FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Maltese: Għalhekk, jekk ikun hemm sinjali ta' stimulazzjoni eċċessiva tal-ovarji bħal pereżempju livell ta' oestradiol fis-serum > 5,500 pg/mL jew > 20,200 pg/mL u/jew ≥ 40 follikolu b'kollox, hu rakkomandat li jitwaqqaf hCG u lil-pazjenti jingħataw parir biex jkollhomx x'jaqsmu mas-sieħeb tagħhom jew jużaw metodi kontraċettivi barrier għal mill-inqas erbat ijiem. OHSS tista' tiggrava malajr (f' 24 siegħa) jew fuq diversi ġranet biex issir avveniment mediku serju.
English: • fibroid tumours of the uterus incompatible with pregnancy;
Maltese: • fibrojdi tal-utru li jkunu inkompatibbli mat-tqala;
English: • The usual starting dose of this medicine is 150 to 225 IU each day, from day 2 or 3 of your menstrual cycle.
Maltese: • Id-doża tal-bidu normali ta' din il-mediċina hi ta' 150 sa 225
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 900 IU/1.5 mL solution for injection follitropin alfa
Maltese: IU/1.5 mL injezzjoni follitropin alfa
English: This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Maltese: Dan jista' jindika li l-ovarji kellhom reazzjoni żejda għall-kura u li żviluppaw ċisti ovarji kbar [ara wkoll sezzjoni 2 taħt “Sindrome ta' Iperstimulazzjoni tal-Ovarji (OHSS)”].
English: Ovaleap 300 IU/0.5 mL solution for injection
Maltese: Ovaleap 300 IU/0.5 mL: Kull skartoċċ fih 300
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and number of fertilised eggs or embryos placed inside you.
Maltese: Meta tkun qiegħda tagħmel użu mit-teknoloġija ta' riproduzzjoni assistita, ir-riskju ta' tqala multipla jkun relatat mal-età tiegħek, ilkwalità u l-għadd ta' bajd fertilizzat jew embrijuni mpoġġija ġo fik.
English: Ovaleap contains 10.0 mg per mL benzyl alcohol
Maltese: mg ta' benzyl alcohol f'kull mL
English: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
Maltese: Reazzjonijiet fis-sit talinjezzjoni (eż. uġigħ, eritema, ematoma, nefħa u/jew irritazzjoni fis-sit talinjezzjoni)
English: Package size
Maltese: 7 pilloli
English: EU Number
Maltese: 14-il pillola
English: ATCvet code: QP51AX08.
Maltese: QP51AX08.
English: United Kingdom Virbac Ltd,
Maltese: Virbac Ltd,
English: Medicines Agency http://www.ema.europa.eu/.
Maltese: Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: MARKETING AUTHORISATION NUMBERS EU/2/18/234/001-006
Maltese: EU/2/18/234/001-006
English: Tartrazine (E 102)
Maltese: Tartariżin (E 102)
English: Halofuginone Halofuginone Bovine 10 μg/kg
Maltese: Ħalofuġinon Bovina 10 μg/kg
English: Benzoic acid (E 210) Lactic acid (E 270) Tartrazine (E 102) Water, Purified
Maltese: Aċidu benżojku (E 210) Aċidu lattiku (E 270) Tartrażin (E 102)
English: Contraindications
Maltese: KONTRAINDIKAZZJONIJIET
English: The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5 μg/ml, respectively.
Maltese: Il-konċentrazzjoni sabiex tinpedixxi 50% u 90% tal-parassiti f'testijiet li saru in vitro huwa ta' IC50 < 0.1 μg/ml u IC90 ta' 4.5 μg/ml, rispettivament.
English: België/Belgique/Belgien VIRBAC BELGIUM NV Esperantolaan 4
Maltese: VIRBAC BELGIUM NV Esperantolaan 4
English: The active substance in Kriptazen is an allowed substance as described in Table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'Kriptazen hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: 4 to 12 ml pump
Maltese: Pompa ta' 4 sa 12-il ml
English: Benzoic acid (E 210)
Maltese: Aċidu benżoiku (E 210)
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Maltese: Is-sustanza attiva, ħalofuġinon, hija aġent anti-protożoiku li ġej mill-grupp tal-quinazolinon (ċikli polieteri nitroġenużi).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: ES-08950 Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40
Maltese: Esplugues de Llobregat (Barcelona) Tel. : + 34-(0)93 470 79 40
English: Pu l awska 314 PL-02 819 Warszawa Tel.: + 48 22 855 40 46
Maltese: PL-02 819 Warszawa Tel.: + 48 22 855 40 46
English: Incompatibilities
Maltese: Inkompatibilitajiet:
English: 4 ml pump
Maltese: Pompa ta' 4 ml
English: Once broached, use by …
Maltese: Ladarba jittaqqab, uża fi żmien …
English: Suomi/Finland VIRBAC
Maltese: Suomi/Finland
English: AT-1180 Wien Tel: +43-(0)1 21 834 260
Maltese: Wien Tel: +43-(0)1 21 834 260
English: PSUR submission for Kriptazen shall be synchronised and submitted at the same frequency as for the reference product, Halocur.
Maltese: Is-sottomissjonijiet ta' PSUR għal Kriptazen għandhom jiġu sinkronizzati u sottomessi bl-istess frekwenza bħal tal-prodott ta' referenza, Halocur.
English: Magyarország VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл: +36703387177
Maltese: VIRBAC HUNGARY KFT Szent Istvàn krt.11.II/21., HU-1055 Budapest Teл:
English: The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals treated displaying adverse reactions) - Common (more than 1 but less than 10 animals in 100 animals treated) - Uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - Rare (more than 1 but less than 10 animals in 10,000 animals treated) - Very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal itrattati) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal itrattati) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal itrattati)
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Maltese: L-għola konċentrazzjoni fil-plażma (Cmax ) hija ta' 4 ng/ml.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone
Maltese: VETERINARJU Kriptazen 0.5 mg/ml soluzzjoni orali għal għoġġiela halofuginone
English: Major Incompatibilities
Maltese: .2 Inkompatibilitajiet maġġuri
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Maltese: Sintomi ta' tossiċità jinkludu dijareja, demm fil-ħmieġ, tnaqqis fl-aptit, deidratazzjoni, telqa u għejja.
English: Pull two or three times, respectively, for administration of the desired volume (8 ml for calves weighing more than 35 kg but less than or equal to 45 kg and 12 ml for calves weighing more than 45 kg but less than or equal to 60 kg, respectively).
Maltese: Iġbed darbtejn jew tlieta, rispettivament, għall-amministrazzjoni tal-volum mixtieq (8 ml għallgħoġġiela ta' 35 - 45 kg u 12 ml għall-għoġġiela ta' 45 - 60 kg, rispettivament).
English: The dosage is: 100 μg of halofuginone / kg bw, once a day for 7 consecutive days; i.e. 2 ml of Kriptazen / 10 kg bw, once a day for 7 consecutive days.
Maltese: Id-doża hija ta': 100 μg ta' ħalofuġinon / kg piż tal-ġisem, darba kuljum għal sebat ijiem konsekuttivi, i.e. 2 ml ta' Kriptazen / 10 kg piż tal-ġisem, darba kuljum għal sebat ijiem konsekuttivi.
English: PHARMACEUTICAL FORM Oral solution.
Maltese: Soluzzjoni orali.
English: 13o χλμ Ε.Ο.
Maltese: Laħam u ġewwieni tal-annimali: 13-il ġurnata.
English: Liver Kidney
Maltese: Fwied Kliewi
English: Boxes with a metering pump:
Maltese: Flixkun mingħajr pompa:
English: The bioavailability of the drug in the calf following single oral administration is about 80%.
Maltese: Il- bijodisponibbilità tal-mediċina wara doża waħda orali fl-għoġġiela hija ta' madwar 80%.
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Maltese: Il-ħin sabiex nofs il-prodott ikun eliminat huwa ta' 11.7 siegħat meta jingħata fil-vina u ta' 30.84 siegħat meta jingħata f'doża waħda orali.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Maltese: Lattat ħalofuġinon huwa melħ li l-kwalitajiet u effikaċja anti-protożoiċi tiegħu fuq Cryptosporidium parvum ġew iddimostrati kemm in vitro, kif ukoll f'infezzjonijiet artifiċjali u naturali.
English: Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.
Maltese: 13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520
English: Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Maltese: Aġenti anti-protożoiċi oħrajn, ħalofuġinon.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: NUMRI TAL-AWTORIZZAZZJONI(JIET) GĦAT-TQEGĦID FIS-SUQ
English: VIRBAC Sp. z o.o.
Maltese: VIRBAC Sp. z o.o. ul. Pu l awska 314
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains:
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Sustanza attiva:
English: For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution.
Maltese: Għall-kura ta' għoġġiela anoressiċi, il-prodott għandu jingħata f'nofs litru soluzzjoni ta' elettrolit.
English: Marker residue Animal species MRLs
Maltese: DIKJARAZZJONI TAL-MRLs
English: In new born calves: - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of cryptosporidiosis.
Maltese: - Prevenzjoni kontra dijareja kkawżata minn Cryptosoridium pavarum dijanjostikat, f'irziezet li għandhom storja ta' kriptosporidjosi.
English: Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jkunu fis-suq.
English: 3) Remove the protector cap from the tip of the nozzle of the pump.
Maltese: 2) Neħħi t-tapp tal-flixkun u ssikka l-pompa.
English: Carton with bottle and dosing device
Maltese: Kartuna bil-flixkun u strument tad-dożaġġ
English: Unchanged halofuginone is the major component in the tissues.
Maltese: Ħalofuġinon mhux modifikat, huwa l-akbar komponent fit-tessuti.
English: It is mainly active on the free stages of the parasite (sporozoïte, merozoïte).
Maltese: Huwa l-aktar attiv fl-istadji liberi tal-parassita (sporożojte, merożojte).
English: Pharmacodynamic properties
Maltese: 5.1 Kwalitajiet farmakodinamiċi
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Maltese: Il-konċentrazzjoni ta' ħalofuġinon fil-plażma wara doża amministrata ripetutament b'mod orali hija simili għall-profil farmokinetiku ta' doża waħda.
English: Each package also contains a plastic metering pump delivering 4 ml volumes and two dip tubes (one to fit a 500 ml bottle and one to fit a 1000 ml bottle).
Maltese: Kull pakkett fih ukoll pompa tal-kejl tal-plastik li tagħti volumi ta' 4 ml u żewġ tubi biex tbill (wieħed biex jitwaħħal ma' flixkun ta' 500 ml u wieħed biex jitwaħħal ma' flixkun ta' 1,000 ml).
English: Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate.
Maltese: soluzzjoni jew flixkun wieħed ta' 1,000 ml li fih 980 ml tas-soluzzjoni, ssiġillat b' tapp tal-polietilin ta' densità għolja, flimkien ma' jew mingħajr pompa tal-kejl, b'tubu biex tbill magħmul minn aċetat ta' vinil-etilene.
English: Antiparasitic agents/ Agents acting against protozoa
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: Nru 37/2010 jew huma ikkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: 1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml bottle) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on.
Maltese: 1) Agħżel it-tubu ddisinjat għat-tul tal-flixkun (l-iqsar wieħed għall-flixkun ta' 490 ml u l-itwal wieħed għal 980 ml) u daħħlu fit-toqba miftuħa li tinsab fil-bażi tal-għatu tal-pompa.
English: Halofuginone (as lactate salt)
Maltese: Frat (għoġġiela tat-twelid):
English: The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
Maltese: L-għola livelli tal-prodott instabu fil-fwied u l-kliewi.
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains:
Maltese: Sustanzi mhux attivi:
English: Package with a metering pump:
Maltese: Flixkun b'pompa:
English: PACKAGE LEAFLET: Kriptazen 0.5 mg/ml oral solution for calves NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC 1ère avenue - 2065 m - LID 06516 Carros France
Maltese: Kull pakkett fih ukoll pompa tal-kejl tal-plastik li tagħti volumi ta' 4 sa 12-il ml u żewġ tubi biex tbill (wieħed biex jitwaħħal ma' flixkun ta' 500 ml u wieħed biex jitwaħħal ma' flixkun ta' 1,000 ml).
English: (as lactate salt) Excipients:
Maltese: Data tal-ewwel awtorizzazzjoni:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves.
Maltese: Kriptazen 0.5 mg/ml soluzzjoni orali għal għoġġiela.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: 6.1 Lista ta' ingredjenti
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
Maltese: Isem u indirizz tal-manifattur<i> responsabbli mill-ħruġ tal-lott VIRBAC
English: Cardboard box with a 500 ml bottle containing 490 ml or a 1000 ml bottle containing 980 ml, with or without a dosing pump.
Maltese: Kaxxa tal-kartun bi flixkun ta' 500 ml li fih 490 ml jew flixkun ta' 1,000 ml li fih 980 ml, flimkien jew mingħajr pompa tad-dożaġġ.
English: Specific pharmacovigilance requirements:
Maltese: Rekwiżiti speċifiċi ta' farmakoviġilanza:
English: 5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Maltese: Iġbed il-grillu tal-pompa tal-kejl kompletament għal rilaxx tad-doża li tkun daqs 4 ml ta' soluzzjoni.
English: Content (concentration)
Maltese: Kontenut (Konċentrat)
English: EU/1/15/1024/001 Keytruda 50 mg Powder for concentrate for solution for infusion
Maltese: EU/1/15/1024/001 Keytruda 50 mg Trab għall-konċentrat għal soluzzjoni għallinfużjoni kunjett (ħġieġ)
English: 101 International Drive Portsmouth, New Hampshire
Maltese: Portsmouth, New Hampshire
English: nivolumab (n = 135)
Maltese: (n = 135)
English: Appendix V.
Maltese: Appendiċi V.
English: Systemic immunosuppression
Maltese: Immunosuppressjoni sistemika
English: 31st March 2017
Maltese: 31 ta' Marzu 2017
English: Ελλάδα
Maltese: FEJN MA
English: The incidence of adrenal insufficiency was 0.4% (1/248; Grade 3).
Maltese: L-inċidenza ta' insuffiċjenza adrenali kienet ta' 0.4% (1/248; Grad 3).
English: Excipients: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, water for injections.
Maltese: Eċċipjenti: sodium citrate dihydrate, sodium chloride, mannitol (E421), pentetic acid, polysorbate 80, sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet.
English: docetaxel (n = 137)
Maltese: (n = 137)
English: Pack size of 1 vial.
Maltese: Daqs tal-pakkett ta' 1 kunjett.
English: Randomised phase 3 study vs. docetaxel (CA209017)
Maltese: Studju ta' fażi 3 randomizzat vs. docetaxel (CA209017)
English: September 2015
Maltese: 30 ta' Settembru 2015
English: Overall survival Events
Maltese: Sopravivenza totali Avvenimenti
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Maltese: Luxembourg/Luxemburg Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: Be aware of important symptoms of inflammation.
Maltese: Oqgħod attent għal sintomi importanti ta' infjammazzjoni.
English: Polyolefin containers
Maltese: Kontenituri tal-polyolefin
English: Severity
Maltese: Severità
English: Nivolumab showed numerically less effect on OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05 ) and ORR (9.1% vs 16.7%).
Maltese: Nivolumab wera, numerikament, effett inqas fuq l-OS (HR 1.85; 95% CI: 0.76, 4.51), PFS (HR=1.76; 95%-CI: 0.77, 4.05) u l-ORR (9.1% vs 16.7%).
English: Use a separate infusion line for the infusion.
Maltese: Uża linja ta' infużjoni separata għall-infużjoni.
English: Permanently discontinue Nivolumab BMS Note: Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4).
Maltese: Nota: Il-gradi tat-tossiċità huma konformi man-National Cancer Institute Common Terminology Criteria for Adverse Events [Kriterji tat-Terminoloġija Komuni tal-Istitut Nazzjonali tal-Kanċer] Verżjoni 4.0 (NCI-CTCAE
English: In CA209017 and CA209063, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 13.2% for decreased lymphocytes, 9% for hyponatraemia, 2.9% for hypercalcaemia and hyperkalaemia, 2.5% for decreased haemoglobin (all Grade 3), 2.0% for hypokalaemia, 1.6% for decreased neutrophil count, 1.3% for hypomagnesaemia, 1.2% for hypocalcaemia, 0.8% for increased total bilirubin, and 0.4% for increased AST, decreased platelet, hypermagnesaemia, and hypernatraemia.
Maltese: F'CA209017 u CA209063, is-sehem ta' pazjenti li esperjenzaw bidla mil-linja bażi għal anormalità tal-laboratorju ta' Grad 3 jew 4 kien kif ġej: 13.2% għal tnaqqis fil-limfoċiti, 9% għal iponatremja, 2.9% għal iperkalċemja u iperkalimja, 2.5% għal tnaqqis fl-emoglobina (Grad 3 kollha), 2.0% għal ipokalimja, 1.6% għal tnaqqis fl-għadd ta' newtrofili, 1.3% għal ipomagnesimja, 1.2% għal ipokalċimija, 0.8% għal żieda fil-bilirubin totali, u 0.4% għal żieda fl-AST, tnaqqis fil-plejtlets, ipermagnesimja, u ipernatremja.
English: Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2.
Maltese: Ir-reazzjonijiet avversi rrapportati fis-sett ta' dejta kondiviż (n=248) ta' CA209017 u CA209063 huma ppreżentati fit-Tabella 2.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Maltese: Nivolumab huwa antikorp monoklonali tal-immunoglobulina umana G4 (IgG4) (HuMAb) li jeħel ma' riċettur ta' mewt ipprogrammata-1 (PD-1) u jimblokka l-interazzjoni tiegħu ma' PD-L1 u PD-L2.
English: Frequencies are defined as: 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).
Maltese: Il-frekwenzi huma ddefiniti bħala: 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).
English: Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group).
Maltese: L-istudju CA209017 inkluda numru limitat ta' pazjenti ≥ 75 sena (11 fil-grupp ta' nivolumab u 18 filgrupp ta' docetaxel).
English: Probability of Survival
Maltese: Probabbiltà ta' Sopravivenza
English: The metabolic pathway of nivolumab has not been characterised.
Maltese: Il-passaġġ metaboliku ta' nivolumab ma ġiex ikkaratterizzat.
English: Immune-related rash
Maltese: Raxx relatat mal-immunità
English: In study CA209017, hypercalcaemia was more frequently reported in the nivolumab group (31/130, 24%) than in the docetaxel group (9/124, 7%).
Maltese: Fi studju CA209017, iperkalċemja ġiet irrapportata b'mod aktar frekwenti fil-grupp ta' nivolumab (31/130, 24%) milli fil-grupp ta' docetaxel (9/124, 7%).
English: Permanently discontinue Nivolumab BMS
Maltese: Waqqaf Nivolumab BMS b'mod permanenti
English: In the phase 1 study MDX1106-03, pneumonitis, including a Grade 4 case in 1 patient, was reported in 3/37 patients (8.1%) with NSCLC receiving nivolumab 3 mg/kg.
Maltese: Fi studju ta' fażi 1 MDX1106-03, pulmonite, inkluż każ wieħed ta' Grad 4, ġew irrapportati fi 3/37 pazjent (8.1%) b'NSCLC li ngħataw nivolumab 3 mg/kg.
English: The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg.
Maltese: Il-farmakokinetika (PK) ta' nivolumab hija lineari fil-medda tad-doża ta' 0.1 sa 10 mg/kg.
English: Tel: + 386 1 236 47 00
Maltese: s r.o. Tel: + 386 1 236 47 00
English: The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses.
Maltese: Ir-riċettur PD-1 huwa regolatur negattiv tal-attività taċ-ċelloli-T li ntwera li huwa involut fil-kontroll tar-risponsi immuni taċ-ċelloli-T.
English: The PFS was measured by RECIST version 1.1.
Maltese: Il-PFS tkejjel b'RECIST verżjoni 1.1.
English: Nivolumab 3 mg/kg showed an overall response rate of 14.5% (95% CI: 8.7-22.2%), a median OS of 8.21 months (95% CI: 6.05-10.9 months ), and a median PFS of 1.87 months (95% CI 1.77-3.15 months.
Maltese: Nivolumab 3 mg/kg wera rata ta' rispons ġenerali ta' 14.5% (95% CI: 8.7-22.2%), OS medjan ta' 8.21 xhur (95% CI: 6.0510.9 xhur), u PFS medjana ta' 1.87 xhur (95% CI 1.77-3.15 xhur.
English: 31st December 2017 30th September 2017
Maltese: 31 ta' Diċembru 2017 30 ta' Settembru 2017
English: Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Maltese: Rakkomandazzjoni għall-użu ta' terapija ta' sostituzzjoni tal-ormoni hi pprovduta f'sezzjoni 4.4.
English: Inflammation of the liver (hepatitis).
Maltese: Infjammazzjoni tal-fwied (epatite).
English: • Relevant information (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) for the following safety concerns:
Maltese: • Informazzjoni relevanti (eż. serjetà, severità, frekwenza, ħin għall-feġġa, riversibilità tal-AE kif applikabbli) għat-tħassib li ġej dwar is-sigurtà:
English: Median time to onset was 10.5 weeks (range: 2.1-27.0).
Maltese: 5 ġimgħat (medda: 2.1-27.0).
English: Nivolumab BMS infusion is compatible with PVC and polyolefin containers, glass bottles, PVC infusion sets and in-line filters with polyethersulfone membranes with pore sizes of 0.2 µm to 1.2 µm.
Maltese: L-infużjoni ta' Nivolumab BMS hija kompatibbli ma' kontenituri tal-PVC u tal-poliolefina, fliexken tal-ħġieġ, settijiet tal-infużjoni tal-PVC u filtri fil-pajp b'riti tal-polyethersulfone b'daqsijiet tal-pori ta' 0.2 μm sa 1.2 μm.
English: The study included patients (18 years or older) who have experienced disease progression during or after one prior platinum doublet-based chemotherapy regimen and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Maltese: L-istudju inkluda pazjenti (li għandhom 18-il sena jew iktar) li kellhom progressjoni talmarda waqt jew wara reġim wieħed preċedenti ta' kimoterapija bbażata fuq platinum doublet u punteġġ ta' stat ta' prestazzjoni ta' Eastern Cooperative Oncology Group (ECOG) ta' 0 jew 1.