natgillin/translations-raw huggingface dataset:
The recommended dose is 0.5 mg Macimorelin Aeterna Zentaris per kg body weight.
Preporučena doza lijeka Macimorelin Aeterna Zentaris iznosi 0,5 mg po kg tjelesne težine.
The concomitant use with medicinal products that are known to induce torsades de pointes should be avoided (see also section 4.5).
Potrebno je izbjegavati istodobnu primjenu lijekova za koje se zna da izazivaju torsades de pointes (vidjeti također dio 4.5).
The effects of macimorelin on ECG parameters were investigated in a dedicated Thorough QT study of a supra-therapeutic dose of macimorelin (2 mg/kg) and in a single-ascending dose study, which included three dose levels of macimorelin (0.5 mg/kg, 1 mg/kg and 2 mg/kg).
Učinci macimorelina na parametre EKG-a ispitivani su u posebnom temeljitom ispitivanju QT intervala kod supraterapijske doze macimorelina (2 mg/kg) te u ispitivanju povećanja jednostruke doze, koje je uključilo tri razine doze macimorelina (0,5 mg/kg, 1 mg/kg i 2 mg/kg).
The safety and efficacy of macimorelin in patients with renal and/or hepatic impairment have not been established (see also section 5.2).
Oštećenje bubrežne i/ili jetrene funkcije Sigurnost i djelotvornost macimorelina u bolesnika s oštećenjem bubrežne i/ili jetrene funkcije nisu ustanovljene (vidjeti također dio 5.2).
38 (27%) in Group A, 37 (26%) in Group B, 40 (29%) in Group C and 25 (18%) in Group D. One out of 154 MAC tests (0.6%) performed failed due to a technical error and 27 out of 157 ITTs (17.2%) performed failed because induction of severe hypoglycemia (i.e., the stimulus) could not be achieved.
Jedan od 154 provedena MAC testa (0,6 %) nije uspio zbog tehničke greške, a 27 od 157 provedenih ITT testova (17,2 %) nije uspjelo jer nije bilo moguće inducirati tešku hipoglikemiju (tj. stimulus).
In dose finding studies in healthy subjects, maximum stimulation of GH secretion was achieved following single dose administration of 0.5 mg/kg macimorelin.
U ispitivanjima određivanja doze provedenim u zdravih ispitanika maksimalna stimulacija lučenja hormona rasta postignuta je nakon primjene jednokratne doze macimorelina od 0,5 mg/kg.
Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours.
Srednja vrijednost terminalnog poluvijeka eliminacije (T1/2) macimorelina iznosi 4,1 sat.
Macimorelin is metabolised mainly by CYP3A4 in vitro.
Macimorelin se in vitro metabolizira uglavnom pomoću enzima CYP3A4.
GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK).
Razine hormona rasta određivane su centralno pomoću testa IDS-iSYS (Immunodiagnostic Systems
Preclinical data from safety pharmacology, repeated dose toxicity and genotoxicity studies reveal no specific hazard for humans.
Neklinički podatci ne upućuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Aeterna Zentaris GmbH
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Aeterna Zentaris GmbH
Determine the number of Macimorelin Aeterna Zentaris sachets needed based on body weight: one sachet will be required for a patient weighing up to 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Odredite broj vrećica lijeka Macimorelin Aeterna Zentaris potrebnih na temelju tjelesne težine: jedna vrećica potrebna je za bolesnika težine do 120 kg, dvije vrećice potrebne su ako bolesnik teži više od
• that could reduce the growth hormone response to macimorelin such as: atropine, propylthiouracil, growth hormone medicines
• koji bi mogli smanjiti odgovor hormona rasta na macimorelin, kao što su atropin, propiltiouracil, lijekovi za hormon rasta
The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
Preporučena pojedinačna doza rekonstituirane suspenzije sadrži 500 mikrograma macimorelina po kg tjelesne težine.
Each sachet contains 60 mg macimorelin (as acetate).
Jedna vrećica sadrži 60 mg macimorelina (u obliku acetata).
Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin.
Bolesnicima na nadomjesnoj terapiji hormonom rasta (somatotropin) ili na terapiji lijekom koji izravno utječe na lučenje somatotropina u hipofizi (npr. analozi somatostatina, klonidin, levodopa i agonisti dopamina) treba savjetovati da prekinu to liječenje najmanje 1 mjesec prije nego što prime testnu dozu macimorelina.
Contains lactose monohydrate 1,691.8 mg per sachet.
Pomoćna(e) tvar(i) s poznatim učinkom Sadrži 1691,8 mg laktoze hidrata po vrećici.
CYP3A4 is the major enzyme to metabolize macimorelin.
Biotransformacija CYP3A4 glavni je enzim kojim se metabolizira macimorelin.
D-60314 Frankfurt am Main Germany
D-60314 Frankfurt am Main
Marketing Authorisation Holder and Manufacturer Aeterna Zentaris GmbH
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Aeterna Zentaris GmbH
Macimorelin causes an increase of about 11 ms in the corrected QT (QTc) interval by an unknown mechanism (see also section 5.1).
Nekim nepoznatim mehanizmom macimorelin uzrokuje produljenje korigiranog QT (QTc) intervala za oko 11 ms (vidjeti također dio 5.1).
Repeat testing may be warranted in this situation.
U toj situaciji može biti potrebno ponoviti testiranje.
Medicinal products with a potential to induce torsades de pointes
Lijekovi koji mogu izazvati torsades de pointes
What you need to know before Macimorelin Aeterna Zentaris is given 3.
Što morate znati prije nego primite Macimorelin Aeterna Zentaris 3.
• a bitter or metallic taste (dysgeusia)
• gorak/metalni okus (poremećen osjet okusa)
• that could increase growth hormone levels: such as clonidine, levodopa, insulin
• koji bi mogli povisiti razine hormona rasta, kao što su klonidin, levodopa, inzulin
Patients with a deficiency affecting hormones other than GH (e.g. adrenal, thyroidal and/or gonadal insufficiency, diabetes insipidus) should be adequately replaced with the other deficient hormones before any testing for a deficiency of GH stimulation is performed, to exclude a stimulation failure due to a secondary GH deficiency.
Bolesnici s nedostatkom drugih hormona osim hormona rasta Bolesnicima s nedostatkom drugih hormona osim hormona rasta (npr. insuficijencija nadbubrežne žlijezde, štitnjače i/ili spolnih žlijezda, insipidni dijabetes) treba na odgovarajući način nadomjestiti nedostatak drugih hormona prije testiranja na nedostatak stimulacije hormona rasta kako bi se isključila neuspješna stimulacija zbog sekundarnog nedostatka hormona rasta.
• The other ingredients are: lactose monohydrate (see section 2 under ‘Macimorelin Aeterna Zentaris contains lactose'), colloidal anhydrous silica,
• Drugi sastojci su: laktoza hidrat (pogledajte dio 2. pod naslovom „Macimorelin Aeterna Zentaris sadrži laktozu”), koloidni bezvodni silicijev dioksid, krospovidon tipa A, saharinnatrij dihidrat i natrijev stearilfumarat (pogledajte dio 2. pod naslovom „Macimorelin Aeterna Zentaris sadrži natrij”).
The diagnostic efficacy of Macimorelin Aeterna Zentaris was established in a randomized, open-label, single dose, cross-over study (AEZS-130-052) comparing the level of agreement between the macimorelin test (MAC) results and insulin tolerance test (ITT) results.
otvorenom, ukriženom ispitivanju jedne doze (AEZS-130-052) u kojem se uspoređivala razina slaganja rezultata dobivenih macimorelinskim testom (MAC) i onih dobivenih testom podnošljivosti inzulina (ITT).
MedDRA organ class
MedDRA klasifikacija organskih sustava
Macimorelin is an orally available peptidomimetic with growth hormone (GH) secretagogue activity similar to ghrelin.
Mehanizam djelovanja Macimorelin je oralno raspoloživ peptidomimetik sa sekretagognom aktivnošću za hormon rasta sličnom grelinu.
If any of the above applies to you, or if you are not sure, talk to your doctor or nurse before you are given this medicine.
Ako se išta od prethodno navedenog odnosi na Vas ili ako niste sigurni, obratite se liječniku ili medicinskoj sestri prije nego što primite lijek.
Concomitant use of strong CYP3A4 inducers with Macimorelin Aeterna Zentaris can decrease macimorelin plasma levels significantly and thereby lead to a false positive result (see also section 4.5).
Istodobna primjena snažnih induktora enzima CYP3A4 i lijeka Macimorelin Aeterna Zentaris može značajno sniziti koncentracije macimorelina u plazmi i tako dovesti do lažno pozitivnih rezultata
Dizziness has been reported by some patients taking macimorelin.
U nekih bolesnika koji su uzimali macimorelin zabilježena je omaglica.
The use of Macimorelin Aeterna Zentaris must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency.
4.2 Doziranje i način primjene Primjenu lijeka Macimorelin Aeterna Zentaris mora nadzirati liječnik ili zdravstveni radnik s iskustvom u dijagnosticiranju nedostatka hormona rasta.
Step 5
5. korak
Macimorelin showed a dose-dependent release of GH after oral dosing.
Macimorelin je pokazao o dozi ovisno otpuštanje hormona rasta nakon peroralnog doziranja.
PHARMACEUTICAL FORM Granules for oral suspension in sachet.
Granule za oralnu suspenziju u vrećici.
Tell your doctor if you are taking medicines that may impact the accuracy of the diagnostic test. Avoid concomitant use with medicines:
Obavijestite svojeg liječnika ako uzimate lijekove koji mogu utjecati na točnost dijagnostičkog testa.
Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus.
downstream), pa u ranoj fazi hipotalamičke lezije otpuštanje rezerve pohranjenog hormona rasta iz prednjeg režnja hipofize, potaknuto macimorelinom, može dovesti do lažno negativnog rezultata.
You may not perform strenuous physical exercises 24 hours before the test. You can drink up to 100 mL of still water within 1 hour before and within 1 hour after intake of Macimorelin Aeterna Zentaris.
Možete popiti do 100 ml obične vode unutar 1 sata prije i 1 sata poslije primjene lijeka Macimorelin Aeterna Zentaris.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SACHET
PODATCI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
Step 7
7. korak
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
The suspension must be used within 30 minutes after preparation.
Suspenzija se mora upotrijebiti u roku od 30 minuta nakon pripreme.
Discontinuation of therapy with growth hormone (GH) or medicinal products directly affecting the pituitary secretion of somatotropin Patients on replacement therapy with growth hormone (GH, somatotropin) or on medicinal products directly affecting the pituitary secretion of somatotropin (e.g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
Bolesnicima na nadomjesnoj terapiji hormonom rasta (somatotropin) ili na terapiji lijekom koji izravno utječe na lučenje somatotropina iz hipofize (npr. analozi somatostatina, klonidin, levodopa i agonisti dopamina) treba savjetovati da prekinu to liječenje najmanje 1 mjesec prije nego što prime macimorelin.
The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product.
Otpuštanje hormona rasta treba procijeniti na tri uzorka krvi uzeta 45, 60 i 90 minuta nakon primjene lijeka.
Step 2
2. korak
Uncommon side effects (may affect up to 1 in 100 people):
Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba): • bol u trbuhu
STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 60 mg macimorelin (as acetate).
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna vrećica sadrži 60 mg macimorelina (u obliku acetata).
You will have three blood samples taken to measure growth hormone, one sample each at 45, 60 and 90 minutes after taking the test dose.
Za mjerenje hormona rasta uzet će Vam tri uzorka krvi i to po jedan uzorak 45, 60 i 90 minuta nakon što ste uzeli testnu dozu.
Post-hoc analysis with a cut-off point of 3.0 ng/mL for the ITT
testa od 3,0 ng/ml.
The most common adverse reactions associated with Macimorelin Aeterna Zentaris reported in Study 052 (see section 5.1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%).
(vidjeti dio 5.1) u 154 bolesnika bile su disgeuzija (5 %), glavobolja, umor, mučnina (svaka po 3 %),
One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg.
Za bolesnika tjelesne težine ≤ 120 kg potrebna je jedna vrećica, a za bolesnika težine veće od 120 kg potrebne su dvije vrećice.
The oral bioavailability may be limited (among others) by first pass metabolism via CYP3A4 (see section 4.5).
Oralna bioraspoloživost može biti ograničena (među ostalim) metabolizmom prvog prolaza putem
Macimorelin is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Nema dostupnih informacija o sigurnosti i učincima macimorelina tijekom dugotrajne primjene.
Long-term use
Dugotrajna primjena
Step 4
4. korak
Draw venous blood samples for growth hormone determination at 45, 60 and 90 minutes after administration.
Izvadite uzorke venske krvi za određivanje hormona rasta 45, 60 i 90 minuta nakon primjene.
The suspension volume in mL equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Primjerice, bolesniku od 70 kg bit će potrebno 70 ml suspenzije macimorelina.
The suspension must be taken within 30 minutes after preparation.
Suspenziju se mora uzeti unutar 30 minuta nakon pripreme.
Patients with Cushing's disease or on supra-physiologic glucocorticoid therapy
Bolesnici s Cushingovom bolešću ili na suprafiziološkoj glukokortikoidnoj terapiji Hiperkortizolizam ima značajan utjecaj na hipotalamo-pituitarno-adrenalnu os.
DIRECTIONS FOR PREPARATION AND USE
15. UPUTE ZA UPORABU
In a diagnostic study comparing macimorelin with the insulin tolerance test (ITT) stimulated GH concentrations after macimorelin were on average 1.4 fold higher than in the ITT.
stimulirane koncentracije hormona rasta bile su nakon primjene macimorelina u prosjeku 1,4 puta više od onih u ITT testu.
Step 6
6. korak
• tremor
• vrtoglavica
Macimorelin Aeterna Zentaris is presented as white to off-white granules for oral suspension.
Kako Macimorelin Aeterna Zentaris izgleda i sadržaj pakiranja Macimorelin Aeterna Zentaris dobiva se u obliku bijelih do bjelkastih granula za oralnu suspenziju.
A healthcare professional must supervise the preparation and use of Macimorelin Aeterna Zentaris.
Pripremu i primjenu lijeka Macimorelin Aeterna Zentaris mora nadzirati zdravstveni radnik.
The following medicinal products may impact the accuracy of the diagnostic test. Concomitant use is to be avoided with (see also section 4.2 and section 4.4):
Potrebno je izbjegavati istodobnu primjenu (vidjeti također dio 4.2 i dio 4.4):
• tiredness
• mučnina
Step 3
3. korak
A potential for increased oral bioavailability and macimorelin plasma concentration with use of strong CYP3A4/P-gp-inhibitors cannot be excluded.
Mogućnost povećane oralne bioraspoloživosti i koncentracije macimorelina u plazmi kod primjene sa snažnim inhibitorima enzima CYP3A4 / proteina P-gp Nisu provedena ispitivanja interakcija s inhibitorima enzima CYP3A4 / proteina P-gp.
Biotransformation
Slično produljenje
What you need to know before Macimorelin Aeterna Zentaris is given
Što morate znati prije nego primite Macimorelin Aeterna Zentaris Ne smijete primiti Macimorelin Aeterna Zentaris
Positive agreement is the proportion of subjects with a positive ITT (i.e., those who have GHD per the ITT) who also have a positive macimorelin test. With a high level of positive agreement, the MAC test will not wrongly diagnose an individual with GHD per the ITT as not having GHD.
Pozitivno slaganje podrazumijeva udio ispitanika s pozitivnim ITT testom (tj. oni koji imaju nedostatak hormona rasta prema ITT testu) i pozitivnim MAC testom.
Macimorelin induced GH release was lower in patients with higher BMI.
Otpuštanje hormona rasta izazvano macimorelinom bilo je manje u bolesnika s višim indeksom tjelesne mase.
The volume of suspension in mL needed for the recommended macimorelin dose of 0.5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension.
Volumen suspenzije u mililitrima potreban za preporučenu dozu macimorelina od 0,5 mg/kg jednak je bolesnikovoj tjelesnoj težini u kg.
Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet macimorelin
Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju u vrećici macimorelin
• medicines to correct the heart rhythm (antiarrhythmic medicines such as amiodarone, procainamide, quinidine or sotalol)
• lijekovi za korekciju srčanog ritma (antiaritmici kao što je amiodaron, prokainamid, kinidin ili sotalol) • svi drugi lijekovi koji mogu produljiti QT interval ili izazvati torsades de pointes.
What Macimorelin Aeterna Zentaris contains
Macimorelin Aeterna Zentaris sadrži natrij
How Macimorelin Aeterna Zentaris is given
Kako primjenjivati Macimorelin Aeterna Zentaris
STATEMENT OF ACTIVE SUBSTANCE(S) Contains 60 mg macimorelin (as acetate) After reconstitution: 500 micrograms macimorelin/mL
Nakon rekonstitucije: 500 mikrograma macimorelina/ml
Tell your doctor if you are taking medicines that can alter your heart rhythm, such as:
Obavijestite svojeg liječnika ako uzimate lijekove koji mogu promijeniti srčani ritam, kao što su: • lijekovi za liječenje psihoze (kao što je klorpromazin, haloperidol)
Macimorelin should be used with caution in patients with proarrhythmic condition (e.g., history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
(npr. infarkt miokarda u anamnezi, srčano zatajenje ili produljeni QTc interval u EKG-u, definiran kao
The suspension must be administered within 30 minutes after preparation.
Suspenzija se mora primijeniti unutar 30 minuta nakon pripreme.
NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension macimorelin
Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju macimorelin
• Medicinal products that directly affect the pituitary secretion of growth hormone (such as somatostatin, insulin, glucocorticoids, and cyclooxygenase inhibitors such as acetylsalicylic acid or indometacin).
inzulin, glukokortikoidi i inhibitori ciklooksigenaze kao što je acetilsalicilatna kiselina ili indometacin)
How Macimorelin Aeterna Zentaris is stored
Kako čuvati Macimorelin Aeterna Zentaris
4.4 Special warnings and precautions for use
4.4 Posebna upozorenja i mjere opreza pri uporabi Interpretacija rezultata macimorelinskog testa
6.6 Special precautions for disposal and other handling
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Suspenziju mora pripremiti i primijeniti zdravstveni radnik.
Aeterna Zentaris GmbH Weismuellerstrasse 50 60314 Frankfurt am Main Germany
Aeterna Zentaris GmbH Weismuellerstrasse 50
• that could have a direct influence on growth hormone secretion by the pituitary gland: such as somatostatin, insulin, glucocorticoids, acetylsalicylic acid,
• koji bi mogli imati izravan utjecaj na lučenje hormona rasta u hipofizi, kao što su somatostatin,
Macimorelin Aeterna Zentaris is indicated as a single-dose diagnostic test. No information is available on the safety and effects of macimorelin during long-term use.
Macimorelin Aeterna Zentaris indiciran je kao dijagnostički test u jednoj dozi.
These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
Te abnormalnosti EKG-a činila su odstupanja
Common
Njemačka
NAME OF THE MEDICINAL PRODUCT Macimorelin Aeterna Zentaris 60 mg granules for oral suspension in sachet
Macimorelin Aeterna Zentaris 60 mg granule za oralnu suspenziju u vrećici
In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable.
U bolesnika u dobi do 60 godina, dijagnostička uspješnost macimorelinskog testa (MAC) i testa tolerancije inzulina (engl. insulin tolerance test, ITT) bila je slična.
Negative agreement is the proportion of subjects with a negative ITT (i.e., those who do not have GHD per the ITT) who also have a negative MAC test. With a high level of negative agreement, the MAC test will not wrongly diagnose an individual without GHD per the ITT as having GHD.
ITT testom (tj. one koji nemaju nedostatak hormona rasta prema ITT testu) te negativnim MAC
In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
U bolesnika s visokim indeksom tjelesne mase do 40 kg/m2
Aeterna Zentaris GmbH Weismüllerstrasse 50 D-60314 Frankfurt am Main Germany
Aeterna Zentaris GmbH Weismüllerstrasse 50
An exploratory analysis was conducted on the performance of the MAC based on an ITT cut-off point of 3.0 ng/mL.
Post hoc analiza s graničnom vrijednošću od 3,0 ng/ml za ITT test Eksploratorna analiza provedena je za učinkovitost MAC testa na temelju granične vrijednosti ITT
Driving and using machines Dizziness can occur with Macimorelin Aeterna Zentaris.
Prilikom primjene lijeka Macimorelin Aeterna Zentaris može se pojaviti omaglica.
Point estimates for sensitivity and specificity were 87% and 96% from not matched Group A subjects, respectively.
Točkovne procjene osjetljivosti i specifičnosti u nepodudarnih ispitanika skupine
Abdominal pain
Poremećaji probavnog sustava mučnina bol u abdomenu proljev
Feeling cold Hunger Thirst
Opći poremećaji i reakcije na mjestu primjene umor osjećaj vrućine osjećaj hladnoće glad žeđ
What Macimorelin Aeterna Zentaris is and what it is used for
Što je Macimorelin Aeterna Zentaris i za što se koristi Lijek sadržava djelatnu tvar koja se naziva macimorelin.
Elderly
DJECE
MARKETING AUTHORISATION HOLDER
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
Vial (glass)
Bočica (staklo)
EU Number
Broj (EU) odobrenja Ime
Pharmaceutical form Route of administration Immediate Packaging Content Pack size EU/1/13/873/001 Xofigo 1100 kBq/mL Solution for injection Intravenous use
EU/1/13/873/001
Name Strength
Sastav Veličina pakovanja
Packaging
Libertek
Package size l t o r
EU/1/11/666/001
Action is needed in the following circumstances:
Potrebno je reagirati u sljedećim okolnostima:
Your doctor can advise you what would be best.
Vaš će Vas liječnik savjetovati što bi bilo najbolje.
Date of first authorisation: 23 june 2017
Datum prvog odobrenja: 23. lipanj 2017
9/L, then treatment must be stopped immediately.
9/L, tada se liječenje mora odmah prekinuti.
A risk to newborns or infants cannot be excluded.
Ne može se isključiti rizik za novorođenče ili dojenče.
No specific antidote is known.
Nije poznat specifičan antidot.
It is not known how commonly they occur.
Nije poznato koliko se često one javljaju.
This leaflet was last revised in .
Ova uputa je zadnji puta revidirana u
In particular, tell your doctor if you are taking the following:
Posebice recite liječniku ako uzimate sljedeće:
Children and adolescents below the age of 18 years should not take this medicine because it has not been studied in this age group.
Djeca i adolescenti mlađi od 18 godina ne smiju uzimati ovaj lijek jer nije ispitan u ovoj dobnoj skupini.
White blood cells help your body to fight infections.
Bijele krvne stanice pomažu Vašem tijelu da se bori protiv infekcija.
One-sided 97.5% repeated CI (lower limit)
Jednostrani 97,5% ponovljeni CI (donja granica)
Two-sided 99.24% CI
Dvostrani 99,24 % CI
9/L, which would represent
9/L, što bi odgovaralo
Brain infection called PML
Infekcija mozga nazvana PML