natgillin/translations-raw huggingface dataset:
In an exploratory subgroup analysis performed in the TOGA (BO18255) trial there was no apparent benefit on overall survival with the addition of Herceptin in patients with ECOG PS 2 at baseline [HR 0.96 (95 % CI 0.51-1.79)], non measurable [HR 1.78 (95 % CI 0.87-3.66)] and locally advanced disease [HR 1.20 (95 % CI 0.29-4.97)]. 
V eksplorativni analizi podskupin, ki so jo opravili v preskušanju ToGA (BO18255), ni bilo opazne koristi v celokupnem preživetju z dodatkom zdravila Herceptin pri bolnikih z oceno splošnega stanja zmogljivosti po ECOG (Eastern Cooperative Oncology Group) 2 pred začetkom zdravljenja [razmerje ogroženosti 0,96 (95-% interval zaupanja 0,51 do 1,79)], bolnikih z nemerljivo boleznijo [razmerje ogroženosti 1,78 (95-% interval zaupanja 0,87 do 3,66)] in bolnikih z lokalno napredovalo boleznijo [razmerje ogroženosti 1,20 (95-% interval zaupanja 0,29 do 4,97)].
• low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever 
· bolečina v prsnem košu · bolečina v trebuhu · bolečina v sklepih · majhno število rdečih in belih krvnih celic (ki pomagajo pri boju z okužbo), včasih s povišano telesno temperaturo
In patients with EBC eligible for neoadjuvant-adjuvant treatment, Herceptin should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses of doxorubicin 180 mg/m2 or epirubicin 360 mg/m2. 
Neoadjuvantno-adjuvantno zdravljenje Pri bolnikih z zgodnjim rakom dojk, ki so primerni za neoadjuvantno-adjuvantno zdravljenje, se zdravilo Herceptin uporablja sočasno z antraciklini le pri bolnikih, ki še niso bili zdravljeni s kemoterapijo, in to samo pri shemah z majhnimi odmerki antraciklinov (največji kumulativni odmerek doksorubicina 180 mg/m2 ali epirubicina 360 mg/m2).
• inability to sleep (insomnia) 
· nespečnost (insomnija)
Herceptin has been used in clinical trials as monotherapy for patients with MBC who have tumours that overexpress HER2 and who have failed one or more chemotherapy regimens for their metastatic disease (Herceptin alone). 
Zdravilo Herceptin so v kliničnih preskušanjih uporabljali kot monoterapijo pri bolnikih z metastatsko obliko raka dojk, katerih tumorji so čezmerno izražali HER2 in pri katerih je prišlo do napredovanja bolezni po eni ali več kemoterapevtskih zdravljenjih njihove metastatske bolezni (le zdravilo Herceptin).
Caution is recommended with Herceptin subcutaneous formulation as severe pulmonary events have been reported with the use of the intravenous formulation in the post-marketing setting (see section 4.8). 
Pri uporabi subkutane oblike zdravila Herceptin je potrebna previdnost, saj so v obdobju po prihodu zdravila na trg pri uporabi intravenske oblike poročali o hudih pljučnih zapletih (glejte poglavje 4.8).
• inflammation or scarring of the lungs. 
· vneta ali zabrazgotinjena pljuča
Analyses with longer term follow-up of a median duration exceeding 40 months supported the noninferior efficacy of Herceptin subcutaneous compared to Herceptin intravenous with comparable results of both EFS and OS (3-year EFS rates of 73% in the Herceptin intravenous arm and 76% in the Herceptin subcutaneous arm, and 3-year OS rates of 90% in the Herceptin intravenous arm and 92% in the Herceptin subcutaneous arm). 
podpirajo neinferiornost učinkovitosti zdravila Herceptin v subkutani obliki v primerjavi z zdravilom Herceptin v intravenski obliki s primerljivimi rezultati za preživetje brez dogodka in celokupno preživetje (3-letno preživetje brez dogodka: 73 % v skupini, ki je prejemala intravensko obliko zdravila Herceptin in 76 % v skupini, ki je prejemala subkutano obliko zdravila Herceptin; celokupno preživetje: 90 % za zdravilo Herceptin v intravenski obliki in 92 % za zdravilo Herceptin v subkutani obliki).
Subcutaneous formulation 
Subkutana oblika
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 600 mg/5 mL trastuzumab. 
Ena viala vsebuje 600 mg/5 ml trastuzumaba.
In the pivotal trial, the rate of all grade ARRs was 37.2 % with the Herceptin intravenous formulation and 47.8 % with the Herceptin subcutaneous formulation; severe grade 3 reactions were reported in 2.0 % and 1.7 % of the patients, respectively during the treatment phase; no severe grade 4 or 5 reactions were observed. 
V ključni študiji je bila med obdobjem zdravljenja pogostnost vseh reakcij, povezanih z aplikacijo, 37,2-% pri intravenski obliki zdravila Herceptin in 47,8-% pri subkutani obliki zdravila Herceptin; o resnih neželenih učinkih stopnje 3 so poročali pri 2,0 % bolnikov, ki so prejemali intravensko obliko, in pri 1,7 % bolnikov, ki so prejemali subkutano obliko.
1 Year N = 1693 
Herceptin 1 leto n = 1693
Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with Herceptin will experience some form of infusion-related reaction. 
Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo zdravilo Herceptin, pojavi neka oblika reakcij, povezanih z infuzijo.
• abnormal heart rhythm 
· upočasnjeno bitje srca · nenormalen srčni ritem
Aseptic reconstitution and dilution: 
Aseptična rekonstitucija in redčenje
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 
ali - docetaksel intravensko - 75 mg/m2 v obliki intravenske infuzije v 1 uri, vsake 3 tedne, skupaj 6
In the NSABP B-31 and NCCTG N9831 studies Herceptin was administered in combination with paclitaxel, following AC chemotherapy. 
V študijah NSABP B-31 in NCCTG N9831 so zdravilo Herceptin dajali v kombinaciji s paklitakselom, po kemoterapiji z doksorubicinom in ciklofosfamidom (kemoterapiji AC).
80.9 %) in favour of the AC→DH (Herceptin) arm and 4.6 percentage points (85.5 % versus 80.9 %) in favour of the DCarbH (Herceptin) arm compared to AC→D. 
5,8 odstotne točke (86,7 % v primerjavi z 80,9 %), korist skupine DCarbH (zdravilo Herceptin) pa za
AUC0-21days 
AUC0-21.
Roche Diagnostics GmbH 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
In the post-marketing setting, cases of fetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the fetus, have been reported in pregnant women receiving Herceptin. 
V obdobju po prihodu zdravila na trg so pri nosečnicah, ki so prejemale zdravilo Herceptin, poročali o primerih motenj v rasti plodovih ledvic in/ali njihovem delovanju, v povezavi z oligohidramnijem, od katerih so bili nekateri povezani s smrtno hipoplazijo pljuč pri plodu.
New injections should be given at least 2.5 cm away from an old site. 
2,5 cm oddaljeno od prejšnjega mesta injiciranja.
In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered Herceptin concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and Herceptin). 
V enem od treh ključnih preskušanj, v katerem je bila na voljo mediana časa sledenja 5,5 leta (BCIRG006), so pri bolnikih, ki so zdravilo Herceptin prejeli sočasno s taksanom po antraciklinski terapiji, opazili stalno rast v kumulativnem deležu simptomatskih neželenih učinkov, povezanih s srcem, ali neželenih učinkov, povezanih z iztisnim deležem levega prekata (LVEF), do 2,37 %; v dveh primerjalnih skupinah (antraciklin in ciklofosfamid, ki jima je sledil taksan ali taksan, karboplatin in zdravilo Herceptin) pa je ta delež znašal približno 1 %.
The pivotal trial BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus treatment with Herceptin intravenous formulation based on coprimary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively) (See Section 5.1. of Herceptin subcutaneous formulation SmPC). 
Ključno preskušanje BO22227 so zasnovali, da bi dokazali neinferiornost zdravljenja s subkutano obliko zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin glede na soprimarni farmakokinetični končni cilj (Ctrough trastuzumaba pred odmerkom 8. cikla) in končni cilj, povezan z učinkovitostjo (delež pCR ob definitivni operaciji) (glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila za subkutano obliko zdravila Herceptin).
One 6 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 5 mL of solution (600 mg of trastuzumab). 
Ena 6-ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 5 ml raztopine (600 mg trastuzumaba).
These events have occasionally been fatal and may occur as part of an infusion-related reaction or with delayed onset. 
Ti učinki se lahko pojavijo kot del infuzijske reakcije ali pa nastopijo kasneje.
The majority of patients experienced resolution of symptoms and subsequently received further infusions of Herceptin. 
Pri večini bolnikov so simptomi izzveneli in so z infundiranjem zdravila Herceptin nadaljevali.
In 3 pivotal EBC clinical trials of adjuvant intravenous Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %). 
V treh ključnih kliničnih preskušanjih pri adjuvantnem zdravljenju zgodnjega raka dojk z intravensko obliko zdravila Herceptin v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (to je, da niso prejeli zdravila Herceptin), in pri bolnikih, ki so prejeli zdravilo Herceptin zaporedno po taksanu (0,3 do 0,4 %).
Biopsy specimenstaining pattern 
Vzorci biopsijevidez preparata po barvanju
L-histidine hydrochloride monohydrate α,α-trehalose dihydrate 
L-histidinijev klorid monohidrat α,α-trehaloza dihidrat
confidence interval for the difference in pCR rates was -4.0, establishing the non-inferiority of Herceptin subcutaneous for the co-primary endpoint 
Spodnja meja enostranskega 97,5-% intervala zaupanja za razliko v deležu pCR je bila -4,0, kar dokazuje neinferiornost subkutane oblike zdravila Herceptin za soprimarno končno točko.
• Doxorubicin 60mg/m2 and paclitaxel 150 mg/m2, administered 3-weekly for 3 cycles, 
· doksorubicin 60 mg/m2 in paklitaksel 150 mg/m2, dana enkrat na tri tedne, 3 cikle; temu je sledil
As a three-weekly regimen the recommended initial loading dose of Herceptin is 8 mg/kg body weight. 
Pri 3-tedenskem režimu je priporočen uvajalni odmerek zdravila Herceptin 8 mg/kg telesne mase.
The AUC0-21 days following Cycle 12 dose was approximately 20 % higher with the Herceptin subcutaneous formulation than the Herceptin intravenous dose, with mean AUC values of 2610 µg/mL•day and 2179 µg/mL•day, respectively. 
cikla je bila približno 20 % večja pri subkutani obliki zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin s povprečnimi vrednostmi AUC 2610 µg/ml•dan za subkutano obliko in 2179 µg/ml•dan za intravensko obliko.
• If you have any further questions, ask your doctor, pharmacist or nurse. 
· Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Detection of HER2 overexpression or HER2 gene amplification in breast cancer Herceptin should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. 
Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2 pri raku dojk Zdravilo Herceptin se uporablja le pri bolnikih, katerih tumorji čezmerno izražajo HER2 ali imajo amplifikacijo gena HER2, določeno s točno in validirano metodo.
Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without Herceptin. 
Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m2,
Median duration of response (months) (95 %CI) 
Mediana časa odgovora (meseci) (95-% IZ)
• Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 
· Pri bolnikih, ki imajo hudo dispnejo v mirovanju zaradi komplikacij napredovale maligne bolezni, ali pri tistih, ki potrebujejo zdravljenje s kisikom.
NCCTG N9831 at the time of the definitive DFS analysis Parameter 
NCCTG N9831 v času končne analize preživetja brez bolezni*
Herceptin IV is provided in sterile, preservative-free, non-pyrogenic, single use vials. 
Intravenska oblika zdravila Herceptin je na voljo v sterilnih, apirogenih vialah za enkratno uporabo, ki so brez konzervansa.
Herceptin IV (N = 263) 
Povzetek patološkega popolnega odgovora (pCR) Herceptin iv. (n = 263)
p-value versus 
p-vrednost v primerjavi z AC
Despite the cross-over to 
Kljub prehodu na zdravilo
If LVEF has not improved, or declined further, or symptomatic CHF has developed, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom Herceptin, razen če je korist za posameznega bolnika večja od tveganja.
A careful risk-benefit assessment should be made before deciding to treat with Herceptin. 
Pred odločitvijo za zdravljenje z zdravilom Herceptin je treba skrbno pretehtati razmerje med koristjo in tveganjem.
The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus Herceptin. 
Podatki so tudi nakazali, da sočasna uporaba kapecitabina ali sočasna uporaba kapecitabina in zdravila Herceptin na farmakokinetiko cisplatina ni vplivala.
One vial of 5 mL contains 600 mg of trastuzumab. 
Ena viala (5 ml) vsebuje 600 mg trastuzumaba.
The pharmacokinetic results for the co primary endpoint, Ctrough pre dose Cycle 8, showed non-inferiority of the Herceptin subcutaneous compared to the Herceptin intravenous dose adjusted by body weight. 
najnižjo koncentracijo pred 8. ciklom, so pokazali neinferiornost subkutane oblike zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin, prilagojeno glede na telesno maso.
- Study BO16348 was designed to compare one and two years of three-weekly Herceptin treatment versus observation in patients with HER2 positive EBC following surgery, established chemotherapy and radiotherapy (if applicable). 
randomiziranih preskušanjih: - Študija BO16348 je bila zasnovana za primerjavo enoletnega in dvoletnega zdravljenja z zdravilom Herceptin (odmerjanjem na 3 tedne) z opazovanjem bolnikov z zgodnjo obliko HER2-pozitivnega raka dojk po operaciji, standardni kemoterapiji in radioterapiji (kar so uporabili).
A vial of Herceptin aseptically reconstituted with sterile water for injections (not supplied) is chemically and physically stable for 48 hours at 2ºC - 8 ºC after reconstitution and must not be frozen. 
Po aseptični rekonstituciji vsebine viale zdravila Herceptin s sterilno vodo za injekcije (ni dodana) je pripravljena raztopina kemijsko in fizikalno stabilna 48 ur pri temperaturi 2 °C-8 °C.
Herceptin vial: 
Viala zdravila Herceptin:
This can lead to symptoms such as breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, palpitations (heart fluttering or irregular heart beat) (see 2. 
To lahko privede do simptomov, kot so težave z dihanjem (vključno s težavami z dihanjem ponoči), kašelj, zadrževanje tekočine (otekanje) v nogah ali rokah, hitro ali močno utripanje srca (trepetanje srca ali nereden srčni utrip) (glejte 2. poglavje, Pregledi srca).
Study BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus Herceptin intravenous formulation based on co-primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively). 
Študijo BO22227 so zasnovali, da bi dokazali neinferiornost subkutane oblike zdravila Herceptin v primerjavi z intravensko obliko zdravila Herceptin glede na soprimarni farmakokinetični končni cilj (Ctrough trastuzumaba pred odmerkom 8. cikla) in končni cilj, povezan z učinkovitostjo (delež pCR ob definitivni operaciji).
Herceptin 600 mg solution for injection in vial Trastuzumab 
Herceptin 600 mg raztopina za injiciranje v viali trastuzumab
Table 11 Post-Hoc Exploratory Analysis Results from the Joint Analysis NSABP B-31/NCCTG N9831* and BCIRG006 Clinical Studies Combining DFS Events and Symptomatic Cardiac Events 
Post-hoc eksplorativna analiza podatkov iz skupne analize kliničnih študij NSABP B31/NCCTG N9831* in BCIRG 006, ki vključujejo dogodke preživetja brez bolezni in simptomatske srčne dogodke.
Median follow-up 8 years** 
Dolgoročno spremljanje**
The hypodermic injection needle must be attached to the syringe immediately prior to administration followed by volume adjustment to 5 mL. 
Hipodermična injekcijska igla se mora pritrditi injekcijski brizgi tik pred aplikacijo, potem pa je treba prilagoditi volumen na 5 ml. Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Severe pulmonary events have been reported with the use of Herceptin in the post-marketing setting (see section 4.8). 
V obdobju po prihodu zdravila na trg so pri uporabi zdravila Herceptin poročali o hudih pljučnih zapletih (glejte poglavje 4.8).
The efficacy results from study BO18225 are summarized in Table 13: Table 13 Efficacy Results from BO18225 
Rezultati učinkovitosti za preskušanje BO18225 so povzeti v preglednici 13.
One 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab. 
Ena 15 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo, ki vsebuje 150 mg trastuzumaba.
Severe pulmonary adverse reactions occur in association with the use of Herceptin and have been associated with a fatal outcome. 
Pljučni zapleti V povezavi z uporabo zdravila Herceptin se pojavljajo hudi pljučni neželeni učinki, ki so bili povezani tudi s smrtnim izidom.
At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%). 
in 79,4 % v skupini AC → P, z absolutno koristjo 7,4 % (95-% IZ 4,9 %, 10 %).
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. 
Če se LVEF ne izboljša ali pride do nadaljnjega zmanjšanja ali se razvije simptomatsko kongestivno srčno popuščanje, je potreben resen razmislek o prekinitvi zdravljenja z zdravilom Herceptin, razen če je korist za posameznega bolnika večja od tveganja.
Amongst the most serious and/or common adverse reactions reported in Herceptin usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions. 
Herceptin (intravenske in subkutane oblike), so motnje v delovanju srca, reakcije, povezane z aplikacijo, hematotoksičnost (še posebno nevtropenija), okužbe in pljučni zapleti.
A total of 595 patients with HER2-positive, operable or locally advanced breast cancer (LABC) including inflammatory breast cancer received eight cycles of either Herceptin intravenous formulation or Herceptin subcutaneous formulation concurrently with chemotherapy (4 cycles of docetaxel, 75 mg/m2 intravenous infusion, followed by 4 cycles of FEC ([5-Fluorouracil, 500 mg/m2; epirubicin, 75 mg/m2; cyclophosphamide, 500 mg/m2 each intravenous bolus or infusion]), followed by surgery, and continued therapy with Herceptin intravenous formulation or Herceptin subcutaneous formulation as originally randomized for 10 additional cycles, for a total of one year of treatment. 
75 mg/m2 z intravensko infuzijo, sledili so 4 cikli FEC (5-fluorouracil 500 mg/m2, epirubicin 75 mg/m2, ciklofosfamid 500 mg/m2, vsi dani z intravenskim bolusom ali infuzijo), sledila je operacija in nadaljevanje zdravljenja z intravensko obliko zdravila Herceptin ali subkutano obliko zdravila
ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. 
V in vitro študijah je do s trastuzumabom posredovane ADCC preferenčno prihajalo na rakastih celicah, ki so čezmerno izražale HER2, v primerjavi s celicami, pri katerih se HER2 ni čezmerno izražal.
Acne 
· akne
Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group (> 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment. 
Pri bolnikih s telesno maso < 51 kg je bila povprečna AUC v stanju dinamičnega ravnovesja približno 80 % večja po subkutanem kot po intravenskem zdravljenju, medtem ko je bila v skupini z največjo telesno maso (> 90 kg) AUC 20 %
• throat infections 
· okužbe grla
Overall Survival, Median months Progression-Free Survival, Median months 
Preživetje brez napredovanja bolezni, mediana (meseci) Čas do napredovanja bolezni, mediana (meseci) Celokupni odgovor na zdravljenje,
The recommended initial loading dose of Herceptin is 4 mg/kg body weight. 
Tedenski režim Priporočen uvajalni odmerek zdravila Herceptin je 4 mg/kg telesne mase.
The pharmacokinetics of trastuzumab at a dose of 600 mg administered three-weekly by the subcutaneous route was compared to the intravenous route (8 mg/kg loading dose, 6 mg/kg maintenance every three weeks) in the phase III study BO22227. 
Farmakokinetiko trastuzumaba v fiksnem odmerku 600 mg, dajano trikrat na teden subkutano, so primerjali z intravenskim dajanjem (uvajalni odmerek 8 mg/kg, vzdrževalni odmerek 6 mg/kg vsake 3
Other symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. 
Drugi simptomi so lahko še občutek slabosti (navzea), bruhanje, bolečina, povečana napetost mišic in tresenje, glavobol, omotica, težave z dihanjem, piskanje pri dihanju, visok ali nizek krvni tlak, motnje srčnega ritma (hitro ali močno utripanje srca, trepetanje srca ali nereden srčni utrip), otekanje obraza in ustnic, izpuščaj in občutek utrujenosti.
The difference between formulations was mainly observed during the adjuvant treatment phase (monotherapy) and was mainly due to postoperative wound infections, but also to various other infections such as respiratory tract infections, acute pyelonephritis and sepsis. 
Nastala je pretežno zaradi pooperativnih okužb rane in tudi zaradi drugih okužb, kot so okužbe respiratornega trakta, akutni pielonefritis in sepse.