FrancophonIA/ELRC3.0 huggingface dataset:
English: Lumbar spine mean (SD) change from baseline BMD Z-scorea NA
Slovenian: Povprečni (SD) Zindeks MGK ledvene hrbtenicea
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Slovenian: Da bi odkrili kakršno koli pozno virološko ponovitev bolezni je treba po prekinitvi zdravljenja redno nadzorovati ravni serumske ALT in HBV DNA.
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Slovenian: Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi (zvišanje mlečne kisline v krvi), ki je bila včasih smrtna.
English: ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir (300 mg q.d./100 mg q.d.)
Slovenian: Zaviralci proteaze atazanavir/ritonavir (300 enkrat dnevno/100 enkrat dnevno)
English: Flares after treatment discontinuation: Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy.
Slovenian: Poslabšanje po prenehanju zdravljenja: O akutnem poslabšanju hepatitisa so poročali tudi pri bolnikih, ki so prekinili zdravljenje hepatitisa B. Poslabšanja po zdravljenju so po navadi povezana z zvišanjem ravni HBV DNA, večina poslabšanj pa mine spontano.
English: Efavirenz/Emtricitabine/Tenofo vir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: efavirenz/emtricitabin/ dizoproksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Slovenian: Z-indeksi MGK so se pri 64 osebah, ki so se 96 tednov zdravile z dizoproksiltenofoviratom, zmanjšali za -0,012 za ledveno hrbtenico in za -0,338 za celo telo.
English: dizziness
Slovenian: izpuščaj
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see section 4.4).
Slovenian: Uporaba dizoproksiltenofovirata pri pediatričnih bolnikih z ledvično okvaro ni priporočljiva (glejte poglavje 4.4).
English: The use of tenofovir disoproxil is not recommended in paediatric patients with renal impairment (see section 4.2).
Slovenian: Uporaba dizoproksiltenofovirata pri pediatričnih bolnikih z ledvično okvaro ni priporočljiva (glejte poglavje 4.2).
English: lactic acidosis Nervous system disorders: Very common:
Slovenian: Bolezni živčevja: Zelo pogosti:
English: A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Slovenian: Pri bolnikih, ki so dizoproksiltenofovirat prejemali v kombinaciji z zaviralcem proteaze okrepljenim z ritonavirjem ali kobicistatom, so poročali o večjem tveganju za ledvično okvaro.
English: Renally eliminated medicinal products
Slovenian: Zdravila, ki se izločajo preko ledvic
English: Tenofovir disoproxil 245 mg n = 250
Slovenian: 245 mg dizoproksiltenofovirata n = 250
English: The following side effects are very common (may affect more than 1 in 10 people):
Slovenian: Naslednji neželeni učinki so zelo pogosti (prizadenejo lahko najmanj 1 od 10 bolnikov):
English: • feeling bloated,
Slovenian: • občutek siljenja na bruhanje
English: Baseline
Slovenian: astenija
English: Bone Mineral Density (BMD) data from Study GS-US-174-0115 are summarized in Table 8: Table 8: Bone Mineral Density Evaluation at Baseline, Week 72 and 192
Slovenian: Podatki o mineralni gostoti kosti (MGK) iz študije GS-US-174-0115 so povzeti v preglednici 8:
English: Titanium dioxide Triacetin
Slovenian: Filmska obloga laktoza monohidrat hipromeloza titanov dioksid triacetin indigotin
English: - Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Slovenian: - Zdravila Dizoproksiltenofovirat Zentiva se ne sme uporabljati sočasno z dipivoksiladefoviratom.
English: Response to treatment with tenofovir disoproxil was comparable in nucleoside-experienced (n = 51) and nucleoside-naïve (n = 375) patients and in patients with normal ALT (n = 21) and abnormal ALT (n = 405) at baseline when studies GS-US-174-0102 and GS-US-174-0103 were combined.
Slovenian: Pri kombinaciji študij GS-US-174-0102 in GS-US-174-0103 je bil odziv na zdravljenje z dizoproksiltenofoviratom pri bolnikih, ki so bili zdravljeni z nukleozidi (n = 51), in bolnikih, ki še niso bili zdravljeni z nukleozidi (n = 375), ter pri bolnikih z normalno ravnijo ALT (n = 21) in nenormalno ravnijo ALT (n = 405), ob izhodiščni točki, primerljiv.
English: PLBtenofovir disoproxil
Slovenian: dipivoksiladefovirat
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 125
Slovenian: 10 mg dipivoksiladefovirata prehod na 245 mg dizoproksiltenofovirata n = 125
English: AUC: ↔ Cmax: ↑ 47%
Slovenian: AUC: ↔ Cmax: ↑ 47 % Cmin: ↑ 47 %
English: c 48 weeks of double-blind adefovir dipivoxil followed by 48 weeks open-label tenofovir disoproxil .
Slovenian: c 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 48-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: g Figures presented are cumulative percentages based upon a Kaplan Meier analysis including data collected after the addition of emtricitabine to open-label tenofovir disoproxil (KM-ITT).
Slovenian: g Prikazane številke so kumulativni odstotki na podlagi Kaplan-Meierjeve analize, vključno s podatki,
English: Use of tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Slovenian: Dizoproksiltenofovirata naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
English: f 48 weeks of double-blind adefovir dipivoxil followed by 96 weeks open-label tenofovir disoproxil .
Slovenian: f 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 96-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Darunavir/Ritonavir (300 mg/100 mg b.i.d.)
Slovenian: darunavir/ritonavir (300/100 dvakrat dnevno)
English: Serology (%) HBeAg loss/ seroconversion n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a
Slovenian: Izguba/serološka konverzija HBsAg n k n n a
English: Whole body mean (SD) BMD Z-scorea
Slovenian: Povprečni (SD) Zindeks MGK za celo teloa
English: p 48 weeks of double-blind adefovir dipivoxil followed by 336 weeks open-label tenofovir disoproxil.
Slovenian: 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 336-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Adefovir dipivoxil 10 mg roll over to tenofovir disoproxil 245 mg n = 90
Slovenian: 10 mg dipivoksiladefovirata prehod na 245 mg dizoproksiltenofovirata n = 90d
English: Hepatitis C virus antiviral agents
Slovenian: Okužba z virusom hepatitisa B
English: Lumbar spine mean (SD) BMD Z-scorea
Slovenian: Povprečni (SD) Zindeks MGK ledvene hrbtenice a
English: The following side effects are common (may affect up to 1 in 10 people):
Slovenian: Naslednji neželeni učinki so pogosti (prizadenejo lahko do 1 od 10 bolnikov):
English: A consistent response to treatment with tenofovir disoproxil 245 mg was seen regardless of baseline HIV-1 RNA and CD4 count.
Slovenian: Ne glede na začetno vrednost HIV-1 RNA in števila CD4 je bil odziv na zdravljenje z 245 mg dizoproksiltenofoviratom enak.
English: NA
Slovenian: i
English: • changes to your urine and back pain caused by kidney problems, including kidney failure,
Slovenian: • vnetje ledvic, izločanje večjih količin urina in občutek žeje • spremembe urina in bolečine v križu zaradi motenj v delovanju ledvic, vključno z odpovedjo ledvic
English: h 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil .
Slovenian: h 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Tenofovir disoproxil Zentiva
Slovenian: Pred začetkom jemanja zdravila Dizoproksiltenofovirat Zentiva se posvetujte z zdravnikom ali farmacevtom.
English: i 48 weeks of double-blind adefovir dipivoxil followed by 144 weeks open-label tenofovir disoproxil .
Slovenian: i 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: • Contact your doctor before you restart taking Tenofovir disoproxil Zentiva tablets.
Slovenian: • Preden začnete ponovno jemati zdravilo Dizoproksiltenofovirat Zentiva, se posvetujte z zdravnikom.
English: No clinically significant pharmacokinetic interactions when tenofovir disoproxil was co-administered with entecavir.
Slovenian: Pri sočasni uporabi dizoproksiltenofovirata in entekavirja ni bilo klinično pomembnih farmakokinetičnih interakcij.
English: NA = Not Applicable a BMD Z-scores not adjusted for height and weight b Primary safety endpoint through week 72
Slovenian: navedba smiselno ni potrebna navedba smiselno ni potrebna a Z-indeks MGK ni prilagojen za telesno višino in maso b
English: o 48 weeks of double-blind tenofovir disoproxil followed by 336 weeks open-label.
Slovenian: o 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 336-tedensko nezaslepljeno zdravljenje.
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV, non-HBV infected adult patients with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Slovenian: Farmakokinetične parametre za tenofovir so določili po vzetju enkratnega odmerka 245 mg dizoproksiltenofovirata pri 40 odraslih bolnikih, ki niso bili okuženi s HIV ali z virusom HBV, z različnimi stopnjami ledvične okvare.
English: n 48 weeks of double-blind adefovir dipivoxil followed by 240 weeks open-label tenofovir disoproxil .
Slovenian: n 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 240-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended (see section
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina ni priporočena (glejte poglavje 4.4).
English: g 48 weeks of double-blind tenofovir disoproxil followed by 144 weeks open-label.
Slovenian: g 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 144-tedensko nezaslepljeno zdravljenje.
English: k 48 weeks of double-blind adefovir dipivoxil followed by 192 weeks open-label tenofovir disoproxil .
Slovenian: 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi 192-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Emtricitabine: AUC: ↔ Cmax: ↔ Cmin: ↔
Slovenian: emtricitabin: AUC: ↔ Cmax: ↔ Cmin: ↔
English: 192h 240j
Slovenian: (n = 2), 240.
English: e 48 weeks of double-blind tenofovir disoproxil followed by 96 weeks open-label.
Slovenian: 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 96-tedensko nezaslepljeno zdravljenje.
English: If you think that you may have lactic acidosis, contact your doctor immediately.
Slovenian: • občutek siljenja na bruhanje, bruhanje in bolečine v trebuhu Če menite, da bi lahko imeli laktacidozo, se nemudoma posvetujte s svojim zdravnikom.
English: d 48 weeks double-blind adefovir dipivoxil followed by up to 192 weeks open-label tenofovir disoproxil .
Slovenian: 48-tedensko dvojno slepo zdravljenje z dipivoksiladefoviratom, ki mu sledi do 192-tedensko nezaslepljeno zdravljenje z dizoproksiltenofoviratom.
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, sofosbuvir/velpatasvir/voxil aprevir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksil aprevirja in darunavirja/ritonavirja lahko povečajo neželene učinke povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic.
English: HIV-1 clinical studies: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in two studies in 653 treatment-experienced patients receiving treatment with tenofovir disoproxil (n = 443) or placebo (n = 210) in combination with other antiretroviral medicinal products for 24 weeks and also in a double-blind comparative controlled study in which 600 treatment-naïve patients received treatment with tenofovir disoproxil 245 mg (n = 299) or stavudine (n = 301) in combination with lamivudine and efavirenz for 144 weeks.
Slovenian: V drugi dvojno slepi kontrolirani primerjalni študiji je 600 še nezdravljenih bolnikov 144 tednov prejemalo 245 mg dizoproksiltenofovirata (n = 299) ali stavudin (n = 301) v kombinaciji z lamivudinom in efavirenzom.
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, ledipasvir/sofosbuvir and atazanavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, ledipasvirja/sofosbuvirja in atazanavirja/ritonavirja lahko povečajo neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: Unless clearly necessary, concomitant use of these medicinal products which are secreted by the same renal pathway is not recommended, but if such use is unavoidable, renal function should be monitored weekly (see section 4.5).
Slovenian: Sočasna uporaba teh zdravil, ki se izločata po isti ledvični metabolni poti, ni priporočljiva, razen kadar je to neizogibno.
English: Tenofovir: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
Slovenian: AUC: ↔ Cmax: ↑ 42% Cmin: ↔
English: j 48 weeks of double-blind tenofovir disoproxil followed by 192 weeks open-label.
Slovenian: j 48-tedensko dvojno slepo zdravljenje z dizoproksiltenofoviratom, ki mu sledi 192-tedensko nezaslepljeno zdravljenje.
English: Whole body BMD at least 6% decreaseb
Slovenian: Najmanj 6% zmanjšanje MGK za celo telob navedba smiselno ni potrebna navedba smiselno ni potrebna
English: Darunavir: AUC: ↔ Cmax: ↔ Cmin: ↓ 34%
Slovenian: AUC: ↔ Cmax: ↔ Cmin: ↓ 34%
English: • Do not stop any anti-HIV medicines prescribed by your doctor when you start Tenofovir disoproxil Zentiva if you have both HBV and HIV.
Slovenian: • Če imate okužbo z virusom HBV in virusom HIV, potem takrat, ko začnete jemati zdravilo Dizoproksiltenofovirat Zentiva, ne prenehajte jemati drugih zdravil proti okužbi z virusom HIV, ki vam jih je predpisal zdravnik.
English: Magnesium stearate
Slovenian: Motnje v delovanju jeter
English: + Atazanavir/Ritonavir (300 mg q.d./100 mg q.d.)
Slovenian: atazanavir/ritonavir (300 mg enkrat dnevno /100 mg enkrat dnevno) + emtricitabin/ dizoproksiltenofovirat (200 mg/245 mg enkrat dnevno)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva vsebuje laktozo monohidrat Zdravilo Dizoproksiltenofovirat Zentiva vsebuje laktozo monohidrat, Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom .
English: rhabdomyolysis1, muscular weakness1
Slovenian: 1, mišična oslabelost
English: Increased plasma concentrations of tenofovir resulting from co-administration of tenofovir disoproxil, sofosbuvir/velpatasvir and lopinavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasne uporabe dizoproksiltenofovirata, sofosbuvirja/velpatasvirja in darunavirja/ritonavirja lahko povečajo neželene reakcije, povezane z dizoproksiltenofoviratom, vključno z ledvičnimi boleznimi.
English: Adefovir dipivoxil
Slovenian: PLBdizopro ksiltenofovi rat
English: Tenofovir disoproxil Zentiva should not be given to adolescents with existing kidney problems.
Slovenian: Mladostniki, ki imajo težave z ledvicami, ne smejo prejeti zdravila Dizoproksiltenofovirat Zentiva.
English: Lumbar spine BMD at least 6% decreaseb
Slovenian: Najmanj 6% zmanjšanje MGK ledvene hrbtenice b navedba smiselno ni potrebna navedba smiselno ni potrebna
English: Sofosbuvir/Velpatasvir (400 mg/100 mg q.d.)
Slovenian: Priporočilo glede sočasne uporabe z 245 mg dizoproksiltenofovirata sofosbuvir/velpatasvir (400 mg/100 mg enkrat dnevno)
English: Whole body mean (SD) BMD Z-scorea Whole body mean (SD) change from baseline BMD Z-scorea
Slovenian: Povprečna (SD) sprememba Z-indeksa MGK za celo telo od izhodiščaa navedba smiselno ni potrebna navedba smiselno ni potrebna
English: The relevance of these findings for humans is not known.
Slovenian: Pomembnost teh ugotovitev za človeka ni znana.
English: You can use:
Slovenian: Uporabite lahko:
English: • think you may be pregnant or
Slovenian: • mislite, da bi lahko bili noseči, ali
English: These could be signs of a severe allergic reaction.
Slovenian: To so lahko znaki hude alergijske reakcije.
English: • Any part appears cracked or broken.
Slovenian: • se kateri koli del zdi počen ali zlomljen;
English: Date of first authorisation: Date of latest renewal:
Slovenian: Datum prve odobritve: Datum zadnjega podaljšanja:
English: For more information, see section 5.1.
Slovenian: Za več informacij glejte poglavje 5.1.
English: Your doctor or nurse will show you how to inject yourself.
Slovenian: Zdravnik ali medicinska sestra vam bosta pokazala, kako si boste injekcije dajali sami.
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Slovenian: Kot pri vseh beljakovinskih zdravilih, obstaja možnost nastanka imunogenosti.
English: Do not try to warm the syringe by using a heat source such as hot water or microwave.
Slovenian: Ne poskušajte ogrevati brizge z viri toplote, kot sta vroča voda ali mikrovalovna pečica.
English: (≥ 1/100 to < 1/10)
Slovenian: (≥1/100 do <1/10)
English: Your doctor will tell you what you can take to ease the bone pain.
Slovenian: Zdravnik vam bo povedal, kaj lahko vzamete za lajšanje bolečine v kosteh;
English: Tell your doctor if you experience those symptoms.
Slovenian: Obvestite zdravnika, če se pri vas pojavijo ti simptomi.
English: In case of doubt DO NOT open this pack and take another pack instead.
Slovenian: Če ste v dvomih, pakiranja NE ODPRITE, pač pa vzemite drugo pakiranje.
English: INSERT the needle into skin.
Slovenian: VSTAVITE iglo v kožo.
English: Step 2: Get ready
Slovenian: 2. korak: Pripravite se
English: Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Slovenian: Zato je treba skrbno spremljati velikost vranice (npr. s kliničnim pregledom, ultrazvokom).
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Slovenian: Vezalna protitelesa sicer nastajajo, kot se to pričakuje pri vseh bioloških zdravilih, vendar pa trenutno niso povezana z nevtralizirajočo aktivnostjo.
English: For subcutaneous use.
Slovenian: Za subkutano uporabo.
English: Apply a plaster if needed.
Slovenian: Če je treba, nanj namestite obliž.
English: White blood cells are important as they help your body fight infection.
Slovenian: Bele krvničke so pomembne, ker se vašemu telesu pomagajo boriti proti okužbam.
English: • It is important that you do not try to give yourself the injection unless you have received training from your doctor or healthcare provider.
Slovenian: • Pomembno je, da si injekcije ne poskušate dati sami, če vas tega ne nauči zdravnik ali izvajalec storitev zdravstvenega varstva.
English: The concentration is 10 mg/ml based on protein only**.
Slovenian: Koncentracija je 10 mg/ml na podlagi beljakovine same**.
English: This leaflet was last revised in {MM/YYYY}
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}
English: This should be considered when interpreting bone-imaging results.
Slovenian: To je treba upoštevati pri interpretaciji izvidov na podlagi slikanja kosti.
English: • Outer area of upper arm (only if someone else is giving you the injection).
Slovenian: • zunanji del nadlakti (le v primeru, da vam injekcijo da kdo drug).
English: The frequency category was estimated from a statistical calculation based upon 1,576 patients receiving pegfilgrastim in nine randomised clinical trials.
Slovenian: Kategorija pogostnosti je ocenjena s statističnim izračunom na podlagi podatkov o 1.576 bolnikih, ki so prejemali pegfilgrastim v devetih randomiziranih kliničnih preskušanjih.
English: Your doctor may decide that it would be more convenient for you to inject Grasustek yourself.
Slovenian: Vaš zdravnik se bo morda odločil, da bi bilo za vas prikladneje, če si zdravilo Grasustek injicirate sami.
English: Store in a refrigerator (2 °C-8 °C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: Do not use this medicine if you notice it is cloudy or there are particles in it.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je zdravilo motno ali da so v njem delci.
English: However, the long-term effects of pegfilgrastim have not been established in AML; therefore, it should be used with caution in this patient population.
Slovenian: Vendar pa dolgoročni učinki pegfilgrastima pri AML niso ugotovljeni, zato ga je treba pri tej populaciji bolnikov uporabljati previdno.
English: It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Slovenian: Pomembno je, da nemudoma pokličete svojega zdravnika, če se pojavi bolečina v zgornjem levem delu trebuha ali v predelu leve rame, saj je lahko povezana s težavami z vranico;
English: No adverse events directly attributable to this degree of leukocytosis have been reported.
Slovenian: Ne poročajo o neželenih dogodkih, ki bi jih bilo možno neposredno pripisati tej stopnji levkocitoze.
English: G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach, Osterreich
Slovenian: G.L.Pharma GmbH Schlossplatz 1, 8502 Lannach,
English: Such elevation in white blood cells is transient, typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
Slovenian: Takšno zvišanje belih krvničk je prehodno, ga tipično opazimo od 24 do 48 ur po uporabi zdravila in se sklada s farmakodinamskimi učinki tega zdravila.
English: This may be a sign of a problem with your spleen (splenomegaly)
Slovenian: To je lahko znak, da imate težave z vranico (splenomegalija);
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na pegfilgrastim, filgrastim, beljakovine, pridobljene iz bakterij E. coli, ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Polska Alvogen Pharma Sp. Z o.o.
Slovenian: Alvogen Pharma Sp. Z o.o.
English: Other medicines and Grasustek Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Grasustek Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobnejše informacije so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: It must be a clear and colourless liquid.
Slovenian: Biti mora bistra in brezbarvna tekočina;
English: Healthcare professionals only The trade name of the medicine should be clearly recorded in the patient file.
Slovenian: Le za zdravstvene delavce V bolnikovi dokumentaciji mora biti jasno zabeleženo zaščiteno ime zdravila.