natgillin/translations-raw huggingface dataset:
The product is recommended in piglets weighing between 0.9 and 3 kg.
Zdravilo je priporočljivo uporabljati pri pujskih s telesno maso od 0,9 do 3 kg.
The “No MRL required” classification for iron dextran and iron glucoheptonate is considered to apply to gleptoferron as gleptoferron is expected to release iron dextran and iron glucoheptonate.
Na splošno velja, da se razvrščanje železnega dekstrana in železovega glukoheptonata, ki ne zahteva MRL, uporablja za gleptoferon, saj naj bi slednji sproščal železov dekstran in železov glukoheptonat.
STATEMENT OF THE MRLs The active substances in Forceris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010: Pharmacologically active substances
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovine v zdravilu Forceris so dovoljene učinkovine, kot so navedene v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
For the 100 ml vials, the rubber stopper may be punctured up to 30 times.
Gumijasti zamašek 100-mililitrske viale lahko preluknjate do 30-krat.
Not for use in animals from which milk is produced for human consumption.
Ni dovoljena uporaba pri živalih, ki proizvajajo mleko za prehrano ljudi.
Pregnancy and lactation: Not applicable.
Brejost in laktacija: Ni smiselno
Sodium chloride Docusate sodium Simethicone emulsion Silica, colloidal anhydrous Povidone
6.1 Seznam pomožnih snovi fenol natrijev klorid natrijev dokusat emulzija simetikona silicijev dioksid, koloidni, brezvodni povidon voda za injekcije
During overdosage studies, a transient reduced erythrocyte count, haematocrit and hemoglobin concentration without clinical signs was observed after day 14 following single administration in the target animal safety studies at three times the highest recommended dose (mean 261 mg/piglet toltrazuril and 1156 mg/piglet iron).
V študijah o prevelikem odmerjanju so po 14 dneh enkratne uporabe pri preučevanju varnosti na ciljnih živalih opazili prehodno zmanjšano število eritrocitov ter koncentracijo hematokrita in hemoglobina brez kliničnih znakov, in sicer pri trikrat preseženem najvišjem priporočenem odmerku (v povprečju 261 mg toltrazurila/pujska in 1156 mg železa/pujska).
For the 250 ml and 500 ml vials, the rubber stopper may be punctured up to 20 times.
Gumijasti zamašek 250mililitrske in 500-mililitrske viale lahko preluknjate do 20-krat.
Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
Ne uporabljajte na pujskih, pri katerih obstaja sum pomanjkanja vitamina E in/ali selena.
After intramuscular injection of 1.5 ml/piglet of Forceris, iron is absorbed rapidly from the injection site into the capillaries and the lymphatic system and a maximal concentration of 645 µg/ml was reached after approximately 0.5 day, the AUC was about 699 day.µg/ml.
Po intramuskularnem injiciranju 1,5 ml zdravila Forceris na pujska se je železo hitro absorbiralo iz mesta injiciranja v kapilare in limfni sistem, pri čemer je bila maksimalna koncentracija 645 µg/ml dosežena po približno 0,5 dneva, koncentracija AUC pa je bila približno 699 dni.µg/ml.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE DOBAVE IN UPORABE Na veterinarski recept.
STATEMENT OF ACTIVE SUBSTANCES 1 ml contains 30 mg toltrazuril and 133 mg iron (III) (as gleptoferron)
NAVEDBA UČINKOVIN(E) En ml vsebuje 30 mg toltrazurila in 133 mg železa (III) (v obliki gleptoferona)
CONTRAINDICATIONS Do not use in piglets suspected to be suffering from a deficiency of vitamin E and/or selenium.
KONTRAINDIKACIJE Ne uporabljajte na pujskih, pri katerih obstaja sum pomanjkanja vitamina E in/ali selena.
MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001-003
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/235/001-003
After intramuscular administration of 1.5 ml/piglet of Forceris the maximal concentration of 10 mg/l for toltrazuril sulfone was reached about 13 days after administration (Tmax ranging from 10 to 19 days), and the AUC was about 183 day.mg/l.
Po intramuskularnem dajanju zdravila Forceris 1,5 ml/pujska je bila najvišja koncentracija toltrazuril sulfona v vrednosti 10 mg/l dosežena približno 13 dni po dajanju (Tmax v razponu od 10 do 19 dni), koncentracija AUC pa približno 183 dni.mg/l.
After intramuscular administration of 1.5 ml/piglet of Forceris, maximal concentrations of 7 mg/l of toltrazuril were reached about 6 days after administration (Tmax ranging from 4 to 7 days), and the AUC was about 57 day.mg/l.
Po intramuskularnem dajanju zdravila Forceris 1,5 ml/pujska so bile najvišje koncentracije toltrazurila v vrednosti 7 mg/l dosežene približno 6 dni po dajanju (Tmax v razponu od 4 do 7 dni), koncentracija AUC pa približno 57 dni.mg/l.
MARKETING AUTHORISATION NUMBER(S) EU/2/19/235/001 (100 ml)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/19/235/001 (100 ml)
Deaths have been reported very rarely in piglets following the administration of parenteral iron injections.
Po parenteralnem injiciranju železa so v zelo redkih primerih poročali o smrtnih primerih pri pujskih.
Box with 1 vial of 250 ml.
Škatla z eno 250-mililitrsko vialo.
NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Forceris 30 mg/ml + 133 mg/ml suspenzija za injiciranje za pujske
NAME OF THE VETERINARY MEDICINAL PRODUCT Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets toltrazuril / iron (III) (as gleptoferron)
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Forceris 30 mg/ml + 133 mg/ml suspenzija za injiciranje za pujske toltrazuril/železo (III) (v obliki gleptoferona)
PACKAGE LEAFLET Forceris 30 mg/ml + 133 mg/ml suspension for injection for piglets
NAVODILO ZA UPORABO Forceris 30 mg/ml + 133 mg/ml suspenzija za injiciranje za pujske
Box with 1 vial of 500 ml.
Škatla z eno 500-mililitrsko vialo.
Muscle Skin and fat Liver Kidney
mišice koža in maščoba jetra ledvice železo (kot gleptoferon)
Box with 1 vial of 100 ml.
Škatla z eno 100-mililitrsko vialo.
Active substances:
Farmakološko aktivne snovi
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO »ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM« Zdravilo shranjujte nedosegljivo otrokom!
EXPIRY DATE EXP {month/year} Once broached, use within 28 days.
Odprto zdravilo uporabite v 28 dneh.
Shelf life after first opening the immediate packaging: 28 days.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odprtju stične ovojnine: 28 dni
All mammalia n food producing species
Vse vrste sesalcev za proizvodnj o živil mišice maščoba jetra ledvice
30.0 mg
30,0 mg železo (III)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
PODATKI NA ZUNANJI OVOJNINI OVOJNINA
monthly for 13 months;
mesečno v obdobju 13 mesecev;
You may require medical attention.
Mogoče boste potrebovali medicinsko pomoč.
They are usually mild to moderate.
Navadno so blagi do zmerni.
If this happens, do not drive or use any tools or machines until you are feeling well again.
Če pride do tega, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet normalno.
The primary evidence of efficacy was based on objective response rates.
Primarni dokaz učinkovitosti je temeljil na stopnjah objektivne odzivnosti.
However, the mechanism of the observed interaction is presently unknown.
Vendar trenutno mehanizem opažene interakcije ni znan.
Bilirubin elevation was below 3 %.
Bilirubin se je zvišal za manj kot 3 %.
The doctor will monitor the growth at regular visits.
Zdravnik bo spremljal rast na rednih pregledih.
The adverse reactions were similar in all indications, with two exceptions.
Neželeni učinki so bili podobni pri vseh indikacijah, z dvema izjemama.
Take the medicine pack with you.
Škatlo zdravil vzemite s seboj.
(Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
(V pojasnilo: od 411 bolnikov jih je bilo 353 zdravljenih v programu razširjenega dostopa brez zbranih podatkov o primarnem odzivu.)
In 6 of these patients follow-up now exceeds 4 years.
6 od teh bolnikov zdaj spremljajo že več kot 4 leta.
• Swallow the capsules whole with a large glass of water.
• Kapsule pogoltnite cele z velikim kozarcem vode.
These generally occur within the first several months of therapy.
Te se običajno pojavijo v prvih nekaj mesecih zdravljenja.
You should wash your hands immediately after opening the capsules.
Takoj po odpiranju kapsul si umijte
Not known (frequency cannot be estimated from the available data):
Pogostnost neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
Follow all your doctor's instructions carefully, even if they differ from the general information contained in this leaflet.
Skrbno se ravnajte po vseh navodilih svojega zdravnika, tudi če se razlikujejo od splošnih informacij v tem navodilu za uporabo.
The data was similar when re-analysed to include only those patients age 55 or older.
Podatki so bili podobni pri ponovni analizi, v katero so vključili le bolnike, stare 55 let ali več.
Haematological response criteria (all responses to be confirmed after ≥ 4 weeks): CHR:
Kriteriji hematološkega odziva (vsi odzivi morajo biti potrjeni po ≥ 4 tednih): CHR:
Therefore, it is highly recommended that patients be weighed regularly.
Zato je zelo priporočljivo bolnike redno tehtati.
• Then continue with your normal schedule.
• Nato nadaljujte z jemanjem zdravila po običajnem razporedu.
Tell your doctor if you are using medicines that prevent the formation of blood clots.
Povejte svojemu zdravniku, če uporabljate zdravila, ki preprečujejo strjevanje krvi.
Your doctor may prescribe a higher or lower dose depending on how you respond to treatment.
Zdravnik vam lahko predpiše večji ali manjši odmerek, odvisno od tega, kako se odzivate na zdravljenje.
• Decreased or increased skin sensitivity.
• zmanjšana ali povečana občutljivost kože,
• Difficulty in sleeping (insomnia).
• težave s spanjem (nespečnost),
However, in these patients caution is recommended.
Vendar pri teh bolnikih priporočamo previdnost.
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Mehanizem in pomen teh ugotovitev iz študij karcinogenosti pri podganah za ljudi doslej še nista pojasnjena.
• If you are being treated for Ph-positive ALL:
• Če se zdravite zaradi Ph-pozitivne ALL:
Treatment should be continued as long as the patient continues to benefit.
Z zdravljenjem je treba nadaljevati, dokler to bolniku koristi.
These white cells usually help the body to fight infection.
Te bele krvničke telesu navadno pomagajo v borbi proti okužbi.
Some side effects may be serious.
Nekateri neželeni učinko so lahko resni.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Datum prve odobritve: 25. september 2013
• Headache or feeling tired.
• glavobol ali občutek utrujenosti,
If you think you may be allergic but are not sure, ask your doctor for advice.
Če mislite, da bi bili lahko alergični, a niste prepričani, se posvetujte s svojim zdravnikom.
Currently available published data are summarised in section 5.1 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
To vključuje tako spontano sporočene primere kot tudi resne neželene učinke iz študij v teku, iz programov razširjene uporabe, študij klinične farmakologije in raziskovalnih študij neodobrenih indikacij.
Treatment resulted in worsening of normally suppressed malarial infections in these animals.
Dajanje zdravila je povzročilo poslabšanje normalno obvladanih malarijskih okužb pri teh živalih.
The safety database for children with Ph+ ALL is very limited though no new safety concerns have been identified.
Čeprav je baza podatkov za otroke s Ph+ ALL zelo majhna, zaenkrat niso odkrili nobenih novih pomislekov glede varnosti.
Leukaemia is a cancer of white blood cells.
Levkemija je rak belih krvničk.
9/l) were observed in 3.6 % and < 1 % of patients, respectively.
9/l) pri 3,6 % oziroma < 1 % bolnikov.
The current estimate of the median survival of the previously untreated and treated patients was 7.7 and 4.7 months, respectively.
Tekoča ocena povprečnega preživetja predhodno nezdravljenih in zdravljenih bolnikov je bila 7,7 in 4,7 meseca.
In addition, paediatric patients have been treated in two phase I studies and one phase II study.
Poleg tega so zdravili pediatrične bolnike v dveh študijah faze I in eni študiji faze II.
• Dermatofibrosarcoma protuberans (DFSP).
• s protuberantnim dermatofibrosarkomom (DFSP).
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
V razvrstitvah pogostnosti so neželeni učinki navedeni po pogostnosti, najpogostejši najprej.
Mean absolute bioavailability for imatinib is 98 %.
Povprečna absolutna biološka uporabnost imatiniba je 98 %.
Thereafter, treatment can be resumed as appropriate depending on the initial severity of the event.
Nato se lahko zdravljenje spet začne po ustrezni shemi, odvisni od začetne resnosti reakcije.
Generally the reported outcome in these cases was “improved” or “recovered”.
V navedenih primerih je bil izid prevelikega odmerjanja večinoma opisan kot “izboljšanje stanja” ali “okrevanje”.
• if you have or have ever had a liver, kidney or heart problem.
• če imate ali ste kdaj imeli težave z jetri, ledvicami ali srcem;
All patients achieved partial and/or complete response.
Pri vseh bolnikih je prišlo do delnega in/ali popolnega odziva.
The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Translokacija t(17:22)[(q22:q13)] oziroma njen genski produkt sta bila prisotna pri skoraj vseh bolnikih z odzivom na zdravljenje z imatinibom.
Consolidation therapy II, IV
konsolidacijska terapija II, IV
No specific dose recommendation is necessary in older people.
Pri starejših ljudeh niso potrebna posebna priporočila glede odmerjanja.
In the clinical study 38 % of patients were ≥ 60 years of age and 12 % of patients were ≥ 70 years of age.
V klinični študiji je bilo 38 % bolnikov starih ≥ 60 let, 12 % bolnikov pa je bilo starih ≥ 70 let.
The rate of haematological response was 70 % with a duration of 2-3 months.
Stopnja hematološkega odziva je bila 70 %, njegovo trajanje pa 2-3 mesece.
Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section 4.2.
Zdravljenje z imatinibom lahko prekinemo ali odmerek zmanjšamo, kot je priporočeno v poglavju 4.2.
If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.
Če zdravila ne morete jemati tako, kot vam je predpisal zdravnik, ali se vam zdi, da zdravila ne potrebujete več, takoj pokličite zdravnika.
Imatinib administration to patients without the genetic translocation generally results in no improvement.
Uporaba imatiniba pri bolnikih brez genetske translokacije večinoma ni povzročila izboljšanja.
The dose recommendation is currently based on a small number of paediatric patients (see sections 5.1 and 5.2).
Priporočila za odmerjanje trenutno temeljijo na majhnem številu pediatričnih bolnikov (glejte poglavji 5.1 in 5.2).
• Do not take a double dose to make up a forgotten dose.
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
You will also have blood tests and be weighed regularly.
Zdravnik vam bo delal tudi preiskave krvi in vas redno tehtal.
In 61 of these 117 patients FIP1L1-PDGFRα fusion kinase was identified.
Pri 61 od teh 117 bolnikov so odkrili FIP1L1-PDGFRα fuzijsko kinazo.
Ki values in human liver microsomes were 27, 7.5 and 7.9 μmol/l, respectively.
Vrednosti Ki v mikrosomih človeških jeter so bile 27, 7,5 oziroma 7,9 μmol/l.
The overall survival is 65 months since diagnosis (range 25-234).
Celotno preživetje je 65 mesecev od postavitve diagnoze (razpon 25 - 234).
Do not open or crush the capsules unless you have difficulty in swallowing (e.g. in children).
Kapsul ne odpirajte in ne mečkajte, razen v primeru težav s požiranjem (na primer pri otroku).
There is no experience with the treatment of children below 2 years of age.
Z zdravljenjem otrok, mlajših od 2 let, ni nobenih izkušenj.
The duration of imatinib therapy can vary with the treatment program selected, but generally longer exposures to imatinib have yielded better results.
Trajanje zdravljenja z imatinibom je lahko različno glede na izbrani program zdravljenja, vendar pa je na splošno daljša izpostavljenost imatinibu prinesla boljše rezultate.
Study ADE10 Prephase
Študija ADE10 predhodna faza
Older people: Imatinib pharmacokinetics have not been studied in older people.
Starejši ljudje: Farmakokinetike imatiniba pri starejših ljudeh niso posebej proučili.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Če se uporablja med nosečnostjo, je treba bolnico poučiti o možnih nevarnostih za plod.
Five (5) patients responded, 3 completely and 2 partially.
Do odziva je prišlo pri petih (5) bolnikih, pri 3 do popolnega in pri 2 do delnega.
If you have any questions about how Imatinib medac works or why this medicine has been prescribed for you, ask your doctor.
Če imate kakšna vprašanja glede tega, kako zdravilo Imatinib medac deluje ali zakaj vam je bilo predpisano to zdravilo, vprašajte zdravnika.
11) Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
11) Poročali so o primerih s smrtnim izidom pri bolnikih z napredovalo boleznijo, s hudimi okužbami, hudo nevtropenijo in z drugimi resnimi spremljajočimi stanji.
The amount of Imatinib medac given will depend on your child's condition, body weight and height.
Potrebna količina zdravila Imatinib medac bo odvisna od otrokovega stanja, telesne mase in višine.
BM = bone marrow, PB = peripheral blood
BM = kostni mozeg, PB = periferna kri
• if you are taking the medicine levothyroxine because your thyroid has been removed.
• če jemljete zdravilo levotiroksin, ker so vam odstranili ščitnico;
The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Mediano trajanje zdravljenja v študiji B2225 je bilo 6,2 meseca z najdaljšim trajanjem 24,3 mesece.
The rate of response was also higher in the patients treated at 600 mg (33 %) as compared to the patients treated at 400 mg (16 %, p = 0.0220).
Stopnja odziva je bila tudi večja pri bolnikih, zdravljenih s 600 mg (33 %), kot pri bolnikih, zdravljenih s 400 mg (16 %, p = 0,0220).
Non-neoplastic lesions not identified in earlier preclinical studies were the cardiovascular system, pancreas, endocrine organs and teeth.
Ne-neoplastične lezije organov, ki jih v prejšnjih predkliničnih študijah niso opazili, obsegajo srčnožilni sistem, pankreas, endokrine organe in zobe.
The median duration of therapy in the published literature ranged between 4 weeks and more than 20 months.
Mediano trajanje zdravljenja v objavljeni literaturi se je gibalo od 4 tednov do več kot 20 mesecev.
The first 37 patients were started at 400 mg, the protocol was subsequently amended to allow higher dosing and the remaining 223 patients were started at 600 mg.
Prvih 37 bolnikov je začelo zdravljenje s 400 mg, protokol je bil pozneje dopolnjen, tako da je omogočal večje odmerjanje, tako da je preostalih 223 bolnikov začelo zdravljenje s 600 mg.
Imatinib should not be used during pregnancy unless clearly necessary.
Imatiniba ne smete uporabljati pri nosečnicah, razen če je nujno potrebno.
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n = 10).
Limfoidna blastna kriza: Omejeno število bolnikov so vključili v študije prve faze (n = 10).
The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Do znižanja števila belih krvnih celic in nevtrofilcev je prišlo večinoma v prvih šestih tednih zdravljenja, po tem obdobju pa so bile vrednosti relativno stabilne.
In this study, 31 % of patients achieved a haematological response (36 % in previously untreated patients and 22 % in previously treated patients).
V tej študiji je 31 % bolnikov doseglo hematološki odziv (36 % pri predhodno nezdravljenih bolnikih in 22 % pri predhodno zdravljenih bolnikih).
Events that have been reported at different dose ranges are as follows:
V različnih obsegih odmerkov so poročali o naslednjih dogodkih:
An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
Nepričakovano hitro naraščanje telesne mase je treba skrbno raziskati in izvajati ustrezne podporne in terapevtske ukrepe, če je potrebno.
As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Kot so nedavno objavili, je 21 od teh 65 bolnikov doseglo tudi popolno molekularno remisijo po mediano 28 mesecih spremljanja (razpon 13-67 mesecev).
Dose adjustment for adverse reactions in all indications in adults and paediatric patients
Prilagoditev odmerjanja zaradi neželenih učinkov pri vseh indikacijah pri odraslih in pediatričnih bolnikih
Women of childbearing potential Women of childbearing potential must be advised to use effective contraception during treatment.
Ženske v rodni dobi Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
A major response combines both complete and partial responses: complete (0 % Ph+ metaphases), partial (1-35 %)
Pomemben odziv združuje tako popolne kot delne odzive: popoln (0 % Ph+ metafaz), delen (1
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta (na primer paracetamol), vključno z zdravili rastlinskega izvora (na primer šentjanževko).
Study 0102 38-month data Myeloid blast crisis (n = 260) % of patients (CI95 %)
Študija 0102 podatki pri 38 mesecih mieloidna blastna kriza (n = 260) % bolnikov (IZ95 %)
Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Kaže, da se podatki o varnosti iz te študije ujemajo z varnostnim profilom imatiniba pri bolnikih s Ph+ ALL.
(≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
*, interstitial lung disease*
*, intersticijska pljučna bolezen*
Some children and adolescents taking Imatinib medac may have slower than normal growth.
Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Imatinib medac, je lahko rast počasnejša od normalne.
Clinical studies in MDS/MPD
Klinične študije pri MDS/MPD
The most important changes included cardiac hypertrophy and dilatation, leading to signs of cardiac insufficiency in some animals.
Najbolj pomembne spremembe vključujejo hipertrofijo in dilatacijo srca, ki povzročata znake srčnega popuščanja pri nekaterih živalih.
The preclinical safety profile of imatinib was assessed in rats, dogs, monkeys and rabbits.
Predklinični varnostni profil imatiniba je bil ocenjen pri podganah, psih, opicah in kuncih.