FrancophonIA/ELRC3.0 huggingface dataset:
English: • The vaccine has been shown to reduce clinical signs and mortality and reduce virus shedding in infected chickens.
Maltese: • Il-vaċċin wera li jnaqqas is-sinjali kliniċi u l-mortalità u jnaqqas it-tixrid tal-vajrus f'tiġieġ infettati.
English: • If the circulating avian influenza field virus has a different N component to the N1 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Maltese: • Jekk il-vajrus ta' l-influwenza avjarju li jiċċirkola għandu komponent N differenti mill-N1li jinsab fil-vaċċin, jista' jkun possibbli li wieħed jagħmel differenza bejn vaċċin minn għasfur infettat u dak vaċċinat permezz ta' test dijanjostiku sabiex jiġu misjuba antikorpi Neuraminidase.
English: This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.
Maltese: Dan huwa għaliex il-kontroll ta' l-influwenza avjarja hija r-responsabbilità ta' l-awtoritajiet veterinarji nazzjonali f'konsultazzjoni mal-Kummissjoni Ewropea.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H7N1
Maltese: PUBBLIKA EWROPEW (EPAR) INFLUWENZA NOBILIS H7N1 Sommarju EPAR għall-pubbliku
English: • The vaccine has been shown reduce virus shedding in infected ducks.
Maltese: • Il-vaċċin wera t-tnaqqis fit-tixrid tal-vajrus f'papri infettati.
English: The company also performed a laboratory study in chickens with a vaccine similar to Nobilis Influenza H7N1.
Maltese: Il-kumpanija għamlet studju fil-laboratorju wkoll fuq tiġieġ permezz ta' vaċċin simili għallInfluwenza Nobilis H7N1.
English: This means that vaccinated birds make antibodies against these two antigens.
Maltese: Dan ifisser li għasafar vaċċinati jipproduċu antikorpi kontra dawn iż-żewġ antiġeni.
English: Nobilis Influenza H7N1 is a vaccine.
Maltese: L-Influwenza Nobilis H7N1 huwa vaċċin.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H7N1 to Intervet International BV on 14/05/2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea, għall-Influweza Nobilis H7N1 lil Intervet International BV fil-14/05/2007.
English: Nobilis Influenza H7N1 has been authorised under “Exceptional Circumstances”.
Maltese: Influwenza Nobilis H7N1 ġie awtorizzat taħt “Ċirkustanzi Eċċezzjonali”.
English: Other information about Nobilis Influenza H7N1:
Maltese: Informazzjoni oħra dwar l-Influwenza Nobilis H7N1:
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropea (EPAR).
English: Nobilis Influenza H7N1 is a vaccine used in chickens and ducks to protect against avian influenza.
Maltese: L-Influwenza Nobilis H7N1 huwa vaċċin użat fit-tiġieġ u l-papri sabiex jiġu protetti kontra linfluwenza avjarja.
English: The vaccine reduces the signs of flu in chickens and the excretion (shedding) and transmission (spreading) of the virus by the infected chickens and ducks.
Maltese: Il-vaċċin inaqqas is-sinjali ta' influwenza fit-tiġieġ u l-ħmieġ (ħrif) u trasmissjoni (tixrid) tal-vajrus minn tiġieġ u papri infettati.
English: What is the risk associated with Nobilis Influenza H7N1?
Maltese: X'inhu r-riskju assoċjat ma' l-Influwenza Nobilis H7N1?
English: This vaccine has some of the same ingredients but a different antigen (virus) to Nobilis Influenza H7N1.
Maltese: Dan il-vaċċin fih l-istess ingredjenti b'antiġenu differenti (vajrus) millInfluwenza Nobilis H7N1 .
English: When compared, the subcutaneous and intramuscular routes were shown to produce the same responses.
Maltese: Il-mezzi subkutaneji u intramuskolari meta mqabbla wrew li jipproduċu l-istess effetti.
English: When it is given to chickens and ducks, the birds' immune system (their natural defence mechanism) makes antibodies (a special type of protein) to fight the disease.
Maltese: Meta tingħata lit-tiġieġ u lil papri, is-sistema immunitorja ta' l-għasafar (il-mekkaniżmu tad-difiża naturali tagħhom) toħloq antikorp (tip speċjali ta' proteina) sabiex tiġġieled il-mard.
English: The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).
Maltese: Il-vaċċin huwa injettat b'mod intramuskolari (f'muskolu) jew b'mod subkutaneju (taħt il-ġilda).
English: The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in reducing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Maltese: Il-Kumitat għall Użu ta' Prodotti Mediċinali għal użu Veterinarju kkonkluda li l-vaċċin wera li huwa effettiv fit-tnaqqis ta' mard kliniku fit-tjur u jista' jkun għodda utli fil-kontroll tal-firxa ta' infezzjoni ta' l-influwenza avjarja.
English: What is Nobilis Influenza H7N1?
Maltese: X'inhi l-Influwenza Nobilis H7N1?
English: The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.
Maltese: Il-vaċċin ma fihx ingredjenti li jistgħu jkunu ta' riskju għall-konsumaturi ta' għasafar vaċċinati.
English: How does Nobilis Influenza H7N1 work?
Maltese: Kif ġiet studjata l-Influwenza Nobilis H7N1?
English: The company carried out laboratory studies using Nobilis Influenza H7N1 in chickens and ducks.
Maltese: Il-kumpanija għamlet studji fil-laboratorju fuq tiġieġ u papri permezz ta' l-użu ta' l-Infuwenza Nobilis H7N1.
English: Belgium Teva Pharma B.V. Computerweg 10
Maltese: Il-Ġermanja Teva Pharma B.V. Computerweg 10
English: Slovak Republic Teva Pharma B.V. Computerweg 10
Maltese: Ir-Rumanija Teva Pharma B.V. Computerweg 10
English: (Invented) Name Strength
Maltese: Isem (ivvintat) Qawwa
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali,
English: Slovenia
Maltese: Ir-Repubblika Slovakka
English: It may harm them,
Maltese: Disturbi psikjatriċi nuqqas ta' mistrieħ,
English: CIOMS frequency categories: Very Common (>=10%); Common (>=1%<10%),Uncommon (>=0.1% - <1%), Rare (>=0.01% - <0.1%), Very Rare (<0.01%).
Maltese: Kategoriji tal-frekwenza ta' CIOMS: Komuni Ħafna (>=10%); Komuni (>=1% - <10%), Mhux Komuni (>=0.1% - <1%), Rari (>=0.01% - <0.1%), Rari Ħafna (<0.
English: The individual incremental recovery ranged from 0.50 to 1.76 [(IU/dL)/(IU/kg)].
Maltese: L-irkupru inkrimentali individwali varja minn 0.50 sa 1.76 [(IU/dL)/(IU/kg)].
English: See section 4.4 for information on parvovirus B19 infection.
Maltese: Ara sezzjoni 4.4 għal informazzjoni dwar infezzjoni bil-parvovirus B19.
English: In total 6375 administrations of CEPROTIN have been given.
Maltese: B'kollox kien hemm 6375 amministrazzjoni ta' CEPROTIN.
English: Preferred Term
Maltese: Terminu Ppreferut
English: Nervous System Disorders
Maltese: Disturbi fis-Sistema Nervuża
English: Immune System Disorders
Maltese: Disturbi fis-Sistema Immuni
English: • surgery or invasive therapy is imminent
Maltese: • kirurġija jew terapija intensiva tkun imminenti
English: Human albumin, sodium chloride and sodium citrate.2H2O
Maltese: Albumina umana, sodium chloride u sodium citrate.2H2O
English: System Organ Class Adverse Reaction
Maltese: Sistema tal-Klassifika tal-Organi
English: APC has also been shown to have profibrinolytic effects.
Maltese: Ġie ppruvat ukoll li APC għandha effetti profibrinolitiċi.
English: Pharmacotherapeutic group: group antithrombotic; ATC Code: B01AD12
Maltese: Kategorija farmakoterapewtika: kategorija kontra t-trombożi; Kodiċi ATC:
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Maltese: Il-miżuri meħuda jistgħu jkunu ta' valur limitat kontra virus mhux miksija bħall-parvovirus B19.
English: After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.
Maltese: Wara rikostituzzjoni s-soluzzjoni jkollha pH ta' bejn 6.7 u 7.3 u osmolalità ta' mhux anqas minn 240 mosmol/kg.
English: Date of first authorisation: 16 July 2001 Date of last renewal: 16 July 2006
Maltese: Data tal-aħħar tiġdid: 16 ta' Lulju 2006
English: 21asymptomatic subjects with homozygous or double heterozygous protein C deficiency were evaluated for pharmacokinetic data.
Maltese: Ġew evalwati 21suġġett asimtomtomatiku b'defiċjenza tal-proteina omożigota jew eterożigota doppja għal informazzjoni farmakokinetika.
English: 5 ml Sterilised Water for Injections
Maltese: 5 ml Ilma Sterilizzat għall-Injezzjonijiet
English: CEPROTIN belongs to a class of medicines called antithrombotics.
Maltese: CEPROTIN jagħmel parti minn klassi ta' mediċini msejħa antitrombotiċi.
English: Frequency Category by infusions
Maltese: Kategorija talFrekwenza b'infużjonijiet
English: 10 ml Sterilised Water for Injections
Maltese: 10 ml Ilma Sterilizzat għall-injezzjonijiet
English: The individual half-lives varied from 4.4 to 15.8 hours using a compartmental model and from 4.9 to 14.7 using the non-compartmental method.
Maltese: 8 sigħat bl-użu tal-mudell kumpartimentali u minn 4.9 sa 14.7 sigħat bl-użu tal-mudell mhux kumpartimentali.
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 ml/kg/min.
Maltese: CEPROTIN għandu jiġi amministrat b'rata massima ta' injettar ta' 2 ml kull minuta ħlief fit-tfal li għandhom piż korporali ta' < 10 kg, fejn ir-rata ta' injezzjoni m'għandhiex taqbeż 0.2 ml/kg/min.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Maltese: Il-miżuri meħuda huma meqjusa effettivi għal virus miksija bħal ngħidu aħna l-virus talimmunodefiċjenza umana (HIV), il-virus tal-epatite B u l-virus tal-epatite C, u għall-virus mhux miksi tal-epatite A.
English: Powder: - The active substance is human protein C - The other ingredients are human albumin, sodium chloride and sodium citrate.2H2O.
Maltese: - Is-sustanza attiva hija l-proteina umana C - Is-sustanzi l-oħra huma l-albumina umana, sodium chloride u sodium citrate.2H2O.
English: Indication was prevention and treatment of purpura fulminans and thrombotic disease, enrolling overall 14 subjects of 2 days old throughout adolescence.
Maltese: L-indikazzjoni kienet prevenzjoni u trattament ta' purpura fulminans u mard trombotiku, li globalment irreġistraw 14-il suġġett ta' età ta' jumejn waqt l-adoloxxenza.
English: During clinical studies with CEPROTIN, a total of 3 non-serious adverse drug reactions (ADRs) were reported in 1 of 67 patients enrolled (rash and pruritus (grouped as hypersensitivity), and dizziness).
Maltese: Waqt studji kliniċi b'CEPROTIN, kienu rrapportati b'kollox 3 reazzjonijiet avversi mhux serji għall-mediċina (ADRs) f'1 mis-67 pazjent irreġistrat (raxx u ħakk (miġbura flimkien bħala sensittività eċċessiva), u sturdament).
English: Other medicines and CEPROTIN
Maltese: Mediċini oħra u CEPROTIN
English: BAXTER AG Industriestrasse 67 A-1221 Vienna Austria
Maltese: Baxter AG Industriestrasse 67 A-1221 Vienna L-Awstrija
English: Other experience with CEPROTIN covers case reports and a clinical study in overall 69 paediatric patients with acquired protein C deficiency.
Maltese: Esperjenza oħra b'CEPROTIN tkopri rapporti dwar każijiet u studju kliniku f'69 pazjent pedjatriku globalment li kellhom defiċjenza akkwiżita ta' proteina Ċ.
English: The study is a randomized, double-blind, placebo-controlled dose-finding study, in the indication of acquired protein C deficiency due to meningococcal sepsis (IMAG 112).
Maltese: L-istudju hu randomised, double-blind, bi plaċebo bħala kontrolli għat-tfitxija tal-aħjar doża, fl-indikazzjoni ta' defiċjenza ta' proteina Ċ akkwiżita minħabba sepsis meningokokkali (IMAG 112).
English: * One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 ml of normal plasma.
Maltese: Waħda (IU) ta' proteina Ċ tikkorispondi għall-attività imkejla b'mod amidolitikali ta' proteina Ċ f'1 ml ta' plażma normali.
English: In patients receiving prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Maltese: F'pazjenti li jirċievu amministrazzjoni profilattika ta' proteina Ċ, livelli ogħla ta' tnaqqis għandhom mnejn ikunu meħtieġa f'sitwazzjonijiet ta' riskju ogħla ta' trombożi (bħal infezzjoni, trawma, jew intervent kirurġiku).
English: Solvent Sterilised Water for Injections
Maltese: Solvent Ilma Sterilizzat għall-injezzjonijiet
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Maltese: Il-miżuri meħuda huma meqjusa effettivi għal virus miksija bħall-HIV, HBV u HCV u għall-virus mhux miksi HAV.
English: APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation.
Maltese: APC hija protease tas-serine b'effetti qawwija ta' kontra l-koagulazzjoni, speċjalment fil-preżenza tal-kofattur proteina S. APC jeżerċita l-effett tiegħu bl-inattivazzjoni tal-għamliet attivati tal-fatturi V u VIII li jwasslu għat-tnaqqis fil-formazzjoni ta' trombin.
English: • one transfer needle • one filter needle
Maltese: • labra tat-trasferiment • labra tal-filtru
English: How to store CEPROTIN
Maltese: Tużax CEPROTIN
English: The following ADRs have been reported in the post-marketing experience:
Maltese: Dawn l-ADRs li ġejjin ġew irrapportati fl-esperjenza ta' wara t-tqegħid fis-suq:
English: • The following side effects were rarely observed during clinical studies (less than 1 case in 1000 administrations given to patients): itching (pruritus), rash and dizziness.
Maltese: • L-effetti sekondarji li ġejjin kienu osservati b'mod rari waqt studji kliniċi (anqas minn każ wieħed f'1000 amministrazzjoni mogħtija lil pazjenti): ħakk (pruritus), raxx u sturdament.
English: A protein C activity of 100 % should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment.
Maltese: Attività tal-proteina Ċ ta' 100% għandha tintlaħaq fil-bidu u l-attività għandha tibqa' tinżamm ogħla minn 25% għal kemm idum it-trattament.
English: In the context of clinical experience several bleeding episodes have been observed.
Maltese: Fil-kuntest tal-esperjenza klinika kienu osservati diversi episodji ta' emorraġija.
English: If the patient is switched to permanent prophylaxis with oral anticoagulants, protein C replacement is to be discontinued only when stable anticoagulation is obtained (see section 4.5).
Maltese: Jekk il-pazjent jiġi maqlub għal profilassi permanenti b'sustanzi orali kontra l-koagulazzjoni tad-demm, is-sostituzzjoni tal-proteina Ċ għandha titwaqqaf biss meta tinkiseb antikoagulazzjoni stabbli (ara sezzjoni 4.5).
English: Protein C from human plasma purified by mouse monoclonal antibodies.
Maltese: Proteina Ċ mill-plażma tal-bniedem ppurifikata b'antikorpi monoklonali tal-ġurdien.
English: In patients with HIT, symptoms such as arterial and venous thrombosis, disseminated intravascular coagulation (DIC), purpura, petechiae and gastrointestinal bleeding (melena), may occur.
Maltese: F'pazjenti b'HIT, jistgħu jseħħu sintomi bħalma huma trombożi talarterja u tal-vina, koagulazzjoni intravaskulari mifruxa (DIC), purpura, tbenġil, u emorraġija fl-imsaren (melena).
English: CEPROTIN should be administered at a maximum injection rate of 2 ml per minute.
Maltese: CEPROTIN għandu jingħata b'rata massima ta' injezzjoni ta' 2 ml fil-minuta.
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular / repeated receipt of human plasma-derived Protein C products.
Maltese: Għandu tiġi kkunsidrata vaċinazzjoni xierqa (epatite A u B) għal pazjenti li jirċievu b'mod regolari/ripetut prodotti tal-Proteini C derivati minn plażma umana.
English: • when coumarin therapy is not feasible.
Maltese: • meta t-terapija bil-kumarina ma tkunx vijabbli.
English: In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists (e.g. warfarin), a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent.
Maltese: F'pazjenti li jibdew kura b'sustanzi orali kontra l-koagulazzjoni tad-demm li jappartjenu għall-klassi ta' antagonisti għall-vitamina K (p.e. warfarina), jista' jkun hemm stat temporanju ta' koagulazzjoni eċċessiva qabel ma l-effett mixtieq ta' kontra l-koagulazzjoni tad-demm isir evidenti.
English: CEPROTIN is used in the treatment and prevention of thrombotic and haemorrhagic skin lesions (named purpura fulminans) in patients with severe congenital protein C deficiency.
Maltese: CEPROTIN jintuża fil-kura u l-prevenzjoni ta' feriti trombotiċi u emorraġiċi tal-ġilda (imsejħa purpura fulminans) f'pazjenti b'defiċjenza konġenita severa ta' proteina Ċ.
English: Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, pruritus, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing.
Maltese: Il-pazjenti għandhom jiġu infurmati dwar is-sinjali bikrija tar-reazzjonijiet ta' sensittività eċċessiva, li jistgħu jinkludu anġjoedema, ħruq u tingiż fil-post talinjezzjoni, kesħa, fwawar, raxx, ħakk, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, ħedla, nawsja, nuqqas ta' kwiet, takikardija, uġigħ tas-sider, tnemnim, rimettar, u tħarħir.
English: Sodium chloride: 88 mg/vial Sodium citrate.
Maltese: Sodium chloride: 88 mg/kunjett Sodium citrate: 2H2O: 44 mg/kunjett
English: This transient effect may be explained by the fact that protein C, itself a vitamin K dependent plasma protein, has a shorter half-life than most of the vitamin K dependent proteins (i.e. II, IX and X).
Maltese: Dan l-effett temporanju jista' jiġi spjegat bil-fatt li l-proteina Ċ, li hija nnifisha proteina tal-plażma dipendenti fuq il-vitamina K, għandha half-life iqsar mill-biċċa l-kbira tal-proteini dipendenti fuq il-vitamina K (jiġifieri II, IX u X).
English: Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Maltese: Infezzjoni bil-parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni tal-fetu) u għal persuni b'immunodefiċjenza jew eritrpoesi akbar (p.e. anemija emolitika).
English: 2H2O: 22 mg/vial
Maltese: Sodium chloride: 44 mg/kunjett Sodium citrate: 2H2O: 22 mg/kunjett
English: Parvovirus B 19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Maltese: Infezzjoni bil-parvovirus B19 tista' tkun serja għal nisa tqal (infezzjoni tal-fetu) u għal persuni li s-sistema immunitarja tagħhom hija depressa jew li għandhom xi tipi ta' anemija (p.e. sickle cell disease jew anemija emolitika).
English: The quantity of sodium in the maximum daily dose may exceed 200 mg.
Maltese: L-ammont ta' sodju fid-doża massima ta' kuljum jista' jaqbeż 200 mg.
English: The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Maltese: Il-varjazzjoni wiesgħa f'reazzjonijiet individwali timplika li l-effetti ta' CEPROTIN fuq il-parametri ta' koagulazzjoni għandhom jiġu kkontrollati b'mod regolari.
English: The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C. Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications.
Maltese: Is-sostituzzjoni tal-proteina C f'pazjenti b'defiċjenza ta' proteina Ċ huwa mistenni li jikkontrolla jew - jekk jingħata b'mod profilattiku - jevita kumplikazzjonijiet trombotiċi.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Il-miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, eżami tad-donazzjonijiet individwali u ta' puls ta' plażma għal indikaturi speċifiċi ta' infezzjoni, u l-inklużjoni ta' passi effettivi tal-manifattura għat-twaqqif/tneħħija ta' virus.
English: It is converted by thrombin/thrombomodulin-complex on the endothelial surface to activated protein C (APC).
Maltese: Hija tiġi mibdula bil-kumpless trombin/trombomodulin fil-wiċċ endoteljali għal proteina Ċ attivata (APC).
English: CEPROTIN is indicated in purpura fulminans and coumarin-induced skin necrosis in patients with severe congenital protein C deficiency.
Maltese: CEPROTIN huwa indikat f'purpura fulminans u f'nekrosi tal-ġilda kkaġunata minn kumarina f'pazjenti li għandhom defiċjenza konġenitali serja tal-Proteina Ċ.
English: The protein C plasma activity was measured by chromogenic assay.
Maltese: L-attività tal-proteina Ċ fil-plażma ġiet imkejla b'assaġġ kromoġeniku.
English: No interactions with other medicinal products are currently known.
Maltese: Attwalment mhumiex magħrufa interazzjonijiet ma' prodotti mediċinali oħra.
English: The distribution of the related ADRs is as follows:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Maltese: Ikkostitwixxi mill-ġdid it-trab xott ta' CEPROTIN għal soluzzjoni għall-injezzjonijiet, bis-solvent fornut (Ilma Sterilizzat għall-Injezzjonijiet) billi tuża l-labra sterilizzata tat-trasferiment.
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived Protein C products.
Maltese: It-tabib tiegħek jista' jissuġġerilek li tikkunsidra li tieħu tilqima kontra l-epatite A u B jekk inti tirċievi b'mod regolari/ripetut prodotti tal-proteina Ċ derivati minn plażma umana.
English: For instructions on reconstitution of the medicinal product before administration, see section.6.6.
Maltese: Għal struzzjonijiet fuq ir-rikostituzzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Based on the limited clinical experience in children from reports and studies covering 83 patients, dosing guidelines for adult subjects are considered valid for neonatal and paediatric patient population (see section 5.1).
Maltese: Abbażi tal-esperjenza klinika ristretta miksuba fi tfal minn rapporti u studji li jkopru 83 pazjent, il-linji gwida dwar dożaġġi f'suġġetti adulti huma kkunsidrati validi għal popolazzjonijiet ta' trabi li għadhom jitwieldu u pazjenti pedjatriċi (ara sezzjoni 5.1).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse protein or heparin, except for control of life-threatening thrombotic complications.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 jew għal proteina tal-ġrieden, jew għal eparina, għajr għal kontroll ta' komplikazzjonijiet mit-trombożi li jkunu ta' theddida għall-ħajja.
English: Powder
Maltese: Sturdament
English: • while initiating coumarin therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi