natgillin/translations-raw huggingface dataset:
It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Pričakovali so, da bo zdravilna učinkovina zavirala encim, imenovan ciklooksigenaza, ki sodeluje pri proizvajanju prostaglandinov, snovi, ki so vključene v vnetne procese.
By reducing the production of prostaglandins, Diractin is expected to reduce the inflammation and pain caused by osteoarthritis.
Pričakovali so, da se bosta z zmanjšanjem proizvodnje prostaglandinov zmanjšala tudi vnetje in bolečina, ki ju povzroča osteoartritis.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that any benefits of Diractin did not outweigh the identified risks.
CHMP je v času umika menil, da koristi zdravila Diractin ne odtehtajo znanih tveganj.
How is Diractin expected to work?
Kako naj bi zdravilo Diractin delovalo?
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Diractin
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da se zdravila Diractin ne more odobriti za zdravljenje simptomov vnetja in bolečine, povezanih z osteoartritisom.
Do not open before use.
Ne odpirajte pred uporabo.
4 vials:
4 viale:
Not known (cannot be estimated from available data)
- Neznana pogostnost (ni je mogoče oceniti iz razpoložljivih podatkov):
Grounds for one additional renewal
Razlogi za eno dodatno podaljšanje
The clinical significance of these antibodies is not known.
Klinični pomen teh protiteles ni znan.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).
zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1000, < 1/100); redki (≥ 1/10.000, < 1/1000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States).
Izpostavljenost je bila namreč majhna zaradi omejenega trženja zdravila in njegovega nedavnega začetka (v EU se je začelo tržiti šele v avgustu 2011 in samo v nekaj državah članicah).
Not surprisingly, the antibody peak concentration was higher after the second exposure.
Ni presenetljivo, da je koncentracija protiteles bila največja po drugi izpostavitvi.
Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014
Datum podaljšanja dovoljenja za promet: 19. februar 2014
Treatment requires a single surgery.
Zdravljenje zahteva samo en kirurški poseg.
It is possible they may impair the effectiveness of this medicine or cause an immune system response.
Morda bodo poslabšala učinkovitost tega zdravila ali povzročila odziv imunskega sistema.
Place it subcutaneously if possible.
Če je mogoče, jo postavite subkutano.
It has been observed following use (see section 4.8).
To so opazili po uporabi (glejte poglavje 4.8).
For intraosseous use.
Za intraosalno uporabo.
This should be considered in follow-up of patients with CT or X-ray.
To je treba upoštevati pri sledenju bolnikov s CT ali rentgenografijo.
The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Kolagenski matriks je netopen in je sestavljen iz delcev, velikih 75-425 µm.
Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Preden prejmete to zdravilo, natančno preberite navodilo, saj vsebuje pomembne informacije za vas.
This is normally done under a full general anaesthetic so you will not be awake during the surgery.
Ta se navadno opravi pod splošno anestezijo, zato med posegom ne boste budni.
The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal.
Rezultati radioloških in histoloških preiskav v tej študiji so pokazali celjenje kosti pri začetni in ponavljajoči se izpostavitvi pri isti živali.
Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 USA
Olympus Biotech Corporation 9 Technology Drive West Lebanon NH 03784 ZDA
The maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Največji odmerek tega zdravila ne sme presegati 2 enot (6,6 mg eptotermina alfa), saj učinkovitosti in varnosti pri večjih odmerkih niso raziskovali.
This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously.
Ta učinek, imenovan karcinogenost trdnih snovi, so pogosto opazili pri podganah, ki so jim podkožno vsadili trdne snovi (plastične ali kovinske).
The reconstituted medicinal product should be used immediately.
Rekonstituirano zdravilo je treba uporabiti takoj.
A small quantity (one unit) of this medicine is reconstituted and placed directly on each side of the spine at the site requiring fusion.
Majhna količina (ena enota) tega zdravila se rekonstituira in nanese neposredno na obe strani hrbtenice na mestu, kjer je potrebna fuzija.
Do not insert a needle through the stoppers.
Ne vstavljajte igel skozi zamaška.
What Opgenra is and what it is used for.
Kaj je zdravilo Opgenra in za kaj ga uporabljamo
Single dose and repeat dose studies in a range of animal models (rats and primates) were performed.
Opravljene so bile študije enkratnih in večkratnih odmerkov na nizu živalskih modelov (podganah in primatih).
However, there is no evidence to suggest that heterotopic ossification is linked to sarcoma development in humans.
Vendar ni dokazov, da je heterotopična okostenitev povezana z razvojem sarkoma pri človeku.
However the rate of malformations was similar to those from historical controls.
Vendar je bila stopnja deformacij podobna kot pri kontrolah iz preteklih preskusov.
Repeat use of this bone morphogenetic protein (BMP) is not recommended.”
Ponavljajoča se uporaba tega proteina za morfogenezo kosti (BMP) ni priporočena.”
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproščanje zadevne serije.
In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals.
V drugi študiji so opazili razliko pri pridobivanju telesne mase pri imuniziranih odraslih samicah med 14. in 21. dnem laktacije v primerjavi z živalmi iz kontrolne skupine.
The CHMP recommend an additional five-year renewal based on the following pharmacovigilance grounds: the clinical experience with the product in the designated indication has been very limited in the EU during the first 5-year period of marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) priporoča dodatno petletno podaljšanje na podlagi naslednjih farmakovigilančnih razlogov: v prvih 5 letih veljavnosti dovoljenja za promet je bilo v EU pridobljenih zelo malo kliničnih izkušenj z uporabo zdravila za določeno indikacijo.
In a clinical study of the medicinal product, antibodies to the protein eptotermin alfa were detected in 194 out of 207 (94%) patients treated with it and 18 out of 86 (21%) treated with autograft bone (control group).
V klinični študiji so protitelesa proti eptoterminu alfa določili pri 194 od 207 (94 %) bolnikov, zdravljenih s tem zdravilom, in pri 18 od 86 (21 %) bolnikov, zdravljenih z avtolognim presadkom kosti (kontrolna skupina).
Opgenra must not be used in patients who:
Zdravilo Opgenra se ne sme uporabljati pri bolnikih:
The frequency and severity of post-operative adverse events was similar in both test and control groups.
Pogostnost in resnost neželenih učinkov po kirurškem posegu sta bili pri obeh preskusnih in kontrolnih skupinah podobni.
The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra.
Ključna študija pri 295 bolnikih je vključila neistrumentalno postero-lateralno lumbalno fuzijo pri 208 bolnikih, ki so se zdravili z zdravilo Opgenra.
Clinical studies to investigate the efficacy and safety of this medicinal product in cervical spine surgery have not been performed; consequently its use outside the region of the lumbar spine cannot be recommended.
Kliničnih študij učinkovitosti in varnosti tega zdravila pri kirurških posegih na cervikalni hrbtenici niso opravili, zato uporaba zunaj lumbalnega območja hrbtenice ni priporočena.
The MAH shall agree the details of an education programme for surgeons with the National Competent Authorities and must implement such programme nationally to ensure that:
Imetnik dovoljenja za promet se bo z nacionalnimi pristojnimi organi dogovoril o podrobnih informacijah o izobraževalnem programu za kirurge in bo uvedel ta program na nacionalni ravni, da bi zagotovil:
Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Farmakoterapevtska skupina: zdravila za bolezni kosti, proteini za morfogenezo kosti, oznaka ATC: M05BC02
Talk to your doctor if you have any of the following: - Common (may affect up to 1 in 10 people):
Če opazite katerega koli od naslednji neželenih učinkov, se pogovorite s svojim zdravnikom: - Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov ):
Opgenra is intended only for single use in each patient.
Zdravilo Opgenra je namenjeno enkratni uporabi pri enem bolniku.
- Uncommon (may affect up to 1 in 100 people):
- Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
Therefore, Opgenra may only be administered to the fusion site under adequate vision and with utmost care.
Zato se sme zdravilo Opgenra uporabljati le na mestu fuzije pod ustreznim nadzorom in skrajno previdno.
However, results from implantation studies in animals demonstrate that the active substance eptotermin alfa is released from the implant site over several weeks and never reaches a level higher than 3% of the total amount implanted in the peripheral blood.
Vendar rezultati iz študij implantacije pri živalih kažejo, da se zdravilna učinkovina eptotermin alfa sprošča iz mesta vsaditve več tednov in da koncentracija v periferni krvi nikoli ne preseže 3 % skupne vsajene količine.
Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Pomembno visoke titre protiteles IgG proti OP-1 so odkrivali v mleku skozi ves čas študije postnatalne faze do 28. dne laktacije (glejte poglavje 4.6).
For storage conditions after reconstitution, see section 6.3.
Za pogoje shranjevanja po rekonstituciji glejte poglavje 6.3.
Do not place a drain directly in the implant or fusion site.
Drenažne cevke ne postavljajte neposredno v mesto vsaditve ali fuzije.
Use of Opgenra does not guarantee fusion; additional surgeries may be required.
Uporaba zdravila Opgenra ne zagotavlja fuzije, zato bodo morda potrebne dodatne operacije.
The clinical study results suggest that there does not appear to be any association between neutralizing antibodies and the development of adverse events related to the immune system.
Rezultati te klinične študije kažejo, da ni povezave med nevtralizirajočimi protitelesi in pojavom neželenih učinkov, povezanih z imunskim sistemom.
• that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients
• enkratni uporabi zdravila; - podrobne informacije o študijah nadzora v obdobju trženja, vključno z informacijami o tem, kako so se vključevali bolniki.
• product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
• premik zdravila (to so opazili, kadar se je zdravilo zmešalo s sintetičnim zdravilom, ki se uporablja za polnjenje praznine v kosti).
The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established.
Največji odmerek pri človeku ne sme presegati 2 enot, saj učinkovitost in varnost spinalne fuzije pri večjih odmerkih nista bili ugotovljeni.
In the study populations, some patients with common pre-existing co-morbidities (e.g. cardiovascular, respiratory, genitourinary disorders, neoplasms) experienced exacerbations of their prior disease during the long term (three year) follow up period.
V populaciji bolnikov, ki so sodelovali v študiji, so se pri nekaterih bolnikih s pogostimi obstoječimi sočasnimi boleznimi (npr. kardiovaskularnimi, respiratornimi ali genitourinarnimi boleznimi in neoplazmami) pojavile eksacerbacije obstoječe bolezni v dolgotrajnem (triletnem) obdobju sledenja.
There have been reports of swelling and infection following the use of this medicine with synthetic bone substitutes.
Poročali so o otekanju in okužbah po uporabi tega zdravila s sintetičnimi kostnimi polnili.
The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6).
Klinični pomen teh ugotovitev za uporabo končnega zdravila pri človeku ni gotov (glejte poglavje 4.6).
Contents of the pack and other information.
Vsebina pakiranja in dodatne informacije
The MAH shall submit the results of a study or studies to investigate the long term safety and efficacy of patients treated with Opgenra and also actual drug utilisation in real life.
Imetnik dovoljenja za promet predloži rezultate študije ali študije, da se razišče dolgoročna varnost in učinkovitost pri bolnikih, zdravljenih z zdravilom Opgenra in tudi dejanska uporaba zdravil v vsakodnevnem življenju.
This specialised medicine is used instead of autograft bone (some of a patient's own bone taken from the hip) to fuse the spine.
To specializirano zdravilo se uporablja namesto avtolognega kostnega presadka (kadar se košček bolnikove kosti vzame iz kolka), da se hrbtenica zraste.
The vials are maintained sterile within individual blisters and packaged together in an outer tray and box.
Viali sta sterilno pakirani v posamezna pretisna omota in pakirani skupaj v zunanji pladenj ter škatlo.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6.
Študije s protitelesi proti OP-1 so pokazale neko navzkrižno reaktivnost s sorodnimi proteini za morfogenezo kosti, BMP-5 in BMP-6.
Each vial is secured in a sterile blister.
Vsaka viala je zavarovana s sterilnim pretisnim omotom.
Opgenra has no known pharmacological effect on neuro-motor coordination or performance consequently it is unlikely to alter any pre-existing skills used for driving vehicles or operating machines.
Zdravilo Opgenra nima znanih farmakoloških učinkov na nevromotorično koordinacijo ali zmogljivost, zato ni verjetno, da bo spremenilo obstoječo sposobnost za vožnjo ali upravljanje s stroji.
Opgenra is contraindicated in children aged 0 to 12 years old, adolescents aged 12 to 18 years and the skeletally immature.
Zdravilo Opgenra je kontraindicirano pri otrocih starih od 0 do 12 let, mladostnikih starih od 12 do 18 let in osebah z nezrelim skeletom.
The peak antibody response was seen 3 months following treatment.
Največji odziv protiteles so opazili 3 mesece po zdravljenju.
• increased bone formation or bone formation outside of the fusion area (heterotopic bone formation),
• povečana tvorba kosti ali tvorba kosti zunaj območja fuzije (heterotopična tvorba kosti),
• have an active infection at the site of spinal fusion or history of recurring infections;
• z znano aktivno okužbo mesta spinalne fuzije ali ponavljajočimi se okužbami v anamnezi;
Do not use this medicine after the expiry date which is stated on the carton and blisters.
Tega zdravila ne smete uporabljati po izteku roka uporabnosti, ki je naveden na škatli in pretisnih omotih.
Provide adequate haemostasis to ensure that the material stays at the surgical site.
Poskrbite za ustrezno hemostazo in tako zagotovite, da material ostane na mestu kirurškega posega.
There is limited experience on the use of the medicinal product in patients with renal or hepatic impairment therefore caution with its use in such patients is advised.
Izkušnje pri uporabi tega zdravila pri bolnikih z ledvično ali jetrno okvaro so omejene, zato se pri uporabi pri teh bolnikih svetuje previdnost.
The pattern of unrelated post-operative adverse events varied with the extent of surgical trauma, procedural complications and the pre-operative health of the patient.
Vzorec nepovezanih pooperacijskih neželenih učinkov se je razlikoval glede na stopnjo kirurške travme, zaplete pri postopku in zdravje bolnika pred kirurškim posegom.
• There is a possibility that new antibodies can form in your body when this medicine is used.
• Obstaja verjetnost, da bodo po uporabi tega zdravila v telesu nastala nova protitelesa.
The powders come in glass vials.
Prašek je pakiran v steklenih vialah.
• the recommended methods for reconstitution of the product prior to implantation
• priporočenih metod za rekonstitucijo zdravila pred vsaditvijo,
The frequency of adverse reactions listed in the table below is based on the following convention:
Pogostnost neželenih učinkov, navedenih v preglednici spodaj, je razvrščena na naslednji način:
Some patients that had a history of heart problems or were prone to frequent infections became worse after being administered this medicine.
Nekaterim bolnikom s težavami s srcem ali nagnjenostjo k pogostim okužbam se je po tem, ko so prejeli to zdravilo, stanje poslabšalo.
• the risks of ectopic bone formation
• tveganju ektopične tvorbe kosti,
Any material dislodged from the fusion site can cause ectopic ossification in the surrounding tissues with potential complications.
Snovi, ki se odstranijo z mesta fuzije, lahko povzročijo ektopično okostenitev v obkostnih tkivih z morebitnimi zapleti.
To fuse a single level of the lumbar region of the spine, one unit of medicinal product is used on each side of the spine.
Za fuzijo ene ravni lumbalnega predela hrbtenice se uporabi ena enota zdravila na vsaki strani hrbtenice.
Remove the reconstituted product from the sterile bowl with a sterile instrument such as a spatula or curette.
Rekonstituirano zdravilo odstranite iz sterilne posode s sterilnim instrumentom, na primer spatulo ali kireto.
This leaflet was last revised in <Month YYYY>.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
• have an active malignancy or are undergoing treatment for a malignancy;
• ki imajo aktivno maligno tvorbo ali ki se zdravijo zaradi malignih tvorb;
Common: bone formation increased (heterotopic bone formation)
Pogosti: povečana tvorba kosti (heterotopična tvorba kosti)
Opgenra is an osteoinductive and osteoconductive medicinal product.
Zdravilo Opgenra je osteoinduktivno in osteokonduktivno zdravilo.
In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Pri dveletni raziskavi podkožnega vsadka pri podganah so po pričakovanjih opazili nastanek heterotopičnih kosti.
Prior to use of the product, surgeons should be provided with educational material containing: a copy of the SPC a detailed description of:
Pred uporabo tega zdravila je treba kirurgom ponuditi izobraževalni material, ki vključuje: kopijo Povzetka glavnih značilnosti zdravila; podroben opis:
• embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant
• embrio-fetotoksičnosti in potrebi po uporabi učinkovite kontracepcije pri ženskah v rodni dobi dve leti po vsaditvi,
Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group.
V preskusni skupini so nevtralizirajoča protitelesa nastala pri 26 % bolnikov, v kontrolni skupini pa pri 1 % bolnikov.
The edges of the crimp caps are sharp and may cut or damage gloves.
Robovi zapork so ostri in lahko zarežejo ali poškodujejo rokavice.
• wound problems including infection, discharge and rupture.
• težave z rano, vključno z okužbo, izcedkom in raztrganjem.
Patients with a known history of heart disease or frequent infections should be identified and observed more closely following surgery.
Bolnike z znano boleznijo srca v anamnezi ali pogostimi okužbami je treba identificirati in jih po kirurškem posegu pozorneje opazovati.
Adverse events recorded during the clinical studies following such surgery and not specifically causally related to the implanted materials included superficial wound infection, wound dehiscence, osteomyelitis, complications of mechanical support, haematoma formation, nausea, vomiting, fever and pain.
Neželeni učinki, ki so jih opazili med kliničnimi študijami po takšnih kirurških posegih, ki niso bile vzročno-posledično povezane z vsajenimi materiali, so vključevale površinske okužbe rane, odprtje rane, osteomielitis, zaplete pri mehanski opori, nastanek hematoma, navzejo, bruhanje, zvišano telesno temperaturo in bolečino.
The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period.
V obdobju opazovanja je bila telesna masa potomcev v skupini, ki je prejela zdravljenje, manjša kot pri kontrolni skupini.
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Zdravilo Opgenra je indicirano za posterolateralno lumbalno fuzijo vretenc pri odraslih bolnikih s spondilolistezo, pri katerih avtologni presadek ni bil uspešen ali pa je kontraindiciran.
Use in cervical spine
Uporaba na cervikalni hrbtenici
Carefully apply the product to the prepared site on each side of the spine, bridging the dorsal surfaces of the adjacent transverse processes.
Zdravilo previdno nanesite na pripravljeni mesti na obeh straneh hrbtenice, pri čemer premostite dorzalni površini sosednjih transverzalnih izrastkih.
This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it.
Ta skupina zdravil povzroči rast nove kosti na mestu, kjer ga je zdravnik nanesel (vsadil).
• localised swelling, swelling over the implant site,
• lokalizirano otekanje, otekanje nad mestom implantacije,
Opgenra is contraindicated in children (<12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3).
Zdravilo Opgenra je kontraindicirano pri otrocih (starih manj kot 12 let), mladostnikih (12-18 let) in osebah z nezrelim skeletom (glejte poglavje 4.3).
Tell your doctor if you are taking or have recently taken any other medicines.
Druga zdravila in zdravilo Opgenra Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo.
This medicinal product should be used by an appropriately qualified surgeon.
To zdravilo lahko uporabljajo le ustrezno usposobljeni kirurgi.
Do not breast-feed your baby during treatment with this medicine.
Med zdravljenjem s tem zdravilom ne dojite.
The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs with two long bone defects treated with repeat implantations.
Učinek protiteles proti OP-1 na celjenje kosti so raziskovali pri psih, po dveh okvarah dolgih kosti, zdravljenih z večkratnimi vsaditvami.
What you need to know before you are administered Opgenra.
Kaj morate vedeti, preden boste prejeli zdravilo Opgenra
*Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line.
*Eptotermin alfa je humani rekombinantni osteogeni protein 1 (OP-1), pridobljen iz celične linije jajčnikov kitajskega hrčka (Chinese Hamster Ovary - CHO).
One unit of Opgenra powder for implantation suspension comes as two separate powders.
Ena enota praška zdravila Opgenra za suspenzijo za implantacijo je pakirana v dve ločeni viali.