese: (Ara Sezzjoni 4 “Effetti sekondarji li jista' jkollu”).
English: Half-life (h) Maximum Plasma Concentration Post Infusion (IU/dl) Mean Residence Time (h)
Maltese: Half-life (h) Konċentrazzjoni Massima fil-Plasma Wara l-Infużjoni (IU/dl)
English: Table 3 Summary of Pharmacokinetic Parameters of ADVATE per Age Group with severe haemophilia A (baseline factor VIII < 1%)
Maltese: Tabella 3 Sommarju tal-Parametri Farmakokinetiċi ta' ADVATE skont il-Grupp ta' Età b'emofilja A severa (fattur VIII tal-linja bażi < 1%)
English: A non-interventional prospective registry (PASS-INT-004) documented ITI in 44 paediatric and adult subjects of whom 36 completed ITI therapy.
Maltese: Reġistru prospettiv mingħajr intervent (PASS-INT-004) iddokumenta ITI f'44 individwu adult pedjatriku li 36 minnhom lestew it-terapija ta' ITI.
English: Singapore
Maltese: Is-Singapor
English: Uncommon (PTPs)d Very common (PUPs)
Maltese: Mhux komuni (PTPs)d Komuni ħafna (PUPs)d
English: Feeling abnormal
Maltese: Sensazzjoni ta' anormalità
English: In study 060201 two long-term prophylaxis treatment schemes have been compared in 53 PTPs: an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) with a standard prophylactic dosing regimen (20 to 40 IU/kg every 48 ±6 hours, n=30).
Maltese: Fi studju 060201, żewġ skemi ta' kura bi profilassi fit-tul tqabblu fi 53 PTPs: skeda ta' dożaġġ iggwidata farmakokinetika individwalizzata (fil-medda ta' 20 sa 80 IU ta' fattur VIII għal kull kg piż tal-ġisem f'intervalli ta' 72 ± 6 sigħat, n=23) bi skeda ta' dożaġġ profilattika standard (20 sa 40 IU/kg kull 48 ±6 sigħat, n=30).
English: Frequency categories are defined according to 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: Il-kategoriji ta' frekwenza huma mfissra skont il-konvenzjoni li ġejja: 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).
English: Distribution at Steady State (dl/kg) Clearance (ml/kg*h)
Maltese: Ħin Medju ta' Residenza (h) Volum ta' Distribuzzjoni fi Stat Fiss (dl/kg) Eliminazzjoni (ml/kg*h)
English: Administration Use Aseptic Technique
Maltese: Amministrazzjoni Uża Teknika Asettika
English: Time (h)
Maltese: NUMRU(I)
English: Excipients: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, glutathione (reduced).
Maltese: Eċċipjenti: mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, u glutathione (ridott).
English: Connect the syringe to BAXJECT II (Fig. d).
Maltese: Qabbad is-siringa ma' BAXJECT II (Fig. d).
English: The table is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Maltese: It-tabella hija skont il-klassifikazzjoni tal-organi tas-sistema MedDRA (SOC u Livell ta' Terminu Ppreferut).
English: Dose (IU) = body weight (kg) x desired Factor VIII rise (% of normal) x 0.5
Maltese: Doża (IU) = piż tal-ġisem (kg) x żieda fil-Fattur VIII mixtieq (% tan-normali) x 0.5
English: A total of 195 subjects with severe haemophilia A (baseline factor VIII < 1%) provided PK parameters that were included in the Per-Protocol PK analysis set.
Maltese: Total ta' 195 individwu b'emofilja A severa (fattur VIII tal-linja bażi < 1%) ipprovdew parametri PK li ġew inklużi fis-sett ta' analiżi PK Skont il-Protokoll.
English: Uncommon side effects (may affect up to 1 in 100 people) Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment)), dizziness, flu, fainting, abnormal heartbeat, red itchy bumps on the skin, chest discomfort, injection site bruise, injection site reaction, itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, sore throat, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, reduced percentage of red blood cells, increase in a type of white blood cells (monocytes), and pain in the upper abdomen or lower chest.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) Impedituri ta' Fattur VIII (għal pazjenti li jkunu rċivew kura fil-passat b'Fattur VIII (aktar minn 150 jum ta' kura)), sturdament, influwenza, ħass ħażin, taħbit tal-qalb mhux normali, nefħiet ħomor u b'ħakk fuq il-ġilda, skumdità fis-sider, tbenġil fis-sit tal-injezzjoni, reazzjoni fis-sit tal-injezzjoni, ħakk, żieda fl-għaraq, togħma mhux tas-soltu fil-ħalq, fwawar tal-menopawsa, emigranji, indeboliment tal-memorja, tertir, dijarea, dardir, rimettar, qtugħ ta' nifs, griżmejn muġugħa, infezzjoni tal-kanali limfatiċi, tibjid tal-ġilda, infjammazzjoni fl-għajnejn, raxxijiet, tagħriq eċċessiv, nefħa fis-saqajn u r-riġlejn, perċentwali mnaqqsa tal-għadd ta' ċelluli ħomor tad-demm, żieda f'tip ta' ċelloli bojod tad-demm (monoċiti), u wġigħ fil-parti ta' fuq tal-addome jew fil-parti ta' isfel tas-sider.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 02 March 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 02 ta' Marzu 2004
English: Respiratory, thoracic and mediastinal disorders Dyspnoea
Maltese: Disturi respiratorji, toraċiċi u medjastinali
English: Excipients with known effect: 0.45 mmol sodium (10 mg) per vial.
Maltese: Eċċipjenti b'effett magħruf: 0.45 mmol sodium (10 mg) kull kunjett.
English: a
Maltese: e
English: ADVATE is indicated in all age groups.
Maltese: ADVATE huwa indikat f'kull grupp ta' età.
English: Data on Immune Tolerance Induction (ITI) in patients with inhibitors have been collected.
Maltese: Inġabret dejta dwar l-Induzzjoni tat-Tolleranza Immuni (ITI) f'pazjenti b'impedituri.
English: Should a significant increase occur, reducing the rate of administration or temporarily interrupting the injection usually allows the symptoms to disappear promptly (see sections 4.4 and 4.8).
Maltese: Jekk isseħħ żieda sinifikanti, it-tnaqqis tar-rata tal-amministrazzjoni jew l-interruzzjoni temporanja tal-injezzjoni normalment jippermettu li s-sintomi jisparixxu minnufih (ara sezzjonijiet 4.4 u 4.8).
English: Octocog alfa is a glycoprotein consisting of 2332 amino acids with an approximate molecular mass of 280 kD.
Maltese: Octocog alfa hija glikoproteina li tikkonsisti f'2,332 aċidu amminiku b'piż molekulari ta' madwar 280 kD.
English: Clinical studies with ADVATE included 418 subjects with at least one exposure to ADVATE reporting in total 93 adverse drug reactions (ADRs).
Maltese: Studji kliniċi b'ADVATE inkludew 418-il individwu b'għallinqas espożizzjoni waħda għal ADVATE li b'kollox irrapportaw 93 reazzjoni avversa għall-mediċina (ADRs).
English: Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids.
Maltese: Octocog alfa (il-fattur VIII ta' koagulazzjoni tal-bniedem (rDNA)) huwa proteina ppurifikata li għandha 2332 aċidu aminiku.
English: Children (n=30)
Maltese: Tfal (n=30)
English: Required units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Maltese: Unitajiet Meħtieġa (IU) = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur VIII (%) x 0.5.
English: - The other ingredients are mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, and glutathione (reduced).
Maltese: - Is-sustanzi l-oħra huma mannitol, sodium chloride, histidine, trehalose, calcium chloride, trometamol, polysorbate 80, u glutathione (ridott).
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII.
Maltese: Kategorija farmakoterapewtika: antiemorraġiċi: fattur VIII tal-koagulazzjoni tad-demm.
English: Solvent vial: 5 ml sterilised water for injections
Maltese: Kunjett tas-solvent: 5 ml ilma sterilizzat għall-injezzjonijiet.
English: Frequency of doses (hours)/duration of therapy (days)
Maltese: Frekwenza tad-dożi (sigħat)/dewmien tat-terapija (ġranet)
English: A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: The usual dose of octocog alfa is 20 to 40 IU per kg body weight, administered every 2 to 3 days.
Maltese: Id-doża normali ta' octocog alfa hi bejn 20 u 40 IU għal kull kg ta' piż tal-ġisem, amministrata kull jumejn jew 3 ijiem.
English: INFORMATION IN BRAILLE ADVATE 2000
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 2000
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Maltese: Tabella 1 Gwida għal dożaġġ u episodji ta' emorraġija u kirurġija Grad ta' emorraġija/tip ta' proċedura kirurġika
English: The factor VIII/von Willebrand Factor complex consists of two molecules (factor VIII and von Willebrand Factor) with different physiological functions.
Maltese: Il-fattur VIII/kumpless tal-Fattur von Willebrand jikkonsisti f'żewġ molekuli (fattur VIII u l-fattur von Willebrand) b'funzjonijiet fiżjoloġiċi differenti.
English: Marketing Authorisation Holder Baxter AG
Maltese: FIS-SUQ Baxter AG
English: b) The unexpected decrease in coagulation factor VIII levels occurred in one patient during continuous infusion of ADVATE following surgery (postoperative days 10-14).
Maltese: It-tnaqqis mhux mistenni fil-livelli ta' fattur VIII tal-koagulazzjoni seħħ f'pazjent wieħed waqt infużjoni kontinwa ta' ADVATE wara l-kirurġija (ġranet ta' wara l-operazzjoni 10-14).
English: INFORMATION IN BRAILLE ADVATE 1500
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 1500
English: Solvent Sterilised water for injections
Maltese: Solvent Ilma sterilizzat għall-injezzjonijiet.
English: Minor
Maltese: Minuri
English: ADVATE is usually injected into a vein (intravenously) by your doctor or nurse.
Maltese: ADVATE ġeneralment jingħata ġo vina (fil-vini) minn tabib jew infermiera.
English: INFORMATION IN BRAILLE ADVATE 3000
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 3000
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Categories of these analyses for infants (1 month to <2 years of age), children (2 to <5 years of age), older children (5 to <12 years of age), adolescents (12 to <18 years of age), and adults (18 years of age and older) were used to summarize PK parameters, where age was defined as age at time of PK infusion.
Maltese: Kategoriji ta' dawn l-analiżi għal tfal żgħar ħafna (1 xahar sa <sentejn), tfal (sentejn sa <5 snin), tfal ikbar fl-età (5 snin sa <12-il sena), adolexxenti (12-il sena sa <18-il sena), u adulti (minn 18-il sena 'l fuq) intużaw biex jingħata sommarju tal-parametri PK, fejn l-età ġiet definita bħala l-età fil-ħin ta' infużjoni PK.
English: The solvent vial has a blue stripe.
Maltese: Il-kunjett bis-solvent fih strixxa blu.
English: ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology.
Maltese: ADVATE fih is-sustanza attiva octocog alfa, il-fattur VIII ta' koagulazzjoni umana li jiġi magħmul bit-teknoloġija rikombinanti tad-DNA.
English: Volume of
Maltese: U KWANTITATTIVA
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse or hamster proteins.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għall-proteini tal-ġurdien jew tal-ħamster.
English: INFORMATION IN BRAILLE ADVATE 250
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 250
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at 25 °C.
Maltese: Madankollu, l-istabbiltà kimika u fiżika waqt l-użu intweriet għal 3 sigħat f'temperatura ta' 25 °C.
English: Hypersensitivityc
Maltese: Sensittività eċċessivaċ
English: Connect the syringe to BAXJECT II / BAXJECT III.
Maltese: Qabbad is-siringa ma' BAXJECT II/BAXJECT III.
English: The safety and haemostatic efficacy of ADVATE in the paediatric population are similar to that of adult patients.
Maltese: Is-sigurtà u l-effikaċja emostatika ta' ADVATE fil-popolazzjoni pedjatrika huma simili għal dawk ta' pazjenti adulti.
English: The pharmacokinetic guided dosing regimen (according to a specific formula) was targeted to maintain factor VIII trough levels ≥ 1% at the inter-dosing interval of 72 hours.
Maltese: L-iskeda ta' dożaġġ iggwidata farmakokinetika (skont formula speċifika) ġiet immirata sabiex iżżomm livelli minimi tal-fattur VIII ≥ 1% fl-intervall ta' bejn doża u oħra ta' 72 siegħa.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Maltese: IgG diretti lejn l-attività prokoagulanti tal-fattur VIII, li jiġu kwantifikati f'Unitajiet Bethesda (BU) għal kull ml ta' plażma billi tintuża l-analiżi modifikata (modified assay).
English: Frequencya
Maltese: Frekwenzaa
English: What ADVATE contains - The active substance is octocog alfa (human coagulation Factor VIII produced by recombinant DNA technology).
Maltese: X'fih ADVATE - Is-sustanza attiva hi octocog alfa (Fattur VIII tal-koagulazzjoni uman magħmul minn teknoloġija tad-DNA rikombinanti).
English: Very common (PUPs)d
Maltese: Komuni ħafna (PUPs)
English: INFORMATION IN BRAILLE ADVATE 1000
Maltese: INFORMAZZJONI BIL-BRAILLE ADVATE 1000
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Maltese: Din il-mediċina fiha 0.45 mmol ta' sodju (10 mg) kull kunjett.
English: Powder vial and 5 ml solvent preassembled in BAXJECT III system.
Maltese: Kunjett bit-trab u 5 ml ta' solvent immuntati minn qabel f'sistema BAXJECT III.
English: Powder vial and 2 ml solvent preassembled in BAXJECT III system.
Maltese: Kunjett bit-trab u 2 ml ta' solvent immuntati minn qabel f'sistema BAXJECT III.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ADVATE in all subsets of the paediatric population in haemophilia A (congenital factor VIII deficiency) in "Immune Tolerance Induction (ITI) in patients with haemophilia A (congenital factor VIII deficiency) who have developed inhibitors to factor VIII" and "treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency)".
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'ADVATE f'kull sett tal-popolazzjoni pedjatrika fl-emofilja A (nuqqas tal-fattur VIII konġenitali) f'“Induzzjoni tat-Tolleranza Immuni (ITI) f'pazjenti b'emofilja A (nuqqas tal-fattur VIII konġenitali) li żviluppaw impedituri għal fattur VIII” u “kura u profilassi ta' fsada f'pazjenti b'emofilja A (nuqqas tal-fattur VIII konġenitali)”.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) potentially life-threatening reactions (anaphylaxis) and other allergic reactions (hypersensitivity), general disorders (tiredness, lack of energy).
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa (il-frekwenza ma tistax tiġi stmata mid-data disponibbli) reazzjonijiet li jkunu potenzjalment ta' periklu għall-ħajja (anafilassi) u reazzjonijiet allerġiċi oħrajn (sensittività eċċessiva), disturbi ġenerali (għeja, nuqqas ta' enerġija).
English: Insert the white plastic spike through the ADVATE powder stopper.
Maltese: Daħħal il-ponta bajda tal-plastik ġot-tapp ta' ADVATE trab.