natgillin/translations-raw huggingface dataset:
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.
In a large controlled randomised study, mifamurtide used at the recommended dose and schedule with other medicinal products that have known renal (cisplatin, ifosfamide) or hepatic (high-dose methotrexate, ifosfamide) toxicities did not exacerbate those toxicities and there was no need to adjust mifamurtide dose. 
U velikom kontroliranom randomiziranom ispitivanju, mifamurtid primijenjen u preporučenoj dozi i prema preporučenom rasporedu s drugim lijekovima koji su toksični za bubrege (cisplatin, ifosfamid) ili jetru (metotreksat u visokoj dozi, ifosfamid) nije pojačao toksičnost i nije bilo potrebe za prilagodbu doze mifamurtida.
The no-adverse-effect level for mifamurtide in animals corresponds roughly to the 2 mg/m2 recommend dose for humans. 
Razina mifamurtida koja ne izaziva nuspojave kod životinja približno odgovara preporučenoj dozi za ljude od 2 mg/m2.
Therefore, the use of high-dose NSAIDs is contraindicated (see section 4.3). 
Stoga je primjena visokih doza NSAIL kontraindicirana (vidjeti dio 4.3).
Each carton contains 1 vial and 1 single-use, non-pyrogenic, sterile filter for MEPACT supplied in a PVC-grade blister. 
Jedna kutija sadrži 1 jednu bočicu i 1 jednokratni, nepirogeni sterilni filtar za MEPACT pakiran u PVC blister.
Patients with a history of venous thrombosis, vasculitis or unstable cardiovascular disorders should be closely monitored during mifamurtide administration. 
Bolesnike koji u anamnezi imaju vensku trombozu, vaskulitis ili nestabilnu kardiovaskularnu bolest treba tijekom primjene mifamurtida pomno nadzirati.
The patient experienced shaking, chills, fever, nausea, vomiting, uncontrollable coughing, shortness of breath, cyanotic lips, dizziness, weakness, hypotension, tachycardia, hypertension and hypothermia leading to study discontinuation. 
Bolesnik je imao drhtavicu, zimicu, vrućicu, mučninu, povraćanje, nekontrolirani kašalj, nedostatak zraka, cijanotičke usne, omaglicu, slabost, hipotenziju, tahikardiju, hipertenziju i hipotermiju što je dovelo do isključenja iz ispitivanja.
Occasional allergic reactions have been associated with mifamurtide treatment, including rash, shortness of breath and grade 4 hypertension (see section 4.8). 
S liječenjem mifamurtidom povezane su povremene alergijske reakcije, uključujući osip, nedostatak zraka i hipertenziju stupnja 4 (vidjeti dio 4.8).
MEPACT must be reconstituted, filtered using the filter provided and further diluted using aseptic technique, prior to administration. 
MEPACT se mora rekonstituirati, profiltrirati kroz priloženi filtar i dalje razrijediti aseptičkim postupkom, prije primjene.
Additionally, the geometric mean plasma AUCinf of free (non-liposome associated) MTP-PE in mild and moderate hepatic impairment were 47% higher than the corresponding values in the matched normal hepatic function groups. 
Dodatno, geometrijska srednja vrijednost plazmatskog AUCinf slobodnog (ne-liposomalnog) MTP-PE kod blagog i umjerenog oštećenja jetre bila je 47% viša od odgovarajućih vrijednosti u skupini s normalnom funkcijom jetre.
System organ class 
Klasifikacija organskih sustava Kategorije učestalosti
It can also be administered as an outpatient. 
Može ga se davati i ambulantno.
Hepatic pain 
Hepatička bol
The recommended dose of MEPACT is 2 mg mifamurtide/m body surface area. 
Preporučena doza lijeka MEPACT je 2 mg mifamurtida/m tjelesne površine.
An osteosarcoma patient in a phase II study who had high creatinine level at enrolment showed an increase in blood urea and blood creatinine which was associated with mifamurtide use. 
Kod jednog bolesnika s osteosarkomom u ispitivanju faze II koji je imao zabilježenu visoku vrijednost kreatinina, pokazalo se da je liječenje mifamurtidom bilo povezano s povećanjem ureje i kreatinina u krvi.
Powder for concentrate for dispersion for infusion Pack of 1 vial of powder, 1 sterile filter 
Prašak za koncentrat za disperziju za infuziju Pakiranje s 1 bočicom praška,1 sterilni filtar
Delpharm Novara S.r.l. 
Delpharm Novara S.r.l. Via Crosa, 86
Concurrent use with high-dose non-steroidal-anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors) (see section 4.5). 
Istodobna primjena s visokim dozama nesteroidnih protuupalnih lijekova (NSAIL, inhibitori ciklooksigenaze) (vidjeti dio 4.5).
MEPACT contains sodium 
MEPACT sadrži natrij
Gastrointestinal disorders were frequently associated with mifamurtide administration, including nausea (57%) and vomiting (44%) in about half of patients, constipation (17%), diarrhoea (13%) and abdominal pain (see section 4.4). 
Poremećaji probavnog sustava su često bili povezani s primjenom mifamurtida, uključujući mučninu (57%) i povraćanje (44%) u oko polovice bolesnika, zatvor (17%), proljev (13%) i abdominalnu bol (vidjeti dio 4.4).
In patients with a history of asthma or other chronic obstructive pulmonary disease, consideration should be given to administration of bronchodilators on a prophylactic basis. 
Kod bolesnika s astmom ili drugom kroničnom opstruktivnom bolesti pluća u anamnezi, potrebno je razmisliti o profilaktičkoj primjeni bronhodilatatora.
For intravenous use after reconstitution, filtering using the filter provided and further dilution. 
Za intravensku primjenu nakon rekonstitucije, filtriranja priloženim filtrom i dodatnog razrjeđivanja.
Concurrent use with ciclosporin or other calcineurin inhibitors (see section 4.5). 
Istodobna primjena s ciklosporinom ili drugim inhibitorima kalcineurina (vidjeti dio 4.5).
If your problems increase, you should contact your doctor, as these may have been caused by MEPACT when used with chemotherapy. 
Ako se poteškoće pogoršaju, trebate se obratiti svom liječniku, jer to može biti uzrokovano lijekom MEPACT kada se primjenjuje uz kemoterapiju.
Dyspnoea, Tachypnoea, Cough 
Dispneja, tahipneja, kašalj
All patients received a total dose of cisplatin of 480 mg/m2 as part of their induction (neoadjuvant) and/or maintenance (adjuvant) chemotherapy regimen. 
Svi bolesnici primili su ukupnu dozu cisplatina od 480 mg/m kao dio neoadjuvantnog i/ili adjuvantnog kemoterapijskog protokola.
It is recommended to separate the administration times of mifamurtide and doxorubicin or other lipophilic medicinal products if used in the same chemotherapy regimen. 
Preporučuje se razdvojiti vrijeme primjene mifamurtida i doksorubicina ili drugih lipofilnih lijekova koji se koriste u istom režimu kemoterapije.
In vitro interaction studies showed that liposomal and non-liposomal mifamurtide do not inhibit the metabolic activity of cytochrome P450 in pooled human liver microsomes. 
In vitro ispitivanja interakcija pokazala su da liposomalni i neliposomalni mifamurtid ne inhibira metaboličku aktivnost citokroma P450 u združenim ljudskim mikrosomima jetre.
There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; therefore, dose adjustments are not necessary for these patients. 
Nema klinički značajnog utjecaja blagog do umjerenog oštećenja bubrega (klirens kreatinina ≥ 30 ml/min) ili jetre (Child-Pugh stadij A ili B) na farmakokinetiku mifamurtida; stoga kod tih bolesnika nije potrebna prilagodba doze.
The vial should then be shaken vigorously for 1 minute while keeping the filter and syringe attached. 
9. Bočicu zatim treba snažno tresti 1 minutu držeći filtar i štrcaljku i dalje pričvršćene.
Anaemia has very commonly been reported when mifamurtide is used in conjunction with chemotherapeutic agents. 
Anemija je bila vrlo često prijavljivana kad se mifamurtid koristio istodobno s kemoterapeuticima.
These are typically mild to moderate, transient in nature and generally respond to palliative treatment (e.g., paracetamol for fever). 
Bile su uglavnom blage do umjerene, prolazne prirode i općenito s dobrim odgovorom na palijativno liječenje (npr. paracetamol za vrućicu).
Dizziness, vertigo, fatigue and blurred vision have shown as very common or common undesirable effects of mifamurtide treatment. 
Omaglica, vrtoglavica, umor i zamućen vid pokazali su se kao vrlo česte ili česte nuspojave liječenja mifamurtidom.
Additionally, the systemic exposures AUC from zero to infinity (AUCinf of free (non-liposome associated) MTP-PE in mild or moderate renal insufficiency were similar to those observed in healthy adult subjects with normal renal function. 
Dodatno, sistemska izloženost AUC od nule do beskonačno (AUCinf) slobodnom (ne-liposomalnom) MTP-PE u ispitanika s blagim do umjerenim oštećenjem bubrega bila je slična onoj opaženoj u zdravih odraslih ispitanika s normalnom funkcijom bubrega.
It is not known whether MEPACT passes to human milk. 
Nije poznato izlučuje li se MEPACT u majčino mlijeko kod ljudi.
50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide. 
Staklena bočica (staklo tipa I) od 50 ml sa sivim čepom od butilne gume, aluminijskim prstenom i plastičnom flip-off kapicom koja sadrži 4 mg mifamurtida.
Administration of mifamurtide was commonly associated with transient neutropenia, usually when used in conjunction with chemotherapy. 
Primjena mifamurtida bila je često povezana s prolaznom neutropenijom, obično kad se je koristio istodobno s kemoterapijom.
Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates. 
Za mifamurtid se, stoga, ne očekuju interakcije s metabolizmom tvari koje su supstrat za jetreni citokrom P450.
Musculoskeletal and connective tissue disorders Low grade pain was very common in patients receiving mifamurtide, including myalgia (31%), back pain (15%), extremity pain (12%) and arthralgia (10%). 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol niske razine bila je vrlo česta kod bolesnika koji primaju mifamurtid, uključujući mijalgiju (31%), bol u leđima (15%), bol u ekstremitetima (12%) i artralgiju (10%).
Very common side effects (may affect more than 1 in 10 people): - fever, shaking/shivering, weakness, tiredness or general discomfort - nausea and/or vomiting, diarrhoea or constipation - headache or dizziness - rapid beating of the heart - high blood pressure or low blood pressure - no appetite for food - sweating - pain, including general pain, pain in your muscles and/or joints and pain in back, chest, 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 ljudi): - vrućica, tresavica/drhtanje, slabost, umor, opća nelagoda - mučnina i/ili povraćanje, proljev ili zatvor - glavobolja ili omaglica - ubrzan rad srca - povišen krvni tlak ili snižen krvni tlak - gubitak teka - znojenje - bol, uključujući opću bol, bol u mišićima i/ili zglobovima i bol u leđima, prsnom košu, trbuhu,
It is unknown whether mifamurtide is excreted in human milk. 
Nije poznato izlučuje li se mifamurtid u majčino mlijeko kod ljudi.
Based upon the review of the cases, a causal association between mifamurtide and the occurrence of pericardial effusion is considered likely in view of cases with a plausible TTO, absence of other causative factors, and positive dechallenge. 
Temeljem ocjene slučajeva utvrđena je vjerojatna uzročno-posljedična veza između mifamurtida i pojave perikardijalnog izljeva, s obzirom na slučajeve u kojima je vrijeme do nastupa bilo vjerojatno, odsutnost drugih uzročnih čimbenika te povlačenje nuspojave nakon ukidanja primjene lijeka (pozitivan dechallenge).
Episodes of neutropenic fever should be monitored and managed appropriately. 
Epizode febrilne neutropenije treba pratiti i primjereno zbrinjavati.
Haemorrhage was observed in animals at very high doses. 
Pri vrlo visokim dozama kod životinja je primijećeno krvarenje.
In the SmPC of mifamurtide, pericarditis is mentioned in section 4.4. 
U sažetku opisa svojstava lijeka za mifamurtid perikarditis se navodi u dijelu 4.4.
Other generalised symptoms that were typically mild to moderate and very common included hypothermia (23%), malaise (13%), pain (15%), asthenia (13%) and chest pain (11%). 
Drugi opći simptomi koji su tipično bili blagi do umjereni i vrlo česti uključivali su hipotermiju (23%), malaksalost (13%), bol (15%), asteniju (13%) i bol u prsištu (11%).
• Sodium chloride 9 mg/mL (0.9%) solution for injection, 100 mL bag 
• 0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju, vrećica od 100 ml
Metabolism and nutritional disorders Anorexia (21%) was very commonly reported in phase I and II studies of mifamurtide 
Poremećaji metabolizma i prehrane Anoreksija (21%) je bila vrlo često prijavljivana u ispitivanjima
Sepsis, Cellulitis, Nasopharyngitis, Catheter site infection, Upper respiratory tract infection, Urinary tract infection, Pharyngitis, Herpes simplex infection 
Sepsa, celulitis, nazofaringitis, infekcija na mjestu katetera, infekcije gornjih dišnih puteva, infekcije mokraćnih puteva, faringitis, Herpes simplex infekcija
Paraesthesia, Hypoaesthesia, Tremor, Somnolence, Lethargy 
Parestezija, hipoestezija, tremor, somnolencija, letargija
• MEPACT powder for concentrate for dispersion for infusion (vial) 
• MEPACT prašak za koncentrat za disperziju za infuziju (bočica)
Talk to your doctor before using MEPACT: if you have or have had problems with your heart or blood vessels, like blood clots (thrombosis), bleeding (haemorrhage) or inflammation of the veins (vasculitis). 
Upozorenja i mjere opreza Obavijestite svog liječnika prije primjene lijeka MEPACT: - ako imate ili ste imali problema sa srcem ili krvnim žilama, poput krvnih ugrušaka (tromboze), krvarenja (hemoragije) ili upale vena (vaskulitis)- trebat će Vas pažljivije nadzirati dok primate terapiju s lijekom MEPACT.
The filter luer connector cap should not be removed at this time. 
U ovom trenutku se ne smije skidati poklopac s luer spojnice.
MEPACT is administered by intravenous infusion over a period of 1 hour. 
Način primjene MEPACT se primjenjuje intravenskom infuzijom tijekom razdoblja od 1 sata.
Respiratory distress 
Smetnje disanja
The cap of the vial should be removed and the stopper cleaned using an alcohol pad. 
S bočice treba ukloniti kapicu i čep očistiti jastučićem od vate natopljenom alkoholom.
Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders. 
Stoga je sažetak opisa svojstava lijeka za mifamurtid potrebno ažurirati kako bi se perikardijalni izljev uvrstio kao nuspojava unutar klasifikacije organskih sustava u dijelu 4.8., pod „Srčani poremećaji”.
General disorders and administration site conditions The majority of patients experience chills (89%), fever (85%) and fatigue (53%). 
Većina bolesnika iskusila je zimicu (89%), vrućicu (85%) i umor (53%).
In vivo administration of mifamurtide resulted in the inhibition of tumour growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma. 
In vivo primjena mifamurtida rezultirala je inhibicijom tumorskog rasta kod miševa i štakora s metastazama na plućima, s karcinomom kože i jetre te s fibrosarkomom.
The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection according to the detailed instructions shown below. 
Volumen rekonstituirane suspenzije koji odgovara izračunatoj dozi izvuče se kroz priloženi filtar i dalje razrijedi s dodatnih 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju prema detaljnim uputama u nastavku.
Each vial contains 4 mg mifamurtide*. 
Jedna bočica sadrži 4 mg mifamurtida*.
Skin and subcutaneous disorders Hyperhidrosis (11%) was very common in patients receiving mifamurtide in uncontrolled studies. 
Hiperhidroza (11%) je bila vrlo česta kod bolesnika koji su mifamurtid primali u nekontroliranim ispitivanjima.
The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (figure 4). 
Mjesto ubrizgavanja na vrećici treba prebrisati jastučićem od vate natopljenom alkoholom i ubrizgati suspenziju iz štrcaljke u izvornu vrećicu s preostalih 50 ml 0,9%-tne (9 mg/ml) otopine natrijeva klorida za injekciju (slika 4).
However, no specific subset analyses for efficacy are available in patients < 18 years of age and ≥ 18 years of age. 
< 18 godina starosti i ≥ 18 godina starosti.