natgillin/translations-raw huggingface dataset:
Nitisinone treatment leads to normalised porphyrin metabolism with normal erythrocyte porphobilinogen synthase activity and urine 5-aminolevulinate, decreased urinary excretion of succinylacetone, increased plasma tyrosine concentration and increased urinary excretion of phenolic acids. 
Farmakodinamični učinki Zdravljenje z nitizinonom omogoča, da se vzpostavi normala presnova porfirina z normalnim delovanjem eritrocitne porfobilinogen-sintaze in 5-aminolevulinatom v urinu, da se zmanjša izločanje sukcinilacetona z urinom, poveča koncentracija tirozina v plazmi in tudi odvajanje fenola z urinom.
Fertility There are no data on nitisinone affecting fertility. 
Plodnost Podatkov o vplivu nitizinona na plodnost ni.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Predpisovanje in izdaja zdravila je le s posebnim režimom (Glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
In patients with HT1, these intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate. 
Pri bolnikih s HT-1 se ta intermediata pretvorita v toksična presnovka sukcinilaceton in sukcinilacetoacetat.
Nitisinone caused an approximate 30% decrease in chlorzoxazone AUC∞, indicative of a weak induction of CYP2E1. 
Nitizinon je povzročil znižanje AUC∞ klorzoksazona za približno 30 %, ki kaže na šibko indukcijo encima CYP 2E1.
Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment. 
Razpoložljivi podatki klinične študije so pokazali, da se je sukcinilaceton v urinu pri več kot 90 %
The active ingredient of Nitisinone MDK is nitisinone. 
Zdravilna učinkovina v zdravilu Nitisinone MDK je nitizinon.
During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4). 
Prilagoditev odmerka Med rednim nadzorovanjem je treba spremljati sukcinilaceton v urinu, teste delovanja jeter in raven alfa-fetoproteina (glejte poglavje 4.4).
A patient displaying visual disorders during treatment with nitisinone should without delay be examined by an ophthalmologist. 
Če se pri bolniku med zdravljenjem z nitizinonom pojavijo motnje vida, mora nemudoma opraviti okulistični pregled.
In rats, exposure via milk resulted in reduced mean pup weight and corneal lesions. 
Pri podganah se je izpostavljenost prek mleka pokazala v zmanjšani povprečni telesni masi mladiča in lezijah roženice.
If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination. 
Če opazite neželene učinke, povezane z očmi, se takoj dogovorite z zdravnikom za očesni pregled.
Adjunct to the nitisinone treatment, a diet deficient in phenylalanine and tyrosine is required and should be followed by monitoring of plasma amino acids (see sections 4.4 and 4.8). 
Poleg zdravljenja z nitizinonom je potrebna dieta z nizko vsebnostjo fenilalanina in tirozina, pri čemer je treba nadzorovati aminokisline v plazmi (glejte poglavji 4.4 in 4.8).
If you become pregnant you should contact your doctor immediately. 
Če zanosite, morate o tem takoj obvestiti zdravnika.
Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171) 
Ovojnica kapsule - želatina - titanov dioksid (E 171)
Contents of the pack and other information What Nitisinone MDK contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nitisinone MDK
Elevated tyrosine levels 
Zelo pogosti povečane ravni tirozina
The recommended total daily dose is 1 mg/kg body weight administered orally. 
Priporočeni celotni dnevni odmerek je 1 mg/kg telesne mase, ki se daje peroralno.
It is recommended that if nitisinone treatment is initiated with food, this should be maintained on a routine basis, see section 4.5. 
Če se zdravljenje z nitizinonom začne ob hrani, se priporoča, da se to vzdržuje rutinsko, glejte poglavje 4.5.
What Nitisinone MDK is and what it is used for 
Kaj je zdravilo Nitisinone MDK in za kaj ga uporabljamo
Adverse reactions affecting the MedDRA system organ class ‘Blood and lymphatic system disorders' subsided during continued nitisinone treatment. 
Neželeni učinki, ki vplivajo na organske sisteme v skupini bolezni krvi in limfatičnega sistema, so pri nadaljnjem zdravljenju z nitizinonom izzveneli.
Nitisinone treatment leads to elevated tyrosine levels. 
Zdravljenje z nitizinonom vodi v zvišane ravni tirozina.
Nitisinone treatment may therefore result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9. 
Zdravljenje z nitizinonom zato lahko povzroči zvišane plazemske koncentracije sočasno dajanih zdravil, ki se presnavljajo predvsem preko encima CYP 2C9.
Nitisinone did not show carcinogenic potential in a 26-week carcinogenicity study in transgenic mice (TgrasH2). 
26-tedenski študiji kancerogenosti pri transgenskih miših (TgrasH2) nitizinon ni pokazal kancerogenega potenciala.
Liver monitoring 
Spremljanje jeter
The capsule contains a white to off-white powder. 
Kapsula vsebuje bel do belkast prašek.
There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment. 
Za starejše bolnike ali bolnike z ledvično ali jetrno okvaro ni posebnih priporočil glede odmerjanja.
Treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease (hereditary tyrosinemia type 1). 
Zdravljenje s tem zdravilom lahko začne in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni (dedna tirozinemija tipa 1).
Other uncommon side effects - increased number of white blood cells (leucocytosis), - itching (pruritus), skin inflammation (exfoliative dermatitis), rash. 
Drugi občasni neželeni učinki - povečano število belih krvnih celic (levkocitoza), - srbečica (pruritus), vnetje kože (eksfoliativni dermatitis), izpuščaj.
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible. 
Če ste vzeli večji odmerek zdravila Nitisinone MDK, kot bi smeli Če ste vzeli prevelik odmerek tega zdravila, se čim prej posvetujte z zdravnikom ali farmacevtom.
Therefore, it is recommended that if nitisinone treatment with Nitisinone MDK hard capsules is initiated with food, this should be maintained on a routine basis, see section 4.2. 
Če se zdravljenje z nitizinonom z zdravilom Nitisinone MDK trde kapsule začne ob hrani, se priporoča, da se to vzdržuje rutinsko, glejte poglavje 4.2.
Blepharitis 
Občasni blefaritis
- Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment. 
- Oftalmolog bo vaše oči pregledal pred zdravljenjem z nitizinonom in nato v rednih intervalih.
This leaflet was last revised in 
Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
Nitisinone has shown embryo-foetal toxicity in the mouse and rabbit at clinically relevant dose levels. 
Nitizinon je pri kliničnih odmerkih pokazal znake embriofetalne toksičnosti pri miših in kuncih.
A pre- and postnatal development study in the mouse showed statistically significant reduced pup survival and pup growth during the weaning period at dose levels 125- and 25-fold higher, 
Študije o pre- in postnatalnem razvoju pri miših so pokazale statistično značilno zmanjšano preživetje mladičev, izpostavljenih 125-krat večjim odmerkom, in zmanjšanje rasti mladičev po odstavitvi pri 25-krat večjih odmerkih v primerjavi z največjim priporočenim odmerkom za človeka.
If you experience any side effects, shorter intervals are recommended. 
Če se pojavijo kakršni koli neželeni učinki, so priporočljivi pogostejši kontrolni pregledi.
No mutagenic but a weak clastogenic activity was observed in in vitro studies. 
Pri študijah in vitro niso opazili mutagenosti, temveč le rahlo klastogensko aktivnost.
What you need to know before you take Nitisinone MDK Do not take Nitisinone MDK: 
Kaj morate vedeti, preden boste vzeli zdravilo Nitisinone MDK Ne jemljite zdravila Nitisinone MDK
60 hard capsules 
60 trdih kapsul
If you forget to take a dose, contact your doctor or pharmacist. 
Če ste pozabili vzeti odmerek zdravila, se posvetujte z zdravnikom ali farmacevtom.
Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone caused a 2.3-fold increase in AUC∞ of the CYP2C9 substrate tolbutamide, which is indicative of a moderate inhibition of CYP2C9. 
Klinična študija medsebojnega delovanja z nitizinonom 80 mg v stanju dinamičnega ravnovesja je pokazala, da je nitizinon povzročil 2,3-kratno zvišanje AUC∞ substrata CYP 2C9 tolbutamida, ki kaže na zmerno zaviranje encima CYP 2C9.
Other medicines and Nitisinone MDK 
Druga zdravila in zdravilo Nitisinone MDK
If urine succinylacetone is still detectable one month after the start of nitisinone treatment, the nitisinone dose should be increased to 1.5 mg/kg body weight/day. 
Če en mesec po začetku zdravljenja z nitizinonom v urinu še vedno zasledite sukcinilaceton, je treba odmerek nitizinona povečati na 1,5 mg/kg telesne mase na dan. Na podlagi ocene biokemičnih parametrov bo morda potreben odmerek 2 mg/kg telesne mase na dan.
The recommended initial daily dose in the paediatric and adult population is 1 mg/kg body weight administered orally. 
Priporočeni začetni dnevni odmerek za otroke in odrasle je 1 mg/kg telesne mase, ki se jemlje peroralno.
The medicine can be stored for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which it must be discarded. 
Zdravilo lahko shranjujete zunaj hladilnika dva meseca, po prvem odprtju steklenico, pri temperaturi do 25 °C, potem ga je treba zavreči.
Elevated levels of tyrosine have been associated with eye-related adverse reactions, such as e.g. corneal opacities and hyperkeratotic lesions. 
Povečane ravni tirozina so povezane z neželenimi učinki, povezanimi z očmi, kot so motnjava roženice in hiperkeratozne lezije.
Based on in vitro studies, nitisinone is not expected to inhibit CYP1A2, 2C19 or 3A4-mediated metabolism or to induce CYP1A2, 2B6 or 3A4/5. 
1A2, 2C19 ali 3A4, ali inducirati encimov CYP 1A2, 2B6 ali 3A4/5.
Eye problems could be a sign of inadequate dietary control (see section 4). 
Težave z očmi, glejte poglavje 4, so lahko znak neustrezne diete.
In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism. 
Študije in vitro, pri katerih so uporabili človeške mikrosome jeter in s cDNA izražene encime P450,
Probability of no HCC (95% confidence interval) at 
Verjetnost za nepojav HCK (95 % interval zaupanja) po na začetku po 2 letih po 4 letih po 6 letih
Can be stored for a single period of 2 months at a temperature not above 25°C, after which it must be discarded. 
Zdravilo lahko shranjujete dva meseca pri temperaturi do 25 °C, potem ga je treba zavreči.
Thrombocytopenia, leucopenia, granulocytopenia 
Pogosti trombocitopenija, levkopenija, granulocitopenija
Platelet and white blood cell (WBC) monitoring 
Spremljanje trombocitov in belih krvnih celic
respectively, the maximum recommended human dose, with a trend toward a negative effect on pup survival starting from the dose of 5 mg/kg/day. 
Trend negativnega učinka na preživetje mladičev se začne pri odmerku 5 mg/kg/dan.
Succinylacetone should not be detectable in urine or plasma when the nitisinone dose is properly adjusted. 
Pri ustrezno prilagojenem odmerku nitizinona se v urinu ali plazmi sukcinilaceton ne bi smel pojavljati.
It is recommended that a slit-lamp examination of the eyes is performed before initiation of nitisinone treatment and thereafter regularly, at least once a year. 
Pred začetkom zdravljenja z nitizinonom in nato redno, a vsaj enkrat na leto, je priporočljivo opraviti pregled oči s špranjsko svetilko.
Accidental ingestion of nitisinone by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels. 
Pri osebah, ki imajo normalno dieto brez omejitve tirozina in fenilalanina in pomotoma zaužijejo nitizinon, se bo raven tirozina povečala.
What Nitisinone MDK looks like and contents of the pack 
Izgled zdravila Nitisinone MDK in vsebina pakiranja
If you start Nitisinone MDK treatment by taking it with food, it is recommended that you carry on taking it with food throughout your course of treatment. 
Zdravilo Nitisinone MDK skupaj s hrano in pijačo Če boste zdravljenje začeli z jemanjem zdravila Nitisinone MDK s hrano, je priporočljivo, da tako nadaljujete ves čas zdravljenja.
During the shelf life, the patient may store the capsules for a period of 2 months, after first opening the bottle, at a temperature not above 25°C, after which the medicinal product must be discarded. 
24 mesecev Med rokom uporabnosti lahko bolnik shranjuje kapsule pri temperaturi do 25 °C dva meseca, po prvem odprtju steklenico, potem pa jih mora zavreči.
Leukocytosis 
Občasni levkocitoza
≤ 24 months 
Začetna starost ≤ 24 mesecev
Other common adverse reactions include thrombocytopenia, leucopenia, and granulocytopenia. 
Drugi pogosti neželeni učinki vključujejo trombocitopenijo, levkopenijo in granulocitopenijo.
Do not take a double dose to make up for a forgotten dose. 
Če ste pozabili vzeti zdravilo Nitisinone MDK Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Nitisinone MDK capsules are 15.7 mm long, white, opaque, hard gelatin capsules, imprinted with “Nitisinone” and the strength “2 mg”, “5 mg” or “10 mg”, in black. 
Kapsule Nitisinone MDK so trde želatinske kapsule motno bele barve dolžine 15,7 mm, vtisnjen imajo napis »Nitisinone« in jakost »2 mg«, »5 mg«, ali »10 mg« v črni barvi.
By inhibiting the normal catabolism of tyrosine in patients with HT-1, nitisinone prevents the accumulation of the toxic intermediates maleylacetoacetate and fumarylacetoacetate. 
HT-1, nitizinon prepreči kopičenje toksičnih intermediatov, kot sta maleilacetoacetat in fumarilacetoacetat.
Exfoliative dermatitis, erythematous rash, pruritus 
Občasni eksfoliativni dermatitis, kožni izpuščaji, pruritus
Nitisinone treatment should be initiated and supervised by a physician experienced in the treatment of HT-1 patients. 
4.2 Odmerjanje in način uporabe Zdravljenje z nitizinonom mora začeti in nadzorovati zdravnik, usposobljen za zdravljenje bolnikov z dedno tirozinemijo tipa 1.
Imprint ˗ Black iron oxide (E172) ˗ Shellac 
Tiskarsko črnilo: črn železov oksid (E 172)
In the rabbit, nitisinone induced a dose-related increase in malformations (umbilical hernia and gastroschisis) from a dose level 2.5-fold higher than the maximum recommended human dose (2 mg/kg/day). 
Pri kuncih je pri odmerkih, večjih od 2,5-kratnega največjega priporočenega odmerka za človeka (2 mg/kg/dan), povzročil od odmerka odvisno povečanje pogostosti malformacij (umbilikalne hernije in gastroshize).
Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway. 
4-hidroksifenilpiruvat-dioksigenaze, ki v katabolni poti tirozina katalizira stopnjo pred fumarilacetoacetat-hidrolazo.
The biochemical defect in hereditary tyrosinemia type 1 (HT-1) is a deficiency of fumarylacetoacetate hydrolase, which is the final enzyme of the tyrosine catabolic pathway. 
Mehanizem delovanja Biokemična motnja pri dedni tirozinemiji tipa 1 (HT-1) je pomanjkanje fumarilacetoacetat-hidrolaze,
Capsule content: pregelatinised maize starch Capsule shell: gelatin, titanium dioxide (E171) Printing ink: black iron oxide (E172), shellac glaze 
- Druge sestavine zdravila so: Vsebina kapsule: predgeliran (koruzni) škrob Ovojnica kapsule: želatina titanov dioksid (E 171)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Treatment with nitisinone was also found to result in reduced risk for the development of hepatocellular carcinoma compared to historical data on treatment with dietary restriction alone. 
Poleg tega so odkrili, da zdravljenje z nitizinonom, v primerjavi s podatki o zdravljenju zgolj s predpisano dieto, zmanjšuje tveganje za razvoj hepatocelularnega karcinoma (HCK).
No formal food interactions studies have been performed with Nitisinone MDK hard capsules. 
Formalnih študij interakcij zdravila Nitisinone MDK trde kapsule s hrano niso opravili, vendar so med zbiranjem podatkov o učinkovitosti in varnosti nitizinon dajali skupaj s hrano.
Nitisinone MDK 5 mg: Each capsule contains 5 mg nitisinone. 
Nitisinone MDK 5 mg: ena kapsula vsebuje 5 mg nitizinona.
Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain 
Pogosti konjunktivitis, motnjava roženice, keratitis, fotofobija,
Nitisinone MDK 2 mg: Each capsule contains 2 mg nitisinone. 
Nitisinone MDK 2 mg: ena kapsula vsebuje 2 mg nitizinona.
Nitisinone MDK 10 mg: Each capsule contains 10 mg nitisinone. 
Nitisinone MDK 10 mg: ena kapsula vsebuje 10 mg nitizinona.
How to take Nitisinone MDK 
Kako jemati zdravilo Nitisinone MDK
Each capsule contains 2 mg nitisinone. 
Ena kapsula vsebuje 2 mg nitizinona.
Talk to your doctor or pharmacist before taking Nitisinone MDK. 
Pred začetkom jemanja zdravila Nitisinone MDK se posvetujte z zdravnikom ali farmacevtom.
Each capsule contains 5 mg nitisinone. 
Ena kapsula vsebuje 5 mg nitizinona.
Each capsule contains 10 mg nitisinone. 
Ena kapsula vsebuje 10 mg nitizinona.
Eye-related adverse reactions, such as conjunctivitis, corneal opacity, keratitis, photophobia, and eye pain, related to elevated tyrosine levels are therefore common. 
fotofobija in bolečine v očeh, povezane s povečanimi ravnmi tirozina, so zato pogosti.
2 years 4 years 6 years 
Starost na začetku zdravljenja 2 leti 4 leta 6 let
Your liver will be checked at regular intervals because the disease affects the liver. 
Ker bolezen prizadene jetra, vam bodo v časovnih razmikih opravili redne preglede jeter.
How to store Nitisinone MDK 
Shranjevanje zdravila Nitisinone MDK
Eye disorders 
bolečine v očeh
Always take this medicine exactly as your doctor has told you. 
Pri jemanju zdravila natančno upoštevajte navodila zdravnika.
Posology 
Vtis
Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4). 
Klinična študija medsebojnega delovanja z nitizinonom 80 mg v stanju dinamičnega ravnovesja je pokazala, da je nitizinon zmerni zaviralec encima CYP 2C9 (2,3-kratno zvišanje AUC tolbutamida),
Dose adjustment 
Odmerjanje
A more restricted tyrosine and phenylalanine diet should be implemented in case the plasma tyrosine level is above 500 micromol/L. 
500 mikromolov/l, je treba z dieto še bolj zmanjšati vnos tirozina in fenilalanina.
Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone 
Nitisinone MDK 2 mg trde kapsule Nitisinone MDK 5 mg trde kapsule Nitisinone MDK 10 mg trde kapsule nitizinon
White, opaque capsules of 15.7 mm imprinted with black ink “10 mg” on the cap and “Nitisinone” on the body. 
Kapsule, velikosti 15,7 mm, motno bele barve s črnim vtisom »10 mg« na pokrovčku in »Nitisinone«
Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules 
Nitisinone MDK 2 mg trde kapsule Nitisinone MDK 5 mg trde kapsule Nitisinone MDK 10 mg trde kapsule
White, opaque capsules of 15.7 mm imprinted with black ink “2 mg” on the cap and “Nitisinone” on the body. 
Kapsule, velikosti 15,7 mm ,motno bele barve s črnim vtisom »2 mg« na pokrovčku in »Nitisinone«
White, opaque capsules of 15.7 mm imprinted with black ink “5 mg” on the cap and “Nitisinone” on the body. 
Kapsule, velikosti 15,7 mm, motno bele barve s črnim vtisom »5 mg« na pokrovčku in »Nitisinone«
- If you get any side effects, talk to your doctor or pharmacist. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Contents of the pack and other information 
Shranjevanje zdravila Nitisinone MDK Vsebina pakiranja in dodatne informacije
Package leaflet: Information for the user Nitisinone MDK 2 mg hard capsules Nitisinone MDK 5 mg hard capsules Nitisinone MDK 10 mg hard capsules nitisinone 
Navodilo za uporabo Nitisinone MDK 2 mg trde kapsule Nitisinone MDK 5 mg trde kapsule Nitisinone MDK 10 mg trde kapsule nitizinon
It is therefore difficult to recommend an optimum method. 
Zaradi tega je težko priporočiti najboljšo metodo.
● Risk Management Plan (RMP) 
• Načrt za obvladovanje tveganja (RMP)
The recommended dose is... 
Priporočeni odmerek je...
- if you are suffering from any other illness, especially if you think you have an infection. 
- če imate katero koli drugo bolezen, predvsem če menite, da imate okužbo.
The following information is intended for healthcare professionals only 
Naslednje informacije so namenjene samo zdravstvenemu osebju
Date of first authorisation: 15 September 2008. 
Datum prve odobritve: 15. september 2008.
Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful. 
Čeprav te interakcije niso uradno raziskali, ni dokazov, da bi bilo takšno medsebojno delovanje škodljivo.
- if you have osteoporosis. 
- če imate osteoporozo.
Date of latest renewal: 25 July 2013. 
Datum zadnjega podaljšanja: 25. julij 2013.
You will hear a “click”, which confirms activation of the safety device. 
Zaslišali boste »klik«, ki potrdi aktivacijo varnostnega pripomočka.
European retrospective study (2004) 
Evropska retrospektivna študija (2004)
International retrospective study (2006) 
Mednarodna retrospektivna študija (2006)
Particular attention should be paid to haematological values and infectious diseases. 
Pri tem je treba posebno pozornost nameniti hematološkim vrednostim in infekcijskim boleznim.
Long-term safety follow-up of donors is ongoing. 
Zaradi zagotavljanja varnosti, je trenutno v teku dolgoročno spremljanje darovalcev.
Your treatment will usually last for about 14 days. 
Zdravljenje bo običajno trajalo okoli 14 dni.
Publication Period of study 
Publikacija Obdobje študije
Biograstim treatment will last for 4 to 5 days. 
Zdravljenje z zdravilom Biograstim bo trajalo 4 do 5 dni.
Component of a multipack, cannot be sold separately. 
Skupno pakiranje, ni mogoče prodajati ločeno.
Some of the information you require is given at the end of this package leaflet, but proper treatment of your disease requires close and constant co-operation with your doctor. 
Nekateri napotki, ki jih boste pri tem potrebovali, so na koncu teh navodil, vendar pravilno zdravljenje vaše bolezni zahteva tesno in stalno sodelovanje z vašim zdravnikom.
Regular monitoring of blood counts is recommended (see above). 
Priporoča se redno spremljanje števila krvnih celic (glejte zgoraj).
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim. 
Med kliničnimi študijami je bilo zdravilu Biograstim izpostavljenih 541 bolnikov z rakom in 188 zdravih prostovoljcev.
Do not use it if the date has passed the last day of the month shown. 
Ne uporabite ga, če je zadnji dan navedenega meseca že potekel.
White cells are important as they help your body fight infection. 
Bele krvničke so pomembne, saj vašemu telesu pomagajo, da se bori proti okužbam.
The volume of distribution in blood is approximately 150 mL/kg. 
Volumen porazdelitve v krvi znaša približno 150 ml/kg.
In some disease types however, longer treatment lasting up to about one month may be required. 
Pri nekaterih vrstah obolenj pa je potrebno tudi daljše zdravljenje, ki lahko traja do enega meseca.
You will need to have your injections at about the same time every day. 
Injekcije si boste morali vsak dan dajati približno ob istem času.
Only use each syringe for one injection. 
Vsako injekcijsko iglo uporabite samo za eno injiciranje.
If you have a fever or any of these symptoms, it is important to contact your doctor immediately. 
Če imate zvišano telesno temperaturo ali katerega koli izmed teh simptomov, je pomembno, da takoj obvestite svojega zdravnika.