natgillin/translations-raw huggingface dataset:
Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Z izjemo laktacidoze je splošni varnostni profil metformina pri bolnikih z zmerno ledvično okvaro podoben varnostnemu profilu pri bolnikih z normalnim delovanjem ledvic.
• The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
• odbor CHMP je pregledal vse podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, o varnosti in učinkovitosti zdravil, ki vsebujejo metformin, za zdravljenje sladkorne bolezni tipa 2 pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min), pri tem pa se je osredotočil na tveganje za laktacidozo;
• The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
• odbor CHMP je obravnaval dokaze iz epidemioloških študij, ki so pokazali, da je laktacidoza zelo redko stanje, ki se najpogosteje pojavlja pri bolnikih z akutno ledvično ali kardiorespiratorno boleznijo ali sepso.
In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Poleg tega bodo redne farmakovigilančne dejavnosti zajemale tudi kumulativni pregled in namenski vprašalnik o nadaljnjem spremljanju primerov laktacidoze, ki bosta predložena v naslednjih poročilih PSUR.
Overall, metformin has been used safely in patients with moderate renal impairment at reduced doses without causing significant metformin or lactate plasma elevations.
Na splošno se metformin v zmanjšanem odmerku pri bolnikih z zmerno ledvično okvaro uporablja varno, ne da bi povzročal bistveno zvišanje ravni metformina ali laktata v plazmi.
• The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
• odbor CHMP je menil, da obstajajo dokazi iz kliničnih in epidemioloških študij, ki kažejo na ugodne učinke uporabe zdravil, ki vsebujejo metformin, pri bolnikih z zmerno ledvično okvaro (GFR 30-59 ml/min);
In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Poleg tega bo rutinsko zmanjševanje tveganja vključevalo tudi kumulativni pregled laktacidoze v poročilih PSUR in temu namenjen vprašalnik.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for metformin containing products
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo metformin.
The most common side-effects observed in association with metformin use in diabetic individuals are mild to moderate gastrointestinal events including diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
Najpogostejši neželeni učinki, ki so jih opazili v povezavi z uporabo metformina pri posameznikih s sladkorno boleznijo, so blagi do zmerni učinki na prebavila, vključno z drisko, slabostjo, bruhanjem, bolečinami v trebuhu in zmanjšanim tekom.
In addition, although causality cannot be ruled out, other factors rather than metformin are most likely the causes of lactic acidosis.
Poleg tega so najverjetnejši vzrok laktacidoze drugi dejavniki in ne metformin, čeprav vzročne povezave ni mogoče izključiti.
• The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
• odbor CHMP je menil, da se tveganje za laktacidozo pri bolnikih z zmerno ledvično okvaro lahko zmanjša z jasnimi priporočili za odmerjanje, dodatnim spremljanjem ravni GFR pred in med zdravljenjem ter s posodobljenimi opozorili in previdnostnimi ukrepi v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Iz tega sledi, da se morebitno povečano tveganje za laktacidozo pri bolnikih z zmerno ledvično okvaro (GFR nad 30 ml/min) lahko v zadostni meri zmanjša z jasnimi priporočili za odmerjanje, dodatnim spremljanjem ravni GFR pred in med zdravljenjem ter s posodobljenimi opozorili in previdnostnimi ukrepi v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
In view of the above, the CHMP concluded that the benefit-risk balance of metformin containing medicinal products is favourable subject to changes to the product information as described above.
Z upoštevanjem zgoraj navedenega je odbor CHMP zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
The CHMP, as a consequence, considers that the benefit-risk balance of metformin containing products remains favourable subject to the amendments to the product information.
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo metformin, še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
The educational programme is aimed:
Izobraževalni program je namenjen:
See section 5.1.
Glejte poglavje 5.1.
No interaction studies have been performed.
Študij medsebojnega delovanja niso izvedli.
The clinical relevance of these effects is unknown.
Klinični pomen teh učinkov je neznan.
Your surgeon will know which bones to avoid.
Vaš kirurg bo vedel, za katere kosti gre.
Date of latest renewal: 20 July 2012
Datum prve odobritve: 9. september 2002 Datum zadnjega podaljšanja: 20. julij 2012
• adequate fracture reduction and stabilization to ensure mechanical stability
• primerna redukcija in stabilizacija zloma, kar zagotavlja mehansko stabilnost;
No clinical data are available; potential risk for human is unknown.
Klinični podatki niso na voljo, možno tveganje za ljudi ni znano.
10 DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA
Warnings and precautions to be discussed with your doctor
Opozorila in previdnostni ukrepi, o katerih se morate pogovoriti s svojim zdravnikom
REVERSE {number} {YYYY MM}
HRBTNA STRAN {številka} {LLLL MM}
This radiographic finding may be asymptomatic or symptomatic.
Ta radiološka najdba je lahko asimptomatska ali simptomatska.
The product must be used within 2 hours after preparation.
Uporabite v 2 urah po pripravi.
6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
6422 PJ Heerlen Nizozemska tel. +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
The doctor will determine how much InductOs you will receive, depending on the size and number of fractures.
Zdravnik bo določil, koliko zdravila InductOs boste prejeli glede na velikost in število zlomov.
Talk to your doctor if you have any of the following:
Posvetujte se s svojim zdravnikom, če imate kaj od naslednjega:
The oedema was delayed in onset and usually occurred in the first week post-operation.
Edem je nastopil pozno in se je običajno pojavil v prvem tednu po operaciji.
While no harmful effects have been noted, the long-term effects are unknown.
Pri tem niso opazili nikakršnih neželenih učinkov, vendar njihovi dolgoročni učinki niso znani.
The remaining patients participated in studies using InductOs for indications not currently approved in the EU.
Preostali bolniki so sodelovali v študijah uporabe zdravila InductOs za indikacijo, ki trenutno v EU še ni odobrena.
Additional educational materials for healthcare professionals are available on the following URL: [URL to be included] <and the <Member State> website>.
Dodatna izobraževalna gradiva za zdravstvene delavce so na voljo na naslednji povezavi: [povezava bo vključena tu] <in na spletni strani <države članice>>.
Dispense onto matrix and wait 15 min.
Nanesite na ogrodje in počakajte 15 min.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
The healthcare professional educational material should contain:
Izobraževalni material za zdravstvene delavce mora vsebovati:
• The product should not be placed in direct contact with certain types of bones.
• Zdravilo ne sme biti v neposrednem stiku z določenimi kostmi.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden prejmete to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
What you need to know before you receive InductOs
Kaj morate vedeti, preden boste prejeli zdravilo InductOs
Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Počakajte NAJMANJ 15 minut, preden uporabite pripravljeno zdravilo InductOs.
These data are supplemented with information from use of InductOs in the general population.
Ti podatki so dopolnjeni z informacijami o uporabi dravila InductOs pri splošni populaciji.
Immune response
Imunski odgovor
All patients who were tested for neutralizing antibodies to bone morphogenetic protein-2 were negative.
Vsi bolniki, ki so bili testirani za nevtralizirajoča protitelesa proti kostnemu morfogenetskemu proteinu-2, so bili negativni.
The selected pieces can be further cut as required.
Izbrane kose lahko po potrebi dodatno razrežete.
• Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta.
For these special populations, the physician is advised to give a careful consideration to the benefits and risks for the specific patient before using InductOs.
Za te posebne skupine bolnikov se zdravniku svetuje, da skrbno oceni razmerje med tveganji in koristmi za posameznega bolnika, preden uporabo zdravilo InductOs.
The MAH shall ensure that in each Member State where InductOs is marketed, all healthcare professionals who are expected to use InductOs are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo InductOs trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali zdravilo InductOs, prejeli naslednji izobraževalni paket:
• adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation)
• primeren nevrovaskularni status (npr. odsotnost utesnitvenega sindroma, majhno tveganje amputacije);
There were no other alterations in foetal external, visceral, or skeletal morphology.
Drugih sprememb zunanje, visceralne ali skeletne morfologije plodov ni bilo.
5 Observed during use in acute tibia fractures * Additional information provided below
5Opaženo med uporabo pri akutnih zlomih golenice * Dodatne informacije so na voljo spodaj
InductOs should be used by an appropriately qualified surgeon.
Zdravilo InductOs naj uporablja le ustrezno usposobljen kirurg.
These results were independently corroborated by a radiology panel blinded to treatment.
Te rezultate je neodvisno potrdila skupina radiologov, ki niso imeli dostopa do podatkov o zdravljenju.
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6. 6.3 Rok uporabnosti
Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital if you have localised swelling, which may result in breathing difficulties, after InductOs has been used in surgery of the upper (neck) region of your spine.
Svojemu zdravniku takoj povejte ali takoj pojdite na urgenco najbližje bolnišnice, če imate lokalizirano oteklino, ki lahko povzroči težave z dihanjem, če so zdravilo InductOs uporabili v operaciji zgornjega (vratnega) predela vaše hrbtenice.
InductOs must not be used in concentrations higher than 1.5 mg/ml (see section 4.9).
Zdravilo InductOs se ne sme uporabljati v koncentracijah, višjih od 1,5 mg/ml (glejte poglavje 4.9).
• at increasing awareness about the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of InductOs and providing guidance on how to manage these risks.
• za zvečanje zavedanja tveganja za heterotopično osifikacijo in možnega tveganja napak pri zdravljenju in nepravilne uporabe zdravila InductOs ter za podajanje smernic, kako ta tveganja obvladati.
Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Bone formation outside the intervertebral disc space is not desirable as it may have a deleterious impact on local neurovascular structures.
Tvorba kosti zunaj medvretenčnega prostora ni zaželena, ker lahko poškoduje lokalne nevrovaskularne strukture.
Considering the type of product, systemic exposure of the suckling infant is not expected, however a risk to the newborn/infant cannot be excluded.
Glede na vrsto izdelka sistemske izpostavljenosti doječih otrok ne pričakujemo, vendar pa tveganja za novorojenca/dojenčka ni mogoče izključiti.
• if you are still growing (skeletally immature).
• če še rastete (če vaše okostje še ni zrelo);
Clinical pharmacology studies demonstrate that the matrix alone is not osteoinductive and is no longer present in biopsies taken as early as 16 weeks post-implantation.
Klinične farmakološke študije kažejo, da matriks sam ni osteoinduktiven in že 16 tednov po implantaciji ni več prisoten v takrat odvzetih biopsijskih vzorcih.
1 matrix
1 matriks
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
It is not known if InductOs passes into breast milk.
Ni znano, ali zdravilo InductOs prehaja v materino mleko.
Localised infection
Lokalizirana okužba
• Very common (may affect more than 1 in 10 people):
• zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
Radiographic, biomechanical and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone.
Radiografski, biomehanski in histološki testi induciranega kostnega tkiva kažejo, da to tako biološko kot biomehansko deluje kot nativna kost.
What InductOs is and what it is used for
Kaj je zdravilo InductOs in za kaj ga uporabljamo
Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Najvišje koncentracije dibotermina alfa v obtoku (0,1 % implantiranega odmerka) so bile zabeležene v 6 urah po implantaciji.
• The sponge is white and it is presented in a plastic blister.
• Goba je bela in je dobavljena v plastičnem pretisnem omotu.
The medical staff will prepare InductOs in the operating room.
Medicinsko osebje bo pripravilo zdravilo InductOs v operacijski dvorani.
The safety and efficacy of InductOs in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila InductOs pri otrocih, mlajših od 18 let, še nista bili dokazani.
• Two needles (stainless steel).
• dve igli (iz nerjavečega jekla).
• absence of large segmental defect repair of long bones, in which significant soft tissue compression can occur
• brez obsežnih reparacijskih procesov velikih segmentnih defektov dolgih kosti, pri katerih lahko pride do pomembne kompresije mehkih tkiv.
In case of overdose (i.e. a patient receives a concentration or amount of dibotermin alfa greater than recommended), treatment should be supportive.
bolnik prejme večjo koncentracijo ali količino dibotermina alfa, kot je priporočeno) mora biti zdravljenje podporno.
Failure to follow the product preparation instructions in section 6.6 and the method of administration in section 4.2 may compromise the safety and efficacy of InductOs.
Če se ne boste ravnali po navodilih za pripravo zdravila v poglavju 6.6 in po navodilih za način uporabe v poglavju 4.2, boste ogrozili varnost in učinkovitost zdravila InductOs.
Water for injections
Vehikel voda za injekcije
Long-bone fracture and soft-tissue management procedures should be based on standard practice, including control of infection.
Oskrba zlomov dolgih kosti in poškodb mehkih tkiv mora temeljiti na standardnih postopkih, vključno z obvladovanjem okužbe.
Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins, ATC code: M05BC01
Farmakoterapevtska skupina: zdravila za zdravljenje bolezni kosti, proteini za morfogenezo kosti; oznaka ATC: M05BC01.
The Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom mora skupaj s pristojnim nacionalnim organom pripraviti vsebino in obliko izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in drugimi vidiki programa.
Frequencies are defined as very common (≥1/10) or common (≥1/100 to <1/10).
Pogostnosti neželenih učinkov so opredeljene kot zelo pogosti (≥1/10) ali pogosti (≥1/100 do <1/10).
Other medicines and InductOs
Druga zdravila in zdravilo InductOs
• Water for injections is a clear colourless liquid presented in a glass vial.
• Voda za injekcije je bistra, brezbarvna tekočina v stekleni viali.
Osteolysis* Resorption bone increased*
osteoliza* povečana resorpcija kosti*
Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Združljivost je bila dokazana s titanom, polietereterketonom (PEEK) in homologno kostjo.
Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Dibotermin alfa (rekombinantni humani protein za morfogenezo kosti-2; rhBMP-2) je človeški protein, pridobljen iz rekombinantne vrste ovarijskih celic kitajskega hrčka (CHO - »Chinese Hamster Ovary«).
The number of secondary and subsequent interventions was significantly reduced for the InductOs patients, particularly with regard to more invasive interventions, such as bone graft and exchange nailing (P = 0.0326).
Pri bolnikih z zdravilom InductOs se je število sekundarnih in nadaljnjih intervencij značilno zmanjšalo, zlasti kar zadeva agresivnejše posege, kot so kostni vsadki in menjava žeblja (P = 0,0326).
A close monitoring of the patient for any adverse reactions and the success of the treatment is recommended.
Priporoča se tudi skrbno nadziranje pojava neželenih reakcij in uspeha zdravljenja pri bolniku.
EU/1/02/226/002
EU/1/02/226/001 EU/1/02/226/002
The frequency of this side effect is unknown and cannot be estimated from the available data.
Pogostnost je neznana in je ni mogoče oceniti iz razpoložljivih podatkov.
In some circumstances an exaggeration of these processes can lead to complications such as nerve compression (due to heterotopic ossification) or device dislocation (associated with bone resorption or osteolysis).
V nekaterih pogojih lahko pretirana procesa povzročita zaplete, kot sta kompresija živcev (zaradi heterotopične osifikacije) ali migracija vstavka (povezano z resorpcijo kosti ali osteolizo).
• Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
• patološkimi zlomi, kakršni so značilni tudi (ne pa samo) za Pagetovo bolezen ali kostne metastaze.
The frequency of adverse reactions in patients exposed to treatment with InductOs is presented in the table below.
Pogostnost neželenih učinkov pri bolnikih, izpostavljenih zdravljenju z zdravilom InductOs, je predstavljena v spodnji preglednici.
To prevent overloading the matrix, it is important to reconstitute the dibotermin alfa and to wet the entire matrix as described below.
Da boste preprečili preobremenitev matriksa, morate dibotermin alfa pripraviti in celotno ogrodje navlažiti, kot je opisano spodaj.
The safety and efficacy of InductOs have not been established in the following conditions:
Varnosti in učinkovitosti zdravila InductOs niso ugotovili v naslednjih okoliščinah:
In addition, several non-clinical studies indicate that there is a negative feedback mechanism at the molecular level that limits bone induction by BMPs.
Poleg tega številne predklinične študije kažejo, da na molekularnem nivoju deluje negativni povratni mehanizem, ki omejuje indukcijo kosti s strani BMP.
Patients were followed for 12 months after soft-tissue closure.
Bolnike so opazovali 12 mesecev po zaprtju mehkih tkiv (zašitju rane).
• for treating a fracture that is disease-related (e.g., fractures due to Paget's disease or cancer).
• za zdravljenje bolezenskih zlomov (npr. zlomi kot posledica Pagetove bolezni ali raka);
− If you have any further questions, ask your doctor.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
• Some patients may develop antibodies (made by your body to fight a foreign protein) to InductOs.
• Pri nekaterih bolnikih se lahko razvijejo protitelesa (ki jih vaše telo izdela za borbo proti tuji beljakovini) proti zdravilu InductOs.
When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Po intravenski aplikaciji je bila končna razpolovna doba dibotermina alfa pri podganah 16 minut, pri opicah cinomolgus pa 6,7 minut.
• An active infection at the operative site
• akutno okužbo v operativnem območju;
• Common (may affect up to 1 in 10 people): Additional bone growth, movement of the implanted medical device, localised fluid build-up and pain radiating from your back to your leg (sciatica)
• pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): dodatna rast kosti, premikanje vsajenega medicinskega pripomočka, lokalizirano kopičenje tekočine in bolečina, ki izžareva iz hrbta v nogo (išias);
If you think you have an allergic reaction to collagen, contact your doctor.
Če menite, da imate alergijsko reakcijo na kolagen, se posvetujte s svojim zdravnikom
Lower back spine fusion surgery Talk to your doctor if you have any of the following:
Operacija za fuzijo ledvenega dela hrbtenice Posvetujte se s svojim zdravnikom, če imate kaj od naslednjega:
• Common (may affect up to 1 in 10 people):
• pogosti (pojavijo se lahko pri do 1 od 10 bolnikov):
• Healthcare professionals educational material
• izobraževalni material za zdravstvene delavce.
As part of the pharmacological mechanism of action of dibotermin alfa, bone remodelling occurs (see section 5.1).
Kot del farmakološkega mehanizma delovanja dibotermina alfa se pojavi remodeliranje kosti (glejte poglavje 5.1).