natgillin/translations-raw huggingface dataset:
Suspension for injection.
Suspenzija za injiciranje
Packaging Content Package size Withdrawal period
Ovojnina Vsebina Velikost pakiranja
(*) equivalent to titre prior to inactivation (log10)
(*) Ekvivalent titru pred inaktivacijo
Subcutaneous Type I glass bottle with butyl elastomere closure
Ovce in govedo Subkutano Steklenička (steklo tipa I) z butil elastomerno zaporko
Invented Name
Izmišljeno ime Jakost
Medicinal product no longer authorised
Zdravilo nima veā dovoljenja za promet
Strength
Karenca
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, v skladu s postopki iz Poglavja 4 Naslova III Direktive 2001/83/ES.
This product information is the outcome of the referral procedure to which this Commission decision relates.
Te informacije o zdravilu so rezultat napotitvenega postopka, na katerega se nanaša ta sklep Komisije.
Product information
Informacije o zdravilu
Annex III Product information
Priloga III Informacije o zdravilu
The valid product information is the final version achieved during the Coordination group procedure.
Veljavne informacije o zdravilu so končna različica, dogovorjena med postopkom skupine za usklajevanje.
This summary was last updated in 07-2016.
Povzetek je bil nazadnje posodobljen 07-2016.
This study was extended to almost 4 years and confirmed the long-term benefits and safety of HyQvia.
Ta študija je bila podaljšana na skoraj štiri leta, pri čemer so bile potrjene dolgoročne koristi in varnost zdravila HyQvia.
The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Evropska komisija je dovoljenje za promet z zdravilom HyQvia, veljavno po vsej Evropski uniji, izdala 16. maja 2013.
The main measure of effectiveness was the number of serious bacterial infections that developed over one year of treatment.
Glavno merilo učinkovitosti je bilo število resnih bakterijskih okužb, ki so se pojavile v enem letu zdravljenja.
IgG has been used as a medicine since the 1950s and has a wide range of activity against organisms that can cause infection.
IgG se v medicini uporablja od petdesetih let preteklega stoletja in ima širok razpon delovanja proti organizmom, ki povzročajo okužbe.
It contains immunoglobulin G (IgG), which is a type of antibody.
Vsebuje imunoglobulin G (IgG), ki je vrsta protitelesa.
What measures are being taken to ensure the safe and effective use of HyQvia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila HyQvia?
The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo HyQvia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The study showed that HyQvia was able to reduce this number to 0.03 per year.
Študija je pokazala, da se je z uporabo zdravila HyQvia število okužb zmanjšalo na 0,03 na leto.
This is a summary of the European public assessment report (EPAR) for HyQvia.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo HyQvia.
The dose and frequency of infusions (how often it is given) depend on the individual patient and may need to be adjusted depending on their response.
Odmerek in pogostost infundiranja (pogostost dajanja zdravila) se določi za vsakega bolnika posebej in se ju po potrebi prilagodi glede na njegov odziv.
Other information about HyQvia
Druge informacije o zdravilu HyQvia
The most common side effects with HyQvia (which may affect more than 1 in 10 people) are local reactions such as swelling and discomfort at the site of the infusion.
Najpogostejši neželeni učinki zdravila HyQvia (ki lahko prizadenejo več kot 1 osebo od 10) so lokalne reakcije, kot so otekline in neprijeten občutek na mestu infundiranja.
HyQvia must not be given into a blood vessel or a muscle.
Zdravila HyQvia se ne sme dajati v krvno žilo ali mišico.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of HyQvia have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila HyQvia, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The Committee therefore decided that HyQvia's benefits are greater than its risks and recommended that it be approved for use in the EU.
CHMP je zato zaključil, da so koristi zdravila HyQvia večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
HyQvia is used as ‘replacement therapy' to treat:
Zdravilo HyQvia se uporablja kot „nadomestno zdravljenje‟ pri:
What are the risks associated with HyQvia?
Kakšna tveganja so povezana z zdravilom HyQvia?
What benefits of HyQvia have been shown in studies?
Kakšne koristi je zdravilo HyQvia izkazalo v študijah?
What is HyQvia and what is it used for?
Kaj je zdravilo HyQvia in za kaj se uporablja?
In accordance with current guidelines for these medicines, HyQvia was investigated in one main study lasting over a year and involving 89 patients with PID who had already had treatment with human normal immunoglobulin for at least three months.
Zdravilo HyQvia so v skladu s trenutnimi smernicami za tovrstna zdravila proučevali v eni glavi študiji, ki je trajala več kot eno leto in v katero je bilo vključenih 89 bolnikov s PID, ki so že pred tem najmanj tri mesece prejemali humani polispecifični imunoglobulin.
• low levels of antibodies in the blood in patients who have chronic lymphocytic leukaemia or myeloma (two cancers affecting different types of white blood cell) and who have frequent infections.
• nizkih ravneh protiteles v krvi pri bolnikih s kronično limfocitno levkemijo ali mielomom (dvema vrstama raka, ki prizadeneta različne vrste belih krvnih celic), ki so dovzetni za pogoste okužbe.
These are patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
To so bolniki, ki imajo v krvi premalo protiteles (beljakovin, ki pomagajo telesu pri premagovanju okužb in drugih bolezni), ki jih imenujemo tudi imunoglobulini.
It is not intended to provide practical advice on how to use HyQvia.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Patients or their carers may be able to give HyQvia themselves once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko zdravilo HyQvia dajejo sami, če so bili za to ustrezno usposobljeni.
Why is HyQvia approved?
Zakaj je bilo zdravilo HyQvia odobreno?
The possibility of patients or their carers giving the medicine themselves at home may also improve the convenience of the product.
Ker lahko bolniki ali njihovi negovalci zdravilo dajejo doma sami, je zdravilo zato tudi priročnejše.
Human normal immunoglobulin has been used to treat these diseases for many years.
Humani polispecifični imunoglobulin se za zdravljenje zgoraj omenjenih bolezni uporablja že vrsto let.
• primary immunodeficiency syndromes (PID, when patients are born with an inability to produce enough antibodies);
• sindromih primarne imunske pomanjkljivosti (PID, pri bolnikih s prirojeno nezmožnostjo tvorjenja zadostnega števila protiteles);
Although there had been concerns that antibodies that develop against recombinant hyaluronidase could cause side effects by affecting the natural version of the enzyme, the results of studies were reassuring.
Čeprav so obstajali pomisleki, da bi lahko protitelesa, ki se tvorijo proti rekombinantni hialuronidazi, povzročila neželene učinke zaradi vpliva na naravni encim, so rezultati študij te zadržke ovrgli.
For more information about treatment with HyQvia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom HyQvia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
HyQvia must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or hyaluronidase or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Zdravila HyQvia ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani polispecifični imunoglobulin ali hialuronidazo ali katero koli drugo sestavino zdravila, ter bolniki, ki so alergični na druge vrste imunoglobulinov, zlasti če imajo pomanjkanje (zelo nizke ravni) imunoglobulina A (IgA) s protitelesi proti IgA.
This is a form of the natural human enzyme, hyaluronidase, which breaks down a substance called hyaluronic acid that is present in the tissues in the tiny spaces between cells and so makes the area between cells temporarily more liquid.
To je oblika naravnega človeškega encima, hialuronidaze, ki razgrajuje snov, imenovano hialuronska kislina, ki je prisotna v tkivih v majhnih prostorih med celicami, in tako povzroči, da so medcelični prostori začasno bolj tekoči.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that HyQvia produces a similar reduction in the number of serious bacterial infections to that seen with other immunoglobulin products, and using recombinant hyaluronidase allows subcutaneous infusions to be given at much longer intervals, although local reactions are slightly more common.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je ugotovil, da zdravilo HyQvia podobno zmanjšuje število resnih bakterijskih okužb kot druga zdravila, ki vsebujejo imunoglobulin, in da se lahko zaradi uporabe rekombinantne hialuronidaze subkutane infuzije dajejo v veliko daljših premorih, četudi so lokalne reakcije nekoliko pogostejše.
This was below the predefined number needed to show effectiveness (which is one infection per year), and was similar to that seen with other licensed human normal immunoglobulin products.
Ta številka je bila nižja od predhodno določene, ki naj bi dokazala učinkovitost zdravila (tj. ena okužba na leto), in je bila podobna tisti, ki so jo zabeležili pri drugih odobrenih zdravilih, ki vsebujejo humani polispecifični imunoglobulin.
HyQvia can only be obtained with a prescription and treatment should be started and monitored by a doctor or nurse experienced in treating immunodeficiency syndromes.
Predpisovanje in izdaja zdravila HyQvia je le na recept, zdravljenje z njim pa lahko predpiše in spremlja samo zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem sindromov imunske pomanjkljivosti.
HyQvia also contains recombinant human hyaluronidase.
Zdravilo HyQvia vsebuje tudi rekombinantno humano hialuronidazo.
HyQvia is available as two solutions for infusion (drip) under the skin.
Zdravilo HyQvia vsebuje dve raztopini za infundiranje (kapalno infuzijo) pod kožo.
HyQvia works by restoring abnormally low IgG levels to their normal range in the blood.
Zdravilo HyQvia deluje tako, da nenormalno nizke ravni IgG v krvi zviša na normalno raven.
For practical information about using HyQvia, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila HyQvia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Detailed information about using HyQvia is provided in the package leaflet.
Podrobne informacije o uporabi zdravila HyQvia so na voljo v navodilu za uporabo.
The active substance in HyQvia, human normal immunoglobulin, is a highly purified protein extracted from the blood.
Zdravilna učinkovina zdravila HyQvia, humani polispecifični imunoglobulin, je visoko prečiščena beljakovina, pridobljena iz krvi.
For the full list of all side effects reported with HyQvia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila HyQvia, glejte navodilo za uporabo.
HyQvia is used in patients with immunodeficiency syndromes.
Uporablja se pri odraslih s sindromi imunske pomanjkljivosti.
When given under the skin before the normal human immunoglobulin, it helps to deliver the active substance under the skin, and assists its absorption into the body.
Ko se infundira pod kožo pred humanim polispecifičnim imunoglobulinom, omogoči lažje prehajanje zdravilne učinkovine pod kožo in pospeši njeno absorpcijo v telo.
Human normal immunoglobulin
HyQvia humani polispecifični imunoglobulin
A solution containing recombinant human hyaluronidase is given first and a solution containing human normal immunoglobulin (100 mg/ml) is then given by infusion in the same place.
Najprej se infundira raztopina z rekombinantno humano hialuronidazo, nato pa na istem mestu še raztopina s humanim polispecifičnim imunoglobulinom (100 mg/ml).
The product also contains recombinant human hyaluronidase, which is an enzyme used to help deliver the human normal immunoglobulin under the skin and improve its absorption into the body.
Zdravilo vsebuje tudi rekombinantno humano hialuronidazo, tj. encim, ki omogoči lažje prehajanje humanega polispecifičnega imunoglobulina pod kožo in pospeši njegovo absorpcijo v telo.
How does HyQvia work?
Kako zdravilo HyQvia deluje?
How is HyQvia used?
Kako se zdravilo HyQvia uporablja?
HyQvia contains the active substance human normal immunoglobulin.
Zdravilo HyQvia vsebuje zdravilno učinkovino humani polispecifični imunoglobulin.
These signs include:
Ti znaki so:
Ref.: EMA/777733/2009 EMEA/H/C/253
: EMA/777733/2009 EMEA/H/C/253
This summary was last updated in 12-2009.
Povzetek je bil nazadnje posodobljen 12-2009.
In addition, the baby must have a normal heart rate.
Poleg tega mora imeti plod normalno srčno frekvenco.
The main measure of effectiveness was whether the treatment had worked after a week.
Glavno merilo učinkovitosti je bila uspešnost zdravljenja po enem tednu.
The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000.
Evropska komisija je dovoljenje za promet z zdravilom Tractocile, veljavno po vsej Evropski uniji, odobrila dne 20. januarja 2000.
Tractocile atosiban EPAR summary for the public
Tractocile atosiban Povzetek EPAR za javnost
No side effects have been noted in the newborn baby.
Pri novorojenčkih niso opazili nobenih neželenih učinkov.
Treatment should be started as soon as possible after diagnosis of pre-term labour.
Zdravljenje je treba začeti čim prej po diagnozi prezgodnjega porajanja.
The marketing authorisation holder is Ferring Pharmaceuticals A/S.
Imetnik dovoljenja za promet z zdravilom je družba Ferring Pharmaceuticals A/S.
Both contain the active substance atosiban (7.5 mg per millilitre).
Obe vsebujeta zdravilno učinkovino atosiban (7,5 mg na mililiter).
• regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
• - redne kontrakcije maternice, ki trajajo vsaj 30 sekund, s pogostnostjo najmanj štiri v 30 minutah,
Other information about Tractocile:
Druge informacije o zdravilu Tractocile:
If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.
Če se kontrakcije maternice spet pojavijo, se lahko zdravljenje z zdravilom Tractocile v času nosečnosti ponovi največ trikrat.
The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin.
Učinkovina v zdravilu Tractocile, atosiban, je antagonist naravnega hormona oksitocina.
Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients.
Zdravila Tractocile ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) atosiban ali katero koli drugo sestavino zdravila.
The Committee decided that Tractocile's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila Tractocile večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342).
Rezultati vseh treh glavnih študij skupaj kažejo, da je bilo en teden po zdravljenju nosečih še 60 % žensk (201 od 337), zdravljenih z zdravilom Tractocile, v primerjavi z 48 % žensk (163 od 342), zdravljenih s primerjalnimi zdravili.
Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Zdravilo Tractocile se injicira v veno v treh zaporednih korakih v razponu največ 48 ur: najprej injekcija v veno (6,75 mg), ki ji sledi visokoodmerna triurna infuzija (18 mg na uro), in nato infuzija z manjšim odmerkom (6 mg na uro), ki traja do 45 ur.
There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group.
V študije je bilo vključenih premalo žensk, nosečih manj kot 28 tednov, da bi bilo mogoče ovrednotiti učinkovitost zdravila Tractocile v primerjavi z beta-agonisti pri tej skupini.
Tractocile was compared with ritodine, terbutaline and salbutamol (all from a different class of medicines used in pre-term labour called beta-agonists).
Zdravilo Tractocile so primerjali z ritodinom, terbutalinom in salbutamolom (vsi trije spadajo v drugo skupino zdravil, ki se uporablja pri prezgodnjem porajanju, imenovano beta-agonisti).
It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby.
Ne sme se uporabljati pri ženskah, ki so noseče manj kot 24 tednov ali več kot 33 tednov ali pri katerih pride do prezgodnjega razpoka plodnega mehurja (kadar voda prezgodaj odteče) po 30 tednu nosečnosti, v primeru krvavitve iz maternice, eklampsije (nevarnega stanja ob koncu nosečnosti, ki ga povzročijo toksini v krvi) ali preeklampsije (stanja, ki lahko povzroči eklampsijo), v primeru težav s plodom ali posteljico oziroma kadar bi bilo nadaljevanje nosečnosti nevarno za mater ali dojenčka.
What benefit has Tractocile shown during the studies?
Kakšne koristi je zdravilo Tractocile izkazalo med študijami?
By blocking the action of oxytocin, Tractocile prevents contractions and causes the womb to relax, helping to delay birth.
Z zaviranjem delovanja oksitocina zdravilo Tractocile prepreči kontrakcije in povzroči, da se maternica sprosti, kar pomaga k odložitvi poroda.
The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick).
Najpogostejši neželeni učinek zdravila Tractocile (opažen pri več kot 1 bolnici od 10) je navzeja (slabost).
The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je zdravilo Tractocile izkazalo enako učinkovitost pri preprečevanju prezgodnjega poroda, kot je bila ugotovljena pri beta-agonistih, ter da je do boljših rezultatov pri uporabi zdravila Tractocile prišlo zaradi boljšega prenašanja tega zdravila.
Treatment with Tractocile should be carried out by a doctor who has experience in the treatment of pre-term labour.
Zdravljenje z zdravilom Tractocile mora izvajati zdravnik z izkušnjami s prezgodnjim porajanjem.
This means that atosiban blocks the action of oxytocin.
To pomeni, da atosiban zavira delovanje oksitocina.
The full EPAR for Tractocile is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tractocile je na voljo tukaj.
• dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.
• odprtje materničnega vratu od 1 do 3 cm in stanjšanje za 50 % ali več.
What is the risk associated with Tractocile?
Kakšna tveganja so povezana z zdravilom Tractocile?
The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.
Zdravilo Tractocile je v primerjavi z beta-agonisti boljše rezultate morda izkazalo zato, ker povzroča manj neželenih učinkov, zaradi česar so bolnice lahko prejele celoten cikel zdravljenja.
The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies.
Učinkovitost zdravila Tractocile kot terapije za preprečevanje prezgodnjega poroda so proučevali v treh glavnih študijah pri 742 ženskah, ki so bile noseče 23 do 33 tednov.
For the full list of all side effects reported with Tractocile, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Tractocile, glejte navodilo za uporabo.
Tractocile is a solution for injection, and a concentrate that is made up into a solution for infusion (drip into a vein).
Zdravilo Tractocile je raztopina za injiciranje in koncentrat za pripravo raztopine za infundiranje (kapalno infuzijo v veno).
Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely).
Zdravilo Tractocile se uporablja za odložitev poroda pri odraslih ženskah, ki so noseče 24 do 33 tednov, če izkazujejo znake, da bi utegnilo priti do prezgodnjega nastopa poroda.
Why has Tractocile been approved?
Zakaj je bilo zdravilo Tractocile odobreno?
Oxytocin is the hormone involved in starting contractions of the womb.
Oksitocin je hormon, ki sodeluje pri sprožitvi krčenja maternice.
How has Tractocile been studied?
Kako je bilo zdravilo Tractocile raziskano?
What is Tractocile used for?
Za kaj se zdravilo Tractocile uporablja?
How does Tractocile work?
Kako zdravilo Tractocile deluje?
What is Tractocile?
Kaj je zdravilo Tractocile?
How is Tractocile used?
Kako se zdravilo Tractocile uporablja?
Further information on Prasugrel Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Prasugrel Mylan so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Podjetje je izvedlo tudi študije, ki so pokazale, da je zdravilo „bioekvivalentno“ referenčnemu zdravilu.
The materials will include information on how to prescribe the medicine safely and remind doctors that the medicine is not recommended for patients over the age of 75 years.
To bo vključevalo informacije o varnem predpisovanju zdravila in opozorilo zdravnikom, da uporaba zdravila pri bolnikih, starejših od 75 let, ni priporočena.
It includes unstable angina (a severe type of chest pain) and heart attack.
Vključuje nestabilno angino pektoris (hudo obliko bolečine v prsih) in srčni infarkt.
This means that it helps to prevent blood clots from forming.
To pomeni, da pomaga preprečevati nastajanje krvnih strdkov.