natgillin/translations-raw huggingface dataset:
België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B-1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32-(0)2 370 92 11
79 België/ Belgique/ Belgien Rue de Stalle/ Stallestraat 73 B- 1180 Bruxelles/ Brussel/ Brüssel Tél/ Tel: + 32 - (0) 2 370 92 11
81 PACKAGE LEAFLET:
81 NAVODILO ZA UPORABO
What Neoclarityn orodispersible tablet is and what it is used for 2.
Kaj je zdravilo Neoclarityn orodisperzibilna tableta in za kaj jo uporabljamo 2.
Before you take Neoclarityn orodispersible tablet 3.
Kaj morate vedeti, preden boste uporabili zdravilo Neoclarityn orodisperzibilna tableta 3.
How to take Neoclarityn orodispersible tablet 4.
Kako jemati zdravilo Neoclarityn orodisperzibilna tableta 4.
How to store orodispersible tablet 6.
Shranjevanje zdravila Neoclarityn orodisperzibilna tableta 6.
WHAT NEOCLARITYN ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO NEOCLARITYN ORODISPERZIBILNA TABLETA IN ZA KAJ GA UPORABLJAMO
Neoclarityn orodispersible tablet is an antiallergy medicine that does not make you drowsy.
Neoclarityn orodisperzibilna tableta je zdravilo proti alergiji, ki ne povzroča zaspanosti.
Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Neoclarityn orodisperzibilna tableta lajša simptome alergijskega rinitisa (vnetje nosnih poti zaradi alergije, na primer seneni nahod ali alergija na pršice).
Neoclarityn orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn orodisperzibilna tableta se uporablja tudi za lajšanje simptomov urtikarije, (težave s kožo zaradi alergije).
BEFORE YOU TAKE NEOCLARITYN ORODISPERSIBLE TABLET
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO NEOCLARITYN ORODISPERZIBILNA TABLETA
Do not take Neoclarityn orodispersible tablet:
Ne uporabljajte zdravila Neoclarityn orodisperzibilna tableta
Neoclarityn orodispersible tablet, or to loratadine.
orodisperzibilna tableta ali loratadin.
Neoclarityn 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Neoclarityn 2, 5 mg orodisperzibilna tableta je indiciran za zdravljenje odraslih in otrok (starost 6 let ali več).
Take special care with Neoclarityn orodispersible tablet
Bodite posebno pozorni pri uporabi zdravila Neoclarityn orodisperzibilna tableta
82 Neoclarityn orodispersible tablet does not need to be taken with water or liquid.
82 Jemanje zdravila Neoclarityn orodisperzibilna tableta skupaj s hrano in pijačo Zdravila Neoclarityn orodisperzibilna tableta vam ni treba jemati z vodo ali tekočino.
Additionally, Neoclarityn orodispersible tablet may be taken with or without a meal.
Neoclarityn orodisperzibilno tableto lahko tudi zaužijete z ali brez hrane.
If you are pregnant or nursing a baby taking Neoclarityn is not recommended.
Če ste noseči ali če dojite otroka vam ne priporočamo uporabe zdravila Neoclarityn.
Important information about some of the ingredients of Neoclarityn orodispersible tablet This product contains aspartame.
Pomembne informacije o nekaterih sestavinah zdravila Neoclarityn orodisperzibilna tableta To zdravilo vsebuje aspartam.
HOW TO TAKE NEOCLARITYN ORODISPERSIBLE TABLET
KAKO JEMATI ZDRAVILO NEOCLARITYN ORODISPERZIBILNA TABLETA
Children 6 to 11 years of age: take one 2.5 mg Neoclarityn orodispersible tablet once a day.
Otroci, stari od 6 do 11 let, naj jemljejo eno 2, 5 mg orodisperzibilno tableto zdravila Neoclarityn enkrat na dan.
Adults and adolescents (12 years of age and older): take two 2.5 mg Neoclarityn orodispersible tablets once a day.
Zaužijte dva odmereka zdravila Neoclarityn 2, 5 mg orodisperzibilna tableta enkrat na dan.
However, if you take more Neoclarityn orodispersible tablet than you were told to, contact your doctor or pharmacist.
Pri naključnem prevelikem odmeranju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Neoclarityn orodisperzibilna tableta kot bi morali, posvetujte s svojim zdravnikom ali farmacevtom.
If you forget to take Neoclarityn orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Če ste pozabili vzeti zdravilo Neoclarityn orodisperzibilna tableta Če ste pozabili vzeti odmerek pravočasno, ga vzemite čimprej, potem pa nadaljujte z ustaljenim režimom odmerjanja.
Like all medicines, Neoclarityn can cause side effects although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Neoclarityn neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
However, fatigue, dry mouth and headache
Pri odraslih je bila pogostnost neželenih učinkov pri jemanju zdravila Neoclarityn približno enaka kot pri jemanju tablet placeba, vendar so pri njih pogosteje poročali o pojavu utrujenosti, suhih ust in glavobola med jemanjem zdravila kot med jemanjem tablet placeba.
HOW TO STORE NEOCLARITYN ORODISPERSIBLE TABLET
SHRANJEVANJE ZDRAVILA NEOCLARITYN ORODISPERZIBILNA TABLETA
Do not use Neoclarityn orodispersible tablet after the expiry date which is stated on the carton and blister.
Zdravila Neoclarityn orodisperzibilna tableta ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
Tell your pharmacist if you notice any change in the appearance of Neoclarityn orodispersible tablet.
Ne uporabljajte zdravila Neoclarityn orodisperzibilna tableta, če opazite kakršnekoli spremembe videza.
What Neoclarityn orodispersible tablet looks like and contents of the pack
Izgled zdravila orodisperzibilna tableta in vsebina pakiranja
Neoclarityn 2.5 mg orodispersible tablet is light red, speckled, and round with “ K” branded on one side.
Neoclarityn 2, 5 mg orodisperzibilne tablete so svetlo rdeče okrogle pikčaste tablete z oznako ″ K ″ na eni strani.
France 34 avenue Léonard de Vinci F-92400 Courbevoie Tél: + 33-(0)1 80 46 40 40
85 France 34 avenue Léonard de Vinci F- 92400 Courbevoie Tél: + 33 - (0) 1 80 46 40 40
86 PACKAGE LEAFLET:
86 NAVODILO ZA UPORABO
How to store Neoclarityn orodispersible tablet 6.
Shranjevanje zdravila Neoclarityn orodisperzibilna tableta 6.
Do not take Neoclarityn orodispersible tablet
Ne uporabljajte zdravila Neoclarityn orodisperzibilna tableta
Neoclarityn 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Neoclarityn 5 mg orodisperzibilna tableta je indiciran za zdravljenje odraslih in mladostnikov (starost 12 let ali več).
Taking Neoclarityn orodispersible tablet with food and drink 87 Neoclarityn orodispersible tablet does not need to be taken with water or liquid.
87 Jemanje zdravila Neoclarityn orodisperzibilna tableta skupaj s hrano in pijačo Zdravila Neoclarityn orodisperzibilna tableta vam ni treba jemati z vodo ali tekočino.
Adults and adolescents (12 years of age and older): take one 5 mg Neoclarityn orodispersible tablet once a day.
Zaužijte en odmerek zdravila Neoclarityn 5 mg orodisperzibilna tableta enkrat na dan.
In adults, side effects were about the same as with a dummy tablet.
Pri odraslih je bila pogostnost neželenih učinkov pri jemanju zdravila Neoclarityn približno
However, fatigue, dry mouth and headache were reported more often than with a dummy tablet.
88 enaka kot pri jemanju tablet placeba, vendar so pri njih pogosteje poročali o pojavu utrujenosti, suhih ust in glavobola med jemanjem zdravila kot med jemanjem tablet placeba.
88 During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Med trženjem zdravila Neoclarityn so zelo redko poročali o primerih hudih alergijskih reakcij (težave z dihanjem, piskajoče in sopihajoče dihanje, srbenje, koprivnica in otekanje) ter izpuščajev.
Neoclarityn 5 mg orodispersible tablet is light red, speckled, and round with “ A” branded on one side.
Neoclarityn 5 mg orodisperzibilne tablete so svetlo rdeče okrogle pikčaste tablete z oznako ″ A ″ na eni strani.
Neoclarityn orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Neoclarityn orodisperzibilne tablete so na voljo v pretisnih omotih 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 in 100 orodisperzibilnih tablet.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
89 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44-(0)1 707 363 636
90 Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
Neoclarityn oral solution is an antiallergy medicine that does not make you drowsy.
Neoclarityn peroralna raztopina je zdravilo proti alergiji, ki ne povzroča zaspanosti.
Neoclarityn oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Ti simptomi vključujejo kihanje, srbenje nosu ali izcedek iz nosu, srbenje ustnega neba in oči, vnetje očesne veznice, rdeče ali solzne oči.
Neoclarityn oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn peroralna raztopina se uporablja tudi za lajšanje simptomov urtikarije, (težave s kožo zaradi alergije).
of Neoclarityn.
Neoclarityn.
Neoclarityn oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Zdravilo Neoclarityn peroralna raztopina je indiciran za zdravljenje otrok, starih od 1 do 11 let, mladostnikov (starost 12 let ali več) ter odraslih, vključno s starostniki.
92 Taking Neoclarityn with food and drink Neoclarityn may be taken with or without a meal.
92 Uporaba zdravila Neoclarityn skupaj s hrano in pijačo Neoclarityn se lahko jemlje s hrano ali brez nje.
If you are pregnant or nursing a baby, taking Neoclarityn oral solution is not recommended.
Če ste noseči ali če dojite otroka vam ne priporočamo uporabe zdravila Neoclarityn.
Important information about some of the ingredients of Neoclarityn Neoclarityn oral solution contains sorbitol.
Pomembne informacije o nekaterih sestavinah zdravila Neoclarityn Neoclarityn peroralna raztopina vsebuje sorbitol.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Neoclarityn oral solution.
Kar zadeva trajanje zdravljenja, bo vaš zdravnik najprej ugotovil vrsto alergijskega rinitisa, ki jo imate, in na podlagi tega določil, kako dolgo naj bi jemali zdravilo Neoclarityn peroralna raztopina..
If you take more Neoclarityn than you should Take Neoclarityn oral solution only as it is prescribed for you.
Če ste vzeli večji odmerek zdravila Neoclarityn, kot bi smeli Zdravilo Neoclarityn peroralna raztopina jemljite le tako, kot vam je bilo predpisano.
However, if you take more Neoclarityn oral solution than you were told to, contact your doctor or pharmacist.
Pri naključnem prevelikem odmeranju zdravila ni pričakovati resnejših težav, kljub temu pa se v primeru, da ste zaužili več zdravila Neoclarityn peroralna raztopina, kot bi morali, posvetujte s svojim zdravnikom ali farmacevtom.
93 4.
93 4.
Like all medicines, Neoclarityn oral solution can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Neoclarityn peroralna raztopina neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
In most children and adults, side effects with Neoclarityn were about the same as with a dummy solution or tablet.
Pri večini otrok in odraslih so bili neželeni učinki pri jemanju zdravila Neoclarityn približno enaki kot pri jemanju peroralne suspenzije placeba ali tablet.
Marketing Authorisation Holder and Manufacturer
94 Imetnik dovoljenja za promet z zdravilom in izdelovalec
94 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Povzetek pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
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 vašem zdravstvenem stanju ali zdravljenju, preberite Navodila za uporabo (ki so prav tako sestavni del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če želite več informacij o podlagi za priporočila CHMP, preberite Znanstveno razpravo (ki je prav tako sestavni del EPAR).
NeoRecormon is a white powder and solvent in a vial, which is made up into a solution for injection.
Zdravilo NeoRecormon je bel prašek in vehikel v viali, za pripravo raztopine za injiciranje.
NeoRecormon is also available in a cartridge and a pre-filled syringe.
Zdravilo NeoRecormon je na voljo tudi v vložkih ali predhodno napolnjenih injekcijskih brizgah.
NeoRecormon exists in various strengths, from 1000 IU/ ml to 60,000 IU/ ml (see the Package Leaflet for full details).
Zdravilo NeoRecormon je na voljo v različnih jakostih, od 1. 000 i. e. / ml do 60. 000 i. e. / ml (celotne podrobnosti najdete v Navodilu za uporabo).
NeoRecormon contains the active ingredient epoetin beta.
Zdravilo NeoRecormon vsebuje zdravilno učinkovino epoetin beta.
NeoRecormon is used for the prevention or treatment of anaemia (fewer than normal red blood cells in the blood) of various causes.
Zdravilo NeoRecormon se uporablja za preprečevanje ali zdravljenje anemije (manjšega števila rdečih krvničk v krvi kot normalno), ki je posledica različnih vzrokov.
It may be used in babies, children, and adults depending on the cause of the anaemia: • Treating anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin • Preventing anaemia in premature babies • Treating anaemia in adult patients with cancer who are receiving chemotherapy (the medicines used for the treatment of cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
Uporabljati ga je dopustno pri dojenčkih, otrocih in odraslih, odvisno od vzrokov anemije: • zdravljenje anemije, povezane z dolgotrajno ledvično odpovedjo, če telo ne proizvaja dovolj naravnega hormona eritropoetina • preprečevanje anemije pri nedonošenčkih • zdravljenje anemije pri odraslih bolnikih z rakom, ki prejemajo kemoterapijo (zdravila, namenjena za zdravljenje raka), če kemoterapija kostnemu mozgu preprečuje tvorjenje zadostnega števila krvnih celic.
It can also be used in patients who are going to have an operation and donate their own blood before surgery (autologous blood transfusion) to increase the amount of blood that can be taken.
Uporabljati ga je mogoče tudi pri bolnikih, ki bodo imeli kirurški poseg in pred operacijo darujejo svojo lastno kri (avtologna transfuzija krvi), da bi tako povečali količino krvi, ko jo je mogoče odvzeti.
Please see the Package Leaflet for full details.
Celotne podrobnosti najdete v Navodilu za uporabo.
NeoRecormon can be given intravenously (injected into a vein) or subcutaneously (injected under the skin).
Zdravilo NeoRecormon se lahko daje intravensko (z injiciranjem v žilo) ali subkutano (z injiciranjem pod kožo).
A doctor who has experience in the care of patients with the types of anaemia NeoRecormon should start treatment with NeoRecormon.
Zdravljenje z zdravilom NeoRecormon mora vpeljati zdravnik z izkušnjami z zdravljenjem bolnikov s temi vrstami anemije.
The doses and dosage schedules (how often NeoRecormon is injected, and for how long) vary depending on why NeoRecormon is used, and are adjusted according to the response.
Odmerki in režim odmerjanja (kako pogosto se zdravilo NeoRecormon injicira in kako dolgo) so odvisni od razlogov za uporabo zdravila NeoRecormon ter se prilagajajo glede na odziv.
Please see the Package Leaflet for full details.
Celotne podrobnosti najdete v Navodilih za uporabo.
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Hormon, imenovan eritropoetin, spodbuja tvorbo rdečih krvničk iz kostnega mozga.
Epoetin beta, the active ingredient of NeoRecormon, is a copy of the erythropoietin found in the body.
Epoetin beta, zdravilna učinkovina zdravila NeoRecormon, je kopija eritropoetina, ki ga najdemo v telesu.
In patients receiving chemotherapy 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Epoetin beta se proizvaja po metodi, imenovani » tehnologija rekombinantne DNK «: izdela ga bakterija, ki je 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged or in patients with long-term kidney failure and other conditions, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged prejela gen (DNK), ki ji omogoča njegovo tvorjenje.
NeoRecormon works by stimulating production of red blood cells in the same way as erythropoietin.
Pri bolnikih, ki prejemajo kemoterapijo ali pri bolnikih z dolgotrajno ledvično odpovedjo in drugimi stanji, lahko anemija povzroči pomanjkanje eritropoetina ali nezadostna odzivnost telesa na eritropoetin, ki se naravno nahaja v telesu.
The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic kidney failure (1663 patients, including some comparative studies against placebo [dummy treatment]), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison to no treatment), and in cancer patients (1204 patients with different types of cancer, comparison with placebo).
Učinkovitost zdravila NeoRecormon pri zdravljenju ali preprečevanju anemije je bila preučevana v številnih raziskavah, ki so vključevale anemijo pri kronični ledvični odpovedi (1663 bolnikov, vključno z nekaterimi primerjalnimi raziskavami v primerjavi s placebom), avtologno transfuzijo krvi (419 bolnikov, primerjava s placebom), anemijo pri nedonošenčkih (177 dojenčkov, primerjava z stanjem brez zdravljenja) in bolniki z rakom (1204 bolniki z različnimi vrstami raka, primerjava s placebom).
The main measure of effectiveness in most clinical studies was whether NeoRecormon increased the red blood cells in the blood (by measuring haemoglobin levels, the protein found in red blood cells that carries oxygen around the body, or the volume of red cells), or reduced the need for blood transfusion.
Glavni pokazatelj učinkovitosti pri večini kliničnih raziskav je bil, ali je zdravilo NeoRecormon povečalo koncentracijo rdečih krvničk v krvi (z merjenjem ravni hemoglobina, proteina, ki ga najdemo v rdečih krvničkah in je prenašalec kisika v telesu, ali volumna rdečih krvničk) ali je zmanjšalo potrebo po transfuziji krvi.
What benefit has NeoRecormon shown during the studies?
Kakšne koristi je zdravilo NeoRecormon izkazalo med raziskavami?
NeoRecormon was significantly more effective than placebo (dummy treatment) at increasing haemoglobin levels in patients with various types of anaemia, including those with kidney disease.
Zdravilo NeoRecormon je bilo pri povečevanju ravni hemoglobina pomembno učinkovitejše od placeba pri bolnikih z različnimi vrstami anemije, vključno s tistimi z ledvičnim obolenjem.
It increases the amount of blood that can be taken from patients before surgery for autologous blood transfusion.
Zdravilo poveča količino krvi za avtologno transfuzijo, ki jo je mogoče odvzeti bolniku pred kirurškim posegom.
It reduces the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
Nadalje zmanjšuje potrebo po transfuziji pri nedonošenčkih in bolnikih z rakom, ki prejemajo kemoterapijo.
Most side effects occur in patients with chronic renal failure or cancer.
Največ neželenih stranskih učinkov se pojavlja pri bolnikih s kronično ledvično odpovedjo ali rakom.
The most common side effects are an increase in blood pressure or the worsening of an existing headache or hypertension (high blood pressure).
Najpogostejši neželeni stranski učinki so zvišanje krvnega pritiska ali poslabšanje obstoječega glavobola ali hipertenzija (visok krvni pritisk).
For the full description of the side effects reported with NeoRecormon, please see the Package Leaflet.
Celovit opis neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila NeoRecormon, najdete v Navodilih za uporabo.
NeoRecormon should not be used in people who may be hypersensitive (allergic) to epoetin beta or any of the other ingredients, and in patients who have poorly controlled high blood pressure.
Zdravilo NeoRecormon se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi (alergični) na epoetin beta ali katero drugo sestavino, ter pri bolnikih, ki imajo slabo nadzorovan visok krvni pritisk.
The Committee for Medicinal products for Human Use (CHMP) decided that NeoRecormon’ s benefits are greater than its risks to patients to treat and prevent various types of anaemia.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila NeoRecormon pri zdravljenju in preprečevanju različnih vrst anemije večje od z njim povezanih tveganj.
They recommended that NeoRecormon be given marketing authorisation.
Zato je priporočil odobritev dovoljenja za promet z zdravilom NeoRecormon.
Other information about NeoRecormon:
Druge informacije o zdravilu NeoRecormon:
The European Commission granted a marketing authorisation valid throughout the European Union, for NeoRecormon to Roche Registration Limited on 17 July 1997.
Evropska komisija je dovoljenje za promet z zdravilom NeoRecormon, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 17. julija 1997.
The Marketing Authorisation was renewed on 17 July 2002.
Dovoljenje za promet z zdravilom je bilo podaljšano 17. julija 2002.
The full EPAR for NeoRecormon is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NeoRecormon je na voljo tukaj.
50000 IU
50. 000 i. e.
powder: multidose vial (glass); solvent: ampoule (glass)
prašek: večodmerna viala (steklo); vehikel: ampula (steklo)
Solution 5000 IU/ ml)
10 ml (rekonst. raztopina 5000 i. e. / ml)
100000 IU
100. 000 i. e.
Solution 20000 IU/ ml)
5 ml (rekonst. raztopina 20. 000 i. e. / ml)
10000 IU
10. 000 i. e.
powder and solvent: two- chamber cartridge (glass)
prašek in vehikel: dvoprekatni vložek (steklo)
Solution 10000 IU/ ml)
1 ml (rekonst. raztopina 10. 000 i. e. / ml)
20000 IU
20. 000 i. e.
Solution 20000 IU/ ml)
1 ml (rekonst. raztopina 2000 i. e. / ml)
0.3 ml (1667 IU/ ml)
0, 3 ml (1667 i. e. / ml)
0.3 ml (3333 IU/ ml)
0, 3 ml (3333 i. e. / ml)
0.3 ml (6667 IU/ ml)
0, 3 ml (6667 i. e. / ml)
3000 IU
3000 i. e.
0.3 ml (10000 IU/ ml)
0. 3 ml (10000 i. e. / ml)
5000 IU
5000 i. e.
0.3 ml (16667 IU/ ml)
0. 3 ml (16667 i. e. / ml)
10000 IU
10000 i. e.
0.6 ml (16667 IU/ ml)
0. 6 ml (16667 i. e. / ml)
20000 IU
20000 i. e.
0.6 ml (33333 IU/ ml)
0. 6 ml (33333 i. e. / ml)
60000 IU
60000 i. e.