natgillin/translations-raw huggingface dataset:
In study ESS30008, 260 patients with virologic suppression on a first line therapy regimen containing abacavir 300 mg plus lamivudine 150 mg, both given twice daily and a PI or NNRTI, were randomised to continue this regimen or switch to Kivexa plus a PI or NNRTI for 48 weeks. 
U studiji ESS30008, 260 bolesnika u kojih je pri prethodnom liječenju abakavirom u dozi od 300 mg dvaput na dan i lamivudinom u dozi od 150 mg dvaput na dan uz inhibitor proteaze (IP) ili nenukleozidni inhibitor reverzne transkriptaze došlo do supresije virusa, randomizirani su tako da su
Clinically significant reduction of susceptibility to abacavir has been demonstrated in clinical isolates of patients with uncontrolled viral replication, who have been pre-treated with and are resistant to other nucleoside inhibitors. 
U kliničkim izolatima bolesnika s nekontroliranom replikacijom virusa koji su prethodno liječeni drugim inhibitorima nukleozida i rezistentni su na njih, zabilježeno je klinički značajno smanjenje osjetljivosti na abakavir.
Section 4 of this leaflet. 
u dijelu 4 ove Upute.
Neurological/Psychiatry 
Neurološki/psihijatrijski simptomi glavobolja, parestezija
Virologic Response Based on Plasma HIV-1 RNA < 50 copies/ml ITT-Exposed Population M=F switch included 
Virološki odgovor na temelju plazmatskih razina HIV-1 RNK < 50 kopija/ml
CNA109586 (ASSERT study), a multi-centre, open label, randomised study of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir/emtricitabine (TDF/FTC, 300mg/200mg), each given once daily with efavirenz (EFV, 600mg) in ART naïve, HLA-B*5701 negative, HIV-1 infected adults.The virologic results are summarised in the table below: 
CNA109586 (ASSERT ispitivanje) je multicentrično, otvoreno, randomizirano ispitivanje o abakavir/lamivudinu (ABC/3TC, 600mg/300mg) i tenofovir/emtricitabinu (TDF/FTC, 300mg/200mg),
No Kivexa dosage adjustment necessary. 
Nije potrebno prilagođavanje doze lijeka Kivexa.
Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated. 
Ponovno uvođenje ABC-a može rezultirati puno bržom i težom reakcijom, što može biti fatalno, stoga je ponovno uvođenje kontraindicirano.
Similar reductions in HIV-1 RNA as measured by average area under the curve minus baseline were observed, indicating that the Kivexa group was non-inferior to the abacavir plus lamivudine twice daily group (AAUCMB, -1.65 log10 copies/ml versus -1.83 log10 copies/ml respectively, 95% CI -0.13, 0.38). 
Podjednako smanjenje HIV-1 RNK, određeno prema prosječnoj površini pod krivuljom umanjenoj za početne vrijednosti, pokazuju da je skupina koja je primala lijek Kivexa jednako vrijedna kao skupina koja je primala abakavir plus lamivudin dvaput na dan (AAUCMB; -1,65 log10
Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for two years. 
Nakon dvogodišnje primjene abakavira primijećena je blaga degeneracija miokarda u miševa i štakora.
Very rare side effects that may show up in blood tests are: • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). 
Vrlo rijetke nuspojave koje se mogu pojaviti u krvnim pretragama su:
• diarrhoea 
• kašalj
Similar clinical success (point estimate for treatment difference: -1.7, 95% CI -8.4, 4.9) was observed for both regimens. 
U oba režima liječenja zabilježen je sličan klinički uspjeh (ocijenjena razlika u razlici liječenja: -1,7;
Repeat-dose toxicity 
Toksičnost višekratnih doza
Placental transfer of abacavir and lamivudine has been shown to occur in humans. 
Pokazalo se da abakavir i lamivudin prolaze kroz placentu u ljudi.
The clinical relevance of this is unknown. 
Klinički značaj ovog nalaza nije poznat.
CYTOTOXICS Cladribine/Lamivudine 
CITOTOKSICI kladribin/lamivudin
Retinoid compounds (e.g. isotretinoin)/Lamivudine No drug interaction studies 
Nedostatni podaci na osnovu kojih bi se preporučila prilagodba doze spojevi retinoida (npr. isotretinoin) /lamivudin Nema studija interakcije lijekova.
Very rare side effects 
Manje česte nuspojave
Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine .There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues: these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia). 
Postoje izvješća o poremećaju funkcije mitohondrija kod HIV- negativne dojenčadi koja je bila in utero i/ili postnatalno izložena analozima nukleozida; ova izvješća su se pretežno odnosila na liječenje režimima koji su sadržavali zidovudin.
Therapy 
RETINOIDI
The safety and efficacy of Kivexa has not been established in patients with significant underlying liver disorders. 
U bolesnika s ozbiljnom podležećom bolesti jetre nije ustanovljena sigurnost i djelotvornost primjene lijeka Kivexa.
(estimated hazard ratio: 2.33, 95% CI: 1.46, 3.72, p=0.0003). 
0,39%; 95% CI: -6,63; 7,40).
SIDE 2 
PRILOG III.
Baseline CD4 category 50-100 21/40 (53%) 
000 kopija/mL Početna CD4 kategorija <50 3/6 (50%)
Zidovudine/Abacavir 
zidovudin/abakavir
The proportion of treatment-experienced patients in the CAL30001 study with HIVRNA <50 copies/mL at Week 48 by genotypic sensitivity score in optimized background therapy (OBT) are tabulated The impact of major IAS-USA defined mutations to abacavir or lamivudine and multi-NRTI resistance associated mutations to the number of baseline mutations on response was also evaluated. 
Udio ranije liječenih bolesnika u ispitivanju CAL30001 koji su imali HIV-RNA <50 kopija/mL u 48. tjednu, prema indeksu genotipske osjetljivosti u optimiziranom osnovnom liječenju (eng. optimized background therapy) (OBT) je tablično prikazan.
Management of ABC HSR reaction 
Zbrinjavanje reakcije preosjetljivosti na ABC
The adverse reactions considered at least possibly related to abacavir or lamivudine are listed by body system, organ class and absolute frequency. 
Nuspojave za koje se smatra da bi mogle biti povezane s abakavirom ili lamivudinom navedene su prema organskim sustavima i apsolutnoj učestalosti pojavljivanja definiranoj kao: vrlo česte (>1/10),
Gastrointestinal tract 
Tablični prikaz nuspojava
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confer high-level resistance to lamivudine. 
U bolesnika zaraženih HIV-1, koji su primali antiretrovirusnu terapiju koja uključuje lamivudin, dolazi do stvaranja varijanti M184V ili M184I.
Common: fatigue, malaise, fever. 
Često: vrućica, letargija, umor Često: umor, malaksalost, vrućica
• Kivexa should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavircontaining regimen. 
statusom, niti u bolesnika s negativnim HLA-B*5701 statusom za koje se sumnja da su imali reakciju preosjetljivosti na abakavir tijekom prethodnog liječenja režimom koji je sadržavao abakavir (npr. Ziagen, Trizivir, Triumeq).
Other symptoms include: 
Oni uključuju:
Magyarország GlaxoSmithKline Kft. Tel.: + 36 1 225 5300 
GlaxoSmithKline d.o.o Tel:++385 1 6051 999
Phenytoin/Lamivudine 
fenitoin/lamivudin
Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats. 
Ispitivanja lamivudina na životinjama pokazala su povećanu ranu smrtnost embrija u kunića,
Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital). 
Ako Vaš liječnik nije dostupan, morate odmah zatražiti medicinsku pomoć negdje drugdje (npr. odjel hitne pomoći u najbližoj bolnici).
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine 
Jedna filmom obložena tableta sadrži 600 mg abakavira (u obliku abakavirsulfata) i 300 mg lamivudina.
Lamivudine is cleared renally. 
Lamivudin se eliminira bubregom.
Respiratory tract 
• otežano disanje
You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Kivexa. 
STRANA 2 Ako mislite da imate reakciju preosjetljivosti na lijek Kivexa morate odmah kontaktirati svog liječnika.
infection 
Liječenje
Abacavir hypersensitivity 
Preosjetljivost na abakavir
Uncommon: Transient rises in liver enzymes (AST, ALT), Rare: Hepatitis 
Manje često: prolazni porast razina jetrenih enzima (AST, ALT),
These results indicate that FDC can be taken with or without food. 
Ovi rezultati ukazuju da se fiksna kombinacija može uzimati neovisno o obroku.
A similar virologic response was observed for both regimens (point estimate for treatment difference at week 48: 0.39%, 95% CI: -6.63, 7.40). 
Sličan virološki odgovor zapažen je za oba režima (točna procijenjena razlika liječenja u 48. tjednu:
Hepatic impairment 
Rijetko: hepatitis
However, some patients with a suspected ABC hypersensitivity reaction may not have the HLA-B*5701 allele. 
ABC ne moraju imati HLA-B*5701 alel.
Huis ter Heideweg 62 
U križnom ispitivanju na 60
GlaxoSmithKline s.r.o. 
Slovenská republika GlaxoSmithKline Slovakia s. r. o.
• stomach pains 
• bolovi u trbuhu
Musculoskeletal 
ANTIRETROVIRUSNI
2) you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill 
2) razvijete jedan ili više simptoma iz barem DVIJE od sljedećih skupina: - vrućica
Hepatobiliary disorders 
Metabolički parametri
ABC QD + 3TC QD + EFV QD (N=384) Number of Baseline Mutations1 
ABC QD + 3TC QD + EFV QD (N=384)
Abacavir-resistant isolates of HIV-1 have been selected in-vitro in wild-type strain HIV-1 (HXB2) and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115). 
Odabrani su izolati HIV-1 koji su bili rezistentni na abakavir in-vitro u divljim sojevima HIV-1 (HXB2)
Baseline RNA category >=100,000 copies/mL 
Početna RNA kategorija >=100
Baseline CD4 category <50 
Početna RNA kategorija <100
This should take approximately 30 minutes. 
Za to je potrebno oko 30 minuta.
This is done by your doctor or a nurse, who will also monitor you during that time. 
To će učiniti liječnik ili medicinska sestra, koji će Vas za to vrijeme nadgledati.
Always use this medicine exactly as your doctor has told you. 
Uvijek koristite ovaj lijek točno onako kako Vam je rekao liječnik.
Adults > 30 years 
Odrasli > 30 godina
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Ovaj lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
It is especially important to tell your doctor if you are taking medicines containing any of the following active substances: 
Posebno je važno da obavijestite liječnika ako uzimate lijekove koji sadrže neku od sljedećih djelatnih tvari:
Do not use this medicine if you notice any visible signs of deterioration. 
Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakve vidljive znakove propadanja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA/DATUM OBNOVE ODOBRENJA
Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ako uzimate ili ste nedavno uzimali ili biste mogli uzeti bilo koje druge lijekove.
In the event of such an overdose, contact your doctor or nearest hospital. 
U slučaju takvog predoziranja, javite se svom liječniku ili u najbližu bolnicu.
Paediatric population < 2 years 
Pedijatrijska populacija < 2 godine
It has similar immunostimulatory effects as natural MDP. 
Ima slične imunostimulirajuće učinke kao i prirodni MDP.
It will be given to you twice a week (at least three days apart) for the first 12 weeks, then once a week for 24 more weeks. 
Primat ćete ga dva puta tjedno (s razmakom od najmanje tri dana) tijekom prvih 12 tjedana, a zatim jednom tjedno još 24 tjedna.
The majority of these events were reported as either mild or moderate. 
Većina ovih nuspojava prijavljene su kao ili blage ili umjerene.
Supportive measures should be based on institutional guidelines and the clinical symptoms observed. 
Suportivne mjere treba temeljiti na institucijskim smjernicama i opaženim kliničkim simptomima.
A frequency of ‘not known (cannot be estimated from available data)' is considered appropriate. 
Učestalost „nepoznato (ne može se procijeniti iz dostupnih podataka)” smatra se prikladnom.
You should take your temperature as you may have a fever. 
Morate izmjeriti tjelesnu temperaturu, jer možda imate vrućicu.
Dose and duration of treatment 
Doza i trajanje liječenja
Materials required but not provided: 
Oprema koja je potrebna, ali nije priložena:
You do not need to be hospitalised to receive MEPACT. 
Ne morate biti primljeni u bolnicu da bi ste primili MEPACT.
The safety and efficacy of mifamurtide in children aged 0 to 2 years have not been established. 
Sigurnot i djelotvornost mifamurtida u djece u dobi od 0 do 2 godine nije utvrđena.
Date of first authorisation: 6 March 2009 Date of latest renewal: 20 February 2019 
Datum posljednje obnove odobrenja: 20. veljače 2019.
This includes medicines that may be obtained without a prescription. 
To uključuje i one koje ste nabavili bez recepta.
MEPACT will be administered only under the supervision of a specialist physician. 
MEPACT će se primjenjivati samo pod nadzorom liječnika specijaliste.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine. 
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
It is not recommended to give this medicine to children below the age of 2 years because information on how safe and how well this medicine works is not available for this age group. 
Nije preporučljivo davati ovaj lijek djeci mlađoj od 2 godine, jer nema dostupnih informacija koliko je siguran i djelotvoran za njihovu dobnu skupinu.
Volume 
Volumen
During this time the liposomes are formed spontaneously (figure 2). 
Za to vrijeme spontano se stvaraju liposomi (slika 2).
Not known (cannot be estimated from the available data): - abnormal accumulation of fluid around the heart (pericardial effusion) 
Nepoznato (ne može se procijeniti iz dostupnih podataka): - neuobičajeno nakupljanje -tekućine oko srca (perikardijalni izljev)
In the event of an overdose, it is recommended that appropriate supportive treatment be initiated. 
U slučaju predoziranja preporučuje se započeti prikladno suportivno liječenje.
Other medicines and MEPACT 
Drugi lijekovi i MEPACT
Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), not known (cannot be estimated from the available data). 
Kategorije učestalosti su definirane prema sljedećem dogovoru: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); nepoznato (ne može se procijeniti iz dostupnih podataka).
A fever with a low white blood cell count (neutropenia) may be a sign of serious infection. 
Vrućica sa smanjenim brojem bijelih krvnih zrnaca (neutropenija), može biti znak ozbiljne infekcije.
Reconstituted suspension 
Pripremljena suspenzija
Specific studies addressing reproductive function, perinatal toxicity and carcinogenic potential have not been performed. 
Specifična ispitivanja utjecaja na reproduktivnu funkciju, perinatalnu toksičnost i kancerogeni potencijal nisu provedena.
What MEPACT is and what it is used for 
Što je MEPACT i za što se koristi
There were no results from general toxicity studies that suggested harmful effects on male or female reproductive organs. 
Nema podataka iz ispitivanja opće toksičnosti koji bi ukazivali na štetne učinke na muške ili ženske reproduktivne organe.
MEPACT is used to treat osteosarcoma (bone cancer) in children, adolescents and young adults (between 2 and 30 years). 
MEPACT se koristi za liječenje osteosarkoma (karcinoma kosti) kod djece, adolescenata i mladih odraslih (između 2 i 30 godina).
These data indicate that neither total nor free mifamurtide accumulated during the treatment period. 
Ti podaci pokazuju da se ni ukupni niti slobodni mifamurtid ne akumuliraju tijekom razdoblja liječenja.
The second episode involved multiple grand mal seizures over the course of days. 
Druga epizoda uključivala je višestruke grand mal epileptičke napadaje tijekom više dana.
MEPACT has not been tested in pregnant women. 
MEPACT nije ispitan u trudnica.
Like all medicines, MEPACT can cause side effects, although not everybody gets them. 
Kao i svi drugi lijekovi, MEPACT može uzrokovati nuspojave, ali one se neće javiti kod svakoga.
None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included. 
Nijedan od bolesnika s osteosarkomom liječenih u ispitivanjima nije bio u dobi od 65 godina ili stariji, a u randomiziranom ispitivanju faze III bili su uključeni samo bolesnici u dobi do 30 godina.
MEPACT must not be administered as a bolus injection. 
MEPACT se ne smije primijeniti kao bolus injekcija.
It stimulates your immune system to help your body kill tumour cells. 
Potiče imunološki sustav kako bi tijelu pomogao uništiti tumorske stanice.
Based on the prevalence of the disease, children and young adults were studied in the pivotal trial. 
Na temelju prevalencije ove bolesti, u pivotalnim ispitivanjima ispitivana su djeca i mlađi odrasli.
These are not expected at the recommended dose, however monitoring of clotting parameters after the first dose and once again after several doses is recommended. 
To se ne očekuje kod preporučenih doza, ali preporučuje se nakon prve doze i ponovno nakon nekoliko doza provjeriti parametre zgrušavanja.
It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks. 
Treba ga primijeniti kao adjuvantnu terapiju nakon resekcije: dva puta tjedno s razmakom od najmanje 3 dana tijekom 12 tjedana, nakon čega slijedi primjena jedan puta tjedno tijekom dodatnih 24 tjedana, odnosno ukupno 48 infuzija u 36 tjedana.
Pharmacotherapeutic group: Immunostimulants, Other immunostimulants, ATC code: L03AX15 
Farmakoterapijska skupina: Imunostimulatori, Ostali imunostimulatori, ATK oznaka: L03AX15
Therefore, there are not sufficient data to recommend the use of MEPACT in patients > 30 years of age. 
Stoga nema dovoljno podataka da bi se preporučila primjena lijeka MEPACT kod bolesnika starijih od 30 godina.
If symptoms are persistent and worsening, administration should be delayed or discontinued. 
Ako simptomi ustraju ili se pogoršavaju, primjenu treba odgoditi ili prekinuti.
It may be difficult to distinguish allergic reactions from exaggerated inflammatory responses, but patients should be monitored for signs of allergic reactions. 
Razlikovanje alergijske reakcije od pretjeranog upalnog odgovora može biti teško, no kod bolesnika treba pratiti znakove alergijske reakcije.
You should not stop treatment with MEPACT before finishing the course of treatment without discussing with your doctor first. 
Ne smijete prekinuti liječenje lijekom MEPACT prije predviđenog završetka terapije bez da se prethodno posavjetujete sa svojim liječnikom.
If you stop using MEPACT 
Ako prestanete uzimati MEPACT
Many of the very commonly reported adverse reactions as shown in the following summary table are thought to be related to the mechanism of action of mifamurtide (see table 1). 
Za većinu vrlo često prijavljenih nuspojava, kao što je prikazano u zbirnoj tablici koja slijedi, smatra se da su povezane s mehanizmom djelovanja mifamurtida (vidjeti tablicu 1).
Post-procedural pain 
Postproceduralna bol
Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1). 
Sigurnost i djelotvornost su ocijenjene u ispitivanjima na bolesnicima koji su bili u dobi od 2 do 30 godina pri postavljanju dijagnoze (vidjeti dio 5.1).
White to off-white homogeneous cake or powder. 
Bijeli do bjelkasti homogeni kolačić ili prašak.
The mean area under the curve (AUC) was 17.0 ± 4.86 h x nM and Cmax (maximum concentration) was 15.7 ± 3.72 nM. 
Srednja vrijednost područja ispod krivulje AUC bila je 17,0 ± 4,86 h x nM, a Cmax (maksimalna koncentracija) bila je 15,7 ± 3,72 nM.
• 1 single use 60 or 100 mL sterile syringe with luer lock 
• 1 jednokratna sterilna štrcaljka od 60 ili 100 ml sa luer lock spojnicom
See section 2 “MEPACT contains sodium” 
Pogledajte dio 2 „MEPACT sadrži natrij“.
What MEPACT is and what it is used for What you need to know before you use MEPACT How to use MEPACT 
Što je MEPACT i za što se koristi Što morate znati prije nego počnete primjenjivati MEPACT Kako primjenjivati MEPACT
In 2 of 4 patients with lung metastases, radioactivity was associated with lung metastases. 
U 2 od 4 bolesnika s plućnim metastazama radioaktivnost je bila povezana s plućnim metastazama.
Detailed information on warnings and precautions relating to side effects that could occur while you are taking the medicine is presented in section 4. 
Detaljnije informacije o upozorenjima i predostrožnostima povezanim s nuspojavama koje bi se mogle javiti tijekom primjene lijeka prikazane su u dijelu 4.
Takeda France SAS Immeuble Pacific 11-13 Cours Valmy 92800 - Puteaux France 
Takeda France SAS Immeuble Pacific 11-13 cours Valmy 92800 - Puteaux Francuska
The majority of patients experience chills, fever and fatigue especially during the first administration of MEPACT. 
Većina bolesnika ima zimicu, vrućicu i umor, posebno tijekom prve primjene lijeka MEPACT.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of mifamurtide therapy to the woman. 
Odluku o nastavku/prekidu dojenja ili nastavku/prekidu liječenja treba donijeti uzimajući u obzir korist od dojenja za dijete i korist od liječenja mifamurtidom za ženu.
MTP-PE is a potent activator of monocytes and macrophages. 
MTP-PE je potentni aktivator monocita i makrofaga.
Taking into account the PRAC Assessment Report on the PSUR(s) for mifamurtide, the scientific conclusions of the CHMP are as follows: 
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za mifamurtid, znanstveni zaključci CHMP-a su sljedeći:
It is not necessary to interrupt your schedule of MEPACT if your chemotherapy is delayed; you should complete 36 weeks (9 months) of treatment with MEPACT without an interruption. 
Nema potrebe prekidati raspored primjene lijeka MEPACT ukoliko se odgodi primjena kemoterapije; 36 tjedana (9 mjeseci) liječenja lijekom MEPACT treba završiti bez prekida.
In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level. 
U ispitivanju faze I, bila je jedna prijava ozbiljne alergijske reakcije koja se pojavila nakon prve infuzije mifamurtida, primijenjenog u dozi od 6 mg/m2.
In sensitive species (rabbit and dog) the highest daily dose of liposomal mifamurtide that did not cause adverse effects was 0.1 mg/kg, corresponding to 1.2 and 2 mg/m2, respectively. 
U osjetljivih vrsta (kunić i pas) najveća dnevna doza liposomalnog mifamurtida koja nije izazvala nuspojave iznosila je 0,1 mg/kg, što odgovara 1,2 i 2 mg/m2.
Mifamurtide was not mutagenic and did not cause teratogenic effects in rats and rabbits. 
Mifamurtid nije bio mutagen i nije pokazao teratogeno djelovanje kod štakora i kunića.