FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.
Maltese: F'eżamijiet kliniċi Cetrotide intuża mal-gonadotropin uman tal-menopawża (HMG), iżda esperjenza limitata bl-ormon li jistimula l-follikulu (FSH) miksub bit-teknoloġija tat-tfassil tad-DNA tissuġġerixxi effikaċja simili.
English: Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see section 4.4).
Maltese: OHSS ħafif sa moderat (WHO grad I jew II) jista' jseħħ bħala riskju intrinsiku talproċedura tal-istimulazzjoni (ara sezzjoni 4.4).
English: Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Maltese: Prevenzjoni ta' ovulazzjoni prematura f'pazjenti li qed jingħataw stimulazzjoni kkontrollata tal-ovarji, segwita minn ġbir ta' bajd bħala parti mit-teknika ta' riproduzzjoni assistita.
English: This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins
Maltese: Dan l-avveniment għandu jkun ikkunsidrat bħala riskju intrinsiku tal-proċedura ta' stimulazzjoni bil-gonadotropini.
English: The subcutaneous administration of single doses (0.25 mg to 3 mg cetrorelix) and also daily dosing over 14 days show linear kinetics.
Maltese: L-amministrazzjoni taħt il-ġilda ta' doża waħda (0.25 mg sa 3 mg cetrorelix) u ta' doża kuljum għal 14-il ġurnata turi kinetika linejari.
English: 1 powder vial with 0.25 mg cetrorelix.
Maltese: Kunjett wieħed bit-trab b'0.25 mg cetrorelix.
English: Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Maltese: OHSS minn ħafif sa moderat (WHO grad I jew II) kien irrappurtat b'mod komuni u għandu jiġi kkunsidrat bħala riskju intrinsiku tal-proċedura tal-istimulazzjoni.
English: Cetrotide 0.25 mg powder and solvent for solution for injection Cetrorelix
Maltese: Cetrotide 0.25 mg trab u solvent għal soluzzjoni għall-injezzjoni Cetrorelix
English: The unopened medicine may be stored in the original package at room temperature (not above 30°C) for up to three months.
Maltese: Il-mediċina mhux miftuħa tista' tinħażen fil-pakkett oriġinali f'temperatura tal-kamra (mhux aktar minn 30°C) sa mhux aktar minn tliet xhur.
English: Cetrotide is one of the medicines used during ‘assisted reproductive techniques' to help you get pregnant.
Maltese: Cetrotide huwa wieħed mill-mediċini użati f'‘metodi tekniċi ta' riproduzzjoni assistita biex jgħinuk tinqabad tqila.
English: Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Maltese: Wara li jingħata għall-ewwel darba, hu ssuġġerit li l-pazjent jinżamm taħt osservazzjoni medika għal 30 minuta biex ikun ċert li m'hemm l-ebda reazzjoni allerġika/psewdo-allerġika għall-injezzjoni.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Each vial contains 0.25 mg cetrorelix (as acetate).
Maltese: Kull kunjett fih 0.25 mg ta' cetrorelix (bħala acetate).
English: The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Maltese: Il-prevalenza ta' anomaliji konġenitali wara l-użu ta' teknoloġiji ta' riproduzzjoni assistita (ART) bi jew mingħajr antagonisti ta' GnRH tista' tkun ftit ogħla milli wara konċepimenti spontanji, għalkemm mhuwiex ċar jekk dan huwiex relatat ma' fatturi inerenti mal-infertilità tal-koppja jew mal-proċeduri tal-ART.
English: Treatment with Cetrotide should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
Maltese: It-trattament b'Cetrotide għandu jibda fil-ħames jew sitt ġurnata tal-istimulazzjoni tal-ovarji (madwar 96 sa 120 siegħa wara l-bidu tal-istimulazzjoni tal-ovarji) b'gonadotropini urinarji jew miksuba bitteknoloġija tat-tfassil tad-DNA, u għandu jitkompla matul il-perijodu ta' trattament b'gonadotropini inkluża l-ġurnata li fiha jkun hemm l-induzzjoni tal-ovulazzjoni.
English: Powder Mannitol
Maltese: Mannitol
English: Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition.
Maltese: Għandha tingħata attenzjoni speċjali lin-nisa b'sinjali u sintomi ta' kundizzjonijiet allerġiċi attivi jew fil-passat magħruf ta' predispożizzjoni allerġika.
English: • In the solvent: water for injections.
Maltese: • Fis-solvent: ilma għall-injezzjonijiet.
English: Paediatric population There is no relevant use of Cetrotide in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Cetrotide fil-popolazzjoni pedjatrika.
English: 1 injection needle (20 gauge) 1 hypodermic injection needle (27 gauge) 2 alcohol swabs.
Maltese: Labra waħda tal-injezzjoni (20 gauge) Labra waħda ipodermika tal-injezzjoni (27 gauge) Żewġ tajjar bl-alkoħol
English: There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure.
Maltese: Hemm esperjenza limitata s'issa bl-għoti ta' cetrorelix matul proċedura ripetuta tal-istimulazzjoni talovarji.
English: Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8).
Maltese: Każijiet ta' reazzjonijiet allerġiċi/psewdo-allerġiċi, li jinkludu anafilassi ta' theddida għall-ħajja malewwel doża ġew irrappurtati (ara sezzjoni 4.8).
English: The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity.
Maltese: L-iktar reazzjonijiet avversi rrappurtati b'mod komuni huma reazzjonijiet fis-sit tal-injezzjoni bħal eritema, nefħa u ħakk li jkunu normalment temporanji fin-natura tagħhom, u ħfief fl-intensità.
English: Merck Europe B.V.
Maltese: GĦALL-ĦRUĠ TALLOTT B.
English: Uncommon (may affect up to 1 in 100 women):
Maltese: Mhux komuni (jistgħu jaffettwaw sa mara 1 minn kull 100):
English: Allergic reactions - Warm, red skin, itching (often in your groin or armpits), red, itchy, raised areas (hives), runny nose, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing or serious difficulty breathing, or dizziness.
Maltese: • Fawra, ġilda ħamra, ħakk (spiss fl-irqiq ta' bejn il-koxxa u ż-żaqq jew l-abt tiegħek), partijiet ħomor, bil-ħakk, minfuħin (ħorriqija), imnieħer inixxi, rata ta' taħbit tal-qalba mgħaġġla jew irregolari, nefħa f'ilsienek u fi griżmejk, għatis, tħarħir jew diffikultà serja biex tieħu n-nifs, jew sturdament.
English: NAME OF THE MEDICINAL PRODUCT Cetrotide 0.25 mg powder and solvent for solution for injection cetrorelix
Maltese: TAL-PRODOTT MEDIĊINALI Cetrotide 0.25 mg trab u solvent għal soluzzjoni għall-injezzjoni Cetrorelix
English: At a dose of 0.25 mg per injection repeated injections every 24 hours will maintain the effect of cetrorelix.
Maltese: B'doża ta' 0.25 mg kull injezzjoni, injezzjonijiet ripetuti kull 24 siegħa jżommu l-effett ta' cetrorelix.
English: • Feeling sick (nausea)
Maltese: • Tħossok imdardra (nawseja)
English: Then, gently pull back the plunger, in order to draw the medicine from the vial into the syringe.
Maltese: Mhumiex mistennija effetti ħżiena jekk aċċidentalment inti tinjetta aktar minn din il-mediċina milli suppost.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg
Maltese: INDIVIDWALI 0.25 mg
English: For each vial, the pack also contains: - one needle with a yellow mark - for injecting the sterile water into the vial and drawing the made up medicine out from the vial - one needle with a grey mark - for injecting the medicine into your belly - two alcohol swabs for cleaning
Maltese: Poġġi kull ma għandek bżonn fuq wiċċ nadif: - kunjett wieħed ta' trab - siringa waħda mimlija għal-lest b'ilma sterili (solvent) - labra tal-injezzjoni b'marka safra - għall-injezzjoni tal-ilma sterili fil-kunjett u għall-ġbid tal-mediċina li tkun għadha kif ġiet magħmula, 'il barra mill-kunjett - labra tal-injezzjoni b'marka griża - għall-injezzjoni tal-mediċina fiż-żaqq - żewġ tajjar bl-alkoħol.
English: No signs of medicinal product-related local irritation or incompatibility were noted in dogs after intravenous, intraarterial and paravenous injection when cetrorelix was administered in doses clearly above the intended clinical use in man.
Maltese: L-ebda sinjali ta' irritazzjoni lokali jew inkompatibilità marbuta mal-prodott mediċinali ma kienu osservati fil-klieb wara injezzjoni ġol-vini, ġol-arterji jew paraveni meta cetrorelix kien ingħata f'doża li b'mod ċar kienet aktar minn dik intenzjonata għall-użu kliniku fuq il-bniedem.
English: No formal drug-drug interaction studies have been performed with cetrorelix.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni bejn mediċina u oħra b'cetrorelix.
English: • Gently pull back the plunger of the syringe.
Maltese: • Pazjenti b'indeboliment sever tal-kliewi.
English: Ovarian Hyperstimulation Syndrome (OHSS) This may occur due to the other medicines that you are using to stimulate your ovaries.
Maltese: Is-sindromu ta' Stimulazzjoni Eċċessiva tal-Ovarji (OHSS) Matul jew wara l-istimulazzjoni tal-ovarji, jista' jseħħ is-sindromu ta' stimulazzjoni eċċessiva talovarji.
English: The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening.
Maltese: Il-kontenut ta' kunjett wieħed (0.25 mg cetrorelix) irid jingħata darba kuljum, b'intervalli ta' 24 siegħa, jew filgħodu jew filgħaxija.
English: Cetrorelix dose-dependently inhibits the secretion of LH and FSH from the pituitary gland.
Maltese: Aqra sew dan il-fuljett kollu qabel tibda tuża din il-mediċina peress li fih informazzjoni importanti għalik.
English: Batch
Maltese: JEW
English: Treatment with Cetrotide should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
Maltese: It-trattament b'Cetrotide għandu jibda fil-ħames ġurnata tal-istimulazzjoni tal-ovarji (madwar 96 sa 108 siegħa wara l-bidu tal-istimulazzjoni tal-ovarji) b'gonadotropini urinarji jew miksuba bitteknoloġija tat-tfassil tad-DNA u għandu jitkompla matul il-perijodu ta' trattament b'gonadotropini sal-lejl ta' qabel il-ġurnata li fiha jkun hemm l-induzzjoni tal-ovulazzjoni.
English: 5 How to store Cetrotide Contents of the pack and other information How to mix and inject Cetrotide
Maltese: Kontenut tal-pakkett u informazzjoni oħra Kif tħallat u tinjetta Cetrotide
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 0.25 mg cetrorelix (as acetate).
Maltese: Kull kunjett bit-trab jinkludi 0.25 mg cetrorelix (bħala acetate).
English: The unopened product may be stored in the original package at room temperature (not above 30°C) for up to three months.
Maltese: Il-prodott mhux miftuħ jista' jinħażen fil-pakkett oriġinali f'temperatura tal-kamra (mhux aktar minn 30°C) sa mhux aktar minn tliet xhur.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Maltese: Effetti sekondarji oħrajn
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Cetrotide 0.25 mg
Maltese: Injetta l-kontenut ta' kunjett wieħed (0.25 mg Cetrotide) darba kuljum.
English: It is available in packs of 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes (not all pack sizes may be marketed).
Maltese: Dan jinstab f'pakketti ta' kunjett wieħed u siringa mimlija għal-lest waħda jew 7 kunjetti u 7 siringi mimlija għal-lest (jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq).
English: - The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest.
Maltese: • L-OHSS jista' jsir iktar serju b'ovarji mkabbrin b'mod evidenti, tnaqqis fil-produzzjoni talawrina, żieda fil-piż, diffikultà fit-teħid tan-nifs jew fluwidu fl-istonku tiegħek jew f'sidrek.
English: Uncommon: Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.
Maltese: Mhux komuni: Reazzjonijiet allerġiċi/psewdo-allerġiċi sistemiċi li jinkludu anafilassi ta' periklu għall-ħajja.
English: Absorption The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Maltese: Assorbiment Il-mod assolut ta' kif jinfirex fil-ġisem cetrorelix mogħti taħt il-ġilda hu ta' madwar 85%.
English: The powder vial contains 0.25 mg cetrorelix and the pre-filled syringe contains 1 ml solvent.
Maltese: Il-kunjett bit-trab fih 0.25 mg cetrorelix u s-siringa mimlija għal-lest fiha 1 mL ta' solvent.
English: (See next section ‘How much to use').
Maltese: (Ara s-sezzjoni li jmiss ‘Kemm għandek tuża').
English: NAME OF THE MEDICINAL PRODUCT Cetrotide 0.25 mg powder and solvent for solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Cetrotide 0.25 mg trab u solvent għal soluzzjoni għall-injezzjoni.
English: If blood appears:
Maltese: Mhux komuni:
English: In females, cetrorelix delays the LH surge and consequently ovulation.
Maltese: Indeboliment tal-fwied Cetrorelix ma ġiex studjat f'pazjenti b'indeboliment tal-fwied, u għalhekk hi rrakkomandata l-kawtela.
English: • You can carry out the following injections yourself as long as your doctor has made you aware of the symptoms that may indicate allergy and of the possibly serious or life-threatening consequences that would need immediate treatment (see section 4 ‘Possible side effects').
Maltese: • Tista' tagħti l-injezzjonijiet li ġejjin inti stess sakemm it-tabib tiegħek ikun avżak bis-sintomi li jistgħu jindikaw allerġija u tal-konsegwenzi serji u ta' theddida għall-ħajja li huma possibbli, li jkunu jeħtieġu kura immedjata (ara sezzjoni 4 ‘Effetti sekondarji possibbli').
English: No target organ toxicity could be observed from acute, subacute and chronic toxicity studies in rats and dogs following subcutaneous administration of cetrorelix.
Maltese: L-ebda effett tossiku fl-organi li fuqhom jaħdem cetrorelix ma kien osservat minn studji dwar effett tossiku akut, bejn akut u kroniku, u kroniku fuq ġrieden u klieb wara amministrazzjoni għal taħt ilġilda ta' cetrorelix.
English: Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.
Maltese: Każijiet mhux komuni ta' sensittività eċċessiva li jinkludu reazzjonijiet psewdo-allerġiċi/anafilattojdi kienu rrappurtati.
English: 1 pre-filled syringe contains 1 ml of water for injections.
Maltese: Siringa waħda mimlija għal-lest fiha 1 mL ta' ilma għall-injezzjonijiet.
English: 1 hypodermic injection needle (27 gauge)
Maltese: Labra waħda tal-injezzjoni (20 gauge) Labra waħda tal-injezzjoni ipodermika (27 gauge)
English: Cetrorelix competes with the binding of endogenous LHRH to these receptors.
Maltese: Cetrorelix jikkompeti ma' l-għaqda ta' LHRH endoġeni għal dawn ir-riċetturi.
English: Due to this mode of action, cetrorelix controls the secretion of gonadotropins (LH and FSH).
Maltese: B'dan il-mod, cetrorelix jikkontrolla t-tnixxija talgonadotropini (LH u FSH).
English: Pregnancy and breast-feeding Do not use Cetrotide if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Maltese: Ir-raġuni għal dan hija li jekk il-bajd jiġi lliberat kmieni wisq (ovulazzjoni prematura), jista' jkun li ma jkunx possibbli li t-tabib tiegħek jiġborhom.
English: In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way.
Maltese: Investigazzjonijiet in vitro wrew li mhux probabbli li jkun hemm interazzjonijiet ma' prodotti mediċinali li huma mmetabolizzati biċ-ċitokromu P450 jew glukurinizzati jew konjugati b'xi mod ieħor. Madankollu, ilpossibbiltà ta' interazzjonijiet ma' gonadotropini jew prodotti mediċinali li jistgħu jistimulaw ilħelsien tal-istamina f'individwi li huma suxxettibbli,ma tistax tiġi totalment eskluża.
English: EMA/257977/2014 EMEA/V/C/003678
Maltese: EMEA/V/C/003678
English: The percentage of dogs with protective levels of antibodies for parvovirus ranged from 73 to 100%, for parainfluenza virus 73 to 97% and for leptospira 59 to 96%.
Maltese: Il-perċentwal ta' klieb b'livelli protettivi ta' antikorpi għall-parvovirus kienu f'firxa minn 73 sa 100%, għall-virus talparainfluwenza minn 73 sa 97% u għal-leptospira 59 sa 96%.
English: The effectiveness of Versican Plus DHPPi/L4 was initially investigated in a field study involving 129 dogs.
Maltese: L-effikaċja ta' Versican Plus DHPPi/L4 ġiet investigata inizjalment fi studju li involva 129 kelb.
English: • canine parainfluenza virus and canine adenovirus type 2, which cause kennel cough;
Maltese: • virus tal-parainfluwenza tal-klieb u adenovirus tal-klieb tip 2, li jikkawżaw il-‘kennel cough';
English: Versican Plus DHPPi/L4 is a veterinary vaccine that contains live attenuated (weakened) canine distemper virus, canine adenovirus type 2, canine parvovirus type 2b and canine parainfluenza virus type 2 as well as inactivated (killed) strains of Leptospira bacteria.
Maltese: Versican Plus DHPPi/L4R huwa vaċċin veterinarju li fih il-virus distempra tal-klieb, l-adenovirus tal-klieb tat-tip 2, il-parvovirus tat-tip 2b u l-virus parainfluenza tal-klieb tat-tip 2 ħajjin u attenwati (imdgħajfa) kif ukoll razez inattivati (maqtula) ta' batterji ta' Leptospira.
English: This will help protect them against distemper, adenovirus liver infection, parvovirosis, kennel cough and leptospirosis.
Maltese: Dan jgħin jipproteġihom kontra distempra, infezzjoni tal-fwied mill-adenovirus, parvovirus, ‘kennel cough', leptospirożi .
English: Canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine
Maltese: Distempra tal-klieb, adenovirus tal-klieb, parvovirus tal-klieb, virus talparainfluenza tal-klieb (ħaj attenwat) u vaċċin (inattivat) leptospirożi tal-klieb
English: • canine distemper, an infectious disease which is sometimes called ‘hard pad' since dogs can develop thickening of the skin on the foot pads, as well as runny nose, cough, fever, vomiting, diarrhoea, excessive salivation and in some cases fits;
Maltese: • Distempra tal-klieb, marda infettiva li xi drabi tissejjaħ ‘hard pad' minħabba li l-klieb jistgħu jiżviluppaw ħxuna fil-ġilda tal-pads tas-saqajn, kif ukoll imnieħer iqattar, sogħla, deni, rimettar, dijarea, bżieq eċċessiv u f'xi każijiet aċċessjonijiet;
English: Laboratory studies were conducted subsequently to determine the period of protection against distemper, canine adenovirus (type 1 and 2) and parvovirus.
Maltese: L-istudji fil-laboratorju saru biex ikun determinat il-perjodu ta' protezzjoni kontra d-distempra, ladenovirus tal-klieb (tat-tip 1 u 2) u l-parvovirus.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus DHPPi/L4 is a shortlived swelling of up to 5 cm which may occur at the injection site after vaccination.
Maltese: L-effett sekondarju l-aktar komuni (li deher f'iktar minn 1 minn kull 100 kelb) b'Versican Plus DHPPi/L4 huwa nefħa għal ftit ħin sa 5 cm li tista' tifforma fis-sit tal-injezzjoni wara t-tilqima.
English: Versican Plus DHPPi/L4 contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Maltese: Versican Plus DHPPi/L4 fih aġġuvant (idrossidu tal-aluminju) biex iżid ir-rispons immunitarju.
English: Versican Plus DHPPi/L4 is a vaccine.
Maltese: Versican Plus DHPPi/L4 huwa vaċċin.
English: Versican Plus DHPPi/L4 is available as a lyophilisate (freeze-dried pellet) with a solvent for injection.
Maltese: Versican Plus DHPPi/L4R huwa disponibbli bħala lijofilizzat (pellit imnixxfa bl-iffriżar) b'solvent għal injezzjoni.
English: The viruses in Versican Plus DHPPi/L4 are alive but they have been attenuated (weakened) so that they do not cause disease; they are combined with killed (inactivated) strains of Leptospira bacteria.
Maltese: Il-virusis f' Versican Plus DHPPi/L4 huma ħajjin iżda ġew attenwati (imdgħajfa) biex ma jikkawżawx mard; huma kkombinati ma' razez maqtulin (inattivati) tal-batterji Leptospira.
English: • canine adenovirus type 1, which causes an acute liver infection that may produce signs of jaundice (yellowing of the skin and eyes);
Maltese: • adenovirus tal-klieb tat-tip 1, li jikkawża infezzjoni akuta tal-fwied li tista' toħloq sinjali ta' suffejra (sfurija tal-ġilda u l-għajnejn);
English: For revaccination, a single dose of Versican Plus DHPPi/L4 is required every three years for distemper, canine adenovirus (type 1 and type 2) and parvovirus.
Maltese: Għall-vaċċinazzjoni mill-ġdid, doża singola ta' Versican Plus DHPPi/L4 hija meħtieġa kull tliet snin għad-distempra, l-adenovirus tal-klieb (tat-tip 1 u 2) u l-parvovirus.
English: Annual revaccination is required for protection against parainfluenza virus and leptospirosis.
Maltese: Vaċċinazzjoni millġdid kull sena hija meħtieġa għall-protezzjoni kontra l-virus tal-parainfluwneza u l-leptospirożi.
English: What is Versican Plus DHPPi/L4?
Maltese: X'inhu Versican Plus DHPPi/L4?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus DHPPi/L4 exceed the risks for the approved indications and recommended that Versican Plus DHPPi/L4 be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Versican Plus DHPPi/L4 huma akbar mir-riskji għal indikazzjonijiet approvati u rrakkomanda li Versican Plus DHPPi/L4 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and results in bleeding,
Maltese: • leptospirożi, marda batterjali li tista' tiġi trażmessa minn urina infettata u tirriżulta fi fsad, epatite
English: Versican Plus DHPPi/L4 is used to protect dogs against:
Maltese: Versican Plus DHPPi/L4 jintuża biex jipproteġi lill-klieb kontra:
English: Other information about Versican Plus DHPPi/L4:
Maltese: Tagħrif ieħor dwar Versican Plus DHPPi/L4:
English: What is the risk associated with Versican Plus DHPPi/L4?
Maltese: X'inhu r-riskju assoċjat ma' Versican Plus DHPPi/L4?
English: Date of first authorisation: 22 March 2002 Date of latest renewal: 24 January 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu 2002 Data tal-aħħar tiġdid: 24 ta' Jannar 2012
English: Both groups had similar demographics.
Maltese: Iż-żewġ gruppi kellhom demografiċi simili.
English: 4.3 Contraindications
Maltese: 4.3 Kontra-indikazzjonijet
English: Rare (1/10,000 to <1/1000)
Maltese: Rari (1/10,000 sa <1/1000)
English: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Maltese: Sindromu ta' Stevens-Johnson, eritema multiforme, dermatite bil-qxur
English: Acetylsalicyclic acid and other NSAIDs
Maltese: Acetylsalicyclic acid u NSAIDs oħra
English: No data are available.
Maltese: M'hemm l-ebda dejta disponnibli.
English: Use with oral anticoagulants
Maltese: Użu ma' antikoagulanti orali
English: Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Maltese: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belġjum