natgillin/translations-raw huggingface dataset:
13 tegn på overfølsomhedsreaktioner.
13 should be informed of the early signs of hypersensitivity reactions.
14 Meget sjælden (< 1/ 10. 000)
14 Very rare (< 1/ 10,000)
Beskrevet nedenfor under "Alvorlige bivirkninger rapporteret siden markedsføringen".
Described below under ‘ serious adverse reactions reported during the post-marketing period’.
Indenfor hver enkelt frekvensgruppe skal bivirkningerne opstilles efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
4. 4 – Venøse tromber såsom tromboflebit, dyb venetrombe og lungeemboli i relation hertil.
In the vast majority of cases the patients were predisposed to arterial thrombotic disorders either due to underlying disease, age, atherosclerotic or current medical conditions as described in section 4.4. – Venous thrombotic events such as thrombophlebitis, deep vein thrombosis and hereto related pulmonary embolism.
Patienter med øget risiko for venetrombotiske lidelser grundet samtidige lidelser, tidligere trombotiske lidelse, post- operativ immobilisation eller venøs katerisation skal monitoreres omhyggeligt – Trombotiske hændelser i leveren.
Patients at increased risk of venous thrombotic disorders either due to concurrent conditions, previous history of thrombotic events, post surgery immobilisation or venous catheterisation should be carefully monitored. – Thrombotic events of the liver.
15 Der er rapporteret isolerede tilfælde, hvor patienter med faktor VII- mangel har udviklet antistoffer mod faktor VII efter behandling med NovoSeven.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with NovoSeven.
Et tilfælde af angioneurotisk ødem er blevet spontant rapporteret hos en patient med Glanzmanns trombasteni efter administration af NovoSeven.
15 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
Dosisproportionaliteten blev etableret i børn for de undersøgte doser på 90 og 180 µg/ kg kropsvægt, hvilket er i overensstemmelse med tidligere resultater ved lavere doser (17, 5– 70 µg/ kg rekombinant faktor VIIa).
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/ kg rFVIIa).
Enkeltdosisfarmakokinetik med NovoSeven, 15 og 30 µg pr. kg legemsvægt, udviste ingen signifikant forskel mellem de to doser med hensyn til dosisuafhængige parametre: samlet legemsclearance (70, 8- 79, 1 ml/ time. kg), fordelingsvolumen ved steady state (280- 290 ml/ kg), middelopholdstid (3, 75- 3, 80 timer) og halveringstid (2, 82- 3, 11 timer).
16 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
Hvis produktet ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser brugerens ansvar og er normalt ikke mere end 24 timer ved 2°C - 8°C, medmindre rekonstitutionen har fundet sted under kontrollerede og validerede aseptiske forhold.
If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
17 – Må ikke udsættes for frost, da det kan skade hætteglasset med solvens.
– Store NovoSeven in a refrigerator (2°C - 8°C) – Store in original package in order to protect from light – Do not freeze to prevent damage to the solvent vial.
Det lukkede hætteglas er udstyret med en forseglet snap- off hætte, som er lavet af polypropylen.
17 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Steril engangssprøjten er fremstillet af polypropylen.
The sterile disposable syringe is made of polypropylene.
NovoSeven pakningen indeholder: – 1 hætteglas (5 ml) med hvidt pulver (NovoSeven) til injektionsvæske, opløsning – 1 hætteglas (5 ml) med solvens (vand til injektionsvæsker) til rekonstitution – 1 steril hætteglas adapter til rekonstitution – 1 steril engangssprøjte til rekonstitution og administration – 1 sterilt infusionssæt til administration – 2 alkoholservietter til rensning af hætteglassenes gummipropper – Indlægsseddel med brugsanvisning.
The NovoSeven package contains: – 1 vial (5 ml) with white powder (NovoSeven) for solution for injection – 1 vial (5 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
Afsprit gummipropperne, og lad dem tørre inden brug
Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use.
• Fjern beskyttelsespapiret fra hætteglasadapteren.
• Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap.
18 hætteglasset med pulver.
Push the plunger slowly to inject the water into the powder vial.
NovoSeven må ikke opbevares i plasticsprøjter efter rekonstitution.
18 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
NovoSeven 4, 8 mg (240 KIE) - pulver og solvens til injektionsvæske, opløsning
NovoSeven 4.8 mg (240 KIU) - powder and solvent for solution for injection
KVALITATIV OG KVANTITATIV SAMMENSÆTNING NovoSeven markedsføres som pulver og solvens til opløsning til injektion og indeholder 4, 8 mg eptacog alfa (aktiveret) per hætteglas (svarende til 240 KIE/ hætteglas) 1 KIE svarer til 1. 000 IE (internationale enheder)
1 KIU equals 1000 IU (International Units).
Alle hjælpestoffer er anført under pkt 6. 1.
For a full list of excipients see section 6.1.
20 Nuværende klinisk erfaring giver ikke basis for en generel differentiering i doseringen mellem børn og voksne, selvom børn har en hurtigere clearance end voksne.
20 Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
2) En enkelt injektion på 270 µg pr. kg. legemsvægt
1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals If further treatment is required, one additional dose of 90 µg per kg body weight can be administered 2) One single injection of 270 µg per kg body weight
Så snart der er opnået hæmostase, kan dosisintervallet øges successivt til hver 4., 6., 8. eller 12. time, så længe behandling skønnes indiceret.
Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8, or 12 hours for as long as treatment is judged to be indicated.
21 Til behandling af patienter med blødningsepisoder og til forebyggelse af blødning ved kirurgi eller invasive procedurer anbefales en dosis på 15- 30 µg pr. kg legemsvægt hver 4. - 6. time, indtil hæmostase er opnået.
21 Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne eller muse -, hamster - eller okseprotein.
Hypersensitivity to the active substance, or to any of the excipients, or to mouse, hamster or bovine protein.
22 tegn på overfølsomhedsreaktioner.
22 should be informed of the early signs of hypersensitivity reactions.
23 Meget sjælden (< 1/ 10. 000)
23 Very rare (< 1/ 10,000)
4. 2. 1.
It is important that the dosage regimen of NovoSeven is compliant with the recommended dosage as stated in section 4.2.
4. 4. – Venøse tromber såsom tromboflebit, dyb venetrombe og lungeemboli i relation hertil.
In the vast majority of cases the patients were predisposed to arterial thrombotic disorders either due to underlying disease, age, atherosclerotic or current medical conditions as described in section 4.4. – Venous thrombotic events such as thrombophlebitis, deep vein thrombosis and hereto related pulmonary embolism.
24 Der er rapporteret isolerede tilfælde, hvor patienter med faktor VII- mangel har udviklet antistoffer mod faktor VII efter behandling med NovoSeven.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with NovoSeven.
Et tilfælde af angioneurotisk ødem er blevet spontant rapporteret hos en patient med Glanzmanns trombasteni efter administration af NovoSeven.
24 One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of NovoSeven.
Ved hjælp af et faktor VIIa - assay blev de farmakokinetiske egenskaber for NovoSeven undersøgt i 12 pædiatriske - (2- 12 år) og 5 voksne patienter i blødningsfri tilstand.
Using the FVIIa assay, the pharmacokinetic properties of NovoSeven were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state.
Enkeltdosisfarmakokinetik med NovoSeven, 15 og 30 µg pr. kg legemsvægt, udviste ingen signifikant forskel mellem de to doser med hensyn til dosisuafhængige parametre: samlet legemsclearance (70, 8- 79, 1 ml/ time. kg), fordelingsvolumen ved steady state (280- 290 ml/ kg), middelopholdstid (3, 75- 3, 80 timer) og halveringstid (2, 82- 3, 11 timer).
25 Single dose pharmacokinetics of NovoSeven, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
26 – Må ikke udsættes for frost, da det kan skade hætteglasset med solvens.
– Store NovoSeven in a refrigerator (2°C - 8°C) – Store in original package in order to protect from light – Do not freeze to prevent damage to the solvent vial.
Det lukkede hætteglas er udstyret med en forseglet snap- off hætte, som er lavet af polypropylen.
26 The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
NovoSeven pakningen indeholder: – 1 hætteglas (12 ml) med hvidt pulver (NovoSeven) til injektionsvæske, opløsning – 1 hætteglas (12 ml) med solvens (vand til injektionsvæsker) til rekonstitution – 1 steril hætteglas adapter til rekonstitution – 1 steril engangssprøjte til rekonstitution og administration – 1 sterilt infusionssæt til administration – 2 alkoholservietter til rensning af hætteglassenes gummipropper – Indlægsseddel med brugsanvisning.
The NovoSeven package contains: – 1 vial (12 ml) with white powder (NovoSeven) for solution for injection – 1 vial (12 ml) with solvent (Water for injections) for reconstitution – 1 sterile vial adapter for reconstitution – 1 sterile disposable syringe for reconstitution and administration – 1 sterile infusion set for administration – 2 alcohol swabs for cleansing the rubber stoppers on the vials – Package leaflet with instructions for use.
27 hætteglasset med pulver.
Push the plunger slowly to inject the water into the powder vial.
NovoSeven må ikke opbevares i plasticsprøjter efter rekonstitution.
27 The enclosed disposable syringe is compatible with the reconstituted preparation, but do not store reconstituted NovoSeven in plastic syringes.
NovoSeven 1mg (50 KIE) - pulver og solvens til injektionsvæske, opløsning
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection
NovoSeven markedsføres som pulver og solvens til opløsning til injektion og indeholder 1 mg eptacog alfa (aktiveret) per hætteglas (svarende til 50 KIE/ hætteglas).
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/ vial).
1 KIE svarer til 1. 000 IE (internationale enheder).
1 KIU equals 1000 IU (International Units).
50. 000 dalton, produceret i baby hamster nyreceller (BHK celler) ved rekombinant DNA- tekonolgi.
eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Dalton produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Efter rekonstitution indeholder produktet 1 mg/ ml eptacog alfa (aktiveret) og 10 mg/ ml saccharose, når det opløses med solvens.
After reconstitution, the product contains 1 mg/ ml eptacog alfa (activated) and 10 mg/ ml sucrose when reconstituted with solvent.
Hvidt lyofiliseret pulver.
White lyophilized powder.
Klar, farveløs opløsning.
Solvent: clear colourless solution.
6, 0.
The reconstituted solution has a pH of approximately 6.0.
Hæmofili A eller B med inhibitorer eller forventet at have høj anamnetisk respons
Posology Haemophilia A or B with inhibitors or expected to have a high anamnestic response
29 Efter den første dosis NovoSeven kan der være behov for yderligere injektioner.
Following the initial dose of NovoSeven further injections may be repeated.
Behandlingens varighed og injektionsintervallet varierer alt efter sværhedsgraden af blødningen, den invasive procedure eller operationen.
The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive
Dosering til børn Nuværende klinisk erfaring giver ikke basis for en generel differentiering i doseringen mellem børn og voksne, selvom børn har en hurtigere clearance end voksne.
Dosing in children Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults.
Der er ingen klinisk erfaring med administration af enkeltdosis på 270 µg per kg. legemsvægt hos ældre patienter.
There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.
30 Faktor VII- mangel
30 Factor VII deficiency
Dosis, dosering og dosisinterval Til behandling af patienter med blødningsepisoder og til forebyggelse af blødning ved kirurgi eller invasive procedurer anbefales en dosis på 15- 30 µg pr. kg legemsvægt hver 4. - 6. time, indtil hæmostase er opnået.
Dose, dose range and dose interval The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μ g per kg body weight every 4 - 6 hours until haemostasis is achieved.
Efter indgivelse af rFVIIa har protrombintid (PT) og aktiveret partiel tromboplastintid (APTT) vist sig at blive forkortede, men der er ikke påvist nogen korrelation mellem PT og APTT og den kliniske effekt af rFVIIa.
After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.
På grund af risikoen for tromboemboliske komplikationer, skal der udvises forsigtighed når NovoSeven administreres til patienter med hjertesygdomme, til patienter med leversygdom, til postoperative patienter, til nyfødte eller til patienter med risiko for tromboemboliske fænomener eller udbredt intravaskulær koagulation.
Because of the risk of thromboembolic complications, caution should be excercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation.
Hvis der opstår allergiske eller en type af anafylaktiske reaktioner, skal administration ophøre straks.
If allergic or anaphylactic-type reactions occur, the administration should be discontinued
31 tegn på overfølsomhedsreaktioner.
In case of shock, standard medical treatment for shock should be implemented.
Risikoen for trombose hos patienter med faktor VII mangel, som behandles med NovoSeven, er ukendt.
The risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown.
Patienter, der har problemer med sjælden arvelig fructoseintolerans, glucosemalabsorption eller saccharose- isomaltasemangel, bør ikke bruge dette præparat.
Patients with rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose- isomaltase insufficiency should not take this medicine
Der er rapporteret få tilfælde af koagulationsforstyrrelser som forhøjet
Few cases of coagulopathic disorders such as increased D-dimer and consumptive coagulopathy have been reported.
32
32 disseminated intravascular coagulation as described in section 4.4 should be carefully monitored.
Hjerte Meget sjælden (< 1/ 10. 000)
Cardiac disorders Very rare (< 1/ 10,000)
33 Der har været rapporteret isolerede tilfælde af overfølsomhedsreaktioner siden markedsføringen herunder anafylaktiske reaktioner.
Isolated cases of hypersensitivity reactions including anaphylactic reactions have been reported post- marketing.
Der er ikke rapporteret antistoffer mod faktor VII hos patienter med hæmofili A eller B.
33 There have been no reports of antibodies against factor VII in haemophilia A or B patients.
Der er rapporteret isolerede tilfælde, hvor patienter med faktor VII- mangel har udviklet antistoffer mod faktor VII efter behandling med rFVIIa.
Isolated cases of factor VII deficient patients developing antibodies against factor VII have been reported after treatment with rFVIIa.
Disse patienter er tidligere blevet behandlet med humant plasma og/ eller plasmaderiveret faktor VII.
These patients have previously been treated with human plasma and/ or plasma- derived factor VII.
Patienter med faktor VII mangel, som behandles med NovoSeven, bør monitoreres for faktor VII antistoffer.
Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies.
Et tilfælde af angioneurotisk ødem er blevet spontant rapporteret hos en patient med Glanzmanns trombasteni efter administration af rFVIIa.
One case of angioneurotic oedema has been reported spontaneously in a patient with Glanzmann’ s thrombasthenia after administration of rFVIIa.
Ved hjælp af et faktor VII koagulations- assay blev de farmakokinetiske egenskaber for rFVIIa undersøgt i et dosis- eskaleringsstudie med 35 raske kaukasiske og japanske personer.
Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study.
Personerne blev stratificeret i henhold til køn og etnisk gruppe og doseret med 40, 80 og 160 µg rFVIIa per kg kropsvægt og/ eller placebo (3 doser hver).
Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight and/ or placebo (3 doses each).
Den gennemsnitlige fordelingsvolumen ved steady state varierede fra 130- 165 ml/ kg, den gennemsnitlige clearance varierede fra 33, 3 til 37, 2 ml/ kg. time og den gennemsnitlige terminalhalveringstid varierede fra 3, 9 til 6 timer.
The mean steady state volume of distribution ranged from 130 to 165 ml/ kg, the mean values of clearance ranged from 33.3 to 37.2 ml/ kg. h, and the mean terminal half-life ranged from 3.9 to 6.0 hours.
34 Ved hjælp af et faktor VIIa assay blev de farmakokinetiske egenskaber for rFVIIa undersøgt hos 12 pædiatriske - (2- 12 år) og 5 voksne patienter i blødningsfri tilstand.
Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state.
Dosisproportionaliteten blev etableret i børn for de undersøgte doser på 90 og 180 µg/ kg kropsvægt, hvilket er i overensstemmelse med tidligere resultater ved lavere doser (17, 5– 70 µg / kg rFVIIa).
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/ kg rFVIIa).
Den gennemsnitlige clearance var cirka 50% højere i pædiatriske patienter i forhold til voksne (78 versus 53 ml/ kg. time), hvorimod den gennemsnitlige terminalhalveringstid var 2, 3 timer i begge grupper.
Mean volume of distribution at steady state was 196 ml/ kg in
Den gennemsnitlige fordelingsvolumen ved steady state var 196 ml/ kg i pædiatriske patienter versus 159 ml/ kg i voksne.
34 paediatric patients versus 159 ml/ kg in adults.
Enkeltdosisfarmakokinetik med rFVIIa, 15 og 30 µg pr. kg legemsvægt, udviste ingen signifikant forskel mellem de to doser med hensyn til dosisuafhængige parametre: samlet legemsclearance (70, 8- 79, 1 ml/ time. kg), fordelingsvolumen ved steady state (280- 290 ml/ kg), middelopholdstid (3, 75- 3, 80 timer) og halveringstid (2, 82- 3, 11 timer).
Single dose pharmacokinetics of rFVIIa, 15 and 30 μ g per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/ h. kg), volume of distribution at steady state (280 - 290 ml/ kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h).
Natriumchlorid Kalciumchloriddihydrat Glycylglycin Polysorbat 80 Mannitol Saccharose Methionin Saltsyre (til pH- justering) Natriumhydroxid (til pH- justering)
Powder Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Sucrose Methionine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Histidin Hydrogenchlorid (til pH- justering) Natriumhydroxid (til pH- justering) Vand til injektionsvæsker
Solvent Histidine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
35 Produktets opbevaringstid, pakket med henblik på salg, er 2 år.
The shelf life is 2 years for the product packed for sale.
Det er blevet påvist, at produktet efter rekonstitution er kemisk og fysisk stabilt i 6 timer ved 25°C og i 24 timer ved 5°C.
After reconstitution, chemical and physical stability have been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Hvis produktet ikke anvendes straks, er opbevaringstid og opbevaringsbetingelser brugerens ansvar og og bør ikke være mere end 24 timer ved 2°C- 8°C, medmindre rekonstitutionen har fundet sted under kontrollerede og validerede aseptiske forhold.
If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and should not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
6. 4 Særlige opbevaringsforhold
35 6.4 Special precautions for storage
6. 3.
– Store powder and solvent below 25°C. – Store powder and solvent protected from light. – Do not freeze to prevent damage to the solvent vial. – For storage conditions of the reconstituted medicinal product, see section 6.3.
De lukkede hætteglas er udstyret med en forseglet snap- off hætte, som er lavet af polypropylen.
The NovoSeven package contains Type I glass vials closed with a chlorobutyl rubber stopper, covered with an aluminium cap. The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.
Hver enkelt NovoSeven pakning indeholder: – 1 hætteglas (2 ml) med hvidt pulver til injektionsvæske, opløsning – 1 hætteglas (2 ml) med solvens til rekonstitution
Each NovoSeven package contains: – 1 vial (2 ml) with white powder for solution for injection – 1 vial (2 ml) with solvent for reconstitution
• NovoSeven pulver og solvens tempereres til stuetemperatur inden rekonstitution.
• NovoSeven powder and solvent vials should be at room temperature at reconstitution.
Brug en engangssprøjte af passende størrelse og en hætteglasadapter, nål til overførsel (20 – 26G) eller andet egnet udstyr.
Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.