natgillin/translations-raw huggingface dataset:
In spite of this, a small increase in cortisol suppression was seen after administration of fixed-dose combination compared to the monoproducts.
Kljub temu so po uporabi kombinacije budezonida in formoterola v fiksnem odmerku opažali blago okrepitev supresije izločanja kortizola v primerjavi z izdelki, ki vsebujejo le po eno učinkovino.
It is recommended that serum potassium levels are monitored during these circumstances.
da v teh primerih redno spremljate serumsko koncentracijo kalija.
If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your ‘reliever inhaler'.
Če se pojavi kateri od teh simptomov, takoj nehajte uporabljati inhalator Budezonid/formoterol Teva Pharma B.V.
Some patients may require up to a maximum of 2 inhalations twice daily.
Pri nekaterih bolnikih bosta morda potrebna največ 2
Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate) .
En odmerek vsebuje približno 10 miligramov laktoze (v obliki monohidrata).
Your doctor may consider adding steroid tablets to your usual treatment during periods of stress (for example, when you have a chest infection or before an operation).
Med obdobji stresa (npr. če imate okužbo v prsnem košu ali pred operacijo) vam bo zdravnik morda poleg vašega običajnega zdravljenja predpisal še steroide v tabletah.
There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.
Pri tistih bolnikih, ki sočasno dobijo anestetik iz skupine halogeniranih ogljikovodikov, je večja nevarnost pojava aritmij.
Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery.
Zato je treba razmisliti o dodatni uporabi sistemskih kortikosteroidov v obdobjih stresa,
Patients should be advised to have their rescue inhaler available at all times.
Bolnikom svetujte, naj imajo inhalator z olajševalemc vedno pri roki.
• Nausea (feeling sick).
• občutek siljenja na bruhanje (navzea),
Breathe in forcefully and deeply through the mouthpiece.
Nato vdihnite skozi ustnik tako globoko in močno, kot morete.
Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors) are likely to markedly increase plasma levels of budesonide and concomitant use should be avoided.
Močni zaviralci CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, posakonazol, klaritromicin,
Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax.
Ne poskušajte razstaviti inhalatorja ter odstraniti ali zasukati pokrovčka ustnika.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht,The Netherlands 12.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska
Lactose contains small amounts of milk protein which may cause allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega zdravila posvetujte z zdravnikom.
In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
tako, da so ga primerjali z drugim odobrenim inhalacijskim zdravilom s fiksno kombinacijo istih učinkovin, in sicer budezonidom in formoterolom; dokazali so, da mu je enakovredno tako glede sistemske izpostavljenosti (varnost) kot glede odlaganja v pljučih (učinkovitost).
Some patients may require up to a maximum of 4 inhalations twice daily.
Pri nekaterih bolnikih bodo morda potrebni največ 4
Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms should be used as maintenance therapy only.
320 mikrogramov/9,0 mikrogramov je treba uporabljati le kot vzdrževalno zdravljenje.
Hyperglycaemia
OVOJNINAH FOLIJA
What you need to know before you use Budesonide/Formoterol Teva Pharma B.V.
Kaj morate vedeti, preden boste uporabili zdravilo Budezonid/formoterol Teva Pharma
Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section 4.4).
takoj prekiniti, režim zdravljenja ponovno ovrednotiti in po potrebi uvesti drugo vrsto zdravljenja (glejte poglavje 4.4).
Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, The Netherlands.
Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nizozemska Izdelovalec
/inhalation twice daily), and a short acting β2 adrenoceptor agonist as needed.
80 mikrogramov/4,5 mikrogramov/vdih, dvakrat na dan) in kratkodelujoči agonist adrenergičnih receptorjev β2 po potrebi.
Advising the patient to rinse the mouth out with water after each dose will minimise the risk.
bolniku naročite, naj si po vsakem vzdrževalnem odmerku spere usta z vodo.
Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Stranska ploskev: En dovedeni odmerek vsebuje 160 mikrogramov budezonida in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
If you stop using Budesonide/Formoterol Teva Pharma B.V.
Če ste prenehali uporabljati zdravilo Budezonid/formoterol Teva Pharma B.V.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
If you forget to use Budesonide/Formoterol Teva Pharma B.V.
Če ste pozabili uporabiti zdravilo Budezonid/formoterol Teva Pharma B.V.
If you get any side effects, talk to your doctor,pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
To je enakovredno odmerjenemu odmerku 400 mikrogramov budezonida in 12 mikrogramov formoterolijevega fumarata dihidrata.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking Budesonide/Formoterol Teva Pharma B.V. - do NOT use this medicine unless your doctor tells you to.
Nosečnost, dojenje in plodnost • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden vzamete zdravilo Budezonid/formoterol Teva Pharma B.V.
Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
vsebuje dve različni zdravilni učinkovini: budezonid in formoterolijev fumarat dihidrat.
Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Sprednja ploskev: Ta dovedeni odmerek je enakovreden odmerjenemu odmerku 200 mikrogramov budezonida in 6 mikrogramov formoterolijevega fumarata dihidrata.
Check with your doctor, pharmacist or nurse if you are not sure.
se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Budesonide/Formoterol Teva Pharma B.V. is taken as regular maintenance treatment with a separate rapidacting bronchodilator reliever inhaler.
Budezonid/formoterol Teva Pharma B.V.V takem primeru profilaktične uporabe je treba razmisliti o uporabi hitrodelujočega bronhodilatatorja.
Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Stranska ploskev: En dovedeni odmerek vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Sprednja ploskev: ta dovedeni odmerek je enakovreden odmerjenemu odmerku 400 mikrogramov budezonida in 12 mikrogramov formoterolijevega fumarata dihidrata.
Manufacturer:
Začetek:
This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
To je enakovredno odmerjenemu odmerku 200 mikrogramov budezonida in 6 mikrogramov formoterolijevega fumarata dihidrata.
Budesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
ko je primerna kombinacija zdravil (inhalacijski kortikosteroid in dolgodelujoči agonist adenoreceptorjev β2): - pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z inhalacijskimi kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti adrenergičnih receptorjev β2, ki so predpisani za uporabo po potrebi.
To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Za zdravljenje astme vam bo zdravnipredpisal dva inhalator Budezonid/formoterol Teva Pharma B.V.
• It is important to use Budesonide/Formoterol Teva Pharma B.V. every day, even if you have no asthma symptoms at the time.
uporabite vsak dan, tudi če trenutno nimate simptomov astme.
The prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Klinično pomembna adrenalna supresija se lahko pojavi tudi pri bolnikih, ki so imeli podaljšano zdravljenje z visokimi odmerki inhalacijskih kortikosteroidov, še posebej v odmerkih, višjih od priporočenih.
Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of Budesonide/Formoterol Teva Pharma B.V.
Ko so simptomi astme dobro obvladani, bo vaš zdravnik morda predlagal, da odmerek zdravila Budezonid/formoterol Teva Pharma B.V.
How to use Budesonide/Formoterol Teva Pharma B.V.
Kako uporabljati zdravilo Budezonid/formoterol Teva Pharma B.V.
Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4) The patient may notice a taste when using Budesonide/Formoterol Teva Pharma B.V. due to the lactose excipient.
Bolnikom svetujte tudi, naj si po inhaliranju sperejo usta z vodo (glejte poglavje 4.4).
If you feel you are getting breathless or wheezy while using Budesonide/Formoterol Teva Pharma B.V., you should continue to use Budesonide/Formoterol Teva Pharma B.V. but go to see your doctor as soon as possible, as you may need additional treatment.
zdi, da dihanje postaja težje ali piskajoče, zdravilo uporabljajte še naprej, vendar pa čim prej obiščite zdravnika, saj boste morda potrebovali dodatno zdravljenje.
To treat your asthma your doctor will prescribe Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Astma Za zdravljenje astme vam bo zdravnik predpisal inhalator Budezonid/formoterol Teva Pharma B.V.
• Steroid medicines that you take by mouth (such as prednisolone).
• steroidna zdravila za peroralno uporabo (npr. prednizolon).
Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Priprava novega inhalatorja Budezonid/formoterol Teva Pharma B.V.
The use of Budesonide/Formoterol Teva Pharma B.V. follows three simple steps: open, breathe and close which are outlined below.
zajema tri preproste korake: odprite, vdihnite in zaprite, ki so opisani spodaj.
- in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
- pri bolnikih, pri katerih bolezni ne moremo ustrezno nadzorovati z inhalacijskimi kortikosteroidi ter kratkodelujočimi inhalacijskimi agonisti adrenergičnih receptorjev β2, ki so predpisani za uporabo po potrebi; ali - pri bolnikih, pri katerih bolezen že ustrezno nadzorujemo tako z inhalacijskimi kortikosteroidi kot z dolgodelujočimi agonisti adrenergičnih receptorjev β2.
Budesonide/Formoterol Teva Pharma B.V. has no or negligible influence on the ability to drive and use machines.
nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
Pri uporabi velikih odmerkov agonistov adrenergičnih receptorjev β2 lahko nastopi potencialno huda hipokaliemija.
Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
vsebuje 120 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim ustnikom.
Budesonide/Formoterol Teva Pharma B.V. 160 micrograms/4.5 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
160 mikrogramov/4,5 mikrogramov, prašek za inhaliranje (budezonid/formoterolijev fumarat dihidrat)
Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
320 mikrogramov/9 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
Budesonide/Formoterol Teva Pharma B.V. contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
vsebuje zdravilni učinkovini formoterol in budezonid, ki imata različna mehanizma delovanja, njuni učinki pri zmanjšanju pogostnosti poslabšanj astme pa so aditivni.
Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
vsebuje 60 inhalacij zdravila in ima belo ohišje s polprozornim vinsko rdečim pokrovčkom ustnika.
Budesonide/Formoterol Teva Pharma B.V. 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
160 mikrogramov/4,5 mikrogramov prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat
The most common symptoms that may occur after if you use more Budesonide/Formoterol Teva Pharma B.V. than you should are trembling, headache or a rapid heartbeat.
Budezonid/formoterol Teva Pharma B.V., kot bi smeli, so tresenje, glavobol in hitro bitje srca.
Not applicable.
ostane optimalen.
If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler', then seek medical advice.
Če se pojavi piskajoče ali oteženo dihanje ali kateri koli drug simptom astmatičnega napada,
Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
En dovedeni odmerek (odmerek, ki pride iz ustnika Spiromax) vsebuje 160 mikrogramov budezonida in 4,5 mikrogramov formoterolijevega fumarata dihidrata.
Budesonide/Formoterol Teva Pharma B.V. pharmacokinetic profile
Farmakokinetični profil zdravila Budezonid/formoterol Teva Pharma B.V.
No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
Pri sočasni uporabi obeh učinkovin pa niso ugotavljali povečane incidence neželenih učinkov.
Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled shortacting β2 adrenoreceptor agonists.
ni ustrezno pri odraslih bolnikih z blago obliko astme, ki ni ustrezno nadzorovana z inhalacijskim kortikosteroidi in inhalacijskimi kratkodelujočimi agonisti adrenoreceptorjev β2, ki se uporabljajo po potrebi.
Patients should be reassessed regularly by their prescriber/health care provider so that the dose of Budesonide/Formoterol Teva Pharma B.V. remains optimal.
Zdravnik , ki predpisuje zdravilo, mora bolnike redno ocenjevati, tako da odmerek zdravila Budezonid/formoterol Teva Pharma B.V.
• Feeling restless, nervous, agitated, anxious or angry.
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov • nemir, živčnost, agitiranost, tesnobnost ali jeza,
Start Teva Pharma B.V.
Pharma B.V.
Medicinal product subject to medical prescription.
V tem primeru je treba zdravljenje z zdravilom
The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
Budesonide/formoterol maintenance therapy
Astma Vzdrževalno zdravljenje astme z budezonidom/formoterolom
• Bruising of the skin.
• hitro bitje srca, • podplutbe na koži,
Budesonide/Formoterol Teva Pharma B.V. is NOT indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
ni indicirano za uporabo pri otrocih, starih 12 let ali manj, ali mladostnikih, starih od 13 do 17 let.
If Budesonide/Formoterol Teva Pharma B.V. therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
prekiniti zaradi prevelikega odmerka formoterola, ki je sestavina zdravila, je treba poskrbeti za ustrezno zdravljenje z inhalacijskim kortikosteroidom.
Other medicines and Budesonide/Formoterol Teva Pharma B.V. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Candida infections in the oropharynx
Infekcijske in parazitske bolezni pogosti okužbe s kandido v ustnih in žrelu
Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
320 mikrogramov/9 mikrogramov, prašek za inhaliranje (budezonid/formoterolijev fumarat dihidrat)
Keep the mouthpiece cover closed after the removal of foil wrap.
Po odstranitvi ovoja iz folije naj bo pokrovček ustnika zaprt.
If any of the following happen to you, stop using Budesonide/Formoterol Teva Pharma B.V. and talk to your doctor immediately:
Če vas skrbi, ali je prav, da še naprej uporabljate zdravilo Budezonid/formoterol Teva Pharma B.V., se posvetujte z zdravnikom.
• you are diabetic.
• če imate sladkorno bolezen.
Prolongation of QTc-interval
supraventrikularna tahikardija, ekstrasistole angina pektoris podaljšanje intervala QTc
Budesonide/Formoterol Teva Pharma B.V. contains lactose Lactose is a type of sugar found in milk.
Laktoza je vrsta sladkorja, ki jo najdemo v mleku.
How to store Budesonide/Formoterol Teva Pharma B.V.
Kaj je zdravilo Budezonid/formoterol Teva Pharma B.V.
Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
odmerek vsebuje 320 mikrogramov budezonida in 9 mikrogramov formoterolijevega fumarata dihidrata.
Serious asthma-related adverse reactions and exacerbations may occur during treatment with Budesonide/Formoterol Teva Pharma B.V..
Pomembne informacije o simptomih astme Če se vam med zdravljenjem z zdravilom Budezonid/formoterol Teva Pharma B.V.
Budesonide/Formoterol Teva Pharma B.V. is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
NI namenjeno za uporabo pri otrocih, starih 12 let in manj, ali mladostnikih, starih od 13 do 17 let.
Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler.
Vdihnite: Namestite ustnik med zobe in stisnite ustnice okrog njega.
What you need to know before you use Budesonide/Formoterol Teva Pharma B.V. (page 5) 3.
in za kaj ga uporabljamo (stran 3) Kaj morate vedeti, preden boste uporabili zdravilo Budezonid/formoterol Teva Pharma B.V.
What Budesonide/Formoterol Teva Pharma B.V. looks like and contents of the pack Budesonide/Formoterol Teva Pharma B.V. is an inhalation powder.
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Budezonid/formoterol Teva Pharma B.V.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Budesonide/Formoterol Teva Pharma B.V.320 mcg/9 mcg inhalation powder budesonide/formoterol fumarate dihydrate
320 mcg/9 mcg prašek za inhaliranje budezonid/formoterolijev fumarat dihidrat za inhaliranje
Important information about your asthma symptoms
za odpravljanje teh simptomov astme.
Patients should be reminded to take their Budesonide/Formoterol Teva Pharma B.V. maintenance dose as prescribed, even when asymptomatic.
Bolnike je treba opozoriti, naj uporabljajo vzdrževalni odmerek zdravila Budezonid/formoterol Teva
Dizziness
Odmerjanje
Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
med poslabšanjem astme ali v obdobju pomembnega oziroma akutnega poslabšanja simptomov astme.
EU Number Invente d Name
EU številka Izmišljeno ime
Packaging Content (concentration)
Ovojnina Vsebina (koncentracija)
Lyophilisate and solvent for suspension for injection
Liofilizat in vehikel za suspenzijo za injiciranje
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per
FHV F2): ≥ 104,9 CCID50 na odmerek Inaktivirani
1 falcon tube with 1, 2 or 3 vials + 1 syringe + 18G intravenous catheter + 2
1 epruveta Falcon z 1, 2 ali 3 vialami + 1 brizga + G 18 intravenski kateter + 2 Vicryl o č
Vial (glass/alu)
Viala (steklo/alu)
EU/1/09/563/001
EU/1/09/563/001 ChondroCelect 10 000 celic/µl
Invented name Strength Pharmaceutical Form
Številka EU Izmišljeno ime Jakost
Implantation suspension
Celična suspenzija za implantacijo
Route of Administration
Farmacevtska oblika Pot uporabe
The treatment will be repeated every two weeks.
Zdravljenje se bo ponovilo na vsaka dva tedna.
They may differ from the general information contained in this leaflet.
Lahko se razlikujejo od splošnih informacij v tem navodilu.
Do not interchange.
Ne zamenjujte.
Unopened vial 30 months.
Neodprta viala 30 mesecev
All dose modifications should be based on the worst preceding toxicity.
Vse spremembe odmerkov morajo temeljiti na najhujši predhodni toksičnosti.
SD= standard deviation
SD = standardni odklon
It must be protected from light, and it must not be frozen.
Zaščititi jo morate pred svetlobo in je ne smete zamrzovati.
It is especially important that you tell your doctor if you have been given irinotecan in any form earlier.
Še zlasti je pomembno, da zdravniku poveste, če ste že kdaj prej prejemali irinotekan v kateri koli obliki.
Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Mrtva ali inaktivirana cepiva se lahko dajejo, vendar je odziv na takšna cepiva lahko zmanjšan.
What to do in case of diarrhoea
Kaj storiti v primeru driske
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
Genotoxic and carcinogenic potential
Genotoksični in kancerogeni potencial
Patients should be monitored for signs of infections.
Bolnike je treba spremljati glede znakov okužbe.
Patients received treatment until disease progression or unacceptable toxicity.
Bolniki so prejemali zdravljenje do napredovanja bolezni ali do nesprejemljive toksičnosti.