natgillin/translations-raw huggingface dataset:
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.
The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe.
11. Štrcaljku zatim treba odvojiti od filtra i na štrcaljku sa suspenzijom staviti novu iglu.
The freeze-dried powder has to be reconstituted into a liquid suspension, filtered using the filter provided and further diluted before use.
Od praška osušenog smrzavanjem treba pripremiti tekuću suspenziju, profiltrirati ju kroz priloženi filtar i dodatno razrijediti prije primjene.
What MEPACT looks like and contents of the pack MEPACT is a white to off-white homogeneous cake or powder for concentrate for dispersion for infusion.
Mepact je bijeli do bjelkasti homogeni kolačić ili prašak za koncentrat za disperziju za infuziju.
Chemical and physical stability has been demonstrated for 6 hours up to 25 ºC.
Rekonstituirana suspenzija Kemijska i fizikalna stabilnost u primjeni dokazane su tijekom 6 sati na temperaturi do 25ºC.
The most frequent adverse reactions are chills, pyrexia, fatigue, nausea, tachycardia and headache.
Najčešće nuspojave su zimica, pireksija, umor, mučnina, tahikardija i glavobolja.
Upper abdominal pain, Dyspepsia, Abdominal distension, Lower abdominal pain
Bol u gornjem dijelu abdomena, dispepsija, distenzija abdomena, bol u donjem dijelu abdomena
Adverse reactions are classified according to system organ class and frequency.
Nuspojave su razvrstane prema klasifikaciji organskih sustava i učestalosti.
As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended.
Nema farmakokinetičkih podataka o mifamurtidu kod bolesnika s teškim oštećenjem bubrega ili jetre te je kod tih bolesnika pri primjeni mifamurtida potreban oprez.
Vertigo, Tinnitus, Hearing loss
Vrtoglavica, tinitus, gubitak sluha
Mifamurtide treatment was continued for the remainder of the study without seizure recurrence.
U preostalom vremenu ispitivanja, liječenje mifamurtidom nastavljeno je bez ponovne pojave epileptičkog napadaja.
How to use MEPACT
Kako primjenjivati MEPACT
The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (Child-Pugh class A; n = 9) or moderate (Child-Pugh class B; n = 8) hepatic impairment and in age, sex-, and weight-matched healthy adults with normal hepatic function (n = 19).
Farmakokinetika jednostruke doze od 4 mg mifamurtida nakon jednosatne intravenske infuzije ispitana je u odraslih dobrovoljaca s blagim (Child-Pugh stadij A, n=9) ili umjerenim (Child-Pugh stadij B, n=8) oštećenjem jetre i u zdravih odraslih s normalnom jetrenom funkcijom (n=19) usklađenih po dobi, spolu i tjelesnoj težini.
Each mL reconstituted suspension contains 0.08 mg mifamurtide.
Jedan ml rekonstituirane suspenzije sadrži 0,08 mg mifamurtida.
From a microbiological point of view, immediate use is recommended.
S mikrobiološkog stajališta, preporučuje se odmah primijeniti pripremljenu suspenziju.
Do not use MEPACT: - if you are allergic to mifamurtide or any of the other ingredients of this medicine (listed in section 6).
Nemojte primati MEPACT: - ako ste alergični na mifamurtid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako uzimate lijekove koji sadrže ciklosporin ili druge inhibitore kalcineurina ili visoke doze nesteroidnih protuupalnih lijekova (pogledajte „Uzimanje drugih lijekova“ u nastavku).
Myalgia, Arthralgia, Back pain, Pain in extremity
Mialgija, artralgija, bol u leđima, bol u ekstremitetima
Powder for concentrate for dispersion for infusion
Prašak za koncentrat za disperziju za infuziju.
If you have long-lasting or worsening symptoms, you should contact your doctor, as MEPACT treatment may need to be delayed or discontinued.
Ako imate dugotrajne simptome ili se oni pogoršavaju, obratite se liječniku, jer možda će trebati odgoditi ili prekinuti liječenje lijekom MEPACT. - ako u anamnezi imate astmu ili druge poremećaje disanja.
How MEPACT is given
Kako se MEPACT primjenjuje
Pleural effusion, Exacerbated dyspnoea, Productive cough, Haemoptysis, Wheezing, Epistaxis, Exertional dyspnoea, Sinus congestion, Nasal congestion, Pharyngolaryngeal pain
Pleuralni izljev, pogoršanje dispneje, produktivni kašalj, hemoptiza, piskanje, epistaksa, dispneja u naporu, začepljenje sinusa, začepljenje nosa, faringolaringealna bol
You should use effective contraception if you are being treated with MEPACT.
Za vrijeme liječenja lijekom MEPACT morate koristiti učinkovitu kontracepciju.
Powder for concentrate for dispersion for infusion 4 mg mifamurtide
Prašak za koncentrat za disperziju za infuziju 4 mg mifamurtida
The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (n = 9) or moderate (n = 8) renal impairment and in age-, sex-, and weight-matched healthy adults with normal renal function (n = 16).
Farmakokinetika jednostruke doze od 4 mg mifamurtida nakon jednosatne intravenske infuzije ispitana je u odraslih dobrovoljaca s blagim (n=9) ili umjerenim (n=8) oštećenjem bubrega i u zdravih odraslih s normalnom bubrežnom funkcijom (n=16) usklađenih po dobi, spolu i tjelesnoj težini.
- The other ingredients are 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS).
- Druge pomoćne tvari su 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC) i 1,2-dioleoil sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS).
Each vial contains 4 mg of mifamurtide.
Jedna bočica sadrži 4 mg mifamurtida.
1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC) 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold
Periferni edem, edem, upala sluznice, eritem na mjestu infuzije, reakcije na mjestu infuzije, bol na mjestu katetera, nelagoda u prsištu, osjećaj hladnoće
You may experience more severe side effects, including fever, chills, fatigue, nausea, vomiting, headache and high blood pressure or low blood pressure.
Ako primite više lijeka MEPACT nego što ste trebali Možete imati teže nuspojave, uključujući vrućicu, zimicu, umor, mučninu, povraćanje, glavobolju i povišeni ili sniženi krvni tlak.
MEPACT 4 mg powder for concentrate for dispersion for infusion
MEPACT 4 mg prašak za koncentrat za disperziju za infuziju.
The lyophilised powder should be allowed to reach a temperature between approximately 20 C-25 °C prior to reconstitution, filtering using the filter provided and dilution.
Liofilizirani prašak mora prije rekonstitucije, filtriranja kroz priloženi filtar i razrjeđivanja doseći temperaturu od oko 20°C do 25°C.
Inflammatory response
Upalni odgovor
Volume to withdraw = [12.5 x calculated dose (mg)] mL
Volumen suspenzije koji treba izvući za određenu dozu računa se na sljedeći način: Potrebni volumen = [12,5 x izračunata doza (mg)] ml Za jednostavniji izračun može poslužiti sljedeća tablica.
MEPACT 4 mg powder for concentrate for dispersion for infusion mifamurtide
MEPACT 4 mg prašak za koncentrat za disperziju za infuziju mifamurtid
The sodium chloride 9 mg/mL (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger.
7. 0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju se dodaje u bočicu sporim, čvrstim pritiskom klipa štrcaljke.
Excipients: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Pomoćne tvari: 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC), 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
How to store MEPACT
Kako čuvati MEPACT