FrancophonIA/ELRC3.0 huggingface dataset:
English: Suliqua 100units/ml + 33 microgram/ml solution for injection in a pre-filled pen Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms Lixisenatide in 3 ml solution.
Maltese: Suliqua 100 unità/ml + 33 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest fiha 300 unità ta' insulin glargine* u 100 mikrogramma lixisenatide f'soluzzjoni ta' 3 ml.
English: • Beta-blockers or clonidine, for high blood pressure.
Maltese: • Imblokkaturi tar-riċetturi beta jew clonidine, għall-pressjoni tad-demm għolja.
English: Concentrated hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: Test your blood glucose levels after 10-15 minutes after taking sugar.
Maltese: Ittestja l-livelli tal-glukożju fid-demm tiegħek wara 10-15-il minuta wara li tieħu z-zokkor.
English: Each pen contains 300 units of insulin glargine and 150 micrograms lixisenatide in 3 ml solution.
Maltese: Kull pinna fiha 300 unità ta' insulin glargine u 150 mikrogramma lixisenatide f'soluzzjoni ta' 3 ml.
English: Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution.
Maltese: Skartoċċ tal-ħġieġ tat-tip I bla kulur bi planġer iswed (lastku bromobutyl) u għatu flanġ (tal-aluminju) b'diski laminati li jissiġillaw imdaħħlin fih (lastku bromobutyl man-naħa tal-prodott mediċinali u polyisoprene fuq in-naħa ta' barra) li fih 3 ml ta' soluzzjoni.
English: Be especially aware of the following:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Dose selector Injection button
Maltese: Selettur tad-doża Buttuna tal-injezzjoni
English: Dyspepsia Abdominal pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Each pen contains 300 units of insulin glargine and 100 micrograms lixisenatide in 3 mL solution.
Maltese: Kull pinna fiha 300 unità ta' insulin glargine u 100 mikrogramma lixisenatide f'soluzzjoni ta' 3 ml.
English: NAME OF THE MEDICINAL PRODUCT Suliqua 100 units/mL + 50 micrograms/mL solution for injection in a pre-filled pen Suliqua 100 units/mL + 33 micrograms/mL solution for injection in a pre-filled pen insulin glargine + lixisenatide
Maltese: Suliqua 100 unità/ml + 50 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Suliqua 100 unità/ml + 33 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest insulin glargine + lixisenatide
English: The cardiovascular safety of insulin glargine and lixisenatide has been established in the ORIGIN and ELIXA clinical trials, respectively.
Maltese: Is-sigurtà kardjovaskulari ta' insulin glargine u lixisenatide ġiet stabbilita fil-provi kliniċi ORIGIN u
English: Pull off the pen cap.
Maltese: Formazzjoni ta' antikorpi
English: Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.
Maltese: L-għoti ta' Suliqua jista' jikkawża l-formazzjoni ta' antikorpi kontra insulin glargine u/jew lixisenatide.
English: C-cell hyperplasia and adenoma were seen at all doses in rats and a no observed adverse effect level (NOAEL) could be not defined.
Maltese: Fil-firien, dehru iperplasja u adenoma taċ-ċellola C f'kull doża u ma setax jiġi definit livell fejn mhu osservat ebda effett avvers (NOAEL, no observed adverse effect level).
English: Each ml contains 100 units of insulin glargine and 50 micrograms lixisenatide.
Maltese: Kull ml fih 100 unità ta' insulin glargine u 50 mikrogramma lixisenatide.
English: Take about 15 to 20 grams sugar straight away - such as glucose, sugar cubes or a sugary drink.
Maltese: Ħu madwar 15 sa 20 gramma zokkor minnufih - bħal glukożju, dadi tazzokkor jew xarba biz-zokkor.
English: Hepatic dysfunction is not expected to affect the pharmacokinetics of lixisenatide.
Maltese: Disfunzjoni tal-fwied mhux mistennija li taffettwa l-farmakokinetika ta' lixisenatide.
English: Consistent with a relatively constant concentration/time profile of insulin glargine over 24 hours with no pronounced peak when administered alone, the glucose utilisation rate/time profile was similar when given in the insulin glargine/lixisenatide combination.
Maltese: B'mod konsistenti mal-profil relattivament kostanti ta' konċentrazzjoni/ħin ta' insulin glargine fuq perjodu ta' 24 siegħa mingħajr l-ebda livelli għoljin li jidhru b'mod ċar meta jingħata waħdu, il-profil tar-rata tal-użu tal-glukożju/ħin kien simili meta ingħata fil-kombinazzjoni ta' insulin glargine/lixisenatide.
English: • Each dose step you dial contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide.
Maltese: • Kull grad fuq l-iskala tad-doża li ddawar fih unità 1 ta' insulin glargine u 0.5 mikrogramma ta' lixisenatide.
English: Each ml contains 100 units insulin glargine and 50 micrograms lixisenatide.
Maltese: Kull ml fih 100 unità insulin glargine u 50 mikrogramma lixisenatide.
English: • Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
Maltese: • Inibituri tal-enzima li tikkonverti anġjotensin (ACE - angiotensin converting enzyme) għal problemi tal-qalb jew pressjoni għolja tad-demm.
English: The starting dose of Suliqua isbased on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:
Maltese: Id-doża tal-bidu ta' Suliqua hija bbażata fuq it-trattament preċedenti ta' kontra d-dijabete, u b'tali mod li ma tinqabiżx id-doża tal-bidu rrakkomandata ta' 10 mcg lixisenatide:
English: The median duration of study follow-up was 25.8 and 25.7 months in the lixisenatide group and the placebo group, respectively.
Maltese: 7 xhur fil-grupp ta' lixisenatide u fil-grupp ta' plaċebo, rispettivament.
English: The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine and lixisenatide in Suliqua.
Maltese: Il-proporzjon ta' insulin glargine/lixisenatide m'għandu l-ebda impatt fuq il-PK ta' insulin glargine u lixisenatide f'Suliqua.
English: • For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied
Maltese: Suliqua meta mqabbel ma' insulin glargine (100 unità/ml).
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Maltese: Mediċini użati fid-dijabete, insulini u analogi għall-injezzjoni, b'azzjoni fit-tul.
English: Suliqua 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen
Maltese: Suliqua 100 unità/ml + 50 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Suliqua 100 unità/ml + 33 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Maltese: Wara l-għoti ta' lixisenatide 20 mcg flimkien ma' digoxin 0.25 mg fi stat fiss, l-AUC ta' digoxin ma kinitx affettwata.
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Maltese: Ġie mbassar li jkun hemm aktar dewmien fit-tmax u tnaqqis fis-Cmax ta' paracetamol bid-doża ta' manteniment ta' 20 mcg.
English: Results at 30 weeks - Add-on to metformin clinical study (mITT population) Suliqua
Maltese: Riżultati fit-30 ġimgħa - Studju kliniku ta' terapija miżjuda ma' metformin (popolazzjoni mITT)
English: This type 2 diabetes population had the following characteristics: Mean age was 60.0 years with the majority (56.3%) being aged of 50 to 64 years, and 53.3 percent were female.
Maltese: L-età medja kienet 60.0 sena bil-parti l-kbira (56.3%) li kellhom minn 50 sa 64 sena, u 53.3 fil-mija kienu nisa.
English: See also section 2 “What you need to know before you use Suliqua” for information on sodium and metacresol.
Maltese: Ara wkoll sezzjoni 2 “X'għandek tkun taf qabel tuża Suliqua” għal informazzjoni dwar sodium u metacresol.
English: Methionine
Maltese: Frekwenza
English: This medicinal product contains metacresol, which may cause allergic reactions.
Maltese: Dan il-prodott mediċinali fih metacresol, li jista' jikkawża reazzjonijiet allerġiċi.
English: • Headache.
Maltese: (ipogliċemija).
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from beta cells and suppresses glucagon from alpha cells in the pancreas.
Maltese: Ir-riċettur GLP-1 huwa l-mira għal GLP-1 nattiv, ormon incretin endoġenu li jsaħħaħ is-sekrezzjoni tal-insulina li tiddependi fuq il-glukożju miċ-ċelloli beta u jrażżan il-glukagon miċ-ċelluli alfa tal-frixa.
English: How to store Suliqua
Maltese: Tinjettax Suliqua.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on OAD treatment A total of 1170 patients with type 2 diabetes were randomised in an open label, 30-week, activecontrolled study to evaluate the efficacy and safety of Suliqua compared to the individual components, insulin glargine (100 units/ml) and lixisenatide (20 mcg).
Maltese: Total ta' 1170 pazjent b'dijabete tat-tip 2 intgħażlu b'mod arbitrarju għal studju ta' 30 ġimgħa kkontrollat b'mod attiv fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża biex tiġi evalwata l-effikaċja u s-sigurtà ta' Suliqua meta mqabbla mal-komponenti individwali, insulin glargine (100 unità/ml) u lixisenatide (20 mcg).
English: STEP 5: Inject the dose
Maltese: PASS 5:
English: Suliqua combines two active substances with complementary mechanisms of action to improve glycaemic control: insulin glargine, a basal insulin analog (mainly targeting fasting plasma glucose), and lixisenatide, a GLP-1 receptor agonist (mainly targeting postprandial glucose).
Maltese: Mekkaniżmu ta' azzjoni Suliqua jgħaqqad flimkien żewġ sustanzi attivi b'mekkaniżmi ta' azzjoni kumplimentari biex itejjeb il-kontroll gliċemiku: insulin glargine, analogu ta' insulina tal-bażi (li l-mira tiegħu hija l-aktar il glukożju fil-plażma waqt is-sawm), u lixisenatide, agonist tar-riċettur ta' GLP-1 (li l-mira tiegħu hija l-aktar il-glukożju ta' wara l-ikel).
English: • Always use needles that are compatible for use with Suliqua pen.
Maltese: • Dejjem uża labar li huma kompatibbli mal-użu tal-pinna Suliqua.
English: Prior to launch of Suliqua in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials for Suliqua, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel ma Suliqua jitqiegħed fis-suq ta' kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAH) irid jaqbel mal-Awtorità Kompetenti Nazzjonali dwar il-kontenut u l-format tal-materjal edukattiv għal Suliqua,inkluż il-mezzi ta' komunikazzjoni, mod ta' distribuzzjoni u kwalunkwe aspett ieħor tal-programm.
English: Starting dose
Maltese: Selettur tad-doża
English: Events per patient-year, n
Maltese: Avvenimenti f'sena ta' trattament ta' pazjenti, n
English: Each pen contains 3 ml of solution for injection, equivalent to 300 units insulin glargine and 100 micrograms lixisenatide.
Maltese: Kull pinna fiha 300 unità insulin glargine u 100 mikrogramma lixisenatide.
English: These factors include: - change in the injection area - improved insulin sensitivity (e.g. by removal of stress factors) - unaccustomed, increased or prolonged physical activity - intercurrent illness (e.g. vomiting, diarrhoea) - inadequate food intake - missed meals - alcohol consumption - certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency) - concomitant treatment with certain other medicinal products (see section 4.5).
Maltese: - ċerti disturbi endokrinarji mhux ikkumpensati, (eż. fl-ipotirojdiżmu u fl-insuffiċjenza tal-parti anterjuri tal-glandola pitwitarja jew insuffiċjenza adrenokortikali) - trattament fl-istess waqt b'ċerti prodotti mediċinali oħra (ara sezzjoni 4.5)
English: Not in-use pens.
Maltese: Uża pinna ġdida.
English: The time course of action of insulins, including Suliqua, may vary between individuals and within the same individual.
Maltese: It-tul ta' ħin ta' azzjoni tal-insulini, inkluż Suliqua, jista' jvarja bejn l-individwi u fl-istess individwu.
English: Before injecting Suliqua
Maltese: Meta tinjetta Suliqua
English: • You have a certain type of nerve damage (called “diabetic autonomic neuropathy”).
Maltese: • Inti għandek ċertu tip ta' ħsara fin-nervituri (msejħa “newropatija awtonomika tad-dijabete”).
English: Figure: Mean HbA1c(%) at start of screening, randomization point and Each Time Point (Completers) and at Week 30 - mITT population
Maltese: Medja ta' HbA1c(%) fil-bidu tal-eżami, fil-punt tal-għażla arbitrarja u f'Kull Punt ta' Ħin (Dawk li temmew l-istudju) u f'Ġimgħa 30 - popolazzjoni mITT
English: Acute pancreatitis
Maltese: Postijiet fejn tinjetta
English: • For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose.
Maltese: • Għal insulina tal-bażi darbtejn kuljum jew insulin glargine (300 unità/ml), id-doża preċedenti totali ta' kuljum li ntużat qabel għandha titnaqqas b'20% biex tingħażel id-doża tal-bidu ta'
English: Suliqua (30-60) pen
Maltese: Pinna Suliqua (30
English: Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide
Maltese: It-teħid flimkien ma' prodotti mediċinali oħra
English: • Change the needle (see STEP 6 Remove the needle and STEP 2 Attach a new needle) then do a safety test (see STEP 3).
Maltese: Neħħi l-labra u PASS 2 Waħħal labra ġdida) imbagħad agħmel test ta' sigurtà (ara PASS 3).
English: Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin (see section 4.4 and 5.1 for available data on the different combinations).
Maltese: Biex jiġu evitati żbalji fil-medikazzjoni bejn Suliqua u prodotti mediċinali oħra kontra d-dijabete li jiġu injettati, inkluż iż-żewġ pinen differenti ta' Suliqua (ara sezzjoni 4.4), it-tikketta tal-insulina għandha dejjem tiġi ċċekkjata qabel kull injezzjoni.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Maltese: <Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva/i
English: In clinical studies with insulin glargine (100 units/ml) the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin.
Maltese: Insulin glargine Fi studji kliniċi b'insulin glargine (100 unità/ml) l-effett ta' tnaqqis fil-livelli tal-glukożju fuq bażi molari (i.e., meta t-tnejn jingħataw bl-istess doża) ta' insulin glargine minn ġol-vini huwa bejn wieħed u ieħor l-istess bħal dak tal-insulina tal-bniedem.
English: Mean body weight (kg) Baseline (mean)
Maltese: Linja bażi (medja) Bidla f'LS mil-linja bażi (medja)
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on basal insulin A total of 736 patients with type 2 diabetes participated in a randomised, 30-week, active-controlled, open-label, 2-treatment arm, parallel-group, multicenter study to evaluate the efficacy and safety of Suliqua compared to insulin glargine (100 units/ml).
Maltese: Total ta' 736 pazjent b'dijabete tat-tip 2 ipparteċipaw fi studju arbitrarju, ta' 30 ġimgħa, ikkontrollat b'mod attiv, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża,
English: In-use pens
Maltese: TIKKETTA TAL-PINNA
English: Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
Maltese: Lixisenatide jistimula s-sekrezzjoni tal-insulina meta l-glukożju fid-demm jiżdied iżda mhux f'normogliċemija, li tillimita r-riskju ta' ipogliċemija.
English: Effect of age, race, and gender on the pharmacokinetics of insulin glargine has not been evaluated.
Maltese: Insulin glargine L-effett tal-età, tar-razza u tas-sess tal-persuna fuq il-farmakokinetika ta' insulin glargine ma ġiex ivvalutat.
English: *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Maltese: *Mhux inkluż fil-proċedura ta' ttestjar step-down speċifikata minn qabel
English: HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Maltese: Hydrochloric acid ikkonċentrat (għall-aġġustament tal-pH)
English: SC
Maltese: Ltd.
English: Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen Insulin glargine + lixisenatide
Maltese: Suliqua 100 unità/ml + 33 mikrogramma/ml soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Insulin glargine + lixisenatide
English: • Stomach ache
Maltese: Ż-ŻGĦAR EWLENIN
English: In case of gastrointestinal adverse reactions, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Maltese: F'każ ta' reazzjonjiet gastrointestinali avversi, għandu jinbeda trattament xieraq ta' sostenn skont is sinjali u s-sintomi kliniċi tal-pazjent.
English: Each dose step of Suliqua contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide,.
Maltese: Kull grad fuq l-iskala tad-doża fih unità 1 ta' insulin glargine u 0.5 mikrogramma ta' lixisenatide.
English: Nasopharyngitis Upper respiratory tract infection
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3).
Maltese: - imbagħad irrepeti t-test ta' sigurtà (PASS 3).
English: EMA/91202/2010 EMEA/H/C/1055
Maltese: EMA/91202/2010
English: The European Commission granted a marketing authorisation valid throughout the EU for ImmunoGam to Cangene Europe Limited on 16 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal ImmunoGam lil Cangene Europe Limited fis-16 ta' Marzu 2010.
English: ImmunoGam provides ‘passive' protection.
Maltese: ImmunoGam tipprovdi protezzjoni ‘passiva'.
English: Of the 178 babies who completed the study, 174 (98%) remained free of hepatitis B infection.
Maltese: Mill-178 tarbija li temmew l-istudju, 174 (98%) baqgħu ħielsa minn infezzjoni tal-epatite B.
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, dizziness, nausea, arthralgia (joint pain), back pain, myalgia (muscle pain), fatigue (tiredness), induration (hardening at the injection site), malaise (feeling unwell), pain at injection site and pyrexia (fever).
Maltese: Effetti sekondarji b'ImmunoGam mhumiex komuni. Madankollu, l-effetti sekondarji li ġejjin jiġu osservati f'pazjent wieħed sa 10 pazjenti kull 1,000: uġigħ ta' ras, sturdament, dardir, artralġija (uġigħ fil-ġogi), uġigħ fid-dahar, mijalġija (uġigħ fil-muskoli), għeja, twebbis (twebbis fis-sit tal-injezzjoni), malaise (tħossok ma' tiflaħx), uġigħ fis-sit tal-injezzjoni u pireksja (deni).
English: This document is a summary of the European Public Assessment Report (EPAR) for ImmunoGam.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal ImmunoGam.
English: ImmunoGam has been investigated in one main study involving 253 newborn babies whose mothers were carriers of the virus and 42 adults who had potentially been exposed to the virus.
Maltese: ImmunoGam ġiet investigata fi studju wieħed prinċipali li involva 253 tarbija tat-twelid li ommijiethom kienu ġarriera tal-virus u 42 adult li kienu potenzjalment esposti għall-virus.
English: ImmunoGam human hepatitis B immunoglobulin
Maltese: ImmunoGam immunoglobina tal-epatite B tal-bniedem
English: This summary was last updated in 04-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 01-2010.
English: Other information about ImmunoGam:
Maltese: Informazzjoni oħra dwar ImmunoGam:
English: Haemodialysed patients should received 8 to 12 IU per kilogram body weight up to a maximum of 500 IU, every two months.
Maltese: Pazjenti li ssirilhom l-emodijaliżi għandhom jingħataw 8 sa 12 IU kull kilogramma ta' piż tal-ġisem sa massimu ta' 500
English: This is comparable to the protection rate seen with similar treatments in published literature.
Maltese: Dan jitqabbel ma' rata ta' protezzjoni osservata bi trattamenti simili fir-riċensjoni ppubblikata.
English: • people accidentally exposed to the virus who are not known to have been vaccinated fully;
Maltese: • nies li ġew esposti b'mod aċċidentali għall-virus li mhumiex magħrufa li kienu ġew imlaqqmin sew;
English: • people at continuous risk of hepatitis B infection who have not responded to vaccination.
Maltese: • nies f'riskju kontinwu ta' infezzjoni bl-epatite B li ma rrispondewx għat-tilqim.
English: What is ImmunoGam?
Maltese: X'inhu ImmunoGam?
English: • patients who have had haemodialysis (a blood clearance technique used in people with kidney problems).
Maltese: • pazjenti li kellhom emodijaliżi (teknika ta' tindif tad-demm użata f'nies bi problemi fil-kliewi).
English: People accidentally exposed to the virus should receive at least 500 international units (IU) as soon as possible and preferably within 24 to 72 hours of exposure.
Maltese: Nies li ġew esposti b'mod aċċidentali għall-virus għandhom jingħataw mill-inqas 500 unità internazzjonali (IU) mill-aktar fiss u preferibbilment fi żmien 24 sa 72 siegħa mill-espożizzjoni.
English: Although ImmunoGam itself was not tested in experimental models, the applicant presented adequate data from studies using similar medicines.
Maltese: Għalkemm ImmunoGam stess ma ġietx ittestjata f'mudelli sperimentali, l-applikant ippreżenta dejta adegwata minn studji li jużaw mediċini simili.
English: Why has ImmunoGam been approved?
Maltese: Għaliex ġiet approvata ImmunoGam?
English: The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
Maltese: Is-sustanza attiva ta' ImmunoGam, immunoglobina tal-epatite B tal-bniedem, hija antikorp purifikat meħud mid-demm tal-bniedem.
English: ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
Maltese: ImmunoGam hija soluzzjoni għall-injezzjoni li fiha s-sustanza attiva immoglobina tal-epatite B talbniedem.
English: What is the risk associated with ImmunoGam?
Maltese: X'inhu r-riskju assoċjat ma' ImmunoGam?
English: ImmunoGam should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Maltese: ImmunoGam ma għandhiex tintuża f'nies li jistgħu ikunu ipersensittivi (allerġiċi) għas-sustanza attiva, għal xi wieħed mill-ingredjenti l-oħrajn jew għall-immunoglobini tal-bniedem, b'mod speċjali fejn ikollhom defiċjenza (livelli baxxi ħafna) ta' immunoglobina A (IgA) u għandhom l-antikorpi kontra
English: ImmunoGam was effective at protecting against hepatitis B virus infection.
Maltese: ImunoGam kien effettiv fil-protezzjoni kontra infezzjoni bil-virus tal-epatite B.
English: Newborn babies whose mothers are carriers of the hepatitis B virus should receive 30 to 100 IU/kg at birth or as soon as possible after birth.
Maltese: Trabi tat-twelid li ommijiethom huma ġarriera tal-virus tal-epatite B għandhom jingħataw 30 sa 100 IU/kg mat-twelid jew l-aktar fiss possibbli wara t-twelid.
English: What benefit has ImmunoGam shown during the studies?
Maltese: Liema benefiċċju wera ImmunoGam waqt l-istudji mwettqa?
English: ImmunoGam is used to provide protection against the hepatitis B virus.
Maltese: ImmunoGam tintuża sabiex tipprovdi protezzjoni kontra l-virus tal-epatite B.