natgillin/translations-raw huggingface dataset:
IVEMEND should be used with caution in these patients (see sections 4.4 and 5.2).
Pri teh bolnikih je treba zdravilo IVEMEND uporabljati previdno (glejte poglavji 4.4 in 5.2).
How to use IVEMEND
Kako uporabljati zdravilo IVEMEND
fosaprepitant dose were also observed following an oral dose of [
C]-fosaprepitanta so bili opaženi tudi po peroralnem odmerku [
Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness.
Najhujše reakcije na mestu infundiranja so se pojavile pri določeni vrsti kemoterapevtskih zdravil, ki lahko povzročijo opeklino ali mehurje na koži (vezikanti) s stranskimi učinki, vključno z bolečino, otekanjem in rdečino.
Adults The entire volume of the prepared infusion bag (150 ml) should be administered.
Odrasli Infundirati je treba celotno količino (150 ml) v pripravljeni vrečki za infundiranje.
In human washed blood cells also evidence of hemolysis was found with non-commercial formulations at fosaprepitant concentrations of 2.3 mg/ml and higher, although tests in human whole blood were negative.
V spranih človeških krvnih celicah so ob uporabi nekomercialnih pripravkov ugotovili tudi znake hemolize pri koncentraciji fosaprepitanta 2,3 mg/ml ali več, testi na polni človeški krvi pa so bili negativni.
2 mg/kg intravenously OR 2 mg/kg orally (EMEND oral suspension)
2 mg/kg intravensko ALI 2 mg/kg peroralno (peroralna suspenzija EMEND)
Investigations blood pressure increased uncommon
Preiskave zvišan krvni tlak občasni
Paediatric patients 12 years and older
Pediatrični bolniki, stari 12 let ali več
Safety data following the administration of the 3-day IV/oral/oral regimen were also included.
Vključeni so bili tudi podatki o varnosti po uporabi 3-dnevne i.v./p.o./p.o.
Gender No dose adjustment is necessary based on gender (see section 5.2).
Spol Odmerka ni treba prilagoditi glede na spol (glejte poglavje 5.2).
2 - < 6 years old
2 - < 6 let
Maximum dose 80 mg
največji odmerek 80 mg
In an additional active-controlled clinical study in 1,169 adult patients receiving aprepitant and HEC, the adverse reactions profile was generally similar to that seen in the other HEC studies with aprepitant.
V dodatni z zdravilno učinkovino nadzorovani klinični študiji pri 1.169 odraslih bolnikih, ki so prejemali aprepitant in zelo emetogeno kemoterapijo, je bil profil neželenih učinkov na splošno podoben tistemu v drugih HEC študijah z aprepitantom.
The metabolism of aprepitant occurs largely via oxidation at the morpholine ring and its side chains and the resultant metabolites were only weakly active.
Presnova aprepitanta poteka večinoma z oksidacijo na morfolinskem obroču in na njegovih stranskih verigah; aktivnost tako nastalih presnovkov je šibka.
IVEMEND can affect other medicines both during and after treatment with IVEMEND.
Zdravilo IVEMEND lahko vpliva na delovanje drugih zdravil, tako med kot po koncu zdravljenja z njim.
There are some medicines that should not be taken with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also ‘Do not use IVEMEND').
Nekaterih zdravil se skupaj z zdravilom IVEMEND ne sme uporabljati (kot so pimozid, terfenadin, astemizol in cisaprid) ali pa je treba njihov odmerek prilagoditi (glejte tudi "Zdravila IVEMEND ne smete prejeti").
It is anticipated that IVEMEND would cause less or no greater induction of CYP2C9, CYP3A4, and glucuronidation than that caused by the administration of the 3-day oral aprepitant regimen, for which a transient induction with its maximum effect 6-8 days after first aprepitant dose has been observed.
Pričakujemo, da zdravilo IVEMEND povzroči manjšo ali pa vsaj ne večje indukcije CYP2C9, CYP3A4 in glukuronidacije v primerjavi s 3-dnevnim režimom zdravljenja s peroralnim aprepitantom, pri katerem so opazili prehodno indukcijo z največjim učinkom 6-8 dni po prvem odmerku aprepitanta.
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see section 6.2).
Zdravila ne smete pripravljati ali mešati z raztopinami, za katere ni bila dokazana fizikalna in kemična kompatibilnost (glejte poglavje 6.2).
The safety profile of the 3-day IV fosaprepitant regimen in paediatric patients is expected to be similar to that of the 1-day fosaprepitant regimen as the low daily trough levels do not significantly increase the exposures on subsequent days.
Varnostni profil 3-dnevne intravenske sheme fosaprepitanta je pri pediatričnih bolnikih predvidoma podoben kot pri 1-dnevni shemi fosaprepitanta, saj nizke dnevne najnižje koncentracije v naslednjih dneh izpostavljenosti bistveno ne povečajo.
Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4.
Deksametazon je treba vzeti 1. dan 30 minut pred kemoterapijo ter od 2. do 4. dne zjutraj.
After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).
Po rekonstituciji in redčenju 1 ml raztopine vsebuje 1 mg fosaprepitanta (1 mg/ml) (glejte poglavje 6.6).
The frequency categories in the table are based on studies in adults; the observed frequencies in the paediatric studies were similar or lower.
Kategorije pogostnosti v preglednici temeljijo na študijah pri odraslih; v študijah pri pediatričnih bolnikih so bile opažene pogostnosti podobne ali manjše.
Carcinogenic potential in rodents was only investigated with orally administered aprepitant.
Kancerogeni potencial je bil pri glodavcih ovrednoten le pri peroralnem dajanju aprepitanta.
In patients 12 years and older, the volume to be administered is calculated as follows:
Za bolnike, stare 12 let ali več, je treba količino za infundiranje izračunati tako:
In patients 6 months to less than 12 years, the volume to be administered is calculated as follows:
Za bolnike, stare od 6 mesecev do manj kot 12 let, je treba količino za infundiranje izračunati tako:
In the performed safety pharmacology and repeated dose toxicity studies with dogs, fosaprepitant Cmax and aprepitant AUC values were up to 3 times and 40 times, respectively, higher than clinical values.
V izvedenih študijah farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih na psih, je bila vrednost Cmax fosaprepitanta do 3-krat večja od klinične vrednosti, vrednost AUC aprepitanta pa do 40-krat večja od klinične vrednosti.
The terminal half-life of aprepitant following a 150 mg intravenous dose of fosaprepitant was approximately 11 hours.
Končni razpolovni čas aprepitanta po 150 mg intravenskem odmerku fosaprepitanta je bil približno 11 ur.
IVEMEND is used in adults, adolescents, and children aged 6 months or older in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that is a strong or moderate trigger of nausea and vomiting.
Zdravilo IVEMEND se uporablja pri odraslih, mladostnikih in otrocih, starih 6 mesecev ali več, v kombinaciji z drugimi zdravili za preprečevanje navzee (siljenja na bruhanje) in bruhanja zaradi kemoterapije (zdravljenje raka), ki je močan ali zmeren povzročitelj siljenja na bruhanje in bruhanja.
Therefore, breast-feeding is not recommended during treatment with IVEMEND.
Zato med zdravljenjem z zdravilom IVEMEND dojenje ni priporočljivo.
The 3-day oral aprepitant regimen resulted in an about 30-35 % reduction in AUC of CYP2C9 substrates and up to a 64 % decrease in ethinyl estradiol trough concentrations.
Pri 3-dnevnem režimu zdravljenja s peroralnim aprepitantom se je AUC substratov za CYP2C9 zmanjšala za približno 30-35 %, koncentracija etinilestradiola tik pred naslednjim odmerkom pa za do 64 %.
Instructions of how to reconstitute and dilute IVEMEND 150 mg
Navodila za rekonstitucijo in redčenje zdravila IVEMEND 150 mg
• Volume to administer (ml) = recommended dose (mg/kg) x weight (kg) o Note: Do not exceed maximum doses (see section 4.2).
• Količina za apliciranje (ml) = priporočeni odmerek (mg/kg) x telesna masa (kg) o Opomba: Ne prekoračite največjih odmerkov (glejte poglavje 4.2).
The most common adverse reactions reported at a greater incidence in adults treated with the aprepitant regimen than with standard therapy in patients receiving HEC were: hiccups (4.6 % versus 2.9 %), alanine aminotransferase (ALT) increased (2.8 % versus 1.1 %), dyspepsia (2.6 % versus 2.0 %), constipation (2.4 % versus 2.0 %), headache (2.0 % versus 1.8 %), and decreased appetite (2.0 % versus 0.5 %).
Najpogostejši neželeni učinki pri zelo emetogeni kemoterapiji (HEC), o katerih so pri odraslih, ki so se zdravili z aprepitantom, poročali pogosteje kot pri bolnikih med standardno obliko zdravljenja so: kolcanje (4,6 % proti 2,9 %), zvišana vrednost alanin aminotransferaze (ALT ) (2,8 % proti 1,1 %), dispepsija (2,6 % proti 2,0 %), zaprtje (2,4 % proti 2,0 %), glavobol (2,0 % proti 1,8 %) in zmanjšan apetit (2,0 % proti 0,5 %).
Fosaprepitant is the prodrug of aprepitant and when administered intravenously is converted rapidly to aprepitant (see section 5.2).
Fosaprepitant je predzdravilo aprepitanta, ki se po intravenski aplikaciji hitro pretvori v aprepitant (glejte poglavje 5.2).
The powder is reconstituted and diluted before use.
Pred uporabo je treba prašek raztopiti in razredčiti.
Additionally, in a placebo-controlled clinical trial in adult patients receiving MEC, safety was evaluated for 504 patients receiving a single dose of IVEMEND 150 mg compared to 497 patients receiving the control regimen.
Poleg tega so v s placebom nadzorovanem kliničnem preskušanju pri odraslih bolnikih, ki so prejemali MEC, ovrednotili varnost pri 504 bolnikih, ki so prejeli enkraten odmerek zdravila IVEMEND 150 mg, in pri 497 bolnikih, ki so prejeli kontrolno shemo zdravljenja.
The medicinal product must not be reconstituted or mixed with solutions for which physical and chemical compatibility has not been established (see Summary of Product Characteristic (SmPC), section 6.2).
Zdravila ne smete pripravljati ali mešati z raztopinami, za katere ni bila dokazana fizikalna in kemična kompatibilnost (glejte poglavje 6.2 Povzetka glavnih značilnosti zdravila (SmPC)).
In patients with ESRD undergoing haemodialysis, the AUC0- of total aprepitant decreased by 42 % and Cmax decreased by 32 %.
Pri bolnikih s končno ledvično odpovedjo na hemodializi je bila AUC0- celokupnega aprepitanta za 42 % manjša, Cmax pa za 32 % nižja.
Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective.
Zaradi antiemetičnega delovanja aprepitanta zdravljenje z zdravili za spodbujanje bruhanja lahko ne bo učinkovito.
Your doctor may ask you to take other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist' (such as ondansetron) for preventing nausea and vomiting.
Zdravnik vam bo morda naročil, da uporabljate druga zdravila za preprečevanje navzee (siljenja na bruhanje) in bruhanja, vključno s kortikosteroidom (kot je deksametazon) in zaviralcem 5HT3 (kot je ondansetron).
An interaction with orally administered chemotherapeutic medicinal products metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded.
Interakcij s peroralno danimi kemoterapevtiki, ki se primarno ali delno presnavljajo s CYP3A4 (npr. etopozid, vinorelbin), ne moremo izključiti.
Positron emission tomography (PET) imaging studies, using a highly specific NK1-receptor tracer, in healthy young men administered a single intravenous dose of 150 mg fosaprepitant (N=8) demonstrated brain NK1 receptor occupancy of ≥100 % at Tmax, and 24 hours, ≥97 % at 48 hours, and between 41 % and 75 % at 120 hours, following dosing.
Pri študijah s pozitronsko emisijsko tomografijo (PET) so pri zdravih mladih moških, ki so prejeli enkratni intravenski odmerek 150 mg fosaprepitanta (N = 8), z uporabo visoko specifičnega označevalca receptorjev NK1 ugotovili, da je zasedenost možganskih receptorjev NK1 ≥ 100 % pri Tmax in po 24 urah, ≥ 97 % po 48 urah in med 41 % in 75 % po 120 urah po prejemu odmerka.
Control regimen (N =498) **
Kontrolna shema (N = 498) **
IVEMEND should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below.
Zdravilo IVEMEND se mora dati v kombinaciji s kortikosteroidom in z antagonistom 5-HT3, kot je razloženo v naslednjih preglednicah.
The appearance of the reconstituted solution is the same as the appearance of the diluent.
Videz rekonstituirane raztopine je enak videzu topila.
Depending on the chemotherapy treatment, there are two ways IVEMEND may be given: IVEMEND is given only on Day 1 (single day of chemotherapy) IVEMEND is given on Day 1, 2, and 3 (single or multiple days of chemotherapy) o Oral formulations of aprepitant may be prescribed on Days 2 and 3 instead of IVEMEND.
Zdravilo IVEMEND je mogoče uporabiti na dva načina, odvisno od kemoterapije: Zdravilo IVEMEND se uporabi le 1. dan (kemoterapija le en dan) Zdravilo IVEMEND se uporabi 1., 2. in 3. dan (kemoterapija en dan ali več dni) o Namesto zdravila IVEMEND je mogoče 2. in 3. dan predpisati peroralne oblike aprepitanta.
Intravenous administration in paediatric patients aged 6 months and older is recommended through a central venous catheter and should be administered over 30 minutes in patients aged 12 years and older or over 60 minutes in patients less than 12 years of age (See section 6.6).
Pri pediatričnih bolnikih, starih 6 mesecev ali več, je intravensko dajanje zdravila priporočljivo izvesti po centralnem venskem katetru; pri bolnikih, starih 12 let ali več, mora infundiranje trajati 30 minut, pri bolnikih, mlajših od 12 let, pa 60 minut (glejte poglavje 6.6).
In the same analysis, safety was evaluated for 199 patients receiving either HEC or MEC and a single dose of IVEMEND at or above the recommended 3-day regimen of IVEMEND.
V isti analizi so varnost ocenili pri 199 bolnikih, ki so prejemali ali HEC ali MEC in enkratni odmerek zdravila IVEMEND v priporočeni 3-dnevni odmerni shemi zdravila IVEMEND ali več.
Aprepitant is excreted in the milk of lactating rats after intravenous administration of fosaprepitant as well as after oral administration of aprepitant.
Aprepitant so zasledili v mleku doječih podgan tako po intravenskem dajanju fosaprepitanta kot po peroralnem dajanju aprepitanta.
Fosaprepitant placebo and dexamethasone placebo (on Day 1) were used to maintain blinding.
Fosaprepitant placebo in deksametazon placebo (1. dan) so uporabili z namenom, da je bila študija slepa.
Withdraw the entire volume from the vial and transfer it into an infusion bag containing 145 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection to yield a total volume of 150 ml and final concentration of 1 mg/ml.
Iz viale izvlecite celoten volumen raztopine in jo dodajte v infuzijsko vrečko s 145 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje, da dobite skupni volumen 150 ml in končno koncentracijo 1 mg/ml.
The adverse reactions profiles in the Multiple-Cycle extension of HEC and MEC studies in adults for up to 6 additional cycles of chemotherapy were generally similar to those observed in Cycle 1.
Profili neželenih učinkov so bili v podaljšku HEC in MEC študij pri odraslih z več ciklusi zdravljenja (do 6 dodatnih ciklusov kemoterapije) na splošno podobni tistim po prvem ciklusu.
Aprepitant cannot be removed by haemodialysis.
Aprepitanta iz telesa ni mogoče odstraniti s hemodializo.
Intravenous administration in adults occurs preferably through a running intravenous infusion over 20-30 minutes.
Pri odraslih je zdravilo najbolje aplicirati v obliki 20-30-minutne intravenske infuzije.
When using combined IVEMEND and EMEND regimens, please refer to the Summary of Product Characteristics (SmPC) section 4.5 for EMEND capsules or EMEND for oral suspension.
V primeru uporabe kombiniranih shem z zdraviloma IVEMEND in EMEND glejte poglavje 4.5 Povzetka glavnih značilnosti zdravila (SmPC) kapsul EMEND oziroma peroralne suspenzije EMEND.
Parenteral medicines should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.
Zdravila za parenteralno uporabo morate pred aplikacijo pregledati glede tujih delcev ali spremembe barve vedno, kadar raztopina in vsebnik to omogočata.
6 - < 12 years old
6 - < 12 let
In a toxicity study in juvenile dogs treated with fosaprepitant from postnatal day 14 to day 42, a decreased testicular weight and Leydig cell size were seen in the males at 6 mg/kg/day and increased uterine weight, hypertrophy of the uterus and cervix, and oedema of vaginal tissues were seen in females from 4 mg/kg/day.
V študiji toksičnosti pri mladih psih, ki so od 14. do 42. dne postnatalno prejemali fosaprepitant, so pri samcih opažali manjšo maso testisov in manjšo velikost Leydigovih celic pri odmerku 6 mg/kg/dan, pri samicah pa večjo maso maternice, hipertrofijo maternice in materničnega vratu ter edem nožničnih tkiv pri odmerkih od 4 mg/kg/dan.
- The other ingredients are: disodium edetate (E386), polysorbate 80 (E433), lactose anhydrous, sodium hydroxide (E524) (for pH adjustment) and/or hydrochloric acid diluted (E507) (for pH adjustment).
- Druge sestavine zdravila (pomožne snovi) so: dinatrijev edetat (E386), polisorbat 80 (E433), brezvodna laktoza, natrijev hidroksid (E524) (za uravnavo pH) in/ali razredčena klorovodikova kislina (E507) (za uravnavo pH).
Table 7: Percent of adult patients receiving Highly Emetogenic Chemotherapy responding by treatment group and phase - Cycle 1
Preglednica 7: Odstotek odraslih bolnikov, ki so prejemali zelo emetogeno kemoterapijo z odzivom po zdravljenih skupinah in fazi - 1. ciklus
In humans, fosaprepitant administered intravenously was rapidly converted to aprepitant within 30 minutes following the end of infusion.
Pri človeku se fosaprepitant hitro pretvori v aprepitant, v 30 minutah po koncu infundiranja.
Metabolites are excreted in urine and via biliary excretion in faeces.
Presnovki se izločajo z urinom ter prek izločanja z žolčem v blatu.
Dexamethasone: The oral dexamethasone dose should be reduced by approximately 50 % when coadministered with fosaprepitant (see section 4.2).
Deksametazon: Pri uporabi fosaprepitanta je treba peroralni odmerek deksametazona zmanjšati za približno 50 % (glejte poglavje 4.2).
The frequency categories given in the table are based on the studies in adults; the observed frequencies in the paediatric studies were similar or lower, unless shown in the table.
Kategorije pogostnosti v preglednici temeljijo na študijah pri odraslih; v študijah pri pediatričnih bolnikih so bile opažene pogostnosti podobne ali manjše, razen če je drugače navedeno v preglednici.
• Volume to administer (ml) = recommended dose (mg/kg) x weight (kg) o Note: Do not exceed maximum doses (see Summary of Product Characteristic (SmPC), section 4.2).
• Količina za apliciranje (ml) = priporočeni odmerek (mg/kg) x telesna masa (kg) o Opomba: Ne prekoračite največjih odmerkov (glejte poglavje 4.2 Povzetka glavnih značilnosti zdravila (SmPC)).
In patients with severe renal impairment, the AUC0- of total aprepitant (unbound and protein bound) decreased by 21 % and Cmax decreased by 32 %, relative to healthy subjects.
Pri bolnikih s hudo okvaro ledvic je bila AUC0- celokupnega aprepitanta (nevezanega in vezanega na beljakovine) za 21 % manjša, Cmax pa za 32 % nižja kot pri zdravih preiskovancih.
After reconstitution and dilution: 24 hours at 25°C.
Po rekonstituciji in redčenju: 24 ur pri temperaturi 25 °C.
It is anticipated that fosaprepitant would cause less or no greater induction of CYP2C9, CYP3A4 and glucuronidation than that caused by the administration of oral aprepitant.
Pričakujemo, da fosaprepitant povzroči manjšo ali pa vsaj ne večje indukcije CYP2C9, CYP3A4 in glukuronidacije v primerjavi s peroralnim aprepitantom.
Interaction studies with fosaprepitant 150 mg and 5-HT3 antagonists have not been conducted; however, in clinical interaction studies, the oral aprepitant regimen did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron).
Študij medsebojnega delovanja fosaprepitanta 150 mg in antagonistov 5-HT3 niso izvedli; vendar pa v kliničnih študijah medsebojnega delovanja zdravljenje s peroralnim aprepitantom ni imelo klinično pomembnih učinkov na farmakokinetiko ondansetrona, granisetrona ali hidrodolasetrona (aktivnega presnovka dolasetrona).
All metabolites observed in urine, faeces and plasma following an intravenous 100 mg [
Vsi presnovki, opaženi v urinu, blatu in plazmi po 100 mg intravenskem odmerku [
After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml).
Po rekonstituciji in redčenju 1 ml raztopine vsebuje 1 mg fosaprepitanta (1 mg/ml).
Gently invert the bag 2-3 times.
Vrečko 2 do 3-krat nežno obrnite.
, Mg including Hartman's and lactated Ringer's solutions.
), vključno s Hartmanovo raztopino in raztopino Ringerjevega laktata.
What IVEMEND looks like and contents of the pack IVEMEND is a white to off-white powder for solution for infusion.
Izgled zdravila IVEMEND in vsebina pakiranja Zdravilo IVEMEND je bel do sivobel prašek za raztopino za infundiranje.
Administration and infusion site reactions
Reakcije na mestu aplikacije/infundiranja
Paediatric patients 2 to less than 12 years
Pediatrični bolniki, stari od 2 leti do manj kot 12 let
Necrosis was also reported in some patients with concomitant vesicant chemotherapy.
Pri nekaterih bolnikih so pri sočasni uporabi kemoterapije z vezikanti poročali tudi o nekrozi.
IVEMEND contains the active substance fosaprepitant which is converted to aprepitant in your body.
Zdravilo IVEMEND vsebuje zdravilno učinkovino fosaprepitant, ki se v telesu pretvori v aprepitant.
245.3 mg of fosaprepitant dimeglumine (equivalent to 150 mg fosaprepitant) to aprepitant, 23.9 mg of phosphoric acid and 95.3 mg of meglumine are liberated.
Pri pretvorbi 245,3 mg dimegluminijevega fosaprepitanta (kar ustreza 150 mg fosaprepitanta) v aprepitant se sprosti 23,9 mg fosforjeve (V) kisline in 95,3 mg meglumina.
Aprepitant regimen (N =1,134) **
Aprepitant (N = 1.134) **
As a weak inhibitor of CYP3A4, the fosaprepitant 150 mg single dose can cause a transient increase in plasma concentrations of co-administered active substances that are metabolised through CYP3A4.
Kot šibek zaviralec CYP3A4 lahko fosaprepitant v enkratnem 150 mg odmerku povzroči prehodno zvišanje plazemskih koncentracij sočasno uporabljenih zdravilnih učinkovin, ki se presnavljajo s CYP3A4.
Caution is advised when warfarin, acenocoumarol, tolbutamide, phenytoin or other active substances that are known to be metabolised by CYP2C9 are administered with IVEMEND.
Pri uporabi zdravila IVEMEND in varfarina, acenokumarola, tolbutamida, fenitoina ali drugih zdravilnih učinkovin, ki se presnavljajo s CYP2C9, svetujemo previdnost.
10 ml Type I clear glass vial with a chlorobutyl or bromobutyl rubber stopper and an aluminum seal with a grey plastic flip off cap.
10-ml viala iz prozornega stekla tipa I z zamaškom iz klorobutilne ali bromobutilne gume, zaprta z aluminijastim obročkom in s sivo dvižno zaporko.
Blood and lymphatic system disorders febrile neutropenia, anaemia uncommon
Bolezni krvi in limfatičnega sistema febrilna nevtropenija, anemija občasni
Musculoskeletal and connective tissue disorders muscular weakness, muscle spasms rare
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišična oslabelost, mišični krči redki
In children and adolescents (6 months to 17 years of age), the recommended dose of IVEMEND is based on the patient's age and weight.
Priporočeni odmerek zdravila IVEMEND za otroke in mladostnike (stare od 6 mesecev do 17 let) temelji na bolnikovi starosti in telesni masi.
115 mg intravenously
115 mg intravensko