natgillin/translations-raw huggingface dataset:
There was no evidence of acute or multiple dose-related toxicity in studies of up to 6 months, or reproductive toxicity in teratology, female fertility or late gestational toxicity/ placental transfer studies.
V študijah teratogenosti, ženske plodnosti ali pozne gestacijske toksičnosti/ placentnega prehoda, ki so trajale do šest mesecev, niso ugotovili akutne ali z večkratnim odmerjanjem povezane toksičnosti.
No long-term animal studies have been performed to establish the carcinogenic potential of Herceptin, or to determine its effects on fertility in males.
Nobenih dolgotrajnih študij na živalih za ugotovitev kancerogenega potenciala zdravila Herceptin ali
L-histidine hydrochloride L-histidine α ,α -trehalose dihydrate polysorbate 20
L- histidinijev klorid L- histidin α, α- trehaloza dihidrat polisorbat 20
Do not dilute with glucose solutions since these cause aggregation of the protein.
Ne redčite z raztopinami glukoze, ker le- te povzročajo agregacijo beljakovin.
Herceptin should not be mixed or diluted with other products except those mentioned under section 6.6.
Zdravilo Herceptin smemo mešati ali razredčevati le s snovmi, navedenimi v poglavju 6. 6.
After reconstitution with sterile water for injections the reconstituted solution is physically and chemically stable for 48 hours at 2°C – 8°C.
Po rekonstituciji s sterilno vodo za injekcije je pripravljena raztopina fizikalno in kemično stabilna 48 ur pri temperaturi od 2- 8 °C.
Solutions of Herceptin for infusion are physically and chemically stable in polyvinylchloride, polyethylene or polypropylene bags containing 0.9% sodium chloride for 24 hours at temperatures not exceeding 30°C.
Raztopine zdravila Herceptin za infundiranje so v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo 0, 9% natrijev klorid, fizikalno in kemično stabilne 24 ur pri temperaturah, ki ne presežejo 30 °C.
The product is not intended to be stored after reconstitution and dilution
Zdravilo ni namenjeno shranjevanju po rekonstituciji in razredčitvi, razen če je to potekalo v kontroliranih in validiranih aseptičnih pogojih.
21 unless this has taken place under controlled and validated aseptic conditions.
Če se zdravilo ne uporabi takoj, so časi in pogoji shranjevanja odgovornost uporabnika.
Store in a refrigerator (2°C – 8°C)
Shranjujte v hladilniku (2 °C – 8 °C).
One 15 ml clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film.
Ena 15 ml viala iz prozornega stekla tipa I z butilnim gumijastim zamaškom, laminiranim s fluorirano smolo.
Each carton contains one vial.
Vsaka škatlica vsebuje eno vialo.
Preparation for Administration Appropriate aseptic technique should be used.
Priprava za uporabo Uporabiti je potrebno ustrezno aseptično tehniko.
Each vial of Herceptin is reconstituted with 7.2 ml of sterile water for injections (not supplied).
Vsebino viale zdravila Herceptin rekonstituiramo v 7, 2 ml sterilne vode za injekcije (ni dodana).
This yields a 7.4 ml solution for single-dose use, containing approximately 21 mg/ ml trastuzumab, at a pH of approximately 6.0.
Rekonstitucija da 7, 4 ml raztopine za enkratno uporabo, ki vsebuje približno 21 mg/ ml trastuzumaba, s pH približno 6, 0.
A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Štiri odstoten presežek volumna omogoča, da na nalepki naveden odmerek 150 mg res odvzamemo iz viale.
Causing excessive foaming during reconstitution or shaking the reconstituted Herceptin may result in problems with the amount of Herceptin that can be withdrawn from the vial.
22 med rekonstitucijo ali tresenje že pripravljene raztopine zdravila Herceptin lahko povzroči težave s količino zdravila Herceptin, ki ga odvzamemo iz viale.
1) Using a sterile syringe, slowly inject 7.2 ml of sterile water for injections in the vial containing the lyophilised Herceptin, directing the stream into the lyophilised cake.
Navodila za rekonstitucijo 1) Uporabite sterilno brizgo, počasi injicirajte 7, 2 ml sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo Herceptin, usmerite curek na liofiliziran prašek.
2) Swirl vial gently to aid reconstitution.
2) Vialo rahlo vrtite do raztopitve.
Determine the volume of the solution required: • based on a loading dose of 4 mg trastuzumab/ kg body weight, or a subsequent weekly dose of 2 mg trastuzumab/ kg body weight:
za uvajalni odmerek 4 mg trastuzumaba/ kg telesne mase ali za nadaljnje tedenske odmerke 2 mg trastuzumaba/ kg telesne mase s pomočjo formule:
Volume (ml) = Body weight (kg) x dose (4 mg/ kg for loading or 2 mg/ kg for maintenance) 21 (mg/ ml, concentration of reconstituted solution) • based on a loading dose of 8 mg trastuzumab/ kg body weight, or a subsequent 3-weekly dose of 6 mg trastuzumab/ kg body weight:
volumen (ml) = telesna masa( kg) x odmerek (4 mg/ kg za uvajanje ali 2 mg/ kg za vzdrževanje) 21 (mg/ ml, koncentracija pripravljene raztopine)
Volume (ml) = Body weight (kg) x dose (8 mg/ kg for loading or 6 mg/ kg for maintenance) 21 (mg/ ml, concentration of reconstituted solution)
volumen (ml) = telesna masa (kg) x odmerek (8 mg/ kg za uvajanje ali 6 mg/ kg za vzdrževanje) 21 (mg/ ml, koncentracija pripravljene raztopine)
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 ml of 0.9% sodium chloride solution.
Primerno količino raztopine je treba odvzeti iz viale in dodati infuzijski vrečki, ki vsebuje 250 ml 0, 9% raztopine natrijevega klorida.
Do not use with glucose-containing solutions (see 6.2).
Ne uporabljajte raztopin, ki vsebujejo glukozo (glejte poglavje 6. 2).
Parenteral solutions should be inspected visually for particulates and discoloration prior to administration.
Parenteralne raztopine je treba vizualno pregledati na prisotnost delcev in obarvanost pred dajanjem zdravila.
22 No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Med zdravilom Herceptin in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečkami inkompatibilnosti niso opazili.
28 August 2000/ 28 August 2005
28. avgust 2000 / 28. avgust 2005
Roche Diagnostics GmBH, Pharma Biotechnology Production Nonnenwald 2 82372 Penzberg Germany
Roche Diagnostics GmbH, Pharma Biotechnology Production Nonnenwald 2 82372 Penzberg Nemčija
not applicable
Navedba smiselno ni potrebna.
The MAH will continue to submit periodic safety update reports (PSURs) on a six-monthly basis.
Imetnik dovoljenja za promet bo nadaljeval z oddajo rednega posodobljenega poročila o varnosti zdravila (PSUR) vsakih šest mesecev.
After reconstitution 1 ml concentrate contains 21 mg of trastuzumab
Po rekonstituciji 1 ml koncentrata vsebuje 21 mg trastuzumaba
L-histidine hydrochloride, L-histidine, polysorbate 20, α ,α -trehalose dehydrate.
L- histidinijev klorid, L- histidin, polisorbat 20, α, α- trehaloza dihidrat.
For intravenous use after reconstitution and dilution Read the package leaflet before use.
Za intravensko uporabo po rekonstituciji in razredčitvi Pred uporabo preberite priloženo navodilo
< Justification for not including Braille accepted >
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
VIAL LABELS
NALEPKE NA VIALI
Herceptin 150 mg powder for infusion
Herceptin 150 mg prašek za infuzijo
Herceptin 150 mg powder for concentrate for solution for infusion trastuzumab
Herceptin 150 mg prašek za koncentrat za raztopino za infundiranje trastuzumab
What Herceptin is and what it is used for 2.
Kaj je zdravilo Herceptin in za kaj ga uporabljamo 2.
Before you use Herceptin 3.
Kaj morate vedeti, preden boste uporabili zdravilo Herceptin 3.
How to use Herceptin 4.
Kako uporabljati zdravilo Herceptin 4.
How to store Herceptin 6.
Možni neželeni učinki 5 Shranjevanje zdravila Herceptin 6.
WHAT HERCEPTIN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO HERCEPTIN IN ZA KAJ GA UPORABLJAMO
Each pack of Herceptin contains one vial.
Vsako pakiranje zdravila Herceptin vsebuje eno vialo.
This vial contains a white to pale yellow lyophilised (“ freeze-dried”) powder for concentrate for solution for infusion.
Ta viala vsebuje bel do rahlo rumen liofiliziran (sušen s hitrim zamrzovanjem) prašek za koncentrat za raztopino za infundiranje.
The lyophilised powder must be reconstituted and diluted before use.
Liofiliziran prašek je pred uporabo potrebno raztopiti in razredčiti.
Herceptin contains the active substance trastuzumab, which is a humanised monoclonal antibody.
Zdravilo Herceptin vsebuje zdravilno učinkovino trastuzumab, ki je humanizirano monoklonsko protitelo.
This is similar to the antibodies produced naturally by the body which protect it against infections with viruses and bacteria.
To je podobno protitelesom, ki jih telo naravno izdeluje za zaščito pred okužbami z virusi in bakterijami.
Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body called antigens.
Monoklonska protitelesa so beljakovine, ki specifično prepoznajo in se vežejo na točno določene beljakovine v telesu, imenovane antigeni.
Trastuzumab binds selectively to an antigen called human epidermal growth factor 2 (HER2).
Trastuzumab se selektivno veže na antigen, ki se imenuje humani epidermalni rastni dejavnik 2 (HER2).
When Herceptin binds to HER2 it stops the growth of such cells.
Ko se zdravilo Herceptin veže na HER2, zaustavi rast teh celic.
Herceptin is prescribed by doctors for the treatment of patients with early breast cancer, where it is used after you have finished your chemotherapy, and for the treatment of patients with metastatic breast cancer (i. e., breast cancer that has spread beyond the original tumour) who have tumours that produce large amounts of HER2.
Zdravilo Herceptin predpisujejo zdravniki za zdravljenje bolnikov z zgodnjim rakom dojk, kjer ga uporabljajo po kemoterapiji in bolnikov z metastatsko obliko raka dojk (to pomeni, da se je rak dojk razširil izven prvotnega tumorja), katerih tumorji izločajo velike količine HER2.
It is used alone in conditions where other treatments proved unsuccessful.
Zdravilo uporabljamo samostojno v primerih, kjer so bile ostale oblike zdravljenja dokazano neuspešne.
It is also used in combination with the chemotherapy agents paclitaxel or docetaxel as first treatment for metastatic breast cancer.
Uporablja se tudi v kombinaciji s citostatikoma paklitakselom ali docetakselom kot prvo zdravljenje metastatskega raka dojk.
It is also used in combination with an aromatase inhibitor for the treatment of patients with HER2-positive and hormone receptor-positive metastatic breast cancer.
Zdravilo uporabljamo tudi v kombinaciji z zaviralcem aromataze za zdravljenje bolnikov z metastatsko obliko raka dojk s HER2 pozitivnimi in pozitivnimi hormonskimi receptorji.
If you receive Herceptin with paclitaxel, docetaxel or an aromatase inhibitor you should also read the package inserts for these products.
Če prejemate zdravilo Herceptin s paklitakselom, docetakselom ali zaviralcem aromataze, preberite tudi navodila za uporabo teh zdravil.
BEFORE YOU USE HERCEPTIN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO HERCEPTIN
Do not use Herceptin
Ne uporabljajte zdravila Herceptin
- If you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients.
- če ste alergični na trastuzumab, murine (mišje) beljakovine ali katerokoli sestavino zdravila.
- If you have severe breathing problems at rest due to your cancer or if you need oxygen
- če imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s
treatment.
kisikom.
32 Take special care with Herceptin
32 Bodite posebno pozorni pri uporabi zdravila Herceptin
- If you have had heart failure, coronary artery disease or high blood pressure.
- če ste imeli srčno popuščanje, koronarno arterijsko bolezen ali visok krvni tlak.
This is because
Zdravilo
Herceptin can cause heart failure.
Herceptin lahko namreč povzroči srčno popuščanje;
- If you have ever had chemotherapy with a drug called doxorubicin or a drug related to
- če ste kadarkoli prejeli kemoterapijo z zdravilom, ki se imenuje doksorubicin ali zdravilo
doxorubicin (your doctor can advise you here).
sorodno doksorubicinu (tu vam lahko svetuje vaš zdravnik).
These drugs can damage heart muscle and increase the risk of heart problems with Herceptin.
Ta zdravila lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob jemanju z zdravilom Herceptin.
- If you are breathless.
- Če težko dihate.
Herceptin can cause breathing difficulties, especially when it is first given.
Zdravilo Herceptin lahko povzroči težave z dihanjem, še posebej, ko ga
This could be more serious if you are already breathless.
Težave so lahko resne, če že težko dihate.
Apart from breathing difficulties, Herceptin can cause fever, chills, flu-like symptoms, swelling of the face and lips, rash, wheezing, heart rhythm disturbances and blood pressure changes.
Poleg težav z dihanjem, lahko zdravilo Herceptin povzroči zvišano telesno temperaturo, mrzlico, simptome podobne gripi, otekanje obraza in ustnic, kožni izpuščaj, sopenje, motnje srčnega ritma in spremembe krvnega tlaka.
These effects mainly occur with the first infusion and during the first few hours after the start of the infusion.
Ti učinki se pojavijo predvsem med prvo infuzijo in prvih nekaj ur po pričetku infuzije.
Occasionally, symptoms start later than six hours after the infusion begins.
Občasno se lahko simptomi pojavijo po več kot 6 urah po pričetku infuzije.
If either of these happens to you, contact your doctor immediately.
Če se karkoli od naštetega zgodi vam, takoj obvestite svojega zdravnika.
You will therefore be observed by a health care professional during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions.
Zato boste med infuzijo in še najmanj šest ur po pričetku prve infuzije ter dve uri po začetku nadaljnjih infuzij pod nadzorom zdravstvenega osebja.
If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Če se pojavijo tovrstne reakcije, bodo infuzijo upočasnili ali prekinili in vas lahko po potrebi zdravili zaradi neželenih učinkov.
Very rarely, patients with severe breathing difficulties before treatment have died when they are given Herceptin.
Zelo redko je pri bolnikih s hudimi težavami z dihanjem pred pričetkom zdravljenja, med infuzijo zdravila Herceptin prišlo do smrtnih primerov.
Your doctor will closely supervise your therapy with Herceptin.
Vaš zdravnik bo zelo podrobno spremljal vaše zdravljenje z zdravilom Herceptin.
Treatment with Herceptin may affect the heart.
Zdravljenje z zdravilom Herceptin lahko vpliva na vaše srce.
Therefore, your heart function will be checked before and during the treatment with Herceptin.
Zato mora biti pred pričetkom zdravljenja in med zdravljenjem z zdravilom Herceptin delovanje srca nadzorovano.
If you develop any signs of heart failure (i. e., inadequate pumping of blood by the heart), you may have to stop Herceptin.
Če bo pri vas nastopil katerikoli znak srčnega popuščanja (to pomeni, da vaše srce ne črpa dovolj krvi), boste morda morali zdravljenje s Herceptinom prekiniti.
It may take up to 6 months for Herceptin to be removed from the body.
Da se zdravilo Herceptin popolnoma izloči iz vašega telesa lahko traja tudi do 6 mesecev.
Therefore, you should tell your doctor or pharmacist that you have had Herceptin if you start any new medication in the 6 months after stopping treatment.
Če se v obdobju do 6 mesecev po prenehanju zdravljenja z zdravilom Herceptin pričnete zdraviti s katerimkoli drugim novim zdravilom, obvestite svojega zdravnika ali farmacevta, da ste dobivali zdravilo Herceptin.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
Please tell your doctor or pharmacist that you have had Herceptin if you start any medication in the 6 months after stopping treatment with Herceptin.
Prosimo, obvestite svojega zdravnika ali farmacevta, da ste prejemali zdravilo Herceptin, če se v 6 mesecih po zaključku zdravljenja z zdravilom Herceptin pričnete zdraviti s katerimkoli novim zdravilom.
Use in children and adolescents At present, Herceptin is not recommended for anyone under the age of 18 years because there is not enough information in this age group.
Uporaba pri otrocih in mladostnikih Trenutno zdravilo Herceptin ni priporočljivo za osebe mlajše od 18. leta starosti, ker za to starostno skupino ni na voljo dovolj podatkov.
Pregnancy and breast-feeding Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant.
Nosečnost in dojenje Pred začetkom zdravljenja morate svojemu zdravniku povedati, če ste noseči, če mislite, da ste noseči ali če nameravate zanositi.
In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing foetus within the amniotic sac has been observed in pregnant women receiving Herceptin.
V redkih primerih so pri nosečnicah, ki so prejemale zdravilo Herceptin, opazili zmanjšanje količine (amnijske) tekočine, ki obdaja razvijajoči se plod v amnijski ovojnici.
Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy.
Zdravnik vam bo svetoval glede tveganja in koristi jemanja zdravila Herceptin v času nosečnosti.
Do not breast-feed your baby during Herceptin therapy and for 6 months after the last dose of Herceptin.
Med zdravljenjem z zdravilom Herceptin in šest mesecev po zadnjem odmerku zdravila Herceptin ne smete dojiti.
33 We do not know whether Herceptin could affect your ability to drive a car or operate machinery.
33 Vpliv na sposobnost upravljanja vozil in strojev Ne vemo, ali bi zdravilo Herceptin lahko vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev.
However, if you experience symptoms, such as chills or fever, during an infusion of Herceptin (see 4.), you should not drive or use machines until these symptoms disappear.
Vendar v primeru pojava simptomov, kot so mrzlica ali zvišana telesna temperatura, med infuzijo zdravila Herceptin (glejte poglavje 4.) ne smete voziti ali upravljati strojev, dokler ti simptomi ne izginejo.
HOW TO USE HERCEPTIN
KAKO UPORABLJATI ZDRAVILO HERCEPTIN
Dosage and frequency of administration Your doctor will prescribe a dose and treatment regimen that is right for you.
Odmerjanje in pogostnost dajanja Vaš zdravnik vam bo predpisal odmerek in režim zdravljenja, ki bo primeren le za vas.
For early breast cancer, Herceptin is given every 3 weeks.
Pri zgodnji obliki raka dojk se zdravilo Herceptin daje vsak 3. teden.
The intravenous infusion (“ drip”) will be given over approximately 90 minutes.
Intravensko infuzijo (“ kapalna infuzija ”) boste prejeli v 90 minutah.
For metastic breast cancer, Herceptin is given once a week.
Pri metastatskem raku dojk se zdravilo Herceptin daje enkrat na teden.
It is given as an intravenous infusion (“ drip”) by a health care professional.
V obliki intravenske infuzije (“ kapalne infuzije ”) ga daje usposobljeno medicinsko osebje.
The first dose is given over 90 minutes.
Prvi odmerek se daje v času 90- tih minut.
The subsequent doses may be given over 30 minutes.
Nadaljnji odmerki se lahko dajejo v času 30- tih minut.
You will also be observed for some time at the end of each infusion (see 2. under “ Take special care with Herceptin”).
Bodite posebno pozorni pri uporabi zdravila Herceptin).
Alternatively for metastatic breast cancer, Herceptin can also be given every 3 weeks.
Pri metastatskem raku dojk lahko damo zdravilo Herceptin tudi vsak 3. teden.
The intravenous infusion (“ drip”) will be given over approximately 90 minutes.
Intravensko infuzijo (“ kapalno infuzijo ”) boste prejeli v približno 90 minutah.
Some of these side effects may be serious and may lead to hospitalisation.
Nekateri od teh učinkov so lahko resni in lahko vodijo do bolnišnične oskrbe.
During a Herceptin infusion, chills, fever and other flu like symptoms may occur.
Med infuzijo zdravila Herceptin se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi gripi podobni simptomi.
These are very common (more than 10 out of 100 patients).
Ti so zelo pogosti (več kot pri 10 od 100 bolnikov).
They mainly occur with the first infusion and are temporary.
Pojavijo se zlasti med prvo infuzijo in so začasni.
Other infusion-related 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 z infuzijo povezani simptomi so občutek slabosti (navzeja), bruhanje, bolečina, povečana napetost mišic in tresenje, glavobol, omotica, težave z dihanjem, sopenje, visok ali nizek krvni tlak, motnje srčnega ritma (močno utripanje srca, trepetanje srca ali nereden srčni utrip), otekanje obraza in ustnic, izpuščaj in občutek utrujenosti.
These symptoms can be serious and some patients have died (see 2. under “ Take special care with Herceptin”).
Ti simptomi so lahko hudi in opisani so primeri smrti med zdravljenjem (glejte poglavje 2. pod Bodite posebno pozorni pri uporabi zdravila Herceptin).
You will be observed by a health professional during and after each infusion.
Med in po vsaki infuziji boste pod nadzorom zdravstvenega osebja.
If you develop a reaction, they will slow down or stop the infusion and may give you treatment to counteract the side effects.
Če se pri vas pojavi reakcija, bodo upočasnili ali prekinili infuzijo in vas primerno zdravili zaradi neželenih učinkov.
The infusion may be continued after the symptoms improve.
Po izboljšanju simptomov lahko z infuzijo nadaljujemo.
Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion.
Drugi neželeni učinki se lahko pojavijo kadarkoli med zdravljenjem z zdravilom Herceptin in niso povezani le z infuzijo.
Heart problems can sometimes occur and can be serious.
Včasih se lahko pojavijo težave s srcem, ki so lahko resne.
They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart (pericarditis), and heart rhythm disturbances.
Vključujejo slabenje srčne mišice z možnim prehodom v srčno popuščanje, vnetje osrčnika (perikarditis) in motnje srčnega ritma.
Your doctor will monitor your heart regularly during treatment but you should tell your doctor immediately if you notice breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the legs or arms, or palpitations (heart fluttering or irregular heart beat).
Če pa opazite težave z dihanjem (vključno s težavami z dihanjem ponoči), kašelj, zadrževanje tekočine (otekanje) v nogah ali rokah ali močno utripanje srca (trepetanje srca ali nereden srčni utrip), o tem nemudoma obvestite svojega zdravnika.
Other very common side effects of Herceptin, occurring in more than 10 out of 100 patients, are: diarrhoea, weakness, skin rashes, chest pain, abdominal pain, joint pain, and muscle pain.
Drugi zelo pogosti neželeni učinki zdravila Herceptin, ki se pojavijo pri več kot 10 od 100 bolnikov, so: driska, oslabelost, kožni izpuščaj, bolečina v prsnem košu, bolečina v trebuhu, bolečina v sklepih in mišicah.