FrancophonIA/ELRC3.0 huggingface dataset:
English: The onset of pulmonary symptoms such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function together with an increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS) (see section 4.8).
Maltese: infiltrati pulmonari u deterjorament fil-funzjoni pulmonari flimkien ma' żieda fl-għadd tan-newtrofili, jistgħu jkunu sinjali preliminari tas-Sindromu ta' Problemi Respiratorji
English: The first injection should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni għandha ssir taħt superviżjoni medika diretta.
English: Check the appearance of Lonquex.
Maltese: Iċċekkja d-dehra ta' Lonquex.
English: There is no evidence that such an interaction would be harmful.
Maltese: M'hemm l-ebda evidenza li interazzjoni bħal din se tkun ta' ħsara.
English: In 2 studies (XM22-02 and XM22-03) in patients with breast cancer receiving chemotherapy consisting of doxorubicin and docetaxel, mean maximum blood concentrations of 227 and 262 ng/ml were reached after median times to maximum concentration (tmax) of 44 and 48 hours.
Maltese: F'2 studji (XM22-02 u XM22-03) f'pazjenti b'kanċer tas-sider li kienu qed jirċievu kimoterapija li tikkonsisti minn doxorubicin u docetaxel, il-medja tal-konċentrazzjonijiet massimi fid-demm ta' 227 u
English: Lonquex may be removed from the refrigerator and stored below 25°C for a maximum single period of up to 3 days.
Maltese: Lonquex jista' jitneħħa mill-friġġ u jinħażen f'temperatura ta' inqas minn 25°C għal perjodu wieħed massimu ta' sa 3 ijiem.
English: A risk to the breast-fed child cannot be excluded.
Maltese: Ir-riskju gћat-trabi li qed jiġu mredda' mhux eskluż.
English: It could be a consequence of a spleen disorder (see section4 “Possible side effects”).
Maltese: jkun konsegwenza ta' disturb fil-milsa (ara sezzjoni 4 “Effetti sekondarji possibbli”).
English: These results suggest that the G-CSF moiety of lipegfilgrastim confers the expected activity of this growth factor: stimulation of proliferation of haematopoietic progenitor cells, differentiation into mature cells and release into the peripheral blood.
Maltese: Dawn ir-riżultati jissuġġerixxu li l-moijetà ta' G-CSF ta' lipegfilgrastim tikkawża l-attività mistennija ta' dan il-fattur ta' żvilupp: stimulazzjoni ta' proliferazzjoni ta' ċelluli proġenituri ematopoijetiċi, differenzazzjoni ġo ċelluli maturi u emorraġija periferali.
English: The first pivotal (phase III) clinical study XM22-03 was an active-controlled study in 202 patients with stage II-IV breast cancer receiving up to 4 cycles of chemotherapy consisting of doxorubicin and docetaxel.
Maltese: 202 pazjenti b'kanċer tas-sider ta' stadju II-IV li kienu qed jirċievu sa 4 ċikli ta' kimoterapija li tikkonsisti minn doxorubicin u docetaxel.
English: Each ml of solution contains 10 mg lipegfilgrastim.
Maltese: Kull ml ta' soluzzjoni fih 10 mg ta' lipegfilgrastim.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4).
Maltese: Reazzjonijiet pulmonari avversi, b'mod partikulari pnewmonja interstizjali, ġew irrappurtati (ara sezzjoni 4.4).
English: Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim, lenograstim or pegfilgrastim.
Maltese: Ġeneralment, avvenimenti ta' glomerulonefrite għaddew wara tnaqqis fid-doża jew twaqqif ta' filgrastim, lenograstim jew pegfilgrastim.
English: Teva Biotech GmbH Dornierstraße 10 D-89079 Ulm Germany
Maltese: Teva Biotech GmbH Dornierstraße 10
English: In the case of overdose, WBC and platelet count should be performed regularly and spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Maltese: Fil-każ ta' doża eċċessiva, WBC u għadd tal-plejtlits għandhom isiru regolarment u d-daqs tal-milsa għandu jiġi mmonitorjat b'attenzjoni (eż. eżami kliniku, ultrasound).
English: This medicine contains 30 mg sorbitol in each pre-filled syringe.
Maltese: Din il-mediċina fiha 30 mg sorbitol f'kull siringa mimlija għal-lest.
English: How to store Lonquex
Maltese: X'inhu Lonquex
English: The linear pathway is likely due to extracellular protein degradation by neutrophil elastase and other plasma proteases.
Maltese: Il-passaġġ lineari hu x'aktarx minħabba degradazzjoni extraċellulari tal-proteini minn elastase tan-newtrofili u proteases oħrajn tal-plażma.
English: Put everything you need within easy reach (the Lonquex pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Maltese: Poġġi dak kollu li teħtieġ fejn jista' jintlaħaq faċilment (is-siringa ta' Lonquex mimlija għal-lest, tajjara bl-alkoħol, biċċa faxxa/ġarża jew ġarża/tajjara sterilizzata u l-kontenitur li ma jistax jittaqqab).
English: The mean terminal half-lives were approximately 29 and 31 hours after a single subcutaneous injection of 6 mg lipegfilgrastim during the first cycle of chemotherapy.
Maltese: Il-half lives terminali medji kienu ta' madwar 29 u 31 siegħa wara injezzjoni waħda taħt il-ġilda ta' 6 mg ta'
English: Lonquex treatment should be initiated and supervised by physicians experienced in oncology or haematology.
Maltese: Lonquex tikseb għajnuna medika immedjatament.
English: Vascular disorders - Capillary leak syndrome Cases of capillary leak syndrome have been reported in postmarketing experience after administration of G-CSF or derivatives.
Maltese: Disturbi vaskulari - Sindromu ta' tnixxija kapillari - Każijiet ta' sindromu ta' tnixxija kapillari kienu rrappurtati fl-esperjenza ta' wara t-tqegħid fissuq wara l-għoti ta' G-CSF jew derivattivi.
English: Sickle cell crisis has been associated with the use of G-CSF or derivatives in patients with sickle cell anaemia (see section 4.8).
Maltese: Kriżi taċ-ċelluli sickle ġiet assoċjata mal-użu ta G-CSF jew derivati f'pazjenti b'anemija taċ-ċelluli sickle (ara sezzjoni 4.8).
English: Remember
Maltese: ISEM
English: Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' lipegfilgrastim, f'soluzzjoni ta' 0.6 ml.
English: After a single subcutaneous injection of 6 mg lipegfilgrastim during the fourth cycle, the maximum blood concentrations were lower than observed in the first cycle (mean values 77 and 111 ng/ml) and were reached after median tmax of 8 hours.
Maltese: lipegfilgrastim matul ir-raba' ċiklu, il-konċentrazzjonijiet massimi fid-demm kienu iktar baxxi minn dawk osservati fl-ewwel ċiklu (medja tal-valuri ta' 77 u 111 ng/ml) u ntlaħqu wara tmax medjan ta'
English: Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
Maltese: Għandha tingħata attenzjoni partikulari biex wieħed jiddistingwi d-dijanjosi tat-trasformazzjoni tal-blasts ta' lewkimja majelodje kronika minn lewkimja majelodje akuta.
English: Sodium hydroxide (for pH-adjustment) Sorbitol (E420)
Maltese: Sodium hydroxide (għal aġġustament tal-pH)
English: Subcutaneous use
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Nausea.
Maltese: infezzjoni.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: • It is important to contact your doctor immediately if you have any of the following symptoms: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
Maltese: - Hu importanti li tikkuntattja lit-tabib tiegħek immedjatament jekk ikollok xi wieħed minn dawn is-sintomi li ġejjin: nefħa, li tista' tkun assoċjata ma' li persuna tagħmel l-awrina inqas frekwenti, diffikultà biex tieħu n nifs, nefħa addominali u sensazzjoni li wieħed iħossu mimli, u sensazzjoni ġenerali ta' għeja.
English: Patients with sickle cell anaemia
Maltese: Pazjenti b'anemija taċ-ċelluli sickle
English: The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated.
Maltese: Il-potenzjal għal interazzjoni mal-lithium, li jippromwovi wkoll il-ħruġ ta' newtrofili, ma ġiex investigat b'mod speċifiku.
English: It is unknown whether lipegfilgrastim/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk lipegfilgrastim/metaboliti jiġux eliminati mill-ħalib tas-sider tal-bniedem.
English: Human G-CSF is a glycoprotein that regulates the production and release of functional neutrophils from the bone marrow.
Maltese: G-CSF umana hi glikoproteina li tirregola l-produzzjoni u lħruġ ta' newtrofili funzjonali mill-mudullun.
English: • Cough, fever and difficult or painful breathing can be signs of uncommon serious pulmonary side effects, such as pneumonia and acute respiratory distress syndrome, which may be fatal.
Maltese: - Sogħla, deni u teħid tan-nifs diffiċli jew bl-uġigħ jistgħu jkunu sinjali ta' effetti sekondarji mhux komuni serji, bħal pnewmonja u sindromu ta' problema respiratorja akuta, li jistgħu jkunu fatali.
English: Once-per-cycle dosing of lipegfilgrastim was investigated in two pivotal randomised, double-blind clinical studies in patients undergoing myelosuppressive chemotherapy.
Maltese: Dożaġġ ta' lipegfilgrastim darba kull ċiklu ġie investigat f'żewġ studji kliniċi importanti ħafna, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, f'pazjenti li kienu qed jirċievu kimoterapija li trażżan l-attività tal-mudullun.
English: Capillary leak syndrome has been reported after administration of G-CSF or derivatives and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Maltese: Sindromu ta' tnixxija kapillari ġie rrappurtat wara l-għoti ta' G-CSF jew derivattivi u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edema u emokonċentrazzjoni.
English: Not known
Maltese: OĦRA TAL
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers (e.g. C-reactive protein and white blood cell count).
Maltese: Issintomi li ħassew kienu jinkludu deni, uġigħ fl-addome, telqa, uġigħ fid-dahar u żieda fil-markaturi infjammatorji (eż. proteina C-reattiva u għadd ta' ċelluli bojod tad-demm).
English: Incidence (%) 95 % CI
Maltese: 95 % CI
English: • Chest pain.
Maltese: Aħżen fi friġġ.
English: Table 1: Adverse reactions System organ class
Maltese: Sistema tal-klassifika tal-organi Frekwenza
English: Lipegfilgrastim and filgrastim induced a marked increase in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes and/or lymphocytes.
Maltese: Lipegfilgrastim and filgrastim ikkawżaw żidiet notevoli fl-għadd tan-newtrofili tad-demm periferali fi żmien 24 siegħa, b'żidiet żgħar fil-monoċiti u/jew limfoċiti.
English: Your doctor will also check your urine regularly as other medicines similar to this one (e.g. other granulocyte colony stimulating factors such as filgrastim, lenograstim or pegfilgrastim) can possibly harm the tiny filters inside your kidneys (glomerulonephritis; see section “4.
Maltese: lenograstim jew pegfilgrastim) possibilment jistgħu jagħmlu ħsara lill-filtri ż-żgħar ġewwa l-kliewi (glomerulonefrite; ara sezzjoni “4.
English: • Allergic reactions such as skin rash, raised itchy areas of skin and serious allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported uncommonly (may affect up to 1 in 100 people).
Maltese: Splenomegalija, ġeneralment asintomatika, ġiet irrappurtata (ara sezzjoni 4.4) Reazzjonijiet ta' sensittività eċċessiva bħal reazzjonijiet allerġiċi tal-ġilda, urtikarja, anġjoedema u reazzjonijiet allerġiċi serji jistgħu jseħħu.
English: Each pre-filled syringe contains 6 mg lipegfilgrastim in 0.6 ml solution.
Maltese: Kull siringa mimlija għal-lest fiha 0.6 ml ta' soluzzjoni.
English: UAB "Sicor Biotech" Tel: +370 5 266 0203
Maltese: Tel: +370 5 266 0203
English: Other medicines and Lonquex
Maltese: Għalxiex jintuża Lonquex
English: Each ml of solution for injection contains 10 mg of lipegfilgrastim.
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fih 10 mg ta' lipegfilgrastim.
English: • a pre-filled syringe of Lonquex,
Maltese: Jekk tinsa tuża Lonquex
English: After subcutaneous injection of 6 mg lipegfilgrastim at three different sites (upper arm, abdomen and thigh) in healthy volunteers, the bioavailability (peak concentration and area under the curve [AUC]) was lower after subcutaneous injection in the thigh compared to subcutaneous injection in the abdomen and in the upper arm.
Maltese: Wara injezzjoni taħt il-ġilda ta' 6 mg ta' lipegfilgrastim fi tliet siti differenti (in-naħa ta' fuq tad driegħ, l-addome u l-koxxa) f'voluntiera b'saħħithom, il-bijodisponibilità (konċentrazzjoni massima u żona taħt il-kurva
English: Each pre-filled syringe contains 6 mg lipegfilgrastim.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' lipegfilgrastim.
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 3 820 73 73
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
English: Injection site reactions*
Maltese: Reazzjonijiet tal-ġilda*
English: Avoid vigorous shaking.
Maltese: Evita ċaqliq bis-saħħa.
English: • a piece of gauze bandage or a sterile gauze swab,
Maltese: - biċċa faxxa/ġarża jew ġarża/tajjara sterilizzata,
English: Nausea*
Maltese: Nawsja*
English: Page 2/2
Maltese: Paġna 2 minn 2
English: Opinion following an Article 6(12)F F referral for Porcilis M Hyo EMA/345914/2010
Maltese: Opinjoni wara referenza skont l-Artikolu 6(12)F F għal Porcilis M Hyo EMA/345914/2010
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was France2 and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland, Hungary, Ireland, Italy, Malta, Luxembourg, Lithuania, Latvia, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia and the United Kingdom.
Maltese: L-applikazzjoni ġiet sottomessa skont il-qafas tal-Artikolu 6 tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003, fejn l-Istat Membru ta' Referenza kien Franza2 u l-Istati Membri Kkonċernati kienu l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, il-Ġermanja, id-Danimarka, l-Estonja, il-Greċja, Spanja, il-Finlandja, l-Ungerija, l-Irlanda, l-Italja Malta, il-Lussemburgu, il-Litwanja, il-Latvja, l-Olanda, in-Norveġja, il-Polonja, il-Portugall, l-Isvezja, isSlovenja, is-Slovakkja u r-Renju Unit.
English: Hyo
Maltese: għal
English: The Mutual Recognition Procedure (FR/V/0158/001/II/002) started on 30 January 2009.
Maltese: Il-Proċedura ta' Rikonoxximent Reċiproku (FR/V/0158/001/II/002) bdiet fit-30 ta' Jannar 2009.
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae.
Maltese: Porcillis M Hyo huwa prodott mediċinali immunoloġiku veterinarju li fih Mycoplasma hyopneumonise.
English: 16 August 2010
Maltese: fis-16 ta' Awwissu 2010
English: referral for Porcilis M
Maltese: Porcilis M Hyo
English: Opinion following an Article 6(12)
Maltese: Opinjoni wara referenza skont l-Artikolu 6(12)
English: 1 Article 6(12) of Commission Regulation (EC) No 1084/2003.
Maltese: 1 L-Artikolu 6(12) tar-Regolament tal-Kummissjoni (KE) Nru 1084/2003.
English: Committee for medicinal products for veterinary use (CVMP)
Maltese: Il-Kumitat għall-prodotti mediċinali għall-użu veterinarju (CVMP)
English: Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April
Maltese: Ġew ipprovduti spjegazzjonijiet bil-miktub mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq fil-15 ta' Jannar 2010 u fl-20 ta' April 2010 ġiet sottomessa informazzjoni supplimentari.
English: On 2 October 2009 the United Kingdom on behalf of France, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality, safety and efficacy of the simultaneous administration of Porcilis M Hyo with Porcilis PRRS.
Maltese: Fit-2 ta' Ottubru 2009, ir-Renju Unit, f'isem Franza,, irrefera l-kwistjoni lill-Aġenzija skont l-Artikolu 39 tad-Direttiva 2001/82/KE kif emendata permezz ta'referenza għall-Artikolu 6(12) tar-Regolament (KE) Nru 1084/2003 minħabba tħassib imqajjem minn Spanja dwar il-kwalità, is-sigurtà u l-effikaċja ta' għoti simultanju ta' Porcillis M Hyo ma' Porcillis PRRS.
English: The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr A.M. Brady as co-rapporteur.
Maltese: Rubio Montejano bħala rapporteur.
English: The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis M Hyo concerning simultaneous administration with Porcilis PRRS.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Intervet International B.V., issottometta applikazzjoni għal varjazzjoni ta' Tip II soġġetta għall-Proċedura ta' Rikonoxximent Reċiproku għal Porcillis M Hyo fir-rigward ta' għoti fl-istess ħin ma' Porcillis PRRS.
English: During the procedure Dr C. Muñoz Madero replaced Dr C. Rubio Montejano as rapporteur.
Maltese: Muñoz Madero ħa post Dr C.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis M Hyo satisfies the criteria for approval.
Maltese: Fuq il-bażi tal-istima li għamlu r-rapporteurs tad-data disponibbli dak il-ħin, fid-19 ta' Mejju 2010, isCVMP adotta opinjoni li tirrakkomanda li l-applikazzjoni għall-varjazzjoni applikata għall-prodott mediċinali veterinarju Porcillis M Hyo tissodisfa l-kriterji għall-approvazzjoni.
English: The referral procedure started on 14 October 2009.
Maltese: Il-proċedura ta' referenza bdiet fl-14 ta' Ottubru 2009.
English: Having considered all data submitted the CVMP concluded that:
Maltese: Wara li kkunsidra d-dejta kollha sottomessa, is-CVMP ikkonkluda li:
English: The reference Member State (RMS) is the Czech Republic and 10 concerned Member States (CMS) are involved: Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom.
Maltese: L-Istat Membru ta' referenza (RMS) huwa r-Repubblika Ċeka u huma involuti 10 Stati Membri kkonċernati (CMS): l-Awstrija, id-Danimarka, Franza, il-Ġermanja, l-Irlanda, l-Italja, il-Pajjiżi l-Baxxi, il-Portugall, Spanja u r-Renju Unit.
English: Environmental risk
Maltese: Riskju ambjentali
English: Clavulanic acid, a naturally-occurring substance is a beta-lactamase inhibitor and chemical synergist for amoxicillin.
Maltese: Clavulanic acid, sustanza li tinstab b'mod naturali, hija inibitur ta' beta-lactamase u sinerġista kimika għal amoxicillin.
English: According to the guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005) the Environmental Risk Assessment targets at effects of the combination product.
Maltese: Skont il-linja gwida dwar il-prodotti farmaċewtiċi b'kombinazzjoni fissa (EMEA/CVMP/83804/2005), ilValutazzjoni tar-Riskju Ambjentali timmira lejn l-effetti tal-prodott ikkombinat.
English: The PECsurfacewater was calculated to be 31.80 μg/l for amoxicillin and 1.09 μg/l for clavulanic acid.
Maltese: Il-PECilma tal-wiċċ ġiet ikkalkolata li hija 31.80 μg/l għall-amoxicillin u 1.09 μg/l għal clavulanic acid.
English: PECsoil (combination) was 1086 μg/kg.
Maltese: Il-(kombinazzjoni) tal-PECħamrija kienet ta' 1086 μg/kg.
English: The proposed indications for STRENZEN 500/125 mg/g powder for use in drinking water for pigs are treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Maltese: L-indikazzjonijiet proposti għal STRENZEN 500/125 mg/g trab għal użu fl-ilma tax-xorb għallħnieżer huma t-trattament ta' infezzjonijiet fl-apparat tan-nifs ikkawżati minn mikroorganiżmi suxxettibbli għat-taħlita ta' amoxicillin/clavulanic acid, jiġifieri Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp. u infezzjonijiet gastrointestinali kkawżati minn Clostridium spp., E. coli u Salmonella spp.
English: Czech Republic Novartis Animal Health Inc. Schwarzwaldallee 215
Maltese: Id-Danimarka Novartis Animal Health Inc.
English: The data collected from different public sources on metabolites indicate that there are no environmental risks (according to current ERA methodology).
Maltese: Id-dejta miġbura minn sorsi pubbliċi differenti dwar il-metaboliti tindika li ma hemm ebda riskju ambjentali (skont il-metodoloġija attwali tal-ERA).
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-isem, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi ta' annimal, metodu ta' amministrazzjoni, applikant fl-Istati Membri
English: The PECsoil value 869 μg/kg was used in the subsequent assessment.
Maltese: Il-valur tal-PECħamrija ta' 869 μg/kg intuża fil-valutazzjoni sussegwenti.
English: The application in question, submitted via the decentralised procedure, is a generic application according to Art. 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water registered in the Czech Republic (No.96/069/98-C).
Maltese: L-applikazzjoni inkwistjoni, sottomessa permezz tal-proċedura deċentralizzata, hija applikazzjoni ġenerika skont l-Art. 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Amoksiklav 500/125 mg/g trab għal użu fl-ilma tax-xorb irreġistrat fir-Repubblika Ċeka (Nru.96/069/98-C).
English: The applicant submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Maltese: L-applikant issottometta applikazzjoni għal proċedura deċentralizzata għal STRENZEN 500/125 mg/g trab għal użu fl-ilma tax-xorb għall-ħnieżer skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Amoksiklav 500/125 mg/g trab għal użu fl-ilma taxxorb awtorizzat fir-Repubblika Ċeka (MA Nru. 96/069/98-C).
English: The PECsurfacewater (combination) was 32.89 μg/l.
Maltese: Il(kombinazzjoni) tal-PECilma tal-wiċċ kienet ta' 32.89 μg/l.
English: The product containing amoxicillin and clavulanic acid (in the form of the potassium salt) at a ratio 4:1 is indicated for treatment of infections caused by microorganisms in intensively reared pigs including respiratory diseases.
Maltese: Il-prodott li fih amoxicillin u clavulanic acid (fil-forma tal-melħ tal-potassju) fi proporzjon ta' 4:1 huwa indikat għall-kura tal-infezzjonijiet ikkawżati minn mikroorganiżmi fi ħnieżer imrobbija b'mod intensiv, inkluż mard respiratorju.