natgillin/translations-raw huggingface dataset:
The solvent for Docefrez is a 35.4% w/w solution of ethanol (anhydrous) in polysorbate 80.
Raztopina za Docefrez je 35,4 % raztopina etanola (brez vode) v polisorbatu 80.
Neutropenia (G3/4: 83.2%);
Nevtropenija (S3/4: 32 %),
• Induction chemotherapy followed by radiotherapy (TAX 323).
Indukcijska kemoterapija in nato radioterapija (TAX 323)
Do not use Docefrez
UPORABA ZDRAVILA DOCEFREZ
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2
Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
Docetaxel 75 mg/m² single agent
Docetaksel 75 mg/m2 v monoterapiji
Weight decreased
odmerek docetaksela prekinite.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of powder contains 80 mg docetaxel (anhydrous).
Vsaka viala z enim odmerkom v obliki praška vsebuje 80 mg docetaksela (brez vode).
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8).
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
Nausea (G3/4: 2.4%);
Omotica (S3/4: 2,3 %),
• dry mouth, difficulty or painful swallowing, inflammation of the gullet (oesophagitis)
• znižanje krvnega tlaka (hipotenzija), srčne okvare; neredni srčni utrip (aritmija); • suha usta, težavno ali boleče požiranje, vnetje požiralnika (oesophagitis);
Hearing impaired (G3/4: 1.2%)
Okvara sluha (S3/4: 1,2
Number.
faze.
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Letargija (S3/4: 3,4 %) pireksija (S3/4: 0,6 %),
20 mg docetaxel (anhydrous).
20 mg docetaksela.
Hazard ratio (95%CI) **p-value
Razmerje tveganja (95 % IZ) **p-vrednost
Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
stomatitis, dispepsija, bolečine v trebuhu
Adjusted Hazard ratio (95%CI) *p-value
Popravljeno razmerje tveganja (95 % IZ) *p-vrednost
The solvent for Docefrez is a solution of 35.4% w/w Ethanol (anhydrous) in Polysorbate 80.
Raztopina za Docefrez je raztopina 35,4% etanola (brez vode) v polisorbatu 80.
5 ml colourless type 1 glass vial with grey bromobutyl rubber stopper and sealed with a dark green colour flip-off aluminium seal.
5-mililitrska viala iz prozornega stekla tipa 1 s sivim brombutilnim zamaškom in temnozeleno aluminijasto zaporko.
Febrile neutropenia (G3/4: NA)
vročica (S 3/4: NA),
Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docefrez v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
• dizziness, hearing impaired
• dehidracija; • vrtoglavica, poslabšan sluh;
Docetaxel 75 mg/m² in combination with cisplatin: MedDRA system organ classes
Docetaksel 75 mg/m2 v kombinaciji z cisplationom Organski sistemi po
Ischemia myocardial
Disgevzija/parozmija,
5 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with brown colour flip-off with aluminium seal.
5-mililitrska viala iz prozornega stekla tipa 1 s sivim brombutilnim zamaškom in rjavo aluminijasto
80 mg docetaxel (anhydrous).
80 mg docetaksela.
Docefrez 20 mg powder for concentrate for solution for infusion
Docefrez 20 mg prašek in raztopilo za koncentrat infuzijske tekočine
If docetaxel powder, reconstituted concentrate, or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranjeDocefreza v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
G3/4 Blood bilirubin G3/4 AST increased increased (<2.5%);
Zvečanje bilirubina v krvi S3/4 (2,5 %),
Read all of this leaflet carefully before you start using this medicine.
Pred uporabo natančno preberite navodila.
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Nevtropenični zapleti pri bolnicah, ki so prejemale TAC z ali brez primarne profilakse z G-CSF
Epistaxis (G3/4: 0%); Dyspnoea (G3/4: 0.6%);
Epistaksa (S3/4: 0 %), dispneja (S3/4: 0,6 %), kašelj (S3/4: 0 %)
Overall Age category 1 <50 years
Celotno Starostna kategorija 1
Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Driska (S3/4: 19,7 %), navzea (S3/4: 16 %), stomatitis (S3/4:
Arrythmia (G3/4:0.7%)
Aritmija (S3/4: 0,2 %)
Subset Analyses-Adjuvant Therapy in Patients with Node-negative Breast Cancer Study
Docetaksel za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami,
If docetaxel powder, reconstituted concentrate or solution for infusion should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride prašek, pripravljen koncentrat ali raztopina docetaksela za infundiranje v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
Peripheral motor neuropathy (G3/4: 2.5%)
periferna motorična nevropatija (S3/4: 2 %)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of powder contains 20 mg docetaxel (anhydrous).
Vsaka viala za en odmerek v obliki praška vsebuje 20 mg docetaksela (brez vode).
At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Akutno levkemijo so po mediano 77 mesečnem spremljanju zabeležili pri 1 od 532 (0,2 %) bolnicah,
*un-adjusted log-rank test
CP je bilo značilno daljše (log-rang test, p =
Asthenia (G3/4: 10.0%); Pyrexia (G3/4: NA);
Letargija (S3/4: 4,0 %), pireksija (S3/4: 3,6 %),
• one single-dose powder vial with 80 mg docetaxel (plus 18% overfill: 94.4 mg) and
V vsakem pakiranju je : • ena viala z enim odmerkom praška z 80 mg docetaksela (plus 18 % dodatka celotni vsebini: 94,4 mg)
4 ml (35.4% w/w ethanol in polysorbate 80)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4 ml (35,4 % etanola v polisorbatu 80)
Median progression free survival (months) (95%CI)
Mediano preživetje brez napredovanja bolezni (meseci) (95 % IZ)
Docefrez 80 mg, Powder for Concentrate for Solution for Infusion
Docefrez, 80 mg, prašek in vehikel za pripravo koncentrata za raztopino za infundiranje
Sverige Sun Pharmaceutical Industries Europe B.V.
IMETNIK DOVOLJENJA ZA PROMET Sun Pharmaceutical Industries Europe B.V.
STATEMENT OF ACTIVE SUBSTANCE(S)
(KRT) po protokolu (TPF/KRT).
PREPARATION GUIDE FOR USE WITH DOCEFREZ 80 MG, POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
NAVODILO ZA UPORABO DOCEFREZ 80 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
Docefrez 80 mg powder and solvent for concentrate for solution for infusion
Docefrez 80 mg prašek in raztopilo za koncentrat infuzijske tekočine docetaksel
PREPARATION GUIDE FOR USE WITH DOCEFREZ 20 MG, POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
NAVODILO ZA UPORABO Docefrez 20 mg koncentrat in vehikel za raztopino za infundiranje Docetaksel
Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4: 0.6%)
periferna senzorična nevropatija (S3/4:0,6 %)
Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Letargija (S3/4: 19,0 %), zvišana telesna temperatura (S3/4: 2,3 %),
Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Hipotenzija (S3/4: 0 %), vnetje žile (S 3/4: 0 %)
Batch:
do:
1 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with dark blue flip-off with aluminium seal.
1-mililitrska viala iz prozornega stekla tipa 1 s sivim brombutilnim zamaškom in temnomodro aluminijasto zaporko.
• The Docefrez 80 mg vial contains a white to off white lyophilised powder in a 15 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with red flip-off aluminium seal.
• Viala Docefrez 80 mg vsebuje bel do sivo bel liofoliziran prašek, v 15 ml cevasti brezbarvni viali z
Fever (G3/4: 1.2%)
(S3/4: 1,2 %)
In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either Docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Druga je na 3 tedne dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml«min) v 30-60 minutah, tretja pa na 4 tedne (VCis) vinorelbin (V) 25 mg/m2 v 6-10 minutah 1.,
Hearing impaired (G3/4: 0%).
Okvara sluha (S3/4: 0 %)
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Indukcijska kemoterapija in nato kemoradioterapija (TAX324)
Constipation (G3/4:
Nevtropenija (S3/4:
Immune system disorders Metabolism and nutrition disorders
Presnovne in prehranske motnje anoreksija
Stomatitis/Pharyngitis (G3/4:
Motnja solzenja (S3/4:
Arrhythmia (G3/4:
Pruritični izpuščaj (S3/4:
Docefrez 80 mg powder and solvent for concentrate for solution for infusion Docetaxel
Docefrez 80 mg prašek in raztopilo za koncentrat infuzijske tekočine docetaksel intravenska uporaba
The overfill ensures that after dilution with the entire extractable volume of the accompanying solvent vial for Docefrez, there is a minimal extractable reconstituted solution of 3.36 ml containing 80 mg docetaxel (anhydrous).
Docefrez, minimalni izločljivi volumen 3,36 ml, ki vsebuje 80 mg docetaksela (brez vode).
Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Astenija (S3/4: 3 %), pireksija (S3/4: 1 %), utrujenost/šibkost (S3/4: 5 %), periferni edemi (S3/4: 1 %),
Exfoliative rash (G3/4: 0.3%)
Eksfoliacijski izpuščaj (S3/4: 0,3
Infection (G3/4: 3.3%)
Okužba (S3/4: 6,3 %),
Alopecia; Erythema; Rash; Nail disorders
Alopecija, eritem, izpuščaj,
Stomatitis (G3/4: 6.0%);
Omotica (S3/4: 2,0 %),
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15.
Shranjevanje zdravila Docefrez 12.
If Docefrez powder, reconstituted solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docefrez v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
Infections (G3/4;5.7%; including sepsis and pneumonia, fatal in
Okužba, povezana z bolezni vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
1 ml (35.4% w/w ethanol in polysorbate 80)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 ml (35,4 % etanola v polisorbatu 80)
Nausea (G3/4: 3.3%);
Utrujenost (S3/4: 3,9 %),
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
(TAC), sta se febrilna nevtropenija in/ali nevtropenična okužba redkeje pojavili pri bolnicah, ki so prejemale primarno profilakso z G-CSF.
G3/4 Blood bilirubin increased
zvečanje bilirubina v krvi S3/4
Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Docefrez v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Rezultate učinkovitosti povzema spodnja tabela: Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca Končna točka
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy
Aritmija (S3/4: 2,0 %) Miokardna ishemija
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
docetaksel so aplicirali v 1-urni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan. Bolnice, ki so doživele zapleteno nevtropenijo (febrilna nevtropenija, dolgotrajna nevtropenija ali okužba), so kot sekundarno profilakso dobile G
Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
(S3/4: 1,2 %), gastrointestinalna krvavitev (S3/4: 0,4 %)
Positive
učinki
(95% CI) ***p-value
(95 % IZ) Razmerje tveganja (95 % IZ) *vrednost p
Epistaxis (G3/4: 0%);
(S3/4: 0 %)
Venous disorder (G3/4:
Venska bolezen (S3/4:
Docefrez 20 mg powder and solvent for concentrate for solution for infusion
Docefrez 20 mg prašek in vehikel za pripravo koncentrata za raztopino za infundiranje
Docetaxel 100 mg/m² single agent
Docetaksel 100 mg/m2 v monoterapiji Organski sistemi po
EU Procedure number
Številka EU
Invented name Strengths Pharmaceutical Form Route of administration
Izmišljeno ime Jakost
Packaging Content
Vsebina
Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
336 (4 pakiranja po 84) trdih kapsul
(Invented) name Strength Pharmaceutical Form Route of Administration
Pot uporabe Ovojnina
Within 1 month of Commission Decision.
V enem mesecu po sklepu Komisije.
These should be submitted to the National Competent Authorities:
Predložiti jih je treba pristojnim nacionalnim organom.
The clinical study report should be submitted to the relevant National Competent Authorities:
Poročilo o klinični študiji je treba predložiti ustreznemu pristojnemu nacionalnemu organu.
The details of the visual reminder should be agreed at national level further to a user test taking into account input from local patient representatives.
O podrobnostih vizualnega opomnika se je treba dogovoriti na nacionalni ravni, poleg tega pa je potreben uporabniški preskus, pri čemer je treba upoštevati pripombe lokalnih predstavnikov bolnikov.
The study design should aim to evaluate and quantify the effectiveness of the Risk Management Measures, and should include a pre- and post-implemented analysis and assessment.
Študija bi morala biti zasnovana tako, da bi se z njo ocenila in izmerila učinkovitost ukrepov za obvladovanje tveganja, ter bi morala vključevati analizo in oceno pred zdravljenjem in po njem.
A visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products-containing oral retinoids acitretin, alitretinoin and isotretinoin.
Vizualni opomnik na zunanji ovojnini za opozorilo bolnici o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila je treba uvesti pri vseh zdravilih, ki vsebujejo peroralne retinioide acitretin, alitretinoin in izotretinoin.
The marketing authorisation holder(s) for oral retinoids acitretin, alitretinoin and isotretinoin shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Imetniki dovoljenja za promet z zdravilom za peroralne retinioide acitretin, alitretinoin in izotretinoin izpolnijo naslednje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
The MAHs of oral retinoids containing acitretin, alitretinoin or isotretinoin shall develop and submit educational materials according to the agreed key elements.
Imetniki dovoljenja za promet z zdravilom, ki vsebujejo peroralne retinioide acitretin, alitretinoin ali izotretinoin, pripravijo in predložijo izobraževalno gradivo v skladu z dogovorjenimi ključnimi elementi.
In order to assess the effectiveness of the updated risk minimisation measures in women of childbearing potential resulting from this referral procedure, MAH(s) of oral retinoids acitretin, alitretinoin and isotretinoin should conduct and submit the results of a drug utilisation study (DUS).
Da bi se ocenila učinkovitost posodobljenih ukrepov za zmanjšanje tveganja pri ženskah v rodni dobi na podlagi tega napotitvenega postopka, morajo imetniki dovoljenja za promet z zdravilom, ki vsebujejo peroralne retinioide acitretin, alitretinoin in izotretinoin, izvesti študijo o uporabi zdravil ter predložiti njene rezultate.
These materials should ensure that prescribers are informed and the patients understand and acknowledge the risks associated with oral retinoids acitretin, alitretinoin and isotretinoin in-utero exposure.
in bolnice poučeni ter razumejo tveganja, povezana z izpostavljenostjo peroralnim retinioidom acitretin, alitretinoin in izotretinoin v maternici, in potrjujejo seznanjenost z njimi.
25 mg Film-coated tablet
Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
EU/1/07/383/001 Januvia
Številka (EU) dovoljenja za promet
Page 2 of 2
Velikost pakiranja
The programme may last up to approximately a year.
Program lahko traja do približno enega leta.
However, knowledge on the long-term effect of the medicine is limited.
Vendar je znanje o dolgoročnih učinkih tega zdravila omejeno.
The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom ChondroCelect, veljavno po vsej Evropski uniji, izdala 5. oktobra 2009.
The full EPAR for ChondroCelect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ChondroCelect je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.
Družba izvaja tudi opazovalno študijo, da bi pridobila več informacij o varnosti in učinkovitosti zdravila ChondroCelect.
Cartilage in the knee can be damaged because of an accident, such as a fall, or because they wear off.
Hrustanec v kolenu se lahko poškoduje pri nezgodi, kot je denimo padec, ali zaradi obrabe.
What measures are being taken to ensure the safe and effective use of ChondroCelect?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ChondroCelect?
This is a summary of the European public assessment report (EPAR) for ChondroCelect.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ChondroCelect.
A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila ChondroCelect je bil pripravljen načrt obvladovanja tveganj.
The defects were on the femoral condyle and were between 1 and 5 cm2 in size.
Okvare so bile na femoralnem kondilu, velikosti od 1 do 5 cm2.
For more information about treatment with ChondroCelect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom ChondroCelect preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
ChondroCelect is a medicine that is prepared specially for each individual patient and can only be used to treat the particular patient it was prepared for.
Zdravilo ChondroCelect se pripravi za vsakega bolnika posebej in ga je mogoče uporabljati samo za zdravljenje bolnika, za katerega je bilo pripravljeno.
Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Bolniki, ki se zdravijo z zdravilom ChondroCelect, morajo opraviti poseben rehabilitacijski program, ki vključuje tudi fizioterapijo.
Other information about ChondroCelect
Druge informacije o zdravilu ChondroCelect
The main measures of effectiveness were how well the defects had healed after one year and the change in the patients' Knee Injury and Osteoarthritis Outcome Score (KOOS) after one and three years of treatment.
Glavni merili učinkovitosti sta bili dejstvo, kako dobro so se okvare popravile po enem letu, in sprememba v bolnikovem KOOS (Knee Injury and Osteoarthritis Outcome Score - merjenje izida ob poškodbi kolena in osteoartritisu) po enem in po treh letih od zdravljenja.
What benefit has ChondroCelect shown during the studies?
Kakšne koristi je zdravilo ChondroCelect izkazalo med študijami?
ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow's blood).
Zdravila ChondroCelect ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katero koli drugo sestavino zdravila ali na goveji serum (kravjo kri).
The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
CHMP je menil, da je zdravilo ChondroCelect učinkovito pri zdravljenju okvar kolenskega hrustanca velikosti od 1 do 5 cm2 in da je njegov varnostni profil sprejemljiv.
It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Prav tako se ne sme uporabljati pri bolnikih z napredovalim osteoartritisom kolena (boleznijo, ki povzroča otekanje in bolečine v kolenu) in osebah s femoralno rastno ploščo (zaključnim predelom stegnenice), ki ni še povsem zaprta.
The KOOS was measured by patients rating the severity of their symptoms.
Izid KOOS so bolniki izmerili sami in pri tem ocenjevali resnost simptomov.
The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect.
Hrustančne celice se nato vzgojijo in razmnožijo v laboratoriju v količini, ki zadostuje za pripravo celične suspenzije, ki se uporablja za zdravljenje okvar hrustanca.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ChondroCelect.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product.
Poleg tega bo družba, ki izdeluje zdravilo ChondroCelect, vsem kirurgom in drugim zdravstvenim delavcem, ki rokujejo z zdravilom ChondroCelect ali ga uporabljajo, zagotovila izobraževalno gradivo o uporabi zdravila.
This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient's cartilage.
To pomeni, da se odvzamejo bolniku, se vzgojijo izven telesa in se nato uporabijo za vsadek v bolnikov hrustanec.
ChondroCelect is a suspension for implantation that contains cartilage cells.
ChondroCelect je suspenzija za implantacijo, ki vsebuje hrustančne celice.