natgillin/translations-raw huggingface dataset:
More patients in the ChondroCelect treatment group, compared to patients in the microfracture group, had undergone previous knee surgery (88% versus 77%).
zdravljeni z zdravilom ChondroCelect, je v primerjavi z bolniki v skupini, zdravljeni s postopkom mikrofrakture, že imelo predhodno operacijo kolena (88 % proti 77 %).
In a randomized, controlled study in the target population, 51 patients were treated with ChondroCelect.
Povzetek varnostnega profila V randomizirani, nadzorovani študiji ciljne populacije je bilo 51 bolnikov zdravljenih z zdravilom
Where possible, concomitant knee problems should be corrected prior to or at the latest at the time of ChondroCelect implantation.
Kjer je mogoče, je treba sočasne težave s koleni odpraviti pred implantacijo zdravila ChondroCelect ali vsaj ob njej.
No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.
Pri klinični koristi med zdravilom ChondroCelect in mikrofrakturo v tem trenutku ni bilo mogoče opaziti statistično pomembnih razlik.
Photophobia, Transient ischaemic attack
prehodna ishemična ataka
Hypertrophic scar, Postoperative wound complication, Pruritus,
hipertrofična brazgotina, pooperativni zapleti z rano, pruritus,
Overall, the clinically relevant benefit of ChondroCelect implantation observed over baseline after 36 months was maintained up to 60 months after treatment.
ChondroCelect, opažena po 36 mesecih, ohranila do 60 mesecev po zdravljenju.
The falcon tube is placed in a plastic screw top container together with surgery materials (one sterile syringe of 1 ml, one 18G intravenous catheter and two pieces of Vicryl 6.0) and a temperature monitor.
Epruveta Falcon je shranjena v plastičnem vsebniku z navojnim zamaškom skupaj s kirurškim materialom (ena 1 ml sterilna brizga, en intravenski kateter 18 G in dva kosa šivalnega materiala Vicryl 6.0) in kontrolno napravo za temperaturo.
There are no data on the use of ChondroCelect during breast-feeding.
Ni podatkov o uporabi zdravila ChondroCelect med dojenjem.
In the subgroup of patients with recent symptom onset (< 3 years) the clinical benefit of ChondroCelect over microfracture was significantly larger, confirming the results at 36 months after treatment.
Pri poskupini bolnikov z nedavnim pojavom simptomov (< 3 leta) so bile klinične koristi zdravila ChondroCelect v primerjavi z mikrofrakturo veliko večje, kar je potrdilo rezultate
Implantation of ChondroCelect is to be performed during arthrotomy under sterile conditions and requires both preparation of the defect bed and a seal (biological membrane) to secure the implant.
Implantacijo zdravila ChondroCelect je treba izvesti med artrotomijo v sterilnih pogojih, za zaščito implantata pa se zahteva priprava okvarjenega ležišča in tudi tesnjenje (biološka membrana).
Full technical details on the procedures associated with this implantation technique are provided in the ChondroCelect user manual.
Popolni tehnični podatki o postopkih, povezanih s tehniko implantacije, so na razpolago v navodilih za bolnika za zdravilo ChondroCelect.
Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the product, it is possible that you will not be eligible for treatment with ChondroCelect.
Primeri, v katerih zdravila ChondroCelect ni mogoče uporabiti Tudi če je kirurg že vzel majhen vzorec hrustančnih celic (biopt), potreben za izdelavo izdelka, je mogoče, da ne boste primerni za zdravljenje z zdravilom ChondroCelect.
ChondroCelect is intended solely for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI).
Zdravilo ChondroCelect je namenjeno samo za avtologno zdravljenje hrustanca in se daje bolnikom v postopku implantacije avtolognih hondrocitov (ACI - Autologous Chondrocyte Implantation).
Upon implantation, the patient should follow an appropriate rehabilitation schedule and physical activity should be resumed as recommended by the physician.
Rehabilitacija Po implantaciji mora bolnik izvajati ustrezen rehabilitacijski program in telesne dejavnosti po priporočilih zdravnika.
Concomitant knee problems like early osteoarthritis, osteochondritis dissecans (OCD), instability of the knee, cartilage lesions at other locations than the femoral condyle, lesions of knee ligaments or of the meniscus, varus or valgus malalignment (abnormal weight distribution in the knee), and inflammatory joint disease are potential complicating factors.
Sočasne težave s koleni, kot so zgodnji osteoartritis, disekantni osteohondritis (OCD), nestabilnost kolena, hrustančne lezije na drugih mestih kot na femoralnem kondilu, lezije kolenskih vezi ali meniskusa, varusna ali valgusna deformacija (nenormalna razporeditev teže v kolenu) in vnetna bolezen sklepov, so potencialni oteževalni dejavniki.
ChondroCelect was compared to the procedure of microfracture in the repair of symptomatic single cartilage lesions of the femoral condyles of the knee.
Zdravilo ChondroCelect je bilo primerjano s postopkom mikrofrakture pri zdravljenju posameznih simptomatskih lezij hrustanca femoralnega kondila kolena.
NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension
IME ZDRAVILA ChondroCelect 10000 celic/mikroliter suspenzija za implantacijo
Pt initials {patient initials}
bolnika) {začetnice bolnika}
Other medicines and ChondroCelect
Druga zdravila in zdravilo ChondroCelect
Fibrin glues are routinely used in ACI procedures to seal the outside margins and to improve the water-tightness of the compartment of the biological membrane used to cover the defect.
Fibrinska lepila se rutinsko uporabljajo v postopkih ACI - Autologous Chondrocyte Implantation za tesnjenje zunanjih robov in izboljšanje neprepustnosti vode dela biološke membrane, ki se uporabi za pokritje okvare.
Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
V 36-mesečnem pooperativnem obdobju spremljanja je do neželenih učinkov prišlo pri 78,4 %
The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding.
Varna uporaba zdravila ChondroCelect med nosečnostjo ali dojenjem ni bila dokazana.
ChondroCelect 10,000 cells/microlitre implantation suspension.
Navodilo za uporabo ChondroCelect 10000 celic/mikroliter suspenzija za implantacijo
- ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
- Zdravilo ChondroCelect se ne priporoča za zdravljenje okvar hrustanca na drugih mestih kot na femoralnem kondilu.
Pt N° {patient number}
Št. bolnika {številka bolnika}
Using fibrin glue only, instead of stitches, to secure the implant is not recommended.
Uporaba samo fibrinskega lepila brez šivov za pritrditev vsadka ni priporočena.
During open-knee surgery, the cartilage cells are implanted into the cartilage defect.
Med operacijo na odprtem kolenu se hrustančne celice implantira v okvarjeni hrustanec.
The vials are placed in a sterile falcon tube with a plastic screw top.
Viale so shranjene v sterilni epruveti Falcon s plastičnim navojnim zamaškom.
ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.
Zdravilo ChondroCelect je namenjeno samo za avtologno uporabo in ga je treba uporabljati v kombinaciji z debridementom (čiščenjem rane z odstranjevanjem odmrlega, poškodovanega ali okuženega tkiva), fizičnim tesnjenjem lezije (namestitvijo biološke membrane, prednostno kolagenske membrane) in rehabilitacijo.
Related to ChondroCelect:
V povezavi z zdravilom ChondroCelect:
After the 5 year follow-up period, 37 patients were evaluated in the ChondroCelect arm and 40 in the microfracture arm.
Po 5-letnem kontrolnem obdobju so ocenili 37 bolnikov iz kraka z zdravilom ChondroCelect in 40 iz mikrofrakcijskega kraka.
- If you have any further questions, ask your doctor, surgeon or physical therapist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, kirurgom ali fizioterapevtom.
Limited clinical data on exposed pregnancies are available.
Na voljo so omejeni klinični podatki o uporabi avtolognih hrustančnih celic med nosečnostjo.
Tabulated list of adverse reactions They are listed by System Organ Class and frequency.
Navedeni so po organskih sistemih in pogostnosti.
Very common side effects (affects more than 1 user in 10) include: joint pain (arthralgia), overgrowth of cartilage cells (cartilage hypertrophy), crackling or clicking sensation when articulating the knee (joint crepitation), and joint swelling.
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 bolniku od 10 bolnikov) vključujejo: bolečina v sklepu (artralgija), prekomerna rast hrustančnih celic (hipertrofija hrustanca), občutek prasketanja ali pokanja ob premikanju kolena (pokanje sklepa) in otekanje sklepa.
• Informed consent for the patients to be signed prior to the treatment with ChondroCelect
• privolitev bolnikov, ki s podpisom zagotovijo, da so seznanjeni z zdravljenjem z zdravilom
The training materials for surgeons shall include the following key messages and components:
ChondroCelect pred njegovim začetkom Gradivo za usposabljanje kirurgov mora vsebovati naslednje ključne podatke in elemente:
Most side effects of ChondroCelect implantation are side effects related to open-knee surgery.
Večina neželenih učinkov implantacije zdravila ChondroCelect je povezana z odprto operacijo na kolenu.
Implantation suspension.
suspenzija za implantacijo
ChondroCelect is not recommended for pregnant and breast-feeding women.
Uporabe zdravila ChondroCelect se ne priporoča pri nosečnicah in doječih materah.
There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
Po kliničnem izidu KOOS (Knee Injury and Osteoarthritis Outcome Score - merjenje izida ob poškodbi kolena in osteoartritisu) se je stanje neprestano izboljševalo 36 mesecev pri obeh zdravljenih rokah.
This is called ‘autologous chondrocyte implantation' (ACI).
„implantacija avtolognih hondrocitov“ (ACI).
Before re-suspension the cells are settled to the bottom of the container forming an off-white layer and the excipient is a clear colourless liquid.
suspenzija za implantacijo Pred resuspenzijo se celice nahajajo na dnu vsebnika in oblikujejo belkasto plast, pomožna snov pa je prozorna brezbarvna tekočina.
This cartilage sample will be used to make ChondroCelect.
Ta vzorec hrustanca se uporabi za izdelavo zdravila ChondroCelect.
Seven patients treated with ChondroCelect needed re-intervention, compared to 10 patients in the microfracture group.
Pri sedmih bolnikih, zdravljenih z zdravilom ChondroCelect, so bili potrebni ponovni posegi, v skupini zdravljeni z mikrofrakturo pa je takšnih bolnikov 10.
Tell your doctor immediately if you notice any of these symptoms.
Če opazite katerega koli izmed teh simptomov, o tem nemudoma obvestite svojega zdravnika.
Do not use ChondroCelect if you: are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
Kaj morate vedeti, preden boste uporabili zdravilo ChondroCelect Ne uporabljajte zdravila ChondroCelect: - če ste alergični na katero koli sestavino tega zdravila (navedeno v poglavju 6), ali goveji serum.
ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
Zdravilo ChondroCelect se uporablja za zdravljenje posameznih simptomatskih okvar hrustanca femoralnega kondila kolena pri odraslih.
ChondroCelect consists of autologous cultured cartilage cells.
Zdravilo ChondroCelect je sestavljeno iz avtologno gojenih hrustančnih celic.
adverse reactions are presented in order of decreasing seriousness.
V vsaki skupini pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
The surgical procedure will have a major influence on your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Kirurški postopek bo imel velik vpliv na vašo sposobnost upravljanja vozil in strojev.
Patient number (Pt N°) {patient number} Patient initials (Pt initials) {patient initials}
Številka bolnika (št. bolnika) {številka bolnika}
Visit 2: ChondroCelect implantation
Drugi obisk: implantacija zdravila ChondroCelect
For implantation.
Način uporabe za implantiranje
EXP {DD month YYYY} at {hours} CET
Uporabno do: {DD mesec LLLL} ob {ura} po srednjevropskem času
Children and adolescents The use of ChondroCelect is not recommended in children and adolescents below 18 years.
Zdravilo ChondroCelect se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
oznaka ATC: M09AX02
Impaired healing, Implant site hypersensitivity, Peripheral edema, Pyrexia
preobčutljivost mesta implantacije, periferni edem, pireksija granulomatozna lezija
NAME OF THE MEDICINAL PRODUCT ChondroCelect
IME ZDRAVILA ChondroCelect
Falcon tube
OVOJNINAH Epruveta Falcon
At this time point 41 patients were evaluated in the ChondroCelect arm and 49 were evaluated in the microfracture arm.
Do takrat je bilo ocenjenih 41 bolnikov, zdravljenih z zdravilom ChondroCelect, in 49 bolnikov, zdravljenih s postopkom mikrofrakture.
If you get any side effects, talk to your doctor or physical therapist.
Če opazite kateri koli neželeni učinek, se posvetujte s svojo zdravnikom ali fizioterapevtom.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING White screw top container
PODATKI NA ZUNANJI OVOJNINI Bel vsebnik z navojnim zamaškom
If you have any further questions on the use of this medicine, ask your doctor or physical therapist.
Če imate glede zdravljenja z zdravilom ChondroCelect kakršnakoli dodatna vprašanja, se obrnite na vašega zdravnika ali fizioterapevta.
See section 4.
(glejte poglavje 4.4).
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA <{MM/LLLL}>
The implantation should be followed by an appropriate rehabilitation schedule for approximately one year, as recommended by the physician (see section 4.4).
Implantaciji mora slediti ustrezen rehabilitacijski načrt za približno eno leto po priporočilih zdravnika
Cartilage hypertrophy
Hipertrofija hrustanca
Keep the product vial(s) within the falcon tube in the outer plastic screw top container in order to protect from light and bacterial/fungal contamination.
Vialo (viale) shranjujte v epruveti Falcon v zunanjem plastičnem vsebniku z navojnim zamaškom, da bi zdravilo zaščitili pred svetlobo in bakterijsko/glivično kontaminacijo.
The median time since onset of knee injury was slightly longer in the ChondroCelect group than in the microfracture group (2.0 years versus 1.6 years).
kot v skupini, zdravljeni s postopkom mikrofrakture (2,0 leti proti 1,6 let).
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC , ODGOVOREN ZA SPROŠČANJE
- If you get any of the side effects, talk to your doctor, surgeon or physical therapist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, kirurgom ali fizioterapevtom.
Common side effects ( affects in 1 to 10 users in 100) include: restriction of knee motion (arthrofibrosis, decreased joint range of motion, decreased mobility), excessive amount of joint fluid in the joint (joint effusion), joint lock, joint inflammation (arthritis, bursitis, synovitis), cavity filled with fluid in the knee (bone cyst, synovial cyst), bone swelling, cartilage disorder (chondropathy), benign bony growth (exostosis), blood in a joint (haemarthrosis), joint instability, joint stiffness, loose body in joint, weakening of muscle (muscle atrophy, Trendelenburg's sign), degenerative joint disorder (osteoarthritis), tendon disorder, inflammation of the tendon (tendonitis), impaired healing, treatment failure, gait disturbance, implant site hypersensitivity, peripheral edema, fever (pyrexia), postoperative wound complication (wound site reaction) ,wound infection (including erysipelas), redness, scar overgrowth, itching, scar pain, wound loosening, wound secretion loosening of the graft or membrane (graft complication, graft delamination), injury (cartilage injury, joint injury), blood clot in the deep vein of the leg (deep vein thrombosis), large bruise (haematoma), superficial vein inflammation (phlebitis), nausea, pain or nerve disorder (pain in extremity, peripheral neuropathy, complex regional pain syndrome, autonomic neuropathy), syncope, apnea, arthroscopy.
neuspeh zdravljenja, motnje hoje, preobčutljivost mesta implantata, periferni edem, povišana telesna temperatura (pireksija), pooperativni zapleti ran (reakcija na mestu rane), okužba rane (vključno z erizipelom), rdečina, prekomerno brazgotinjenje, srbečica, bolečina na mestu brazgotine, ohlapnost rane, izločanje sekreta iz rane, popustitev vsadka ali membrane (zapleti z vsadkom, delaminacija vsadka), poškodbe (poškodbe hrustanca, poškodbe sklepa), krvni strdek v nožni veni (globoka venska tromboza), velika modrica (hematom), vnetje površinskih ven (flebitis), navzea, bolečina ali okvare živcev (bolečina v udih, periferna nevropatija, kompleksni regionalni bolečinski sindrom, avtonomna nevropatija), sinkopa, apneja, artroskopija.
Given the local nature of ChondroCelect adverse reactions on the nursing infant are not anticipated.
Ker se zdravilo ChondroCelect uporablja lokalno, ni pričakovati neželenih učinkov pri dojenem otroku.
Pain in extremity, Peripheral neuropathy, Syncope,
periferna nevropatija, sinkopa,
Keep the product vial(s) within the falcon tube in the plastic screw top container in order to protect from light and bacterial/fungal contamination.
Vialo (viale) shranjujte v epruveti Falcon v plastičnem vsebniku z navojnim zamaškom, da bi zdravilo zaščitili pred svetlobo in bakterijsko/glivično kontaminacijo.
What ChondroCelect looks like and contents of the pack ChondroCelect is a cell suspension (a fluid) for implantation.
Zdravilo ChondroCelect je celična suspenzija (tekočina) za implantacijo.
Graft complication, Graft delamination, Cartilage injury, Injury,
Poškodbe in zastrupitve in zapleti pri posegih zapleti z vsadkom, delaminacija vsadka, poškodbe hrustanca, poškodba, poškodbe sklepa, reakcija na mestu posega
Deep vein thrombosis, Haematoma, Superficial phlebitis
Žilne bolezni globoka venska tromboza, hematom, površinski flebitis maščobna embolija,
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 million autologous human cartilage cells in 0.4 ml, corresponding to a concentration of 10,000 cells/microlitre.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 4 milijone avtolognih hrustančnih celic humanega izvora v 0,4 ml, kar ustreza koncentraciji 10000 celic/mikroliter.
Warnings and precautions Talk to your doctor, surgeon or physiotherapist before using ChondroCelect.
Pred začetkom uporabe zdravila ChondroCelect se posvetujte s svojo zdravnikom, kirurgom ali fizioterapevtom.
ChondroCelect 10,000 cells/microlitre implantation suspension Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine
What ChondroCelect contains - The active substance of ChondroCelect consists of a treatment dose of viable autologous human cartilage cells in vials containing 4 million cells in 0.4 ml, corresponding to a concentration of
- Zdravilna učinkovina zdravila ChondroCelect je sestavljena iz odmerka za zdravljenje iz viabilnih avtolognih hrustančnih celic humanega izvora v vialah, ki vsebujejo 4 milijone celic v 0,4 ml, kar ustreza koncentraciji 10000 celic/mikroliter.
Complete joint haemostasis must be achieved prior to membrane fixation and cell implantation.
Pred fiksacijo membrane in implantacijo celic je treba doseči popolno hemostazo v sklepu.
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora apneja pljučna embolija
Gastrointestinal disorders
Preiskave artroskopija
Within each frequency grouping,
Več bolnikov v skupini,
Uncommon side effects (affects in 1 to 10 users in 1,000 include: anxiety, dermal and visual hypersensitivity ), migraine, mini stroke (transient ischaemic attack), fat entering the circulatory system (fat embolism), vein blockage and inflammation (thrombophlebitis), blockage in a lung artery (lung embolism), itching scar, pain at the front of the knee (chondromalacia), breakdown of knee tissue (gonartrhosis, atrophy), discomfort, chronic inflammation (granulomatous lesion).
kožna in vizualna preobčutljivost), migrena, mini kap (prehodni ishemični napad), vdor maščobe v obtočila (maščobni embolizem), vnetje in blokada ven (tromboflebitis), blokada pljučne arterije (pljučni embolizem), srbeča brazgotina, bolečina v sprednjem delu kolena (hondromalacija), propadanje tkiva kolena (gonartroza, atrofija), nelagodje, kronično vnetje (granulomatozna lezija).
The CHMP decided that the MAH should continue to submit 1-yearly PSURs.
Odbor CHMP je sklenil, da mora imetnik dovoljenja za promet še naprej vsako leto pošiljati redno posodobljena poročila o varnosti zdravila (PSUR).
Hyperesthesia, Migraine,
Trendelenburgov sindrom hiperestezija, migrena, fotofobija,
Name and address of the manufacturer(s) responsible for batch release TiGenix N.V.
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Summary of the safety profile
• povzetek glavnih značilnosti zdravila
Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre.
2.2 Kakovostna in količinska sestava 1 viala zdravila vsebuje 4 milijone avtolognih hrustančnih celic humanega izvora v 0,4 ml celične suspenzije, kar ustreza koncentraciji 10000 celic/mikroliter.
Precautions for use
Previdnostni ukrepi
6.5 Nature and contents of container and special equipment for use, administration or
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo Zdravilo ChondroCelect se uporablja kot en individualni odmerek (epruveta Falcon) za zdravljenje v 1
You can recognize most of the joint- related side effects if you have symptoms like pain, snapping, grinding, locking, swelling, bending limitations and stiffness in the knee.
Večino neželenih učinkov, povezanih s sklepi, lahko prepoznate, če imate simptome, kot so bolečina,
Vascular disorders
tromboflebitis
Chondropathy, Exostosis,
atrofija, nelagodje,
METHOD OF ADMINISTRATION
NAČIN IZDAJANJA ZDRAVILA
Haemarthrosis, Joint instability, Joint stiffness, Loose body in joint, Mobility decreased, Muscle atrophy, Osteoarthritis, Synovial cyst, Synovitis,
Bolezni mišično skeletnega sistema in vezivnega tkiva artrofibroza, zmanjšan obseg gibljivosti v sklepu, efuzija v sklepu, blokada sklepa, artritis, artropatija, cista kosti, otekanje kosti burzitis, hondropatija, eksostoza, hemartroza, nestabilnost sklepa otrdelost sklepa, prosti deli v sklepu, zmanjšana gibljivost, atrofija mišic osteoartritis, sinovialna cista sinovitis, bolezni kit, tendonitis hondromalacija, gonartroza
Wound dehiscence, Wound secretion
aplikacije motnje hoje, slabo celjenje,
• if you are pregnant.
• če ste noseči.
Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
Datum prve pridobitve dovoljenja za promet: 9. marec 2000 Datum zadnjega podaljšanja dovoljenja za promet: 9. marec 2010
These hormones can be measured in your blood.
Ti hormoni se lahko merijo v krvi.
No special precautions for elderly patients are necessary.
Posebni previdnostni ukrepi za starejše bolnike niso potrebni.
In addition, no patient had a definitive recurrence during the 3.7 years of follow-up.
Poleg tega ni bilo pri nobenem od bolnikov definitivne ponovitve v 3,7-letnem spremljanju.
Total number of patients with recurrence
Celotno število bolnikov s ponovitvijo