FrancophonIA/ELRC3.0 huggingface dataset:
English: Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.
Maltese: Attenzjoni speċjali għandha tingħata meta metoclopramide jiġi amministrat, partikolarment meta jingħata ġo vina lill-popolazzjoni anzjana, lil pazjenti b'disturbi ta' kondizzjoni kardijaka (li jinkludu it-titwil ta' QT), pazjenti bi żbilanċ elettrolita mhix ikkorreġuta, bradikardja u dawk li jieħdu mediċini oħra magħrufa li jtawwlu l-intervall QT.
English: Page 2/2
Maltese: Paġna2/2
English: Further information on Arti-Cell Forte can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Arti-Cell Forte received a marketing authorisation valid throughout the EU on 29 March 2019.
Maltese: Arti-Cell Forte ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-29 ta' Marzu 2019.
English: Other information about Arti-Cell Forte
Maltese: Informazzjoni oħra dwar Arti-Cell Forte
English: In a field study involving horses with a history of lameness lasting 2 to 6 months, 50 horses were treated with Arti-Cell Forte and 25 received a placebo (dummy injection) of saline in one fetlock joint.
Maltese: Fi studju fuq il-post li jinvolvi ż-żwiemel bi storja ta' zappip li jdum bejn xahrejn u 6 xhur, 50 żiemel ġew ikkurati b'Arti-Cell Forte u 25 rċevew plaċebo (injezzjoni finta) ta' salina fl-artikolazzjoni metakarpu falanġea.
English: This overview was last updated in June 2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ġunju 2018.
English: What are the risks associated with Arti-Cell Forte?
Maltese: X'inhuma r-riskji assoċjati ma' Arti-Cell Forte?
English: Arti-Cell Forte is a veterinary medicine used to treat mild to moderate lameness linked to non-infective joint inflammation in horses.
Maltese: Arti-Cell Forte huwa mediċina veterinarja użata għall-kura ta' zappip ħafif sa moderat marbut ma' infjammazzjoni konġunta mhux infettiva fiż-żwiemel.
English: The most common side effects with Arti-Cell Forte (which may affect more than 1 in 10 horses) are mild increases in lameness, injection site reactions such as swelling and mild increases in temperature at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Arti-Cell Forte (li jistgħu jaffettwaw aktar minn żiemel 1 f'10 ) huma żidiet ħfief fiz-zappip, reazzjonijiet fis-sit tal-injezzjoni bħal nefħa u żidiet moderati fittemperatura fis-sit tal-injezzjoni.
English: This product contains chondrogenic induced equine mesenchymal stem cells and EAP.
Maltese: L-effetti sekondarji dehru fl-ewwel ġimgħa wara l-użu tal-mediċina.
English: The vials containing equine mesenchymal stem cells and equine allogeneic plasma can be stored and transported either frozen or in liquid nitrogen containers.
Maltese: Il-kunjetti li fihom ċelloli staminali mesenkimali tal-ekwini u l-plażma alloġenejka tal-ekwini jistgħu jinħażnu u jiġu ttrasportati jew iffriżati jew f'kontenituri tan-nitroġenu likwidu.
English: Accidental self-injection can cause pain, local inflammatory reactions and swelling at the injection site which may last for several weeks and possibly cause fever.
Maltese: Awtoinjezzjoni aċċidentali tista' tikkawża wġigħ, reazzjonijiet infjammatorji lokali u nefħa fis-sit tal-injezzjoni li tista' ddum għal diversi ġimgħat u possibbilment tikkawża d-deni.
English: How does Arti-Cell Forte work?
Maltese: Kif jintuża Arti-Cell Forte?
English: Six weeks after treatment 68% of the horses treated with Arti-Cell Forte had a lameness score reduction by 2 or 3 lameness grades compared to none of the horses in the control group.
Maltese: Sitt ġimgħat wara l-kura 68 % taż-żwiemel ikkurati b'Arti-Cell Forte kellhom tnaqqis fil-punteġġ taz-zappip bi 2 jew 3 gradi ta' zappip meta mqabbla mal-ebda wieħed miżżwiemel fil-grupp ta' kontroll.
English: The stem cells in the active substance (mesenchymal stem cells) are treated so that they develop into cartilage cells.
Maltese: Aktar informazzjoni dwar Arti-Cell Forte tista' tinstab fuq is-sit elettroniku tal-Aġenzija:
English: It consists of two vials which are supplied frozen: one vial contains the active substance and a second vial contains equine allogeneic plasma (EAP) which is the liquid part of blood.
Maltese: Din tikkonsisti f'żewġ kunjetti li jiġu fornuti ffriżati: kunjett wieħed fih is-sustanza attiva u t-tieni kunjett fih il-plażma alloġenejka ekwini (EAP) li hija l-parti likwida tad-demm.
English: Further information on Hyrimoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Hyrimoz (adalimumab)
Maltese: Hyrimoz ( Adomumab)
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Hyrimoz and 63% with Humira.
Maltese: Il-proporzjon ta' pazjenti li kellhom tnaqqis ta' mill-inqas 75 % tas-sintomi wara 16-il ġimgħa ta' kura kien ta' 68 % b'Hyrimoz u 63 % b'Humira.
English: The reference medicine for Hyrimoz is Humira.
Maltese: Ilmediċina ta' referenza għal Hyrimoz hija Humira.
English: Hyrimoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Hyrimoz fih is-sustanza attiva adalimumab u huwa “mediċina bijosimili”.
English: Other information about Hyrimoz
Maltese: Informazzjoni oħra dwar Hyrimoz
English: In addition Hyrimoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Maltese: Barra minn hekk, Hyrimoz kien effettiv daqs Humira fi studju li involva 465 pazjent bi psorjażi bi plakka moderata jew gravi.
English: Laboratory studies comparing Hyrimoz with Humira have shown that the active substance in Hyrimoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Hyrimoz ma' Humira wrew li s-sustanza attiva f'Hyrimoz hija simili ħafna għal dik f'Humira f'termini ta' struttura, purità u attività bijoloġika.
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
Maltese: • idradenite suppurativa (akne inversa), marda tal-ġilda fit-tul li tikkawża boċċi, axxessi (ġbir ta'
English: The active substance in Hyrimoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Hyrimoz, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur ta' nekrożi tumorali (TNF).
English: What are the risks associated with Hyrimoz?
Maltese: X'inhuma r-riskji assoċjati ma' Hyrimoz?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Maltese: • spondiloartrite assjali (infjammazzjoni tas-sinsla tad-dahar li tikkawża wġigħ fid-dahar), inkluża spondilite ankilożanti u fejn ir-raġġi X ma jurux mard iżda jkun hemm sinjali ċari ta'
English: For the full list of side effects and restrictions with Hyrimoz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Hyrimoz, ara l-fuljett ta' tagħrif.
English: This means that Hyrimoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Hyrimoz huwa simili ħafna għal mediċina bijoloġika oħra (il-”mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: As for all medicines, data on the use of Hyrimoz are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Hyrimoz hija ssorveljata kontinwament.
English: Hyrimoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Hyrimoz ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: All these data were considered sufficient to conclude that Hyrimoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Hyrimoz jaġixxi bl-istess mod bħal Humira f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: How is Hyrimoz used?
Maltese: Kif jaħdem Hyrimoz?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hyrimoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċiediet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Hyrimoz wera li għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Hyrimoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Maltese: Id-doża u l-frekwenza tal-injezzjoni jiddependu fuq il-kundizzjoni li trid tiġi kkurata u d-doża għat-tfal normalment tiġi kkalkolata skont il-piż tat-tfal; peress li Hyrimoz huwa disponibbli biss f'dożi ta' 40 mg, mhuwiex xieraq għal tfal li jeħtieġu doża inqas minn 40 mg.
English: Studies have also shown that giving Hyrimoz produces similar levels of the active substance in the body to giving Humira.
Maltese: L-istudji wrew ukoll li l-għoti ta' Hyrimoz jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Humira.
English: Like other medicines of its class, Hyrimoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Maltese: Bħal mediċini oħra tal-klassi tiegħu, Hyrimoz jista' jaffettwa l-abbiltà tas-sistema immuni li tiġġieled linfezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li kienu qed jużaw adalimumab.
English: Why is Hyrimoz authorised in the EU?
Maltese: Għaliex Hyrimoz ġie awtorizzat fl-UE?
English: Side effects reported with Hyrimoz are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Hyrimoz huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Because Hyrimoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Hyrimoz.
Maltese: Peress li Hyrimoz huwa mediċina bijosimili, l-istudji dwar l-effettività u s-sigurtà ta' adalimumab li saru b'Humira m'għandhomx bżonn jiġu ripetuti kollha għal Hyrimoz.
English: The company that markets Hyrimoz must provide educational packs for doctors who prescribe the medicine.
Maltese: Il-kumpanija li tqiegħed Hyrimoz fis-suq għandha tipprovdi pakketti edukattivi lit-tobba li jippreskrivu l-mediċina.
English: Cattle
Maltese: Bovini
English: Date of last renewal: 23/03/2010
Maltese: Data ta' l-aħħar tiġdid tal-awtorizzazzjoni: 23/03/2010
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/017/001-006
Maltese: EU/2/99/017/001-006
English: 10 doses (20 ml)
Maltese: 10 dożi (20 ml)
English: 25 doses (50 ml)
Maltese: 25 doża (50 ml)
English: EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
Maltese: EU/2/99/017/001 5 dożi (10 ml) EU/2/99/017/04 10 x 5 dożi (10 x 10 ml) EU/2/99/017/002 10 dożi (20 ml) EU/2/99/017/005 10 x 10 dożi (10 x 20 ml) EU/2/99/017/003 25 doża (50 ml)
English: Duration of immunity: 6 months.
Maltese: Tul tal-immunita': 6 xhur.
English: MERIAL,Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux-69007 Lyon FRANCE
Maltese: Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon
English: Allow the vaccine to reach a temperature of 15°C-25°C.
Maltese: Ħalli l-vaċċin jilħaq temperatura ta' 15°C-25°C.
English: A hypersensitivity reaction may occur.
Maltese: Tista' tikkawża reazzjoni ta' ipersensitivita'.
English: 5 doses (10 ml) 10 x 5 doses (10 x 10 ml) 10 doses (20 ml) 10 x 10 doses (10 x 20 ml) 25 doses (50 ml) 10 x 25 doses (10 x 50 ml)
Maltese: 5 dożi (10 ml) 10 x 5 dożi (10 x 10 ml) 10 dożi (20 ml) 10 x 10 dożi (10 x 20 ml) 25 doża (50 ml) 10 x 25 doża (10 x 50 ml)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/03/2000
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 09/03/2000
English: Onset of immunity: 14 days
Maltese: Bidu tal-immunita': 14-il ġurnata
English: Store and transport refrigerated (2°C- 8°C).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C )
English: a booster injection should be administered at 6 month intervals.
Maltese: injezzjoni booster għandha tiġi amministrata kull 6 xhur.
English: The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody).
Maltese: Id-deletion tal-gE gene tippermetti li ssir differenza bejn annimali vvaċċinati b'vaccini gE-negative (anti gE antikorp negattiv, IBR antikorp li jinnewtralizza l-vajrus positiv) u annimali infettati b'mod naturali (positivi sia għall-antikorp li jinnewtralizza il-vajrus tal-IBR kemm l-antikorp anti gE).
English: Light paraffin oil Benzyl alcohol
Maltese: 6.1 Lista ta' ingredjenti zejt paraffin ħafif Benzyl alcohol
English: Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
Maltese: Bovalto Ibraxion huwa vaċċin li hu gene specific deleted (gE), inattivat u bl'adjuvant miegħu li jaġixxi billi jimmunizza attivament il-bovini; huwa ikkaratterizzat bil-produzzjoni ta' l-antikorpi li jinnewtralizzaw il-vajrus tar-Rinotrakeite Infettiva fil-Bovini.
English: PHARMACEUTICAL FORM Emulsion for injection
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għal injezzjoni.
English: Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03
Maltese: Immunoloġiċi, virus rinotrakeite fil-bovini (IBR)
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U IL-MANIFATTURA RESPONSABBLI
English: Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Maltese: Immunizzazzjoni attiva tal-bovini biex jitnaqqsu s-sintomi kliniċi tar-rinotrakeite fil-bovini (IBR) u field virus excretion.
English: 29 avenue Tony Garnier 69007 LYON France
Maltese: 29 avenue Tony Garnier 69007 Lyon
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovalto Ibraxion emulsion for injection
Maltese: VETERINARJU Emulsjoni Bovalto Ibraxion għal injezzjoni.
English: Each dose (2 ml) contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* adjuvant: light paraffin oil ........................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Maltese: IBR gE deleted, mill-inqas ........................................................................ 0.75 VN.U* adjuvant: zejt paraffin ħafif ……………………………………………………...449.6 sa 488.2 mg * VN.U: titlu tal-antikorp li jinnewtralizza il-vajrus wara t-tlaqqim tal-vaċċin fil-fniek ta' l-Indi.
English: No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.
Maltese: L-ebda effetti mhux mixtieqa ħlief dawk msemmija f'sezzjoni 4.6 ma ġew osservati wara li ġiet amministrata doża eċċessiva.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a) matul il perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................ 0.75 VN.U
Maltese: IBR gE deleted, mill-inqas ……………….. 0.75 VN.U*
English: PACKAGE LEAFLET FOR Bovalto Ibraxion emulsion for injection
Maltese: Emulsjoni Bovalto Ibraxion għal injezzjoni.
English: Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)
Maltese: Fliexken tal-ħġieġ tat-Tip I b'tapp tan-nitril u ssiġillat b'tapp ta' l-aluminju Kaxxa tal-kartun bi flixkun jew 10 fliexken ta' 5 dożi (1 x 10 ml jew 10 x 10 ml) Kaxxa tal-kartun bi flixkun jew 10 fliexken ta' 10 dożi (1 x 20 ml jew 10 x 20 ml) Kaxxa tal-kartun bi flixkun jew 10 flieken ta' 25 doża (1 x 50 ml jew 10 x 50 ml)
English: 4.2 Indications for use, specifying the target species Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Maltese: INDIKAZZJONI(JIET) Immunizzazzjoni attiva tal-bovini biex jitnaqqsu s-sintomi kliniċi tar-rinotrakeite fil-bovini (IBR) u field virus excretion.
English: Store and transport refrigerated (2°C- 8°C), Do not freeze.
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C ) Tiffriżax.
English: Subcutaneous use - SC
Maltese: Taħt il-ġilda SC
English: These are rare and an appropriate symptomatic treatment should be administered.
Maltese: Dan jiġri ħafna u kura sintomatika adegwata għandha tiġi amministrata.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: To the physician:
Maltese: Grupp farmakoterapewtiku:
English: Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession,sale, supply and/or use.
Maltese: Kull persuna li turi l-intenzjoni li timmanifattura, timporta, tippossjedi, tbiegħ, tipprovdi u/jew tuża Bovalto Ibraxion għandha tikkonsulta ma' l-awtorità kompetenti ta' l-Istat Membru dwar il-programmi ta' tilqim kurrenti qabel timmanifattura, timporta, tippossejdi, tbiegħ, tipprovdi u/jew tuża.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: The excipients, including adjuvants, 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: L-addittivi, inkluż l-aġġuvanti, elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma jewsustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fittabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Maltese: Il-manifattura, l-importazzjoni, il-pussess, bejgħ, provista u / jew l-użu ta' Bovalto Ibraxion jista' jkun ipprojbit fi Stat Membru fit-territorju kollu tiegħu jew ġo parti minnu minħabba l-politika nazzjonali tiegħu.
English: Laboratoire Porte des Alpes Rue de l'Aviation-69800 Saint Priest France
Maltese: Laboratoire Porte des Alpes Rue de l'Aviation
English: Each dose of 2 ml contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Maltese: IBR gE deleted, mill-inqas ........................................................................ 0.75 VN.U* * VN.U: titlu tal-antikorp li jinnewtralizza il-vajrus wara t-tlaqqim tal-vaċċin fil-fniek ta' l-Indi.
English: Marketing authorisation holder MERIAL
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ MERIAL
English: ADVICE ON CORRECT ADMINISTRATION See above.
Maltese: U METODU TA' AMMINISTRAZZJONI
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.
Maltese: L-ebda effetti mhux mixtieqa ħlief dawk imsemmija f'”Reazzjonijiet Avversi” ma ġew osservati wara li ġiet amministrata doża eċċessiva.
English: Manufacturer responsible for batch release MERIAL
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 5 doses (10 ml)
Maltese: PIŻ, VOLUM JEW NUMRU TA' DOŻI 5 dożi (10 ml)
English: To the user:
Maltese: Tqala u treddigħ:
English: Bovalto Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
Maltese: Bovalto Ibraxion jista' jintuża waqt it-tqala u fi żmien il-ħalib .
English: The full EPAR for Retacrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Maltese: Dan jiġi f'siringi mimlijin għal-lest li fihom bejn 1,000 u 40 000 unità internazzjonali (IU) tas-sustanza attiva, epoetin zeta.