natgillin/translations-raw huggingface dataset:
The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra.
Klinična učinkovitost in varnost Odprto, prospektivno klinično preskušanje z eno skupino je vključevalo 23 prejemnikov presajenih jeter, ki so predhodno prejemali intravensko imunoglobulinsko profilakso proti hepatitisu tipa B in so naknadno prešli na subkutano zdravilo Zutectra.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) subcutaneous injections on a weekly or fortnightly basis, according to the serum antiHBs concentrations and at the discretion of the physician in charge.
Odmerek se lahko določi za vsakega bolnika posebej in prilagodi s 500 i.e. na največ 1.000 i.e. (v izjemnih primerih do 1.500 i.e.) subkutanih injekcij na teden ali vsaka dva tedna, glede na serumske koncentracije protiteles anti-HBs in po presoji lečečega zdravnika.
Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Humani protein 150 mg/ml, od katerega je najmanj 96 % IgG, z vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa tipa B (HBs) 500 i.e./ml.
Wipe the intended area with an alcohol swab.
Obrišite izbrano mesto injiciranja z alkoholno krpico.
The solution must be brought to room temperature before use.
Zdravilo naj pred uporabo doseže sobno temperaturo (pribl.
The dose can be individually established and adapted from 500 IU up to 1,000 IU (in exceptional cases up to 1,500 IU) weekly or fortnightly.
Odmerek se lahko določi za vsakega bolnika posebej in prilagodi s 500 i.e. na največ 1.000 i.e. (v izjemnih primerih do 1.500 i.e.) na teden ali vsaka dva tedna.
If you get any side effects, talk to your doctor, healthcare professional or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, strokovnim zdravstvenim delavcem ali farmacevtom.
Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA.
Pri osebah s primanjkljajem IgA po dajanju sestavin krvi, ki vsebujejo IgA, lahko pride do razvoja protiteles proti IgA in do anafilaktične reakcije.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
In case of any adverse event after the injection speak to your doctor immediately.
V primeru katerega koli neželenega učinka se takoj posvetujte z zdravnikom.
The following side effects have been reported with Zutectra:
Z zdravilom Zutectra so poročali o naslednjih neželenih učinkih:
Once the injection has been completed, dispose of all needles and empty glass containers without delay in a container intended for sharp objects.
Po končanem injiciranju takoj odvrzite vse igle, injekcijske brizge in prazne steklene vsebnike v zabojček, namenjen ostrim predmetom.
Human protein 150 mg of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU.
Humani protein 150 mg, od katerega je najmanj 96 % IgG, z vsebnostjo protiteles proti površinskemu antigenu virusa hepatitisa tipa B (HBs) 500 i.e..
You should administer the injection immediately after opening the syringe.
Injekcijo si dajte takoj po odprtju injekcijske brizge.
METHOD OF ADMINISTRATION Subcutaneous use
subkutana uporaba
C/Frederic Mompou, 5 - 6° 3a A
C/Frederic Mompou, 5 - 6° 3a A ES-08960 Sant Just Desvern
Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: mail@biotest.com
Faks: + 49 6103 801-150 E-pošta: mail@biotest.com
Prior to the initiation of subcutaneous treatment with Zutectra adequate anti-HBs serum levels should be stabilised with an intravenous hepatitis B immunoglobulin to levels at or above 300-500 IU/l in order to ensure adequate anti-HBs coverage during the transition from intravenous to subcutaneous dosing.
Za zagotavljanje ustrezne ravni protiteles anti-HBs v obdobju prehoda z intravenskega na subkutano odmerjanje je treba pred uvedbo subkutanega zdravljenja z zdravilom Zutectra stabilizirati ustrezno serumsko raven protiteles anti-HBs z intravenskim imunoglobulinom proti hepatitisu tipa B do ravni, ki je enaka ali večja od 300-500 i.e./l.
Do not take a double dose to make up for a forgotten injection.
Če ste pozabili uporabiti zdravilo Zutectra Ne vzemite dvojnega odmerka, če ste pozabili na prejšnjo injekcijo.
Common (may affect up to 1 in 10 people): - injection site reactions: pain, hives (urticaria) at injection site, haematoma (a collection of blood in tissue under the skin), reddening of the skin (erythema).
Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - reakcije na mestu injiciranja: bolečina, izpuščaj (koprivnica) na mestu injiciranja, hematom
Store and transport refrigerated (2°C-8°C).
Zdravilo shranjujte in prevažajte na hladnem (2°C-8°C).
Contents of the pack and other information How to inject Zutectra by yourself or by caregiver
Vsebina pakiranja in dodatne informacije Samoinjiciranje zdravila Zutectra ali injiciranje s strani negovalnega osebja
Buttocks: Use any area where you can pinch up tissue.
Zadnjica: Izberite kateri koli predel, kjer tkivo lahko stisnete in dvignete.
- Remove the protective cap from the syringe.
- Z injekcijske brizge odstranite zaščitno zaporko.
Glycine
Clondalkin
Pack size of five syringes in a blistered pack.
Velikost pakiranja je pet injekcijskih brizg v pretisnem omotu.
No patient experienced HBV re-infection.
Noben bolnik se ni ponovno okužil s HBV. Samoinjiciranje je bilo izvedljivo pri večini bolnikov.
BATCH NUMBER
Številka serije
The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B reinfection prophylaxis.
Kot standard preprečevanja ponovne okužbe s hepatitisom tipa B pride v poštev sočasna uporaba ustreznih virostatikov.
Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack.
Zdravilo Zutectra je na voljo v pakiranjih po 5 napolnjenih injekcijskih brizg v pretisnem omotu.
Allow yourself enough time to inject the whole of the solution until the syringe is empty.
Vzemite si dovolj časa za injiciranje vse tekočine,
PHARMACEUTICAL PARTICULARS
FARMACEVTSKA OBLIKA
It is hard to pinch up the tissue and inject Zutectra yourself using this site.
Na tem mestu boste sami težko stisnili tkivo, dvignili in injicirali zdravilo Zutectra.
One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Ena 1-mililitrska napolnjena injekcijska brizga vsebuje humani imunoglobulin proti hepatitisu tipa B 500 i.e.
What Zutectra is and what it is used for
Kaj je zdravilo Zutectra in za kaj ga uporabljamo Kaj je zdravilo Zutectra
Biotest Hungaria Kft. Torbágy u. 15/A H-2045 Törökbálint Tel.: + 36 23 511 311
Torbágy u. 15/A H-2045 Törökbálint
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19 virus (causative agent of Ringel rubella).
Ukrepi, ki se izvajajo, so morda manj učinkoviti proti virusom brez ovojnice, kot je parvovirus B19 (povzročitelj infekcijskega eritema).
Musculosceletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva mišični spazmi redki*
The active substance is human hepatitis B immunoglobulin 500 IU/ml.
Zdravilna učinkovina je humani imunoglobulin proti hepatitisu tipa B 500 i.e./ml.
49 patients received subcutaneous injections of Zutectra of 500 IU (1 mL) or 1,000 IU (2 mL) (dose adaptation in exceptional cases up to 1,500 IU) per week or fortnightly according to serum anti-HBs trough levels.
Zutectra 500 i.e. (1 ml) ali 1.000 i.e. (2 ml) (prilagoditev odmerka v izjemnih primerih do 1.500 i.e.) na teden ali vsaka dva tedna, glede na najnižje ravni protiteles anti-HBs.
Make sure you use Zutectra as prescribed and as instructed by your doctor to avoid the risk of a hepatitis B re-infection.
Da se izognete tveganju ponovne okužbe s hepatitisom tipa B, zagotovite, da boste uporabljali zdravilo Zutectra, kot vam je bilo predpisano in v skladu z navodili, ki ste jih prejeli od svojega zdravnika.
If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
It is strongly recommended that every time that Zutectra is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Za ohranitev sledljivosti med bolnikom in serijsko številko zdravila je zelo priporočljivo, da se ob vsakem dajanju zdravila Zutectra bolniku zabeležita ime in serijska številka zdravila.
Get rid of any air bubbles that may be in the syringe.
Iz injekcijske brizge odstranite vse morebitne zračne mehurčke.
The colour of the solution can vary from clear to pale yellow up to light brown.
Barva raztopine se lahko spreminja od bistre do bledorumene do svetlorjave.
Zutectra is intended for subcutaneous (under the skin) injection.
Zdravilo Zutectra se uporablja kot subkutana (podkožna) injekcija.
Please tell your doctor or healthcare professional prior to treatment if you have been told that you have antibodies against immunoglobulins of the type IgA in your blood.
če so vam povedali, da imate v krvi protitelesa proti imunoglobulinom tipa IgA.
Please tell your doctor about your treatment with Zutectra prior to any blood test.
Pred vsako krvno preiskavo obvestite svojega zdravnika o zdravljenju z zdravilom Zutectra.
The objective of the study was to evaluate the level of compliance of patients using subcutaneous Zutectra as home selftreatment for preventing hepatitis B re-infection.
Cilj študije je bil oceniti raven sodelovanja bolnikov, ki si zdravilo Zutectra samoinjicirajo doma za preprečitev ponovne okužbe s hepatitisom B. Bolnike naj bi z zdravilom Zutectra zdravili v skladu z informacijami in odmerki, navedenimi v povzetku glavnih značilnosti zdravila.
Zutectra must be brought to room temperature (approx. 23°C-27°C) before use.
Zdravilo Zutectra naj pred uporabo doseže sobno temperaturo (pribl.
Antibody levels >100 IU/l should be maintained in HBsAg and HBV-DNA negative patients.
Pri HBsAg negativnih in HBV-DNK negativnih bolnikih je treba ohranjati serumske ravni protiteles > 100 i.e./l.
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
Ensure that Zutectra is not administered into a blood vessel, because of the risk of shock.
Zaradi tveganja za pojav šoka zagotovite, da zdravilo Zutectra ne bo dano v krvno žilo.
Particularly if you do not have enough immunoglobulins of the type IgA in your blood, allergic reactions such as a sudden fall in blood pressure or shock may occur.
Pojavijo se lahko alergijske reakcije, kot je nenaden padec krvnega tlaka ali šok.
The colour of the solution can vary from clear to pale yellow or light brown.
Barva raztopine se lahko spreminja od bistre do bledorumene ali svetlorjave.
With normal immunoglobulins adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
zvišana telesna temperatura, bruhanje, alergijske reakcije, slabost, bolečine v sklepih, nizek krvni tlak in zmerna bolečina v križu.
Zutectra is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days.
Zdravilo Zutectra se počasi absorbira v bolnikov krvni obtok in doseže najvišjo vrednost z zakasnitvijo
(≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
< 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000);
What Zutectra is used for
Za kaj uporabljamo zdravilo Zutectra
No treatment failure defined as positive HBV-DNA and HBsAg findings occurred during the entire observation period.
opredeljenega kot pozitivne vrednosti HBV-DNA in HBsAg.
Oropharyngeal pain
PRETISNI OMOT
5 pre-filled syringes
Raztopina za injiciranje 5 napolnjenih injekcijskih brizg
The solution is clear and pale yellow or light brown.
Raztopina za injiciranje Raztopina je bistra in bledorumena ali svetlorjava.
Keep this leaflet.
Glejte poglavje
The solution can vary from colourless to pale yellow up to light brown.
Barva raztopine se lahko spreminja od brezbarvne do bledorumene in vse do svetlorjave.
two alcohol swabs, one syringe of Zutectra, one needle suitable for subcutaneous injection.
eno iglo, primerno za podkožno injiciranje.
With other human immunoglobulin preparations the following additional symptoms have been reported: chills headache dizziness fever vomiting mild allergic reactions nausea (urge to vomit) joint pain low blood pressure moderate low back pain injection site reactions: swelling, soreness, redness, hardening of the skin, local heat, itching, bruising and rash.
bolečine v sklepih nizek krvni tlak zmerne bolečine v križu reakcije na mestu injiciranja: oteklina, občutljivost, rdečina, zatrdlina na koži, lokalno povišana temperatura, srbenje, modrice in izpuščaj
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealna bolečina redki*
In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels > 100 IU/l after extended periods between level controls.
Poleg tega se mora za zagotovitev najnižje serumske ravni anti-HBs > 100 i.e./l po podaljšanih razdobjih med posameznimi kontrolami bolnik oziroma negovalno osebje držati tehnike injiciranja in odmerne sheme.
Uncommon (may affect up to 1 in 100 people): - headache - upper abdominal pain (from your chest to the belly button)
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - glavobol,
Furthermore the following reactions have been reported once only: tiredness (fatigue) high blood pressure (hypertension) inflammation of the nose and throat (nasopharyngitis) muscle spasm allergic reactions (hypersensitivity) abnormal heartbeat (palpitations), cardiac discomfort itching (pruritus), rash pain in the mouth and throat
mišični spazem alergijske reakcije nenavaden srčni utrip (palpitacije), srčno nelagodje srbenje (pruritus), izpuščaj bolečina v ustih in žrelu
Biotest Pharma GmbH Landsteinerstrasse 5 D-63303 Dreieich Germany
Landsteinerstrasse 5 D-63303 Dreieich
How to store Zutectra
Shranjevanje zdravila Zutectra
Local reactions at injection sites Swelling, soreness, redness, induration, local heat, itching, bruising and rash.
Oteklina, občutljivost, rdečina, zatrdlina, lokalna vročica, srbenje, modrice in izpuščaj.
Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit.
brez vrednosti pod 100 i.e./l in povprečnimi ravnmi anti-HBs v serumu 254,3 i.e/l ob končnem obisku.
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU injection Human hepatitis B immunoglobulin Subcutaneous use
Zutectra 500 i.e. injekcija humani imunoglobulin proti hepatitisu tipa B subkutana uporaba
If you notice any of the following effects stop the injection and tell your doctor immediately: rash, itching, wheezing, difficulty in breathing, swelling of the eyelids, face, lips, throat or tongue, low blood pressure, fast pulse
težave pri dihanju, otekanje vek, obraza, ustnic, žrela ali jezika, nizek krvni tlak, hiter srčni utrip.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection
FARMACEVTSKA OBLIKA IN VSEBINA
Please tell your doctor about your treatment with Zutectra prior to any vaccination.
Pred vsakim cepljenjem obvestite svojega zdravnika, da ste bili zdravljeni z zdravilom Zutectra.
Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi humani imunoglobulin proti hepatitisu tipa B
Transmissible agents
Prenosljivi povzročitelji bolezni
NN: {number} [national reimbursement number or other national number identifying the medicinal product]
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Obstajajo opogumljajoče klinične izkušnje o neprenašanju virusa hepatitisa tipa A ali parvovirusa B19
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
How to inject Zutectra by yourself or by caregiver
Samoinjiciranje zdravila Zutectra ali injiciranje s strani negovalnega osebja
6.6 Special precautions for disposal and other handling This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use.
6.4 Posebna navodila za shranjevanje Zdravilo shranjujte in prevažajte na hladnem (2°C-8 C).
Most adverse drug reactions (ADRs) were mild to moderate in nature.
Povzetek varnostnega profila Večina neželenih učinkov je bilo blage do zmerne narave.
* single case reports Adverse reactions observed with other human immunoglobulin preparations
Pri uporabi drugih pripravkov s humanimi imunoglobulini so poročali o naslednjih dodatnih simptomih:
The solution should be administered immediately after opening the syringe.
2 leti Raztopino je treba aplicirati takoj po odprtju injekcijske brizge.
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe
Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi
5.1 Pharmacodynamic properties
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti
PHARMACEUTICAL FORM Solution for injection
NAČIN IZDAJANJA ZDRAVILA
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin
Navodilo za uporabo Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi humani imunoglobulin proti hepatitisu tipa B
Tabulated list of adverse reactions
Lokalne reakcije na mestih vboda
INFORMATION IN BRAILLE Zutectra 500 IU
PODATKI V BRAILLOVI PISAVI
This medicine has been prescribed for you only.
Izdaja zdravila je le na recept.
Antibody levels >100 IU/l should be maintained.
> 100 i.e./l.
Immune system disorders
Organski sistem po MedDRA Neželeni učinki
ES-08960 Sant Just Desvern Barcelona Tel: + 34 935 952 661
Barcelona Tel: + 34 935 952 661
If you use more Zutectra than you should
Če ste uporabili večji odmerek zdravila Zutectra, kot bi smeli Posledice prevelikega odmerjanja niso znane.
You should rotate the injection site at every injection.
Vsakič izberite drugo mesto za injiciranje.
Water for injections
INJEKCIJSKA BRIZGA
• Periodic Safety Update Reports
* poročila o posamičnih primerih
Injection site reactions like pain, urticaria at injection site, haematoma and erythema
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja, kot so bolečina, urtikarija na mestu injiciranja, hematom in eritem pogosti izčrpanost, utrujenost redki*
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure.
negativnih odraslih bolnikih vsaj en teden po presaditvi jeter zaradi s hepatitisom tipa B izzvane odpovedi jeter.
Kolarova 7, 10000 Zagreb T: +385 1 2303 446
T: +385 1 2303 446
PT-1050 139 Lisboa
PT-1050 139 Lisboa Tel: + 351 21 193 14 20
Find a clean place where you can spread out all the items you are going to use:
Določite čisto mesto, kamor lahko položite vse, kar boste potrebovali: dve alkoholni krpici, eno injekcijsko brizgo zdravila Zutectra,
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Nervous system disorders
Bolezni živčevja glavobol občasni
This will depend on your individual need.
Odvisen bo od vaših osebnih potreb.
In most cases, either in the morning or in the evening - as one or two puffs once a day.
V večini primerov, bodisi zjutraj ali zvečer - kot en ali dva vpiha enkrat dnevno.
This product was submitted under article 10.3 of the Directive 2001/83/EC.
To zdravilo je bilo predloženo v skladu s členom 10(3) Direktive 2001/83/ES.
Please remember:
Zapomnite si:
It is important that you take Alvesco regularly every day, even if you feel better.
Pomembno je, da zdravilo Alvesco jemljete redno vsak dan, tudi če se počutite bolje.
Dosing recommendation for adults and adolescents:
Priporočeni odmerki za odrasle in mladostnike:
These patients are partially controlled as per the latest GINA guidelines.
Ti bolniki so delno nadzorovani v skladu z najnovejšimi smernicami GINA.
How much Alvesco should I take each day?
Koliko zdravila Alvesco moram vzeti vsak dan?
In most cases you can continue with your treatment.
V večini primerov se zdravljenje lahko nadaljuje.
Follow your doctor's instructions very carefully.
Zelo natančno upoštevajte zdravnikova navodila.
CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE
POGOJI, OCENJENI KOT KLJUČNI ZA VARNO IN UČINKOVITO UPORABO ZDRAVILA, VKLJUČNO S FARMAKOVIGILANCO
Patients experiencing these symptoms should stop using the medicine and seek immediate medical attention.
Bolniki, ki imajo te simptome morajo prenehati uporabljati zdravilo in poiskati takojšnjo zdravniško pomoč.
SCIENTIFIC CONCLUSIONS
ZNANSTVENI ZAKLJUČKI
During the mutual recognition procedure, the regulatory authorities of France were of the opinion that the product raised a potential serious risk to public health on safety and efficacy grounds.
Med postopkom medsebojnega priznavanja so regulatorni organi Francije izrazili mnenje, da zdravilo pomeni možno resno tveganje za javno zdravje na podlagi varnosti in učinkovitosti.
This is usually seen in patients taking high doses over a long period of time.
To se običajno pojavi pri bolnikih, ki dalj časa jemljejo visoke odmerke.
The conditions for the Marketing Authorisation are set out in Annex IV.
Pogoji za dovoljenje za promet so navedeni v Dodatku IV.
The National Competent Authorities, coordinated by the Reference Member State shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder:
Pristojni nacionalni organi, ki jih koordinira referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
This is important as traces of medicine could remain in the container even if you have the impression that it might be empty.
To je pomembno, ker lahko sledi zdravila ostanejo v vsebniku, tudi če je videti prazen.
The medicinal product is for inhalation use only.
Zdravilo se uporablja samo za inhaliranje.
Study MI-129 did not define an adequate primary endpoint in accordance with the current guidelines for asthma.
Študija MI-129 ni podala ustreznega primarnega pokazatelja v skladu s trenutnimi smernicami za astmo.
The container should not be punctured, broken or burned even if it seems empty.
Vsebnika nikoli ne prebadajte, ne poškodujte in ne sežigajte, četudi je videti prazen.
However, this note also refers to the lack of data available to confirm that this approach has additional therapeutic effects after 3 months with the highest dose available.
To navodilo se nanaša tudi na pomanjkanje razpoložljivih podatkov, ki bi potrdili, da bo imel ta pristop ob prejemanju največjega razpoložljivega odmerka po 3 mesecih dodatne terapevtske učinke.