natgillin/translations-raw huggingface dataset:
How is Tenofovir disoproxil Zentiva used?
Kako se zdravilo Dizoproksiltenofovirat Zentiva uporablja?
How has Tenofovir disoproxil Zentiva been studied?
Kako je bilo zdravilo Dizoproksiltenofovirat Zentiva raziskano?
Annex I List of medicinal products and presentations
Seznam nacionalno odobrenih zdravil
Content (concentration)
Stična ovojnina vsebina (koncentracija)
25 June 2015
25. junij 2015
Outcome of procedures under Article 29(4) of Directive 2001/83/EC
Izid postopka v skladu s členom 29(4) Direktive 2001/83/ES
The European Commission adopted a decision on this opinion on 25 June 2015.
Evropska komisija je odločbo v zvezi s tem mnenjem sprejela 25. junija 2015.
The company wanted the authorisation to be recognised in Belgium, Germany, Luxembourg and the Netherlands (the ‘concerned Member States').
Družba je želela, da se dovoljenje za promet z zdravilom prizna v Belgiji, Nemčiji, Luksemburgu in Nizozemski (zadevnih državah članicah).
However, the Member States were not able to reach an agreement and the German and Dutch medicines regulatory agencies referred the matter to the CHMP for arbitration on 24 December 2014.
Vendar države članice niso mogle doseči soglasja, zato sta nemška in nizozemska regulativna agencija za zdravila 24. decembra 2014 zadevo napotila na odbor CHMP v arbitražo.
The CHMP therefore recommended that the marketing authorisation be granted in the concerned Member States.
Odbor CHMP je zato priporočil izdajo dovoljenja za promet z zdravilom v zadevnih državah članicah.
On 23 April 2015, the European Medicines Agency completed two arbitration procedures following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Merisone and Myoson (tolperisone).
Evropska agencija za zdravila je 23. aprila 2015 zaključila dva arbitražna postopka po nesoglasju med državami članicami Evropske unije (EU) glede izdaje dovoljenj za promet z zdraviloma Merisone in Myoson (tolperizon).
Why were Merisone and Myoson reviewed?
Zakaj sta bili zdravili Merisone in Myoson pregledani?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Merisone and Myoson outweigh their risks, and the marketing authorisation granted in Hungary can be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravil Merisone in Myoson večje od z njima povezanih tveganj ter da se dovoljenje za promet, izdano na Madžarskem, lahko prizna v drugih državah članicah EU.
The grounds for the referral were that the bioequivalence studies had only been performed under fasting conditions.
Napotitveni postopek je bil sprožen, ker so študije biološke enakovrednosti izvedli samo pri pogojih na tešče.
The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Natančen način delovanja tolperizona ni znan, vendar menijo, da deluje na možgane in hrbtenjačo, kjer zmanjša živčne imulze, ki povzročajo krčenje in togost mišic.
Merisone and Myoson are generic medicines based on a ‘reference medicine', Mydeton, which is already authorised in the EU.
Merisone in Myoson sta generični zdravili, razviti na osnovi „referenčnega zdravila“ Mydeton, ki je že odobreno v EU.
Meditop Pharmaceutical Co. Ltd. submitted Merisone and Myoson for mutual recognition on the basis of their initial authorisation granted by Hungary on 18 March 2010.
Družba Meditop Pharmaceutical Co. Ltd. je predložila vlogo za medsebojno priznavanje za zdravili Merisone in Myoson na podlagi prvotne odobritve na Madžarskem 18. marca 2010.
By reducing these impulses, tolperisone is believed to reduce muscle contraction and spacticity.
Menijo, da tolperizon z zmanjšanjem teh impulzov zmanjša tudi krčenje mišic in spastičnost.
As the product information for Mydeton was recently updated to say that it should be taken with food, Germany and the Netherlands considered that a bioequivalence study under fed conditions would be required for the granting of a marketing authorisation.
Ker so informacije o zdravilu Mydeton nedavno posodobili tako, da vključujejo navodilo, da ga je treba jemati skupaj s hrano, sta Nemčija in Nizozemska menili, da bi bilo treba za izdajo dovoljenja za promet z zdravilom izvesti študijo biološke enakovrednosti pri pogojih na poln želodec.
What are Merisone and Myoson?
Kaj sta zdravili Merisone in Myoson?
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that because of the characteristics of the active substance of Merisone and Myoson food will affect the absorption of the active substance in the same way as for Mydeton and no further studies are required.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora, je ta sklenil, da bo zaradi lastnosti zdravilne učinkovine v zdravilih Merisone in Myoson hrana vplivala na absorpcijo zdravilne učinkovine na enak način kot pri zdravilu Mydeton, zato niso potrebne dodatne študije.
Merisone and Myoson are identical medicines that are used to treat muscle spasms (involuntary contractions) and spasticity.
Zdravili Merisone in Myoson sta enaki zdravili, ki se uporabljata za zdravljenje mišičnih spazmov (nezavednih krčev) in spastičnosti.
Because Merisone and Myoson are generic medicines, studies have been limited to tests to determine that they are bioequivalent to the reference medicine, Mydeton.
Ker sta zdravili Merisone in Myoson generični zdravili, so bile študije omejene na preskuse za ugotavljanje, ali sta biološko enakovredni referenčnemu zdravilu Mydeton.
The active substance in Merisone and Myoson, tolperisone, is a centrally acting muscle relaxant.
Zdravilna učinkovina v zdravilih Merisone in Myoson, tolperizon, je mišični relaksant, ki deluje na osrednje živčevje.
The CHMP therefore concluded that in the case of Merisone and Myoson the bioequivalence study in the fasting state is sufficient to conclude on the bioequivalence in both the fasting and fed states and that the benefits and risks of Merisone and Myoson can be taken to be the same as the reference medicine's.
Odbor CHMP je zato zaključil, da je v primeru zdravil Merisone in Myoson študija biološke enakovrednosti pri pogojih na tešče zadostna za sklepanje glede biološke enakovrednosti pri pogojih na tešče in poln želodec in da je mogoče sklepati, da so koristi zdravil Merisone in Myoson enake kot pri referenčnem zdravilu.
- If you are very overweight.
- če ste zelo debeli.
This serious allergic reaction needs immediate medical attention.
Ta resna alergijska reakcija zahteva takojšnjo zdravniško pomoč.
QUALITATIVEAND QUANTITATIVE COMPOSITION
KAKOVOSTNA IN KOLIČINSKA SESTAVA
This interference led to a false prolongation of PT and elevation of INR.
Ta interferenca je povzročila lažno podaljšanje PČ in povečanje INR.
The duration of therapy should be in accordance with available official recommendations.
Trajanje zdravljenja mora biti v skladu z razpoložljivimi uradnimi priporočili.
For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Pri okužbah krvi ali srca in okužbah kože se bo zdravnik odločil, kako dolgo vas bo treba zdraviti.
** See section 4.4.
** glejte poglavje 4.4
However, from a microbiological point of view the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
However, there is currently no evidence that a dose reduction is required (see section 5.2).
Vendar pa trenutno ni nobenih dokazov, da je potrebno zmanjšanje odmerka (glejte poglavje 5.2).
The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Uporaba antibiotikov lahko spodbuja prekomerno rast neobčutljivih mikroorganizmov.
The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Najpogostejša vrsta zdravljene okužbe je bila okužba rane (38 % bolnikov), medtem ko je imelo 21 % bolnikov večje abscese.
Important: Please refer to the Summary of Product Characteristics before prescribing.
Pomembno: Prosimo, glejte povzetek glavnih značilnosti zdravila, preden predpišete zdravilo.
Up to 14 Days
Do 14 dni
Mitochondrial loss/damage was also observed; however the role and significance of this finding in the overall pathology are unknown.
Opazili so tudi izgubo/poškodbe mitohondrijev, vendar vloga in pomen te ugotovitve v okviru celotne patologije nista znana.
The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Razširjenost odpornosti lahko pri izbranih vrstah geografsko in časovno variira in lokalne informacije o odpornosti so zaželene, še posebno kadar gre za zdravljenje hudih okužb.
A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Postopek zdravljenja pri okužbah kože običajno traja 1 do 2 tedna.
This mode of administration was only studied in healthy subjects.
Ta način uporabe zdravila so proučevali samo pri zdravih osebah.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Upoštevati je treba uradne smernice za ustrezno uporabo protimikrobnih zdravil.
Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Ker o teh učinkih spontano poroča populacija neznane velikosti, ni mogoče zanesljivo določiti njihove pogostnosti, zato je ta opredeljena kot ''neznana''.
Detailed instructions for use and handling are given at the end of the leaflet.
Podrobna navodila za uporabo in ravnanje z zdravilom so navedena na koncu navodila za uporabo.
Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Daptomicin je antibiotik, ki lahko zaustavi rast določenih bakterij.
- Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
• Bolnike je treba med zdravljenjem redno pregledovati glede kakršnihkoli znakov ali simptomov, ki bi lahko predstavljali miopatijo.
From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji (glejte poglavje 6.3).
In the event of overdose, supportive care is advised.
V primeru prevelikega odmerjanja svetujemo podporno oskrbo.
The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Ugotovljene razlike so najverjetneje posledica normalnega zmanjšanja delovanja ledvic, ki so ga opazili pri starejši populaciji.
The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Primarni cilj študije DAP-PEDS-07-03 je bil oceniti varnost zdravljenja.
The results can suggest poor blood clotting when, in fact, there is no problem.
Izvidi lahko pokažejo slabo strjevanje krvi, čeprav s tem dejansko nimate težav.
- Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake "EXP".
- Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
- kakršno koli nenavadno mravljinčenje ali odrevenelost v dlaneh in stopalih, izguba občutka ali težave z gibanjem.
This results in bacterial cell death with negligible cell lysis.
Rezultat tega je smrt bakterijskih celic z zanemarljivo citolizo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena zgoraj.
Adults (18 years of age and above)
Odrasli (stari 18 let ali več)
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Osebam, ki so starejše od 65 let, lahko dajemo enake odmerke kot drugim odraslim, če njihove ledvice delujejo dobro.
Children and adolescents (1 to 17 years of age)
Otroci in mladostniki (stari od 1 do 17 let)
In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Pri odraslih mora biti uporaba pri bakteriemiji povezana z RIE ali cSSTI, pri pediatričnih bolnikih pa mora biti uporaba pri bakteriemiji povezana z cSSTI.
While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
Natančna pojavnost eozinofilne pljučnice zaradi daptomicina sicer ni znana, vendar je stopnja spontanega poročanja zaenkrat zelo nizka (< 1/10.000).
No patients 1 to <2 years of age were enrolled in the study.
V študijo niso bili vključeni bolniki, stari od 1 do < 2 let.
Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Za spremembe perifernih živcev je bila značilna minimalna do blaga degeneracija aksonov in so jih pogosto spremljale funkcionalne spremembe.
Daptomycin Hospira will usually be given to you by a doctor or a nurse.
Zdravilo Daptomicin Hospira vam bo običajno dal zdravnik ali medicinska sestra.
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Za pogoje shranjevanja po rekonstituciji ter po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
Daptomycin Hospira should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Zdravljenje z daptomicinom je treba v prisotnosti nepojasnjenih mišičnih simptomov prekiniti, če raven CPK doseže več kot 5kratno zgornjo mejo normale.
If superinfection occurs during therapy, appropriate measures should be taken.
Če med zdravljenjem pride do superinfekcije, je treba ustrezno ukrepati.
The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Najvišja koncentracija daptomicina, ki so jo izmerili v mleku, je bila 0,045 μg/ml, kar je nizka koncentracija.
However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Kljub temu pa je treba oceniti delovanje ledvic in odmerek zmanjšati, če obstajajo dokazi za hudo okvaro ledvic.
There was no relevant difference in local tolerability or in the nature and frequency of adverse reactions.
Pomembnih razlik v lokalnem prenašanju ali naravi in pogostnosti neželenih učinkov ni bilo.
CARTON FOR 1 VIAL CARTON FOR 5 VIALS
ŠKATLA ZA 1 VIALO ŠKATLA ZA 5 VIAL
If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day.
Če vaše ledvice ne delujejo dobro, boste daptomicin prejemali manj pogosto, na primer vsak drugi dan.
The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to 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):
Med zdravljenjem ali spremljanjem bolnikov so o naslednjih neželenih učinkih poročali z navedbo pogostnosti, ki je opredeljena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Naravno odporni organizmi po Gramu negativni organizmi * označuje vrsto, za katero velja, da so aktivnost proti njej zadovoljivo dokazali v kliničnih študijah.
*Mean (Standard Deviation) calculated for patients 2 to 6 years of age, since no patients 1 to <2 years of age were enrolled in the study.
*Srednja vrednost (standardna deviacija), izračunana za bolnike, stare od 2 do 6 let, saj v to študijo niso bili vključeni bolniki, stari od 1 do < 2 let.
The results of these studies show that exposures (AUC) in paediatric patients across all doses are generally lower than those in adults at comparable doses.
Rezultati teh študij kažejo, da je pri pediatričnih bolnikih izpostavljenost (AUC) pri vseh odmerkih na splošno manjša kot pri odraslih med uporabo primerljivih odmerkov.
Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
Daptomicin lahko vpliva na laboratorijske preiskave, s katerimi izmerijo, kako dobro se strjuje vaša kri.
Dose adjustments in adult patients with renal impairment by indication and creatinine clearance
Prilagajanje odmerkov pri odraslih bolnikih z okvaro ledvic glede na indikacijo in očistek kreatinina
Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Zdravljenje z daptomicinom je treba takoj prekiniti in uvesti zdravljenje s sistemskimi steroidi, kadar je to primerno.
The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated.
Višina odmerkov za otroke in mladostnike (v starosti od 1 do 17 let) je odvisna od starosti bolnika in vrste zdravljene okužbe.
The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Večina zvečanj vrednosti aminotransferaz je bila toksičnosti stopnje 1-3 in je izzvenela po prekinitvi zdravljenja.
Preparation of the solution for infusion requires an additional dilution step as detailed below.
Za pripravo raztopine za infundiranje so potrebni dodatni koraki za razredčenje, kot je opisano spodaj.
Regular monitoring of renal function is advised (see section 5.2).
Priporočljivo je redno spremljanje delovanja ledvic (glejte poglavje 5.2).
In vitro studies with human hepatocytes indicate that daptomycin does not inhibit or induce the activities of the following human cytochrome P450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4.
Rezultati študij in vitro s človeškimi hepatociti kažejo, da daptomicin niti ne zavira niti ne inducira delovanja naslednjih izooblik človeškega citokroma P450: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 in 3A4.
No fibrosis or rhabdomyolysis was observed.
Fibroze ali rabdomiolize niso opažali.
The mechanism(s) of daptomycin resistance is (are) not fully understood.
Mehanizem (mehanizmi) odpornosti proti daptomicinu ni(so) v celoti pojasnjen(i).
These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
To so lahko znaki redke, a resne pljučne bolezni, ki jo imenujemo eozinofilna pljučnica.
Table 1 Adverse reactions from clinical studies and post-marketing reports
Preglednica 1 Neželeni učinki iz kliničnih študij in poročil v obdobju trženja zdravila
Therefore it is important that your doctor takes into account that you are receiving Daptomycin Hospira.
Zato je pomembno, da vaš zdravnik upošteva, da prejemate daptomicin.
Daptomycin Hospira should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Daptomicina ne smemo uporabljati med nosečnostjo, razen če je to očitno potrebno, tj. samo, če pričakovana korist odtehta možno tveganje.
After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Po čiščenju se gumijastega zamaška ne dotikajte več in pazite, da ne pride v stik s kakršnokoli drugo površino.
It is also used to treat infections in the blood when associated with skin infection.
Uporablja se tudi za zdravljenje okužb krvi, kadar so povezane z okužbo kože.
Other side effects which may occur following daptomycin treatment are described below:
Drugi neželeni učinki, ki se lahko pojavijo pri zdravljenju z daptomicinom, so opisani spodaj:
Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Glede na trajanje študije so bili vsi učinki na mišice, vključno z mikroskopskimi spremembami, popolnoma reverzibilni v 13 mesecih po prekinitvi odmerjanja.
Manufacturer Hospira UK Limited Horizon
Izdelovalec Hospira UK Limited Horizon
Commonly Susceptible Species
Vrste, ki so običajno občutljive
- Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
• Pri vsakem bolniku, pri katerem se pojavijo nepojasnjene bolečine v mišicah, občutljivost, oslabelost ali krči, je treba ravni CPK spremljati na vsaka 2 dni.
The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Enak odmerek priporočamo tudi za osebe, starejše od 65 let, pod pogojem, da njihove ledvice dobro delujejo.
The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection.
Običajni odmerek za odrasle je 4 mg na vsak kilogram (kg) telesne mase enkrat dnevno za okužbe kože oziroma 6 mg na vsak kg telesne mase enkrat dnevno za okužbe srca ali okužbe krvi, ki so povezane z okužbo kože ali srca.
Uncommon: Fatigue, pain * Based on post-marketing reports.
utrujenost, bolečine * Na osnovi poročil v obdobju trženja zdravila.
Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, druga zdravila za zdravljenje bakterijskih infekcij, oznaka ATC: J01XX09
This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly.
To je treba upoštevati pri uvedbi zdravljenja z daptomicinom in v primeru uporabe daptomicina te bolnike spremljati pogosteje kot enkrat tedensko.
In clinical studies, 2,011 adult subjects received daptomycin.
V kliničnih študijah je daptomicin prejemalo 2.011 odraslih preskušancev.
No functional or pathological changes in smooth or cardiac muscle were observed.
V gladkih mišicah ali srčni mišici niso opazili nobenih funkcionalnih ali patoloških sprememb.
Daptomycin Hospira should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Daptomicina ne smemo dajati otrokom, ki so stari manj kot 1 leto, saj so rezultati študij na živalih pokazali, da se pri tej starostni skupini lahko pojavijo hudi neželeni učinki.
Clinical efficacy in paediatric patients
Klinična učinkovitost pri pediatričnih bolnikih
In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with daptomycin met the criteria for systemic inflammatory response syndrome (SIRS).
V dveh kliničnih preskušanjih pri odraslih z zapletenimi okužbami kože in mehkih tkiv je 36 % bolnikov, ki so jih zdravili z daptomicinom, izpolnjevalo merila za sindrom sistemskega vnetnega odziva (SIRS - Systemic Inflammatory Response Syndrome).
This finding was not associated with an effect on muscle contraction.
Ta ugotovitev ni bila povezana z vplivom na krčenje mišic.
In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
V študiji masnega ravnovesja z uporabo radioaktivno označenega materiala se je glede na celotno radioaktivnost z urinom izločilo 78 % danega odmerka, medtem ko je izločanje nespremenjenega daptomicina z urinom znašalo približno 50 % odmerka.