FrancophonIA/ELRC3.0 huggingface dataset:
English: Invented name Strength Pharmaceutical Form
Maltese: Isem inventat
English: Intraperitoneal (IP) use
Maltese: Intraperitonjali (IP)
English: Gonazon implant is a solid, off white, 14x3x1 mm implant.
Maltese: Gonazon huwa impjant solidu, off white, 14 x 3 x 1 mm impjant.
English: 3 - 6 years old
Maltese: 3 - 6 snin
English: ADMINISTRATION:
Maltese: AMMINISTRAZZJONI:
English: <Batch> <Lot> {number}
Maltese: <Lot> {numru}
English: Sodium acetate (tri-hydrate)
Maltese: Aċitat tas-sodju (tri-hydrate)
English: Total kg of fish to be injected 50 kg
Maltese: Piż totali ta' ħut li se jiġi injettat 50 kg
English: Pharmaceutical group: gonadotrophin-releasing hormone.
Maltese: Gonadotrophin - releasing hormone.
English: Excipient: Benzyl alcohol
Maltese: Eċċipjenti: Benzyl alcohol
English: Implant
Maltese: Impjant
English: Gonazon for dogs: Intervet GesmbH Siemensstrasse 107 A-1210 Wien Austria
Maltese: Intervet GesmbH Siemensstrasse 107 A-1210
English: The frequency of induced heat is lower when the first treatment is administered in metoestrus (32%) than in anoestrus (84%).
Maltese: Il-frekwenza ta'namra indotta fi metoestrus (32%) hija anqas minn dik anoestrus(84%).
English: The recommended dose is 32 µg/kg body weight.
Maltese: Id-doża rakkomandata hija ta' 32 mikrogrammi /kg ta' piż ħaj.
English: For a full list of excipients, see section 6.1.
Maltese: Għall-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1
English: Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
Maltese: Sodium hydoxide / Aċidu idrokloridu 4N (għall-aġġustament tal-pH)
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Intervet International Wim de Korverstraat 35 5831 AN Boxmeer Olanda.
English: Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH).
Maltese: Azagly - nafarelin huwa prodott sintetiku li huwa simili għall- Gonadotrophin - releasing hormone (GnRH).
English: Sterile container: 50-ml empty
Maltese: Kontenitur sterili vojt ta' 50 ml
English: For a full list of excipients see section 6.1
Maltese: Għal lista sħiħa ta eċċipjenti ara sezzjoni 6.1
English: Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus).
Maltese: Speċi tas- Salamun tas-sess feminili bhas-Salamun Atlantiku( Salmo solar), Troti tal-Qawsalla (Oncorhynchus mykiss), trota kannella (Salmo trutta) u t-trota l-ħamra (Salvelinus alpinus).
English: The risk of inducing a fertile heat is low in metoestrus (5%).
Maltese: Ir-riskju li jiġi ndott saħna fertili huwa baxx f'metoestrus(5%).
English: The elimination half-life (T1/2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/kg BW are 4.9 h and 6.8 h, respectively.
Maltese: Il-ħin taleliminazzjoni (T1/2) u Mean Residenċe Time tal-prodott wara trattament intraperitonjali fis-salamun ta' 32 mikrogramma /kilogramma piż ħaj huma 4.9 siegħat u 6.8 siegħat rispettivament.
English: Sachet
Maltese: KWANTITA
English: Active substance: Azagly-nafarelin 18.5 mg per implant
Maltese: Sustanza attiva : Azagly-nafarelin 18.5 mg kull impjant
English: Active substance(s)
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata fuq dan il-prodott veterinarju tinsab fuq il-website tal- Agenzija Ewropeja talMediċina (EMEA) http://www.emea.europa.eu
English: The product is contraindicated in bitches intended for breeding (adult and prepubertal) as laboratory studies in which dogs received 3 simultaneous implants for a period of 12 months revealed a reduction in the numbers of live pups at whelping and weaning compared to an untreated control group.
Maltese: Dan il-prodott huwa kontra-indikat f'kelbat intezzjonati biex jitgħammru (adulti u qabel l-puberta`) għax studji fil-laboratorju urew li fi klieb li ħadu 3 impjanti f'daqqa fuq perjodu ta' 12-il xahar, kellhom tnaqqis fin- numru ta' ġriewi ħajjin sa zmien il-ftama, meta mqabbla ma grupp ta'kontroll li ma ġiex trattat.
English: Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate.
Maltese: Azagly - nafarelin 1600 mikrogrammi / millilitru bhala azagly-nafarelin acetate.
English: Pharmacotherapeutic group: Gonadotrophin-Releasing Hormone (GnRH) ATCvet code: QH01CA
Maltese: Gonadotrophin-Releasing Hormone (GnRH) Kodici ATĊ veterinarja:
English: Azagly-nafarelin is a peptide that is primarily degraded by peptidases and not by cytochrome P-450 enzymes.
Maltese: Azagly-nafarelin huwa peptide li jiġi prinċipalment degradat minn petidases u mhux mill-enzimi tascytochrome P-450.
English: 5831 AN Boxmeer The Netherlands
Maltese: Wim de Korverstraat 35 5831 AN Boxmmer Olanda
English: Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35
Maltese: Intervet International BV
English: Solvent vial: 100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
Maltese: Kunjett tas- solvent : kunjett ta' 100 ml magħmul minn ħġieġ ċar li fiha 100 ml likwidu, tap tal-lastiku u crimp cap
English: 2 ml concentrate vials
Maltese: Ta' 2 millilitri ta' konċentrat
English: VIAL CONTAINING CONCENTRATE:
Maltese: Kunjett tal-konċentrat:
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompattibilita, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: REMOVAL:
Maltese: Assorbiment:
English: It is recommended to strip fish after injection at intervals of approximately 50-100 degree days.
Maltese: Huwa rakkomandat li wara l-injezzjoni il-ħut jiġi strippjat f'intervall ta' madwar 50 - 100 gradi ġranet.
English: Avoid self injection.
Maltese: Evita li tinjettaħ lilek innifsek.
English: The diluted solution for injection should be used immediately.
Maltese: Effetti fuq mediċinali oħra ma ġiex investigat.
English: These measures should help to protect the environment.
Maltese: B'hekk tkun qed tipproteġi l-ambjent.
English: Absorption: Following subcutaneous administration of a single implant to dogs (approximate weight of 10 kg), maximum serum concentrations (0.13 µg/ml) of azagly-nafarelin are reached around 3.5 hours.
Maltese: Wara amministrazzjoni ta'impjant wieħed taħt il-ġilda tal-klieb (piż ħaj ta'madwar 10kg), il-konċentrazzjoni massima (0.13µg/ml) ta'azagly-nafarelin tiġi milħuqa madwar 3.5 sigħat.
English: Cured elastomer, resulting from the polymerisation of polydimethylsiloxane and tetrapropylorthosilicate in the presence of stannous octoate.
Maltese: Cured elastomer, li huwa riżultat minn polimerizzazzjoni ta' polydimethylsiloxane u tetrapropylorhosilicate fil-preżenza ta' stannous octoate.
English: Dog (bitches).
Maltese: Jiskadi {xahar/sena}
English: Concentrate vial: 3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
Maltese: Kunjett tal-konċentrat : kunjett ta' 3 ml magħmul minn ħġieġ kannella li fih 2 ml ta' soluzzjoni likwida, tapp tal-lastiku u crimp cap.
English: For Arctic charr, injections should be given only if the water temperature is < 8°C.
Maltese: Fil-każ ta' ħut tat-tip Arctic Charr, l-injezzjoni għandha tingħata biss meta t-temperatura ta' l- ilma hija < 8 ċentigradi.
English: For subcutaneous administration.
Maltese: MOD TA' AMMINISTRAZZJONI
English: Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and  90 % of treated prepubertal bitches.
Maltese: Evidenza ibbażata fuq informazzjoni miġbura bil-prattika, wara trattament wieħed, l-estru ġie prevenut għal 12-il xahar jew aktar f'75% tal-kelbat adulti and  90% fil-klieb qabel il-puberta`.
English: VIAL CONTAINING SOLVENT:
Maltese: Kunjett li fih is-solvent :
English: GnRH analogues are peptides.
Maltese: Kopji tal-GnRH huma peptidi.
English: The table below provides the required volume of concentrate and the required volume of solvent to obtain thepreferred injection volumes of 0.1 ml/kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish.
Maltese: It-tabella ta' hawn taħt turi l-volum ta' konċentrat u solvent li wieħed għandu bżonn sabiex jinjetta laħjar volum ta' 0.1ml/kg, 0.2 ml/kg, 0.5 ml/kg u 1.0 ml / kg ta' ħut.
English: In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of giant breeds over 45 kg bodyweight.
Maltese: Fin-nuqqas ta'informazzjoni klinika, titrattax kelbat ta'anqas mit-3 kg piż ħaj u kelbat ta' razzez kbar li jaqbżu l-45 kg piż ħaj.
English: Gonazon 18.5 mg implant for dogs
Maltese: Gonazon 18.5 mg impjant għall-klieb
English: <Batch> <Lot> <BN> {number}
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI
English: Prepare a small area (e.g. 4 cm²) of the ventral anterior abdominal/ umbilical region for an aseptic procedure.
Maltese: Prepara żona żgħira (e.g. 4 cm 2) anterjuri taż-żaqq in-naħa addominali/umbilikali għall-proċedura assettika.
English: Following a single administration, return to ovarian activity after implant removal may take longer in bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68 days, range 12 to 264 days).
Maltese: Wara amministrazzjoni waħda, l-ovarji jistgħu jdumu aktar ma jiġu attivi wara li jitneħħa l-impjant f'kelbiet trattati qabel il-puberta (medja 255 ġranet, perjodu bejn 36-429 ġranet) milli kelbiet adulti (medja 68 ġranet, perjodu bejn 12 - 264 ġranet).
English: Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously.
Maltese: Azagly-nafarelin, huwa un agonista GnRH, li meta jiġi amministrat kontinwament għandu effeti bifażiċi fuq il-glandola pitwitari.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Doża rakkomandata u l-metodu ta' amministrazzjoni
English: Carton: 1 concentrate vial and 1 solvent vial.
Maltese: Pakkett: kunjett wieħed tal-konċentrat u wieħed tas-solvent.
English: Separate empty sterile containers
Maltese: Kontenituri sterili vojta li jiġu separatament
English: No data are available on repeat treatments in prepubertal bitches.
Maltese: M'hemmx informazzjoni fuq trattamenti ripetuti f'kelbiet ta' qabel il-puberta.
English: Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout.
Maltese: Azagly - nafarelin jiġi assorbit malajr wara trattament intraperitonejali fit-troti.
English: Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout.
Maltese: Azaglynafarelin jigi eliminat malajr mill-plasma wara trattament intraperitonjali fit-troti.
English: Store and transport at 2C - 8C (in a refrigerator).
Maltese: Aħżen u ttrasporta f'temperatura ta' 2Ċ - 8Ċ (fil-friġġ).
English: Initially, it stimulates pituitary function and secretion of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone).
Maltese: Għall-ewwel, jistimola l-funzjoni tal-glandola pitwitari u ssekrezzjoni tal-gonadotropini LH (luteinising hormone) u FSH (follic stimulating hormone).
English: Induced heat is not observed if treatment is started before puberty.
Maltese: Saħna ndotta ma ġietx osservata jekk it-trattament jingħata qabel l-puberta.
English: Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of treated bitches.
Maltese: Evidenza ibbażata fuq informazzjoni miġbura bil-prattika, l-impjant jista' ma jinżammx f'numru ta'kelbiet (1.2%) trattati.
English: In adult bitches, the first treatment should be administered preferably in metoestrus.
Maltese: Għalhekk l-ewwel trattament preferribilment jingħata f'metoestrus.
English: Do not use Gonazon before approximately 10% of the specific broodstock population has ovulated naturally.
Maltese: Tużax Gonazon qabel madwar 10% tal-ħut ikun ovula b'mod naturali.
English: D. STATEMENT OF THE MRLs
Maltese: DIKJARAZZJONI TAL-MRL's
English: Manufacturer responsible for the batch release: Intervet GesmbH
Maltese: PARIR FUQ AMMINISTRAZZJONI B'MOD KORRETT
English: It controls reproduction in fish by modulating the secretion of the pituitary gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), also known in fish endocrinology as GtH-II and GtH-I, respectively.
Maltese: GnRH tikontrolla iċ-ċiklu riproduttiv tal-ħut billi taffetwa l-produzzjoni ta' l-ormoni bhal Pituitary ganadotrophins, luteinizing hormone (LH) u l- follicle stimulating hormone (FSH).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Maltese: PARIR FUQ AMMINISTRAZZJONI KORRETTA
English: One implant.
Maltese: Mhux Applikabbli.
English: Do not use after the expiry date which is stated on the label ‘EXP' Do not store above 25C.
Maltese: Tużax wara d-data tal-iskadenza kif muriha fuq it-tiketta 'EXP' Taħżinx il-fuq minn 25°C.
English: The implant may not be retained in a proportion (1.2%) of treated bitches.
Maltese: L-impjant jista' ma jinżammx f'numru ta'kelbiet (1.2%) trattati.
English: Shelf life of the veterinary medicinal product as packaged for sage: 3 years.
Maltese: Dan il-prodott veterinarju ippakjat idum tajjeb : 3 snin
English: Batch < number >
Maltese: <Lott> {numru}
English: Administration of Gonazon at other stages of the cycle may induce heat that may be fertile.
Maltese: Amministrazzjoni ta'Gonazon fi stadi oħra taċ-ċiklu jista` jinduċi namra li tkun fertili.
English: The unit is sterile and comes in a sealed, light-proof, aluminium foil laminate pouch, packed in an individual carton box.
Maltese: L-istrument huwa sterili u jiġi issiġillat f'pakett tal-folja tal-aluminju, u ippakjat individwali f'kaxxa tal-kartun.
English: Acetic acid, glacial
Maltese: Aċidu idrokloriku
English: Hydrochloric acid Annex II for all food
Maltese: Sodium acetate (trihydrate) Anness II għall-ispeċi kollha
English: A-1210 Wien
Maltese: Intervet GesmbH Siemenssreabe 107 A-1210 Wien Awstrija
English: Subcutaneous administration.
Maltese: Impjant wieħed.
English: If necessary, dissect away any fibrous tissue to free the implant.
Maltese: Jekk ikun hemm bżonn aqta kull tessut fibruż biex jiġi illiberat l-impjant.
English: Dogs (bitches)
Maltese: Klieb (tas-sess femminili)
English: Therefore, if heat is observed, contact with male dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male dogs) cease.
Maltese: Għalhekk kull kuntat ma klieb tas-sess maskili għandu jiġi evitat sakemm kull sinjal ta' namra (nefħa tal vulva, tnixxija ta'demm u attrazzjoni lejn klieb maskili) jieqfu.
English: ATC vet code: QH01CA
Maltese: IL-KLIEM "GĦAT-TRATTAMENT
English: Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent.
Maltese: Kaxxa tal-kartun li fiha kunjett wieħed ta' 2ml soluzzjoni konċentrata u flixkun tal-100ml bis-solvent.
English: Gonazon for fish:
Maltese: Gonazon:
English: Gonazon concentrate for solution for injection of female salmonid fish
Maltese: Gonazon, Konċentrat għall-injezzjoni li jintuża fl-ispeċi femminili tas-salamun
English: For animal treatment only- to be supplied only on veterinary prescription.
Maltese: Għat-Trattament tal-annimali biss - jingħata biss fuq preskrizzjoni veterinarja.
English: Take care to avoid penetrating the abdominal wall musculature or fat tissue.
Maltese: Hemm ukoll kunjett sterilizzat biex tħallat fih.
English: OTHER INFORMATION
Maltese: Sustanza
English: The method of administration is as follows:
Maltese: METODU U MOD TA' AMMINISTRAZZJONI
English: In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus.
Maltese: Fil-kelbiet li l-funzjoni tal-gonadi ġie mwaqqaf b'suċċess għal perjodu ta' 12-il xahar, jista` jingħata t-tieni trattament f'dak il-ħin biex ikompli jiġi inibit l-estru.
English: Avoid accidental self-injection.
Maltese: Evita li tinjetta lilek innifsek.
English: Oral use sachet (LDPE/Alu/LDPE/paper)
Maltese: Qartas (LDPE/Aluminju/LDPE/k arta)
English: Immediate Packaging Content
Maltese: Daqs tal-pakkett
English: 1 sachet
Maltese: 1 qartas
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: Granules for oral suspension
Maltese: Użu orali
English: 2years.
Maltese: 2 sentejn.
English: - The other ingredient is lactose monohydrate (see section 2 under ‘Airexar Spiromax contains lactose').
Maltese: - Is-sustanza l-oħra hija lactose monohydrate (ara sezzjoni 2 taħt ‘Airexar Spiromax fih lactose').
English: Cardiac arrhythmias (including supraventricular
Maltese: Arritmiji kardijaċi (inklużi takikardija supraventrikulari u ekstrasistoli).
English: Airexar Spiromax contains two medicines, salmeterol and fluticasone propionate:
Maltese: Airexar Spiromax fih żewġ mediċini, salmeterol u fluticasone propionate:
English: Frequencies are defined as: very common (≥1/10), common (1/100 to 1/10), uncommon (1/1000 to 1/100), rare (1/10,000 to <1/1000) and not known (frequency cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti 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) u mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli).
English: The study showed that doubling the inhalations of each strength of salmeterol/fluticasone propionate for up to 14 days resulted in a small increase in β agonistrelated adverse events (tremor - 1 patient [1%] vs 0, palpitations - 6 [3%] vs 1 [<1%], muscle cramps -6 [3%] vs 1 [<1%]) and a similar incidence of inhaled corticosteroid related adverse events (e.g. oral candidiasis - 6 [6%] vs 16 [8%], hoarseness - 2 [2%] vs 4 [2%]) compared with one inhalation twice daily.
Maltese: L-istudju wera li rduppjar tal-inalazzjonijiet ta' kull qawwa ta' salmeterol/fluticasone propionate sa 14-il ġurnata irriżulta f'żieda żgħira f'avvenimenti avversi relatati ma' agonisti tar-riċetturi β (rogħda - pazjent wieħed [1%] kontra 0, palpitazzjonijiet - 6 [3%] kontra 1 [<1%], bugħawwieġ fil-muskoli - 6 [3%] kontra 1 [<1%]) u inċidenza simili ta' avvenimenti avversi relatati ma' kortikosterojd meħud man-nifs (eż. kandidjasi orali - 6 [6%] kontra 16 [8%], ħanqa - 2 [2%] kontra 4 [2%]) meta mqabbel ma' inalazzjoni waħda darbtejn kuljum.
English: Rarely, Airexar Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Maltese: Rarament, Airexar Spiromax jista' jikkawża arritmiji kardijaċi eż. takikardija supraventrikulari, ekstrasistoli u fibrillazzjoni tal-atriju, u tnaqqis temporanju ħafif fil-potassium fis-serum b'dożi terapewtiċi għoljin.
English: The estimated 3-year probability of having pneumonia reported as an adverse event was 12.3% for placebo, 13.3% for salmeterol, 18.3% for FP and 19.6% for salmeterol/fluticasone propionate (hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.64, 95% CI: 1.33 to 2.01, p<0.001).
Maltese: Stima tal-probabbiltà ta' 3 snin li wieħed ikollu pulmonite irrappurtata bħala avveniment avvers kienet ta' 12.3% għall-plaċebo, 13.3% għal salmeterol, 18.3% għal FP u 19.6% għal salmeterol/fluticasone propionate (proporzjon ta' periklu għal salmeterol/ fluticasone propionate kontra plaċebo: 1.64, CI ta' 95%: 1.33 sa 2.01, p<0.001).
English: The Salmeterol Multi-center Asthma Research Trial (SMART) SMART was a multi-centre, randomised, double blind, placebo-controlled, parallel group 28-week study in the US which randomised 13,176 patients to salmeterol (50 micrograms twice daily) and 13,179 patients to placebo in addition to the patients' usual asthma therapy.
Maltese: SMART kien studju ta' 28 ġimgħa b'aktar minn ċentru wieħed, randomised, double blind, ikkontrollat bilplaċebo, bi grupp parallel fl-Istati Uniti fejn 13,176 pazjent kienu randomised għal salmeterol (50 mikrogramma darbtejn kuljum) u 13,179 pazjent għal plaċebo flimkien ma' terapija tas-soltu għallażżma tal-pazjent.
English: Airexar Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Maltese: Airexar Spiromax mhux indikat għal użu fi tfal u adolexxenti taħt l-età ta' 18-il sena (ara sezzjoni 4.2).
English: Airexar Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
Maltese: Airexar Spiromax mhux indikat għal użu fit-tfal, b'età ta' 12-il sena u inqas jew adolexxenti b'età ta' 13 sa 17-il sena.
English: Airexar Spiromax 50 micrograms/500 micrograms
Maltese: Airexar Spiromax 50 µg/500 µg
English: Airexar Spiromax is not available on the market at strengths lower than 50/500 microgram.
Maltese: Airexar Spiromax mhuwiex disponibbli fis-suq bħala qawwiet inqas minn 50/500 mikrogramma.
English: Airexar Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate
Maltese: Airexar Spiromax 50 mikrogrammi/500 mikrogrammi trab li jittieħed man-nifs salmeterol/fluticasone propionate
English: Oral infections
Maltese: Infezzjonijiet u infestazzjonijiet
English: There was no significant difference in probability of bone fracture (5.1% placebo, 5.1% salmeterol, 5.4% FP and 6.3% salmeterol/fluticasone propionate; hazard ratio for salmeterol/fluticasone propionate vs placebo: 1.22, 95%
Maltese: Ma kien hemm l-ebda differenza sinifikanti filprobabbiltà ta' ksur fl-għadam (5.1% plaċebo, 5.1% salmeterol, 5.4% FP u 6.3% salmeterol/fluticasone propionate; proporzjon ta' periklu għal salmeterol/fluticasone propionate kontra plaċebo: 1.22, CI ta' 95%: 0.87 sa 1.72, p=0.248.
English: If you stop using Airexar Spiromax
Maltese: Mediċini oħra u Airexar Spiromax
English: Airexar Spiromax is indicated in adults 18 years of age and older only.
Maltese: Airexar Spiromax huwa indikat f'adulti ta' eta' minn 18-il sena 'l fuq biss.
English: Some medicines may increase the effects of Airexar Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta Aerivio Spiromax u t-tabib tiegħek għandu mnejn ikun irid jissorveljak b'attenzjoni jekk qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV: ritonavir, cobicistat).
English: Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Maltese: Marda Kronika Ostruttiva tal-Pulmun (COPD - Chronic Obstructive Pulmonary Disease) Airexar Spiromax huwa indikat għat-trattament sintomatiku ta' pazjenti b'COPD, b'FEV1 <60% tan-normal imbassar (qabel teħid ta' bronkodilatur) u storja ta' aggravar tal-kundizzjoni b'mod ripetut, li għandhom sintomi sinifikanti minkejja terapija regolari bi bronkodilatur.
English: The safety and efficacy of Airexar Spiromax in children and adolescents aged less than 18 years of age has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Airexar Spiromax fit-tfal u fl-adolexxenti ta' età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Airexar Spiromax is indicated for use in adults aged 18 years and older only.
Maltese: Airexar Spiromax huwa indikat għal użu f'adulti ta' eta' minn 18-il sena 'l fuq biss.
English: As Airexar Spiromax contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected.
Maltese: Peress li Airexar Spiromax fih salmeterol u fluticasone propionate, jistgħu jkunu mistennija it-tip u s-severità ta' reazzjonijiet avversi assoċjati ma' kull wieħed mis-sustanzi attivi.