natgillin/translations-raw huggingface dataset:
Very common (experienced in more than 1 in 10 patients): • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets • fever: if this happens you must tell your doctor immediately • allergic reactions as described above • loss of appetite (anorexia) • insomnia • feeling of numbness or pins and needles or pain in the joints of muscles • headache • alteration in sense of taste • inflammation of the eye or increased tearing of the eyes • swelling caused by faulty lymphatic drainage • shortness of breath • nasal drainage; inflammation of the throat and nose; cough
Zelo pogosto (pojavijo se pri več kot 1 od 10 bolnikov): • okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov • zvišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku • alergijske reakcije, kot so opisane zgoraj • izguba apetita (anoreksija) • nespečnost • občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah • glavobol • spremenjeno okušanje • vnetje oči ali močnejše solzenje • otekanje zaradi nepravilne limfatične drenaže • težko dihanje • izcedek iz nosu, vnetje žrela in nosu, kašelj • krvavitev iz nosu • razjede v ustih • draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje • bolečine v trebuhu • želodčne težave • kratkotrajna izguba las in dlak (večinoma se obnovi njihova normalna rast) • pordelost in otekanje dlani ali podplatov, ki lahko povzroči olupljenje kože (to se lahko pojavi
91 • bleeding from the nose • sores in the mouth • stomach upsets including nausea, vomiting and diarrhea, constipation • abdominal pain • indigestion • short term hair loss (in most cases normal hair growth should return) • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) • change in the color of your nails, which may detach • muscle aches and pains; back pain or bone pain • change or absence of menstrual period • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
93 tudi na rokah, obrazu ali telesu) • sprememba barve nohtov, ki lahko odstopijo • bolečine v mišicah, bolečine v hrbtu ali kosteh • spremembe ali izostanek menstruacije • otekanje dlani, stopal, nog • utrujenost ali gripi podobni simptomi • povečanje ali zmanjšanje telesne mase.
Common (experienced in less than 1 in 10 but more than 1 in 100 patients): • oral candidiasis • dehydration • dizziness • hearing impaired • decrease in blood pressure; irregular or rapid heart beat • heart failure • oesophagitis • dry mouth • difficulty or painful swallowing • haemorrhage • raised liver enzymes (hence the need for regular blood tests).
Pogosto (pojavijo se pri manj kot 1 od 10, a več kot pri 1 od 100 bolnikov): • oralna kandidoza • dehidracija • omotica • okvara sluha • znižanje krvnega tlaka, nereden ali hiter srčni utrip • srčno popuščanje • vnetje požiralnika • suha usta • težave ali bolečine pri požiranju • krvavitev • zvečanje jetrnih encimov (zato so potrebne redne preiskave krvi).
Uncommon (experienced in more than 1 in 1,000 but less than 1 in 100 patients): • fainting • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling • inflammation of the colon, small intestine; intestinal perforation • blood clots.
Občasno (pojavijo se pri več kot 1 od 1. 000, a manj kot 1 od 100 bolnikov): • omedlevica • na mestu injiciranja, kožne reakcije, flebitis (vnetje vene) ali otekanje • vnetje debelega črevesa, tankega črevesa, predrtje črevesa • krvni strdki.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali bolnišničnega farmacevta.
HOW TO STORE Docetaxel Winthrop
SHRANJEVANJE ZDRAVILA DOCETAXEL WINTHROP
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Zdravila Docetaxel Winthrop ne smete uporabljati po datumu izteka roka uporabnosti, ki je označen na škatli, pretisnem omotu in vialah.
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
Vendar je osnovna raztopina dokazano kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25 °C).
The infusion solution should be used within 4 hours at room temperature (below 25 °C).
Raztopino za infundiranje je pri sobni temperaturi (do 25 °C) treba uporabiti v 4 urah.
What Docetaxel Winthrop concentrate vial contains
Kaj vsebuje viala zdravila Docetaxel Winthrop koncentrat Zdravilna učinkovina je docetaksel.
Each ml of docetaxel solution contains 40 mg of docetaxel
Ena viala vsebuje 20 mg docetaksela.
One vial contains 20 mg docetaxel.
Pomožna snov je polisorbat 80.
- The other ingredient is polysorbate 80.
94 Kaj vsebuje viala z vehiklom:
What solvent vial contains 13% (w/ w) ethanol 95% in water for injections.
13% (m/ m) 95% etanol, v vodi za injekcije
What Docetaxel Winthrop looks like and contents of the pack Docetaxel Winthrop 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.
Izgled zdravila in vsebina pakiranja Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje je bistra viskozna, rumena do rjavo- rumena raztopina.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
En pretisni omot vsebuje: • eno eno- odmerno vialo koncentrata in • eno eno- odmerno vialo vehikla.
Marketing Authorisation Holder Aventis Pharma S. A.
A.
Manufacturer Aventis Pharma, Dagenham Rainham Road South Dagenham Essex RM10 7XS United Kingdom
Izdelovalec Aventis Pharma, Dagenham Rainham Road South Dagenham Essex RM10 7XS Velika Britanija
93 Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
Portugal sanofi-aventis - Produtos Farmacêuticos, S. A.
95 Portugal España sanofi- aventis - Produtos Farmacêuticos, S. A. sanofi- aventis, S. A.
This leaflet was last approved in {MM/ YYYY}.
Navodilo je bilo odobreno MM/ LLLL
94 The following information is intended for medical or healthcare professionals only:
96 Naslednje informacije so namenjene samo zdravstvenemu osebju:
PREPARATION GUIDE FOR USE WITH Docetaxel Winthrop 20 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR Docetaxel Winthrop
NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE DOCETAXEL WINTHROP 20 mg IN VEHIKLA ZA DOCETAXEL WINTHROP
It is important that you read the entire contents of this procedure prior to the preparation of either the Docetaxel Winthrop premix solution or the Docetaxel Winthrop infusion solution
Pomembno je, da pred pripravo osnovne raztopine zdravila Docetaxel Winthrop ali raztopine za infundiranje zdravila Docetaxel Winthrop v celoti preberete ta navodila.
Docetaxel Winthrop 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ ml docetaxel (anhydrous) in polysorbate 80.
Docetaxel Winthrop 20 mg koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 40 mg brezvodnega docetaksela/ ml v polisorbatu 80.
The solvent for Docetaxel Winthrop is a 13% w/ w solution of ethanol 95% in water for injections.
Vehikel za Docetaxel Winthrop je 13% (m/ m) raztopina 95% etanola v vodi za injekcije.
Docetaxel Winthrop is supplied as single-dose vials.
Docetaxel Winthrop je na voljo v vialah z enim odmerkom.
Each box contains one Docetaxel Winthrop vial (20 mg) and one corresponding solvent for Docetaxel Winthrop vial in a blister pack.
Vsaka škatla vsebuje eno vialo zdravila Docetaxel Winthrop (20 mg) in eno vialo ustreznega vehikla za Docetaxel Winthrop v pretisnem omotu.
Docetaxel Winthrop vials should be stored between 2 °C and 25 °C and protected from light.
Viale Docetaxel Winthrop morajo biti shranjene pri temperaturi med 2 °C in 25 °C in zaščitene pred svetlobo.
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Zdravila Docetaxel Winthrop 20 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in vialah.
2.1 Docetaxel Winthrop 20 mg vial
• Viala Docetaxel Winthrop 20 mg je 7- ml viala iz prozornega stekla z zeleno dvižno zaporko.
• The Docetaxel Winthrop 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Viala Docetaxel Winthrop 20 mg vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ ml.
• Each Docetaxel Winthrop 20 mg vial contains 0.5 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Ena viala Docetaxel Winthrop 20 mg vsebuje 0, 5 ml raztopine docetaksela 40 mg/ ml v polisorbatu 80 (polnilni volumen:
This volume has been established during the development of Docetaxel Winthrop to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem zdravila Docetaxel Winthrop za nadomestitev izgube tekočine, do katere pride med pripravo osnovne raztopine (glejte poglavje 4) zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
2.2 Solvent for Docetaxel Winthrop 20 mg vial
2. 2 Viala z vehiklom za Docetaxel Winthrop 20 mg:
• The solvent for Docetaxel Winthrop 20 mg vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
• Viala z vehiklom za Docetaxel Winthrop 20 mg je 7- ml steklena viala iz prozornega stekla s prosojno, brezbarvno dvižno zaporko.
• The solvent for Docetaxel Winthrop composition is a 13% w/ w solution of ethanol 95% in water for injections.
• Vehikel za Docetaxel Winthrop sestavlja 13% (m/ m) raztopina 95% etanola v vodi za injekcije.
• Each solvent for Docetaxel Winthrop 20 mg vial contains 1.98 ml.
• Vsaka viala z vehiklom za Docetaxel Winthrop 20 mg vsebuje 1, 98 ml vehikla.
This volume has been established based on the fill volume of the Docetaxel Winthrop 20 mg vial.
Ta količina je določena glede na polnilni volumen viale Docetaxel Winthrop 20 mg.
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 20 mg vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dodatek celotne vsebine viale z vehiklom vsebini viale Docetaxel Winthrop 20 mg zagotavlja koncentracijo 10 mg/ ml docetaksela v osnovni raztopini.
95 3.
97 3.
Docetaxel Winthrop is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Winthrop solutions.
Docetaxel Winthrop je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je pri ravnanju in pripravi raztopin zdravila Docetaxel Winthrop potrebna previdnost.
4.1 Preparation of the Docetaxel Winthrop premix solution (10 mg docetaxel/ ml)
4. 1 Priprava osnovne raztopine zdravila Docetaxel Winthrop (10 mg docetaksela/ ml)
4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Winthrop boxes to stand at room temperature (below 25 °C) for 5 minutes.
4. 1. 1 Če so viale shranjene v hladilniku, pustite potrebno število škatel zdravila Docetaxel Winthrop 5 minut stati na sobni temperaturi (do 25 °C).
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Winthrop vial by partially inverting the vial.
4. 1. 2 Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za Docetaxel Winthrop iz viale tako, da vialo delno obrnete.
4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Winthrop vial.
4. 1. 3 Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo zdravila Docetaxel Winthrop.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
4. 1. 4 Odstranite injekcijsko brizgo in iglo ter ročno premešajte tako, da vialo ponavljaje obračate vsaj 45 sekund.
96 4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25 °C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Nato preverite, ali je raztopina homogena in bistra (zaradi polisorbata 80, ki je v pripravku, je penjenje tudi še po 5 minutah normalno).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between + 2 °C and + 8 °C or at room temperature (below 25 °C).
Vendar je osnovna raztopina dokazano kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25 °C).
4.2 Preparation of the infusion solution
4. 2 Priprava raztopine za infundiranje
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
4. 2. 1 Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala z osnovno raztopino.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Glede na odmerek (izražen v mg), ki ga potrebuje bolnik, aseptično izvlecite ustrezno količino osnovne raztopine z 10 mg docetaksela/ ml iz ustreznega števila vial z osnovno raztopino; uporabite graduirane injekcijske brizge z iglo.
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
4. 2. 2 Potrebno količino osnovne raztopine vbrizgajte v 250- ml infuzijsko vrečko ali steklenico, v kateri je 5% raztopina glukoze ali 0, 9% raztopina natrijevega klorida.
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ ml docetaxel is not exceeded.
Če je potrebni odmerek večji od 200 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncentracije docetaksela 0, 74 mg / ml.
4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
4. 2. 3 Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjem sem in tja.
4.2.4 The Docetaxel Winthrop infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
Aplicirati jo je treba aseptično v 1- urni infuziji, pri sobni temperaturi (do 25 °C) in v pogojih običajne svetlobe.
4.2.5 As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
4. 2. 5 Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje Docetaxel Winthrop pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
INFORMATION FOR THE USER Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion docetaxel
99 NAVODILO ZA UPORABO Docetaxel Winthrop 80 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
99 Take special care with Docetaxel Winthrop
100 Bodite posebno pozorni pri uporabi zdravila Docetaxel Winthrop
Docetaxel Winthrop will be administered to you by a healthcare professional.
Docetaxel Winthrop vam bo dal pristojni zdravstveni delavec.
100 Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Winthrop.
Zdravnik bo morda spremenil odmerek in pogostnost odmerjanja glede na izvide vaših preiskav krvi,
Very common (experienced in more than 1 in 10 patients): • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets • fever: if this happens you must tell your doctor immediately • allergic reactions as described above • loss of appetite (anorexia) • insomnia • feeling of numbness or pins and needles or pain in the joints of muscles • headache • alteration in sense of taste • inflammation of the eye or increased tearing of the eyes • swelling caused by faulty lymphatic drainage • shortness of breath • nasal drainage; inflammation of the throat and nose; cough • bleeding from the nose • sores in the mouth • stomach upsets including nausea, vomiting and diarrhea, constipation • abdominal pain
Zelo pogosto (pojavijo se pri več kot 1 od 10 bolnikov): • okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov • zvišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku • alergijske reakcije, kot so opisane zgoraj • izguba apetita (anoreksija) • nespečnost • občutek omrtvelosti, mravljinčenje ali bolečine v sklepih ali mišicah • glavobol • spremenjeno okušanje • vnetje oči ali močnejše solzenje • otekanje zaradi nepravilne limfatične drenaže • težko dihanje • izcedek iz nosu, vnetje žrela in nosu, kašelj • krvavitev iz nosu • razjede v ustih • draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje • bolečine v trebuhu • želodčne težave • kratkotrajna izguba las in dlak (večinoma se obnovi njihova normalna rast) • pordelost in otekanje dlani ali podplatov, ki lahko povzroči olupljenje kože (to se lahko pojavi
101 • indigestion • short term hair loss (in most cases normal hair growth should return) • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) • change in the color of your nails, which may detach • muscle aches and pains; back pain or bone pain • change or absence of menstrual period • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
102 tudi na rokah, obrazu ali telesu) • sprememba barve nohtov, ki lahko odstopijo • bolečine v mišicah, bolečine v hrbtu ali kosteh • spremembe ali izostanek menstruacije • otekanje dlani, stopal, nog • utrujenost ali gripi podobni simptomi • povečanje ali zmanjšanje telesne mase.
Each ml of docetaxel solution contains 40 mg of docetaxel
En ml raztopine docetaksela vsebuje 40 mg brezvodnega docetaksela.
anhydrous.
Ena viala vsebuje 80 mg docetaksela.
One vial contains 80 mg docetaxel.
Pomožna snov je polisorbat 80.
- The other ingredient is polysorbate 80.
103 Kaj vsebuje viala z vehiklom:
What Docetaxel Winthrop looks like and contents of the pack Docetaxel Winthrop 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.
Izgled zdravila in vsebina pakiranja Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje je bistra viskozna, rumena do rjavo- rumena raztopina.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Enpretisni omot vsebuje: • eno eno- odmerno vialo koncentrata in • eno eno- odmerno vialo vehikla.
Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Norge Deutschland sanofi- aventis Norge AS sanofi- Aventis Deutschland GmbH Tlf: +47 67 10 71 00 Tel: +49 (0) 180 2 222010
103 Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Eesti Österreich sanofi- aventis Estonia OÜ Tel: +372 627 34 88
Portugal sanofi-aventis - Produtos Farmacêuticos, S. A.
104 Portugal España sanofi- aventis - Produtos Farmacêuticos, S. A. sanofi- aventis, S. A.
104 The following information is intended for medical or healthcare professionals only:
105 Naslednje informacije so namenjene samo zdravstvenemu osebju:
PREPARATION GUIDE FOR USE WITH Docetaxel Winthrop 80 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR Docetaxel Winthrop
NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE DOCEATXEL WINTHROP 80 mg IN VEHIKLA ZA DOCETAXEL WINTHROP
It is important that you read the entire contents of this procedure prior to the preparation of either the Docetaxel Winthrop premix solution or the Docetaxel Winthrop infusion solution
Pomembno je, da pred pripravo osnovne raztopine Docetaxel Winthrop ali raztopine za infundiranje Docetaxel Winthrop v celoti preberete ta navodila.
Docetaxel Winthrop 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ ml docetaxel (anhydrous) in polysorbate 80.
Docetaxel Winthrop 80 mg koncentrat za raztopino za infundiranje je bistra, viskozna, rumena do rjavorumena raztopina, ki vsebuje 40 mg brezvodnega docetaksela/ ml v polisorbatu 80.
Docetaxel Winthrop is supplied as single-dose vials.
OPREMA Docetaxel Winthrop je na voljo v vialah z enim odmerkom.
Each box contains one Docetaxel Winthrop vial (80 mg) and one corresponding solvent for Docetaxel Winthrop vial in a blister pack.
Vsaka škatla vsebuje eno vialo zdravila Docetaxel Winthrop (80 mg) in eno vialo ustreznega vehikla za Docetaxel Winthrop v pretisnem omotu.
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Zdravila Docetaxel Winthrop 80 mg ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in vialah.
2.1 Docetaxel Winthrop 80 mg vial
• Viala Docetaxel Winthrop 80 mg je 15- ml viala iz prozornega stekla z rdečo dvižno zaporko.
• The Docetaxel Winthrop 80 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Viala Docetaxel Winthrop 80 mg vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ ml.
• Each Docetaxel Winthrop 80 mg vial contains 2.0 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Ena viala Docetaxel Winthrop 80 mg vsebuje 2, 0 ml raztopine docetaksela 40 mg/ ml v polisorbatu 80 (polnilni volumen:
2.2 Solvent for Docetaxel Winthrop 80 mg vial
2. 2 Viala z vehiklom za Docetaxel Winthrop 80 mg:
• The solvent for Docetaxel Winthrop 80 mg vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
• Viala z vehiklom za Docetaxel Winthrop 80 mg je 15- ml steklena viala iz prozornega stekla s prosojno, brezbarvno dvižno zaporko.
• Each solvent for Docetaxel Winthrop 80 mg vial contains 7.33 ml.
• Vsaka viala z vehiklom za Docetaxel Winthrop 80 mg vsebuje 7, 33 ml vehikla.
This volume has been established based on the fill volume of the Docetaxel Winthrop 80 mg vial.
Ta količina je določena glede na polnilni volumen viale Docetaxel Winthrop 80 mg.
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 80 mg vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dodatek celotne vsebine viale z vehiklom vsebini viale Docetaxel Winthrop 80 mg zagotavlja koncentracijo 10 mg/ ml docetaksela v osnovni raztopini.
105 3.
106 3.
106 4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25 °C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Nato preverite, ali je raztopina homogena in bistra (zaradi polisorbata 80, ki je v pripravku, je penjenje tudi še po 5 minutah normalno).
EPAR summary for the public
Povzetek Evropskega javnega poročila o oceni zdravila za javnost
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o svojem zdravstvenem stanju ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del Evropskega javnega poročila o oceni zdravila) ali se posvetujte s svojim zdravnikom ali farmacevtom.