natgillin/translations-raw huggingface dataset:
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 2370 mg vandfri ethanol pr. 6 ml hætteglas, svarende til 60 ml øl eller 25 ml vin.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
I studiet GEICAM 9805 forekom perifer sensorisk neuropati under behandlingen og fortsatte ind i opfølgningsperioden hos 10 patienter (1,9 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen.
In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Docetaxel
Taxespira 120 mg/6 ml concentrate for solution for infusion.
Koncentrationen af docetaxel er 20 mg/ml i hætteglas med Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml og 160 mg/8 ml.
In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
Gastrointestinal blødning (alvorlig: 0,3
Gastrointestinal haemorrhage (severe:
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 395 mg vandfrit ethanol pr. 1 ml hætteglas.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
EU/1/15/1017/004 140 mg/7 ml hætteglas x 1 hætteglas
EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
• rødmen, hudreaktioner, kløe
• flushing, skin reactions, itching
EU/1/15/1017/005 160 mg/8 ml hætteglas x 1 hætteglas
EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Toksikologiske studier på gnavere har vist uønskede påvirkninger af testesfunktionen.
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m 2 som en 1-times infusion efterfulgt af
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m 2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Kræftsmerter (G3/4:
Cancer pain (G3/4:
Taxespira monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel forlængede mediantiden indtil progression (24,6 uger vs. 15,6 uger; p < 0,01) og medianoverlevelsen (15,3 måneder vs. 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs. 25 %, p = 0,10), samlet respons rate (32 % vs. 25 %, p = 0,10).
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p <0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 3160 mg vandfrit ethanol pr. 8 ml hætteglas.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år)).
50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
Ved behandling med docetaxel er der rapporteret om sklerodermi-lignende forandringer, som oftest forudgået af perifert lymfødem.
Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Tabel over bivirkninger efter behandling af gastrisk adenokarcinom med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Dette svarer til 40 ml øl eller 17 ml vin.
This is equivalent to 40 ml of beer or17 ml of wine.
Øget tåreflåd (G3/4: 0 %)
Lacrimation increased (G3/4: 0%)
Øget tåreflåd (G3/4:
Lacrimation increased (G3/4:
186 patienter blev randomiseret til at få docetaxel (100 mg/m2) med eller uden trastuzumab.
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Beskrivelse af udvalgte bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m 2 som enkeltstof
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Median responsvarighed (måneder) (95 % CI)
Median duration of response (months) (95% CI)
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 1580 mg vandfrit ethanol pr. 4 ml hætteglas.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anhydrous per 4 ml vial.
EU/1/15/1017/003 120 mg/6 ml hætteglas x 1 hætteglas
EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Tabel over bivirkninger efter behandling af hoved- og halskræft med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil
Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Metabolisme og ernæring Psykiske forstyrrelser Nervesystemet
Psychiatric disorders Nervous system disorders
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 75 mg/m² i kombination med capecitabin
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
I dette kliniske studie randomiseredes 255 patienter til behandling med docetaxel (75 mg/m² som en 1times intravenøs infusion hver 3. uge) og capecitabin (1.250 mg/m² to gange dagligt i 2 uger efterfulgt af en uges pause).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Docetaxel
Taxespira 80 mg/4 ml concentrate for solution for infusion.
Dyspepsi (G3/4: 0,8 %); gastrointestinale smerter (G3/4: 1,2 %); gastrointestinal blødning (G3/4: 0,4
0.8%); Gastrointestinal pain (G3/4: 1.2%);
Øvre mavesmerter; mundtørhed
Abdominal pain upper; Dry mouth
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).
I studiet GEICAM 9805 fortsatte alopeci, som forekom i løbet af behandlingsperioden, ind i opfølgningsperioden og blev fortsat observeret hos 49 patienter (9,2 %) i TAC-armen og hos 35 patienter (6,7 %) i FAC-armen.
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
I komparator-armen af studiet fik patienterne cisplatin (P) 100 mg/m2 efterfulgt af 5-fluoruracil (F) 1.000 mg/m2 (PF) dagligt i 5 dage.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Dyspnø (G3/4: 1 %); hoste (G3/4: < 1 %); epistaxis (G3/4: <1 %)
Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
• Se det relevante produktresumé vedrørende justering af capecitabin-dosis.
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
Perifer motorisk neuropati (G3/4: 0 %)
Peripheral motor neuropathy (G3/4:
Justeret hazard ratio (95 % CI) *p-værdi
Adjusted hazard ratio (95% CI) *p-value
EU/1/15/1017/002 80 mg/4 ml hætteglas x 1 hætteglas
EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
EU/1/15/1017/001 20 mg/1 ml hætteglas x 1 hætteglas
EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Diarré (G3/4: 6,4 %);
7.8%); Diarrhoea (G3/4: 6.2%);
Epistaxis (G3/4: 0 %); dyspnø (G3/4: 0,6 %); hoste (G3/4: 0
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Diarré (G3/4: 19,7 %); kvalme (G3/4: 16 %); stomatitis (G3/4:
Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Undergruppe Antal patienter
Number of patients in TAC group
Mavesmerter (G3/4:
Diarrhoea (G3/4:
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Perifer motorisk neuropati (G3/4: 0,4 %)
Peripheral sensory neuropathy (G3/4: 0.8%)
Mave-tarm-kanalen Kvalme (G3/4: 9,6 %); Opkastning (G3/4: 7,6 %);
Nausea (G3/4: 9.6%); Vomiting (G3/4:
1 times infusion med cisplatin 75 mg/m 2 på dag 1, efterfulgt af 5-fluoruracil som en kontinuerlig infusion på 750 mg/m2 pr. dag i fem dage.
5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Se trastuzumabs produktresumé vedrørende justering af trastuzumab-dosis.
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Hudreaktion (G3/4:
Neutropenia (G3/4:
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m² som enkeltstof
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Myalgi (alvorlig: 0,5
Myalgia (severe:
Eksfoliativt udslæt (G3/4: 0,3
Exfoliative rash (G3/4: 0.3%)
Øget tåreflåd (G3/4: 0,6 %)
Lacrimation increased (G3/4: <0.1%)
Mave-tarm-kanalen Stomatitis (G3/4: 5,3 %); Diarré (G3/4: 4 %);
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Trombocytopeni (G3/4: 3 %)
Thrombocytopenia (G4: 0.2%)
Hazard ratio: (95 % CI) *p-værdi
Hazard ratio: (95% CI) *p-value
Dermatitis; erythematøst udslæt (G3/4: < 1 %); misfarvning af negle; onykolyse (G3/4: 1 %)
Dermatitis; Rash erythematous (G3/4: <1%); Nail discolouration;
Alopeci;
Constipation;
øofagitis/dysfagi/odynofagi (G3/4: 0,7 %)
Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
Hazard ratio (95 % CI) *p-værdi
Hazard ratio (95% CI) *p-value
Hazard ratio: (95 % CI) **p-værdi
Hazard ratio: (95% CI) **p-value
Hud og subkutane væv Alopeci (persisterende: <
Alopecia; Nail disorders (severe:
Nedsat venstre ventrikelfunktion (G3/4: 0,3
Cardiac left ventricular function decrease (G3/4:
Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning Docetaxel i.v.
Taxespira 20 mg/1 ml concentrate for solution for infusion.
Hazard ratio (95 % CI) **p-værdi
Hazard ratio (95% CI) **p-value
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m 2 til 75 mg/m 2 og/eller fra 75
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
Letargi; smerter
Lethargy; Pain
• Spørg lægen, apotekspersonalet på hospitalet eller sundhedspersonalet, hvis der er mere, du vil
• If you have any further questions, ask your doctor, hospital pharmacist or nurse.
I kombination med cisplatin og 5-fluorouracil Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår: 1) febril neutropeni, 2) prolongeret neutropeni eller 3) neutropenisk infektion.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
23,7 %); opkastning (G3/4: 14,3
1.2%); Oedema (G3/4:
Øre og labyrint Hjerte
Ear and labyrinth disorders Cardiac disorders
I studiet GEICAM 9805 blev det observeret, at perifert ødem, som forekom i løbet af behandlingsperioden, fortsatte ind i opfølgningsperioden hos 4 patienter (0,8 %) i TAC-armen og hos 2 patienter (0,4 %) i FAC-armen.
In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm. Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period, lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Efter kemoterapi bør
Following chemotherapy, patients should receive chemoradiotherapy.
3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke-hæmatologisk toksicitet.
3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
(G3/4: 12,0 %); konstipation (G3/4: 0,4 %)
(G3/4: 1.2%); Dysgeusia (G3/4:
(Mulig mekanisme)
(Possible mechanism)
(Studie udført med 8 patienter)
(Study conducted in 8 patients)
Reaktionen kan være forsinket.
This reaction may be delayed.
Ukendt mekanisme.
Mechanism unknown.
GSS blev udledt ved anvendelse af ANRS 2007 guidelines.
GSS was derived using ANRS 2007 guidelines.
Hos nogle patienter var administration af faktor VIII nødvendig.
In some patients administration of factor VIII was necessary.
Derfor er det meget vigtigt, at du fortæller lægen om enhver ændring i dit helbred.
For this reason, it is very important to talk to your doctor about any changes in your health.
Årsagen hertil er ukendt.
The reason for this is not known.
• hvis man har været i kombinationsbehandling i lang tid
• if they have been taking combination therapy for a long time
Det kan være nødvendigt med ekstra faktor VIII for at kontrollere en blødning
You may need additional factor VIII to control any bleeding.
(Amprenavir uden ritonavir)
(Amprenavir without ritonavir)
Disse indholdsstoffer kan forårsage allergiske reaktioner (nogle gange forsinket).
These ingredients may cause allergic reactions (sometimes delayed).
Gentag punkt 4 til 8 indtil du har taget fuld dosis.
Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Vigtigheden af at overholde hele det anbefalede doseringsregime bør understreges over for alle patienter.
The importance of complying with the full recommended dosing regimen should be stressed to all patients.
Der kan derfor ikke gives nogen anbefalinger for denne patientgruppe.
Therefore, no recommendations can be made in this patient population.
For at undgå, at dette sker, og for at forhindre, at din sygdom forværres, er det meget vigtigt, at du tager al din medicin efter lægens anvisning.
To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.
APVeksponering var 25-35 % lavere under graviditeten.
APV exposure was 25-35% lower during pregnancy.
• problemer med at bevæge sig.
• difficulty moving.
Idet der ikke foreligger kompatibilitetsstudier, må dette lægemiddel ikke blandes med andre lægemidler.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Pædiatrisk / andre populationer
Paediatric / other populations
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, this medicine can cause side effects, but not everyone gets them.
Resultaterne fra de 48 ugers behandling er angivet nedenfor.
Results through 48 weeks of treatment are provided below.
Uge 48 AAUCMB (n)
Week 48 AAUCMB (n)
Studie udført med amprenavir.
Study performed with amprenavir.
 Fortæl lægen, hvis noget af dette gælder for dig.
→Tell your doctor if any of these applies to you.
Disse stoffer kan forårsage en allergisk reaktion hos nogle personer.
These products may cause an allergic reaction in some individuals.
Dette er baseret på sikkerhedsdata fra i alt 864 patienter eksponeret for fosamprenavir/ritonavir i disse tre studier.
This is based on safety data from a total of 864 patients exposed to fosamprenavir/ritonavir in these three studies.
Da det ikke er muligt at opnå denne dosis af fosamprenavir med tabletformuleringen, bør disse patienter behandles med fosamprenavir oral suspension.
As it is not possible to achieve this fosamprenavir dose using the tablet formulation, these patients should be treated with fosamprenavir oral suspension.
Voksne år)
Adult years)
Desuden skal en opdateret RMP fremsendes
An updated RMP should be submitted
Ved denne tilstand dør dele af knoglevævet på grund af nedsat blodforsyning til knoglerne.
With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
• hvis du tager nogen anden form for medicin.
• If you are taking any other medicines.
Du skal gennemse listen af medicin under ”Tag ikke Telzir” i begyndelsen af punkt 2 i denne indlægsseddel.
You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.
Hvis din leversygdom forværres, skal du måske holde op med at tage Telzir for en tid eller permanent.
If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently.
Anvendelsen af større doser ritonavir kan eventuelt føre til en ændret sikkerhedsprofil for kombinationen og kan derfor ikke anbefales.
The use of higher ritonavir doses might alter the safety profile of the combination and therefore is not recommended.
Der er ikke foretaget sammenlignende studier med børn og unge.
No comparative studies have been undertaken in children or adolescents.
Større påvirkning kan forventes, når fluticasonpropionat inhaleres.
Greater effects may be expected when fluticasone propionate is inhaled.
Signifikant  APV forventet
Significant ↓ APV expected
Tag ikke Telzir:
Do not take Telzir:
Efter administration af Telzir er halveringstiden for amprenavir 7,7 timer.
Following administration of Telzir, the half-life of amprenavir is 7.7 hours.
Hvis det sker for dig:  Tal med lægen med det samme.
If this happens to you: →Talk to your doctor immediately.
• ømhed og smerter (især i hofte, knæ eller skulder)
• aches and pains (especially in the hip, knee or shoulder)
Dosisjustering af midazolam bør overvejes, specielt hvis der skal gives mere end en enkelt dosis midazolam.
Dosage adjustment for midazolam should be considered, especially if more than a single dose of midazolam is administered.
Hiv kan blive resistent over for anti-hiv-medicin.
HIV can become resistant to anti-HIV medicines.
Telzir kan gøre dig svimmel og give andre bivirkninger, der gør dig mindre opmærksom.
Telzir can make you feel dizzy and have other side effects that make you less alert.
Data fra et så lille antal patienter, hvor supplerende analyser er udført på GSS-undergrupper, skal fortolkes med forsigtighed.
Data from this small number further analysed by GSS subgroups need to be interpreted with caution.
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spanien
Avenida de Extremadura 3 09400 Aranda de Duero Burgos Spain
Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EC og offentliggjort på den europæiske webportal for lægemidler.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
Key: 1GSS to OBT: Genotypic Sensitivity Score to Optimised Background.
< 6 år
<6 years
I over halvdelen af de rapporterede tilfælde blev behandlingen med proteasehæmmere fortsat eller genoptaget, hvis den havde været afbrudt.
In more than half of the reported cases, treatment with protease inhibitors was continued, or reintroduced if treatment had been discontinued.
Hvis det sker, skal du holde op med at tage Telzir med det samme, og du må aldrig tage det igen.
If this happens, Telzir must be stopped immediately and you must never take it again.
Læs derfor oplysningerne i ”Andre bivirkninger ved kombinationsbehandling mod hiv” under punkt 4 i denne indlægsseddel.
Please read the information on ‘Other side effects of combination therapy for HIV' in section 4 of this leaflet.
Du kan stadig få andre infektioner og sygdomme i forbindelse med din hiv-infektion.
You may still develop other infections and illnesses linked to HIV infection.
Forsigtighed tilrådes, og tæt monitorering anbefales, når denne kombination gives til integrasehæmmer-resistente patienter.
Caution is warranted and close monitoring is recommended when this combination is given in integrase inhibitorresistant patients.
Efter fuldførelse af behandlingsperioden på 48 uger, opfyldte patienter på de europæiske og canadiske sites kriterierne for at deltage i et forlængelsesstudie indtil uge 144, hvor deres behandlingsregime blev fastholdt som under den oprindelige randomisering.
Following completion of the 48 week treatment period, subjects at European and Canadian sites were eligible to participate in a study extension to Week 144 maintaining their treatment regimen as per the original randomisation.