natgillin/translations-raw huggingface dataset:
Valsartan er i høj grad bundet til serumproteiner (94- 97%), hovedsageligt serumalbumin.
Valsartan is highly bound to serum proteins (94 – 97%), mainly serum albumin.
Amlodipin/ valsartan Efter oral administration af Dafiro opnås maksimal plasmakoncentration for valsartan og amlodipin efter henholdsvis 3 timer og 6- 8 timer.
Amlodipine/ Valsartan Following oral administration of Dafiro, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6– 8 hours, respectively.
Hastigheden og graden af Dafiro- absorptionen er ækvivalent med valsartans og amlodipins biotilgængelighed, når de gives som individuelle tabletter.
The rate and extent of absorption of Dafiro are equivalent to the bioavailability of valsartan and amlodipine when administered as individual tablets.
Ældre (65 år og derover) Tiden til maksimal plasmakoncentration af amlodipin er den samme for yngre og ældre patienter.
Elderly (age 65 years or over) Time to peak plasma amlodipine concentrations is similar in young and elderly patients.
Følgende bivirkninger blev set i dyreforsøg, og kan være klinisk relevante:
Adverse reactions observed in animal studies with possible clinical relevance were as follows:
En øget forekomst og sværhedsgrad af renal tubulær basofili/ hyalinisering, dilation og cylindre i urinen, såvel som interstitial lymfocytinflammation og arteriolær medial hypertrofi blev set ved en eksponering på 8- 13 (valsartan) og 7- 8 (amlodipin) gange den kliniske dosis på 160 mg valsartan og 10 mg amlodipin.
An increased incidence and severity of renal tubular basophilia/ hyalinisation, dilation and casts, as well as interstitial lymphocyte inflammation and arteriolar medial hypertrophy were found at an exposure of 8– 13 (valsartan) and 7 – 8 (amlodipine) times the clinical doses of 160 mg valsartan and 10 mg amlodipine.
Dafiro 5 mg/ 160 mg filmovertrukne tabletter
Dafiro 5 mg/ 160 mg film-coated tablets
Mørkegul, oval filmovertrukket tablet, præget med ” NVR ” på den ene side og ” ECE ” på den anden side.
Dark yellow, oval film-coated tablet, imprinted with “ NVR ” on one side and “ ECE” on the other side.
Dafiro 5 mg/ 160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
Dafiro 5 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
14 Børn og unge Dafiro bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
14 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
15 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
16 Interaktioner forbundet med valsartan Samtidig brug frarådes Lithium Der er rapporteret reversible øgede serumkoncentrationer og toksicitet af lithium ved samtidig brug af ACE- hæmmere.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
17 Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
5. 3).
17 other angiotensin II antagonists (see section 5.3).
18 Sygdomme i bevægeapparatet og bindevæv
Musculoskeletal and connective tissue disorders
Almene lidelser og reaktioner på indgivelsesstedet
18 General disorders and administration site conditions
19
19 4.9 Overdose
20 Plasmakoncentrationen korrelerer med virkningen hos både yngre og ældre patienter.
Plasma concentrations correlate with effect in both young and elderly patients.
21 Kombinationen af amlodipin og valsartan giver et dosisrelateret, additivt blodtryksfald på tværs af det terapeutiske dosisinterval.
The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range.
22 Biotransformation:
Biotransformation:
Dafiro 10 mg/ 160 mg filmovertrukne tabletter
Dafiro 10 mg/ 160 mg film-coated tablets
Lysegul, oval filmovertrukket tablet, præget med ” NVR ” på den ene side og ” UIC ” på den anden side.
Light yellow, oval film-coated tablet, imprinted with “ NVR ” on one side and “ UIC” on the other side.
Dafiro 10 mg/ 160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg eller valsartan 160 mg alene eller med Dafiro 5 mg/ 160 mg.
Dafiro 10 mg/ 160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Dafiro 5 mg/ 160 mg.
26 Børn og unge Dafiro bør ikke anvendes til børn under 18 år p. g. a. manglende dokumentation for sikkerhed og virkning.
26 Children and adolescents Dafiro is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
27 Nedsat nyrefunktion Det er ikke nødvendigt at justere dosis hos patienter med mildt til moderat nedsat nyrefunktion (GFR > 30 ml/ min/ 1, 73 m2).
Renal impairment No dosage adjustment of Dafiro is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
28 Interaktioner forbundet med valsartan Samtidig brug frarådes Lithium Der er rapporteret reversible øgede serumkoncentrationer og toksicitet af lithium ved samtidig brug af ACE- hæmmere.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
29 Det anbefales at udføre ultralydsscanning for at tjekke nyrefunktionen og kraniet, hvis fosteret har været udsat for AIIA fra andet trimester.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
30 Sygdomme i bevægeapparatet og bindevæv
Musculoskeletal and connective tissue disorders
31
31 4.9 Overdose
32 Plasmakoncentrationen korrelerer med virkningen hos både yngre og ældre patienter.
Plasma concentrations correlate with effect in both young and elderly patients.
33 Kombinationen af amlodipin og valsartan giver et dosisrelateret, additivt blodtryksfald på tværs af det terapeutiske dosisinterval.
The combination of amlodipine and valsartan produces dose-related additive reduction in blood pressure across its therapeutic dose range.
34 Biotransformation:
Biotransformation:
35 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
37 10.
37 ANNEX II
38 BILAG II
38 A.
40 BILAG III
40 A.
ETIKETTERING
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Dafiro 5 mg/ 80 mg filmovertrukne tabletter amlodipin/ valsartan
Dafiro 5 mg/ 80 mg film-coated tablets amlodipine/ valsartan
44 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
48 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Dafiro 5 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Dafiro 5 mg/ 160 mg film-coated tablets amlodipine/ valsartan
51 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
52 10.
51 10.
53 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
54 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
56 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Dafiro 10 mg/ 160 mg filmovertrukne tabletter amlodipin/ valsartan
Dafiro 10 mg/ 160 mg film-coated tablets amlodipine/ valsartan
58 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
61 10.
60 10.
62 MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
61 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
INDLÆGSSEDDEL
63 PACKAGE LEAFLET:
- Lægen har ordineret Dafiro til dig personligt.
- This medicine has been prescribed for you.
Det kan
It may harm them, even
være skadeligt for andre, selvom de har de samme symptomer, som du har.
if their symptoms are the same as yours.
Dafiros virkning og hvad du skal bruge det til 2.
What Dafiro is and what it is used for 2.
Det skal du vide, før du begynder at tage Dafiro 3.
Before you take Dafiro 3.
Sådan skal du tage Dafiro 4.
How to take Dafiro 4.
Sådan opbevarer du Dafiro 6.
How to store Dafiro 6.
DAFIROS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT DAFIRO IS AND WHAT IT IS USED FOR
Dafiro bruges til at behandle forhøjet blodtryk hos patienter, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
Dafiro is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DAFIRO
BEFORE YOU TAKE DAFIRO
Hvis du
Do not take Dafiro − if you are allergic (hypersensitive) to amlodipine or other medicines of the dihydropyridine type, − if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Dafiro.
- hvis du har alvorlige leverlidelser, som f. eks. biliær cirrhose eller cholestasi.
If you think you may be allergic, talk to your doctor before taking Dafiro. − if you have severe liver problems, such as biliary cirrhosis or cholestasis. − if you have severe kidney problems or if you are having dialysis. − during the last 6 months of pregnancy, see “ Pregnancy and breastfeeding”.
- hvis du har alvorlige nyrelidelser, eller hvis du er i dialysebehandling.
If any of the above applies to you, do not take Dafiro and talk to your doctor.
- de sidste 6 måneder af graviditeten (se afsnittet om ” Graviditet og amning ”).
Take special care with Dafiro − if you have been sick (vomiting or diarrhoea).
Hvis noget af ovenstående gælder for dig, skal du ikke tage Dafiro og du skal underrette din læge.
64 − if you are taking diuretics (a type of medicine also called “ water tablets ” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism ”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
- hvis du har været syg (opkastning eller diarré).
If any of these apply to you, tell your doctor before taking Dafiro.
- hvis du tager anden medicin eller andre stoffer, som øger mængden af kalium i dit blod (f. eks.
You must tell your doctor if you think that you are (or might become) pregnant.
nogle typer diuretika, kaliumtilskud eller salterstatninger, som indeholder kalium).
Dafiro is not recommended in early pregnancy and may cause serious harm to your baby if taken after 3 months of pregnancy (see section “ Pregnancy and breast-feeding”).
- hvis du har problemer med lever eller nyrer.
The use of Dafiro in children and adolescents is not recommended.
- hvis du har en tilstand som påvirker binyren, der hedder ” primær hyperaldosteroisme ”.
Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
- hvis din læge har fortalt dig, at du har en forsnævring af hjerteklappen (kaldes ” aorta - eller
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
mitralklapstenose ”).
Your doctor may need to change the dose or take other precautions.
Hvis dette gælder for dig, så tal med din læge inden du tager Dafiro.
In some cases you may have to stop taking one of the medicines.
Dafiro frarådes i den tidlige periode af graviditet.
This applies especially to the medicines listed below: − lithium (a medicine used to treat some types of depression); − potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; − anticonvulsant agents (e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, St.
Dafiro kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten (se afsnittet om ” Graviditet og amning ”).
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators ”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
Brug af Dafiro til børn og unge frarådes.
Taking Dafiro with food and drink You can take Dafiro with or without food.
Du skal også fortælle din læge, hvis du har fået en nyretransplantation eller hvis du har fået at vide, at du har forsnævret blodtilførelse til nyrerne.
Dafiro and older people Caution is required when increasing the dosage.
Det gælder især for den medicin, som er beskrevet herunder:
Usually, your doctor will advise you to take another medicine instead of Dafiro, as Dafiro is not recommended in early pregnancy, and may cause serious harm to your baby if it is used after 3 months of pregnancy.
- krampehæmmende stoffer (f. eks. carbamazepin, phenobarbital, phenytoin, fosphenytoin,
An appropriate antihypertensive medication must usually replace Dafiro before starting a pregnancy.
Brug af Dafiro sammen med mad og drikke Du kan tage Dafiro med eller uden mad.
Your doctor will normally advise you to stop taking Dafiro as soon as you know you are pregnant.
Dafiro og ældre patienter Der kræves forsigtighed, når dosis øges.
If you become pregnant during therapy with Dafiro, please inform and see your doctor without delay.
Normalt vil din læge råde dig til at tage noget andet medicin i stedet for Dafiro.
Tell your doctor if you are breast-feeding.
Dafiro må ikke bruges under andet og tredje trimester af graviditeten.
Treatment with Dafiro is not recommended during breast- feeding.
Din læge vil normalt råde dig til at stoppe med at tage Dafiro, så snart du ved, at du er gravid.
65 Ask your doctor or pharmacist for advice before taking any medicine.
66 Trafik - og arbejdssikkerhed Denne medicin kan få dig til at føle svimmelhed.
Driving and using machines This medicine may make you feel dizzy.
SÅDAN SKAL DU TAGE DAFIRO
HOW TO TAKE DAFIRO
Tag altid Dafiro nøjagtig efter lægens anvisning.
Always take this medicine exactly as your doctor has told you.
Det vil hjælpe dig med at opnå den bedste virkning og mindske risikoen for bivirkninger.
You should check with your doctor if you are not sure.
Den sædvanlige dosis af Dafiro er én tablet daglig.
This will help you get the best results and lower the risk of side effects.
- Det tilrådes at tage din medicin på samme tidspunkt hver dag, helst om morgenen.
The usual dose of Dafiro is one tablet per day. − It is advisable to take your medicine at the same time each day, preferably in the morning. − Swallow the tablets with a glass of water. − You can take Dafiro with or without food.
Hvis du har taget for meget Dafiro Hvis du har taget for mange Dafiro- tabletter, eller hvis andre har taget dine tabletter, skal du kontakte en læge med det samme.
If you take more Dafiro than you should If you have taken too many tablets of Dafiro, or if someone else has taken your tablets, consult a doctor immediately.
Hvis du har glemt at tage Dafiro Hvis du glemmer at tage din medicin, skal du tage den så snart du kommer i tanke om det.
If you forget to take Dafiro If you forget to take this medicine, take it as soon as you remember.
Dafiro kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Dafiro can cause side effects, although not everybody gets them.
Sjældne (det forekommer hos mindre end 1 ud af 1. 000 patienter):
Rare (affecting less than 1 in 1,000 patients):
67 Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du tale med din læge.
66 If any of these affect you severely, tell your doctor.
SÅDAN OPBEVARER DU DAFIRO
HOW TO STORE DAFIRO
Brug ikke Dafiro efter den udløbsdato, der står på æsken og blisterkortet.
Do not use Dafiro after the expiry date stated on the carton and blister.
Hvad Dafiro indeholder
FURTHER INFORMATION
Hver tablet
What Dafiro contains − The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan.
magnesiumstearat; hypromellose; macrogol 4000; talcum; titandioxid (E171); gul jernoxid (E172).
Each tablet contains 5 mg amlodipine and 80 mg valsartan. − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
68 Dafiros udseende og pakningstørrelse Dafiro 5 mg/ 80 mg tabletter er runde og mørkegule, præget med ” NVR ” på den ene side og ” NV ” på den anden side.
67 What Dafiro looks like and contents of the pack Dafiro 5 mg/ 80 mg tablets are round and dark yellow with “ NVR ” on one side and “ NV” on the other side.
Dafiro er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter.
Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Hvis du vil have yderligere oplysninger om Dafiro, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
69 France Novartis Pharma S. A. S.
68 France Novartis Pharma S. A. S.
70 INDLÆGSSEDDEL:
69 PACKAGE LEAFLET:
Hvis noget af ovenstående gælder for dig, skal du ikke tage Dafiro og du skal underrette din læge.
70 − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
Dafiro kan forårsage alvorlig skade på din baby, hvis det tages efter tredje måned af graviditeten (se afsnittet om ” Graviditet og amning ”).
John’ s wort; − nitroglycerin and other nitrates, or other substances called “ vasodilators”; − medicines used for HIV/ AIDS (e. g. ritonavir) or for treatment of fungal infections (e. g. ketoconazole).
Din læge vil normalt råde dig til at stoppe med at tage Dafiro, så snart du ved, at du er gravid.
71 Ask your doctor or pharmacist for advice before taking any medicine.
72 Trafik - og arbejdssikkerhed Denne medicin kan få dig til at føle svimmelhed.
Driving and using machines This medicine may make you feel dizzy.
73 Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du tale med din læge.
72 If any of these affect you severely, tell your doctor.
Hvad Dafiro indeholder
What Dafiro contains
- De aktive stoffer i Dafiro er amlodipin (som amlodipinbesylat) og valsartan.
- The active substances of Dafiro are amlodipine (as amlodipine besylate) and valsartan.
74 Dafiros udseende og pakningstørrelse Dafiro 5 mg/ 160 mg tabletter er ovale og mørkegule, præget med ” NVR ” på den ene side og ” ECE ” på den anden side.
What Dafiro looks like and contents of the pack Dafiro 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
Dafiro er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter.
73 Dafiro is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
75 France Novartis Pharma S. A. S.
France Novartis Pharma S. A. S.
76 INDLÆGSSEDDEL:
75 PACKAGE LEAFLET:
Hvis noget af ovenstående gælder for dig, skal du ikke tage Dafiro og du skal underrette din læge.
76 − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
Din læge vil normalt råde dig til at stoppe med at tage Dafiro, så snart du ved, at du er gravid.
77 Ask your doctor or pharmacist for advice before taking any medicine.
78 Trafik - og arbejdssikkerhed Denne medicin kan få dig til at føle svimmelhed.
Driving and using machines This medicine may make you feel dizzy.
79 Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du tale med din læge.
78 If any of these affect you severely, tell your doctor.
magnesiumstearat; hypromellose; macrogol 4000; talcum; titandioxid (E171); gul jernoxid (E172); rød jernoxid (E172).
Each tablet contains 10 mg amlodipine and 160 mg valsartan. − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
80 Dafiros udseende og pakningstørrelse Dafiro 10 mg/ 160 mg tabletter er ovale og lysegule, præget med ” NVR ” på den ene side og ” UIC ” på den anden side.
79 What Dafiro looks like and contents of the pack Dafiro 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
81 France Novartis Pharma S. A. S.
80 France Novartis Pharma S. A. S.
Vaccinen indeholder en influenzastamme, der kaldes A/ Viet Nam/ 1194/ 2004 (H5N1).
It contains a flu strain called A/ Viet Nam/ 1194/ 2004 (H5N1).
Daronrix er en vaccine, der kun må bruges, når udbrud af en pandemi officielt er erklæret af Verdens - sundhedsorganisationen (WHO) eller af Den Europæiske Union (EU).
Daronrix is a vaccine that can only be used once a flu ‘ pandemic’ has been officially declared by the World Health Organization (WHO) or European Union (EU).
Den gives ved injektion i overarmsmusk - len.
It is given by injection into the upper arm muscle.
Daronrix er en "modelvaccine".
Daronrix is a ‘ mock-up’ vaccine.
Derfor kan firmaerne ikke fremstille vaccinen på forhånd.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.