natgillin/translations-raw huggingface dataset:
It is important to contact your doctor immediately - if you experience an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face (anaphylaxis), skin rash, itchy rash (urticaria), swelling of the face lips, mouth, tongue or throat (angioedema) and shortness of breath (dyspnoea).
- če se vam pojavi alergijska reakcija, vključno z oslabelostjo, padcem krvnega tlaka, težavami z dihanjem, zatekanjem obraza (anafilaksa), kožnim izpuščajem, srbečim izpuščajem (koprivnica),
There were no differences in the safety profiles for paediatric patients treated for SCN.
Varnostni profili bolnikov, ki so jih zdravili za hudo kronično nevtropenijo, se niso razlikovali od varnostnih profilov drugih bolnikov.
Neutropenia may be due to bone marrow infiltrating opportunistic infections such as Mycobacterium avium complex or malignancies such as lymphoma.
kompleksom Mycobacterium avium ali malignim obolenjem, kot je limfom.
Graft versus Host
Reakcija presadka proti gostitelju (GvHD - Graft versus Host Disease)
Packs containing 1, 5 or 10 pre-filled syringes with 0.8 mL solution or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 mL solution.
Pakiranja po 1, 5 ali 10 napolnjenih injekcijskih brizg z 0,8 ml raztopine ali skupna pakiranja z 10 (2 pakiranji po 5) napolnjenimi injekcijskimi brizgami z 0,8 ml raztopine.
Ratiograstim can be used - to increase the number of white blood cells after treatment with chemotherapy to help prevent infections.
- za povečevanje števila belih krvničk po zdravljenju s kemoterapijo, kot pomoč pri preprečevanju okužb;
For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Za izplavljanje matičnih celic v periferno kri pri bolnikih, zdravljenih z mielosupresivno ali mieloablativno terapijo, ki ji sledi avtologna presaditev matičnih celic iz periferne krvi
Talk to your doctor, pharmacist or nurse before using Ratiograstim.
Pred začetkom uporabe zdravila Ratiograstim se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Dilution to a final concentration less than 0.2 MIU (2 μg) per mL is not recommended at any time.
Zdravila nikoli ne smete razredčiti v tolikšni meri, da bi končna koncentracija padla pod 0,2 milijona i.e. (2 μg).
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/L.
Glede na absolutno število nevtrofilcev pri posameznih bolnikih bodo morda potrebne nadaljnje prilagoditve odmerkov, zato da bi bilo število nevtrofilcev večje od 2,0 x 109/l.
• decrease of platelets which reduces the ability of blood to clot (thrombocytopenia)
zmanjšanje števila trombocitov, kar zmanjša sposobnost strjevanja krvi (trombocitopenija)
How to store Ratiograstim
Shranjevanje zdravila Ratiograstim
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Imetnik dovoljenja za promet z zdravilom ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of ≥ 4 x 10
Pred alogensko presaditvijo matičnih celic iz periferne krvi uporaba filgrastima za izplavljanje matičnih celic pri zdravih darovalcih omogoča, da se zbere ≥ 4 milijone CD34+ celic/kg telesne mase prejemnika pri večini darovalcev, ki so bili deležni dveh levkaferez.
If you have any of the following or combination of the following side effects: swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness.
oteklost ali zabuhlost, ki jo lahko spremlja manj pogostejše odvajanje urina, težko dihanje,
In normal stem cell donors an increase in white blood cells (leukocytosis) and a decrease of platelets may be seen this reduces the ability of your blood to clot (thrombocytopenia), these will be monitored by your doctor.
Pri zdravih darovalcih matičnih celic se lahko opazi povečanje števila belih krvničk (levkocitoza) in zmanjšanje števila trombocitov.
Psychiatic diorders
KLINIČNI PODATKI
EU/1/08/444/005 1 pre-filled syringe EU/1/08/444/006 5 pre-filled syringes EU/1/08/444/008 10 pre-filled syringes EU/1/08/444/011 1 pre-filled syringe with safety device EU/1/08/444/012 5 pre-filled syringes with safety device
EU/1/08/444/005 1 napolnjena injekcijska brizga EU/1/08/444/006 5 napolnjenih injekcijskih brizg EU/1/08/444/008 10 napolnjenih injekcijskih brizg
Infestations
Izplavljanje
Ratiograstim 48 MIU/0.8 mL solution for injection/ infusion Filgrastim
Ratiograstim 48 M i.e./0,8 ml raztopina za injiciranje/infundiranje filgrastim
EU/1/08/444/001 1 pre-filled syringe EU/1/08/444/002 5 pre-filled syringes EU/1/08/444/004 10 pre-filled syringes EU/1/08/444/009 1 pre-filled syringe with safety device EU/1/08/444/010 5 pre-filled syringes with safety device
EU/1/08/444/001 1 napolnjena injekcijska brizga EU/1/08/444/002 5 napolnjenih injekcijskih brizg EU/1/08/444/004 10 napolnjenih injekcijskih brizg brez
A detailed history of HFI symptoms has to be taken of each patient before giving this medicinal product.
Pred dajanjem zdravila mora biti pri bolniku narejena podrobna anamneza, povezana s simptomi dedne intolerance za frukozo.
In patients undergoing a stem cell or bone marrow transplant, Graft versus host disease (GvHD) may occur- this is a reaction of the donor cells against the patient receiving the transplant; signs and symptoms include rash on the palms of your hands or soles of your feet and ulcer and sores in your mouth, gut, liver, skin, or your eyes, lungs, vagina and joints.
Znaki in simptomi vključujejo izpuščaj na dlaneh in podplatih, razjede v ustih, črevesju, jetrih, koži ali očeh, pljučih, vagini in sklepih.
Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi ocetna kislina, koncentrirana; ledocet natrijev hidroksid sorbitol (E420) polisorbat 80 voda za injekcije
The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MIU (10 μg)/kg/day for 5 to 7 consecutive days.
Če se uporablja samostojno, je priporočeni odmerek filgrastima za izplavljanje matičnih celic iz periferne krvi 1,0 x milijonov i.e. (10 μg)/kg/dan od 5 do 7 zaporednih dni.
Assessment of progenitor cell yields
Rezultati meritev števila celic CD34+
Respiratory failurea Pulmonary oedemaa
Bolezni živčevja glavobola omotica hipestezija parestezija
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Aspartate aminotransf erase increased Gammaglutamyl transferase increased
žolčnika in žolčevodov hepatomegalija zvečanje vrednosti zvečanje vrednosti aspartataminotra alkalne fosfatazev krvi nsferaze zvečanje vrednosti gamaglutamil transferaze
Proteinuria Glomerulon ephritis
Bolezni sečil disurija hematurija proteinurija glomerulonefri tis nenormalni izvidi preiskav urina
Transfusion reactione a See section c (Description of selected adverse reactions) b There have been reports of GvHD and fatalities in patients after allogeneic bone marrow transplantation (see section c) c Includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain d Cases were observed in the post-marketing setting in patients undergoing bone marrow transplant or
c vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečine v okončinah, mišičnoskeletne bolečine, mišično-skeletne bolečine v prsih, bolečine v vratu d v obdobju trženja so opažali primere pri bolnikih, ki so jim presadili kostni mozeg ali opravili izplavljanje PBPC
It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
(približno na vsakih 12 mesecev) opravi morfološke in citogenetske preiskave kostnega mozga.
Subsequently the dose may be individually adjusted every 1 to 2 weeks to maintain the average neutrophil count between 1.5 x 109/L and 10 x 109/L.
Za to, da bi povprečno število nevtrofilcev ostalo med 1,5 x 109/l in 10 x 109/l, se odmerek lahko prilagaja glede na posameznika vsak teden oz. vsaka dva tedna.
For PBPC mobilisation in normal donors, filgrastim should be administered at 1.0 MIU (10 μg)/kg/day for 4 to 5 consecutive days.
Odmerjanje Za postopek izplavljanja matičnih celic iz periferne krvi zdravi darovalci 4 do 5 dni zapored prejmejo filgrastim v odmerku 1,0 milijon i.e. (10 μg)/kg/dan.
There was a low frequency (approximately 3 %) of myelodysplastic syndromes (MDS) or leukaemia in clinical trial patients with SCN treated with filgrastim.
V kliničnem preskušanju bolnikov s SCN, ki so dobivali filgrastim, so poročali o mielodisplastičnih sindromih (MDS) ali levkemiji, ki pa niso bili pogosti (pri približno 3 %).
Filgrastim may be given as a 24 hour subcutaneous continuous infusion or subcutaneous injection.
Filgrastim za izplavljanje matičnih celic iz periferne krvi pri samostojni uporabi: Filgrastim lahko dajemo v obliki 24-urne kontinuirane subkutane infuzije ali subkutane injekcije.
Cases of decreased bone density and osteoporosis have been reported in paediatric patients with SCN receiving chronic treatment with filgrastim.
Pediatrični bolniki s hudo kronično nevtropenijo Pri pediatričnih bolnikih s hudo kronično nevtropenijo, ki prejemajo kronično zdravljenje s filgrastimom, so poročali o primerih zmanjšane kostne gostote in osteoporoze.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino (zdravilne učinkovine) ali katero koli pomožno snov,
Treatment with filgrastim alone does not preclude thrombocytopenia and anaemia due to myelosuppressive medicinal products.
Tveganje, povezano s povečanimi odmerki mielosupresivnih zdravil Zdravljenje s filgrastimom samim ne izključuje možnosti pojava trombocitopenije in anemije pri jemanju mielosupresivnega zdravila.
Leukocytosi sa
Kožni vaskulitis
However, the administration of melphalan, carboplatin or BCNU together with filgrastim has been shown to be effective for progenitor mobilisation.
Dolgotrajna uporaba zdravil, kot so melfalan, karmustin (BCNU) in karboplatin pred poskusom izplavljanja krvotvornih matičnih celic, lahko zmanjša pričakovani donos teh celic, vendar pa je bilo ugotovljeno, da je uporaba melfalana, karboplatina ali BCNU skupaj s filgrastimom učinkovita pri izplavljanju krvnih matičnih celic.
Sickle cell crisis, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Pri uporabi filgrastima pri bolnikih z genetsko predispozicijo za srpaste celice ali z anemijo srpastih celic so poročali o srpastoceličnih krizah, ki so bile v nekaterih primerih smrtne.
The recommended starting dose is 0.5 MIU (5 μg)/kg/day as a single dose or in divided doses.
Idiopatična ali ciklična nevtropenija Priporočeni začetni odmerek je 0,5 milijona i.e. (5 μg)/kg/dan v enkratnem odmerku ali v večkratnih odmerkih.
Diarrhoeaa, e Vomitinga,e Nauseaa
Bolezni prebavil diarejaa,e bruhanjea,e navzeaa bolečina v ustih zaprtjee
What Ratiograstim is used for
Za kaj uporabljamo zdravilo Ratiograstim
Splenic rupturea Sickle cell anaemia with crisisa
Bolezni krvi in limfatičnega sistema trombocitopenija anemijae splenomegalijaa zmanjšanje vrednosti hemoglobinae levkocitozaa ruptura vranicea srpastocelična anemija s krizoa
Permanently discontinue Ratiograstim in patients with clinically significant hypersensitivity.
Pri bolnikih s klinično pomembno preobčutljivostjo je treba zdravljenje s filgrastimom trajno prekiniti.
Consideration should be given to temporary discontinuation or dose reduction of filgrastim in patients with severe chronic neutropenia who develop thrombocytopenia (platelet count < 100 x 109/l).
Pri bolnikih s hudo kronično nevtropenijo, pri katerih se pojavi trombocitopenija (število trombocitov < 100 x 109/l), je treba razmisliti o začasni prekinitvi zdravljenja ali zmanjšanju odmerka filgrastima.
Acute respiratory distress syndromea
Žilne bolezni hipertenzija hipotenzija venookluzivna bolezend sindrom kapilarne prepustnostia aortitis
Thrombocyt openia Anaemiae
Psihiatrične motnje insomnija
• nose bleeds (epistaxis)
• krvavitev iz nosu (epistaksa) • zaprtje
Fluid volume disturbances
(pirofosfatna hondrokalcino za) motnje volumna tekočine
1 pre-filled syringe containing 0.8 mL 1 pre-filled syringe with safety device containing 0.8 mL 5 pre-filled syringes containing 0.8 mL 5 pre-filled syringes with safety device containing 0.8 mL 10 pre-filled syringes containing 0.8 mL
1 napolnjena injekcijska brizga z varnostnim pripomočkom, ki vsebuje 0,8 ml
Do not increase the dose your doctor has given you.
Če ste uporabili večji odmerek zdravila Ratiograstim, kot bi smeli Ne povečajte odmerka, ki vam ga je dal zdravnik.
Page 2/2©EMEA 2006
Stran 2/2©EMEA 2006
This summary was last updated in September 2006.
Ta povzetek je bil nazadnje posodobljen 09-2006.
In most cases, these effects are mild and stop without any treatment.
V večini primerov so ti učinki blagi in izzvenijo brez zdravljenja.
The weight lowering effect was relatively moderate (in the range of 6-7 % of the weight before treatment).
Učinek nižanja telesne teže je bil relativno zmeren (v razponu 6-7 % telesne teže pred zdravljenjem).
Two large field trials were conducted, one in Europe and one in the USA, in healthy dogs which had a bodyweight 20% higher than recommended.
Opravljena sta bila dva velika preskusa na terenu (eden v Evropi, drugi v ZDA) na zdravih psih, katerih telesna teža je bila za 20 % višja od priporočene.
It is available in three pack sizes; 55 ml or 120 ml bottles for dogs weighing up to 36 kg and a 210 ml bottle for dogs weighing up to 48 kg.
Na voljo je v treh pakiranjih: plastenka s 55 ml ali 120 ml za pse, ki tehtajo do 36 kg, in plastenka z 210 ml za pse, ki tehtajo do 48 kg.
It is used as part of a programme that also includes controlling the dog's intake of food.
Uporablja se kot del programa, ki obsega tudi nadzor prehranskega vnosa.
This is related to the mode of action of the product.
Ta učinek je povezan z načinom delovanja zdravila.
The dogs also received other medicines during the study as required, such as vaccines, worming tablets, anti-flea or anti-tick treatments, antibiotics and anti-inflammatory medicines.
Psi so med preskusoma po potrebi prejemali tudi druga zdravila, npr. cepiva, tablete proti glistam, zdravila proti bolham in klopom, antibiotike in protivnetna zdravila.
The European Commission granted a marketing authorisation valid throughout the European Union, for Yarvitan to Janssen Animal Health B.V.B.A.
Evropska komisija je dovoljenje za promet z zdravilom Yarvitan, veljavno po vsej Evropski uniji, odobrila družbi Janssen Animal Health B.V.B.A., Belgija, dne 14/11/2006.
If accidental eye contact occurs, flush immediately with lots of water.
Če pride do nenamernega stika z očmi, nemudoma izperite z obilico vode.
If a person accidentally takes the medicine, seek medical advice immediately and show the package leaflet or the label to a doctor.
Če nenamerno zaužijete to zdravilo, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
The dog then receives the medicine for a further 3 weeks, at the same time as the adjusted diet.
Pes nato prejema zdravilo dodatne 3 tedne sočasno s prilagojeno prehrano.
Other information about Yarvitan:
Druge informacije o zdravilu Yarvitan:
This veterinary medicine has been developed especially for dogs and is not for use in humans.
To veterinarsko zdravilo je namenjeno samo psom in ni za prehrano ljudi.
Yarvitan has been studied in dogs in both laboratory and field trials.
Zdravilo Yarvitan je bilo preučeno na psih v laboratoriju in v preskusih na terenu.
Information on the prescription status of this product may be found on the label/outer package.
Podatki o predpisovanju tega zdravila so navedeni na notranji/zunanji ovojnini.
The active substance in Yarvitan, mitratapide, works in the gut by blocking a protein (the microsomal triglyceride transfer protein).
Zdravilna učinkovina v zdravilu Yarvitan, mitratapid, deluje v črevesju z blokiranjem beljakovine (mikrosomske prenašalne beljakovine za trigliceride).
What benefit has Yarvitan shown during the studies?
Kakšne koristi je zdravilo Yarvitan izkazalo med raziskavami?
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) YARVITAN EPAR summary for the public
EMEA/V/C/0113 EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) YARVITAN Povzetek EPAR za javnost
About three-quarters received Yarvitan while the remainder received the medicine with the active substance removed (control group).
Približno tri četrtine psov je prejemalo zdravilo Yarvitan, preostali psi pa so prejemali zdravilo brez zdravilne učinkovine (kontrolna skupina).
The dose to use is calculated according to the weight of the dog and the Yarvitan solution is given with the animal's food.
Uporabljeni odmerek se izračuna glede na telesno težo psa, nato pa se raztopina Yarvitan daje psu s hrano.
Yarvitan at the recommended dose and using the 3-2-3 week treatment schedule reduced body weight in obese dogs when compared to the control group.
Zdravilo Yarvitan je v priporočenem odmerku in ob uporabi urnika zdravljenja 3-2-3 tedne znižalo telesno težo debelih psov v primerjavi s kontrolno skupino.
Yarvitan also has a slight appetite decreasing effect due to its mode of action.
Zdravilo Yarvitan ima zaradi svojega načina delovanja tudi šibek učinek zmanjšanja apetita.
Yarvitan is an oral solution, colourless to slightly yellow in colour.
Zdravilo Yarvitan je brezbarvna do rahlo rumena peroralna raztopina.
Yarvitan contains the active substance mitratapide which helps to reduce weight in dogs.
Zdravilo Yarvitan vsebuje zdravilno učinkovino mitratapid, ki pripomore k znižanju telesne teže psov.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Yarvitan exceed its risks for the management of overweight and obesity in dogs and recommended that Yarvitan be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Yarvitan pri obravnavi prekomerne telesne teže in debelosti psov večje od z njim povezanih tveganj, zato priporoča odobritev dovoljenja za promet z zdravilom Yarvitan.
Vomiting, diarrhoea or softened faeces may occur during treatment.
Med zdravljenjem lahko pride do bruhanja, driske ali mehkejših iztrebkov.
What is Yarvitan used for?
Za kaj se zdravilo Yarvitan uporablja?
A reduced appetite may also occur during treatment.
Med zdravljenjem se lahko apetit psa zmanjša.
The medicine is administered to the dog for 3 weeks, followed by a 2-week medicine-free interval, when the veterinarian will adjust the dog's feeding according to its energy requirements.
Temu sledi dvotedenska prekinitev, ko veterinar prehrano psa prilagaja energijskim potrebam psa.
Why has Yarvitan been approved?
Zakaj je bilo zdravilo Yarvitan odobreno?
How has Yarvitan been studied?
Kako je bilo zdravilo Yarvitan raziskano?
What is the risk associated with Yarvitan?
Kakšna tveganja so povezana z zdravilom Yarvitan?
This protein is normally involved in the absorption of fats from the diet. By blocking the protein Yarvitan decreases the absorption of fats from the gut.
Ko zdravilo Yarvitan blokira beljakovino, se absorpcija maščob iz črevesja zmanjša.
How does Yarvitan work?
Kako zdravilo Yarvitan deluje?
The treatment is an initial measure in an obesity management programme; it has to be combined with changes in diet, which must be continued after treatment is finished.
Zdravilo je treba kombinirati s spremembo prehrane.
For a full list of all side-effects reported with Yarvitan, see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Yarvitan, najdete v Navodilih za uporabo.
Yarvitan is used in adult dogs that are overweight or obese, to help them lose weight.
Zdravilo Yarvitan se uporablja za nižanje telesne teže odraslih psov, ki imajo prekomerno telesno težo oz. so debeli.
700 mg Film-coated tablets
700 mg Filmsko obložene tablete Peroralna uporaba
Bottle (HDPE) 225 ml
Steklenička (HDPE) 225 ml
EU number
Vsebina
50 mg/ml Oral suspension
50 mg/ml Peroralna suspenzija Peroralna uporaba
1 bottle + 10 ml dosing syringe
1 steklenička + brizga za odmerjanje 10 ml
Invented name Strength Pharmaceutical form Route of administration Packaging Content
Številka EU Zaščiteno ime Jakost Farmacevtska oblika Način uporabe zdravila Ovojnina
(Invented) name Strength
Izmišljeno ime
EMEA Number
Številka EU
Pharmaceutical Form Route of Administration Packaging Package size l t o r
Velikost pakiranja o ā
--1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
--1 Influenza A/eq/ Ohio/03 [H3N8] rekombinantni canarypox virus (vCP2242) ≥ 5,3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni canarypox virus (vCP1533) ≥ 5,3 log10 FAID50*/ml
Horses Intramuscular use Vial (glass) 1 ml
Intramuskularno Viala (steklo) 1 ml
Target Species
Ciljna živalska vrsta
Packaging Content Package Size
Ovojnina Vsebina Velikost pakiranja
EU (MA) Number Invented name
EU (MA) Številka
Strength Pharmaceutical Form
Farmacvtska oblika
Further information on Fulphila can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/fulphila.
Več informacij o zdravilu Fulphila je na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/fulphila.
Pain in muscles is also common.
Pogoste so tudi bolečine v mišicah.
This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
To upočasni odstranjevanje filgrastima iz telesa, zato se zdravilo lahko daje manj pogosto.
This means that Fulphila is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
Neutropenia lasted 1 day on average with both medicines.
Pri obeh zdravilih je nevtropenija trajala povprečno en dan.
What measures are being taken to ensure the safe and effective use of Fulphila?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Fulphila?
The most common side effect with Fulphila (which may affect more than 1 in 10 people) is pain in the bones.
Najpogostejši neželeni učinek zdravila Fulphila (ki se lahko pojavi pri več kot 1 bolniku od 10) je bolečina v kosteh.
An overview of Fulphila and why it is authorised in the EU
Pregled zdravila Fulphila in zakaj je odobreno v EU
It is available as a prefilled syringe containing a solution for injection under the skin.
Na voljo je v obliki napolnjene injekcijske brizge, ki vsebuje raztopino za injiciranje pod kožo.
Side effects reported with Fulphila are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Fulphila, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
For more information about using Fulphila, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Fulphila glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
As for all medicines, data on the use of Fulphila are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Fulphila stalno spremljajo.
Fulphila is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Zdravilo Fulphila se daje v obliki enkratnega odmerka v jakosti 6 mg, ki se injicira pod kožo vsaj 24 ur po koncu vsakega ciklusa kemoterapije (zdravljenja z zdravili proti raku).
What benefits of Fulphila have been shown in studies?
Kakšne koristi zdravila Fulphila so se pokazale v študijah?
Why is Fulphila authorised in the EU?
Zakaj je bilo zdravilo Fulphila odobreno v EU?