natgillin/translations-raw huggingface dataset:
12 Following an intravenous dose of 100 mg/ m2 given as a 3 hour infusion to 19 patients with AIDS- related Kaposi’ s sarcoma, the maximum concentrations ranged from 761 to 2,860 ng/ ml (mean 1,530) and average area under the plasma concentration vs. time curve (AUC) was 5,619 ng·h/ ml (range 2,609 - 9,428).
Po intravenskem odmerku 100 mg/ m2, ki ga je s triurno infuzijo dobilo 19 bolnikov, ki imajo z aidsom povezan Kaposijev sarkom, se je največja koncentracija gibala v intervalu od 761 do 2860 ng/ ml (kar pomeni 1530), povprečna površina pod koncentracijo plazme v primerjavi s časovno krivuljo (AUC) pa je bila 5619 ng h/ ml (v intervalu 2609- 9428).
Clearance was 20.6 l/ h/ m2 (range 11 - 38) and the volume of distribution was 291 l/ m2 (range 121 - 638).
Očistek je bil 20, 6 l/ h/ m2 (v intervalu 11- 38), volumen porazdelitve pa 291 l/ m2 (v intervalu 121- 638).
The terminal elimination half-life averaged 23.7 hours (range 12 - 33).
Razpolovni čas popolne izločitve je bil v povprečju 23, 7 ure (v intervalu 12- 33).
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Karcinogeneza, mutageneza, zmanjšana plodnost:
Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/ hypoxanthine-guanine phosphoribosyl transferase (CHO/ HGPRT) gene mutation assay.
Paklitaksel ima in vivo genotoksične učinke (mikronukleusni test pri miših), čeprav pri Amesovem testu ali analizi genskih mutacij z uporabo jajčnika kitajskega hrčka brez gena za hipoksantin- gvanin - fosforibozil- transferazo (CHO/ HGPRT) ni induciral mutagenosti.
Paclitaxel at low doses of 0.6 mg/ kg/ day was associated with low fertility and foetal toxicity in rats.
Pri podganah je bil paklitaksel pri nizkih odmerkih 0, 6 mg/ kg/ dan povezan z zmanjšano plodnostjo in pojavom toksičnosti pri plodu.
Polyethoxylated castor oil, Citric acid (anhydrous), Ethanol (approximately 392 mg/ ml).
Makrogolglicerol ricinolat, citronska kislina (brezvodna) in etanol (približno 392 mg/ ml).
In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Da bi zmanjšali izpostavljenost bolnika mehčalcu DEHP [di - (2- etilheksil) ftalat], ki se sprošča iz PVC infuzijskih vrečk ali kompletov, je potrebno razredčene raztopine zdravila Paxene shranjevati v steklenicah ali plastenkah (polipropilen) ali pa v
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
13 plastičnih vrečkah (polipropilen, poliolefin) ter jih dajati s pomočjo kompletov za aplikacijo iz polietilena.
2 years in the unopened vial.
2 leti v zaprti viali.
Chemical, physical and microbial stability of unused, undiluted product remaining in the vial has been demonstrated for up to 28 days when stored below 25 °C.
Neporabljeneno in nerazredčeneno zdravilo, ki ostane v viali, je kemijsko, fizikalno in mikrobiološko stabilno 28 dni pri temperaturi do 25 °C.
Keep container in the outer carton.
Vsebnik shranjujete v zunanji ovojnini.
30 mg/ 5 ml vial, 100 mg/ 16.7 ml vial, 300 mg/ 50 ml vial packaged in a carton.
Na voljo so štiri velikosti pakiranja: škatlica 30 mg/ 5 ml, vialo, 100 mg/ 16, 7 ml vialo, 150 mg/ 25 ml in vialo 300 mg/ 50 ml.
The Paxene 30 mg vial is a 5 ml clear glass (type I) vial fitted with a flip-off cap.
Viala zdravila Paxene 30 mg je 5 ml viala iz prozornega stekla (tip I) z dvižno zaporko.
The Paxene 100 mg vial is a 20 ml clear glass (type I) vial fitted with a flip-off cap
Viala zdravila Paxene 100 mg je 20 ml viala iz prozornega stekla (tip I) z dvižno zaporko.
The Paxene 150 mg vial is a 30 ml clear glass (type I) vial fitted with a flip-off cap.
Viala zdravila Paxene 150 mg je 30 ml viala iz prozornega stekla (tip I) z dvižno zaporko.
The Paxene 300 mg vial is a 50 ml clear glass (type I) vial fitted with a flip-off cap.
Viala zdravila Paxene 300 mg je 50 ml viala iz prozornega stekla (tip I) z dvižno zaporko.
6.6 Instructions for use, handling and disposal
6. 6 Navodila za pripravo, ravnanje in odlaganja zdravila
Preparation and administration precautions: paclitaxel is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised in handling Paxene.
Ker je paklitaksel citotoksično zdravilo za zdravljenje raka, je, tako kot pri drugih potencialno toksičnih snoveh, tudi pri ravnanju z zdravilom Paxene potrebna previdnost.
If Paxene solution contacts the skin, wash the skin immediately and thoroughly with soap and water.
Če pride raztopina zdravila Paxene v stik s kožo, je potrebno le- to takoj dobro sprati z milom in vodo.
If Paxene contacts mucous membranes, the membranes should be flushed thoroughly with water.
Če pride zdravilo Paxene v stik s sluznicami, je le- te potrebno dobro sprati z vodo.
Paxene should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Paxene naj pripravio in dajo samo osebe, ki so primerno izučene v postopanju z citostatični sredstvi.
Preparation for intravenous infusion:
Priprava za intravensko infundiranje:
Paxene should be diluted in 0.9% w/ v sodium chloride solution for infusion, 5% glucose solution for infusion, or 5% glucose in Ringer’ s solution for infusion to a final concentration of 0.3 to 1.2 mg/ ml.
Zdravilo Paxene lahko razredčimo do končne koncentracije 0, 3 do 1, 2 mg/ ml z 0, 9% (m/ v) raztopino natrijevega klorida za infundiranje, 5% raztopino glukoze za infundiranje ali 5% glukozo v Ringerjevi raztopini za infundiranje.
Following dilution, chemical and physical in-use stability in polypropylene infusion bags has been demonstrated for at least 24 hours below 25 °C.
Po redčenju se fizikalna in kemijska stabilnot v polipropilenskih infuzijskih vrečah ohrani 24 ur, če so shranjene pri temperaturi do 25 °C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8° C, unless dilution has taken place in controlled and validated aseptic conditions.
Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, sta čas in pogoji shranjevanja pred uporabo odgovornost uporabnika; normalno naj bi zdravilo shranjevali največ 24 ur pri temperaturi 2 do 8 °C, razen če je bilo redčenje izvedeno v nadzorovanih in validiranih aseptičnih pogojih.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
14 Zdravila za parenteralno uporabo je potrebno pred uporabo vizualno pregledati na prisotnost delcev in spremembo barve.
Paxene should be administered through an in-line filter with a microporous membrane not greater than 0.22 µm.
Zdravilo Paxene je potrebno dajati preko v sistem vgrajenega filtra z membrano z mikroporami, ki niso večje od 0, 22 µm.
Handling and disposal: procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Potrebno je upoštevati postopke za ustrezno ravnanje in odlaganje citotoksičnih zdravil.
Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ United Kingdom
Norton Healthcare Limited Albert Basin Royal Docks London E16 2QJ Velika Britanija
EU/ 1/ 99/ 113/ 001-002 for 30 mg/ 5 ml and 150 mg/ 25 ml EU/ 1/ 99/ 113/ 003-004 for 100 mg/ 16.7 ml and 300 mg/ 50 ml
EU/ 1/ 99/ 113/ 001- 002 za 30 mg/ 5 ml in 150 mg/ 25 ml EU/ 1/ 99/ 113/ 003- 004 za 100 mg/ 16, 7 ml in 300 mg/ 50 ml
19th July 1999.
1999
IVAX Pharmaceuticals UK (Runcorn, Cheshire), Aston Lane North Preston Brook Runcorn, Cheshire, United Kingdom
IVAX Pharmaceuticals UK (Runcorn, Cheshire) Aston Lane North Preston Brook Runcorn Cheshire Velika Britanija
Ostravská 29/ 305 747 70 Opava – Komárov Czech Republic
Ostravská 29/ 305 747 70 Opava - Komárov Češka
Medicinal product subject to restricted medical prescription (see Annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (Glej Dodatek I:
PSURs:
REDNA POROČILA O VARNOSTI:
The MAH should continue to submit PSURs on a yearly basis.
Imetnik pooblastila MAH mora redna poročila o varnosti pošiljati enkrat letno.
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
CARTON TEXT FOR PAXENE 30 mg/5 ml
BESEDILO NA ŠKATLI ZA PAXENE 30 mg/ 5 ml
Paxene 6 mg/ml concentrate for solution for infusion (paclitaxel)
Paxene 6 mg/ ml koncentrat za raztopino za infundiranje (paklitaksel)
Active ingredient: paclitaxel 6 mg/ml (30 mg/5 ml)
Zdravilna učinkovina: paklitaksel 6 mg/ ml (30 mg/ 5 ml)
Also contains: polyoxyl castor oil; citric acid (anhydrous) and 49.7% (v/v) ethanol
Vsebuje tudi: makrogolglicerol ricinolat, citronsko kislino (brezvodno) in 49, 7% (v/ v) etanola
Concentrate for solution for infusion, 6 mg/ml
Koncentrat za raztopino za infundiranje, 6 mg/ ml
Diluted product to be delivered by intravenous infusion.
Razredčeno zdravilo se daje z intravensko infuzijo.
CAUTION: dilution required.
OPOZORILO: potrebno redčiti.
Expiry Date:
Uporabno do:
Keep container in the outer carton.
Vialo shranjujte v zunanji ovojnini.
Norton Healthcare Limited Albert Basin, Royal Docks London E16 2QJ UK
Norton Healthcare Limited Albert Basin, Royal Docks London E16 2QJ Velika Britanija
Batch Number:
{številka}
Please read enclosed package leaflet.
Prosimo, preberite priloženo navodilo za uporabo.
VIAL TEXT FOR PAXENE 30 mg/5 ml
BESEDILO NA VIALI ZA PAXENE 30 mg/ 5 ml
Intravenous use Read the package leaflet before use
Pred uporabo preberite navodilo za uporabo.
CARTON TEXT FOR PAXENE 100 mg/16.7 ml
BESEDILO NA ŠKATLI ZA PAXENE 100 mg/ 16, 7 ml
Active ingredient: paclitaxel 6 mg/ml (100 mg/16.7 ml)
Zdravilna učinkovina: paklitaksel 6 mg/ ml (100 mg/ 16, 7 ml)
Please read the enclosed package leaflet.
Prosimo, preberite priloženo navodilo za uporabo.
VIAL TEXT FOR PAXENE 100 mg/16.7 ml
BESEDILO NA VIALI ZA PAXENE 100 mg/ 16, 7 ml
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING
PRIMARNI OVOJNINI, KADAR ZUNANJE NI
CARTON TEXT FOR PAXENE 150 mg/25 ml
BESEDILO NA ŠKATLI ZA PAXENE 150 mg/ 25 ml
Active ingredient: paclitaxel 6 mg/ml (150 mg/25 ml)
Zdravilna učinkovina: paklitaksel 6 mg/ ml (150 mg/ 25 ml)
VIAL TEXT FOR PAXENE 150 mg/25 ml
BESEDILO NA VIALI ZA PAXENE 150 mg/ 25 ml
CARTON TEXT FOR PAXENE 300 mg/50 ml
BESEDILO NA ŠKATLI ZA PAXENE 300 mg/ 50 ml
Active ingredient: paclitaxel 6 mg/ml (300 mg/50 ml)
Zdravilna učinkovina: paklitaksel 6 mg/ ml (300 mg/ 50 ml)
VIAL TEXT FOR PAXENE 300 mg/50 ml
BESEDILO NA VIALI ZA PAXENE 300 mg/ 50 ml
32 PACKAGE LEAFLET
32 NAVODILO ZA UPORABO
Read all of this leaflet before you start using this medicine:
Pred uporabo natančno preberite navodilo!
What Paxene is and what it is used for 2.
Kaj je zdravilo Paxene in za kaj ga uporabljamo 2.
Before you use Paxene 3.
Kaj morate vedeti, preden boste uporabili zdravilo Paxene 3.
How to use Paxene 4.
Kako uporabljati zdravilo Paxene 4.
Possible side effects 5 Storing Paxene 6.
Shranjevanje zdravila Paxene 6.
Each ml of the concentrate contains:
Paxene 6 mg/ ml koncentrat za raztopino za infundiranje paklitaksel
• paclitaxel 6 mg as active substance (equivalent to 30 mg/5 ml or 100 mg/16.7 ml or 150 mg/25 ml or 300 mg/50 ml) and • polyoxyl (polyethoxylated) castor oil, citric acid (anhydrous) and ethanol as inactive ingredients.
• 6 mg paklitaksela kot zdravilne učinkovine (ustrezen ekvivalent 30 mg/ 5 ml, 100 mg/ 16, 7 ml, 150 mg/ 25 ml ali 300 mg/ 50 ml) in • makrogolglicerol ricinolat, citronsko kislino (brezvodno) in etanol kot pomožne snovi.
is Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom.
Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, Velika Britanija.
The manufacturer
Izdelovalec
is IVAX Pharmaceuticals s.r.o.,,Ostravská 29/305, 747 70 Opava – Komárov, Czech Republic and IVAX Pharmaceuticals UK (Runcorn, Cheshire), Runcorn, Cheshire, United Kingdom.
IVAX Pharmaceuticals s. r. o., Opava - Komárov, Češka in IVAX Pharmaceuticals UK (Runcorn, Cheshire), Runcorn, Cheshire, Velika Britanija
Your concentrate for solution for infusion is called Paxene.
Vaš koncentrat za raztopino za infundiranje se imenuje Paxene.
These agents are used to treat cancer.
Običajno splošno ime zdravilne učinkovine je paklitaksel ter spada v skupino zdravil, ki jih imenujemo zdravila z delovanjem na novotvorbe in se uporabljajo za zdravljenje raka.
Paxene is a clear, colourless to slightly yellow, thickish solution which comes in vials containing 5 ml, 16.7 ml, 25 ml and 50 ml of concentrate.
Zdravilo Paxene je bistra, brezbarvna do rahlo rumena viskozna tekočina; na voljo je v vialah po 5 ml, 16, 7 ml, 25 ml in 50 ml koncentrata.
Paxene concentrate for solution for infusion is used to treat: • advanced AIDS-related Kaposi’s sarcoma when certain other treatments (liposomal anthracyclines) have been tried but have not worked.
Zdravilo Paxene koncentrat za raztopino za infundiranje se uporablja za zdravljenje: • napredovalega Kaposijevega sarkoma, povezanega z AIDS- om, kadar so bile predhodno že preizkušene druge vrste zdravljenja (antraciklini v obliki liposomov), ki pa niso bile učinkovite.
This is a tumour that arises from blood vessels in the skin or internal organs and typically appears as flat or raised, purple to dark brown patches on the skin. • advanced breast cancer when certain other treatments (standard anthracycline-containing therapy) have been tried but have not worked or when the patient is unsuitable for these treatments. • advanced ovarian cancer or remaining tumour (> 1 cm) after initial surgery, in combination with cisplatin as first-line treatment.
Gre za tumor, ki izvira iz krvnih žil v koži ali notranjih organih in se običajno pojavlja v obliki ravnih ali izbočenih, škrlatnih do temno rjavih lis na koži. • napredovalega raka dojke, kadar so bile predhodno že preizkušene druge vrste zdravljenja (standardno zdravljenje z antraciklini), ki pa niso bile učinkovite, ali kadar tovrstna zdravljenja niso bila primerna za bolnico.
33 • advanced ovarian cancer when certain other treatments (platinum-containing combination therapy without taxanes) have been tried but have not worked (as second-line treatment). • advanced non-small cell lung cancer if potentially curative surgery and/or radiation therapy are not possible, in combination with cisplatin.
33 • napredovalega raka jajčnikov ali preostalega tumorja (> 1 cm) po kirurškem posegu v kombinaciji s cisplatinom kot prvim zdravljenjem prvega izbora. • napredovalega raka jajčnika, kadar so bile predhodno že preizkušene druge vrste zdravljenja (kombinirano zdravljenje s platino brez uporabe taksanov), ki pa niso bile učinkovite (kot zdravljenjem drugega izbora). • napredovalega nedrobnoceličnega raka pljuč, če kirurško zdravljenje in/ ali obsevanje nista možna, v kombinaciji s cisplatinom.
There is limited information to support treatment of this condition.
Podatki o zdravljenju te bolezni so omejeni.
BEFORE YOU USE PAXENE
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO PAXENE
Do not use Paxene:
Ne uporabljajte zdravila Paxene:
• if you are hypersensitive (allergic) to paclitaxel or any of the other ingredients of Paxene; • if you have ever had any problems with your liver; • if you have been told that your white blood cell count is very low; • if you have a serious, uncontrolled infection; • if you are pregnant, may become pregnant or are breast-feeding.
• če ste preobčutljivi za (alergični na) paklitaksel ali katerokoli sestavino zdravila Paxene; • če ste kdaj imeli težave z jetri; • če so vam povedali, da je vaše število belih krvnih telesc zelo majhno; • če imate resno, nenadzorovano okužbo; • če ste noseči, bi lahko zanosili ali če dojite.
Take special care with Paxene:
Bodite posebno pozorni pri uporabi zdravila Paxene:
• Before you start treatment with Paxene and during treatment you will have regular blood tests, to check that it is safe for you to continue with your treatment. • Paxene is not recommended for use in children (under 18 years). • Tell your doctor immediately if you develop severe or prolonged or bloody diarrhoea during or after treatment with Paxene.
• Pred začetkom zdravljenja z zdravilom Paxene in med zdravljenjem vam bodo redno pregledovali kri, da bi ugotovili, ali je nadaljevanje zdravljenja za vas varno. • Zdravila Paxene ni priporočljivo uporabljati pri otrocih, mlajših od 18 let. • Takoj povejte svojemu zdravniku, če se je med ali po zdravljenju z zdravilom Paxene pri vas pojavila huda, dalj časa trajajoča ali krvava driska.
This may be a sign of a serious bowel inflammation (pseudomembranous colitis). • If you experience an irregular heart beat, dizziness or faintness during treatment. • If you previously had radiation treatment (radiotherapy) to your chest (see section 4:
To je namreč lahko znak resnega vnetja črevesja (psevdomembranski kolitis). • Če med zdravljenjem opazite nepravilno bitje srca, vrtoglavice ali omedlevice. • Če so vas zdravili z obsevanjem (radioterapijo) prsnega koša (glejte poglavje 4:
Possible Side Effects). • If you are taking other medicinal products which could interact with paclitaxel (see Using other medicines).
Možni neželeni učinki). • Če jemljete druga zdravila, ki bi lahko medsebojno delovala s paklitakselom (glejte Uporaba drugih zdravil).
Male patients treated with Paxene are advised not to father a child during and up to six months after the treatment.
Moškim bolnikom, ki se zdravijo s Paxenom se priporoča, da ne splodijo otroka med zdravljenjem in do šest mesecev po zdravljenju.
Thus it may not be safe for you to drive or to use machinery for up to several hours after you have had your treatment.
Zdravilo Paxene vsebuje alkohol, zato še več ur po zdravljenju ni varno, da vozite ali upravljate s stroji.
You should be able to drive and use machinery between your treatments with Paxene, unless you feel tired or dizzy
Če ne občutite utrujenosti ali omotičnosti, bi lahko med dvema zdravljenjema z zdravilom Paxene vozili in upravljali s stroji.
Important information about some of the ingredients of Paxene:
Pomembne informacije o nekaterih sestavinah zdravila Paxene:
This product contains approximately 50% by volume of alcohol.
Zdravilo vsebuje približno 50% alkohola glede na prostornino.
Paxene contains polyoxyl castor oil, which can cause an allergic reaction.
Po infundiranju Paxena bo vaša sposobnost vožnje in upravljanja s stroji morda zmanjšana.
34 Using other medicines:
34 Zdravilo Paxene vsebuje makrogolglicerol ricinolat, ki lahko povzroči alergijsko reakcijo.
Please tell your doctor before you are given Paxene if you: • are taking ritonavir, nelfinavir, efavirenz, nevirapine (for the treatment of AIDS) or any other prescribed drugs for your condition; • are taking any other medicines prescribed by a physician for any condition (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals, rifampicin, carbamazepine, phenytoin, phenobarbital); • are taking other medicines that you have bought for yourself without a prescription.
Prosimo, da predno boste prejeli Paxene, svojemu zdravniku poveste, če: • jemljete ritonavir, nelfinavir, efavirenz, nevirapin (za zdravljenje AIDS- a) ali katerokoli drugo zdravilo, ki so vam ga predpisali za vašo bolezen; • jemljete katerokoli drugo zdravilo, ki vam ga je predpisal zdravnik za druge bolezni (npr. eritromicin, fluoksetin, gemfibrozil, antimikotiki imidazolskega tipa, rifampicin, karbamazepin, fenitoin, fenobarbital); • jemljete druga zdravila, ki ste jih kupili brez recepta.
If you see another doctor or visit a hospital, remember to tell them what medicines you are taking.
Če boste obiskali drugega zdravnika ali bolnišnico, morate povedati, katera zdravila prejemate.
AIDS-related Kaposi’s sarcoma:
Kaposijev sarkom, povezan z AIDS- om:
The usual dose of Paxene is 100 mg/m2 of body surface area.
Običajen odmerek zdravila Paxene je 100 mg/ m2 telesne površine.
Advanced breast cancer and ovarian cancer (second-line therapy):
Napredovali rak dojke in jajčnika (zdravljenje drugega izbora):
The usual dose of Paxene is 175 mg/m2 of body surface area.
Običajen odmerek zdravila Paxene je 175 mg/ m2 telesne površine.
Advanced ovarian cancer (first-line therapy):
Napredovali rak jajčnikov (zdravljenje prvega izbora):
Two doses of Paxene may be given:
Prejmete lahko dva odmerka zdravila Paxene:
Paxene 175 mg/m2 of body surface area administrated as a 3 hour infusion into a vein, followed by another medicine, cisplatin, every three weeks; alternatively Paxene 135 mg/m2 given as a 24 hour infusion, followed by cisplatin, every three weeks.
175 mg/ m2 telesne površine zdravila Paxene v obliki 3 urne infuzije v veno in nato drugo zdravilo, cisplatin, vsake tri tedne; drugo odmerjanje je 135 mg/ m2 zdravila Paxene v obliki 24 urne infuzije in nato vsake tri tedne cisplatin.
Advanced non-small cell lung cancer:
Napredovali nedrobnocelični rak pljuč:
The usual dose of Paxene is 175 mg/m2 of body surface area, followed by cisplatin every three weeks.
Običajni odmerek zdravila Paxene je 175 mg/ m2 telesne površine, nato pa cisplatin vsake tri tedne.
Half to one hour before your infusion you will be given two different types of injection (an antihistamine and an H2 antagonist).
Dvanajst in nato šest ur pred infuzijo boste prejeli deksametazon
35 problems, your heart rate may be monitored.
35 (steroid) v obliki tablete ali injekcije.
Side effects may occur while you are receiving Paxene or following treatment.
Med ali po zdravljenju z zdravilom Paxene se bodo pri vas morda pojavili neželeni učinki.
Possible side effects may include:
Možni neželeni učinki so naslednji:
This can cause an allergic reaction - you may become breathless or have trouble breathing, you may notice chest pain, flushing (red face and neck) and a speeding up of your heart, or your blood pressure may fall making you light-headed and sweaty.
• Alergijske reakcije - zdravilo vsebuje makrogolglicerol ricinolat, ki lahko povzroči alergijske reakcije - lahko boste imeli kratko sapo ali težave pri dihanju, morda boste imeli bolečine v prsnem košu, boste zardevali (rdeč obraz in vrat), pospešil se bo vaš srčni utrip ali pa bo padel vaš krvni tlak, zaradi česar boste omotični in potni.
You may notice wheals (localised swellings on your skin), or swelling of your lips and/or your tongue.
Morda boste opazili gnojne mehurčke (lokalizirano zatekanje kože) ali zatekanje ustnic in/ ali jezika.
If any of these symptoms occur, contact your doctor immediately. • Blood disorders temporary low white blood cell counts which may make you more likely to develop infections.
Če se katerikoli od teh simptomov pojavi pri vas, takoj obvestite svojega zdravnika. • Bolezni krvi – začasno zmanjšanje števila belih krvnih celic, zaradi katerega boste morda lažje zboleli za okužbami.
Temporary low platelets counts which can cause unusual bleeding (for example nose bleeds) or unexplained bruising.
Morda bo v krvi začasno zmanjšano tudi število trombocitov, zaradi česar lahko pride do neobičajnih krvavitev (npr. iz nosu) ali nepojasnjenega pojavljanja modric.
A temporary lowering of red blood cells (anaemia) may also occur.
Pojavi se lahko tudi začasno zmanjšanje števila rdečih krvnih telesc (anemija).
You may notice that you become tired and your skin tone becomes pale Very rarely, such changes in your blood can be permanent.
Te spremembe v krvi so zelo redko trajne.
Leukaemia (an abnormal increase in the number of white cells in your blood) may also occur very rarely. • Heart problems - changes in normal heart rate and high/low blood pressure (you may begin to feel light-headed and faint and begin to sweat), thrombosis (blood clots) can occur.
Zelo redko se lahko pojavi tudi levkemija (nenormalno povečanje števila belih krvnih celic). • Težave s srcem - spremembe normalnega srčnega utripa in visok/ nizek krvni tlak (morda boste omotični, omedleli in se začeli potiti) Lahko se pojavijo in tromboza (krvni strdki).