natgillin/translations-raw huggingface dataset:
Fever or chills persisting for more than 8 hours after administration of mifamurtide should be evaluated for possible sepsis.
Ako vrućica ili zimica traju dulje od 8 sati nakon primjene mifamurtida, potrebno je uzeti u obzir moguću sepsu.
The spike should then be inserted into the vial septum firmly until seated.
Šiljak zatim treba čvrsto umetnuti u septum bočice dok ne sjedne.
The bag should be gently swirled to mix the solution.
12. Vrećicu treba nježno okretati kako bi se otopina izmiješala.
There are no data from the use of mifamurtide in pregnant women.
Nema podataka o primjeni mifamurtida kod trudnica.
MEPACT contains the active substance mifamurtide, similar to a component of the cell wall of certain bacteria.
MEPACT sadrži djelatnu tvar mifamurtid, sličnu sastojku stanične stijenke određenih bakterija.
In a randomised phase III study of 678 patients (age range from 1.4 to 30.6 years) with newly-diagnosed resectable high-grade osteosarcoma, the addition of adjuvant mifamurtide to chemotherapy (either doxorubicin cisplatin and methotrexate with or without ifosfamide), significantly increased the 6-year overall survival and resulted in a relative reduction in the risk of death by 28% (p = 0.0313, hazard ratio (HR) = 0.72 [95% confidence interval (CI): 0.53, 0.
U randomiziranom ispitivanju faze III na 678 bolesnika (raspon godina od 1,4 do 30,6) s novodijagnosticiranim resektabilnim osteosarkomom visokog stupnja malignosti, dodatak adjuvantne terapije mifamurtida kemoterapiji (s doksorubicinom, cisplatinom i metotreksatom s ili bez ifosfamida) značajno je povećao ukupno 6-godišnje preživljenje i rezultiralo je relativnim smanjenjem rizika od smrti od 28% (p=0,0313, omjer hazarda (HR) = 0,72 [95% interval pouzdanosti (CI): 0,53,
For further instructions on reconstitution, filtering using the filter provided and dilution of the medicinal product before administration, see section 6.6.
Za dodatne upute o rekonstituciji, filtriranju s priloženim filtrom i razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
Activation of human macrophages by mifamurtide is associated with production of cytokines, including tumour necrosis factor (TNF-), interleukin-1 (IL-1), IL-6, IL-8, and IL-12 and adhesion molecules, including lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1).
Aktivacija ljudskih makrofaga mifamurtidom povezana je sa stvaranjem citokina, uključujući tumor nekrotizirajući faktor (TNF-α), interleukin-1 (IL-1β), IL-6, IL-8 i IL-12 te adhezijskih molekula, uključujući limfocitni funkcionalni antigen-1 (LFA-1) i međustaničnu adhezijsku molekulu-1 (ICAM-1).
Instructions for preparation of MEPACT for intravenous infusion
Upute za pripremu MEPACT intravenske infuzije
These changes were not considered to be clinically meaningful as the maximum tolerated dose (4-6 mg/m2) of mifamurtide is
Smatra se da te promjene nisu klinički značajne jer je maksimalna podnošljiva doza mifamurtida (4-6 mg/m2) 2-3 puta veća od preporučene doze
Mifamurtide is not recommended for use during pregnancy and in women of childbearing potential not using effective contraception.
Mifamurtid se ne preporučuje koristiti tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
Do not use this medicine after the expiry date which is stated on the vial label and the carton after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i na kutiji iza oznake „EXP“.
The vial should be allowed to stand undisturbed for 1 minute to ensure thorough hydration of the dry substance.
Bočicu treba ostaviti da miruje 1 minutu kako bi se osigurala temeljita hidracija suhe tvari.
Regular use of corticosteroids should be avoided when using MEPACT as this may affect the way the medicine works.
Redovito uzimanje kortkosteroida treba izbjegavati kada se koristi MEPACT jer mogu utjecati na njegovo djelovanje.
Nausea, vomiting and loss of appetite are very common adverse reactions to mifamurtide (see section 4.8).
Mučnina, povraćanje i gubitak apetita su vrlo česte nuspojave mifamurtida (vidjeti dio 4.8).
Metabolism of liposomal MTP-PE has not been studied in humans.
Metabolizam liposomalnog MTP-PE nije ispitivan u ljudi.
OUTER PACKAGING
VANJSKO PAKIRANJE
Gastrointestinal toxicity may be exacerbated when mifamurtide is used in combination with high dose, multi-agent chemotherapy and was associated with an increased use of parenteral nutrition.
Gastrointestinalna toksičnost može biti pojačana kad se mifamurtid koristi u kombinaciji s visokim dozama polikemoterapije i povezana je s češćom primjenom parenteralne prehrane.
It is used after you have had surgery to remove the tumour and together with chemotherapy to kill remaining cancer cells to reduce the risk of cancer coming back.
Koristi se nakon operacije kojom je uklonjen tumor i zajedno s kemoterapijom kako bi se uništile preostale tumorske stanice i smanjio rizik ponovnog javljanja bolesti.
There was no effect of mild hepatic impairment on the systemic exposure (AUCinf) of total MTP-PE.
Blago oštećenje jetre nije imalo utjecaja na sistemsku izloženost (AUCinf) ukupnom MTP-PE.
On the basis of the scientific conclusions for mifamurtide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mifamurtide is unchanged subject to the proposed changes to the product information.
Na temelju znanstvenih zaključaka za mifamurtid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) mifamurtid nepromijenjen, uz predložene izmjene informacija o lijeku.
If you have any further questions on the use of this medicine, ask your doctor.
U slučaju bilo kakvih drugih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
During mifamurtide administration, patients should be monitored for unusual signs or symptoms, such as arthritis or synovitis, suggestive of uncontrolled inflammatory reactions.
Tijekom primjene mifamurtida kod bolesnika treba obratiti pažnju na neuobičajene znakove ili simptome, poput artritisa ili sinovitisa, koji ukazuju na nekontroliranu upalnu reakciju.
The maximum tolerated dose in phase I studies was 4-6 mg/m with a high variability of adverse reactions.
Maksimalna podnošljiva doza u ispitivanjima faze I bila je 4-6 mg/m s velikom varijabilnosti nuspojava.
Liposomal and non-liposomal mifamurtide do not induce the metabolic activity or the transcription of cytochrome P450 in primary cultures of freshly isolated human hepatocytes.
Liposomalni i neliposomalni mifamurtid ne potiču metaboličku aktivnost ili transkripciju citokroma P450 u primarnim kulturama svježe izoliranih ljudskih hepatocita.
Pharmacokinetic variability was higher in the moderate hepatic impairment group (co-efficient of variation in systemic exposure [AUCinf] was 50% versus < 30% in the other hepatic function groups).
Famakokinetička varijabilnost bila je veća u skupini s umjerenim oštećenjem jetre (koeficijent varijacije sistemske izloženosti [AUCinf] bio je 50% u odnosu na < 30% u drugim skupinama).
• Filter for MEPACT
• Filtar za MEPACT
In 21 healthy adult subjects mifamurtide was cleared rapidly from serum (minutes) with a half-life of 2.05 ± 0.40 hours, resulting in a very low serum concentration of total (liposomal and free) mifamurtide.
U 21 zdravog odraslog ispitanika mifamurtid se brzo uklonio iz seruma (u minutama) s poluvijekom od 2,05 ± 0,40 sati, rezultirajući vrlo niskom serumskom koncentracijom ukupnog (liposomalnog i slobodnog) mifamurtida.
The recommended dose of mifamurtide for all patients is 2 mg/m body surface area.
Preporučena doza mifamurtida za sve bolesnike je 2 mg/m tjelesne površine.
After injection of radiolabelled liposomes containing mifamurtide, mean half-life of radiolabelled material was biphasic with an α-phase of about 15 minutes and a terminal half-life of approximately 18 hours.
Nakon injiciranja radioaktivno označenih liposoma koji sadrže mifamurtid, srednja vrijednost poluvijeka radioaktivno označenog materijala bila je dvofazna sa α fazom od oko 15 minuta i terminalnim poluvijekom od približno 18 sati.
Data from a six-month dog study of daily intravenous injections of up to 0.5 mg/kg (10 mg/m mifamurtide provide an 8- to 19-fold cumulative exposure safety margin for overt toxicity for the intended clinical dose in humans.
Podaci iz šestomjesečnog ispitivanja na psima svakodnevnih intravenskih injekcija do 0,5 mg/kg (10 mg/m2) mifamurtida pokazuju 8-erostruku do 19-erostruku sigurnosnu marginu kumulativne izloženosti za očitu toksičnost kliničke doze namijenjene ljudima.
Consistent with other generalised symptoms, the very common nervous system disorders were headache (50%) and dizziness (17%).
Sukladno drugim općim simptomima, vrlo česti poremećaji živčanog sustava bili su glavobolja (50%) i omaglica (17%).
It is used in combination with post-operative multi-agent chemotherapy.
Koristi se u kombinaciji s postoperacijskom polikemoterapijom.
There was also one report of a grade 4 allergic reaction (hypertension) requiring hospitalization in the phase III study (see section 4.4).
U ispitivanju faze III bila je, također, i jedna prijava alergijske reakcije stupnja 4 (hipertenzija) koja je zahtjevala hospitalizaciju bolesnika (vidjeti dio 4.4).
It is recommended that the reconstitution of the liposomal suspension should be performed in a laminar flow cabinet utilising sterile gloves using aseptic technique.
Preporučuje se da se rekonstituciju liposomalne suspenzije treba izvoditi u kabinetu s laminarnim protokom zraka uz primjenu sterilnih rukavica i aseptičkim postupkom.
After removing the needle from the syringe, the syringe should be attached to the filter by opening the filter luer connector cap (figure 1).
6. Nakon što se sa štrcaljke ukloni igla, štrcaljku treba učvrstiti na filtar otvaranjem luer spojnice na filtru (slika 1).
Once reconstituted in sodium chloride 9 mg/mL (0.9%) solution, store at room temperature (approximately 20ºC - 25ºC) and use within 6 hours.
Nakon pripreme u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida, čuvati na sobnoj temperaturi (otprilike 20ºC - 25ºC) i upotrijebiti unutar 6 sati.
The liposomes were phagocytosed by cells of the reticuloendothelial system.
Liposome su fagocitirale stanice retikuloendotelnog sustava.
Two patients with pre-existing asthma developed mild to moderate respiratory distress associated with the treatment (see section 4.8).
Kod dva bolesnika s postojećom astmom pojavile su se blage do umjerene smetnje disanja povezane s terapijom (vidjeti dio 4.8).
What MEPACT contains - The active substance is mifamurtide.
Što MEPACT sadrži - Djelatna tvar je mifamurtid.
BSA-normalised clearance and half-life were similar across the age range and consistent with that determined in healthy adult subjects, supporting the recommended dose of 2 mg/m
BSA-normalizirani klirens i poluvijek bili su slični bez obzira na dob i u skladu s utvrđenim kod odraslih zdravih ispitanika, što govori u prilog preporučenoj dozi od 2 mg/m
In a randomised controlled study, the incidence of myeloid malignancy (acute myeloid leukaemia/myelodysplastic syndrome) was the same in patients receiving MEPACT plus chemotherapy as in patients receiving only chemotherapy (2.1%).
U randomiziranom kontroliranom ispitivanju, pojavnost mijeloidnih malignosti (akutna mijeloidna leukemija/mijelodisplastični sindrom) bila je jednaka kod bolesnika koji su dobivali MEPACT uz kemoterapiju kao i kod bolesnika koji su primali samo kemoterapiju ( 2,1%).
One serious incident of subacute thrombosis was reported in early studies, but no serious cardiac events were associated with mifamurtide in a large randomised controlled study (see section 4.4).
U ranim ispitivanjima je zabilježen jedan ozbiljan slučaj subakutne tromboze, no u velikim randomiziranim ispitivanjima nije bilo ozbiljnih srčanih događaja povezanih s mifamurtidom (vidjeti dio 4.4).
Rash, Pruritis, Erythema, Alopecia, Dry skin
Osip, svrbež, eritem, alopecija, suha koža
Mean half-lives of total and free MTP-PE in moderate hepatic impairment were 3.21 hours and 3.15 hours, respectively.
Srednja vrijednost poluvijeka ukupnog i slobodnog MTP-PE kod umjerenog oštećenja jetre bila je 3,21 i 3,15 sati.
The filter and syringe must not be removed from the vial.
Filtar i štrcaljka se ne smiju skinuti s bočice.
Confusional state, Depression, Insomnia, Anxiety
Stanje konfuzije, depresija, nesanica, anksioznost
Also, it has been demonstrated in vitro that high-dose NSAIDs (cyclooxygenase inhibitors) can block the macrophage activating effect of liposomal mifamurtide.
Također, in vitro je dokazano da visoke doze NSAIL (inhibitora ciklooksigenaze) mogu zaustaviti djelovanje liposomalnog mifamurtida na aktivaciju makrofaga.
Major toxic effects associated with these high daily and cumulative doses of mifamurtide were mainly exaggerated pharmacological effects: pyrexia, signs of pronounced inflammatory response manifested as synovitis, bronchopneumonia, pericarditis and inflammatory necrosis of the liver and bone marrow.
Glavni toksični učinci povezani s tim visokim dnevnim i kumulativnim dozama mifamurtida bili su pretjerano farmakološko djelovanje: pireksija, znakovi izraženog upalnog odgovora iskazani kao sinovitis, bronhopneumonija, perikarditis i upalna nekroza jetre i koštane srži.
These are typically mild to moderate and transient and can usually be treated by your doctor, e.g. with paracetamol for fever.
Oni su blagi do umjereni i prolazni i obično ih liječnik može liječiti, npr. vrućicu paracetamolom.
In 28 osteosarcoma patients aged 6 to 39 years serum total (liposomal and free) mifamurtide concentrations declined rapidly with a mean half-life of 2.04 ± 0.456 hours.
U 28 bolesnika s osteosarkomom u dobi od 6 do 39 godina serumske koncentracije ukupnog (liposomalnog i slobodnog) mifamurtida su brzo opadale sa srednjim poluvijekom od 2,04 ± 0,456 sati.
Moderate hepatic impairment resulted in a small increase in AUCinf of total MTP-PE, with the geometric least square mean ratio (expressed as %) for moderate hepatic impairment in reference to the matched normal hepatic function group being 119% (90% confidence interval [CI]: 94.1%-151%).
Umjereno oštećenje jetre rezultiralo je malim povećanjem sistemske izloženosti (AUCinf ) ukupnom MTP-PE, s odnosom geometrijske srednje vrijednosti najmanjeg kvadrata (izraženim kao %) kod umjerenog oštećenja jetre u odnosu na usklađenu skupinu s normalnom funkcijom jetre od 119% (90% interval pouzdanosti [CI]: 94,1%-151%).
The liposomal suspension is infused intravenously over about 1 hour.
Liposomalna suspenzija se primjenjuje intravenskom infuzijom u trajanju od oko 1 sat.
Some very common and common side effects of MEPACT treatment (such as dizziness, vertigo, fatigue and blurred vision) may affect your ability to drive and use machines.
Neke vrlo česte i česte nuspojave liječenja lijekom MEPACT (poput omaglice, vrtoglavice, umora i zamućenog vida) mogu utjecati na sposobnost upravljanja vozilima i strojevima.
Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature (between approximately 20 C-25 °C).
14. Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 6 sati na sobnoj temperaturi (između približno 20°C - 25°C).
The use of mifamurtide concurrently with ciclosporin or other calcineurin inhibitors is contraindicated due to their hypothesised effect on splenic macrophages and mononuclear phagocytic function (see section 4.3).
Istodobna primjena mifamurtida sa ciklosporinom ili drugim inhibitorima kalcineurina je kontraindicirana zbog njihovog pretpostavljenog utjecaja na funkciju makrofaga i mononuklearnih fagocita u slezeni (vidjeti dio 4.3).
Do not refrigerate or freeze the solution.
Otopinu ne čuvati u hladnjaku i ne zamrzavati.
Therefore, MEPACT should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Stoga se MEPACT ne smije koristiti u trudnoći i kod žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici.
However, as the variability in pharmacokinetics of mifamurtide is greater in subjects with moderate hepatic impairment (see section 5.2), and safety data in patients with moderate hepatic impairment is limited, caution when administering mifamurtide to patients with moderate hepatic impairment is recommended.
Međutim, kako je kod bolesnika s umjerenim oštećenjem jetre veća varijabilnost farmakokinetike mifamurtida (vidjeti dio 5.2), a podaci o sigurnosti primjene kod bolesnika s umjerenim oštećenjem jetre su ograničeni, preporučuje se oprez pri primjeni mifamurtida kod bolesnika s umjerenim oštećenjem jetre.
If not used immediately, the reconstituted, filtered and diluted solution in-use storage times and conditions prior to use of the reconstituted product must not be longer than 6 hours at 25 ºC.
Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja rekonstituirane, profiltrirane i razrijeđene otopine prije primjene rekonstituiranog lijeka ne smiju prijeći 6 sati na temperaturi od 25°C.
The reconstituted, filtered and diluted suspension for infusion is a homogenous, white to off-white, opaque liposomal suspension, free of visible particles and free of foam and lipid lumps.
Rekonstituirana, profiltrirana i razrijeđena suspenzija za infuziju je homogena, bijela do bjelkasta, mutna liposomalna suspenzija, bez vidljivih čestica te bez pjene i nakupina lipida.
if you develop chills or shivering, or feel warm.
- ako se pojavi zimica, drhtanje ili osjećaj vrućine.
There was no effect of mild (50 mL/min ≤ creatinine clearance [CLcr] ≤ 80 mL/min) or moderate (30 mL/min ≤ CLcr < 50 mL/min) renal insufficiency on the clearance of total MTP-PE, when compared with that observed in healthy adult subjects with normal renal function (CLcr > 80 mL/min).
Nije bilo utjecaja blagog (50 ml/min ≤ klirens kreatinina [CLcr] ≤ 80 ml/min) ili umjerenog (30 ml/min ≤ CLcr < 50 ml/min) oštećenja bubrega na klirens ukupnog MTP-PE u usporedbi s onim opaženim u zdravih odraslih ispitanika s normalnom funkcijom bubrega (CLcr > 80 ml/min).
Signs and symptoms that were associated with higher doses and/or were dose limiting were not life-threatening, and included fever, chills, fatigue, nausea, vomiting, headache and hypoor hypertension.
Znakovi i simptomi koji su bili povezani s višim dozama i/ili su ograničavali dozu nisu bili po život opasni, a uključivali su vrućicu, zimicu, umor, mučninu, povraćanje, glavobolju i hipotenziju ili hipertenziju.
One patient in the phase III study experienced 2 episodes of grade 4 seizure while on study therapy with chemotherapy and mifamurtide.
Jedan bolesnik iz ispitivanja faze III imao je 2 epizode epileptičkog napadaja 4. stupnja tijekom liječenja kemoterapijom i mifamurtidom.
It should be used with caution in patients with a history of autoimmune, inflammatory or other collagen diseases.
Lijek treba koristiti s oprezom kod bolesnika s autoimunim, upalnim ili drugim kolagenskim bolestima u anamnezi.
Mifamurtide was studied as a single agent in 248 patients with mostly advanced malignancies during the early, single arm phase I and II clinical studies.
Mifamurtid je ispitivan kao jedini lijek u liječenju 248 bolesnika s pretežno uznapredovalim zloćudnim bolestima u ranom kliničkom ispitivanju faze I i II sa jednom skupinom.
Respiratory disorders, including dyspnoea (21%), cough (18%) and tachypnoea (13%) were very commonly reported, and 2 patients with pre-existing asthma developed mild to moderate respiratory distress associated with MEPACT treatment in a phase II study.
Poremećaji dišnog sustava, uključujući dispneju (21%), kašalj (18%) i tahipneju (13%) prijavljivani su vrlo često, a 2 bolesnika s prethodno prisutnom astmom su u ispitivanju faze II razvila blage do umjerene smetnje disanja povezane s liječenjem lijekom MEPACT.
In vitro-treated human monocytes killed allogeneic and autologous tumour cells (including melanoma, ovarian, colon, and renal carcinoma), but had no toxicity towards normal cells.
In vitro tretirani ljudski monociti ubijali su alogene i autologne tumorske stanice (uključujući melanom, karcinom jajnika, kolona i bubrega), ali nisu toksično djelovali na normalne stanice.
It is recommended to separate the times of administration of MEPACT and doxorubicin or other medicines if used in the same chemotherapy treatment regimen.
Preporučuje se razdvojiti vrijeme primjene lijeka MEPACT i doksorubicina ili drugih lijekova ako se koriste u istom protokolu kemoterapije.
Leukopenia, Thrombocytopenia, Granulocytopenia, Febrile neutropenia
Leukopenija, trombocitopenija, granulocitopenija, febrilna neutropenija
No dedicated fertility studies have been conducted with mifamurtide (see section 5.3).
Nisu provedena namjenska ispitivanja plodnosti povezana s mifamurtidom (vidjeti dio 5.3).
Mean half-lives of total and free MTP-PE in mild hepatic impairment were 2.02 hours and 1.99 hours, respectively, and were comparable to those in subjects with normal hepatic function (2.15 hours and 2.26 hours, respectively).
Srednja vrijednost poluvijeka ukupnog i slobodnog MTP-PE kod blagog oštećenja jetre bila je 2,02 sata i 1,99 sati te je bila usporediva s onom kod ispitanika s normalnom funkcijom jetre (2,15 sati i 2,26 sata).
The following events were also observed: haemorrhage and prolongation of coagulation times, infarcts, morphological changes in the wall of small arteries, oedema and congestion of the central nervous system, minor cardiac effects, and slight hyponatraemia.
Uočeni su i sljedeći događaji: krvarenje i produljeno vrijeme zgrušavanja, infarkti, morfološke promjene stijenki malih arterija, edem i kongestija središnjeg živčanog sustava, manji učinci na srce i blaga hiponatremija.
In addition, pericardial effusion is a listed ADR for another immunostimulant, i.e. aldesleukin.
Uz to, perikardijalni izljev naveden je kao nuspojava drugog imunostimulatora, aldesleukina.
MEPACT is then infused directly into your vein (intravenous) over about 1 hour.
MEPACT se zatim daje infuzijom u venu (intravenski) u trajanju od 1 sata.
The desired dose may be withdrawn from the vial by inverting the vial and slowly pulling back on the syringe plunger (figure 3).
Željena doza može se izvući iz bočice okretanjem bočice i polaganim povlačenjem klipa štrcaljke (slika 3).
At 6 hours after injection of radiolabelled liposomes containing 1 mg mifamurtide, radioactivity was found in liver, spleen, nasopharynx, thyroid, and, to a lesser extent, in lung.
Šest sati nakon injiciranja radioaktivno označenih liposoma koji sadrže 1 mg mifamurtida, radioaktivnost je zabilježena u jetri, slezeni, nazofarinksu, štitnoj žlijezdi i u manjem opsegu u plućima.
The pharmacokinetics of mifamurtide have been characterised in healthy adult subjects following a 4 mg intravenous infusion and in paediatric and adult patients with osteosarcoma following a 2 mg/m intravenous infusion.
Farmakokinetika mifamurtida ispitana je u zdravih odraslih ispitanika nakon intravenske infuzije 4 mg, kao i u pedijatrijskih i odraslih bolesnika s osteosarkomom nakon intravenske infuzije 2 mg/m
Because mifamurtide acts through stimulation of the immune system, the chronic or routine use of corticosteroids should be avoided during treatment with mifamurtide.
Budući da se djelovanje mifamurtida temelji na stimulaciji imunološkog sustava, tijekom liječenja mifamurtidom treba izbjegavati kroničnu ili rutinsku primjenu kortikosteroida.
Before using MEPACT, you should discuss with your doctor whether you should take medicine for your asthma when using MEPACT.
Prije primjene lijeka MEPACT morate razgovarati s liječnikom smijete li istodobno s lijekom MEPACT uzimati svoj lijek za astmu.