natgillin/translations-raw huggingface dataset:
Randomiseringen blev stratificeret ud fra PD-L1tumorekspression (TPS ≥ 50% eller &lt; 50%), HPV-status (positiv eller negativ) og ECOG-PS (0 versus 1).
Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or &lt; 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1).
2 patienter ( &lt; 0,1%) seponerede pembrolizumab som følge af hypotyroidisme.
Two patients ( &lt; 0.1%) discontinued pembrolizumab due to hypothyroidism.
Grad ≥ 3 med ASAT eller ALAT &gt; 5 gange ULN eller total-bilirubin &gt; 3 gange ULN
Grade ≥ 3 with AST or ALT &gt; 5 times ULN or total bilirubin &gt; 3 times ULN
• Hvis ALAT eller ASAT er ≥ 3 gange ULN, men &lt; 10 gange ULN uden samtidig total-bilirubinværdi ≥ 2 gange ULN, skal både KEYTRUDA og axitinib pauseres, indtil disse bivirkninger bedres til grad 0-1.
• If ALT or AST ≥ 3 times ULN but &lt; 10 times ULN without concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Årsager til cisplatin-uegnethed var: creatininclearance på &lt; 60 ml/min (50%) ved baseline, ECOG-performance-status på 2 (32%), ECOGperformance-status på 2 og creatinin-clearance på &lt; 60 ml/min (9%) ved baseline og andre (hjertesvigt klasse III, perifer neuropati grad 2 eller højere og høretab grad 2 eller højere; 9%).
Reasons for cisplatin ineligibility included: baseline creatinine clearance of &lt; 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of &lt; 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%).
• Hvis ALAT eller ASAT er ≥ 10 gange ULN eller &gt; 3 gange ULN med samtidig total-bilirubinværdi ≥ 2 gange ULN, skal både KEYTRUDA og axitinib seponeres permanent, og behandling med kortikosteroider kan overvejes.
• If ALT or AST ≥ 10 times ULN or &gt; 3 times ULN with concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered.
Foreløbige data fra en tidlig gennemgang viste en nedsat overlevelse med pembrolizumab som monoterapi hos patienter, hvis tumorer udtrykker PD-L1 med CPS &lt; 10 sammenlignet med standardkemoterapi.
Preliminary data from an early review showed a reduced survival with pembrolizumab monotherapy in patients whose tumours express PD-L1 with a CPS &lt; 10 compared with standard chemotherapy.
På basis af en anbefaling fra en ekstern datamonitoreringskomité blev tilgangen af patienter i armen med pembrolizumab som monoterapi stoppet for patienter, hvis tumorer udtrykker PD-L1 med CPS &lt; 10.
Based on a recommendation by an external Data Monitoring Committee, the accrual in the pembrolizumab monotherapy arm was stopped for patients whose tumours express PD-L1 with a CPS &lt; 10.
Der blev udført en analyse i KEYNOTE-052 hos patienter, som havde tumorer, der udtrykte PD-L1 med CPS &lt; 10 (n=251; 68%) eller ≥ 10 (n=110; 30%) baseret på PD-L1 IHC 22C3 pharmDx
An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS &lt; 10 (n=251; 68%) or ≥ 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDx
Grad ≥ 3 med kreatinin &gt; 3 gange ULN Seponer behandlingen permanent
Grade ≥ 3 with creatinine &gt; 3 times ULN
KG Birkendorfer Straße 65 88397 Biberach an der Riss Tyskland
Boehringer Ingelheim (BIB) Pharma GmbH &amp; Co. KG Birkendorfer Straße 65 88397 Biberach an der Riss Germany
Pembrolizumabs virkning blev vurderet i KEYNOTE-054, et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie hos patienter med komplet resekteret stadie IIIA- ( &gt; 1 mm lymfeknudemetastaser), IIIB- eller IIIC-melanom.
The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA ( &gt; 1 mm lymph node metastasis), IIIB or IIIC melanoma.
Hos de 616 patienter i KEYNOTE-189 var baseline-karakteristika: medianalder 64 år (49% i alderen 65 år eller ældre); 59% mænd; 94% kaukasere og 3% asiater; henholdsvis 43% og 56% med ECOGperformance-status 0 eller 1; 31% PD-L1-negative (TPS &lt; 1%); og 18% med behandlede eller ikke behandlede hjernemetastaser ved baseline.
Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS &lt; 1%); and 18% with treated or untreated brain metastases at baseline.
Yderligere eksklusionskriterier var en anamnese med svære eller livstruende immunrelaterede bivirkninger som følge af behandling med ipilimumab, defineret som en hvilken som helst grad 4-toksicitet eller en grad 3-toksicitet, som krævede behandling med kortikosteroider ( &gt; 10 mg prednison dagligt eller en dosis ækvivalent hermed) i mere end 12 uger; igangværende bivirkninger ≥ grad 2 fra tidligere behandling med ipilimumab; patienter, der tidligere har haft svær overfølsomhed over for andre monoklonale antistoffer; patienter med pneumonitis eller interstitiel lungesygdom i anamnesen; patienter med hiv-, hepatitis B- eller hepatitis C-infektion og ECOG-performance-status ≥ 2.
The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immunerelated adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment ( &gt; 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions ≥ Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status ≥ 2.
Patienter med klinisk signifikant nedsat nyrefunktion (kreatinin &gt; 1,5 x ULN) eller leverfunktion (bilirubin &gt; 1,5 x ULN, ALAT, ASAT &gt; 2,5 x ULN med fravær af levermetastaser) ved baseline blev ekskluderet fra kliniske studier.
Patients with clinically significant renal (creatinine &gt; 1.5 x ULN) or hepatic (bilirubin &gt; 1.5 x ULN, ALT, AST &gt; 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical trials, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment.
(dvs. 6 uger) uden &gt; grad 2 behandlingsrelaterede bivirkninger ved axitinib og som havde et velkontrolleret blodtryk på ≤ 150/90 mm Hg, var det tilladt at øge dosis af axitinib til 7 mg to gange dagligt.
Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. 6 weeks) with no &gt; Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to ≤ 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily.
Patienter med følgende tilstande blev ekskluderet fra kliniske studier: patienter med aktive metastaser i centralnervesystemet; patienter med ECOG-performance-status ≥ 2 (med undtagelse af urotelialt karcinom og RCC); patienter med hiv-, hepatitis B- eller hepatitis C-infektion; patienter med aktiv systemisk autoimmun sygdom; patienter med interstitiel lungesygdom; patienter med pneumonitis i anamnesen, der krævede behandling med systemiske kortikosteroider; patienter, der tidligere har haft svær overfølsomhed over for andre monoklonale antistoffer; patienter i immunsuppressiv behandling samt patienter, der tidligere har haft alvorlige immunrelaterede bivirkninger ved behandling med ipilimumab, defineret som toksicitet af grad 4 eller af grad 3, hvor kortikosteroider ( &gt; 10 mg/dag af prednison eller ækvivalent hermed) i mere end 12 uger var nødvendig.
Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment ( &gt; 10 mg/day prednisone or equivalent) for greater than 12 weeks.
Der blev udført subgruppeanalyser ud fra inklusion i KEYNOTE-426 hos patienter med PD-L1 CPS ≥ 1 [pembrolizumab/axitinib-kombinationen: n=243 (56%) versus sunitinib: n=254 (59%)]; CPS &lt; 1 [pembrolizumab/axitinib-kombinationen: n=167 (39%) versus sunitinib: n=158 (37%)], og hos patienter med IMDC-risikokategorierne lav risiko [pembrolizumab/axitinib-kombinationen: n=138 (32%) versus sunitinib: n=131 (31%)]; middel risiko [pembrolizumab/axitinib-kombinationen: n=238 (55%) versus sunitinib: n=246 (57%)]; og høj risiko [pembrolizumab/axitinib-kombinationen: n=56 (13%) versus sunitinib: n=52 (12%)].
Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS &lt; 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
Der blev udført en analyse i KEYNOTE-045 hos patienter, der havde PD-L1 CPS &lt; 10 [pembrolizumab: n=186 (69%) versus kemoterapi: n=176 (65%)] eller ≥ 10 [pembrolizumab: n=74 (27%) versus kemoterapi: n=90 (33%)] i både pembrolizumab- og kemoterapi-armene (se tabel 20).
An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS &lt; 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
Alvorlige immunrelaterede hudreaktioner forekom hos 89 (1,5%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 5 hos henholdsvis 10 (0,2%), 65 (1,1%) og 1 ( &lt; 0,1%) patienter.
Immune-related severe skin reactions occurred in 89 (1.5%) patients, including Grade 2, 3 or 5 cases in 10 (0.2%), 65 (1.1%) and 1 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab.
Colitis forekom hos 107 (1,8%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 31 (0,5%), 62 (1,1%) og 3 ( &lt; 0,1%) patienter.
Colitis occurred in 107 (1.8%) patients, including Grade 2, 3 or 4 cases in 31 (0.5%), 62 (1.1%) and 3 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab.
Der blev udført en analyse i KEYNOTE-189 hos patienter, som havde PD-L1 TPS &lt; 1% [pembrolizumab-kombination: n=127 (31%) versus kemoterapi: n=63 (31%)], TPS 1-49% [pembrolizumab-kombination: n=128 (31%) versus kemoterapi: n=58 (28%)] eller TPS ≥ 50% [pembrolizumab-kombination: n=132 (32%) versus kemoterapi: n=70 (34%)] (se tabel 14).
An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS &lt; 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or ≥ 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 14).
Der blev udført en analyse i KEYNOTE-407 hos patienter, som havde PD-L1 TPS &lt; 1% [pembrolizumab plus kemoterapiarmen: n=95 (34%) versus placebo plus kemoterapiarmen: n=99 (35%)], TPS 1% til 49% [pembrolizumab plus kemoterapiarmen: n=103 (37%) versus placebo plus kemoterapiarmen: n=104 (37%)] eller TPS ≥ 50% [pembrolizumab plus kemoterapiarmen: n=73 (26%) versus placebo plus kemoterapiarmen: n=73 (26%)] (se tabel 16).
An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS &lt; 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS ≥ 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 16).
Der blev udført en eksploratorisk subgruppeanalyse i KEYNOTE-048 hos patienter, hvis tumorer udtrykte PD-L1 CPS ≥ 1 til &lt; 20 [pembrolizumab plus kemoterapi: n=116 (45%) versus standardbehandling: n=125 (49%) og pembrolizumab som monoterapi: n=124 (48%) versus standardbehandling: n=133 (52%)] (se tabel 26).
An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 1 to &lt; 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 26).
Hypofysitis forekom hos 36 (0,6%) patienter, som fik pembrolizumab, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 13 (0,2%), 19 (0,3%) og 1 ( &lt; 0,1%) patienter.
Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab.
Tabel 26: Effektresultater for pembrolizumab plus kemoterapi og pembrolizumab som monoterapi ud fra PD-L1-ekspression i KEYNOTE 048 (CPS ≥ 1 til &lt; 20)
Table 26: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 Expression in KEYNOTE 048 (CPS ≥ 1 to &lt; 20)
Nefritis forekom hos 22 (0,4%) patienter, som fik pembrolizumab som monoterapi, inklusive tilfælde af grad 2, 3 eller 4 hos henholdsvis 5 (0,1%), 14 (0,2%) og 1 ( &lt; 0,1%) patienter.
Nephritis occurred in 22 (0.4%) patients, including Grade 2, 3 or 4 cases in 5 (0.1%), 14 (0.2%) and 1 ( &lt; 0.1%) patients, respectively, receiving pembrolizumab as monotherapy.
&lt; 5 gange den øvre normalgrænse (ULN)
&lt; 5 times upper limit of normal (ULN)
InfusionsvÃ¦sken mÃ¥ ikke udsÃ¦ttes for direkte sollys eller varme.
The solution must not be exposed to direct sunlight or heat.
Hyppighedskategorierne er defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100).
Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10) and uncommon (≥ 1/1,000 to &lt; 1/100).
• pulsoximetri &gt; 94 % på luft i rummet
• pulse oximetry &gt; 94% on room air
• grad 4 hyponatriæmi ( &lt; 120 mEq/l) på trods af tilstrækkelig væskeindgivelse
• grade 4 hyponatremia ( &lt; 120 mEq/L) despite appropriate fluid management
InfusionsvÃ¦sken skal fremstilles under aseptiske forhold.
The solution for infusion must be prepared under aseptic conditions.
hæmoglobin &gt; 8,0 g/dl
≥ 20,000/µL, haemoglobin &gt; 8.0 g/dL
Infektioner og parasitÃ¦re sygdomme infektion (inklusive pneumoni, hudinfektion, herpes virus infektion, myelitis, encefalomyelitis), device-relateret infektion sepsis
Infections and infestations infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection sepsis
InfusionsvÃ¦sken skal administreres via et perifert eller centralt venekateter.
The solution for infusion should be administered via a peripheral or central intravenous line.
Informationspakken skal indeholde fÃ¸lgende:
The information pack should contain the following:
4.4 Særlige advarsler &lt; for hver enkelt dyreart, som lægemidlet er beregnet til &gt; Ingen.
4.4 Special warnings &lt; for each target species &gt; None.
Indehaver af markedsføringstilladelsen &lt; og fremstiller af batchfrigivelse: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay
Marketing authorisation holder: AIR LIQUIDE Santé INTERNATIONAL 10, rue Cognacq-Jay
&lt; OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE &gt; &lt; OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE &gt; {ART/TYPE}
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Information to appear on a durable plastic label appended directly to the cylinder body.
FARMAKOLOGISKE &lt; EGENSKABER &gt; IMMUNOLOGISKE &gt; EGENSKABER
PHARMACOLOGICAL PROPERTIES
til små katte (1,2 - 2,8 kg) til mellemstore katte ( &gt; 2,8 - 6,25 kg) til store katte ( &gt; 6,25 - 12,5 kg)
for small cats 1.2 - 2.8 kg for medium-sized cats &gt; 2.8 - 6.25 kg for large cats &gt; 6.25 - 12.5 kg
Bravecto 112,5 mg (2-4,5 kg) Bravecto 250 mg ( &gt; 4,5-10 kg) Bravecto 500 mg ( &gt; 10-20 kg) Bravecto 1.000 mg ( &gt; 20-40 kg) Bravecto 1.400 mg ( &gt; 40-56 kg)
Bravecto 112.5 mg (2-4.5 kg) Bravecto 250 mg ( &gt; 4.5 -10 kg) Bravecto 500 mg ( &gt; 10 -20 kg) Bravecto 1,000 mg ( &gt; 20 -40 kg) Bravecto 1,400 mg ( &gt; 40 -56 kg) fluralaner
Til miniaturehunde (2-4,5 kg) Til små hunde ( &gt; 4,5-10 kg) Til mellemstore hunde ( &gt; 10-20 kg) Til store hunde ( &gt; 20-40 kg) Til meget store hunde ( &gt; 40-56 kg)
for very small dogs (2-4.5 kg) for small dogs ( &gt; 4.5-10 kg) for medium-sized dogs ( &gt; 10-20 kg) for large dogs ( &gt; 20-40 kg) for very large dogs ( &gt; 40-56 kg)
Til miniaturehunde (2-4,5 kg) Til små hunde ( &gt; 4,5-10 kg) Til mellemstore hunde ( &gt; 10-20 kg) Til store hunde ( &gt; 20-40 kg) Til meget store hunde ( &gt; 40-56 kg)
for very small dogs (2- 4.5 kg) for small dogs ( &gt; 4.5-10 kg) for medium-sized dogs ( &gt; 10 -20 kg) for large dogs ( &gt; 20 -40 kg) for very large dogs ( &gt; 40 -56 kg)
til miniaturehunde (2 - 4,5 kg) til små hunde ( &gt; 4,5 - 10 kg) til mellemstore hunde ( &gt; 10 - 20 kg) til store hunde ( &gt; 20 - 40 kg) til meget store hunde ( &gt; 40 - 56 kg)
for very small dogs 2 - 4.5 kg for small dogs &gt; 4.5 - 10 kg for medium-sized dogs &gt; 10 - 20 kg for large dogs &gt; 20 - 40 kg for very large dogs &gt; 40 - 56 kg
INDLÆGSSEDDEL: Bravecto 112,5 mg spot-on, opløsning, til små katte (1,2 - 2,8 kg) Bravecto 250 mg spot-on, opløsning, til mellemstore katte ( &gt; 2,8 - 6,25 kg) Bravecto 500 mg spot-on, opløsning, til store katte ( &gt; 6,25 - 12,5 kg)
PACKAGE LEAFLET: Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 - 12.5 kg)
Bravecto 112,5 mg spot-on, opløsning, til små katte (1,2 - 2,8 kg) Bravecto 250 mg spot-on, opløsning, til mellemstore katte ( &gt; 2,8 - 6,25 kg) Bravecto 500 mg spot-on, opløsning, til store katte ( &gt; 6,25 - 12,5 kg) Fluralaner
Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 - 12.5 kg) fluralaner
Bravecto 112,5 mg spot-on, opløsning, til små katte (1,2 - 2,8 kg) Bravecto 250 mg spot-on, opløsning, til mellemstore katte ( &gt; 2,8 - 6,25 kg) Bravecto 500 mg spot-on, opløsning, til store katte ( &gt; 6,25 - 12,5 kg)
Bravecto 112.5 mg spot-on solution for small cats (1.2 - 2.8 kg) Bravecto 250 mg spot-on solution for medium-sized cats ( &gt; 2.8 - 6.25 kg) Bravecto 500 mg spot-on solution for large cats ( &gt; 6.25 - 12.5 kg)
Bravecto 112,5 mg tyggetabletter til miniaturehunde (2-4,5 kg) Bravecto 250 mg tyggetabletter til små hunde ( &gt; 4,5-10 kg) Bravecto 500 mg tyggetabletter til mellemstore hunde ( &gt; 10-20 kg) Bravecto 1.000 mg tyggetabletter til store hunde ( &gt; 20-40 kg) Bravecto 1.400 mg tyggetabletter til meget store hunde ( &gt; 40-56 kg)
Bravecto 112.5 mg chewable tablets for very small dogs (2-4.5 kg) Bravecto 250 mg chewable tablets for small dogs ( &gt; 4.5-10 kg) Bravecto 500 mg chewable tablets for medium-sized dogs ( &gt; 10-20 kg) Bravecto 1,000 mg chewable tablets for large dogs ( &gt; 20-40 kg) Bravecto 1,400 mg chewable tablets for very large dogs ( &gt; 40-56 kg)
INDLÆGSSEDDEL: Bravecto 112,5 mg spot-on, opløsning, til miniaturehunde (2 - 4,5 kg) Bravecto 250 mg spot-on, opløsning, til små hunde ( &gt; 4,5 - 10 kg) Bravecto 500 mg spot-on, opløsning, til mellemstore hunde ( &gt; 10 - 20 kg) Bravecto 1.000 mg spot-on, opløsning, til store hunde ( &gt; 20 - 40 kg) Bravecto 1.400 mg spot-on, opløsning, til meget store hunde ( &gt; 40 - 56 kg)
PACKAGE LEAFLET: Bravecto 112.5 mg spot-on solution for very small dogs (2 - 4.5 kg) Bravecto 250 mg spot-on solution for small dogs ( &gt; 4.5 - 10 kg) Bravecto 500 mg spot-on solution for medium-sized dogs ( &gt; 10 - 20 kg) Bravecto 1,000 mg spot-on solution for large dogs ( &gt; 20 - 40 kg) Bravecto 1,400 mg spot-on solution for very large dogs ( &gt; 40 - 56 kg)
Information om resultatet af denne genansÃ¸gning findes her.
See here for information on outcome of resubmission.
Må ikke anvendes til hunde med anæmi (hæmoglobin &lt; 10 g/dl).
Do not use in dogs with anaemia (haemoglobin &lt; 10 g/dl).
Hæmoglobin &lt; 10g/dl
Haemoglobin &lt; 10 g/dL
Må ikke anvendes til hunde med neutropeni (defineret som absolut neutrofiltælling &lt; 2000 /mm Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller nogen af hjælpestofferne.
Do not use in dogs with neutropenia defined as absolute neutrophil count &lt; 2,000 /mm Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Hvis en af disse hændelser (UPC-forhold &gt; 2 eller albumin &lt; 0,75 LLN) opstår igen, skal behandlingen afbrydes permanent.
If of one of these events (UPC ratio &gt; 2 or albumin &lt; 0.75 LLN) occurs for a second time, treatment should be permanently discontinued.
Må ikke anvendes til hunde med nedsat leverfunktion defineret som AST eller ALAT &gt; 3 × øvre grænse for normalområdet (ULN).
Do not use in dogs suffering from liver impairment, defined as AST or ALT &gt; 3 x Upper Limit of Normal (ULN).
Må ikke anvendes til hunde med nedsat nyrefunktion defineret som urinprotein-kreatininforhold (UPC) på &gt; 2 eller albumin &lt; 2 eller albumin &lt; 1 × nedre grænse for normalområdet.
Do not use in dogs suffering from renal function impairment, defined as Urinary Protein Creatinine (UPC) ratio &gt; 2 or albumin &lt; 1 x Lower Limit of Normal (LLN).
Albumin &lt; 1 LLN eller UPC &gt; 2
Albumin &lt; 1 LLN or UPC &gt; 2
I tilfælde af positive, semikvantitative stix-resultater (protein &gt; 30 mg/dl) bør der foretages urinanalyse for at bestemme urinprotein-kreatinin(UPC)forholdet.
In case of positive semi-quantitative dipstick results (protein ≥ 30 mg/dl), perform urinalysis to determine urinary protein creatinine (UPC) ratio.
Hæmoglobin &lt; 10g/dl og enten fri bilirubin &gt; 1,5 ULN og haptoglobin &lt; 0,1 g/dl eller reticulocytter &lt; 80.000/mm
Haemoglobin &lt; 10 g/dl and either free bilirubin &gt; 1.5 ULN and haptoglobin &lt; 0.1 g/dl or reticulocytes &lt; 80,000/mm
Behandlingen bør afbrydes i tilfælde af: Hæmolytisk anæmi, dvs. hæmoglobin &lt; 10 g/dl og hæmolyse, dvs. fri bilirubin &gt; 1,5 ULN og haptoglobin &lt; 0,1 g/dl, Anæmi på grund af manglende regeneration, dvs. hæmoglobin &lt; 10 g/dl og retikulocytter &lt; 80.000/mm
Treatment should be discontinued in case of: Haemolytic anaemia, i.e. haemoglobin &lt; 10 g/dl and haemolysis, i.e. free bilirubin &gt; 1.5 ULN and haptoglobin &lt; 0.1 g/dl, Anaemia due to lack of regeneration, i.e. haemoglobin &lt; 10 g/dl and reticulocytes &lt; 80,000/mm
Hvis UPC-forholdet &gt; 2 eller kreatinin &gt; 1,5 den øvre grænse for normalområdet (ULN), eller albumin &lt; 0,75 den nedre grænse for normalområdet (LLN) eller blod-urea-nitrogen (BUN) &gt; 1,5 ULN, skal behandlingen seponeres.
If UPC ratio &gt; 2, or creatinine &gt; 1.5 upper limit of normal (ULN), or albumin &lt; 0.75 lower limit of normal (LLN) or blood urea nitrogen (BUN) &gt; 1.5 ULN, discontinue treatment.
I tilfælde af positive, semikvantitative stix-resultater (protein &gt; 30 mg/dl) bør der foretages urinanalyse for at bestemme urinprotein-kreatinin(UPC)-forholdet og tages en blodprøve for at måle kreatinin, albumin og blod-urea-nitrogen (BUN).
In case of positive semiquantitative dipstick results (protein &gt; 30 mg/dl), urinalysis should be performed to determine urinary protein creatinine (UPC) ratio, and a blood sample to measure creatinine, albumin and BUN.