FrancophonIA/ELRC3.0 huggingface dataset:
English: Invented Name
Slovenian: EU številka Izmišljeno ime
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per doses Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose
Slovenian: Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in sev FCV G1): ≥ 2,0 enot v testu ELISA na odmerek Atenuirana Chlamydophila felis (sev 905): ≥ 103,0 EID50 na odmerek Atenuiran virus panleukopenije mačk (PLI IV): ≥ 103,5 CCID50 na odmerek Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97): ≥ 107,2 CCID50 na odmerek
English: Strength harmaceutical Form
Slovenian: Farmacevtska oblika
English: Attenuated feline panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose
Slovenian: Inaktivirani antigeni kalici virusa mačk (sev FCV 431 in sev FCV G1): ≥ 2,0 enot v testu ELISA na odmerke Atenuirana Chlamydophila felis (sev 905): ≥ 103,0 EID50 na odmerek Atenuiran virus panleukopenije mačk (PLI IV): ≥ 103,5 CCID50 na odmerek Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97): ≥ 107,2 CCID50 na odmerek
English: 90 (3 x 30) tablets
Slovenian: Pot uporabe Stična ovojnina Velikost pakiranja plastenka (HDPE) 30 tablet plastenka (HDPE) 90 (3 x 30) tablet
English: Packaging Package size l t o r
Slovenian: Pot uporabe Ovojnina Velikost pakiranja o ā
English: This summary was last updated in 08-2012.
Slovenian: Povzetek je bil nazadnje posodobljen 08-2012.
English: It is used in addition to diet and exercise in the following ways:
Slovenian: Uporablja se kot dodatek k dieti in telesni aktivnosti na naslednje načine:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xelevia on 21 March 2007.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xelevia, veljavno po vsej Evropski uniji, odobrila dne 21. marca 2007.
English: Xelevia is taken at a dose of 100 mg once a day.
Slovenian: Zdravilo Xelevia se jemlje v odmerku 100 mg enkrat na dan.
English: The full EPAR for Xelevia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Xelevia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: EPAR summary for the public sitagliptin
Slovenian: Povzetek EPAR za javnost sitagliptin
English: What benefit has Xelevia shown during the studies?
Slovenian: Kakšne koristi je zdravilo Xelevia izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Xelevia.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xelevia.
English: Other information about Xelevia
Slovenian: Druge informacije o zdravilu Xelevia
English: For more information about treatment with Xelevia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xelevia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Xelevia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Slovenian: Zdravila Xelevia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) sitagliptin ali katero koli drugo sestavino zdravila.
English: In patients with moderately or severely reduced kidney function the dose of Xelevia should be reduced.
Slovenian: Pri bolnikih z delno ali močno okrnjenim delovanjem ledvic je treba odmerek zdravila Xelevia zmanjšati.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xelevia.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Xelevia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Serious side effects reported with Xelevia (generally seen in more than 5% of patients) include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Slovenian: Med resnimi neželenimi učinki, o katerih so poročali pri uporabi zdravila Xelevia (običajno opaženi pri več kot 5 % bolnikov) so pankreatitis (vnetje trebušne slinavke) in preobčutljivostne (alergijske) reakcije.
English: In the studies comparing Xelevia with other medicines, the effectiveness of adding Xelevia to metformin was similar to that of adding glipizide.
Slovenian: V študijah, v katerih so zdravilo Xelevia primerjali z drugimi zdravili, je bila učinkovitost dodajanja zdravila Xelevia metforminu podobna kot pri dodajanju glipizida.
English: If Xelevia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Slovenian: Če se zdravilo Xelevia jemlje s sulfonilsečnino ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina znižati, da se zmanjša tveganje za hipoglikemijo (nizko koncentracijo sladkorja v krvi).
English: The active substance in Xelevia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Slovenian: Zdravilna učinkovina zdravila Xelevia je sitagliptin, ki je zaviralec dipeptidil peptidaze-4 (DPP-4).
English: • two studies compared Xelevia with other antidiabetes medicines.
Slovenian: • v dveh študijah so zdravilo Xelevia primerjali z drugimi zdravili proti sladkorni bolezni.
English: Sitagliptin does not work when the blood glucose is low.
Slovenian: Sitagliptin ne deluje, če je vrednost glukoze v krvi nizka.
English: What is the risk associated with Xelevia?
Slovenian: Kakšna tveganja so povezana z zdravilom Xelevia?
English: Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Slovenian: Zdravilo Xelevia je bilo učinkovitejše od placeba, ko so ga bolniki jemali kot samostojno zdravilo ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
English: Why has Xelevia been approved?
Slovenian: Zakaj je bilo zdravilo Xelevia odobreno?
English: Xelevia was studied in nine studies, involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Slovenian: Zdravilo Xelevia je bilo raziskano v devetih glavnih študijah, ki so vključevale skoraj 6 000 bolnikov s sladkorno boleznijo tipa 2, pri katerih ravni glukoze v krvi niso bile zadostno nadzorovane:
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za nadzor ravni glukoze v krvi ali pri kateri telo ne more učinkovito izrabiti insulina.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Slovenian: Ti hormoni se sproščajo po obroku in stimulirajo trebušno slinavko k tvorjenju insulina.
English: Xelevia is a medicine that contains the active substance sitagliptin.
Slovenian: Xelevia je zdravilo, ki vsebuje zdravilno učinkovino sitagliptin.
English: The CHMP decided that Xelevia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Xelevia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
Slovenian: V kombinaciji s sulfonilsečnino je prišlo do hipoglikemije pri 4,7-13,8 % bolnikov, v kombinaciji z insulinom pa pri 9,6 % bolnikov.
English: In all of the studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: Pri vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni glikoziliranega hemoglobina (HbA1c) v krvi, ki kaže na učinkovitost nadzora ravni glukoze v krvi.
English: Xelevia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Slovenian: Zdravilo Xelevia se uporablja za zdravljenje bolnikov s sladkorno boleznijo tipa 2 za izboljšanje nadzora nad ravnjo glukoze (sladkorja) v krvi.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Slovenian: Deluje tako, da zavre razgradnjo hormonov inkretinov v telesu.
English: In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Slovenian: Pri bolnikih, ki so jemali samo zdravilo Xelevia so se ravni HbA1c zmanjšale za približno 8 % na začetku študij, za 0,48 % po 18 tednih in za 0,61 % po
English: By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Slovenian: Sitagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, kadar so ravni glukoze v krvi previsoke.
English: For the full list of all side effects reported with Xelevia, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Xelevia, glejte navodilo za uporabo.
English: When taken on their own, Xelevia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Xelevia seemed to be slightly lower than that of metformin.
Slovenian: Ob samostojnem jemanju zdravila Xelevia ali metformina so bila znižanja ravni HbA1c podobna, vendar je bilo zdravilo Xelevia malenkost slabše učinkovito kot metformin.
English: • four of the studies compared Xelevia with placebo (a dummy treatment): Xelevia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Slovenian: • v štirih študijah so zdravilo Xelevia primerjali s placebom (zdravilom brez zdravilne učinkovine): zdravilo Xelevia ali placebo so bolniki jemali samostojno v dveh študijah, ki sta vključevali 1 262 bolnikov, kot dodatek metforminu v eni študiji s 701 bolnikom in kot dodatek pioglitazonu (agonistu PPAR-gama) v eni študiji s 353 bolniki;
English: • on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;
Slovenian: • samostojno pri bolnikih, katerih bolezen samo z dieto in telesno vadbo ni zadovoljivo nadzorovana in pri katerih metformin (zdravilo za zdravljenje sladkorne bolezni) ni primeren;
English: • three additional studies compared Xelevia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Slovenian: • v treh dodatnih študijah so zdravilo Xelevia primerjali s placebom, obe zdravili so dodajali drugim zdravilom proti sladkorni bolezni; glimepiridu (drugi vrsti sulfonilsečnine), z metforminom ali brez njega, pri 441 bolnikih ali kombinaciji metformina in rosiglitazona (agonista PPAR-gama) pri 278 bolnikih ali ustaljenemu odmerku insulina, z metforminom ali brez njega, pri 641 bolnikih.
English: • in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Slovenian: • v kombinaciji z metforminom in sulfonilsečnino ali agonistom PPAR-gama pri bolnikih, pri katerih z obema zdraviloma ni vzpostavljen zadosten nadzor;
English: The other study compared Xelevia with metformin, used on their own, in 1,058 patients;
Slovenian: V drugi študiji so zdravilo Xelevia primerjali z metforminom pri 1 058 bolnikih, ki so obe zdravili jemali samostojno;
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Xelevia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Slovenian: Ravni HbA1c so bile po 18 tednih znižane za 1,03 % pri bolnikih, ki so zdravilo Xelevia dodajali metforminu in rosiglitazonu, v primerjavi z znižanjem za 0,31 % pri tistih, ki so kot dodatek prejemali placebo.
English: What is Xelevia used for?
Slovenian: Za kaj se zdravilo Xelevia uporablja?
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;
Slovenian: • v kombinaciji z metforminom ali agonistom PPAR-gama (vrsto zdravila proti sladkorni bolezni), kot je tiazolidinedion, pri bolnikih, katerih bolezen samo z metforminom ali agonistom PPAR-gama ni zadovoljivo nadzorovana;
English: • in combination with insulin, with or without metformin, in patients who are not satisfactorily controlled on a stable dose of insulin.
Slovenian: • v kombinaciji z insulinom z metforminom ali brez njega, pri bolnikih, pri katerih z ustaljenim odmerkom insulina ni vzpostavljen zadosten nadzor.
English: • in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;
Slovenian: • v kombinaciji s sulfonilsečnino (vrsto zdravila proti sladkorni bolezni) pri bolnikih, pri katerih bolezen samo s sulfonilsečnino ni zadovoljivo nadzorovana, metformin pa zanje ni primeren;
English: Finally, they were reduced by 0.59% in patients adding Xelevia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Slovenian: Ravni so se znižale za 0,59 % pri bolnikih, ki so zdravilo Xelevia dodajali insulinu (z metforminom ali brez njega) v primerjavi z zmanjšanjem za 0,03 % pri tistih, ki so kot dodatek jemali placebo.
English: In the additional studies, adding Xelevia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in those adding placebo.
Slovenian: V dodatnih študijah je dodajanje zdravila Xelevia glimepiridu (z metforminom ali brez njega) po 24 tednih znižalo ravni HbA1c za 0,45 % v primerjavi s povečanjem za 0,28 % pri bolnikih, pri katerih so dodajali placebo.
English: How has Xelevia been studied?
Slovenian: Kako je bilo zdravilo Xelevia raziskano?
English: How is Xelevia used?
Slovenian: Kako se zdravilo Xelevia uporablja?
English: What is Xelevia?
Slovenian: Kaj je zdravilo Xelevia?
English: How does Xelevia work?
Slovenian: Kako zdravilo Xelevia deluje?
English: When added to pioglitazone, Xelevia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Slovenian: Če je bilo zdravilo Xelevia dodano pioglitazonu, je po 24 tednih znižalo ravni HbA1c za 0,85 % v primerjavi z znižanjem za 0,15 % pri bolnikih, ki so kot dodatek jemali placebo.
English: One study compared Xelevia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Slovenian: V eni študiji so pri 1 172 bolnikih primerjali zdravilo Xelevia z glipizidom (sulfonilsečnino), obe zdfravili pa so dodajali metforminu.
English: In contrast, they rose by 0.12% and 0.18%, respectively, in the patients taking placebo.
Slovenian: Pri bolnikih, ki so jemali placebo, pa so se povečale za 0,12 % oziroma 0,18 %.
English: HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Slovenian: Če je bilo zdravilo Xelevia dodano metforminu, je po 24 tednih znižalo ravni HbA1c za 0,67 % v primerjavi z znižanjem za 0,02 % pri bolnikih, ki so kot dodatek jemali placebo.
English: The experience in children and adolescents is limited.
Slovenian: Izkušnje pri otrocih in mladostnikih so omejene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 20. november 2018
English: 117 allée des Parcs 69800 Saint-Priest France
Slovenian: 117 allée des Parcs 69800 Saint-Priest Francija
English: - breathing problems.
Slovenian: - težave pri dihanju.
English: - some changes may occur in your blood, but these will be detected by routine blood tests.
Slovenian: - pojavijo se lahko nekatere spremembe v krvi, vendar jih zaznamo z rutinskimi krvnimi preiskavami.
English: Therefore, your doctor may decide that you should not use this medicine.
Slovenian: Zdravnik bo morda presodil, da tega zdravila ne smete uporabljati.
English: You should talk to your doctor about your risks of developing cancers of the blood.
Slovenian: Z zdravnikom se posvetujte o tveganjih za nastanek krvnega raka.
English: 1 See section “Description of selected adverse reactions” below.
Slovenian: 1 Glejte poglavje “Opis izbranih neželenih učinkov” spodaj.
English: Package leaflet: Information for the user
Slovenian: Navodilo za uporabo: Informacije za uporabnika
English: Do not warm the syringe in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Injekcijske brizge ne smete segrevati na kak drug način (na primer, ne segrevajte v mikrovalovni pečici ali v vroči vodi).
English: What you need to know before you use Fulphila Do not use Fulphila - if you are allergic to pegfilgrastim, filgrastim or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Fulphila Ne uporabljajte zdravila Fulphila - če ste alergični na pegfilgrastim, filgrastim, ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: - nausea and headaches.
Slovenian: - slabost in glavoboli.
English: Fulphila is for use in adults aged 18 and over.
Slovenian: Zdravilo Fulphila je namenjeno uporabi pri odraslih, starih 18 ali več let.
English: Healthcare professionals only The trade name of the administered product should be clearly recorded in the patient file.
Slovenian: Samo za zdravstveno osebje Zaščiteno ime uporabljenega zdravila je treba jasno zabeležiti v bolnikovi dokumentaciji.
English: Common (≥ 1/100 to < 1/10)
Slovenian: (≥ 1/10) (≥ 1/100 do < 1/10) (≥ 1/1.000 do do
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, opazimo ga tipično 24 do 48 ur po uporabi zdravila in se sklada s farmakodinamskimi učinki tega zdravila.
English: Your doctor may decide that it would be more convenient for you to inject Fulphila yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Fulphila injicirate sami.
English: • Fulphila is given as an injection into the tissue just under the skin (subcutaneous injection).
Slovenian: • Zdravilo Fulphila se daje kot injekcija v tkivo tik pod kožo (subkutano injiciranje).
English: Fulphila has not been tested in pregnant women.
Slovenian: Zdravila Fulphila pri nosečnicah niso preskusili.
English: See section 2 “Fulphila contains sorbitol and sodium”.
Slovenian: Glejte poglavje 2 »Zdravilo Fulphila vsebuje sorbitol in natrij«.
English: Remove the syringe from the refrigerator.
Slovenian: Vzemite injekcijsko brizgo iz hladilnika.
English: B PUSH the plunger with slow and constant pressure until you feel or hear a “snap”.
Slovenian: B POTISKAJTE bat počasi in s stalnim pritiskom povsem do konca, dokler ne začutite ali zaslišite
English: Your doctor has given you Fulphila to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal zdravilo Fulphila, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
English: Therefore, physicians should use caution when prescribing pegfilgrastim in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Slovenian: Zato morajo biti zdravniki previdni, kadar predpisujejo pegfilgrastim bolnikom s srpastocelično dispozicijo ali s srpastocelično anemijo, spremljati morajo ustrezne klinične parametre in laboratorijski status in biti pozorni na morebitno povezavo tega zdravila z zvečanjem vranice in vazookluzivno krizo.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fulphila therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Fulphila, pri čemer je treba pretehtati koristi dojenja za otroka in koristi zdravljenja za mater.
English: Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Pegfilgrastim ni priporočljiv med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: - increased spleen size.
Slovenian: - povečana vranica.
English:  Do not try to warm the syringe by using a heat source such as hot water or microwave.
Slovenian: X Ne poskušajte ogrevati brizge z viri toplote kot sta vroča voda ali mikrovalovna pečica.
English: The injections should be given into the thigh, abdomen or upper arm.
Slovenian: Injekcije se morajo dati v stegno, trebuh ali zgornji del roke.
English: Uncommon cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Slovenian: Občasno so poročali o primerih Sweetovega sindroma, vendar ima lahko v nekaterih primerih pri tem vlogo osnovna maligna hematološka bolezen.
English: Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of pegfilgrastim with any other medicinal products.
Slovenian: Posebnih študij medsebojnega delovanja ali presnove niso izvedli, vendar klinična preskušanja niso pokazala medsebojnega delovanja pegfilgrastima s kakšnimi drugimi zdravili.
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Slovenian: Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je minil po ukinitvi G-CSF.
English: If you have forgotten a dose of Fulphila, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste pozabili uporabiti odmerek zdravila Fulphila, se morate posvetovati z zdravnikom, da se bosta dogovorila, kdaj si morate injicirati naslednji odmerek.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/l) have been reported (see section 4.4).
Slovenian: Pogosto so poročali o primerih levkocitoze (število belih krvničk > 100 x 109/l) (glejte poglavje 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1329/001 1 pre-filled syringe EU/1/18/1329/002 1 pre-filled syringe with needle guard
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1329/001 1 napolnjena injekcijska brizga EU/1/18/1329/002 1 napolnjena injekcijska brizga s ščitnikom igle