natgillin/translations-raw huggingface dataset:
Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdoms-fri overlevelse (DFS) og total overlevelse (OS), blev det positive fordel/risiko forhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt.
As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demontrated at the final analysis (see section 5.1).
G3/4 Forhøjet bilirubin i blodet (< 5 %);G3/4 forhøjet alkalisk fosfatase i blodet
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
1218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m administreret i løbet af 30-60 minutter hver 3. uge (TCis),
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).
• Som ved alle andre parenterale produkter, skal Docetaxel Zentiva infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
• As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Ethanol, vandfri Citronsyre
Citric acid
Tabel over bivirkninger ved adjuverende behandling med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft - pooled data:
Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Første episode: Reducer 5-FU-dosis med 20 % Anden episode: Reducer så docetaxel-dosis med 20 %
Third episode: reduce docetaxel dose by 20%.
Letargi (G3/4: 3,4 %); Pyreksi (G3/4: 0,6 %);
Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%);
Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9 %) og hos 16 FAC-patienter (2,2 %).
At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Justeret hazard ratio 95% CI p-værdi*
Adjusted hazard ratio 95% CI p-value*
Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
Description of selected adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Hver ml koncentrat indeholder 20 mg docetaxel som trihydrat.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Docetaxel Zentiva i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har fået kemoterapi mod denne tilstand.
Docetaxel Zentiva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
hos patienter med en initialdosis på 75 mg/m docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, 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.
Docetaxel Zentiva er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
I studiet TAX316 forekom perifer sensorisk neuropati i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden hos 84 patienter (11,3 %) i TAC-armen og 15 patienter (2 %) i FAC-armen.
In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: <
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Ikke almindelige ( kan forekomme hos op til 1 ud af 100 patienter):
Uncommon (may affect up to 1 in 100 people):
Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger, som kan forekomme efter infusionen af Docetaxel Zentiva.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Zentiva administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Zentiva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 160 mg/8 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m administreret en time efter doxorubicin
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
For at kunne udtage den korrekte dosis til patienten, kan det være nødvendigt at anvende mere end et hætteglas Docetaxel Zentiva koncentrat til infusionsvæske, opløsning.
More than one vial of Docetaxel Zentiva concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
YDERKARTON/Docetaxel Zentiva 160 mg/8 ml
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Første episode: Reducer docetaxel- og 5-FU-dosis med 20 % Anden episode: Afbryd behandlingen
First episode: reduce 5-FU dose by 20%.
CYTOTOKSISK
Haematology
Docetaxel Zentiva i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
YDERKARTON/Docetaxel Zentiva 20 mg/1 ml
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 20 mg/1 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² i kombination med trastuzumab:
Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
YDERKARTON/Docetaxel Zentiva 80 mg/4 ml
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin:
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin
Indlægseddel: Information til brugeren Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
Package leaflet: Information for the patient Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Indlægseddel: Information til brugeren Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
Package leaflet: Information for the patient Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft for Docetaxel Zentiva 100 mg/m² enkeltstof
Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 75 mg/m² i kombination med capecitabin:
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel Zentiva 75 mg/m² enkeltstof:
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² single agent
FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 80 mg/4 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Docetaxel Zentiva monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
75 mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m pr.
The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Koncentration af docetaxel i Docetaxel Zentiva 160 mg/8 ml er 20 mg/ml.
In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin:
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Docetaxel Zentiva 20 mg/1 ml sterilt koncentrat docetaxel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Indlægseddel: Information til brugeren Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
Package leaflet: Information for the patient Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
• Induktions kemoterapi 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 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/m2 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.
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² i kombination med trastuzumab:
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Metastatisk kastrationsresistent prostatakræft Den anbefalede dosis af docetaxel er 75 mg/m2.
The recommended dose of docetaxel is 75 mg/m2.
75 mg/m til 60 mg/m 2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %);
Abdominal pain (severe: 1%);
Brug ikke Docetaxel Zentiva
You must not be given Docetaxel Zentiva:
Mave-tarmkanalen
Pre-Menopausal
Neutropenisk infektion (G3/4: 2,6%)
Infection associated with G4 neutropenia (G3/4: 4.6%)
Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m administreret som en 30 minutter til
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Feber (G3/4: 1,2 %)
Vomiting (G3/4: 1.2%)
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).
1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 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).
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Koncentration af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml.
In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Koncentration af docetaxel i Docetaxel Zentiva 20 mg/1 ml er 20 mg/ml.
In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Arytmi (G3/4: 0,2 %); Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4:
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
eller cisplatin (100 mg/m på dag 1) og 5-fluoruracil (1000 mg/m pr. dag i 5 dage).
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Hud og subkutane væv Alopeci; Hudlidelser (G3/4:
Alopecia (persisting: Skin disorder (G3/4:
Tabel over bivirkninger ved behandling af hoved- og halskræft med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
INFORMATION I BRAILLE SKRIFT
Baseline cardiac assessment is recommended
Koncentrationen af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml
In Docetaxel Zentiva 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil :
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får.
Between infusions of Docetaxel Zentiva the following may occur, and the frequency may vary with the combinations of medicines that are received
HÆTTEGLAS ETIKET/Docetaxel Zentiva 20 mg/1 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml
HÆTTEGLAS ETIKET/Docetaxel Zentiva 160 mg/8ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
I studiet GEICAM9805 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.
TAC-armen) eller doxorubicin 50 mg/m efterfulgt af fluoruracil 500 mg/m og cyclophosphamid 500
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² enkeltstof:
Tabulated summary of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Antal positive lymfeknuder I alt
Uncommon adverse reactions pneumonia, fatal in
Docetaxel Zentiva 160 mg/8 ml sterilt koncentrat docetaxel intravenøs anvendelse
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
HÆTTEGLAS ETIKET/Docetaxel Zentiva 80 mg/4ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
Revaccination: Revacciner årligt.
Revaccination: Revaccinate annually.
Dato for første markedsføringstilladelse: 19/11/2019.
Date of first authorisation: 19/11/2019
De aktive substanser som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet, falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009.
The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Kaniner.
Rabbits.
For at sikre fuld varighed af immuniteten anbefales det, i dette tilfælde, at vaccinere fra 7 ugers alderen.
To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Administrer 0,2 ml pr. dyr.
Administer 0.2 ml per animal.
Administrer hele hætteglassets indhold.
Administer the total contents of the vial.
En forbigående stigning i legemstemperaturen på 1-2° C kan almindeligvis opstå.
A transient temperature increase of 1-2 °C can commonly occur.
Hver dosis (0,2 ml eller 0,5 ml) rekonstitueret vaccine indeholder:
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Nylig eller latent infektion med vild myxomavirus synes i en vis udstrækning at spille en rolle i dette.
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Dette ses kun hos dyr med aktiv immunitet og har ingen indflydelse på det generelle helbred, ædelysten eller dyrets adfærd.
The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
1 dosis 50 doser
1 dose 50 doses
Høje niveauer af maternelle antistoffer mod myxomatosevirus og/eller RHD-virus kan potentielt reducere virkningen af produktet.
High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Rekonstitueret produkt: falmet pink eller pinkfarvet suspension.
Reconstituted product: off-pink or pink coloured suspension.
Farmakoterapeutisk gruppe: Immunologica til kaniner, levende virale vacciner, ATCvet-kode: QI08AD
Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Må ikke blandes med lægemidler til dyr undtaget solvens der leveres til brug med dette veterinærlægemiddel.
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Opbevaringstid for veterinærlægemidlet (lyofilisatet) i salgspakning: 2 år.
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Det anbefales derfor ikke at vaccinere hankaniner til avl.
Therefore, the vaccination of breeding bucks is not recommended.
Basisvaccination: Administrer 1 dosis vaccine til kaniner fra 5 ugers alderen og opefter.
Primary vaccination: Administer one dose to rabbits from 5 weeks of age onwards.