FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were administered Parsabiv or placebo at a starting dose of 5 mg 3 times per week at the end of haemodialysis and titrated every 4 weeks through week 17 to a maximum dose of 15 mg 3 times per week to achieve target PTH level ≤ 300 pg/mL.
Maltese: Il-pazjenti ngħataw Parsabiv jew plaċebo b'doża tal-bidu ta' 5 mg 3 darbiet fil-ġimgħa fl-aħħar tal-emodijalisi u kellhom titrazzjoni kull 4 ġimgħat sa ġimgħa 17 sa doża massima ta' 15 mg 3 darbiet fil-ġimgħa biex jinkiseb livell immirat ta' PTH ta' ≤ 300 pg/mL.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2.5 mg of etelcalcetide (as hydrochloride).
Maltese: Kull kunjett fih 2.5 mg ta' etelcalcetide (bħala hydrochloride).
English: The ratio of blood-to-plasma [14C]-etelcalcetide concentrations is approximately 0.6.
Maltese: Il-proporzjon tal-konċentrazzjonijiet tad-demm għallplażma ta' [14C]-etelcalcetide huwa madwar 0.6.
English: Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution.
Maltese: U KWANTITATTIVA Parsabiv 2.5 mg soluzzjoni għall-injezzjoni Kull kunjett fih 2.5 mg ta' etelcalcetide (bħala hydrochloride) f'0.5 mL ta' soluzzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10 mg of etelcalcetide (as hydrochloride).
Maltese: Kull kunjett fih 10 mg ta' etelcalcetide (bħala hydrochloride).
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 5 mg solution for injection etelcalcetide
Maltese: Parsabiv 5 mg soluzzjoni għall-injezzjoni etelcalcetide
English: Important information about some of the ingredients of Parsabiv This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Parsabiv Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: A 52-week, single arm extension study to the placebo-controlled and “switch” studies described above was conducted to characterise the long term safety and efficacy of Parsabiv in 891 SHPT patients with CKD on haemodialysis.
Maltese: Sar studju ta' estensjoni ta' 52 ġimgħa bi grupp wieħed tal-istudji kkontrollati bil-plaċebo u tal-istudji “switch” deskritti hawn fuq biex jikkaratterizza s-sigurtà u l-effikaċja fit-tul ta' Parsabiv f'891 pazjent b'SHPT b'CKD fuq l-emodijalisi.
English: Parsabiv 10 mg solution for injection
Maltese: Parsabiv 10 mg soluzzjoni għall-injezzjoni
English: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution.
Maltese: Kull kunjett fih 5 mg ta' etelcalcetide (bħala hydrochloride) f'1 mL ta' soluzzjoni.
English: Muscle spasms
Maltese: Dożi maqbuża
English: Parsabiv 2.5 mg solution for injection
Maltese: Parsabiv 2.5 mg soluzzjoni għall-injezzjoni:
English: • Low phosphate levels in blood
Maltese: • Livelli baxxi ta' fosfat fid-demm
English: In a pre- and post-natal development study in rats there was a minimal increase in perinatal pup mortality, delay in parturition and transient reductions in post-natal growth associated with maternal toxicities of hypocalcaemia, tremoring, and reductions in body weight and food consumption at 1.8 times clinical exposure levels.
Maltese: Fi studju dwar l-iżvilupp ta' qabel u wara t-twelid fil-firien kien hemm żieda minima fil-mortalità tal-frieħ qabel it-twelid, dewmien fittwelid u tnaqqis temporanju fit-tkabbir wara t-twelid assoċjati ma' tossiċitajiet fl-omm ta' ipokalċimija, rogħda, u tnaqqis fil-piż tal-ġisem u fil-konsum tal-ikel b'livelli 1.8 darbiet il-livelli ta' esponiment kliniku.
English: How to store Parsabiv
Maltese: Kif taħżen Parsabiv
English: Very common side effects with Parsabiv are blood calcium decreased, muscle spasms, diarrhoea, nausea, and vomiting.
Maltese: Effetti sekondarji komuni ħafna b'Parsabiv huma tnaqqis fil-kaċju fid-demm, spażmi fil-muskoli, dijarea, dardir, u rimettar.
English: The reduction in PTH is associated with a concomitant decrease in serum calcium and phosphate levels.
Maltese: It-tnaqqis fil-PTH huwa assoċjat ma' tnaqqis fl-istess waqt fil-livelli tal-kalċju u tal-fosfat fis-serum.
English: As a precautionary measure, it is preferable to avoid the use of Parsabiv during pregnancy.
Maltese: Bħala prekawzjoni hu preferibbli li jiġi evitat l-użu ta' Parsabiv waqt it-tqala.
English: Serum calcium levels should be monitored in patients with a history of congestive heart failure while being treated with Parsabiv (see section 4.2), which may be associated with reductions in serum calcium levels.
Maltese: Il-livelli ta' kalċju fis-serum għandhom jiġu mmonitorjati f'pazjenti bi storja ta' insuffiċjenza konġestiva tal-qalb waqt li kienu qed jiġu ttrattati b'Parsabiv (ara sezzjoni 4.2), li tista' tkun assoċjata ma' tnaqqis fil-livelli ta' kalċju fis-serum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of etelcalcetide (as hydrochloride).
Maltese: Kull kunjett fih 5 mg ta' etelcalcetide (bħala hydrochloride).
English: Both studies demonstrated that Parsabiv reduced PTH, while lowering calcium, phosphate and Ca x P. Results of all primary and secondary endpoints were statistically significant and the results were consistent across both studies as shown in table 2.
Maltese: Ir-riżultati talpunti finali primarji u sekondarji kollha kienu statistikament sinifikanti u r-riżultati kienu konsistenti tul iż-żewġ studji kif muri fit-tabella 2.
English: Each vial contains 1 mL solution for injection.
Maltese: Kull kunjett fih 1 mL ta' soluzzjoni għall-injezzjoni.
English: NAME OF THE MEDICINAL PRODUCT Parsabiv 2.5 mg solution for injection Parsabiv 5 mg solution for injection Parsabiv 10 mg solution for injection
Maltese: Parsabiv 2.5 mg soluzzjoni għall-injezzjoni Parsabiv 5 mg soluzzjoni għall-injezzjoni Parsabiv 10 mg soluzzjoni għall-injezzjoni
English: By controlling the levels of PTH, Parsabiv helps to control calcium and phosphate in your body.
Maltese: Billi jikkontrolla l-livelli ta' PTH, Parsabiv jgħin biex jikkontrolla l-kalċju u l-fosfat fil-ġisem tiegħek.
English: Pharmacotherapeutic group: Calcium homeostasis, anti-parathyroid agents.
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: Each vial contains 0.5 mL solution for injection.
Maltese: Kull kunjett fih 0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Concurrent administration of other medicinal products known to reduce serum calcium and Parsabiv may result in an increased risk of hypocalcaemia (see section 4.4).
Maltese: Għoti ta' prodotti mediċinali oħra magħrufa li jnaqqsu l-kalċju fis-serum flimkien ma' Parsabiv jista' jwassal għal żieda fir-riskju ta' ipokalċimija (ara sezzjoni 4.4).
English: In these studies 1% of patients in the Parsabiv group and 0% of patients in the placebo group discontinued treatment due to the adverse event of low serum calcium.
Maltese: F'dawn l-istudji 1% tal-pazjenti fil-grupp Parsabiv u 0% tal-pazjenti fil-grupp tal-plaċebo waqqfu t-trattament minħabba l-avveniment avvers ta' kalċju baxx fis-serum.
English: In the combined placebo-controlled studies, the subject incidence of adjudicated CHF events requiring hospitalisation was 2.2% in the Parsabiv treatment group compared to 1.2% in the placebo group.
Maltese: Fl-istudji kkombinati kkontrollati bi plaċebo, l-inċidenza fl-individwi ta' avvenimenti ta' CHF aġġudikati li kienu jirrikjedu kura fl-isptar kienet ta' 2.2% fil-grupp ta' trattament b'Parsabiv meta mqabbla ma' 1.2% fil-grupp tal-plaċebo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Parsabiv in one or more subsets of the paediatric population in the treatment of hyperparathyroidism (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Parsabiv f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fit-trattament ta' iperparatirojdiżmu (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Parsabiv 2.5 mg solution for injection
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Parsabiv 2.5 mg soluzzjoni għall-injezzjoni
English: The threshold for seizures may be lowered by significant reductions in serum calcium levels.
Maltese: Il-limitu għal aċċessjonijiet jista' jitbaxxa permezz ta' tnaqqis sinifikanti fil-livelli ta' kalċju fis-serum.
English: Parsabiv 5 mg solution for injection
Maltese: Parsabiv 5 mg soluzzjoni għall-injezzjoni:
English: The average duration of haemodialysis prior to study entry was 5.4 years and 68% of patients were receiving vitamin D sterols at study entry, with 83% receiving phosphate binders.
Maltese: It-tul medju tal-emodijalisi qabel id-dħul fl-istudju kien ta' 5.4 snin u 68% tal-pazjenti kienu qed jirċievu sterols tal-vitamina D meta daħlu fl-istudju, b'83% li kienu qed jirċievu phosphate binders.
English: 2 Hyperkalaemia includes preferred terms of hyperkalaemia and blood potassium increased.
Maltese: 2 Iperkalimja tinkludi termini ppreferuti ta' iperkalimja u żieda fil-potassju fid-demm.
English: The expected pharmacological effect of decreased PTH and calcium in blood were observed in animal studies at clinical exposure levels.
Maltese: L-effett farmakoloġiku mistenni ta' PTH u kalċju imnaqqsa fid-demm kien osservat fi studji flannimali f'livelli ta' esponiment kliniku.
English: Worsening heart failure1 QT prolongation1
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: In the event that clinically meaningful decreases in corrected serum calcium levels below the lower limit of the normal range occur and/or symptoms of hypocalcaemia occur, the following management is recommended:
Maltese: F'każ li jseħħ tnaqqis klinikament sinifikanti fil-livelli ta' kalċju ikkoreġut fis-serum taħt il-limitu lbaxx tal-firxa normali u/jew isseħħu sintomi ta' ipokalċimija, huwa rakkomandat l-immaniġġjar li ġej:
English: If formation of anti-etelcalcetide antibodies with a clinically significant effect is suspected, contact the Marketing Authorisation Holder to discuss antibody testing.
Maltese: Jekk ikun hemm suspett ta' formazzjoni ta' antikorpi kontra etelcalcetide b'effett klinikament sinifikanti, ikkuntattja lid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq biex tiddiskuti l-ittestjar għall-antikorpi.
English: At the end of 52 weeks, Parsabiv was not associated with any new safety findings and demonstrated maintenance of treatment effect as evidenced by a decrease in pre-dialysis PTH by > 30% from baseline in 2/3rd of patients.
Maltese: Fi tmiem 52 ġimgħa, Parsabiv ma kien assoċjat mal-ebda sejbiet ġodda ta' sigurtà u wera manteniment tal-effett tat-trattament kif muri minn tnaqqis fil-PTH ta' qabel id-dijalisi b'> 30% mil-linja bażi f'2/3 tal-pazjenti.
English: Results from a study which evaluated changes in corrected serum calcium levels when switching patients from cinacalcet to Parsabiv showed that treatment with Parsabiv, at a starting dose of 5 mg, could be safely initiated after a 7-day discontinuation of cinacalcet, provided that the corrected serum calcium was ≥ 8.3 mg/dL (2.08 mmol/L).
Maltese: Riżultati minn studju li evalwa bidliet fil-livelli ta' kalċju ikkoreġut fis-serum meta l-pazjenti qalbu minn cinacalcet għal Parsabiv urew li trattament b'Parsabiv, b'doża tal-bidu ta' 5 mg, ikun jista' jinbeda mingħajr periklu wara waqfien ta' 7 ijiem ta' cinacalcet, sakemm il-kalċju ikkoreġut fis-serum ikun ≥ 8.3 mg/dL (2.08 mmol/L).
English: If the patient's last administered dose was 2.5 mg, Parsabiv may be reinitiated at the 2.5 mg dose level if PTH is > 300 pg/mL (31.8 pmol/L), and the most recent pre-dialysis serum cCa ≥ 8.3 mg/dL (2.08 mmol/L).
Maltese: Jekk l-aħħar doża li ngħatat lillpazjent kienet ta' 2.5 mg, Parsabiv jista' jerġa' jinbeda mill-ġdid fil-livell tad-doża ta' 2.5 mg jekk PTH ikun >300 pg/mL (31.8 pmol/L), u l-aktar cCa fis-serum qabel id-dijalisi reċenti ikun ≥ 8.3 mg/dL (2.08 mmol/L).
English: Common: may affect up to 1 in 10 people
Maltese: Insuffiċjenza tal-qalb taggrava1 Titwil ta' QT1
English: Patients with lower screening PTH levels were more likely to reach PTH ≤ 300 pg/mL during EAP.
Maltese: Pazjenti b'livelli baxxi ta' PTH waqt l-eżaminazzjoni kienu aktar probabbli li jilħqu PTH ta' ≤ 300 pg/mL waqt EAP.
English: • Muscle spasms
Maltese: • Uġigħ fil-muskoli
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji fuq lannimali ma jurux effetti ħżiena diretti jew indiretti rigward il-fertilità (ara sezzjoni 5.3).
English: Active-controlled study
Maltese: Studju ikkontrollat b'sustanza attiva
English: Parsabiv contains the active substance etelcalcetide, which reduces parathyroid hormone known as PTH.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Maltese: Rakkomandazzjonijiet addizzjonali relatati mal-immaniġġjar ta' kalċju baxx huma pprovduti fittabella hawn taħt.
English: Phosphate
Maltese: FARMAĊEWTIKU
English: Each vial contains 2 mL solution for injection.
Maltese: Kull kunjett fih 2 mL ta' soluzzjoni għall-injezzjoni.
English: There was no effect on male or female fertility when etelcalcetide was administered to rats at exposure levels up to 1.8-fold higher than clinical exposures levels achieved in patients receiving etelcalcetide at 15 mg three times per week.
Maltese: Ma kien hemm l-ebda effett fuq il-fertilità maskili jew femminili meta etelcalcetide ingħata lill-firien f'livelli ta' esponiment sa 1.8 darbiet ogħla mill-livelli ta' esponiment kliniku miksuba f'pazjenti li kienu qed jirċievu etelcalcetide b'doża ta' 15 mg tliet darbiet fil-ġimgħa.
English: Since etelcalcetide lowers serum calcium, patients should be advised to seek medical attention if they experience symptoms of hypocalcaemia and should be monitored for the occurrence of hypocalcaemia (see section 4.2).
Maltese: Tnaqqis fil-kalċju fis-serum assoċjat ma' rogħda, konvulżjonijiet u sejbiet relatati mal-istress kienu osservati f'livelli ta' esponiment kliniku.
English: If clinically meaningful decreases in corrected serum calcium levels occur, steps should be taken to increase serum calcium levels (see section 4.2).
Maltese: Jekk iseħħu tnaqqis klinikament sinifikanti fil-livelli ta' kalċju ikkoreġut fis-serum, għandhom jittieħdu passi biex jiżdiedu l-livelli ta' kalċju fis-serum (ara sezzjoni 4.2).
English: Member State (EU/EEA)
Maltese: Stat Membru (EU/EEA)
English: 050552 Bucharest Romania
Maltese: 050552 Bucharest
English: PRECARGADA PARA SOLUCIÓN INYECTABLE
Maltese: PRECARGADA PARA SOLUCIÓN
English: 80339 München Germany
Maltese: 80339 München
English: 69181 Leimen Germany
Maltese: 69181 Leimen
English: *PFU: plaque forming units
Maltese: *PFU: Unità li tifforma plakka
English: GlaxoSmithKline AS Forskningsveien 2a Postboks 180 Vinderen 0319 Oslo
Maltese: In-Norveġja GlaxoSmithKline AS Forskningsveien 2a Postboks 180 Vinderen 0319 Oslo
English: GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
Maltese: Ir-Rumanija GLAXOSMITHKLINE (GSK) SRL - ROMANIA Costache Negri Street, No. 1-5
English: Slovak Republic Merck Sharp & Dohme B.V Waarderweg 39
Maltese: Is-Slovakkja Merck Sharp & Dohme B.V Waarderweg 39
English: United Kingdom Sanofi Pasteur MSD Limited Mallards Reach
Maltese: Ir-Renju Unit Sanofi Pasteur MSD Limited Mallards Reach
English: Sanofi Pasteur MSD GmbH Paul-Ehrlich-Str. 1
Maltese: Il-Ġermanja Sanofi Pasteur MSD GmbH Paul-Ehrlich-Str.
English: Priorix-Tetra injectieflacon/amp ul, poeder en oplosmiddel voor oplossing voor injectie
Maltese: Priorix-Tetra injectieflacon/ampul, poeder en oplosmiddel voor oplossing voor injectie
English: GlaxoSmithKline Latvia SIA
Maltese: GlaxoSmithKline Latvia
English: VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN INYECTABLE
Maltese: VARIVAX POLVO Y DISOLVENTE PARA SUSPENSIÓN
English: Mumps virus Jeryl Lynn strain (live, attenuated) - 5 x 10
Maltese: Virus tal-Gattone tar-razza Jeryl Lynn (ħaj, attenwat) - 5 x 10
English: GlaxoSmithKline (Cyprus) Ltd 12-14 Kennedy Avenue Kennedy Business Centre
Maltese: GlaxoSmithKline (Cyprus) Ltd 12-14
English: Bruņinieku iela 5 Rīga LV-1001
Maltese: Bruņinieku iela 5
English: MSD Polska Sp. z o.o.
Maltese: MSD Polska Sp. z o.o. Chlodna st., 51
English: Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon
Maltese: Merck Sharp & Dohme Ltd.
English: Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer
Maltese: Durchstechflaschen und Lösungsmittel in Fertigspritzen zur Herstellung einer Injektionslösung
English: LT-08124 Vilnius Lithuania
Maltese: LT-08124
English: Varivax one dose (0.5 ml) contains: varicella virus (zoster vivo) - 1350 PFU*
Maltese: Varivax doża waħda (0.5 ml) fiha: Virus tal-variċella (zoster vivo) - 1350 PFU*
English: GlaxoSmithKline GmbH & Co. KG
Maltese: Il-Ġermanja GlaxoSmithKline GmbH & Co.
English: one dose (0.5 ml) contains: Mumps virus (Strain Jeryl Lynn - B level) - not less than 20 x 10 TCID50
Maltese: doża waħda (0.5 ml) fiha: Virus tal-Gattone (Razza Jeryl Lynnlivell B) - mhux inqas minn 20 x 10 TCID50
English: Rudixax one dose (0.5 ml) contains: live, attenuated rubella virus (strain Wistar RA 27/3) - at least 10
Maltese: Rudixax doża waħda (0.5 ml) fiha: virus tar-rubella ħaj, attenwat (razza Wistar RA 27/3) - mill-inqas 10
English: PRIORIX TETRA one dose (0.5 ml) contains:
Maltese: PRIORIX TETRA doża waħda (0.5 ml) fiha:
English: RUBEATEN BERNA Rubella virus live (Strain Wistar RA 27/3) - not less than 10
Maltese: RUBEATEN BERNA Virus tar-rubella ħaj (Razza Wistar RA 27/3) - mhux inqas minn 10
English: Live attenuated varicella-zoster virus (Oka strain) 103.3 PFU*
Maltese: Virus tal-variċella-zoster ħaj attenwat (razza Oka) - mhux inqas minn 103.3 PFU*
English: Rubella virus Wistar RA 27/3 strain (live, attenuated) - 10
Maltese: Virus tar-rubella tar-razza Wistar RA 27/3 (ħaj, attenwat) - 10
English: Austria
Maltese: Vienna Austria
English: Albert-Schweitzer-Gasse 6 AT-1140 Vienna Austria
Maltese: Albert-Schweitzer-Gasse 6
English: The Netherlands GlaxoSmithKline B.V Huis ter Heideweg 62
Maltese: GlaxoSmithKline B.V Huis ter Heideweg 62 3705 LZ ZEIST The Netherlands
English: United Kingdom SmithKline Beecham plc 980 Great West Road
Maltese: Ir-Renju Unit SmithKline Beecham plc 980
English: Priorix-Tetra one dose (0.5 ml) contains dose:
Maltese: PRIORIX-TETRA doża waħda (0.5 ml) fiha:
English: Priorix-Tetrapowder and solvent for solution for injection in a pre-filled syringe
Maltese: Priorix-Tetrapowder and solvent for solution for injection in a prefilled syringe
English: Mumps virus URABE AM-9 strain (live, attenuated) not less than 5 x 10
Maltese: Virus tal-Gattone tar-razza URABE AM-9 (ħaj, attenwat) - mhux inqas minn 5 x
English: R.O.R., poudre et solvant pour solution injectable.
Maltese: R.O.R. VAX, poudre et solvant pour suspension injectable.
English: Lõõtsa 2
Maltese: Bordetlaan 13
English: GlaxoSmithKline Pharma A/S Nykær 68
Maltese: Id-Danimarka GlaxoSmithKline Pharma A/S
English: Priorix-Tetra powder and solvent for solution for injection in prefilled syringe
Maltese: Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe
English: one dose (0.5 ml) contains: not less than 103.0 CCID50 of the measles virus Enders-Edmonston strain not less than 5 x 103.0 CCID50 of the mumps virus (Jeryl Lynn strain) not less than 103.0 CCID50 of the rubella virus strain
Maltese: f'kull doża ta' 0.5 ml: mhux inqas minn 103.0 CCID50 tal-virus tal ħosba tar-razza Enders-Edmonston, mhux inqas minn 12500 CCID50 tal-virus tal-gattone
English: 3705 LZ ZEIST
Maltese: Huis ter Heideweg 62 3705 LZ ZEIST The Netherlands
English: CCID50 of the measles virus Enders-Edmonston strain, not less than 12500 CCID50 of the mumps virus (Jeryl Lynn strain); and not less than 10 CCID50of the Wistar RA 27/3 rubella virus strains
Maltese: mhux inqas minn 12500 CCID50 tal-virus tal gattone (razza Jeryl Lynn); mhux inqas minn 103.0CCID50 tar-razza tal virus tar-rubella
English: Live attenuated mumps virus (RIT 4385, derived from Jeryl Lynn strain) - not less than 104.4 CCID50
Maltese: CCID50 Virus tal-gattone ħaj attenwat (RIT 4385, derivat mir-razza Jeryl Lynn) - mhux inqas minn 104.4 CCID50
English: Subcutaneous use , Intramascular use
Maltese: Użu għal taħt il-ġilda Intramascular use
English: Live atenuated varicella virus (Strain OKA/Merk) - ≥1350 PFU*
Maltese: Virus tal-variċella ħaj attenwat (Razza OKA/Merk) - ≥1350 PFU*
English: Live attenuated rubella virus (Wistar RA 27/3 strain) - not less than 103.0 CCID50
Maltese: Virus tar-rubella ħaj attenwat (razza Wistar RA 27/3)- mhux inqas minn 103.0
English: Varicella virus, live attenuated, Oka/Merck strain ≥ 1350 PFU*
Maltese: Virus tal-variċella, ħaj attenwat, razza Oka/Merck ≥ 1350 PFU*
English: Priorix-Tetra lag one dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain) - not less than 10
Maltese: PRIORIX-TETRA doża waħda (0.5 ml) fiha: Virus tal-ħosba ħaj attenwat (razza Schwarz) - mhux inqas minn 103.0
English: Slovak Republic GlaxoSmithKline Biologicals S.A.
Maltese: Is-Slovakkja GlaxoSmithKline Biologicals S.A.
English: Live attenuated varicella-zoster virus (Oka strain) - not less than 10
Maltese: Virus tal-variċella-zoster ħaj attenwat (razza Oka) 10
English: Luxembourg Sanofi Pasteur MSD Avenue Jules Bordetlaan 13
Maltese: In-Norveġja Sanofi Pasteur MSD Avenue Jules
English: VARIVAX Powder for Suspension one dose (0.5 ml) contains: Varicella Virus OKA/Merck Strain1350 PFU*
Maltese: doża waħda (0.5 ml) fiha: Virus tal-variċella razza Oka/Merck 1350 PFU*
English: Luxembourg GlaxoSmithKline Biologicals S.A.
Maltese: Il-Lussemburgu GlaxoSmithKline Biologicals S.A.
English: Varivax one dose (0.5 ml) contains: not less than 1350 PFU* of the live attenuated varicella virus (OKA.Merck strain)
Maltese: Varivax doża waħda (0,5 ml) fiha: mhux inqas minn 1350 PFU* tal-virus talvariċella ħaj attenwat (razza OKA.Merck)
English: Varicella virus, strain Oka/Merck live attenuated - 1350 PFU*
Maltese: Virus tal-variċella, razza Oka/Merck ħaj attenwat - 1350 PFU*
English: Varicella, live attenuated (Oka/Merck strain) - 1350 PFU*
Maltese: Variċella, ħaj attenwat(razza Oka/Merck)1350 PFU*
English: Varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Maltese: Tilqim tal-variċella (ħaj) li għandu Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru (EU/EEA)
English: Strength
Maltese: SIA
English: Varicella virus (Oka/Merck): not less than 1350 PFU*
Maltese: Virus tal-variċella (Oka/Merck): mhux inqas minn 1350 PFU*
English: one dose (0.5 ml) contains: Rubella virus live attenuated (Strain Wistar RA 27/3M) - not less than 10 TCID50
Maltese: Virus tar-rubella ħaj attenwat (Razza Wistar RA 27/3M) - mhux inqas minn 10 TCID50
English: Varicella virus strain Oka/Merck (live, attenuated) ≥1350 PFU*
Maltese: Virus tal-variċella razza Oka/Merck (ħaj, attenwat) ≥ 1350 PFU*
English: Measles, mumps and rubella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Maltese: Tilqim tal-ħosba, tal-gattone u tar-rubella (ħaj) li għandu Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru (EU/EEA)
English: Belgium GlaxoSmithKline Biologicals S.A.
Maltese: Il-Finlandja GlaxoSmithKline Biologicals S.A.
English: vaccin à virus vivants atténués contre la rougeole, les oreillons et la rubéole
Maltese: R.O.R., poudre et solvant pour solution injectable. vaccin à virus vivants atténués contre la rougeole, les oreillons et la rubéole
English: Measles vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Maltese: Tilqim tal-ħosba (ħaj) li għandu Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru (EU/EEA)
English: Measles, mumps, rubella and varicella vaccines (live) with Marketing Authorisation in the European Union Member State (EU/EEA)
Maltese: Tilqim tal-ħosba, tal-gattone, tar-rubella u tal-variċella (ħaj) li għandu Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Unjoni Ewropea Stat Membru (EU/EEA)
English: Live attenuated varicella virus (Oka strain)not less than 103.3 PFU*
Maltese: Virus tal-variċella ħaj attenwat (razza Oka)mhux inqas minn 103.3 PFU*