natgillin/translations-raw huggingface dataset:
10 Lanteri-Minet M et al. Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
Prise en charge diagnostique et thérapeutique de la migraine chez l'adulte et chez l'enfant.
• the prophylactic treatment of episodic and chronic cluster headache in adults.
• profilaktičkom liječenju epizodnih i kroničnih cluster glavobolja u odraslih osoba.
− Is favourable for the prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Povoljan za profilaktičko liječenje teške, perzistentne migrene (s aurom ili bez nje) s funkcionalnom onesposobljenošću u odraslih osoba.
Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
Migraine, Tension-Type, Cluster and Medication-Overuse Headache.
Grounds for variation to the terms of the marketing authorisations Whereas
Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
− Is favourable for the prophylactic treatment of episodic and chronic cluster headache in adults.
Povoljan je za profilaktičko liječenje epizodnih i kroničnih cluster glavobolja u odraslih osoba.
2009 Sep;16(9):968-81.
2009 Sep;16(9):968-81. 10 Lanteri-Minet
Clin Pharmacol Ther 19645:201-204
Clin Pharmacol Ther 19645:201-204 5 Curran DA, Lance JW.
15 May A, Leone M, Afra J et al. EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
EFNS guidelines on the treatment of cluster headache and other trigeminal-autonomic cephalalgias.
20 Steffensen C, Maegbaek ML, Laurberg P, Andersen M, Kistorp CMN, Norrelund H, et al. Heart valve disease among patients with hyperprolactinemia: A nationwide population-based cohort study.
20 Steffensen C, Maegbaek ML, Laurberg P, Andersen M, Kistorp CMN, Norrelund H, et al.
Patients should have failed at least 2 classes of drugs before starting methysergide.
Prije početka liječenja metizergidom bolesnici trebaju imati neuspjeh s barem 2 razreda lijekova.
With regard to the indication “cluster headache”, the applicant referred to a review11 which suggested the prophylactic efficacy of methysergide, particularly for the episodic form of cluster headache and to a study12 where 69% of cluster headache patients reported to have good to excellent results.
S obzirom na indikaciju „cluster glavobolje”, podnositelj zahtjeva pozvao se na procjenu11 koja je ukazala na profilaktičku djelotvornost metizergida, posebice za epizodni oblik cluster glavobolje i na
23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL. Fibrotic disorders associated with methysergide therapy for headache.
23 Graham JR, Suby HI, LeCompte PR, Sadowsky NL.
19 Bana DS, MacNeal PS, LeCompte PM. Cardiac murmurs and endocardial fibrosis associated with methysergide therapy.
Cardiac murmurs and endocardial fibrosis associated with methysergide therapy.
However, these results should be taken
Međutim, te rezultate treba uzeti s oprezom jer metode detekcije
CPMP/EWP/788/01 Rev. 1 (2007) 9 Evers S, Afra J, Frese A et al. EFNS guideline on the drug treatment of migraine - revised report of an EFNS task force.
EFNS guideline on the drug treatment of migraine - revised report of an EFNS task force.
Southwell N, Williams J, Mackenzie I. Methysergide In The Prophylaxis Of Migraine.
Southwell N, Williams J, Mackenzie I.
Shekelle RB, Ostfeld AM. Methysergide in the migraine syndrome.
4 Shekelle RB, Ostfeld AM.
2 Pedersen E, Møller CE. Methysergide in migraine prophylaxis.
Methysergide in migraine prophylaxis.
18 Bendtsen L, Birk S, Kasch H et al. Reference programme: Diagnosis and treatment of headache disorders and facial pain.
Bendtsen L, Birk S, Kasch H et al.
Clin Pharmacol Ther 19667(4):520-526 3 Ryan RE. Double-blind crossover comparison of BC-105, methysergide, and placebo in the prophylaxis of migraine headache.
Double-blind crossover comparison of BC-105, methysergide, and placebo in the prophylaxis of migraine headache.
N Engl J Med 1966;274(7):359-68.
N Engl J Med 1966;274(7):359-68. 24 van Bommel EFH, Jansen I, Hendriksz TR, Aarnoudse ALHJ.
This should be taken into consideration.
To treba uzeti u obzir.
Always follow the instructions exactly as your doctor has told you.
Uvijek slijedite upute točno onako kako Vam je rekao liječnik.
The overall reduction was 54%.
Ukupno smanjenje iznosilo je 54 %.
Date of first authorisation: 16 August 2016.
Datum prvog odobrenja: 16. kolovoza 2016.
% reduction
% smanjenja
Your doctor will work out the right dose for you.
Liječnik će izračunati pravu dozu za Vas.
In this short period, a risk to the suckling child cannot be excluded.
U tom se kratkom razdoblju ne može isključiti rizik za dojeno dijete.
Over 52 weeks
Tijekom 52 tjedna
Remove CINQAERO from the refrigerator.
Izvadite CINQAERO iz hladnjaka.
CINQAERO will be given every 4 weeks.
CINQAERO će se davati svaka 4 tjedna.
Possible side effects”).
Moguće nuspojave").
• Serious allergic reactions
• Ozbiljne alergijske reakcije
Do NOT stop treatment with CINQAERO unless your doctor tells you to, even if you feel better.
NEMOJTE prestati s liječenjem lijekom CINQAERO osim ako Vam to ne kaže liječnik, čak i ako se osjećate bolje.
Over 16 weeks
Tijekom 16 tjedana
LT-08409 Vilnius Lithuania
LT-08409 Vilnius Litva
These cases resulted in the discontinuation of treatment.
Ovi su slučajevi doveli do prekida liječenja.
From a microbiological point of view, the product should be used immediately.
S mikrobiološkog gledišta, lijek treba primijeniti odmah.
The concentrate does not contain any preservatives.
Koncentrat ne sadrži konzervanse.
Patients should be instructed on how to recognise symptoms of serious allergic reactions.
Bolesnike treba uputiti u to kako prepoznati simptome ozbiljne alergijske reakcije.
This is not unusual for proteinaceous solutions.
To nije neobično za proteinske otopine.
No data are available for children aged up to 11 years.
Nema dostupnih podataka za djecu u dobi do 11 godina.
This medicine is NOT intended for use in children and adolescents below the age of 18 years.
Ovaj lijek NIJE namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
The recommended dose is based on patient body weight and should only be adjusted for significant changes in body weight.
Preporučena doza temelji se na tjelesnoj težini bolesnika i smije se prilagoditi samo u slučaju značajnih promjena u tjelesnoj težini.
Infusion time may vary depending on the total volume to be infused.
Trajanje infuzije može varirati ovisno o ukupnom volumenu koji se daje infuzijom.
It may take more than one dose before your asthma symptoms improve.
Možda ćete trebati primiti više od jedne doze prije nego što Vam se poboljšaju simptomi astme.
The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Sigurnost i djelotvornost lijeka CINQAERO u djece i adolescenata u dobi do 17 godina nisu ustanovljene za indikaciju lijeka CINQAERO.
● Risk management plan (RMP)
LIJEKA ● Plan upravljanja rizikom (RMP)
Subgroup GINA 4 and 5
Podskupina GINA 4 i 5
Currently available data in adolescents from 12 to 17 years are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Trenutno dostupni podaci za adolescente u dobi od 12 do 17 godina opisani su u dijelovima 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
They were fully resolved with standard treatment with no residual effect.
Potpuno su se povukle uz standardno liječenje bez rezidualnog učinka.
- if you are allergic to reslizumab or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na reslizumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Anaphylactic reaction (see section 4.4) occurred in less than 1% of patients.
Anafilaktička reakcija (vidjeti dio 4.4) nastala je u manje od 1 % bolesnika.
As a precautionary measure, it is preferable to avoid the use of CINQAERO during pregnancy.
Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka CINQAERO tijekom trudnoće.
The most frequently reported adverse reaction during treatment was increased blood creatine phosphokinase, which occurred in approximately 2% of patients.
Najčešće prijavljena nuspojava tijekom liječenja bila je povišena kreatin fosfokinaza u krvi, što se dogodilo u približno 2 % bolesnika.
Other medicines and CINQAERO
Drugi lijekovi i CINQAERO
Results were supported by the secondary efficacy endpoints and were in line with the overall population.
Rezultati su bili poduprti sekundarnim ishodima djelotvornosti i sukladni onima u ukupnoj populaciji.
If a reslizumab infusion is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen.
Ako se propusti primjena infuzije reslizumaba na planirani datum, doziranje treba nastaviti čim prije u indiciranoj dozi i režimu.
b CI = Confidence interval.
b CI = interval pouzdanosti
Interrupting or stopping treatment with this medicine may cause your asthma symptoms to come back.
Prekid ili prestanak liječenja ovim lijekom može dovesti do povratka simptoma astme.
It must not be administered by the subcutaneous, oral or intramuscular route.
Ne smije se primijeniti supkutanim, peroralnim ili intramuskularnim putem.
The solution for infusion is intended only for intravenous use after dilution and should be prepared using aseptic technique as follows:
Otopina za infuziju namijenjena je samo za intravensku primjenu nakon razrjeđivanja i treba biti pripremljena pomoću aseptične tehnike na sljedeći način:
The active substance in this medicine may pass into breast milk but only during the first few days after birth.
Djelatna tvar u ovom lijeku može prijeći u majčino mlijeko, ali samo tijekom prvih nekoliko dana nakon rođenja.
Any concentrate remaining in the vial must be discarded.
Sav koncentrat preostao u bočici mora se baciti.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving reslizumab or the response to new immunisations in patients receiving reslizumab.
Nema dostupnih podataka o sekundarnom prijenosu infekcije s osoba koje su primile živo cjepivo na bolesnike koji primaju reslizumab ili o odgovoru bolesnika koji primaju reslizumab na novu imunizaciju.
Proteinaceous particles might be present.
Mogu biti prisutne proteinske čestice.
Available non-clinical data do not suggest an effect on fertility.
Dostupni neklinički podaci ne ukazuju na utjecaj na plodnost.
In vitro data indicate that IL-5 and reslizumab are unlikely to affect CYP1A2, 3A4 or 2B6 activity.
In vitro podaci pokazuju da IL-5 i reslizumab najvjerojatnije neće utjecati na aktivnost CYP1A2, 3A4 ili 2B6.
Contents of the pack and other information What CINQAERO contains
Sadržaj pakiranja i druge informacije Što CINQAERO sadrži
The solution for infusion should not be infused concomitantly in the same intravenous line with other medicinal products.
Otopina za infuziju ne smije se davati istovremeno kroz istu intravensku liniju s drugim lijekovima.
Parasitic (helminth) infections
Parazitarne infekcije (helminti)
*** Patients weighing more than 188 kg were not studied.
*** Bolesnici tjelesne težine veće od 188 kg nisu ispitani.
*See subsection “Description of selected adverse reactions” below
*Vidjeti odlomak "Opis odabranih nuspojava" niže Opis odabranih nuspojava
Given the small sample size and baseline imbalances resulting from subgroup analysis, no conclusion can be drawn regarding asthma efficacy in the paediatric population.
S obzirom na mali uzorak i početne razlike proizašle iz analize podskupina, ne može se izvući nikakav zaključak u pogledu djelotvornosti kod astme u pedijatrijskoj populaciji.
* This dosing scheme is based on a maximum dose of 3 mg/kg.
* Ova shema doziranja temelji se na maksimalnoj dozi od 3 mg/kg.
Reslizumab has a half-life of about 24 days.
Reslizumab ima poluvijek od približno 24 dana.
Reslizumab has a long half-life (see section 5.2).
Reslizumab ima dugi poluvijek (vidjeti dio 5.2).
If the solution for infusion has been stored in a refrigerator, allow it to reach room temperature (15 °C-25 °C).
Ako se otopina za infuziju čuvala u hladnjaku, dopustite da postigne sobnu temperaturu (15 °C-25 °C).
Treatment duration CINQAERO is intended for long-term treatment.
CINQAERO je namijenjen za dugotrajno liječenje.
If you miss a scheduled dose of CINQAERO, ask your doctor when to schedule your next treatment.
Ako propustite primiti planiranu dozu lijeka CINQAERO, upitajte svog liječnika kada biste mogli planirati sljedeću dozu.
The concentrate must not be used if coloured (except slightly yellow) or if foreign particles are present.
Koncentrat se ne smije primijeniti ako je obojen (osim ako je blago žut) ili ako su prisutne strane čestice.
Pulmonary function tests
Testovi plućne funkcije
Results for FEV1, ACQ and AQLQ are shown in Table 5 below for the overall population, and subgroup GINA 4 and 5.
Rezultati za FEV1, ACQ i AQLQ prikazani su niže u tablici 5 za ukupnu populaciju i za podskupinu GINA 4 i 5.
IL-5 is a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils.
IL-5 je ključni citokin odgovoran za diferencijaciju, sazrijevanje, regrutiranje i aktivaciju ljudskih eozinofila.
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases; ATC code: R03DX08
Farmakoterapijska skupina: lijekovi za opstruktivne bolesti dišnih puteva, drugi sistemski lijekovi za opstruktivne bolesti dišnih puteva; ATK oznaka: R03DX08
Patients with pre-existing helminth infections should be treated before starting reslizumab therapy.
Bolesnike s već postojećim infekcijama helmintima treba liječiti prije početka terapije reslizumabom.
Your doctor or nurse will watch you closely for signs of a reaction.
Liječnik ili medicinska sestra pažljivo će Vas nadzirati zbog znakova reakcije.
The volume (in mL) required from the vial(s) should be calculated as follows: 0.3 x patient body weight (in kg).
Potrebni volumen (u ml) iz bočice(a) treba izračunati na sljedeći način: 0,3 x tjelesna težina bolesnika (u kg).
Sputum eosinophils were measured in a subset of 38 adult patients at the end of therapy.
Eozinofili u sputumu bili su izmjereni u podskupini od 38 odraslih bolesnika na kraju terapije.
Reslizumab has a volume of distribution of approximately 5 L, suggesting minimal distribution to the extravascular tissues.
Reslizumab ima volumen distribucije od približno 5 l, što ukazuje na minimalnu distribuciju u ekstravaskularna tkiva.
Particles might be present.
Mogu biti prisutne čestice.
Elimination Reslizumab clearance is approximately 7 mL/hour.
Eliminacija Klirens reslizumaba približno je 7 ml/sat.
The highest single dose administered intravenously was reported at 12.1 mg/kg and had no clinical consequences for the patient.
Najviša jednokratna doza primijenjena intravenski bila je 12,1 mg/kg i nije imala nikakvih kliničkih posljedica za tog bolesnika.
Peak serum concentrations of approximately 80 µg/mL are typically observed at the end of the infusion.
Vršne koncentracije u serumu od približno 80 µg/ml obično se opažaju na kraju infuzije.
You will be given CINQAERO by a doctor or nurse as an infusion (drip) into a vein.
CINQAERO će Vam davati liječnik ili medicinska sestra kao infuziju ("drip", tj. kap po kap) u venu.
Your doctor or nurse will watch you closely during and after your infusion for signs of an allergic reaction.
Liječnik ili medicinska sestra pažljivo će Vas nadzirati tijekom i nakon infuzije zbog znakova alergijske reakcije.
NAb a FEV1=forced expiratory volume in 1 second b NA=not available c The GINA classification is based on the Global Initiative for Asthma (GINA) definition:
NAb a FEV1=forsirani ekspiratorni volumen u 1. sekundi b NA=nije dostupno c Klasifikacija GINA temelji se na definiciji Globalne inicijative za astmu (engl.
Proportions of patients in GINA steps 4 and 5c
Udio bolesnika u GINA koracima 4 i 5c
Experience in paediatric patients is limited (see section 5.1).
Iskustvo u pedijatrijskih bolesnika je ograničeno (vidjeti dio 5.1).
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of reslizumab in pregnant women.
Nema podataka ili su podaci o primjeni reslizumaba u trudnica ograničeni (manje od 300 trudnoća).
Proteinaceous particles may be present in the concentrate that appear as translucent to white, amorphous particles, some of which may look fibrous.
U koncentratu mogu biti prisutne proteinske čestice koje izgledaju kao prozirne do bijele amorfne čestice, od kojih neke mogu izgledati vlaknasto.
This is particularly important: - if you are receiving other medicines which affect your immune system; - if you have recently received a vaccination or if you are likely to need a vaccination.
- ako primate druge lijekove koji utječu na imunosni sustav; - ako ste nedavno primili cjepivo ili ćete se vjerojatno trebati cijepiti.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment.
U slučaju predoziranja, preporučuje se nadzirati bolesnika zbog znakova i simptoma nuspojava te primijeniti odgovarajuće simptomatsko liječenje.
Table 3 presents the demographics and baseline characteristics of Studies I, II and III.
Tablica 3 prikazuje demografske i početne značajke Ispitivanja I, II i III.
These adverse reactions were observed during or within 20 minutes after completion of the infusion.
Ove nuspojave bile su opažene tijekom ili unutar 20 minuta nakon završetka infuzije.
Efficacy variablea
Varijabla djelotvornostia
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 16 hours at 2 °C-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i obično ne bi smjeli biti dulji od 16 sati na temperaturi od 2 °C do 8 °C, osim ako se razrjeđivanje nije provelo u kontroliranim i validiranim aseptičkim uvjetima.
** The nominal volume of the vials (10 mL or 2.5 mL for each vial) has to be used.
** Mora se primijeniti nominalni volumen bočica (10 ml ili 2,5 ml za svaku bočicu).
There are limited safety data in non-white ethnic populations.
Sigurnosni podaci u nebjelačkih populacija su ograničeni.
What CINQAERO looks like and contents of the pack
Kako CINQAERO izgleda i sadržaj pakiranja
The European Medicines Agency has deferred the obligation to submit the results of studies with CINQAERO in one or more subsets of the paediatric population in asthma (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka CINQAERO u jednoj ili više podskupina pedijatrijske populacije za astmu (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
- The active substance is reslizumab.
- Djelatna tvar je reslizumab.
Improvements were noted in FEV1 at 4 weeks following the first dose of reslizumab.
Poboljšanja u FEV1 bila su zabilježena 4 tjedna nakon prve doze reslizumaba.
It is recommended that the solution for infusion be administered immediately after preparation.
Preporučuje se otopinu za infuziju primijeniti odmah nakon pripreme.
These reactions were observed during or within 20 minutes after completion of the reslizumab infusion and were reported as early as the second dose of reslizumab.
Te su reakcije bile opažene tijekom ili unutar 20 minuta od završetka infuzije reslizumaba i bile su zabilježene već kod druge doze reslizumaba.
Posology CINQAERO is given as intravenous infusion once every four weeks.
CINQAERO se daje kao intravenska infuzija jedanput svaka četiri tjedna.
Available pharmacodynamic/toxicological data in animals have shown excretion of reslizumab in milk.
Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se reslizumab/metaboliti izlučuju u mlijeko.
CINQAERO blocks interleukin-5 activity and reduces the number of eosinophils in your blood and lungs.
CINQUAERO blokira aktivnost interleukina-5 i smanjuje broj eozinofila u krvi i plućima.
Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment.
Bolesnicima treba savjetovati da potraže savjet liječnika ako im nakon početka liječenja astma i dalje bude nekontrolirana ili se pogorša.
A decision to continue the therapy should be made at least annually based on disease severity and level of exacerbation control.
O nastavku liječenja odlučuje se najmanje jedanput godišnje na temelju težine bolesti i razine kontrole egzacerbacija.
CINQAERO is for intravenous infusion only.
CINQAERO se primjenjuje samo intravenskom infuzijom.
Adverse reactions are listed below in Table 2 by system organ class and frequency (frequencies are defined as: very common (≥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
Nuspojave su navedene niže u tablici 2 prema klasifikaciji organskih sustava i učestalosti (učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥ 1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Reslizumab is a humanised monoclonal antibody (IgG4, κ) against the human interleukin-5 (IL-5).
Reslizumab je humanizirano monoklonsko protutijelo (IgG4, κ) protiv ljudskog interleukina-5 (IL-5).
There are limited data available on the use of reslizumab in patients older than 75 years of age.
Dostupni podaci o primjeni reslizumaba u bolesnika starijih od 75 godina su ograničeni.
In common with other monoclonal antibodies, reslizumab is believed to be degraded by enzymatic proteolysis into small peptides and amino acids.
Kao i druga monoklonska protutijela, smatra se da se reslizumab razgrađuje enzimskom proteolizom na male peptide i aminokiseline.
The patient has to be observed over the duration of the infusion and for an appropriate period afterwards.
Bolesnika treba nadzirati tijekom trajanja infuzije i odgovarajućeg razdoblja nakon toga.
Intravenous use, after dilution only.
Primjena u venu, samo nakon razrjeđivanja.
It is unlikely that CINQAERO will affect your ability to drive and use machines.
Mala je vjerojatnost da će CINQAERO utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
Reslizumab is an antibody with a molecular mass of 147 kDaltons and is therefore not expected to be excreted in urine.
Reslizumab je protutijelo molekularne mase od 147 kDa pa se, stoga, ne očekuje da će biti izlučen u mokraći.
The maximum dose is 3 mg per kg of body weight.
Maksimalna doza je 3 mg po kg tjelesne težine.
Store in a refrigerator (2 °C-8 °C).
Čuvati u hladnjaku (2 °C-8 ºC).
Interleukin-5 is a protein your body makes that plays a key role in inflammation in asthma by activating eosinophils.
Interleukin-5 je protein koji se stvara u tijelu i ima ključnu ulogu u upali kod astme time što aktivira eozinofile.
CINQAERO must not be administered as a bolus injection or as undiluted concentrate.
CINQAERO se ne smije primijeniti kao bolus injekcija ili kao nerazrijeđeni koncentrat.
The infusion will take about 20 to 50 minutes.
Infuzija će trajati oko 20 do
Talk to your doctor or nurse before you are given CINQAERO: - if you have a parasitic infection or if you live in an area where parasitic infections are common or if you are travelling to such a region, as this medicine may weaken your body's ability to fight certain types of parasitic infections.
- ako imate parazitarnu infekciju ili živite u području gdje su parazitarne infekcije česte ili putujete u takvo područje jer ovaj lijek može oslabiti sposobnost organizma da se obrani od određenih vrsta parazitarnih infekcija.
Afterwards, CINQAERO could be used during breast-feeding if appropriate.
Nakon tog razdoblja, CINQUAERO se može primjenjivati tijekom dojenja ako se to smatra potrebnim.