FrancophonIA/ELRC3.0 huggingface dataset:
English: A 26-week phase III clinical study compared insulin glulisine with insulin lispro both injected subcutaneously shortly (0-15 minutes) before a meal in children (4-5 years: n=9; 6-7 years: n=32 and 8-11 years: n=149) and adolescents (12-17 years: n=382) with type 1 diabetes mellitus using insulin glargine or NPH as basal insulin.
Danish: I et 26 ugers fase III klinisk studie med sammenligning af insulin glulisin og insulin lispro, begge injiceret subkutant kort tid (0-15 minutter) før et måltid, til børn (4-5år: n=9; 6-7 år: n=32 og 8-11 år: n=149) og unge (12-17 år: n=382) med type 1 diabetes mellitus, som brugte insulin glargin eller NPH som basal insulin, kunne insulin glulisin sidestilles med insulin lispro med hensyn til glykæmisk kontrol afspejlet ved ændringer i glykosyleret hæmoglobin (GHb udtrykt som HbA1c ækvivalent) fra baseline til endepunktet og ved blodglucoseværdier målt af patienterne selv.
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available.
Danish: Findes i pakninger med 1, 3, 4, 5, 6, 8, 9 og 10 fyldte penne.
English: Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system (see section 4.2).
Danish: Apidra hætteglas skal bruges sammen med insulinsprøjter med en passende enhedsskala eller gives via en insulin-infusionspumpe (se pkt.
English: Apidra SoloStar 100 units/ml in pre-filled pen is only suitable for subcutaneous injections.
Danish: Apidra SoloStar 100 enheder/ml i fyldte penne er kun egnet til subkutan injektion.
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: Hvis du for eksempel: - ikke har taget din insulin, eller du ikke har taget nok, eller insulinen har mistet noget af sin virkning, f.eks. på grund af forkert opbevaring, - dyrker mindre motion end sædvanligt eller er stresset (følelsesmæssigt ude af balance, eller er ophidset), eller hvis du har en skade, er blevet opereret, har en infektion eller feber, tager eller har taget visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Apidra”).
English: Do not use this medicine after the expiry date, which is stated on the carton and on the label of the pen after “EXP”.
Danish: Brug ikke Apidra efter den udløbsdato, der står på pakningen og etiketten på pennen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: How to use Apidra
Danish: Sådan skal du tage Apidra
English: GLULISINE - post REGULAR - pre
Danish: GLULISINE - efter REGULAR - før
English: Continuous subcutaneous infusion pump Refer to section 4.2 and 4.4 for advice.
Danish: 4.2 og 4.4 for vejledning.
English: 4 vials of 10ml.
Danish: 4 hætteglas á 10 ml.
English: Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Danish: Hver cylinderampul indeholder 3 ml injektionsvæske, opløsning, svarende til 300 enheder.
English: EU/1/04/285/003 4 vials of 10ml EU/1/04/285/004 5 vials of 10ml.
Danish: EU/1/04/285/001 1 hætteglas á 10 ml EU/1/04/285/002 2 hætteglas á 10 ml EU/1/04/285/003 4 hætteglas á 10 ml EU/1/04/285/004 5 hætteglas á 10 ml
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen 3 ml solution in a cartridge (colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen 3 ml opløsning i en cylinderampul (farveløst glas) med et stempel (elastomerisk bromobutylgummi) og en ombøjet hætte (aluminium) med en prop (elastomerisk bromobutylgummi).
English: It must only be used if the solution is clear and colourless, not when cloudy or with visible particles.
Danish: Opløsningen må kun anvendes, hvis den er klar og farveløs og ikke hvis den er uklar eller med synlige partikler.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH
Danish: Sanofi-Aventis Deutschland GmbH
English: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light.
Danish: Ibrugtagne penne (eller penne taget med som reserve) kan opbevares ved temperaturer under 25°C i indtil 4 uger, væk fra direkte varme eller direkte lys.
English: Apidra 100 Units/ml solution for injection in a cartridge is a clear, colourless, aqueous solution with no particles visible.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning i en cylinderampul er en klar farveløs vandig opløsning uden synlige partikler.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Each pen contains 3 ml of solution for injection, equivalent to 300 Units.
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Hver pen indeholder 3 ml injektionsvæske, opløsning, svarende til 300 enheder.
English: 2 vials of 10ml.
Danish: 2 hætteglas á 10 ml.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Danish: Hver milliliter af opløsningen indeholder 100 enheder af det aktive stof insulin glulisin (svarende til 3,49 mg).
English: 8 pens of 3 ml.
Danish: 8 penne à 3 ml.
English: 10 secs
Danish: 10 sek
English: Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for use”).
Danish: Brug kun nåle der er kompatible til at bruge sammen med SoloStar (se SoloStar brugsanvisning).
English: For information on the treatment of hypoglycaemia, see box at the end of this leaflet.
Danish: Yderligere oplysninger om behandling af hypoglykæmi findes i den indrammede tekst sidst i denne indlægsseddel.
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Danish: Findes i pakninger med 1, 3, 4, 5, 6, 8, 9 og 10 cylinderampuller.
English: For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
Danish: Yderligere oplysninger om behandling af hyperglykæmi findes i den indrammede tekst sidst i denne indlægsseddel.
English: Rubber seal
Danish: Ydre nålekapsel
English: Before using SoloStar, the Instructions for use included in the Package leaflet must be read carefully (see section 6.6).
Danish: Brugsanvisningen for SoloStar skal læses omhyggeligt, før SoloStar anvendes (se pkt.
English: HYPERGLYCAEMIA (high blood sugar levels)
Danish: • har hyperglykæmi (for højt blodsukker).
English: Apidra 100 Units/ml solution for injection in a cartridge 3 ml solution in a cartridge (type I colourless glass) with a plunger (elastomeric bromobutyl rubber) and a flanged cap (aluminium) with a stopper (elastomeric bromobutyl rubber).
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul 3 ml opløsning i en cylinderampul (type 1 farveløst glas) med et stempel (elastomerisk bromobutyl gummi) og en ombøjet hætte (aluminium) med en prop (elastomerisk bromobutyl gummi).
English: Apidra 100 Units/ml solution for injection in a vial 10 ml solution in a vial (type I colourless glass) with a stopper (flanged aluminium overseal, elastomeric chlorobutyl rubber) and a polypropylene tear-off cap.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas 10 ml opløsning i hætteglas (type 1 farveløst glas) med en hætte (ombøjet aluminiumsforsegling, elastomerisk chlorbutyl gummi) og polypropylen låg til afrivning.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Germany
Danish: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt
English: Apidra SoloStar solution for injection in a pre-filled pen.
Danish: Apidra injektion, opløsning i en fyldt pen.
English: Please check section 6.4 of this SPC for instructions on how to store SoloStar.
Danish: 6.4 vedrørende opbevaringsbetingelser for SoloStar.
English: Marketing Authorisation Holder: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany.
Danish: Indehaver af markedsføringstilladelsen: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Tyskland.
English: 8 cartridges of 3ml.
Danish: 8 cylinderampuller à 3 ml.
English: - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - protease inhibitors (used to treat HIV), - atypical antipsychotic medicines (such as olanzapine and clozapine).
Danish: - isoniazid (anvendes til behandling af tuberkulose), - østrogener og gestagener (som f.eks. i p-piller, der anvendes til forebyggelse af graviditet), - phenthiazinderivater (anvendes til behandling af psykiske sygdomme), - somatropin (væksthormon), - sympatomimetika (som f.eks.epinephrine (adrenalin), salbutamol, terbutalin, der anvendes til behandling af astma), - thyreoideahormoner (anvendes til behandling af sygdomme i skjoldbruskkirtlen), - proteasehæmmere (anvendes til at behandle hiv), - atypiske antipsykotiske lægemidler (som f.eks. clozapin, olanzapin).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Danish: Anvend kun klare og farveløse opløsninger.
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis),
Danish: Blodsukkeret kan stige (hyperglykæmi), hvis du tager følgende medicin: - kortikosteroider (som f.eks. kortison, anvendes til behandling af betændelsestilstande), - danazol (medicin der virker på ægløsning), - diazoxid (anvendes til behandling af højt blodtryk), - vanddrivende lægemidler (anvendes til behandling af højt blodtryk eller overdreven væskeophobning), - glucagon (bugspytkirtelhormon, der anvendes til behandling af meget lavt blodsukker (svær hypoglykæmi),
English: 1 vial of 10ml.
Danish: 1 hætteglas á 10 ml
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Shelf life after first use of the pen
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Opbevaringstid efter første anbrud af pennen
English: Keep the cartridge inserted in the pen protected from light.
Danish: Opbevar cylinderampullen isat pennen beskyttet mod lys.
English: Do not use this medicine after the expiry date, which is stated on the carton and on the label of the cartridge after “EXP”.
Danish: Brug ikke Apidra efter den udløbsdato, der står på pakningen og på etiketten på cylinderampullen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Breast-feeding mothers may require adjustments in insulin dose and diet.
Danish: Det kan være nødvendigt at justere insulindosis og kost hos ammende kvinder.
English: B. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.
Danish: B. Kasser nålen sikkert som anbefalet af sundhedspersonalet.
English: carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Apidra").
Danish: Hvis du for eksempel: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok, eller du spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater, medens kunstige sødemidler IKKE er kulhydrater), - mister kulhydrater på grund af opkastning eller diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller en operation eller andre former for stress, - er ved at komme dig efter en sygdom eller efter feber, - tager eller er holdt op med at tage visse andre lægemidler (se punkt 2 ”Brug af anden medicin sammen med Apidra”).
English: Do not use this medicine after the expiry date, which is stated on the carton and on the label of the vial after “EXP”.
Danish: Brug ikke Apidra efter den udløbsdato, der står på pakningen og på hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: After first use: The product may be stored for a maximum of 4 weeks below 25°C.
Danish: Anbrudte hætteglas: Lægemidlet kan opbevares i maksimalt 4 uger under 25°C.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (cartridge)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (cylinderampul)
English: It must only be used if the solution is clear, colourless, with no solid particles visible.
Danish: Det må kun anvendes, hvis opløsningen er klar, farveløs og uden synlige partikler.
English: What Apidra is and what it is used for What you need to know before you use Apidra How to use Apidra
Danish: Det skal du vide, før du begynder at tage Apidra Sådan skal du tage Apidra Bivirkninger
English: Apidra 100 Units/ml solution for injection in a cartridge Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul Hver cylinderampul indeholder 3 ml injektionsvæske, opløsning, svarende til 300 enheder.
English: See the box at the end of this leaflet for further information.
Danish: Yderligere oplysninger findes i den indrammede tekst sidst i denne indlægsseddel.
English: 9 pens of 3 ml.
Danish: 9 penne à 3 ml.
English: Needle
Danish: Pendel
English: Dosage selector
Danish: Doseringsinterval
English: If you forget to use Apidra
Danish: Hvis du har taget for meget Apidra
English: 5 pens of 3 ml.
Danish: 5 penne à 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Hvert hætteglas indeholder 10 ml injektionsvæske, opløsning, svarende til 1000 enheder.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Insulin glulisine
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen insulin glulisin
English: 6 pens of 3 ml.
Danish: 6 penne à 3 ml.
English: Apidra 100 Units/ml solution for injection in a vial Intravenous use
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Intravenøs anvendelse
English: Cartridges in use (in the insulin pen) may be stored for a maximum of 4 weeks below 25°C, away from direct heat or direct light and must not be stored in a refrigerator.
Danish: Cylinderampuller, som er i brug (i insulinpennen) kan opbevares i maksimalt 4 uger under 25°C, væk fra direkte varme eller direkte lys.
English: - you change the area of skin where you inject insulin (for example from the thigh to the upper arm), - you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Danish: - du lider af en alvorlig nyre- eller leversygdom, eller af en anden sygdom, som f.eks. nedsat stofskifte (hypothyreoidisme).
English: 10 pens of 3 ml.
Danish: 10 penne à 3 ml.
English: As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Danish: Ligesom for andre insuliner skal du ved hver injektion skifte til et nyt injektionssted inden for det bestemte hudområde, som du bruger (maveskindet, låret eller overarmen).
English: 1 pen of 3 ml.
Danish: 1 pen à 3 ml
English: GIR - mg/kg/min
Danish: - µU/mL
English: 4 pens of 3 ml.
Danish: 4 penne à 3 ml.
English: 9 cartridges of 3ml.
Danish: 9 cylinderampuller à 3 ml.
English: Injection button
Danish: Påsætning af nålen
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Apidra SoloStar 100 Units/ml in pre-filled pen is only suitable for subcutaneous injections.
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Apidra SoloStar 100 enheder/ml i fyldt pen er kun egnet til subkutane injektioner.
English: 10 cartridges of 3ml.
Danish: 10 cylinderampuller à 3 ml.
English: Solution for injection in a vial.
Danish: Injektionsvæske, opløsning, i et hætteglas.
English: Shelf life for intravenous use
Danish: Opbevaringstid for intravenøs anvendelse
English: 5 cartridges of 3ml.
Danish: 5 cylinderampuller à 3 ml.
English: Apidra 100 Units/ml solution for injection in a cartridge Pens to be used with Apidra 100 units/ml solution for injection in a cartridge Apidra 100 units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul Penne der kan bruges til Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul Apidra 100 enheder/ml i cylinderampuller er kun egnet til subkutan injektion fra en genanvendelig pen.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen.
Danish: Apidra SoloStar 100 enheder/ml, injektionsvæske, opløsning, i en fyldt pen.
English: INSTRUCTIONS ON USE Open here
Danish: Åben her
English: 4 cartridges of 3ml.
Danish: 4 cylinderampuller à 3 ml.
English: Obesity
Danish: Overvægt
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Not in-use pens
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Uanbrudte penne
English: España sanofi-aventis, S.A. Tel: +34 93 485 94 00
Danish: Sanofi - Produtos Farmacêuticos, S.A. Tel: +351 21 35 89 400
English: 6 cartridges of 3ml.
Danish: 6 cylinderampuller à 3 ml.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Handling of the SoloStar pre-filled pen
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Anvendelse af SoloStar fyldt pen
English: Apidra 100 Units/ml solution for injection in a vial Subcutaneous use
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Subkutan anvendelse
English: EU/1/04/285/005 1 cartridge of 3ml EU/1/04/285/006 3 cartridges of 3ml.
Danish: EU/1/04/285/005 1 cylinderampul à 3 ml EU/1/04/285/006 3 cylinderampuller à 3 ml EU/1/04/285/007 4 cylinderampuller à 3 ml EU/1/04/285/008 5 cylinderampuller à 3 ml EU/1/04/285/009 6 cylinderampuller à 3 ml EU/1/04/285/010 8 cylinderampuller à 3 ml EU/1/04/285/011 9 cylinderampuller à 3 ml EU/1/04/285/012 10 cylinderampuller à 3 ml
English: Apidra 100 Units/ml solution for injection in a vial For further details on handling, see section 6.6.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Yderligere oplysninger om håndtering findes under pkt.
English: Never use the solution if it has become cloudy or contains particles; use it only if it is clear and colourless.
Danish: Anved aldrig opløsningen hvis den bliver uklar eller indeholder partikler.
English: MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Germany.
Danish: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main Tyskland.
English: 3 pens of 3 ml.
Danish: 3 penne à 3 ml.
English: What Apidra contains
Danish: Apidra indeholder natrium
English: Excipients
Danish: Insulinforvekslinger
English: In-use pens
Danish: Anbrudte penne
English: Apidra 100 Units/ml solution for injection in a vial Insulin glulisine
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning insulin glulisin
English: 3 cartridges of 3ml.
Danish: 3 cylinderampuller à 3 ml.
English: Apidra SoloStar 100 Units/ml solution for injection in a pre-filled pen Solution for injection in a pre-filled pen.
Danish: Apidra SoloStar 100 enheder/ml injektionsvæske, opløsning, i en fyldt pen Injektionsvæske, opløsning, i en fyldt pen.
English: - If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).
Danish: Følg retningslinierne for behandling af hypoglykæmi (se den indrammede tekst sidst i indlægssedlen).
English: Apidra 100 Units/ml solution for injection in a cartridge Insulin glulisine
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul insulin glulisin
English: NAME OF THE MEDICINAL PRODUCT Apidra 100 Units/ml, solution for injection in a vial Insulin glulisine
Danish: Indlægsseddel: Information til brugeren Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas insulin glulisin
English: Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older.
Danish: Apidra anvendes til at nedsætte for højt blodsukker hos patienter med sukkersyge (”diabetes mellitus”).
English: Apidra 100 Units/ml solution for injection in a cartridge Apidra 100 Units/ml in cartridges is only suitable for subcutaneous injections from a reusable pen.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul Apidra 100 enheder/ml i cylinderampuller er kun egnet til subkutan injektion fra en genanvendelig pen.
English: D-65926 Frankfurt am Main, Germany
Danish: Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Tyskland
English: Apidra 100 Units/ml solution for injection in a vial Solution for injection in a vial.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul.
English: In-use pens For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: Anbrudte penne For opbevaringsforhold, se pkt.
English: Important information about some of the ingredients of Apidra
Danish: Pakningsstørrelser og yderligere oplysninger Apidra indeholder:
English: Apidra 100 Units/ml solution for injection in a cartridge Solution for injection in a cartridge.
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i en cylinderampul Injektionsvæske, opløsning, i en cylinderampul.
English: Apidra 100 Units/ml solution for injection in a cartridge Unopened cartridges
Danish: Apidra 100 enheder/ml injektionsvæske, opløsning, i et hætteglas Uanbrudte hætteglas
English: It is taken once a day with food.
Danish: Det tages én gang dagligt i forbindelse med et måltid.
English: The full EPAR for Tenofovir disoproxil Zentiva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tenofovir disoproxil Zentiva findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function.
Danish: Dosen skal muligvis reduceres eller lægemidlet gives mindre hyppigt hos patienter, der har moderat eller svært nedsat nyrefunktion.
English: Therefore, the CHMP's view was that, as for Viread, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Viread.
English: The Committee recommended that Tenofovir disoproxil Zentiva be approved for use in the EU.
Danish: Udvalget anbefalede, at Tenofovir disoproxil Zentiva godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Tenofovir disoproxil Zentiva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tenofovir disoproxil Zentiva.