natgillin/translations-raw huggingface dataset:
Efter indledning med en startdosis på 10 mg om dagen bør det overvejes at reducere døgndosis til 7, 5 mg ud fra farmakokinetisk modellering (se pkt.
After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, lo based on pharmacokinetic modelling (see section 4.2). no
4. 2). ng
Severe hepatic impairment The use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2). ct
Sikkerhed og virkning af læ
Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with du
fondaparinux er ikke undersøgt formelt hos patienter med HIT II.
Heparin Induced Thrombocytopenia (HIT) type II.
4. 5 Interaktion med andre lægemidler og andre former for interaktion e
The efficacy and safety of fondaparinux have not been formally studied in patients with HIT type II. ro
Risikoen for blødninger er øget ved samtidig administration af fondaparinux og andre præparater der ikk
4.5 Interaction with other medicinal products and other forms of interaction lP
4. 4).
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4). na
I kliniske studier med fondaparinux udviste perorale antikoagulantia (warfarin) ingen interaktion med er
In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux ici
I interaktionsstudier udviste en dosis på 10 mg fondaparinux ingen indflydelse på antikoagulationskontrol med warfarin målt som INR- aktivitet. et
did not influence the anticoagulation monitoring (INR) activity of warfarin. ed
Ved den i interaktionsstudier anvendte dosis på 10 mg idl
At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the M
påvirkede fondaparinux ikke blødningstiden under behandling med acetylsalicylsyre eller piroxicam og heller ikke digoxins farmakokinetik ved steady state. m
pharmacokinetics of digoxin at steady state.
4. 6 Graviditet og amning ge
4.6 Pregnancy and lactation
Fondaparinux udskilles i modermælk hos rotter, om fondaparinux udskilles i modermælk hos mennesket vides ikke.
35 Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene
No studies on the effect on the ability to drive and to use machines have been performed.
lg maskiner.
4.8 Undesirable effects
sa 4. 8 Bivirkninger
e
Sikkerheden ved administration af fondaparinux er evalueret hos 2. 517 patienter, der blev behandlet
d
til for venøse tromboemboliske komplikationer med fondaparinux i gennemsnitligt 7 dage.
The most common adverse
4. 4).
ris reactions were bleeding complications (see section 4.4).
et De bivirkninger, der er rapporteret af investigator, og som i hvert fald muligvis kan tilskrives fondaparinux, er anført efter hyppigheden af hændelsen (meget almindelig ≥ 1/ 10; almindelig ≥ 1/ 100 -
ho The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (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) and system organ
Betydningen af disse bivirkninger bør
ut class by decreasing order of seriousness.
ris fortolkes ud fra den kirurgiske og medicinsk kontekst.
ra
au Blod - og lymfesystem
Immune system
ng
du
Almindelig: blødninger (gastrointestinale, hæmaturi, hæmatom, epistaxis, hæmoptysis, uterine og vaginale blødninger, hæmoartrose, okulare, purpura, blå mærker) e Ikke almindelig: anæmi, trombocytopeni er Sjælden: andre blødninger (hepatiske, retroperitoneale, intrakranielle/ intracerebrale), trombocytæmi
Rare: allergic reaction
Immunsystemet Metabolisme og ernæring Nervesystemet
disorders
læ
Metabolism and ro
Sjælden: allergisk reaktion Sjælden: forhøjet nonprotein nitrogen (NPN) 2) Ikke almindelig: hovedpine
Rare: non-protein-nitrogen (Npn) 2 increased
e
na
Ikke almindelig: kvalme, opkastning Ikke almindelig: leverfunktionsforstyrrelser Sjælden: erythematøst hududslæt, lokal reaktion ved
Hepatobiliary disorders Uncommon: abnormal liver function ed
1) isolerede bivirkninger er kun taget i betragtning, hvis de havde medicinsk relevans 2) NPN står for nonprotein- nitrogen såsom urinstof, urinsyre, aminosyre osv. er
(2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.
4. 9 Overdosering et
36 4.9 Overdose
Der kendes intet antidot til fondaparinux. idl
There is no known antidote to fondaparinux.
den primære årsag.
Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
Man bør overveje at indlede en passende behandling heraf, såsom hæmostase, blodtransfusion, frisk frossen plasma eller plasmaferese. ge
Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
FARMAKOLOGISKE EGENSKABER Læ
PHARMACOLOGICAL PROPERTIES
5. 1 Farmakodynamiske egenskaber
ris 5.1 Pharmacodynamic properties
Farmakoterapeutisk klassifikation: antitrombotiske midler.
ho Pharmacotherapeutic group: antithrombotic agents.
36 Farmakodynamiske virkninger
ut Pharmacodynamic effects
lg aktivitet skyldes antitrombin III (antitrombin) - medieret selektiv hæmning af Faktor Xa.
ra Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
sa 300 gange).
By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the
Hæmning af Faktor Xa standser koagulationsprocessen, hvorved trombinsyntese og trombedannelse reduceres.
e innate neutralization of Factor Xa by antithrombin.
Fondaparinux hæmmer ikke trombin (aktiveret Faktor II) og påvirker ikke trombocytter.
Neutralisation of Factor Xa interrupts the blood ng coagulation cascade and inhibits both thrombin formation and thrombus development.
til I de doser, der anvendes til behandling, påvirker fondaparinux ikke i klinisk relevant omfang rutine koagulationstest som aktiveret partiel tromboplastintid (aPTT), aktiveret koagulationstid (ACT) eller
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets. lo At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) no
et protrombintid (PT) / International Normalised Ratio (INR) eller fibrinolytisk aktivitet eller kapillærblødningstiden.
or prothrombin time (PT)/ International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Ved den
At higher doses, moderate changes in aPTT can occur.
er dosis på 10 mg, som blev anvendt i interaktionsstudier, påvirkede fondaparinux ikke warfarins antikoagulerende virkning (INR) signifikant.
At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin. ct
ris Fondaparinux giver ikke krydsreaktion med sera fra patienter med heparin- induceret trombocytopeni.
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia. du
to Kliniske studier
Clinical studies ro
au Fondaparinux kliniske forsøgsprogram til forebyggelse af venøse tromboemboliske komplikationer (VTE) var tilrettelagt med henblik på at påvise effekten af fondaparinux til behandling af dyb venetrombose (DVT) og lungeemboli (PE).
The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to lP
Over 4. 874 patienter deltog i kliniske kontrollerede fase II - og fase III- studier. e er Behandling af dyb venetrombose I et randomiseret dobbeltblindt klinisk studie med patienter med den bekræftede diagnose akut symptomatisk DVT blev fondaparinux 5 mg (legemsvægt < 50 kg), 7, 5 mg (legemsvægt ≥ 50 kg, ≤ ng
Over 4874 patients were studied in controlled Phase II and III clinical studies. na
100 kg) eller 10 mg (legemsvægt > 100 kg) administreret subkutant en gang daglig sammenlignet med enoxaparinnatrium 1 mg/ kg subkutant to gange daglig.
symptomatic DVT, fondaparinux 5 mg (body weight< 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 kg) or 10 mg (body weight > 100 kg) SC once daily was compared to enoxaparin sodium 1 mg/ kg SC ed
I alt indgik 2. 192 patienter.
twice daily.
blev patienterne behandlet i mindst 5 dage og højst 26 dage (7 dage i gennemsnit).
A total of 2192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Begge grupper fik vitamin K- antagonist, og denne behandling blev sædvanligvis indledt i løbet af 72 timer efter første indgivelse af studiemedicin og fortsatte i 90 ± 7 dage med regelmæssig dosisjustering for at opnå INR 2- 3.
Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 M
VTE og fatal VTE indberettet frem til dag 97.
days, with regular dose adjustments to achieve an INR of 2-3.
Studiet viste, at behandling med fondaparinux ikke er ikk
The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
enoxaparin underlegen (forekomst af VTE henholdsvis 3, 9% og 4, 1%).
Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
Under den indledende behandling optrådte større blødninger hos 1, 1% af de patienter, der fik fonda - parinux, over for 1, 2% af dem, der fik enoxaparin. er
Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin.
Diagnosen et
37 Treatment of Pulmonary Embolism A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
blev bekræftet ved objektive undersøgelser (lungescanning, lungeangiografi eller spiral CT scanning).
The diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan).
Patienter med behov for trombolyse, embolektomi eller vena cava- filter blev udelukket. idl
Patients who required thrombolysis or embolectomy or vena cava filter were excluded.
Randomiserede patienter måtte have fået ufraktioneret heparin under screeningsfasen, men patienter, der havde fået antikoagulantia i terapeutiske doser i over 24 timer, eller som havde ukontrolleret m
Randomised patients could have been pre-treated with UFH during the screening phase but patients treated for more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were excluded.
Fondaparinux 5 mg (legemsvægt < 50 kg), 7, 5 mg (legemsvægt ≥ 50kg, ≤ 100 kg) eller 10 mg (legemsvægt > 100 kg) administreret subkutant en gang daglig blev ge
A total
I begge grupper blev patienterne behandlet i mindst 5 dage og højst 22 dage Læ
d of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22
(7 dage i gennemsnit).
e days (mean 7 days).
Begge grupper fik vitamin K- antagonist, og denne behandling blev sædvanligvis indledt i løbet af 72 timer efter første indgivelse af studiemedicin og fortsatte i 90 ± 7 dage med regelmæssig dosisjustering for at opnå INR 2- 3.
Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular
Studiet viste, at behandling med fondaparinux ikke er ufraktioneret heparin underlegen (forekomst af
Treatment with
37 VTE henholdsvis 3, 8% og 5, 0%).
ho fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 5.0%, respectively).
Under den indledende behandling sås større blødninger hos 1, 3% af de patienter, der fik fondaparinux, sammenlignet med 1, 1% af dem, der fik ufraktioneret heparin.
ut Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
lg 5. 2 Farmakokinetiske egenskaber
ra 5.2 Pharmacokinetic properties
sa Farmakokinetikken for fondaparinuxnatrium skyldes fondaparinux plasmakoncentration, der kvantificeres gennem aktiviteten af anti- faktor Xa.
e The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations ng quantified via anti factor Xa activity.
til anti- Xa assay (de internationale standarder for heparin eller lavmolekylært heparin egner sig ikke til dette formål).
Only fondaparinux can be used to calibrate the anti-Xa assay (the international standards of heparin or LMWH are not appropriate for this use).
Som følge deraf udtrykkes fondaparinux i milligram (mg).
As a result, the concentration of fondaparinux is expressed as milligrams (mg). lo Absorption no
et Absorption Efter subkutan indgift absorberes fondaparinux fuldstændigt og hurtigt med en absolut
After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
ris efter indgift.
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
Plasmakoncentrationer på halvdelen af de gennemsnitlige Cmax- værdier indtræffer 25 minutter efter indgift.
Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing. ct du
to Hos ældre raske forsøgspersoner, fandtes fondaparinux farmakokinetik lineær i området 2- 8 mg ved subkutan indgift.
In elderly healthy subjects, pharmacokinetics of fondaparinux is linear in the range of 2 to 8 mg by subcutaneous route.
Ved en daglig dosis opnås steady state- plasmakoncentration efter 3- 4 dage med en
Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC. ro
au 1, 3 gange øget Cmax og AUC.
Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients lP
Estimater for middel- steady state (Coefficient Variation (CV)) farmakokinetiske parametre for e hoftealloplastik- patienter, der får fondaparinux 2, 5 mg daglig, er:
undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Hos patienter med hoftefrakturer ses følgende steady state - er plasmakoncentrationer, hvilket er forbundet med højere alder:
Cmax (mg/ l) - 0.50 (32%), na
Cmax (mg/ l) – 0, 50 (32%), Cmin (mg/ l) – 0, 19 (58%). ng
Cmin (mg/ l) - 0.19 (58%).
Under behandling af DVT og PE hos patienter, der fik fondaparinux 5 mg (legemsvægt < 50 kg), 7, 5 mg (legemsvægt 50- 100 kg begge inklusive) og 10 mg (legemsvægt > 100 kg) en gang daglig, gav læ
In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body ici
Gennemsnitlige (CV%) farmakokinetiske parametre ved steady state for fondaparinux hos patienter med VTE, der fik det foreslåede behandlingsregime en gang daglig, vurderes til:
weight 50-100 kg inclusive) and 10 mg (body weight > 100 kg) once daily, the body weight-adjusted doses provide similar exposure across all body weight categories.
Cmax (mg/ l) - 1, 41 (23%), Tmax (h) 2, 4 (8%) e
The mean (CV%) steady state ed
og Cmin (mg/ l) - 0, 52 (45%).
Cmax (mg/ l) - 1.41 (23%), Tmax (h) – 2.4 (8%) and Cmin (mg/ l) -0.52 (45%).
De tilsvarende 5% og 95% percentiler er henholdsvis 0, 97 og 1, 92 for ikk
The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for M
Cmax (mg/ l) og 0, 24 og 0, 95 for Cmin (mg/ l).
Cmax (mg/ l), and 0.24 and 0.95 for Cmin (mg/ l).
affinitet og specifikt til antitrombinprotein med en dosisafhængig plasmakoncentrationsbinding (98, 6 - 97, 0% i koncentrationsintervallet fra 0, 5 til 2 mg/ l).
In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/ l).
Fondaparinux bindes ikke væsentligt til andre plasmaproteiner, herunder platelet factor 4 (PF4). et
Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Da fondaparinux ikke bindes til andre plasmaproteiner end antitrombin, er der ingen forventning om idl
38 Since fondaparinux does not bind significantly to plasma proteins other than antithrombin, no interaction with other medicinal products by protein binding displacement are expected.
Metabolisme Selvom en fuldstændig evaluering ikke foreligger, er der ikke fundet tegn på metabolisme af fondaparinux eller dannelse af aktive metabolitter. ge
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Fondaparinux hæmmer ikke CYP450- enzymer (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, Læ
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Derfor forventes det ikke, at fondaparinux vil interagere med andre lægemidler in vivo gennem hæmning af CYP- medieret metabolisme.
Thus, fondaparinux is not expected to interact with other medicinal
Udskillelse/ elimination Eliminationshalveringstiden (t½) er ca.
d products in vivo by inhibition of CYP-mediated metabolism.
17 timer hos raske unge forsøgspersoner og ca.
e Excretion/ Elimination
38 raske ældre forsøgspersoner.
ris The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Særlige befolkningsgrupper
ho Special populations
lg Pædiatriske patienter - Fondaparinux er ikke undersøgt i denne patientgruppe.
ut Paediatric patients - Fondaparinux has not been investigated in this population.
sa Ældre patienter - Nyrefunktionen kan aftage med alderen hvorfor eliminationen af fondaparinux kan være reduceret hos ældre.
ra Elderly patients - Renal function may decrease with age and thus, the elimination capacity for fondaparinux may be reduced in elderly.
Hos patienter over 75 år, der gennemgik ortopædkirurgi og fik 2, 5 mg fondaparinux en gang daglig, blev plasmaclearance vurderet til 1, 2 til 1, 4 gange lavere end hos
In patients > 75 years undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower
til patienter under 65 år.
e than in patients < 65 years.
Ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) er
A similar pattern is observed in DVT and PE treatment patients. ng Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/ min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, plasma lo clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/ min) and on average 2 times lower in patients with moderate renal impairment (creatinine no
ris plasmaclearance ca.
clearance 30 to 50 ml/ min).
Værdierne for terminal halveringstid var 29 timer hos patienter med moderat nedsat nyrefunktion, og 72 timer hos patienter med svært
Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Et tilsvarende mønster ses hos patienter, der behandles for DVT og PE.
A similar pattern is observed in DVT and PE treatment patients. ct
au Legemsvægt - Plasmaclearance af fondaparinux stiger i takt med legemsvægten (9% for hver 10 kg).
Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg). du
Køn - Der blev ikke observeret kønsspecifikke forskelle efter justering for legemsvægt. e Race - Forskelle i farmakokinetik, som kan tilskrives race, er ikke undersøgt prospektivt.
Gender - No gender differences were observed after adjustment for body weight. ro
Imidlertid er påviste studier med asiatiske (japanske), raske forsøgspersoner ingen forskel i den farmakokinetiske profil ved sammenligning med kaukasiske, raske forsøgspersoner.
Race - Pharmacokinetic differences due to race have not been studied prospectively.
Der blev heller ikke observeret ng
However, studies lP
forskelle i plasmaclearance hos sorte og kaukasiske patienter, som gennemgik ortopædkirurgi.
performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Nedsat leverfunktion - Farmakokinetikken af fondaparinux er ikke evalueret hos patienter med nedsat læ
Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery. na
leverfunktion.
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment. ici
5. 3 Prækliniske sikkerhedsdata e
5.3 Preclinical safety data ed
Der er ikke observeret nogen speciel fare for mennesker i prækliniske data baseret på traditionelle ikk
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
studier af sikkerhedsfarmakologi. og genotoksicitet.
in the animal species.
lg Natriumchlorid Vand til injektionsvæsker
Sodium chloride Water for injections Hydrochloric acid Sodium hydroxide
til 6. 2 Uforligeligheder
d 6.2 Incompatibilities
Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må denne medicin ikke
e In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
et blandes med andre lægemidler.
ris products.
er 6. 3 Opbevaringstid
ho 6.3 Shelf life
to 6. 4 Særlige opbevaringsforhold
ut 6.4 Special precautions for storage
Må ikke nedfryses.
ra Do not freeze.
6. 5 Emballagetyper og pakningsstørrelser au e Type I- glascylinder (1 ml), hvorpå er monteret en kanyle 27 gauge og længde 12, 7 mm tilproppet med er en bromobutyl eller chlorobutyl elastomerprop.
e 6.5 Nature and contents of container ng Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a chlorobutyl elastomer plunger stopper. lo Quixidar 7.5 mg/ 0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a magenta no
sikkerhedssystem.
automatic safety system.
6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling ct
Den subkutane injektion foretages ligesom med en klassisk injektionssprøjte. e
The subcutaneous injection is administered in the same way as with a classical syringe. du
Lægemidler til parenteral brug skal kontrolleres visuelt for partikelindhold og misfarvning før indgift. ikk
Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. ro
Instruktion i selvinjektion findes beskrevet i indlægssedlen.
Instruction for self-administration is mentioned in the Package Leaflet. lP
De fyldte Quixidar injektionssprøjter er forsynet med et system til beskyttelse af kanylen, som er
The Quixidar pre-filled syringe has been designed with an automatic needle protection system to prevent needle stick injuries following injection. na
beskytter mod skader pga. nålestik efter injektionen.
Any unused product or waste material should be disposed of in accordance with local requirements.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer. et idl
This medicinal product is for single use only. ici ed
Glaxo Group Ltd Greenford ge
Glaxo Group Ltd M
Middlesex UB6 0NN Storbritannien Læ
Greenford Middlesex UB6 0NN United Kingdom
DATO FOR FØRSTE
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
er Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
ris Detailed information on this medicinal product is available on the website of the European Medicines
Quixidar 10 mg/ 0, 8 ml injektionsvæske, opløsning, fyldt injektionssprøjte.
Quixidar 10 mg/ 0.8 ml solution for injection, pre-filled syringe.