natgillin/translations-raw huggingface dataset:
Du bør fortælle det til din læge, hvis: du tager medicin for Parkinsons sygdom du tager depressionsmidler, angstdæmpende midler eller sovemedicin.
Tell your doctor if:  you are taking medicines for Parkinson’ s disease,  you are taking antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Du kan føle dig døsig hvis Zalasta tages samtidig med disse typer af medicin. du tager fluvoxamin (et antidepressivt middel) eller ciprofloxacin (et bakteriedræbende middel), da det kan blive nødvendigt at ændre din Zalasta dosis.
You might feel drowsy if Zalasta is taken in combination with these medicines,  if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change your Zalasta dose.
Hvis Zalasta og alkohol tages samtidig, kan du blive døsig.
Taking Zalasta with food and drink Zalasta may be taken with or without food.
Graviditet og amning Spørg Deres/ din læge eller apoteket til råds, før De/ du tager nogen form for medicin.
Do not drink any alcohol if you have been given Zalasta as Zalasta and alcohol together may make you feel drowsy.
Graviditet Informer din læge hurtigst muligt, hvis du er gravid eller tror, du er gravid.
Pregnancy Tell your doctor as soon as possible if you are pregnant or think you may be pregnant.
Amning Du bør ikke få denne medicin, mens du ammer, da små mængder Zalasta kan overføres til modermælken.
Breast-feeding You should not be given this medicine when breast-feeding, as small amounts of Zalasta can pass into breast milk.
Trafik - og arbejdssikkerhed Der er risiko for døsighed, når du får Zalasta.
Driving and using machines There is a risk of feeling drowsy when you are given Zalasta.
Vigtig information om nogle af de øvrige indholdsstoffer i Zalasta Zalasta indeholder lactose.
Important information about some of the ingredients of Zalasta Zalasta contains lactose.
195 3.
195 3.
SÅDAN SKAL DE/ DU TAGE ZALASTA
HOW TO TAKE ZALASTA
Tag altid Zalasta nøjagtigt efter lægens anvisning.
Always take Zalasta exactly as your doctor has told you.
Dagsdosis for Zalasta er 5- 20 mg.
The daily dose of Zalasta is between 5 – 20 mg.
Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Zalasta medmindre, at din læge siger det.
Consult your doctor if your symptoms return but do not stop taking Zalasta unless your doctor tells you to.
Zalasta overtrukne tabletter er til at synke.
You should swallow the tablets whole with water.
Hurtig hjerterytme, ophidselse/ aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
If you take more Zalasta than you should Patients who have taken more Zalasta than they should, have experienced the following symptoms: rapid beating of the heart, agitation/ aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Hvis De/ du har glemt at tage Zalasta Tag dine tabletter lige så snart, du kommer i tanke om det.
If you forget to take Zalasta Take your tablets as soon as you remember.
Hvis De/ du holder op med at tage Zalasta Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
If you stop taking Zalasta Do not stop taking your tablets just because you feel better.
Spørg lægen eller apoteket, hvis der er noget, De/ du er i tvivl om eller føler Dem/ dig usikker på.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Meget almindelig (forekommer hos 1 af 10 patienter)
Like all medicines, Zalasta can cause side effects, although not everybody gets them.
Forhøjede niveauer af prolaktin i blodet.
Very common side effects: affect 1 user in 10  Weight gain.  Sleepiness.  Increases in the levels of prolactin in the blood.
Problemer med at tale.
Common side effects: affect 1 to 10 users in 100  Changes in the levels of some blood cells and circulating fats.  Increases in the level of sugars in the blood and urine.  Feeling more hungry.  Dizziness.  Restlessness.  Tremor.
I begyndelsen af behandlingen kan nogle patienter føle svimmelhed eller svaghed (med langsom hjertefrekvens), særlig når man rejser sig fra liggende eller siddende stilling.
196  Muscle stiffness or spasm (including eye movements).  Problems with speech.  Unusual movement (especially of the face or tongue).  Constipation.  Dry mouth.  Rash.  Loss of strength.  Extreme tiredness.  Water retention leading to swelling of the hands, ankles or feet.  In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Ikke almindelig (forekommer hos 1 til 10 af 1. 000 patienter)
Uncommon side effects: affect 1 to 10 users in 1,000  Slow heart rate.  Make you sensitive to sunlight.  Hair loss.
Hårtab.
Rare side effects: affect 1 to 10 users in 10,000  Male or female breast enlargement.
Sukkersyge eller forværring af sukkersyge, af og til ledsaget af ketoacidose (ketonstoffer i blodet og urin) eller bevidstløshed.
Other possible side effects: frequency cannot be estimated from the available data.  Allergic reaction (e. g. swelling in the mouth and throat, itching, rash).  Diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma.  Lowering of normal body temperature.  Seizures, usually associated with a history of seizures (epilepsy).  Combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.  Spasms of the muscle of the eye causing rolling movement of the eye.  Abnormal rhythms of the heart.  Sudden unexplained death.  Blood clots such as deep venous thrombosis of the leg or blood clot on the lung.  Inflammation of the pancreas causing severe stomach pain, fever and sickness.  Liver disease appearing as yellowing of the skin and white parts of the eyes.  Muscle disease presenting as unexplained aches and pains.  Difficulty in passing urine.  Prolonged and/ or painful erection.
I sjældne tilfælde har lægemidler af denne type efter langvarig anvendelse hos kvinder forårsaget, at mælken løber til, at menstruationen udebliver eller menstruationens regelmæssighed ændres.
Rarely women taking medicines of this type for a long time have started to secrete milk and have missed periods or had irregular periods.
Børn af mødre, som har taget Zalasta i den sidste del af graviditeten (3. trimester), kan i meget sjældne tilfælde ryste, være søvnige eller sløve.
Very rarely babies born to mothers who have taken Zalasta in the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or drowsy.
SÅDAN OPBEVARER DE/ DU ZALASTA
HOW TO STORE ZALASTA
197 Opbevares utilgængeligt for børn.
197 Keep out of the reach and sight of children.
Udløbsdato Brug ikke Zalasta efter den udløbsdato, der står på pakningen.
Do not use Zalasta after the expiry date which is stated on the packaging.
YDERLIGERE OPLYSNINGER
What Zalasta contains
Zalasta indeholder - Aktivt stof:
- The active substance is olanzapine.
Olanzapin.
20 mg olanzapine.
Hver Zalasta tablet indeholder enten 2, 5 mg, 5 mg, 7, 5 mg, 10 mg, 15 mg eller 20 mg olanzapin. - Øvrige indholdstoffer: Alfa lactosemonohydrat, pulveriseret cellulose, prægelatiniseret majsstivelse, majsstivelse, kolloid vandfri silica, magnesium stearat.
starch, maize starch, colloidal anhydrous silica, magnesium stearate.
Zalastas udseende og pakningsstørrelse Zalasta 2, 5 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker.
What Zalasta looks like and contents of the pack Zalasta 2.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Zalasta 5 mg tabletter er runde, let bikonveks e, svagt gule med mulighed for individuelle gule prikker og påtrykt ’ 5 ’.
Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 5.
Zalasta 7, 5 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt ’ 7, 5 ’.
Zalasta 7.5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 7.5.
Zalasta 10 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt ’ 10 ’.
Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 10.
Zalasta 15 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt ’ 15 ’.
Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Zalasta 20 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt ’ 20 ’.
Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Zalasta 2, 5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 7, 5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 10 mg tabletter fås i pakker med 7, 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 10 mg tablets: available in boxes of 7, 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 15 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Zalasta 20 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
Indehaveren af markedsføringstilladelsen og fremstiller KRKA, d. d., Novo mesto, Šmarješ cesta 6, 8501 Novo mesto, Slovenien ka
Marketing Authorisation Holder KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka
Fremstiller 1.
Manufacturer 1.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenien ka 2.
KRKA, d. d., Novo mesto, Š marješ cesta 6, 8501 Novo mesto, Slovenia ka 2.
Równoległ5, 02- 235 Warsaw, Polen a
Równoległ 5, 02-235 Warsaw, Poland a
Hvis De/ du vil have yderligere oplysninger om Zalasta skal De/ du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Luxembourg/ Luxemburg KRKA, d. d., Novo mesto Tel.: + 32 (0) 3 321 63 52
Luxembourg KRKA, d. d., Novo mesto Tel.: + 32 3 321 63 52 (BE)
ъ гр я KRKA, d. d., Novo mesto
198 Б л аи ъ гр я KRKA, d. d., Novo mesto Teл + 359 (02) 962 34 50
Tel.: + 361 (0) 3558490
.:
Česká republika KRKA, zastoupení pro Č R Tel.: +420 (0) 221 115 115
Č eská republika KRKA, zastoupení pro Č R Tel.: +420 (0)221 115 115 Danmark KRKA Sverige AB Tel: + 46 8 643 67 66 (SE) Deutschland TAD Pharma GmbH Tel.: +49 (0) 4721 6060 Eesti KRKA, d. d., Novo mesto Tel.: + 372 6 597 365 Ε λδ
Tel.: + 353 (0) 86 3838 282 (IE)
Tel.: + 361 (0)3558490 Malta KRKA Pharma Dublin, Ltd.
Nederland KRKA, d. d., Novo mesto Tel.: + 32 3 321 63 52 (BE)
Tel.: + 353 (0)86 3838 282 (IE) Nederland KRKA, d. d., Novo mesto Tel.: + 32 3 321 63 52 (BE) Norge KRKA Sverige AB Tel: + 46 8 643 67 66 (SE) Österreich KRKA, d. d., Novo mesto Tel.: +49 (0)1754 11 7697
Eesti Österreich KRKA, d. d., Novo mesto Tel.: + 372 (0) 6 597 365
λά α KRKA, d. d., Novo mesto Tel.: +30 (0)210 9581143 España KRKA, d. d., Novo mesto Tel.: +34 615 089809 France KRKA, d. d., Novo mesto Tel.: +33 557 021 923 Ireland KRKA Pharma Dublin, Ltd.
λά α KRKA, d. d., Novo mesto Tel.: +30 (0) 210 9581143
Tel.: + 353 (0)86 3838 282 Ísland KRKA Sverige AB Tel: + 46 8 643 67 66 Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κ πο
Tel.: + 351 (0) 91 727 2035
Tel.: +48 (0)22 573 7503 Portugal KRKA Farmacêutica, Unipessoal Lda.
România KRKA, d. d., Novo mesto Tel.: + 402 (0) 1 310 66 05
Tel.: + 351 (0)21 46 88 115 România KRKA, d. d., Novo mesto Tel. :+ 402 (0)1 310 66 05 Slovenija KRKA, d. d., Novo mesto Tel: + 386 (0)7 33 12 111 Slovenská republika KRKA, d. d., Slovensko o. z.
Suomi/ Finland KRKA Sverige AB Tel: + 46 8 643 67 66
Tel: +421 (0)257104504 Suomi/ Finland KRKA Sverige AB Tel: + 46 8 643 67 66
πο KRKA, d. d., Novo mesto Tel: +30 (0) 210 9581143 (EL)
ύρς KRKA, d. d., Novo mesto Tel: +30 (0)210 9581143 (EL) Latvija KRKA, d. d., Novo mesto Tel.: +371 (0)733 8610 Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0)2 362 742
Lietuva KRKA, d. d., Novo mesto Tel.: +370 (0) 2 362 742
This leaflet was last approved in
199 INDLÆGSSEDDEL:
199 PACKAGE LEAFLET:
Zalasta 5 mg, smeltetabletter Zalasta 7, 5 mg, smeltetabletter Zalasta 10 mg, smeltetabletter Zalasta 15 mg, smeltetabletter Zalasta 20 mg, smeltetabletter Olanzapin
Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets Olanzapine
Hvis du lider af en af de følgende sygdomme, skal du fortælle det til din læge hurtigst muligt:
200 If you suffer from any of the following illnesses tell your doctor as soon as possible: ─ Diabetes ─ Heart disease ─ Liver or kidney disease ─ Parkinson’ s disease ─ Epilepsy ─ Prostate problems ─ A blocked intestine (paralytic ileus) ─ Blood disorders ─ Stroke or “ mini” stroke (temporary symptoms of stroke).
Brug af Zalasta sammen med mad og drikke Zalasta kan tages med eller uden indtagelse af føde.
Taking Zalasta with food and drink Zalasta may be taken with or without food.
Vigtig information om nogle af de øvrige indholdsstoffer i Zalasta Zalasta indeholder indeholder aspartam, som indeholder phenylalanin.
Important information about some of the ingredients of Zalasta Zalasta contains a source of phenylalanine.
Din læge vil fortælle dig, hvor mange Zalasta tabletter, du skal tage og i hvor lang tid, du skal tage dem.
201 Your doctor will tell you how many Zalasta tablets to take and how long you should continue to take them.
Hvordan du tager Zalasta Zalasta tabletter knækker let, så du bør tage forsigtigt på tabletterne.
How to take Zalasta Zalasta tablets break easily, so you should handle the tablets carefully.
Du kan også lægge tabletten i et glas vand, og drikke den med det samme.
Drink it straight away.
202 Spørg lægen eller apoteket, hvis der er noget, De/ du er i tvivl om eller føler Dem/ dig usikker på.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Meget almindelig (forekommer hos 1 af 10 patienter)
202 Like all medicines, Zalasta can cause side effects, although not everybody gets them.
I begyndelsen af behandlingen kan nogle patienter føle svimmelhed eller svaghed (med langsom hjertefrekvens), særlig når man rejser sig fra liggende eller siddende stilling.
Common side effects: affect 1 to 10 users in 100  Changes in the levels of some blood cells and circulating fats.  Increases in the level of sugars in the blood and urine.  Feeling more hungry.  Dizziness.  Restlessness.  Tremor.  Muscle stiffness or spasm (including eye movements).  Problems with speech.  Unusual movement (especially of the face or tongue).  Constipation.  Dry mouth.  Rash.  Loss of strength.  Extreme tiredness.  Water retention leading to swelling of the hands, ankles or feet.  In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
203
203 While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Forlænget og/ eller pinefuld erektion.
Some fatal cases have been reported in this particular group of patients.
Zalasta indeholder
Each orodispersible tablet contains 5 mg, 7.5 mg, 10 mg,
Olanzapin.
15 mg or 20 mg olanzapine.
Hver smeltetablet indeholder enten 5 mg, 7, 5 mg, 10 mg, 15 mg eller 20 mg olanzapin. - Øvrige indholdstoffer:
- The other ingredients are mannitol, microcrystalline cellulose, crospovidone, low-substituted
Mannitol, microkrystallinsk cellulose, crospovidon, lavt substitueret hydroxypropylcellulose, aspartam, kalciumsilikat, magnesium stearate.
hydroxypropylcellulose, aspartame, calcium silicate, magnesium stearate.
Zalastas udseende og pakningsstørrelse Zalasta smeltetabletter 5 mg, 7, 5 mg, 10 mg, 15 mg eller 20 mg er gule, runde, let bikonvekse, marmorerede tabletter med mulighed for individuelle pletter.
What Zalasta looks like and contents of the pack Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets are: round, slightly biconvex, yellow marbled tablets with possible individual spots.
Zalasta 20 mg smeltetabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blisterpakker.
Zalasta 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister packs.
204 Hvis De/ du vil have yderligere oplysninger om Zalasta skal De/ du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/ Belgique/ Belgien KRKA, d. d., Novo mesto Tel.: + 32 (0) 3 321 63 52
204 België/ Belgique/ Belgien KRKA, d. d., Novo mesto Tel.: + 32 (0)3 321 63 52 Б л аи
ъ гр я KRKA, d. d., Novo mesto Tel.: + 359 (02) 962 34 50
ъ гр я KRKA, d. d., Novo mesto Teл + 359 (02) 962 34 50
Magyarország KRKA Képviselet Tel.: + 361 (0) 3558490
Magyarország KRKA Képviselet
Deutschland TAD Pharma GmbH Tel.: +49 (0) 4721 6060 Eesti KRKA, d. d., Novo mesto Tel.: + 372 (0) 6 597 365
λά α KRKA, d. d., Novo mesto Tel.: +30 (0)210 9581143 España KRKA, d. d., Novo mesto Tel.: +34 615 089809 France KRKA, d. d., Novo mesto Tel.: +33 557 021 923 Ireland KRKA Pharma Dublin, Ltd.
Norge KRKA Sverige AB Tel: + 46 8 643 67 66 (SE) Österreich KRKA, d. d., Novo mesto Tel.: +49 (0) 1754 11 7697
Tel.: + 353 (0)86 3838 282 Ísland KRKA Sverige AB Tel: + 46 8 643 67 66 Italia KRKA, d. d., Novo mesto Tel.: +39 069448827 Κ πο
Latvija KRKA, d. d., Novo mesto
Tel.: + 353 (0)86 3838 282 (IE)
United Kingdom KRKA Pharma Dublin, Ltd.
This leaflet was last approved in
205 Tel.: +371 (0) 733 8610
205
Zarzio er et ” biosimilært ” lægemiddel.
Zarzio is a ‘ biosimilar’ medicine.
Det betyder, at Zarzio svarer til et biologisk lægemiddel, som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kendt som "referencelægemidlet").
This means that Zarzio is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Zarzio anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:  til at reducere varigheden af neutropeni (lavt antal af neutrofiler, en type hvide blodlegemer) og forekomsten af febril neutropeni (neutropeni med feber) hos patienter, der får kemoterapi (kræftbehandling), som er cytotoksisk (celledræbende)  til at reducere varigheden af neutropeni hos patienter, der er under behandling for at tilintetgøre knoglemarvsceller inden en knoglemarvstransplantation (som for eksempel hos visse patienter med leukæmi), hvis der er risiko for, at de får langvarig svær neutropeni  til at øge neutrofiltallet og reducere risikoen for infektion (betændelse) hos patienter med neutropeni, der gentagne gange tidligere har haft alvorlige infektioner  til at behandle vedvarende neutropeni hos patienter med fremskreden hiv- infektion for at reducere risikoen for bakterielle infektioner, når andre behandlingsmuligheder ikke er hensigtsmæssige.
Zarzio is used to stimulate the production of white blood cells in the following situations:  to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);  to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;  to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;  to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Zarzio gives sædvanligvis på et specialiseret behandlingscenter, selvom de patienter, der får lægemidlet gennem injektion under huden, selv kan give injektionerne, når de først er blevet behørigt instrueret heri.
Zarzio is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Det aktive stof i Zarzio, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G- CSF).
The active substance in Zarzio, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængigt af hvilken lidelse Zarzio anvendes mod.
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Zarzio is being used for.
Den fuldstændige liste over de indberettede bivirkninger ved Zarzio fremgår af indlægssedlen.
For the full list of all side effects reported with Zarzio, see the Package Leaflet.
Zarzio bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for filgrastim eller andre af indholdsstofferne.
Zarzio should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Zarzio i overensstemmelse med EU’ s krav har en kvalitets -, sikkerheds - og effektprofil, der svarer til Neupogens.
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Zarzio has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Andre oplysninger om Zarzio:
Other information about Zarzio:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zarzio til Sandoz GmbH den 06. februar 2009.
The European Commission granted a marketing authorisation valid throughout the EU for Zarzio to Sandoz GmbH on 06 February 2009.
Den fuldstændige EPAR for Zarzio findes her.
The full EPAR for Zarzio can be found here.
E/ 0, 5 ml injektionsvæske eller infusionsvæske, opløsning i fyldt injektionssprøjte.
Zarzio 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe
E/ 0, 5 ml.
Zarzio is available in strengths of 30 MU/ 0.5 ml and 48 MU/ 0.5 ml.
Zarzio indeholder sorbitol og bør ikke anvendes hos patienter med hereditær fructose- intolerans.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
9 4.5 Interaction with other medicinal products and other forms of interaction
I betragtning af de hurtigt delende myeloide cellers følsomhed over for
The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established.