natgillin/translations-raw huggingface dataset:
Reproductive system and breast disorders
Motnje reprodukcije in dojk ginekomastija
Recent ischaemic stroke
• Okvara jeter
For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
Pri manjših urezninah ali poškodbah, npr. če se urežete, pri britju, navadno ni razloga za skrb, če pa vas glede krvavitve skrbi, se nemudoma posvetujte z zdravnikom (glejte poglavje 4 »Možni neželeni učinki«);
United Kingdom Generics [UK] Ltd Tel: +44 1707 853000
Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800
• Bioequivalence vis-à-vis a valid EU reference medicinal product has been demonstrated, based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
• biološka enakovrednost z referenčnim zdravilom, odobrenim v EU, je bila dokazana na podlagi primernih podatkov v skladu z zahtevami člena 10 Direktive 2001/83/ES (npr. študija biološke enakovrednosti, opravljena z referenčnim zdravilom, odobrenim v EU).
For the suspension of the marketing authorisations to be lifted, the competent authorities of the EU Member States shall ensure that the below condition has been completed by the marketing authorisation holders
Za preklic začasnega umika dovoljenj za promet z zdravilom morajo pristojni organi držav članic Evropske unije zagotoviti, da so imetniki dovoljenj za promet z zdravilom izpolnili naslednji pogoj:
Conditions for lifting the suspension of the marketing authorisation(s)
Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
It is therefore difficult to recommend an optimum method.
Zato je težko priporočiti optimalno metodo.
It is important to tell your doctor if you:
Pomembno je, da svojemu zdravniku poveste, če:
Date of latest renewal: 19 July 2013.
Datum zadnjega podaljšanja: 19. julij 2013.
• think you may be pregnant or
• menite, da bi lahko bili noseči ali
A risk to the breastfed newborns/infants cannot be excluded.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
However, you should not attempt this unless you have been properly trained first by your health care provider.
Vendar pa tega ne poskušajte, če vas zdravstveni delavec za to ni najprej ustrezno usposobil.
- if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- Do not put the cover back on used needles.
- Ne nameščajte pokrovčka nazaj na uporabljene igle.
Do not use this medicine if you notice it is cloudy or there are particles in it.
Ne uporabljate tega zdravila, če opazite, da je motno ali da so v njem delci.
Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound).
zato je treba velikost vranice skrbno spremljati (npr. s kliničnim pregledom, ultrazvokom).
The only consistently reported adverse event was musculoskeletal pain‚ which is no different from the experience in the adult population.
Edini neželen dogodek, o katerem so dosledno poročali, je bil mišično-skeletna bolečina, to pa se ne razlikuje od izkušenj pri odrasli populaciji.
The usual dose varies depending on your illness and weight.
Običajni odmerek je odvisen od vaše bolezni in telesne mase.
In other circumstances, additional leukapheresis may be necessary.
V drugih primerih bo morda potrebna še dodatna levkafereza.
Do not warm Ratiograstim in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Ratiograstim ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
The degree of variation between individual patients and between laboratory assays of CD34+ cells mean that direct comparison between different studies is difficult.
Stopnja variabilnosti med posameznimi bolniki in med laboratorijskimi preiskavami za določanje števila CD34+ celic pomeni, da je neposredna primerjava med različnima študijama težavna.
> 1.0 x 109/L for 3 consecutive days
> 1,0 x 109/l 3 zaporedne dni
In other circumstances, additional leukapheresis are recommended.
V drugih primerih se priporočajo dodatne levkafereze.
It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Prav tako ga je mogoče dajati kot vsakodnevno počasno injekcijo v žilo (temu pravimo intravenska infuzija).
- The safety device prevents needle stick injuries after use, so no special precautions for disposal are required.
- Varnostni pripomoček preprečuje poškodbe zaradi vboda z iglo po uporabi, tako da za odstranjevanje niso potrebni nobeni previdnostni ukrepi.
Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Bolnike, ki se jim pojavijo simptomi sindroma kapilarne prepustnosti, je treba skrbno spremljati, prejeti pa morajo tudi standardno simptomatsko zdravljenje, ki lahko vključuje potrebo po intenzivni negi (glejte poglavje 4.8).
Causes of transient neutropenia such as viral infections should be excluded.
Izključiti je treba vzroke prehodne nevtropenije, na primer virusno okužbo.
Yields in excess of this appear to correlate with more rapid recovery, those below with slower recovery.
Zdi se, da so donosi, večji od najmanjših priporočenih, povezani s hitrejšo obnovo, manjši pa s počasnejšo obnovo.
Push the plunger up to the number (mL) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Ratiograstim, ki vam ga je predpisal vaš zdravnik.
Rates of generation of antibodies against filgrastim is generally low.
Stopnja nastajanja protiteles proti filgrastimu je na splošno nizka.
Some cases of splenic rupture were fatal.
Nekateri primeri rupture vranice so bili smrtni,
Before you inject Ratiograstim you must do the following:
Pred injiciranjem zdravila Ratiograstim morate narediti naslednje:
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Če imate kakršnekoli težave, naj vas ne bo strah poprositi svojega zdravnika ali medicinske sestre za pomoč in nasvet.
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.
Starejši 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.
The additive effect of concomitantly given products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Upoštevati je treba aditivni učinek sočasnega jemanja zdravil, ki vsebujejo sorbitol (ali fruktozo), in sorbitola (ali fruktoze), ki ga vnesemo s hrano.
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.
Prospektivnih randomiziranih primerjav obeh priporočenih metod izplavljanja (z uporabo filgrastima samega, ali v kombinaciji z mielosupresivno kemoterapijo) pri isti populaciji bolnikov ni.
Medicinal products (containing sorbitol/fructose) given intravenously may be life-threatening and should not be given in this population unless there is an overwhelming clinical need and no alternatives are available.
Zdravila, ki vsebujejo sorbitol/fruktozo, aplicirana intravensko, so lahko življenjsko ogrožujoča in morajo biti pri tej starostni skupini kontraindicirana, razen če so klinično nujno potrebna in če na voljo ni druge alternative.
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 čvrste tumorje, limfome in pri limfoidni levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
During long term use cutaneous vasculitis has been reported in 2% of SCN patients.
Med dolgotrajno uporabo so o kožnem vaskulitisu poročali pri 2 % bolnikov s SCN.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may also be seen on some non-myeloid cells in vitro.
Granulocitne kolonije spodbujajoči faktor lahko spodbuja rast mieloičnih celic in vitro, podobne učinke pa je možno opaziti tudi pri nekaterih nemieloičnih celicah in vitro.
If yields are inadequate, as measured by the criteria above, alternative forms of treatment not requiring progenitor support should be considered.
Če donosi celic po zgoraj navedenih kriterijih niso zadostni, je treba premisliti o drugih oblikah zdravljenja, ki ne zahtevajo predhodne podpore matičnih celic.
In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti granulocitne kolonije stimulirajočih faktorjev (G-CSF), je treba v bolnikovo kartoteko zabeležiti lastniško ime uporabljenega zdravila.
When a PBPC transplantation is envisaged it is advisable to plan the stem cell mobilisation procedure early in the treatment course of the patient.
Če je predvidena presaditev PBPC, je priporočljivo postopek izplavljanja matičnih celic načrtovati v zgodnjem obdobju zdravljenja bolnika.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Pri izbiri načina izplavljanja je treba upoštevati splošne cilje zdravljenja pri posameznem bolniku.
- in patients with advanced HIV infection which will help reduce the risk of infections.
- pri bolnikih z napredovalo okužbo z virusom HIV, kar bo pripomoglo k zmanjšanju tveganja za okužbe.
You may experience the following side effects:
Lahko se pojavijo naslednji neželeni učinki:
- before high-dose chemotherapy to make the bone marrow produce more stem cells which can be collected and given back to you after your treatment.
- pred visokimi odmerki kemoterapije, da kostni mozeg proizvede več matičnih celic, ki jih je mogoče odvzeti in vrniti po zdravljenju.
Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
Bolniki z dedno intoleranco za fruktozo ne smejo prejeti tega zdravila, razen če je nujno potrebno.
Infants and young children (below 2 years of age) may not yet be diagnosed with HFI.
Pri dojenčkih in majhnih otrocih (mlajših od 2 let) morda še ni diagnosticirana dedna intoleranca za fruktozo.
If you develop or are likely to develop cancers of the blood, you should not use Ratiograstim, unless instructed by your doctor.
Če se pri vas razvije krvni rak ali je verjetno, da se bo, zdravila Ratiograstim ne smete uporabljati, razen če vam tega ne naroči vaš zdravnik.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Ratiograstim 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 Ratiograstim primerljiv s profilom referenčnega zdravila po subkutanem in intravenskem apliciranju.
Other blood cell changes occur, including anaemia and transient increases in myeloid progenitors, which require close monitoring of cell counts
Pojavijo se tudi druge spremembe krvnih celic, vključno z anemijo in prehodnim povečanjem mieloičnih matičnih celic, zaradi katerih je potrebno skrbno spremljanje števila celic.
This section contains information on how to give yourself an injection of Ratiograstim.
To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Ratiograstim.
In clinical trials, 97 % of patients who responded had a complete response at doses of ≤ 2.4 MIU (24 μg)/kg/day.
V kliničnih preskušanjih so pri 97 % bolnikov, ki so se odzvali na zdravljenje, zabeležili popoln odgovor na odmerke v vrednosti ≤ 2,4 milijona i.e. (24 μg)/kg/dan.
b.Tabulated summary of adverse reactions
b. Tabelarični povzetek neželenih učinkov
The efficacy and safety of Ratiograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Učinkovitost in varnost zdravila Ratiograstim sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne-Hodkinovim limfomom.
This medicine contains 50 mg sorbitol in each mL.
To zdravilo vsebuje 50 mg sorbitola v vsakem ml raztopine.
1995-2000b aAnalysis includes studies involving bone marrow transplant during this period; some studies used GM-CSF (granulocyte-macrophage-colony stimulating factor) bAnalysis includes patients receiving bone marrow transplant during this period
1995-2000b aAnaliza vključuje študije, ki zajemajo presaditev kostnega mozga v tem obdobju; nekatere študije uporabljajo GM-CSF (faktor, ki spodbuja rast granulocitno-makrofagnih kolonij)
Ratiograstim is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines called cytokines.
Zdravilo Ratiograstim je rastni faktor za bele krvničke (granulocitne kolonije stimulirajoči faktor) in spada v skupino zdravil, imenovanih citokini.
Ratiograstim contains sorbitol (E420).
Zdravilo Ratiograstim vsebuje sorbitol (E420).
Your doctor will tell you how much Ratiograstim you should take.
Zdravnik vam bo povedal, koliko zdravila Ratiograstim morate vzeti.
Congenital, idiopathic or cyclic neutropenia:
Način uporabe Prirojena, idiopatska ali ciklična nevtropenija:
No overall differences in safety or effectiveness were observed between subjects over 65 years of age compared to younger adult (>18 years of age) subjects receiving cytotoxic chemotherapy and clinical experience has not identified differences in the responses between elderly and younger adult patients.
V celoti niso opazili razlik v varnosti ali učinkovitosti med preiskovanci, starejšimi od 65 let, in mlajšimi odraslimi preiskovanci (starimi > 18 let), ki so prejemali citotoksično kemoterapijo, klinične izkušnje pa niso pokazale razlik v odzivih med starejšimi in mlajšimi odraslimi bolniki.
Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥ 20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Pri potomcih podgan, ki so jim dali filgrastim v času poroda ali obdobju laktacije, so opazili zamudo v zunanji diferenciaciji in zastoj rasti (≥ 20 µg/kg/dan) in nekoliko zmanjšano stopnjo preživetja (100 µg/kg/dan).
In patients with HIV infection
Bolniki z okužbo HIV
Particular attention should be paid to the number of progenitors mobilised in such patients before the administration of high-dose chemotherapy.
Posebno pozornost je treba posvetiti številu matičnih celic, izplavljenih pri takih bolnikih, preden prejmejo kemoterapijo v velikih odmerkih.
Sixty-five percent of the patients studied in the SCN trial programme were under 18 years of age.
65 % bolnikov, ki so sodelovali v raziskovalnem programu za bolnike s hudo kronično nevtropenijo, je bilo mlajših od 18 let.
After dilution use within 24 hours.
Po redčenju uporabiti v 24 urah.
The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Najmanjši priporočeni donosi ≥ 2,0 milijona CD34+ celic/kg temeljijo na objavljenih podatkih, po katerih so dosegli zadostno hematološko obnovo.
You will need to take Ratiograstim until your white blood cell count is normal.
Zdravilo Ratiograstim boste morali jemati, dokler ne bo število belih krvničk v vaši krvi normalno.
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
Statistical analysis of the relationship between the number of CD34+ cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Statistična analiza razmerja med številom ponovno infundiranih celic CD34+ in hitrostjo vračanja števila trombocitov na normalo po kemoterapiji v velikih odmerkih je pokazala zapleteno, a stalno medsebojno odvisnost.
Effects of filgrastim on pre-natal development have been studied in rats and rabbits.
Učinke filgrastima na prenatalni razvoj so preučevali pri podganah in kuncih.
In assessing the number of progenitor cells harvested in patients treated with filgrastim, particular attention should be paid to the method of quantitation.
Ocena donosa matičnih celic Pri oceni števila matičnih celic, zbranih pri bolnikih, ki se zdravijo s filgrastimom, je treba posvetiti posebno pozornost kvantifikacijski metodi.
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/kg recipient bodyweight.
Z levkaferezo je potrebno pričeti 5. dan, če je potrebno, pa z njo nadaljujte tudi 6. dan, da bi zbrali 4 milijone CD34+ celic/kg telesne mase prejemnika.
- The active substance is filgrastim.
- Zdravilna učinkovina je filgrastim.
These could be symptoms of a condition called “sepsis” (also called "blood poisoning"), a severe infection with whole-body inflammatory response which can be life threatening and needs urgent medical attention.
To so lahko simptomi bolezenskega stanja, imenovanega ''sepsa'' (ki jo imenujemo tudi »zastrupitev krvi«), hude okužbe z vnetnim odzivom po vsem telesu, ki je lahko smrtno nevarna in zahteva nujno medicinsko pomoč.
An increased incidence of embryo-loss has been observed in rabbits at high multiples of the clinical exposure and in the presence of maternal toxicity (see section 5.3).
Pri kuncih so ugotovili večjo incidenco izgube zarodkov pri visokih večkratnikih klinične izpostavitve in ob hkratni toksičnosti za mater (glejte poglavje 5.3).
What should I do before I give myself a subcutaneous injection of Ratiograstim?
Kaj moram narediti, preden si dam subkutano injekcijo zdravila Ratiograstim?
If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 109/L prior to leukapheresis; in general apheresis should not be performed if platelets < 75 x 109/L.
Če je potrebna več kot ena levkafereza, je treba posvetiti posebno pozornost darovalcem, ki so imeli pred levkaferezo število trombocitov < 100 x 109/l; na splošno pa se afereze ne sme izvajati, če je število trombocitov < 75 x 109/l.
Check again to make sure the correct dose of Ratiograstim is in the syringe.
Še enkrat preverite, če je v brizgi ustrezen odmerek zdravila Ratiograstim.
In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Aortitis so v večini primerov diagnosticirali s slikanjem s CT, na splošno pa je izzvenel po ukinitvi
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 izplavljanja 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.
Filgrastim may have a minor influence on the ability to drive and use machines.
Filgrastim ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
How long will I have to take Ratiograstim?
Koliko časa bom moral jemati zdravilo Ratiograstim?
Ratiograstim is a biosimilar medicinal product.
Ratiograstim je biološko podobno zdravilo.
Ratiograstim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Zdravilo Ratiograstim običajno dajemo vsakodnevno v obliki injekcije v tkivo tik pod kožo (temu pravimo subkutana injekcija).
Donors who receive G-CSFs for PBPC mobilisation should be monitored until haematological indices return to normal.
Darovalce, ki so prejeli G-CSF za izplavljanje matičnih celic v periferno kri, je treba spremljati, dokler se hematološke vrednosti ne povrnejo na normalo.
There are reports in the literature where the transplacental passage of filgrastim in pregnant women has been demonstrated.
literaturi so opisani primeri, pri katerih je bilo dokazano prehajanje filgrastima preko placente pri nosečnicah.
Take your Ratiograstim pre-filled syringe out of the refrigerator.
Vzemite napolnjeno injekcijsko brizgo z zdravilom Ratiograstim iz hladilnika.
When diluted in glucose 50 mg/mL (5 %) solution for infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Če je razredčeno v raztopine glukoze 50 mg/ml (5 %) za infundiranje, je zdravilo Ratiograstim kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
Sweets syndrome (acute febrile neutrophilic dermatosis)
Sweetov sindrom (akutna febrilna nevtrofilna dermatoza)
Ratiograstim is a solution for injection/infusion in a pre-filled syringe with or without safety device.
Zdravilo Ratiograstim je raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi z varnostnim pripomočkom ali brez njega.
The safety and efficacy of filgrastim have not been assessed in normal donors < 16 years or > 60 years.
Varnosti in učinkovitosti uporabe filgrastima še niso ovrednotili pri zdravih darovalcih, mlajših od 16 let ali starejših od 60 let.
Other medicines and Ratiograstim
Druga zdravila in zdravilo Ratiograstim
• Inflammation of aorta (the large blood vessel which transports blood from the heart to the body), see section 2
• vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
STATEMENT OF ACTIVE SUBSTANCE(S)
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN (S)
There were no relevant differences between Ratiograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Med zdravilom Ratiograstim in referenčnim zdravilom ni bilo očitne razlike v zvezi s trajanjem hude nevtropenije in nastanka febrilne nevtropenije.
White blood cell counts of 100 x 109/L or greater have been observed in less than 5 % of cancer patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Levkocitoza Število belih krvničk 100 x 109/l ali več so ugotovili pri manj kot 5 % bolnikov z rakom, ki so prejemali filgrastim v odmerkih, večjih od 0,3 M i.e./kg/dan (3 μg/kg/dan).
The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function may be preliminary signs of acute respiratory distress syndrome (ARDS).
Pojav pljučnih znakov, kot so kašelj, zvišana telesna temperatura in dispneja v povezavi z radiološkimi znaki pljučnih infiltratov in poslabšanjem pljučne funkcije, so lahko preliminarni znaki sindroma akutne dihalne stiske (ARDS - Acute Pulmonary Distress Syndrome).
• plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever (Sweets syndrome)
• boleče izbočene razjede slivnate barve na okončinah in včasih na obrazu in vratu, skupaj z vročino (Sweetov sindrom)