natgillin/translations-raw huggingface dataset:
This leaflet was last revised in MM/YYYY
Navodilo je bilo nazadnje revidirano dne MM/LLLL Drugi viri informacij
The mean elimination half-lives of the one-ring opened metabolite B and metabolite C are 0.9-3.9 h (n=5) and 0.5-0.8 h (n=3),
Povprečni razpolovni čas izločanja je za odprti intermediat z enim obročem B 0,9-3,9 h (n=5), za odprti intermediat z enim obročem C pa 0,5-0,8 h (n=3).
The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available.
Pediatrična populacija Varnost in učinkovitost zdravila Savene pri otrocih, mlajših od 18 let, nista bili dokazani.
The adverse reactions were those typically seen with standard chemotherapy and also with dexrazoxane: Nausea/vomiting in about one third of the patients, neutropenia and thrombocytopenia in about half of the patients, more rarely increased concentration of liver enzymes (ALT/AST).
Opazili so neželene učinke, značilne za standardno kemoterapijo in deksrazoksan: slabost/bruhanje so opazili pri približno tretjini bolnikov, nevtropenijo in trombocitopenijo pri približno polovici bolnikov,
For intravenous use after reconstitution and dilution.
Za intravensko uporabo po rekonstituciji in razredčenju.
Savene powder must be reconstituted in 25 ml Savene solvent to obtain a concentrate that must be further diluted in the remaining Savene solvent prior to administration.
Pred dajanjem je treba prašek Savene pripraviti s 25 ml vehikla Savene, da dobite koncentrat, ki ga je treba dodatno razredčiti v preostanku vehikla Savene.
White to off-white lyophilisate.
bel do belkast liofilizat.
How to use Savene
Kako uporabljati zdravilo Savene
Savene must be administered under the supervision of a physician experienced in the use of anticancer medicinal products.
Zdravilo Savene je treba uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi zdravil proti raku.
The steady-state volume of distribution of dexrazoxane was 30.5 L ± 11.1 for day 1 and 35.8 L ± 19.7 for day 2.
Porazdelitveni volumen v stanju dinamičnega ravnovesja deksrazoksana je znašal 30,5 l ±11,1 za 1. dan in 35,8 l ±19,7 za 2. dan. Razpolovni čas terminalne eliminacije je bil konsistenten od 1. do 3. dne (2,1-2,2 h).
The elimination half-life of the two-ring opened metabolite ADR-925 is not given in literature.
925 v literaturi ni objavljen.
Postoperative infection
Zelo pogosti postoperativne okužbe
Talk to your doctor or nurse before using Savene: - Savene should only be given to you if you have an extravasation in connection with anthracycline-containing chemotherapy.
Opozorila in previdnostni ukrepi - Zdravilo Savene lahko prejmete le, če je pri vas prišlo do ekstravazacije v zvezi s kemoterapijo,
• Allergic reactions, symptoms of which could be itching (pruritis), rash, facial/throat swelling,
• alergijske reakcije s simptomi, kot so srbenje (pruritus), izpuščaj, otekanje obraza/žrela,
• Dry mouth
• vnetje ust,
Excipients with known effects: Solvent bottle:
Pomožne snovi z znanimi učinki:
Savene solvent: 500 ml solution in bottles made of Type-I (Ph.Eur.)
500 ml raztopina v steklenicah iz stekla tipa I (po Evropski farmakopeji).
In particular, tell your doctor or nurse if you are taking or may take any of the following medicines: - Vaccines: you must not use Savene if you are going to receive yellow fever vaccine and it is not recommended that you use Savene if you are going to receive a vaccine containing live virus particles.
- Cepiva: zdravila Savene ne smete prejeti, če boste cepljeni proti rumeni mrzlici, hkrati pa uporaba zdravila Savene ni priporočljiva, če boste prejeli cepivo, ki vsebuje delce živih virusov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING KIT BOX (1 KIT CONSISTING OF 10 POWDER VIALS AND 3 SOLVENT BOTTLES)
PODATKI NA ZUNANJI OVOJNINI KOMPLET V ŠKATLI (KOMPLET VSEBUJE 10 VIAL S PRAŠKOM IN 3 STEKLENICE
Before infusion, Savene powder must be reconstituted with 25 ml Savene solvent to give a concentration of 20 mg dexrazoxane per ml.
Pred infundiranjem je treba prašek Savene pripraviti s 25 ml vehikla Savene, da nastane koncentracija 20 mg deksrazoksana na ml.
After reconstitution with 25 ml Savene solvent, 1 ml of concentrate contains 20 mg dexrazoxane.
Po pripravi s 25 ml vehikla Savene, 1 ml koncentrata vsebuje 20 mg deksrazoksana.
wheezing, breathlessness or difficult breathing, changes in levels of consciousness, hypotension,
piskanje v prsih, zasoplost ali težave pri dihanju, spremembe stopnje zavesti, hipotenzija (nizek krvni tlak), nenadna omedlevica.
OTHER SPECIAL WARNING(S), IF NECESSARY To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabiti pod nadzorom zdravnika, ki ima izkušnje pri uporabi citotoksičnih zdravil.
The concentration of dexrazoxane following reconstitution with 25 ml Savene solvent is 20 mg/ml.
Koncentracija deksrazoksana po rekonstituciji s 25 ml vehikla Savene je 20 mg/ml.
What you need to know before you use Savene
Kaj morate vedeti, preden boste uporabili zdravilo Savene Ne uporabljajte zdravila Savene:
B-1420 Braine-L'Alleud Belgium
Rue de la Papyrée 2-4-6 B-1420 Braine-L'Alleud Belgija
Savene must only be administered intravenously.
Zdravilo Savene lahko uporabljate le intravensko.
Initial elimination half lives (alpha) are 0.18-1 h (median 0.34 h) and terminal elimination half lives 1.9-9.1 h (median 2.8 h).
(mediana 0,34 h), končni razpolovni časi izločanja pa 1,9-9,1 h (mediana 2,8 h).
One emergency kit contains 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
En komplet za nujno uporabo vsebuje 10 vial praška Savene in 3 steklenice vehikla Savene s 3 obešali za steklenice.
• Dimethylsulfoxide (DMSO) should not be used in patients who are administered dexrazoxane to treat anthracycline extravasation (see section 5.3)
• Bolniki, ki za zdravljenje antraciklinske ekstravazacije prejmejo deksrazoksan, ne smejo prejeti dimetilsulfoksida (DMSO) (glejte poglavje 5.3).
Savene powder for concentrate Solvent for Savene
prašek za koncentrat Savene vehikel Savene
It is not known whether dexrazoxane is excreted in human milk.
Ni znano, ali se deksrazoksan izloča v materino mleko.
Each ml contains 20 mg of dexrazoxane after reconstitution with 25 ml of Savene solvent.
En ml vsebuje 20 mg deksrazoksana po rekonstituciji s 25 ml vehikla Savene.
• Weight loss, loss of appetite
• izguba telesne mase, izguba teka,
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after reconstitution and dilution.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba po rekonstituciji in redčenju.
Skin reactions have been reported following contact with dexrazoxane.
Po stiku z deksrazoksanom so poročali o kožnih reakcijah.
Adverse reactions reported are listed according to the following frequency:
Pogostnost neželenih učinkov je opisana sledeče:
- The other ingredient(s) are: The solvent which contains sodium chloride, potassium chloride, magnesium chloride hexahydrate, sodium acetate trihydrate, sodium gluconate, sodium hydroxide and water for injections.
- Druge sestavine zdravila so: Vehikel, ki vsebuje natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid in vodo za injekcije.
Women of child-bearing potential/Contraception in males and females Since dexrazoxane possesses mutagenic activity and is used with anthracyclines known to have cytotoxic, mutagenic and embryotoxic properties, both sexually active men and women of childbearing potential should be advised not to father a child/become pregnant and must use effective contraceptive measures during and up to 6 months after treatment.
da imajo citotoksične, mutagene in embriotoksične lastnosti, je treba spolno aktivnim moškim in ženskam v rodni dobi svetovati, da ne zaplodijo otroka/zanosijo ter naj uporabljajo učinkovito kontracepcijo med zdravljenjem in do 6 mesecev po njem.
• Reduction in the number of white blood cells and platelets
• zmanjšano število levkocitov in trombocitov,
Savene powder: Amber-coloured, 36-ml, glass type I vial with stopper made of chlorobutyl rubber and a flip-off cap.
36 ml viala tipa I jantarne barve z zamaškom iz klorobutilne gume in izvlečno zaporko.
The recommended dose is: Day 1: 1000 mg/m2
Priporočeni odmerek je: prvi dan: 1.000 mg/m2 drugi dan: 1.000 mg/m2
Savene is available as an emergency kit consisting of 10 vials of Savene powder and 3 bottles of Savene solvent supplied with 3 bottle hangers.
Zdravilo Savene je na voljo v kompletu za nujno uporabo z 10 vialami praška Savene in 3 steklenicami vehikla Savene s 3 obešali za steklenice.
Clear isotonic solution (295 mOsml/l, pH approx. 7.4).
Steklenica z vehiklom: bistra izotonična raztopina (295 mOsml/l, pH pribl.
Powder vial:
Viala s praškom:
Dexrazoxane has minor influence on the ability to drive and use machines.
Deksrazoksan ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
No of patients with post baseline value
Št. bolnikov s preiskavo po izhodiščni vrednosti
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji ali redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Each vial contains 500 mg dexrazoxane (589 mg dexrazoxane hydrochloride).
Ena viala vsebuje 500 mg deksrazoksana (589 mg deksrazoksan klorida).
OTHER SPECIAL WARNING(S), IF NECESSARY Contains cytotoxics after dilution with concentrate.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Po redčenju koncentrata v vehiklu vsebuje citotoksike.
Dexrazoxane is not recommended in combination with phenytoin.
Deksrazoksan ni priporočljiv ob sočasnem zdravljenju s fenitoinom.
What Savene looks like and contents of the emergency kit The Savene kit consists of Savene powder for concentrate (white to off-white powder) and Savene solvent.
Komplet zdravila Savene je sestavljen iz (belega do umazano belega) praška za koncentrat Savene in vehikla Savene.
- If the medicine is not used immediately, it should be kept at a temperature of 2 to 8 °C (in the refrigerator) and no longer than 4 hours.
- Če zdravila ne uporabite takoj, shranjevanje ne sme biti daljše od 4 ur pri temperaturi od 2 do
Savene is supplied as:
FORMULACIJA Zdravilo je na voljo kot:
Because of the potential for serious adverse reactions in breast-fed infants exposed to dexrazoxane, breast-feeding is contraindicated during Savene therapy (see section 4.3).
Zaradi potencialno resnih neželenih učinkov pri dojenih dojenčkih, ki so izpostavljeni deksrazoksanu, je dojenje med zdravljenjem z zdravilom
Savene contains the active substance dexrazoxane, which acts as an antidote to anti-cancer medicines called anthracyclines.
Kaj je zdravilo Savene in za kaj ga uporabljamo Zdravilo Savene vsebuje učinkovino deksrazoksan, ki deluje kot antidot (protistrup) proti antraciklinom, ki se uporabljajo za zdravljenje raka.
Signs and symptoms of overdosage are likely to consist of leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea, skin reactions and alopecia.
Znaki in simptomi prevelikega odmerjanja so verjetno levkopenija, trombocitopenija, slabost,
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use after dilution with concentrate.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Intravenska uporaba po redčenju koncentrata v vehiklu.
Note that in these studies dexrazoxane was administered prior to anthracyline administration.
Upoštevati je potrebno, da so osebe v teh raziskavah prejele deksrazoksan pred antracilinom.
3.1.4 Allow the vial with the concentrate to stand for 5 minutes at room temperature and check if the solution is homogenous and clear.
3.1.4 Viala s koncentratom naj stoji 5 minut pri sobni temperaturi.
Dizziness, somnolence and syncope have been reported in a few patients included in Savene studies TT01 and TT02 (see section 4.8).
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Pri nekaterih bolnikih, ki so bili vključeni v preučevanje zdravila Savene (študiji TT01 in TT02), so poročali o omotici, somnolenci in sinkopi (glej poglavje 4.8).
Each vial contains 500 mg dexrazoxane as 589 mg dexrazoxane hydrochloride.
Ena viala vsebuje 500 mg deksrazoksana v obliki 589 mg deksrazoksanovega klorida.
Savene contains potassium and sodium
Vsebnost kalija in natrija
ALT
brez
Dyspnoea Pneumonia
Pljučnica
Contents of the pack and other information
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Savene
Dexrazoxane has been shown to possess mutagenic activity.
Dokazano je bilo, da je deksrazoksan mutagen.
sudden fainting
Okvara jeter
• Swelling in arms or legs (oedema)
• otekanje rok in nog (edem),
Day 2: 1000 mg/m2
Drugi dan: 1.000 mg/m2 Tretji dan:
Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate, Sodium gluconate, Sodium hydroxide, Water for injections.
natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat, natrijev glukonat, natrijev hidroksid, voda za injekcije
Superficial thrombophlebitis Venous thrombosis limb
Pogosti površinski tromboflebitis
You must not breast-feed while you are treated with Savene.
Med zdravljenjem z zdravilom Savene ne dojite.
STATEMENT OF ACTIVE SUBSTANCE(S)
SEZNAM POMOŽNIH SNOVI Pomožne snovi - prašek Savene:
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for concentrate for solution for infusion 10 vials of 500 mg dexrazoxane 3 bottles of 500 ml solvent and 3 bottle hangers Emergency kit for the treatment of anthracycline extravasation
prašek in vehikel za koncentrat za raztopino za infundiranje 10 vial s 500 mg deksrazoksana.
PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion.
prašek in vehikel za koncentrat za raztopino za infundiranje
There is limited information about the effect of Savene on fertility - if you have a concern about this speak to you doctor.
Na voljo so omejeni podatki o učinku zdravila Savene na plodnost.
• Inflammation in the mouth
• krvavitev iz nožnice,
Very common
Zelo pogosti slabost
Savene will be given by infusion into one of your veins.
Zdravilo Savene se daje z infuzijo v veno.
Previous history of allergy to dexrazoxane should be carefully considered prior to administration (see section 4.3).
Pred uporabo deksrazoksana je treba skrbno preveriti, ali ima bolnik alergijo na deksrazoksan v anamnezi (glejte poglavje 4.3).
Hepatic and renal-function monitoring
Spremljanje delovanja jeter in ledvic.
Keep vials and bottles in the outer carton in order to protect from light.
Viale in steklenice shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilo
Savene is an anti-cancer agent and the normal procedures for proper handling and disposal of anticancer medicines should be adopted, namely: - Personnel should be trained to reconstitute the medicine - Pregnant staff should be excluded from working with this medicine - Personnel handling this medicine during reconstitution should wear protective clothing including mask, goggles and gloves - Accidental contact with the skin or eyes should be treated immediately and thoroughly with copious amounts of water
- Noseče zdravstvene delavke ne smejo delati s tem zdravilom - Osebe, ki pripravljajo zdravilo, morajo nositi zaščitna oblačila, vključno z zaščitno masko,
Injection site induration Injection site swelling Peripheral oedema Somnolence
Pireksija flebitis na mestu injiciranja eritem na mestu injiciranja, utrujenost induracija na mestu injiciranja, oteklina na mestu injiciranja, periferni edem, somnolenca
respectively.
Savene.
Excipients Savene powder: None
Viala s praškom brez
Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines (see section 4.8).
Pri bolnikih, zdravljenih deksrazoksanom in antraciklini, so opazili anafilaktične reakcije, vključno z angioedemom, kožnimi reakcijami, bronhospazmom, dihalno stisko, hipotenzijo in izgubo zavesti
Do not use Savene: - If you are allergic to dexrazoxane or any of the other ingredients of this medicine (listed in section 6) - If you are planning to become pregnant and do not use adequate contraceptive measures - If you are breast-feeding - If you are given yellow-fever vaccine
- če načrtujete zanositev in ne uporabljate ustrezne kontracepcije - če dojite - če ste prejeli cepivo proti rumeni mrzlici
Injection site pain
Zelo pogosti bolečine na mestu injiciranja
Dexrazoxane may cause foetal harm when administered to pregnant women.
Uporaba deksrazoksana pri nosečnicah lahko škoduje plodu.
Savene is indicated in adults for the treatment of anthracycline extravasation.
4.1 Terapevtske indikacije Zdravilo Savene je indicirano za zdravljenje antraciklinske ekstravazacije pri odraslih.
- Keep the powder vials and solvent bottles in the outer carton in order to protect from light.
- Viale s praškom in steklenice z vehiklom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Preparation guide for use with Savene 20 mg/ml powder and solvent for concentrate for solution for infusion
Navodilo za pripravo zdravila Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje
Chemical and physical in-use stability has been demonstrated for 4 hours when stored at 2 to 8 °C.
Dokazana je bilo da, je pripravljena raztopina pri temperaturi 2 do 8 °C kemijsko in fizikalno stabilna 4 ure.
PHARMACEUTICAL FORM AND CONTENTS 500 ml solvent
500 ml vehikla
Keep the powder vials and solvent bottles in the outer carton in order to protect from light.
Viale s praškom in steklenice z vehiklom shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
The concentrate contains 20 mg dexrazoxane per ml and should be used immediately for further dilution.
Koncentrat vsebuje 20 mg deksrazoksana na ml.
NAME OF THE MEDICINAL PRODUCT Solvent for Savene
Vehikel zdravila Savene
• Dexrazoxane may add to the toxicity induced by the chemotherapy cycle during which the accident took place, requiring careful monitoring of haematological parameters (see section 4.4).
• Deksrazoksan lahko prispeva k toksičnim učinkom, ki jih sproži cikel kemoterapije, med katerim je prišlo do dogodka.
4.1 Before reconstitution and dilution: - Store below 25 °C.
SHRANJEVANJE 4.1 Pred rekonstitucijo in redčenjem:
Savene 20 mg/ml powder and solvent for concentrate for solution for infusion Dexrazoxane
Savene 20 mg/ml praška za koncentrat deksrazoksan
Most common adverse reactions are nausea/vomiting, bone marrow suppression (neutropenia, thrombocytopenia), injection site reactions, diarrhoea, stomatitis and increase in hepatic transaminases (ALT/AST).
supresija kostnega mozga (nevtropenija, trombocitopenija), reakcije na mestu injiciranja, driska,
STORAGE
Starostniki
Batch
Trombociti
Decreased appetite
Presnovne in prehranske motnje Pogosti zmanjšan apetit
Vascular disorders
Organski sistemi
< PC: {number} [product code]
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI <PC: {številka}
Dizziness, tiredness and sudden fainting have been reported in a few patients treated with Savene.
Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih, zdravljenih z zdravilom Savene, so poročali o omotici, utrujenosti in nenadni omedlevici.
Your doctor may reduce your dose if you have kidney problems.
Če imate težave z ledvicami, vam lahko zdravnik zniža odmerek.
Vaginal haemorrhage
Hemoglobin Levkociti Nevtrofilci
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SOLVENT BOTTLE
Izgled zdravila Savene in vsebina pakiranja kompleta za nujno uporabo
NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion dexrazoxane
Navodilo za uporabo Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje deksrazoksan
Wound complication
Pogosti zapleti ran
NAME OF THE MEDICINAL PRODUCT Savene 20 mg/ml powder and solvent for concentrate for solution for infusion.
Savene 20 mg/ml prašek in vehikel za koncentrat za raztopino za infundiranje.
Pregnancy, breast-feeding and fertility
bruhanje, driska, kožne reakcije in alopecija.
Haemoglobin WBC
1118BJ Schiphol Nizozemska
EU (MA) number Invented name Strength Pharmaceutical form Target species Route of administration Packaging Content Package size Withdrawal period
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika Ciljna živalska vrsta Način uporabe Pakiranje Vsebina Velikost pakiranja Karenca
More about Semler
Več o družbi Semler
More about the medicines covered by this review
Več o zdravilih, ki so zajeta v ta pregled
Therefore national authorities can temporarily postpone the suspension in the interest of patients.
Zato lahko nacionalni organi začasni umik začasno preložijo, saj je to v interesu bolnikov.
The review of Semler was initiated on 28 April 2016 at the request of Denmark, Germany, the Netherlands, Spain and the United Kingdom under Article 31 of Directive 2001/83/EC.
Pregled družbe Semler se je začel 28. aprila 2016 na zahtevo Danske, Nemčije, Nizozemske, Španije in Združenega kraljestva v skladu s členom 31 Direktive 2001/83/ES.
Thus, no medicines can be approved on the basis of these studies.
Zato na podlagi teh študij ni mogoče odobriti nobenega zdravila.
Member States should also decide whether recalls of the affected medicines are needed in their territories.
Države članice se morajo odločiti tudi, ali je na njihovem ozemlju potreben odpoklic zadevnih zdravil.
• Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns.
• Bolniki morajo še naprej jemati svoja zdravila, kot jim je bilo predpisano, in se posvetovati z zdravnikom, če imajo kakršna koli vprašanja ali pomisleke.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 2016.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 22. septembra 2016 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
• National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
• Nacionalni organi v EU bodo presodili, kako kritično pomembna so posamezna zdravila v njihovih državah, in podali končne odločitve o začasnem umiku ali ohranitvi dovoljenja za promet z zdravilom, medtem ko bo potekalo pridobivanje novih podatkov.
Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State.
Nekatera zdravila s priporočilom za začasni umik dovoljenja za promet so v določenih državah članicah EU morda kritičnega pomena (npr. zaradi pomanjkanja drugih razpoložljivih možnosti).
The list of medicines recommended to remain on the market can be found here.
Seznam zdravil, ki po priporočilu lahko ostanejo na trgu, je na voljo tukaj.
During the evaluation, alternative studies were provided for some of these medicines.
Med vrednotenjem so bile za nekatera od teh zdravil predložene druge študije.
The CHMP's recommendation concerning these medicines was sent to the European Commission for a legally binding decision valid throughout the EU.
Priporočilo odbora CHMP o teh zdravilih je bilo poslano Evropski komisiji v sprejetje pravno zavezujočega sklepa, ki bo veljal v vsej EU.
These studies show bioequivalence, and therefore, the CHMP recommended that these medicines can remain on the market.
Te študije dokazujejo biološko enakovrednost, zato je odbor CHMP priporočil, da ta zdravila lahko ostanejo na trgu.
• There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Semler.
• Trenutno ni dokazov o nepričakovani škodljivosti ali pomanjkanju učinkovitosti za katero koli od zdravil, odobrenih na podlagi študij, opravljenih v družbi Semler.
Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu http://www.who.int/prequal
Tel. +44 (0)20 3660 8427 E-naslov: press@ema.europa.eu http://www.who.int/prequal