natgillin/translations-raw huggingface dataset:
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.
Biograstim treatment will last for up to 2 weeks and in exceptional cases longer.
Zdravljenje z zdravilom Biograstim bo trajalo do dveh tednov, le v izjemnih primerih bo trajalo dlje.
Dose adjustment is not required in these circumstances.
Prilagajanje odmerka v tem primeru ni potrebno.
Do not remove the cover from the syringe until you are ready to inject.
Ne snemajte pokrovčka z injekcijske brizge, dokler niste pripravljeni na injiciranje.
Possible side effects”).
Možni neželeni učinki«).
Musculoskeletal pain is usually controlled with standard analgesics.
Mišičnoskeletno bolečino običajno obvladujemo s standardnimi analgetiki.
Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
Zaradi tega moramo velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
Once the number of white cells in your blood have returned to normal it may be possible to reduce the dose frequency to less than once per day.
Ko se število belih krvničk v vaši krvi povrne na običajno raven, je pogostost odmerjanja zdravila mogoče zmanjšati na manj kot enkrat dnevno.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Metodo zbiranja je potrebno izbrati glede na splošne cilje zdravljenja pri posameznem bolniku.
From a microbiological point of view, the product should be used immediately.
Z mikrobiološkega vidika morate zdravilo porabiti takoj.
Do not warm Biograstim in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Biograstim ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Germany
AbZ-Pharma GmbH Graf-Arco-Straße 3 89079 Ulm Nemčija
The needle will be covered by the protective sleeve so that you cannot prick yourself.
Igla se bo pokrila z zaščitnim tulcem, da se ne morete zbosti.
If you are receiving this medicine by subcutaneous injection, your doctor may suggest that you learn how to give yourself the injections.
Če to zdravilo prejemate s subkutanim injiciranjem, vam lahko vaš zdravnik predlaga, da se sami naučite dajati injekcije.
The clinical relevance of this finding to multiple dose administration is not clear.
Klinična pomembnost te ugotovitve v zvezi z večkratnimi odmerki ni jasna.
Therefore, your doctor may decide that you should not use this medicine.
Zato se vaš zdravnik lahko odloči, da ne smete jemati tega zdravila.
Idiopathic or cyclic neutropenia
Idiopatična ali ciklična nevtropenija
Subcutaneous use and intravenous use.
Za subkutano in intravensko uporabo.
Very rare: Not known:
Zelo redki: neznana:
Filgrastim has minor or moderate influence on the ability to drive and use machines.
Filgrastim ima zanemarljiv ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
After one to two weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Po eno- ali dvotedenskem zdravljenju se začetni odmerek lahko podvoji ali prepolovi, odvisno od odziva bolnika.
Store in a refrigerator (2 °C - 8 °C).
Shranjujte v hladilniku (2 C - 8 C).
The incidence of these events was similar to that reported in cancer patients.
Pojav teh neželenih učinkov je podoben tistemu, o katerem so poročali pri bolnikih z rakom.
It belongs to a group of proteins called cytokines and is very similar to a natural protein (granulocyte-colony stimulating factor [G-CSF]) produced by your own body.
Spada v skupino beljakovin, imenovanih citokini, in je zelo podobna naravnim beljakovinam (faktor, ki spodbuja razvoj granulocitov [G-CSF]), ki jih izdeluje vaše lastno telo.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravila ne porabite takoj, je uporabnik odgovoren za čas in pogoje hranjenja pred uporabo in ti ne bi smeli trajati dlje kot 24 ur pri temperaturi med 2 in 8 °C, razen če postopek redčenja ni potekal v nadzorovanih in preverjeno aseptičnih pogojih.
What should I do before I give myself a subcutaneous injection of Biograstim?
Kaj moram narediti, preden si dam subkutano injekcijo zdravila Biograstim?
Do not use this medicine if you notice it is cloudy or there are particles in it.
Ne uporabljajte tega zdravila, če opazite, da je motno ali da so v njem delci.
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena spodaj.
Thirty-one percent (31 %) of patients in studies were documented as having palpable splenomegaly.
Pri enaintridesetih odstotkih (31 %) bolnikov, ki so sodelovali v raziskavah, so zabeležili otipljivo splenomegalijo.
Your doctor will tell you when to stop using Biograstim.
Vaš zdravnik vam bo povedal, kdaj morate prenehati jemati zdravilo Biograstim.
It is recommended that the apheresis centre perform a systematic record and tracking of the stem cell donors for at least 10 years to ensure monitoring of long-term safety.
Priporoča se, da center za odvzem krvi sistematično beleži in spremlja darovalce izvornih celic vsaj še 10 let ter darovalcem tako zagotovi dolgoročno varnost.
No undesirable effects directly attributable to this degree of leukocytosis have been reported.
Ne poročajo o neželenih učinkih, ki bi jih bilo možno neposredno pripisati tej stopnji levkocitoze.
There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient population.
Na voljo še ni naključnih primerjav obeh priporočenih metod zbiranja (metodo filgrastim samo ali v kombinaciji z mielosupresivno kemoterapijo) v okviru ene skupine bolnikov.
The solution should be visually inspected prior to use.
Pred uporabo morate raztopino vizualno pregledati.
Push the plunger up to the number (mL) on the syringe that matches the dose of Biograstim that your doctor prescribed.
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Biograstim, ki vam ga je predpisal vaš zdravnik.
This section contains information on how to give yourself an injection of Biograstim.
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Biograstim.
Clinical trials with filgrastim have included a small number of elderly patients but special studies have not been performed in this group and therefore specific dosage recommendations cannot be made.
V kliničnih preskušanjih s filgrastimom je sodelovalo tudi manjše število starejših bolnikov, vendar posebnih raziskav v tej skupini niso izvajali, zato priporočenih odmerkov ne moremo navesti.
Yields in excess of this minimum yield appear to correlate with more rapid recovery, those below with slower recovery.
Vrednosti nad minimalnim številom so najverjetneje povezane s hitrim okrevanjem, tiste pod minimalnim številom pa s počasnim okrevanjem.
Put the needle fully into the skin as shown by your nurse or doctor (see picture 6).
Potisnite iglo do konca v kožo, kot vam je pokazal zdravnik ali medicinska sestra (glejte sliko 6).
In other circumstances, additional leukaphereses are recommended.
V drugih primerih se priporočajo dodatne levkafereze.
Orient the needle away from you and others and activate the safety device by firmly pushing the plunger (see picture 8).
Iglo obrnite stran od sebe in drugih ter aktivirajte varnostni pripomoček, tako da trdno pritisnete bat (glejte sliko 8).
Pharmacotherapeutic group: Immunostimulants, colony stimulating factors, ATC code: L03AA02
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, kolonije spodbujajoči faktorji, oznaka ATC: L03AA02
If you experience fatigue, do not drive or use any tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Če se počutite utrujeni, ne vozite in ne uporabljajte nobenega orodja ali strojev.
Undesirable effect
Neželeni učinek
In other circumstances, additional leukaphereses may be necessary.
V drugih primerih bo morda potrebna še dodatna levkafereza.
Check the appearance of Biograstim.
Preverite videz raztopine Biograstima.
The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Varnost in učinkovitost filgrastima pri bolnikih z de novo AML, mlajših od 55 let in z ugodno citogenetiko [t(8;21), t(15;17) in inv(16)], nista ugotovljeni.
Fatigue, generalised weakness
Pogosti utrujenost, splošna oslabelost
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Iz raziskave o dajanju enkratnega odmerka obstajajo dokazi, da intravenski način dajanja zdravila lahko skrajša trajanje učinka.
Regular urinanalysis should be performed to monitor this event.
Za spremljanje teh bolezenskih stanj je potrebna redna urinska analiza.
Since lithium promotes the release of neutrophils, it is likely to potentiate the effect of filgrastim.
Ker litij pospešuje sproščanje nevtrofilcev, je mogoče, da potencira učinek filgrastima.
The choice of route should depend on the individual clinical circumstance.
Izbira za en ali drug način dajanja zdravila bi morala biti odvisna od posameznih kliničnih okoliščin.
Filgrastim is a protein produced by biotechnology in bacteria called Escherichia coli.
Filgrastim je beljakovina, ki jo izdelujejo s pomočjo biotehnologije v bakterijah, ki se imenujejo Escherichia coli.
Spleen size should be evaluated regularly.
Velikost vranice je potrebno redno pregledovati.
Biograstim has not been tested in pregnant women.
Zdravila Biograstim pri nosečnicah niso preizkusili.
The assessment of undesirable effects is based on the following frequency data: Very common:
Neželeni učinki so opredeljeni po pogostnosti: Zelo pogosti:
Following established chemotherapy for solid tumours, lymphomas and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Po uveljavljeni kemoterapiji za trdne tumorje, limfome in pri limfoidini levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
For maintaining normal neutrophil counts
Ohranjanje normalnega števila nevtrofilcev
The most suitable places to inject yourself are: - the top of your thighs; and - the abdomen, except for the area around the navel (see picture 3).
Najprimernejši mesti za samoinjiciranje sta: - zgornji del stegen; in - trebuh, razen predela okrog popka (glejte sliko 3).
Your doctor will monitor your blood to determine the best time to collect the stem cells.
Vaš zdravnik bo spremljal vašo kri, zato da določi najprimernejši čas za zbiranje izvornih celic.
If someone else is injecting you, they can also use the back of your arms (see picture 4).
Če vam daje injekcijo kdo drug, vam jo lahko da tudi v zadnji del nadlakti (glejte sliko 4).
Check again to make sure the correct dose of Biograstim is in the syringe.
Še enkrat preverite, če je v brizgi ustrezen odmerek zdravila Biograstim.
Filgrastim stimulates the bone marrow (the tissue where new blood cells are made) to produce more blood cells, especially certain types of white cells.
Filgrastim spodbuja kostni mozeg (tkivo, kjer nastajajo krvničke), da proizvaja več krvničk, še posebej določene vrste belih krvničk.
Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
Možnih interakcij z drugimi hemotopoetičnimi rastnimi faktorji in citokini v kliničnih študijah niso posebej raziskali.
Try to self-inject at approximately the same time every day.
Potrudite se, da si boste zdravilo vbrizgali vsak dan ob približno enakem času.
Other medicines and Biograstim
Druga zdravila in zdravilo Biograstim
If you think you are having this type of reaction, you must stop your Biograstim injection and get medical help immediately.
Če menite, da se je pri vas pojavila takšna reakcija, prenehajte z odmerjanjem zdravila Biograstim in takoj poiščite zdravniško pomoč.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
V nekaterih primerih so se simptomi ob vnovični izpostavitvi ponovno pojavili, kar nakazuje vzročni odnos.
A meta-analysis of allogeneic transplant studies, including the results of nine prospective randomized trials, 8 retrospective studies and 1 case-controlled study, did not detect an effect on the risks of acute GvHD, chronic GvHD or early treatment-related mortality.
Metaanaliza študije alogenskih presaditev, vključno z rezultati devetih prospektivnih randomiziranih preskušanj, 8 retrospektivnih študij in 1 s primerom nadzirane študije ni pokazala učinka na tveganje za akutno GvHD, kronično GvHD ali zgodnjo z zdravljenjem povezano smrtnostjo.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Randomizirane, enojno slepe navzkrižne študije z enkratnim odmerkom pri 196 zdravih prostovoljcih so pokazale, da je farmakokinetičen profil zdravila Biograstim primerljiv s profilom referenčnega zdravila po subkutanem in intravenskem apliciranju.
Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Po indukcijskem in konsolidacijskem zdravljenju za hudo mieloično levkemijo je trajanje zdravljenja lahko znatno daljše (tudi do 38 dni), odvisno od vrste, odmerka in sheme odmerjanja citotoksične kemoterapije.
The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Varnostni profil zdravila Biograstim v kliničnih študij se je ujemal z varnostnim profilom referenčnega zdravila, prav tako uporabljenega v teh študijah.
Relative risk (95 % CI) of GvHD and TRM following treatment with G-CSF after bone marrow transplantation
Relativno tveganje (95-% IZ) za GvHD in TRM po zdravljenju z G-CSF po presaditvi kostnega mozga
The excretion of filgrastim in milk has not been studied in animals.
Izločanja filgrastima v mleko pri živalih, niso raziskali.
If the patient is experiencing fatigue, caution is advised when driving a car or operating machines.
Če se bolnik počuti utrujenega, mora biti pri vožnji avtomobila ali pri upravljanju s stroji previden.
However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Ker pa je velik odstotek teh bolnikov obolelih za levkemijo (gre za stanje, za katerega vemo, da je povezano s Sweetovim sindromom), vzročna povezava s filgrastimom ni bila ugotovljena.
Each mL of solution contains 50 mg of sorbitol.
1 ml raztopine vsebuje 50 mg sorbitola.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Pomembno je, da si injekcije ne poskušate dati sami, če vas nista zdravnik ali medicinska sestra tega posebej naučila.
A risk of promotion of a malignant myeloid clone can not be excluded.
Tveganja za napredovanje mieloidnega rakastega klona ne moremo izključiti.
The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Postopek zbiranja in afereze bi moral potekati v sodelovanju z onkološko-hematološkim centrom, ki ima ustrezne izkušnje na tem področju in v katerem lahko na ustrezen način spremljajo krvotvorne matične celice.