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influenza A virus
51 Prevajalska redakcija
izobraževanje
CELEX: 31992L0040
If the haemagglutinin subtype is not known, evidence for infection with influenza A viruses may be obtained by detecting antibodies directed to the group specific antigens.
Če hemaglutininski podtip ni poznan, se lahko okužba z virusi influence A dokaže z ugotavljanjem protiteles proti skupinsko specifičnim antigenom.
52 Prevajalska redakcija
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Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/ CK/ Italy/ 473/ 99), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H7N1 (sev, A/ CK/ Italija/ 473/ 99), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu učinkovitosti.
53 Prevajalska redakcija
izobraževanje
CELEX: 32003D0436
In order to control the spread of infection with low pathogenic avian influenza virus the Commission has approved a vaccination programme by Commission Decision 2002/975/EC(6).
Za nadzor širjenja okužbe z virusom nizko patogene aviarne influence je Komisija z Odločbo Komisije 2002/975/ES [6] odobrila program cepljenja.
54 Prevajalska redakcija
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Inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/ duck/ Potsdam/ 1402/ 86), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H5N2 (sev A/ raca/ Potsdam/ 1402/ 86), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu potentnosti.
55 Prevajalska redakcija
izobraževanje
CELEX: 31992L0040
Because it is important that control measures aimed at limiting the spread of virus should be implemented as soon as possible, each regional laboratory should be in a position to identify any isolated haemagglutinating virus as influenza viruses of H5 or H7 subtype in addition to Newcastle disease virus.
Ker je pomembno, da se ukrepi nadzora, namenjeni omejevanju širjenja virusa, izvedejo kolikor je mogoče hitro, mora biti v vsakem regionalnem laboratoriju dodatno ob določanju virusa atipične kokošje kuge mogoče tudi določanje vsakega hemaglutinirajočega virusa, kot so virusi influence podtipov H5 in H7.
56 Prevajalska redakcija
izobraževanje
CELEX: 31993D0342
if there is suspicion, it must submit samples of each avian influenza virus or paramyxovirus found to specific laboratory testing in accordance with the procedure set out in Annex A;
če obstaja sum, mora predložiti vzorce vsakega odkritega virusa aviarne influence ali paramiksovirusa za posebne laboratorijske preiskave v skladu s postopkom, določenim v Prilogi A;
57 Prevajalska redakcija
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Inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/ duck/ Potsdam/ 2243/ 84), inducing an HI titre of ≥ 6.0 log2 as tested according to the potency test.
Inaktivirani antigen podtipa virusa aviarne influence H5 (sev H5N6, A/ raca/ Potsdam/ 2243/ 84), ki vzbudi titer HI ≥ 6, 0 log2 pri preizkusu učinkovitosti.
58 Prevajalska redakcija
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The Committee for Medicinal Products for Human Use (CHMP) decided that Tamiflu’ s benefits are greater than its risks for the treatment and prevention of influenza, as an additional method in case of a pandemic or when flu vaccines are not effective against the influenza virus causing the seasonal epidemic.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tamiflu pri zdravljenju in preprečevanju gripe kot dodatna metoda v primeru pandemije ali kadar cepiva proti gripi niso učinkovita proti virusu influence, ki povzroča sezonsko epidemijo, večje od z njim povezanih tveganj.
59 Prevajalska redakcija
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The clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non vaccinated animals or vaccinated with a competitive product).
Klinične znake in izločanje virusa influence po okužbi so primerjali med cepljenimi in kontrolnimi živalmi (živali, ki jih niso cepili ali pa so jih cepili s konkurenčnim cepivom).
60 Prevajalska redakcija
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It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector viruses respectively, and a tetanus toxoid (chemically weakened toxins from the tetanus bacterium).
Vsebuje dele dveh sevov virusa konjske influence (gripe), vstavljenih v dva virusa vektorja (prenašalca) canarypox, in toksoid tetanusa (kemično oslabljene toksine iz bakterije tetanusa).
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Similar to the homologous challenge, vaccination against a heterologous challenge reduced virus burden, and reduced haematological (leukopenia) changes associated with highly pathogenic avian influenza infection.
Podobno kot pri injiciranju homolognega virusa je tudi pri cepljenju proti heterolognemu virusu prišlo do zmanjšanja virusnega bremena in do manj izraženih hematoloških sprememb (levkopenija), povezanih z izjemno patogeno okužbo s ptičjo gripo.
62 Prevajalska redakcija
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The protective efficacy of CELVAPAN against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza H5N1 virus was assessed non-clinically in a ferret challenge model.
Učinkovitost cepiva CELVAPAN pri zaščiti pred obolevnostjo in smrtnostjo zaradi okužbe s smrtonosnimi odmerki izredno patogenega virusa ptičje gripe H5N1 je bila ocenjena neklinično na dihurju.
63 Prevajalska redakcija
izobraževanje
CELEX: 31992L0040
the packaging material, the vehicles used to transport eggs referred to in 1 (b) and all premises with which the eggs come into contact are cleaned and disinfected in such a way as to destroy all avian influenza virus;
da se embalaža, vozila, uporabljena za prevoz jajc, navedenih v 1(b), in vsi prostori, ki pridejo v stik z jajci, očistijo in razkužijo na tak način, da se uniči ves virus aviarne influence;
64 Prevajalska redakcija
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The vaccine contains the inactivated ‘ surface antigen ’ from three different strains (types) of influenza (flu) virus as active substances (A/ Solomon Islands/ 3/ 2006, A/ Wisconsin/ 67/ 2005 and B/ Malaysia/ 2506/ 2004).
Cepivo vsebuje kot zdravilno učinkovino inaktiviran „ površinski antigen “ treh različnih sevov (tipov) virusa gripe (A/ Salomonovi otoki/ 3/ 2006, A/ Wisconsin/ 67/ 2005 in B/ Malezija/ 2506/ 2004).
65 Prevajalska redakcija
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Naturally occurring mutations in influenza A/ H1N1 virus associated with reduced susceptibility to oseltamivir in vitro have been detected in patients who, based on the reported information, have not been exposed to oseltamivir.
Pri bolnikih, za katere so poročali, da niso bili izpostavljeni oseltamivirju, so odkrili naravno nastale mutacije virusa influence A/ H1N1, ki so bile povezane z zmanjšano občutljivostjo na oseltamivir in vitro.
66 Prevajalska redakcija
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If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Če ima divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivo, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
67 Prevajalska redakcija
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If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect neuraminidase antibodies.
Če ima divji virus aviarne influence sestavino N, ki se razlikuje od sestavin N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
68 Prevajalska redakcija
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To stimulate active immunity in chickens and ducks against avian influenza virus, H5 subtype. To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Cepivo je namenjeno spodbujanju aktivne imunosti pri piščancih in racah proti virusu aviarne influence podtipa H5 in sproženju serološkega odziva proti N3 neuraminidazi, ki lahko služi kot marker za razlikovanje med okuženimi in cepljenimi živalmi (t. i. strategija DIVA)
69 Prevajalska redakcija
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The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
Seva cepiva vCP1529 in vCP2242 sta rekombinantna Canarypoks virusa, ki izražata hemaglutinin HA gen sevov A/ equi- 2 / Ohio/ 03 (ameriški sev) oziroma A/ equi- 2/ Newmarket/ 2/ 93 (evropski sev) virusa konjske influence.
70 Prevajalska redakcija
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Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in trivalentno virusno cepivo proti influenci.
71 Prevajalska redakcija
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3/ 17 The vaccine strains vCP2242 and vCP1533 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/ equi-2/ Ohio/ 03 (American strain) and A/ equi-2/ Newmarket/ 2/ 93 (European strain), respectively.
Seva cepiva vCP1529 in vCP2242sta rekombinantna Canarypoks virusa, ki izražata hemaglutinin HA gen sevov A/ equi- 2/ Ohio/ 03 (ameriški sev) oziroma A/ equi- 2/ Newmarket/ 2/ 93 (evropski sev) virusa
72 Prevajalska redakcija
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What benefit has Poulvac FluFend H5N3 RG shown during the studies? • The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks. • If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.
Kakšne koristi je zdravilo Poulvac FluFend H5N3 RG izkazalo med raziskavami? • Raziskave so pokazale, da ptice, ki prejmejo cepivo, tvorijo protitelesa proti virusu aviarne influence podtipa H5. • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih in racah. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N3 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
73 Prevajalska redakcija
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34 Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in
74 Prevajalska redakcija
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88 Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
88 trivalentno virusno cepivo proti influenci. Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih s Humiro, ni.
75 Prevajalska redakcija
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If the circulating avian influenza field virus has a different H and/ or N component to the H7N1 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect haemagglutinin and/ or neuraminidase antibodies.
Če ima divji virus aviarne influence sestavino H ali N, ki se razlikuje od sestavin H7N1 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti hemaglutininu ali nevraminidazi.
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In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study).
To velja še posebej pri racionalizaciji lastnosti uporabljenih jajc (ob upoštevanju problema morebitne prisotnosti tujih dejavnikov v običajnih jajcih in možnosti inaktivacije le- teh med postopkom inaktivacije virusa influence, kar podpira ustrezna validacijska študija).
77 Prevajalska redakcija
izobraževanje
CELEX: 32003R1084
In case of a pandemic situation with respect to the human influenza virus, duly recognised by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council(8), competent authorities may exceptionally and temporarily consider the variation to the terms of the marketing authorisation for human influenza vaccines to be accepted after an application has been received and before the end of the procedure laid down in Article 7.
Pri pandemičnih razmerah glede virusa človeške gripe, ki jih uradno prizna Svetovna zdravstvena organizacija ali Skupnost v okviru Odločbe št. 2119/98/ES Evropskega parlamenta in Sveta [8], pristojni organi lahko izjemoma in začasno štejejo spremembo pogojev dovoljenja za promet s cepivi proti človeški gripi za odobreno po prejemu vloge in pred zaključkom postopka iz člena 7.
78 Prevajalska redakcija
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When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to reduce clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine has been shown reduce virus shedding in infected ducks. • The vaccine is able to induce antibodies in a wide range of birds. • 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.
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki. • Dokazano je bilo, da cepivo zmanjša klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih. • Dokazano je bilo tudi, da cepivo zmanjša izločanje virusa pri okuženih racah. • Cepivo spodbudi nastajanje protiteles pri številnih vrstah ptic. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N1 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
79 Prevajalska redakcija
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It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, parts of Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus, inactivated (killed) polioviruses and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘ Hib’, a bacterium that causes meningitis).
Vsebuje naslednje zdravilne učinkovine: toksoide (kemično oslabljene toksine) davice in tetanusa, dele Bordetella pertussis (bakterije, ki povzroča oslovski kašelj), dele virusa hepatitisa B, inaktivirane (mrtve) polioviruse in polisaharide (sladkorje) iz bakterije Haemophilus influenzae tipa b („ Hib “, bakterije, ki povzroča meningitis).
80 Prevajalska redakcija
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When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N2 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki. • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih. • Cepivo je sposobno spodbuditi nastajanje protiteles pri številnih vrstah ptic. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N2 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
81 Prevajalska redakcija
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When compared, the subcutaneous and intramuscular routes were shown to produce the same responses. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens. • The vaccine is able to induce antibodies in a wide range of birds. • If the circulating avian influenza field virus has a different N component to the N6 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Ob primerjavi subkutanega in intramuskularnega načina dajanja zdravila se je izkazalo, da so bili odzivi enaki. • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih. • Cepivo je sposobno spodbuditi nastajanje protiteles pri številnih vrstah ptic. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N6 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
82 Prevajalska redakcija
izobraževanje
CELEX: 32002D0542
All testing of samples for avian influenza and Newcastle disease must be carried out in official laboratories designated by the competent authority, and using diagnostic procedures in accordance with the terms of Annex III of Council Directive 92/66/EEC and of Annex III of Council Directive 92/40/EEC. - Pooling of samples, up to a maximum of five samples of individual birds in one pool, is allowed. - Virus isolates must be submitted without delay to the National Reference laboratory."
Vsa testiranja vzorcev na aviarno influenco in atipično kokošjo kugo se opravijo v uradnih laboratorijih, ki jih določi pristojni organ, z uporabo diagnostičnih postopkov v skladu s pogoji Priloge III Direktive Sveta 92/66/EGS in Priloge III Direktive Sveta 92/40/EGS. - Dovoljena je priprava zbirnih vzorcev, pri katerih vsak zbirni vzorec obsega do največ pet posameznih ptic. - Izolate virusa je treba nemudoma predložiti nacionalnemu referenčnemu laboratoriju."
83 Prevajalska redakcija
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31 Uncommon side effects (affects 1 to 10 users in 1,000): • herpes infection or viral condition due to herpes; infection of the hair roots; shingles; influenza; skin infection due to virus or bacteria • anaemia due to low iron • allergic reaction • obesity around abdomen; decreased appetite; diabetes; increased blood cholesterol and lipids; increased appetite • abnormal dreams; feeling anxious; feelings of deep sadness and unworthiness • pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; decreased feeling or sensitivity, especially in the skin; feeling of tiredness, drowsiness, or lack of energy; numbness or weakness of the arms and/ or legs; tingling or numbness of the hands or feet; sleepiness; tension headache; tremors • visual disturbance • spinning sensation • palpitations; fast or irregular heart beats • harsh, raspy, or strained voice; nosebleed; nasal congestion; throat irritation • stomach inflammation; abdominal pain upper; pain at anus; dry mouth; indigestion; belching; heartburn; red, sore tongue; pain when swallowing; pain related to the mouth; inflammation of the pancreas; ulcer or sore in stomach or upper intestine; bleeding at anus; stomach discomfort • inflammation of liver • acne; redness of skin; unusual distribution of fat on the body or the face; thickening and itching of the skin due to repeated scratching; dry skin • back pain; loss of muscle; pain in bone/ muscle; aching muscles, muscles tenderness or weakness, not caused by exercise; muscle inflammation; pain in arms or legs; inflammation of the tendons • certain kinds of kidney problems; kidney stones; urination at night; frequent urination • erectile dysfunction; breast enlargement in men; menopausal symptoms • chest discomfort; chills; swelling of face; feeling hot; feeling jittery; fever; dryness or abnormal dryness of the skin or mucous membranes • decreased white blood cell count; decreased count of platelets in blood (a kind of cell that helps blood clot), increased level of enzyme from salivary glands or pancreas; blood test showing reduced kidney function; high blood sugar level; sugar present in urine; red blood cells present in urine; weight gain • drug reaction, drug ingestion in quantities greater than recommended
Občasni neželeni učinki (pojavijo se lahko pri 1 do 10 od 1. 000 bolnikov): • okužba s herpesom ali virusne bolezni zaradi herpesa, okužba korenin las ali dlak, pasavec, gripa, virusna ali bakterijska okužba kože • anemija zaradi pomanjkanja železa • alergijska reakcija • debelost okrog trebuha, zmanjšanje apetita, sladkorna bolezen, zvišani holesterol in lipidi v krvi, povečan apetit • nenormalne sanje, občutek tesnobnosti, občutki globoke žalosti in ničvrednosti • bolečina v roki zaradi pritiska na živec, motnje pozornosti, omotica po hitri spremembi položaja telesa, nenormalen okus, večja zaspanost, zmanjšano občutenje ali zaznavanje, zlasti v koži, občutek utrujenosti, zaspanost ali pomanjkanje energije; omrtvelost ali šibkost v rokah in/ ali nogah, mravljinčenje ali omrtvelost v dlaneh ali stopalih, zaspanost, tenzijski glavobol, tresenje • motnja vida • občutek vrtenja • razbijanje srca (palpitacije), hitro ali neredno bitje srca • rezek, hripav ali nenaraven glas, krvavitev iz nosu, zamašenost nosu, draženje žrela • vnetje želodca, bolečina v zgornjem delu trebuha, bolečina v zadnjiku, suha usta, želodčne težave, spahovanje, zgaga, rdeč, pekoč jezik, bolečine pri požiranju, bolečina v ustih, vnetje trebušne slinavke, razjeda ali draženje v želodcu ali zgornjem delu črevesa, krvavitev iz zadnjika, nelagodje v želodcu • vnetje jeter • akne, pordelost kože, nenavadna porazdelitev maščevja na telesu ali obrazu, zadebeljenost in srbenje kože zaradi stalnega praskanja, suha koža • bolečine v hrbtu, izgubljanje mišic, bolečine v kosteh/ mišicah, boleče mišice, občutljivost ali šibkost mišic, ki niso posledica telesne dejavnosti, vnetje mišic, bolečine v rokah ali nogah, vnetje tetiv • določene vrste težav z ledvicami, ledvični kamni, uriniranje ponoči, pogosto uriniranje • erektilna disfunkcija, povečanje prsi pri moških, menopavzalni simptomi • nelagodje v prsih, mrzlica, oteklost obraza, občutek vročine, občutek živčnosti, zvišana telesna temperatura, suhost ali nenormalna suhost kože ali sluznic • zmanjšano število belih krvnih celic, zmanjšano število krvnih ploščic (vrste krvnih celic, ki pomagajo pri strjevanju krvi), zvišana raven encima iz žlez slinavk ali trebušne slinavke, rezultati preiskav krvi, ki kažejo na zmanjšano delovanje ledvic, visok krvni sladkor, sladkor v urinu, rdeče krvne celice v urinu, povečanje telesne mase • reakcija na zdravilo, zaužitje večje količine zdravila, kot je priporočljivo
Prevodi: en > sl
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influenza A virus