natgillin/translations-raw huggingface dataset:
These medicinal products should not be used concomitantly unless the potential benefit outweighs the risks.
Teh zdravil se ne sme uporabljati hkrati, razen če možna korist odtehta tveganja.
The plasma half-life of cilastatin is approximately one hour.
Plazemski razpolovni čas cilastatina je približno ena ura.
Distribution The binding of imipenem to human serum proteins is approximately 20%.
Porazdelitev Vezava imipenema na beljakovine v človeškem serumu je približno 20%.
Variations of colour, from colourless to yellow, do not affect the potency of the product.
Spremembe barve od brezbarvne do rumene ne vplivajo na učinkovitost zdravila.
Pregnancy There are no adequate and well-controlled studies for the use of imipenem/cilastatin in pregnant women.
Nosečnost Pri nosečnicah ni ustreznih in dobro kontroliranih študij o uporabi imipenema/cilastatina.
What TIENAM is and what it is used for Before you use TIENAM How to use TIENAM Possible side effects
Kaj je zdravilo TIENAM in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo TIENAM Kako uporabljati zdravilo TIENAM Možni neželeni učinki
The antibacterial spectrum of imipenem/cilastatin should be taken into account especially in lifethreatening conditions before embarking on any empiric treatment.
Protibakterijski spekter imipenema/cilastatina je treba upoštevati predvsem pri smrtno nevarnih stanjih pred uvedbo kakšnega empiričnega zdravljenja.
A suggested procedure is to add approximately 10 ml of the appropriate infusion solution to the vial.
Predlagani postopek je, da v vialo dodate približno 10 ml ustrezne raztopine za infundiranje.
Activity of dehydropeptidase-I in the kidney returned to normal levels shortly after the elimination of cilastatin from the blood stream.
Aktivnost dehidropeptidaze-I se je v ledvicah normalizirala kmalu po odstranitvi cilastatina iz krvnega obtoka.
Very Rare fulminant hepatitis
Zelo redki fulminantni hepatitis
Incompatibility
Inkompatibilnost
Plasma concentrations
Koncentracija v plazmi
• Imipenem may be actively removed from the cell with an efflux pump.
Imipenem se lahko iz celice aktivno odstranjuje z iztočno črpalko.
Very rare hyperhidrosis, skin texture changes
Zelo redki hiperhidroza, spremembe teksture kože
Paediatric (≥3 months of age)
Pediatrični bolniki ( ≥ 3 mesece starosti)
If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
Če se pojavijo fokalen tremor, mioklonus ali napadi krčev, je bolnike treba nevrološko pregledati in uvesti antikonvulzivno zdravljenje, če ga še ne prejemajo.
Renal impairment To determine the reduced dose for adults with impaired renal function:
Okvara ledvic Določitev zmanjšanega odmerka pri odraslih z okvarjenim delovanjem ledvic:
The total daily dose (i.e. 2000/2000, 3000/3000 or 4000/4000 mg) that would usually be applicable to patients with normal renal function should be selected.
Izbrati je treba skupni dnevni odmerek (tj. 2.000, 3.000 ali 4.000 mg), ki bi običajno ustrezal bolnikom z normalnim delovanjem ledvic.
Germany: ZIENAM
Nemčija: ZIENAM
Approximately 70% of the administered antibiotic was recovered intact in the urine within ten hours, and no further urinary excretion of imipenem was detectable.
Približno 70% uporabljenega antibiotika se nespremenjenega izloči v urinu v desetih urah; dodatno izločanje imipenema v urinu ni bilo zaznavno.
No specific information is available on treatment of overdose with TIENAM.
O zdravljenju prevelikega odmerjanja zdravila TIENAM ni specifičnih informacij.
They are for use only for species not mentioned in the overview of species-related breakpoints or footnotes.
Namenjeni sta samo za uporabo pri vrstah, ki niso omenjene v pregledu mejnih vrednosti, vezanih na vrsto ali opombah.
Concomitant use of an appropriate anti-MRSA agent may be indicated when MRSA infections are suspected or proven to be involved in the approved indications.
Sočasna uporaba ustreznega zdravila proti MRSA je lahko indicirana, če so pri odobrenih indikacijah domnevno ali dokazano vpletene okužbe z MRSA.
Table 1: Reduced dose in adults with impaired renal function and body weight 70 kg*
Preglednica 1: Zmanjšanje odmerka pri odraslih z okvarjenim delovanjem ledvic in telesno maso 70 kg*
Austria: Zienam
Avstrija: Zienam
Diluted solutions should be used immediately.
Razredčene raztopine je treba uporabiti takoj.
Uncommon psychic disturbances including hallucinations and confusional states
Občasni duševne motnje, vključno s halucinacijami in stanji zmedenosti
Simultaneous administration of antibiotics with warfarin may augment its anti-coagulant effects.
Sočasna uporaba antibiotikov in varfarina lahko poveča antikoagulantne učinke varfarina.
It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving TIENAM.
Pomembno je, da zdravniku poveste, če ste noseči ali nameravate zanositi, preden prejmete zdravilo TIENAM.
Very rare pruritus vulvae
Zelo redki pruritus vulvae
Special awareness should be made to neurological symptoms or convulsions in children with known risk factors for seizures, or on concomitant treatment with medicinal products lowering the seizures threshold.
Posebno pozornost je treba nameniti nevrološkim simptomom ali napadom krčev pri otrocih z znanimi dejavniki tveganja za napade krčev oz. med sočasnim zdravljenjem z zdravili, ki znižujejo prag za napade krčev.
If you forget to use TIENAM
Če ste pozabili uporabiti zdravilo TIENAM
The proportionate dose for patients < 70 kg would be calculated using the following formula:
Sorazmerni odmerek za bolnike < 70 kg se izračune po naslednji enačbi:
It is devoid of intrinsic antibacterial activity and does not affect the antibacterial activity of imipenem.
Ta snov ne deluje protibakterijsko in ne vpliva na protibakterijsko delovanje imipenema.
In patients who develop nausea during the infusion, the rate of infusion may be slowed.
Pri bolnikih, pri katerih se med infundiranjem pojavi navzea, se hitrost infundiranja lahko zmanjša.
EUCAST MIC breakpoints for imipenem to separate susceptible (S) pathogens from resistant (R) pathogens are as follows (v 1,1 2010-04-27):
Po EUCAST so mejne vrednosti MIC imipenema za ločevanje občutljivih (O) in rezistentnih (R) patogenov naslednje (v 1.1, 27. 04. 2010):
Do not use TIENAM after the expiry date stated on the container.
Zdravila TIENAM ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku.
These patients should not receive TIENAM unless haemodialysis is instituted within 48 hours.
Ti bolniki ne smejo dobiti zdravila TIENAM, razen če se hemodializa začne v 48 urah.
Gram-positive anaerobes:
Grampozitivni anaerobi:
The use of imipenem/cilastatin is not suitable for treatment of these types of infections unless the pathogen is already documented and known to be susceptible or there is a very high suspicion that the most likely pathogen(s) would be suitable for treatment.
Uporaba imipenema/cilastatina ni primerna za zdravljenje teh okužb, razen če je patogen že dokumentiran in je zanj znano, da je občutljiv, ali če obstaja zelo utemeljen sum, da je/so najverjetnejši patogen/patogeni primeren/primerni za zdravljenje.
The daily dose of TIENAM should be based on the type and severity of infection, the pathogen(s) isolated, the patient's renal function and body weight (see also section 4.4 and 5.1).
Dnevni odmerek zdravila TIENAM mora temeljiti na vrsti in jakosti okužbe, izoliranem patogenu (ali patogenih), bolnikovemu delovanju ledvic in telesni masi (glejte tudi poglavji 4.4 in 5.1).
If the use of TIENAM is deemed necessary, the benefit of breast feeding for the child should be weighed against the possible risk for the child.
Če je ocenjeno, da je uporaba zdravila TIENAM nujna, je treba korist dojenja za otroka pretehtati glede na možno tveganja za otroka.
A positive direct Coombs' test, prolonged prothrombin time, decreased haemoglobin, increases in serum bilirubin, elevations in serum creatinine, elevations in blood urea nitrogen
Občasni pozitiven neposredni Coombsov test, podaljšan protrombinski čas, znižanje hemoglobina, zvišanje bilirubina v serumu, zvišanje kreatinina v serumu, zvišanje dušika sečnine v krvi
TIENAM may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
Zdravilo TIENAM se lahko uporablja za zdravljenje bakterijskih okužb krvi, ki so lahko povezane z zgoraj omenjenimi vrstami okužb.
Repeat with an additional 10 ml of infusion solution to ensure complete transfer of vial contents to the infusion solution.
Ponovite z dodatnimi 10 ml raztopine za infundiranje, da boste zagotovili popoln prenos vsebine viale v raztopino za infundiranje.
Distribution The binding of cilastatin to human serum proteins is approximately 40%.
Porazdelitev Vezava cilastatina na beljakovine v človeškem serumu je približno 40%.
5 Non-species related breakpoint have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
5 Mejni vrednosti, ki nista vezani na vrsto, sta bili določeni predvsem na podlagi podatkov o farmakokinetiki/farmakodinamiki in nista odvisni od porazdelitve MIC za posamezno vrsto.
Tell your doctor if you are taking medicines called valproic acid or sodium valproate (see Using other medicines below).
Zdravniku povejte, če jemljete zdravila, ki vsebujejo valprojsko kislino ali natrijev valproat (glejte Uporaba drugih zdravil, spodaj).
All adverse reactions are listed under system organ class and frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and not known (cannot be estimated from the available data).
Zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
The plasma half-life of imipenem was one hour.
Plazemski razpolovni čas imipenema je ena ura.
There are no data available regarding potential effects of imipenem/cilastatin treatment on male or female fertility.
O možnem vplivu zdravljenja z imipenemom/cilastatinom na plodnost pri moških in ženskah ni na voljo nobenih podatkov.
• Decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins)
Manjše permeabilnosti zunanje membrane gramnegativnih bakterij (zaradi zmanjšanega nastajanja porinov).
This medicinal product is chemically incompatible with lactate and should not be reconstituted in diluents containing lactate.
Zdravilo je kemično inkompatibilno z laktatom in se ga ne sme pripraviti z vehikli, ki vsebujejo laktat.
The selection of imipenem/cilastatin to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Pri izbiri imipenema/cilastatina za zdravljenje posameznega bolnika je treba upoštevati ustreznost uporabe karbapenemskega protibakterijskega zdravila na podlagi dejavnikov, kot so jakost okužbe, prevalenca odpornosti na druga primerna protibakterijska zdravila in tveganje, da zdravilo izberemo za bakterije, odporne na karbapenem.
The pharmacokinetics of imipenem in patients with hepatic insufficiency have not been established.
Farmakokinetika imipenema pri bolnikih z insuficienco jeter ni raziskana.
Staphylococcus coagulase negative (Methicillin-susceptible) Streptococcus agalactiae
Staphylococcus koagulaza-negativen (občutljiv za meticilin) Streptococcus agalactiae
2 The breakpoints for Pseudomonas relate to high dose frequent therapy (1g every 6 hours).
2 Mejne vrednosti za Pseudomonas so povezane z visokoodmernim pogostim zdravljenjem (1 g na
There have been many reports of increases in the anti-coagulant effects of orally administered anticoagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.
Poročali so o številnih primerih povečanja antikoagulantnih učinkov peroralnih antikoagulantov, vključno z varfarinom, pri bolnikih, ki so sočasno dobivali protibakterijska zdravila.
The proportionate dose for patients <70 kg would be calculated by dividing the patient's actual body weight (in kg) by 70 kg multiplied by the respective dose recommended in Table 1.
Sorazmerni odmerek za bolnike s telesno maso < 70 kg izračunate tako, da bolnikovo dejansko telesno maso (v kg) delite s 70 kg in pomnožite z normalnim odmerkom, priporočenim v preglednici 1.
LIST OF EXCIPIENTS Sodium bicarbonate (E500)
SEZNAM POMOŽNIH SNOVI natrijev hidrogenkarbonat (E500)
From table 1 the appropriate reduced dose regimen is selected according to the patient's creatinine clearance.
V preglednici 1 izberite ustrezno shemo z zmanjšanim odmerkom glede na bolnikov očistek kreatinina.
Rare toxic epidermal necrolysis, angioedema, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis
Redki toksična epidermalna nekroliza, angioedem, Stevens-Johnsonov sindrom, multiformni eritem, eksfoliativni dermatitis
The patient should receive TIENAM after haemodialysis and at 12 hour intervals timed from the end of that haemodialysis session.
Bolniki morajo dobiti zdravilo TIENAM po hemodializi in v 12-urnih presledkih od zaključka hemodialize.
Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with imipenem/cilastatin.
Uporaba pri bolnikih z boleznijo jeter: bolnikom z obstoječimi boleznimi jeter je treba med zdravljenjem z imipenemom/cilastatinom kontrolirati delovanje jeter.
Tell your doctor about any medical condition you have or have had including: allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) colitis or any other gastrointestinal disease any central nervous system disorders such as localized tremors or epileptic seizures liver, kidney or urinary problems
Zdravniku povejte za vse bolezni, ki jih imate ali ste jih imeli, vključno s/z: alergijami na katerokoli zdravilo, vključno z antibiotiki (nenadne življensko nevarne alergijske reakcije zahtevajo takojšnje zdravljenje), kolitisom ali katerokoli drugo boleznijo prebavil, katerokoli boleznijo osrednjega živčevja, npr. lokaliziranim tremorjem (tresenjem) ali epileptičnimi napadi, težavami z jetri, ledvicami ali sečili.
If you have further questions, ask your doctor or pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
These experiences have been reported most commonly in patients with CNS disorders (e.g. brain lesions or history of seizures) and/or compromised renal function in whom accumulation of the administered entities could occur.
O teh izkušnjah so najpogosteje poročali pri bolnikih z motnjami osrednjega živčevja (npr. možganskimi lezijami ali anamnezo konvulzij) in/ali slabšim delovanjem ledvic, pri katerih se lahko pojavi kopičenje uporabljenih snovi.
Also, tell your doctor if you are taking valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraine, or schizophrenia) or any blood thinners such as warfarin.
Prav tako zdravniku povejte, če jemljete valprojsko kislino ali natrijev valproat (uporabljata se za zdravljenje epilepsije, bipolarne motnje, migrene ali shizofrenije), ali če jemljete zdravila proti strjevanju krvi, kot je varfarin.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6. 6.3 Rok uporabnosti
Concomitant use of an aminoglycoside may be indicated when Pseudomonas aeruginosa infections are suspected or proven to be involved in the approved indications (see section 4.1).
Sočasna uporaba aminoglikozida je lahko indicirana, če so pri odobrenih indikacijah domnevno ali dokazano vpletene okužbe s Pseudomonas aeruginosa (glejte poglavje 4.1).
Species for which acquired resistance may be a problem: Gram-negative aerobes: Acinetobacter baumannii Pseudomonas aeruginosa
Vrste, pri katerih je lahko problem pridobljena odpornost: Gramnegativni aerobi: Acinetobacter baumannii Pseudomonas aeruginosa
The mean plasma half-lives of imipenem and cilastatin were 91 ± 7.0 minutes and 69 ± 15 minutes, respectively.
Povprečni plazemski razpolovni čas imipenema je bil 91 ± 7,0 minut in cilastatina 69 ± 15 minut.
Rare acute renal failure, oligurial/anuria, polyuria, urine discoloration (harmless and should not be confused with haematuria) The role of TIENAM in changes in renal function is difficult to assess, since factors predisposing to pre-renal azotemia or to impaired renal function usually have been present.
Redki akutna odpoved ledvic, oligurija/anurija, poliurija, obarvanje urina (neškodljivo in se ga ne sme zamenjati za hematurijo) Vlogo zdravila TIENAM pri spremembah delovanja ledvic je težko oceniti, ker so bili običajno prisotni dejavniki, ki povečujejo nagnjenost k predrenalni azotemiji ali okvari delovanja ledvic.
Interaction with valproic acid
Medsebojno delovanje z valprojsko kislino
• Hypersensitivity to any other carbapenem antibacterial agent
Preobčutljivost za kakšno drugo karbapenemsko protibakterijsko zdravilo.
20 ml Type I glass vials.
20 ml viale iz stekla tipa I
Hepatic function should be closely monitored during treatment with imipenem/cilastatin due to the risk of hepatic toxicity (such as increase in transaminases, hepatic failure and fulminant hepatitis).
Med zdravljenjem z imipenemom/cilastatinom je treba natančno kontrolirati delovanje jeter, ker obstaja tveganje hepatotoksičnih učinkov (npr. zvišanja transaminaz, odpovedi jeter in fulminantnega hepatitisa).
TIENAM has not been studied in pregnant women.
Zdravilo TIENAM pri nosečnicah ni raziskano.
Patients with creatinine clearances of 5 ml/min/1.73 m2 should not receive TIENAM unless haemodialysis is instituted within 48 hours.
Bolniki z očistkom kreatinina od 5 ml/min/1,73 m2 ne smejo dobiti zdravila TIENAM, razen če se hemodializa ne začne v 48 urah.
Furthermore, due to the limited susceptibility of specific pathogens associated with e.g. bacterial skin and soft-tissue infections, to imipenem/cilastatin, caution should be exercised.
Poleg tega je potrebna previdnost zaradi majhne občutljivosti specifičnih patogenov, povezanih z npr. bakterijskimi okužbami kože in mehkih tkiv, za imipenem/cilastatin.
Clinical data are insufficient to recommend the use of TIENAM in children under 1 year of age or paediatric patients with impaired renal function (serum creatinine >2 mg/dl).
Kliničnih podatkov ni dovolj, da bi priporočali uporabo zdravila TIENAM pri otrocih, mlajših od 1 leta, ali pediatričnih bolnikih z okvarjenim delovanjem ledvic (kreatinin v serumu >2 mg/dl).
If you stop using TIENAM
Če ste prenehali jemati zdravilo TIENAM
Discontinuation of therapy with imipenem/cilastatin and the administration of specific treatment for Clostridium difficile should be considered.
V poštev pride prenehanje zdravljenja z imipenemom/cilastatinom in uporaba specifičnega zdravljenja, usmerjenega proti Clostridium difficile.
Approximately 70-80% of the dose of cilastatin was recovered unchanged in the urine as cilastatin within 10 hours of administration of TIENAM.
Približno 70 do 80% odmerka cilastatina se je v urin izločilo nespremenjenega v obliki cilastatina v 10 urah po uporabi zdravila TIENAM.
Approximately 10% was found as the Nacetyl metabolite, which has inhibitory activity against dehydropeptidase comparable to that of cilastatin.
Približno 10% se ga je pojavilo v obliki N-acetilnega presnovka, ki zavira dehidropeptidazo podobno kot cilastatin.
Long term studies in animals have not been performed to evaluate carcinogenic potential of imipenemcilastatin.
Dolgoročnih študij za oceno kancerogenega potenciala kombinacije imipenem/cilastatin na živalih ni bilo.
Symptoms of overdose that can occur are consistent with the adverse reaction profile; these may include seizures, confusion, tremors, nausea, vomiting, hypotension, bradycardia.
Simptomi prevelikega odmerjanja, ki se lahko pojavijo, se skladajo s profilom neželenih učinkov; lahko vključujejo napade krčev, zmedenost, tremor, navzeo, bruhanje, hipotenzijo in bradikardijo.
Inherently resistant species: Gram positive aerobes: Enterococcus faecium Gram negative aerobes: Some strains of Burkholderia cepacia (formerly Pseudomonas cepacia) Legionella spp.
Inherentno odporne vrste: Grampozitivni aerobi: Enterococcus faecium Gram negativno aerobes: Nekateri sevi Burkholderia cepacia (prej Pseudomonas cepacia) Legionella spp.
Similarly, the most frequently reported local adverse reactions were phlebitis/thrombophlebitis (3.1%), pain at the injection site (0.7%), erythema at the injection site (0.4%) and vein induration (0.2%).
Podobno so bili najpogosteje poročani lokalni neželeni učinki flebitis/tromboflebitis (3,1%), bolečina ne mestu injiciranja (0,7%), eritem na mestu injiciranja (0,4%) in induracija vene (0,2%).
HOW TO USE TIENAM
KAKO UPORABLJATI ZDRAVILO TIENAM
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship Similar to other beta-lactam antibacterial agents, the time that imipenem concentrations exceed the MIC (T>MIC) has been shown to best correlate with efficacy.
Razmerje med farmakokinetiko in farmakodinamiko (FK/FD) Podobno kot velja za druga betalaktamska protibakterijska zdravila, se je tudi za imipenem pokazalo, da čas, ko koncentracija imipenema presega MIC (t >MIC ) najbolje kolerira z njegovo učinkovitostjo.
Shake well and transfer the resulting mixture to the infusion solution container.
Dobro pretresite in dobljeno mešanico prenesite v vsebnik z raztopino za infundiranje.
Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Zdravljenje bolnikov z bakteriemijo, povezano s katero od navedenih okužb, ali če obstaja sum, da je povezana s katero od njih.
Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see section 6.2 and 6.3): 0.9% sodium chloride.
Vsebino ene viale je treba prenesti v 100 ml ustrezne raztopine za infundiranje (glejte poglavji 6.2 in 6.3): 0,9 % raztopino natrijevega klorida.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s farmacevtom .
Common increases in serum transaminases, increases in serum alkaline phosphatase
Pogosti zvišanje serumskih transaminaz, zvišanje serumske alkalne fosfataze
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for infusion
FARMACEVTSKA OBLIKA IN VSEBINA prašek za raztopino za infundiranje
CNS adverse reactions such as myoclonic activity, confusional states, or seizures have been reported, especially when recommended doses based on renal function and body weight were exceeded.
Poročali so o neželenih učinkih na osrednje živčeve, kot so mioklonična aktivnost, stanja zmedenosti ali napadi krčev, zlasti če so bili prekoračeni priporočeni odmerki na podlagi delovanja ledvic in telesne mase.
When doses of imipenem-cilastatin sodium (approximately 100/100 mg/kg/day or approximately 3 times the usual recommended daily human intravenous dose) were administered to pregnant cynomolgus monkeys at an intravenous infusion rate which mimics human clinical use, there was minimal maternal intolerance (occasional emesis), no maternal deaths, no evidence of teratogenicity, but an increase in embryonic loss relative to control groups (see section 4.6).
Če so odmerke imipenema//-natrijeve soli cilastatina (približno 100/100 mg/kg/dan ali približno 3-kratni običajni priporočeni dnevni intravenski odmerek za človeka) uporabili pri nosečih opicah cynomolgus v intravenski infuziji s hitrostjo, ki posnema klinično uporabo pri človeku, je bila intoleranca mater minimalna (občasno bruhanje), ni bilo maternalnih smrti in nobenih znakov teratogenosti, ugotovili pa so večjo izgubo zarodkov v primerjavi s kontrolno skupino (glejte poglavje 4.4).