natgillin/translations-raw huggingface dataset:
Ovitrelle blev sammenlignet med det naturlige hCG - hormon, der var udvundet af urin.
Ovitrelle was compared to the natural hCG hormone that had been extracted from urine.
Der er desuden gennemført én undersøgelse hos kvinder, der ikke kan få ægløsning.
One study has also been carried out in women who cannot ovulate.
Hvilken fordel viser undersøgelserne, der er ved Ovitrelle?
What benefit has Ovitrelle shown during the studies?
Ovitrelle var lige så effektivt som hCG fra urin til at fremkalde ægløsning, og en dosering på 250 µg var lige så effektiv som en på 500 µg.
Ovitrelle was as effective as urinary hCG in producing ovulation, and the 250 micrograms dose of Ovitrelle was as effective as the 500 micrograms dose.
Hos anovulatoriske kvinder iagttoges ægløsning hos 91, 9% af de kvinder, der blev behandlet med Ovitrelle.
In anovulatory women, ovulation was seen in 91.9% of women treated with Ovitrelle.
De hyppigste bivirkninger (som ses hos mellem 1 og 10 ud af hver 100 patienter) er reaktioner og smerte på indsprøjtningsstedet, hovedpine, træthed, opkast, kvalme, mavesmerter samt overstimulering af æggestokkene (med f. eks. kvalme, vægtøgning og diarré).
The most common side effects (seen in between 1 and 10 patients in 100) are a reaction or pain at the injection site, headache, tiredness, vomiting, nausea (feeling sick), abdominal (tummy) pain, and ovarian hyperstimulation syndrome (e. g. feeling sick, weight gain, diarrhoea).
Overstimulering af æggestokkene opstår, når æggestokkene overreagerer på behandlingen, især når der er anvendt ægløsningsstimulerende medicin.
Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment, especially when medicines to trigger ovulation have been used.
Ovitrelle bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for choriogonadotropin alfa eller andre af indholdsstofferne, eller til patienter med svulster i hypotalamus, hypofyse, ovarier, livmoder eller bryster.
Ovitrelle should not be used in people who may be hypersensitive (allergic) to choriogonadotropin alfa or any of the other ingredients, or in patients with tumours of the hypothalamus and pituitary gland, ovary, uterus or breast.
Det bør ikke anvendes, når der ikke kan opnås nogen virkning (som ved ovariesvigt).
It should not be used when a response cannot be obtained (such as in ovarian failure).
Det bør desuden ikke anvendes til kvinder med forstørrede ovarier, med ovariecyster der ikke skyldes polycystisk ovariesyndrom, med blødning fra skeden af ukendt årsag, eller hos kvinder med ekstrauterin graviditet inden for de foregående tre måneder.
It should not be used in women when there is ovarian enlargement or cyst not due to polycystic ovarian disease, or unexplained vaginal bleeding, or who have had an ectopic pregnancy in the previous 3 months.
Ovitrelle bør heller ikke anvendes til patienter med aktiv thromboembolisk sygdom.
Ovitrelle should also not be used in patients with active thrombo-embolic (clotting) disorders.
Hvorfor er Ovitrelle blevet godkendt?
Why has Ovitrelle been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Ovitrelle er større end risiciene for kvinder med behov for ovulation forud for fertilitetsbehandling og for kvinder, der er anovulatoriske eller oligo- ovulatoriske.
The Committee for Medicinal products for Human Use (CHMP) decided that Ovitrelle’ s benefits are greater than its risks for women who need to ovulate before fertility treatment and in women who are anovulatory or oligo-ovulatory.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Ovitrelle.
They recommended that Ovitrelle be given marketing authorisation.
Andre oplysninger om Ovitrelle:
Other information about Ovitrelle:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ovitrelle til Serono Europe Limited den 2. februar 2001.
The European Commission granted a marketing authorisation valid throughout the European Union, for Ovitrelle to Serono Europe Limited on 2 February 2001.
Denne tilladelse blev fornyet den 2. februar 2006.
The marketing authorisation was renewed on 2 February 2006.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for Ovitrelle kan ses i sin helhed her.
The full EPAR for Ovitrelle is available here.
(glas)
Powder: vial (glass) Solvent: ampoule (glass)
250µg, solvens:
250 micrograms Solvent:
250 mikrogram
250 micrograms Powder and solvent for solution for injection
2 hætteglas + 2 ampuller
2 vials + 2 ampoules
(glas)
Powder: vial (glass) Solvent: vial (glass)
2 hætteglas + 2 hætteglas
2 vials + 2 vials
Injektionsvæske, opløsning
250 micrograms/ Solution for injection 0.5 ml
fyldt injekstions - sprøjte (glas)
Pre-filled syringe (glass)
Ovitrelle 250 mikrogram pulver og solvens til injektionsvæske, opløsning.
Ovitrelle 250 micrograms powder and solvent for solution for injection
For at sikre en leveret dosis af 250 mikrogram, indeholder hvert hætteglas 285 mikrogram choriogonadotropin alfa.
To ensure delivery of a 250 microgram dose, each vial contains 285 micrograms of choriogonadotropin alfa.
Choriongonadotropin alfa produceres ved rekombinant DNA- teknologi i ovarieceller fra kinesiske hamster.
Choriogonadotropin alfa is produced by recombinant DNA technology in Chinese Hamster Ovary cells.
En 250 mikrogram dosis svarer til cirka 6500 IU.
A dose of 250 micrograms is equivalent to approximately 6500 IU.
30 mg saccharose
30 mg sucrose
Pulverets udseende: hvidt til grålighvidt frysetørret pulver Solvensens udseende: klar farveløs væske
Clear colourless solution
Den færdige opløsning har en pH på 6, 5 – 7, 5.
The pH of the reconstituted solution is 6.5 – 7.5
Ovitrelle anvendes til behandling af
Ovitrelle is indicated in the treatment of:
Kvinder, der gennemgår superovulation med henblik på assisteret befrugtning, fx IVF (In Vitro Fertilisering):
Women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF):
Ovitrelle gives for at fremkalde afsluttende follikelmodning og luteinisering efter follikelstimulation.
Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth.
Anovulatoriske eller oligo- ovulatoriske kvinder:
Anovulatory or oligo-ovulatory women:
Ovitrelle gives for at fremkalde ægløsning og luteinisering hos anovulatoriske eller oligo- ovulatoriske patienter efter follikelstimulation.
Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth
Ovitrelle er beregnet til subkutan anvendelse.
Ovitrelle is intended for subcutaneous administration.
Pulveret skal opløses umiddelbart før brug i den medfølgende solvens.
The powder should be reconstituted immediately prior to use with the solvent provided.
Følgende dosering bør anvendes:
The following dosing regimen should be used:
Et hætteglas Ovitrelle (250 mikrogram) indgives 24 til 48 timer efter den sidste injektion af et FSH - eller hMG præparat, dvs. når optimal follikelstimulation er opnået.
One vial of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of an FSH- or hMG preparation, i. e. when optimal stimulation of follicular growth is achieved.
2 Anovulatoriske eller oligo- ovulatoriske kvinder:
2 Anovulatory or oligo-ovulatory women:
Et hætteglas Ovitrelle (250 mikrogram) indgives 24 til 48 timer efter at optimal follikelstimulation er opnået.
One vial of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved.
• Tumorer i hypotalamus eller hypofyse • Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne • Ovarieforstørrelse eller cyste, som ikke skyldes polycystisk ovariesyndrom • Gynækologiske blødninger af ukendt ætiologi • Ovarie -, uterus - eller mammakarcinom • Ekstrauterin graviditet inden for de seneste tre måneder • Aktiv tromboembolisk sygdom
Ovitrelle is contraindicated for safety reasons in case of: • Tumours of the hypothalamus and pituitary gland • Hypersensitivity to the active substance or to any of the excipients • Ovarian enlargement or cyst due to reasons other than polycystic ovarian disease • Gynaecological haemorrhages of unknown aetiology • Ovarian, uterine or mammary carcinoma • Extrauterine pregnancy in the previous 3 months • Active thrombo-embolic disorders
• Primært ovariesvigt • Gonademisdannelse, der er uforenelig med graviditet • Fibromer i uterus, der er uforenelige med graviditet • Post- klimakterielle kvinder
Ovitrelle must not be used when an effective response cannot be obtained, for example: • Primary ovarian failure • Malformations of sexual organs incompatible with pregnancy • Fibroid tumours of the uterus incompatible with pregnancy • Postmenopausal women
Til dags dato er der ikke nogen klinisk erfaring med Ovitrelle ved andre indikationer, der normalt behandles med urinderiveret humant choriogonadotropin.
To date, there is no clinical experience with Ovitrelle in other indications commonly treated with urine derived human chorionic gonadotrophin.
Før behandlingen påbegyndes, bør parrets infertilitet vurderes,, og formodede kontraindikationer for graviditet skal evalueres.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Der bør tages særlige forholdsregler, før der gives Ovitrelle til patienter med klinisk signifikante systemiske lidelser, som kan forværres af graviditet.
Special precautions should be taken before administering Ovitrelle to patients with clinically significant systemic disease where pregnancy could lead to a worsening of the condition.
Patienter, som modtager ovariestimulation, har en øget risiko for at udvikle ovariehyperstimulationssyndrom (OHSS) forårsaget af multipel follikeludvikling.
Patients undergoing ovarian stimulation are at an increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to multiple follicular development
Ovariehyperstimulationssyndrom (OHSS) kan udvikle sig til en alvorlig medicinsk tilstand karakteriseret ved store ovariecyster, som let brister, samt forekomst af ascites som følge af kredsløbsforstyrrelse.
Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts which are prone to rupture and the presence of ascites within a clinical picture of circulatory dysfunction.
Hyperstimulationssyndrom på grund af ekscessiv ovarierespons kan undgås ved at seponere behandling med hCG; patienten rådes til at undgå coitus eller anvende barrieremetoder i mindst 4 døgn.
Patients should be advised to refrain from coitus or use barrier methods for at least 4 days.
Omhyggelig monitorering af østradiolniveau og ovarierespons ved hjælp af ultralyd anbefales for alle patienter før og under stimulationsbehandling.
Careful monitoring of estradiol levels and ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, for all patients.
Risikoen for flerfolds graviditet ved assisteret befrugtning er relateret til antallet af embryoner, der lægges tilbage.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of embryos replaced.
Hos patienter, som gennemgår ovulationsinduktion, ses en øget hyppighed af flerfolds graviditeter og flerfolds fødsler (oftest tvillinger) sammenlignet med naturlig befrugtning.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births (mostly twins) is increased compared with natural conception.
For at minimere risikoen for OHSS eller flerfold graviditet anbefales ultralydsskanninger og østradiolmålinger.
To minimise the risk of OHSS and of multiple pregnancy, ultrasound scans as well as estradiol measurements are recommended.
Ved anovulation er risikoen for OHSS forøget ved en serumøstradiol > 1500 pg/ ml (5400 pmol/ l) og ved flere end 3 follikler med en diameter på 14 mm eller derover.
In anovulation, the risk of OHSS is increased by a serum estradiol level > 1500 pg/ ml (5400 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
Ved assisteret befrugtning er risikoen for OHSS forøget ved en serumøstradiol > 3000 pg/ ml (11000 pmol/ l) og ved 20 eller flere follikler med en diameter på 12 mm eller derover.
In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol > 3000 pg/ ml (11000 pmol/ l) and 20 or more follicles of 12 mm or more in diameter.
Ved et østradiolniveau på > 5500
When the estradiol level is
3 pg/ ml (20000 pmol/ l) og hvor der er 40 eller flere follikler i alt, kan det være påkrævet at seponere behandlingen med hCG.
3 > 5500 pg/ ml (20000 pmol/ l) and when there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Alvorlig ovariehyperstimulationssyndrom kan i sjældne tilfælde kompliceres af hæmoperitonium, akut pulmonelt besvær, ovarie torsion og tromboembolisme.
Severe ovarian hyperstimulation syndrome could be complicated in rare cases by haemoperitoneum, acute pulmonary distress, ovarian torsion, and thromboembolism.
Overholdelse af anbefalingerne vedrørende dosering og administrationsregime for Ovitrelle samt omhyggelig monitorering af behandlingen reducerer forekomsten af hyperstimulation og flerfold graviditet til et minimum.
Adherence to recommended Ovitrelle dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy.
Den kliniske betydning er ukendt.
During Ovitrelle therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Kun patienter, som har modtaget tilstrækkelig instruktion, og som har adgang til eksperthjælp, bør selvadministrere Ovitrelle.
Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Specifikke interaktionsstudier med Ovitrelle og andre lægemidler er ikke udført, dog er der ikke indberettet kliniske signifikante interaktioner med andre lægemidler i forbindelse med hCG - behandling.
No specific interaction studies with Ovitrelle and other medicines have been performed however no clinically significant drug interactions have been reported during hCG therapy.
Ovitrelle kan påvirke måling af serum/ urin- baseret hCG op til ti dage efter injektion og medføre en falsk positiv graviditetstest.
Following administration, Ovitrelle may interfere for up to ten days with the immunological determination of serum / urinary hCG, leading to a false positive pregnancy test.
I betragtning af indikationen, bør man ikke bruge Ovitrelle ved graviditet og amning.
Considering the indication, Ovitrelle should not be administered during pregnancy and lactation.
Der forefindes ikke nogle kliniske data i forbindelse med graviditet.
No clinical data on exposed pregnancies are available.
(se sektion 5. 3).
No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3).
Der forefindes ikke nogle data vedrørende udskillelse af choriongonadotropin i modermælk.
There are no data on the excretion of choriogonadotropin alfa in milk.
Ovariehyperstimulationssyndrom samt opkastning og kvalme.
In comparative trials with different doses of Ovitrelle, the following undesirable effects were found to be associated with Ovitrelle in a dose-related fashion: ovarian hyperstimulation syndrome, and vomiting and nausea.
4% af de patienter, som blev behandlet med Ovitrelle.
Ovarian hyperstimulation syndrome was observed in approximately 4% of patients treated with Ovitrelle.
Alvorlige tilfælde af hyperstimulationssyndrom blev rapporteret hos færre end 0, 5% af patienterne (se sektion 4. 4).
Severe ovarian hyperstimulation syndrome was reported in less than 0.5% patients (see section 4.4).
I sjældne tilfælde er der fundet sammenhæng mellem tromboembolismer og menotrophin/ hCG - behandling.
In rare instances, thromboembolisms have been associated with menotrophin/ hCG therapy.
Selvom denne bivirkning ikke er observeret for Ovitrelle, er der en mulighed for, at det også kan forekomme med Ovitrelle behandling.
Although this adverse event was not observed, there is the possibility that this may also occur with Ovitrelle.
Disse anses for at være ledsagende omstændigheder, der er relateret til behandling med assisteret befrugtning.
These are considered concomitant effects related to Assisted Reproductive Technologies (ART).
4 Efter bedste vurdering af data er følgende bivirkninger observeret efter injektion af Ovitrelle.
After best evidence assessment, the following undesirable effects may be observed after administration of Ovitrelle.
Almindelig (> 1/ 100, < 1/ 10) Gastrointestinale sygdomme:
4 Common (> 1/ 100, < 1/ 10) Gastrointestinal disorders:
Opkastning/ kvalme, mavesmerter Lidelser i det reproduktive system og brystsygdomme:
Vomiting/ nausea, abdominal pain Reproductive system and breast disorders:
Mildt eller moderat ovariehyperstimulationssyndrom Almene lidelser og reaktioner på indgivelsesstedet:
Mild or moderate ovarian hyperstimulation syndrome General disorders and administration site conditions:
Hovedpine, træthed, lokal reaktion/ ømhed ved injektionsstedet
Headache, tiredness, local reaction/ pain at injection site.
Usædvanlig (> 1/ 1000, < 1/ 100) Psykiske lidelser:
Uncommon (> 1/ 1,000, < 1/ 100) Psychiatric disorders:
Depression, irritabilitet, rastløshed Gastrointestinale sygdomme:
Depression, irritability, restlessness Gastrointestinal disorders:
Diarre Lidelser i det reproduktive system og brystsygdomme:
Diarrhoea Reproductive system and breast disorders:
Alvorligt hyperstimulationssyndrom, brystsmerter
Severe ovarian hyperstimulation syndrome, Breast pain
Allergiske reaktioner Sygdomme i hud og subkutane væv:
Very rare (< 1/ 10,000) Immune system disorders: allergic reactions Skin and subcutaneous tissue disorders:
Milde reversible hudreaktioner der manifestere sig ved udslæt.
Mild reversible skin reactions manifesting as rash,
Ikke desto mindre er der en mulighed for, at overdosering kan medføre hyperstimulationssyndrom (OHSS) (se punkt 4. 4)
Nevertheless, there is a possibility that ovarian hyperstimulation syndrome (OHSS) may result from an overdosage of Ovitrelle (see section 4.4).
Farmakoterapeutisk klassifikation: gonadotropiner, ATC kode:
Pharmacotherapeutic group: gonadotropins, ATC code:
Ovitrelle er et lægemiddel, der indeholder choriogonadotropin alfa, der er fremstillet ved hjælp af rekombinant DNA- teknologi.
Ovitrelle is a medicinal product of choriogonadotropin alfa produced by recombinant DNA techniques.
Choriogonadotropin binder til ovarielle theca - (og granulosa -) celler til en transmembran- receptor, der deles med det luteiniserende hormon, LH/ CG- receptoren.
Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/ CG receptor.
Hos kvinder er den primære farmakodynamiske aktivitet genoptagelse af oocyt- meiose, follikel- ruptur (ovulation), dannelse af corpus luteum og produktion af progesteron og østradiol via corpus luteum.
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
Hos kvinder har choriogonadotropin samme effekt som en pludselig LH- stigning der fremkalder ovulation.
In women, Chorionic gonadotropin acts as a surrogate LH- surge that triggers ovulation.
Sammenlignende kliniske afprøvninger viser at en dosis 250 mikrogram Ovitrelle er lige effektiv som 5000 IE og 10000 IE af urin- hCG for at inducere afsluttende follikel modning og tidlig luteinisering ved assisteret befrugtning og lige så effektiv som 5000 IU urin- hCG ved ovulations induktion.
In comparative clinical trials, administration of a dose of 250 micrograms of Ovitrelle was as effective as 5000 IU and 10000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive techniques, and as effective as 5000 IU of urinary hCG in ovulation induction.
Efter intravenøs injektion fordeles choriogonadotropin alfa i den ekstracellulære væske; distributions - halveringstiden er ca.
Following intravenous administration, choriogonadotropin alfa is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours.
6 l og 0, 2 l/ t.
The steady-state volume of distribution and the total clearance are 6 l and 0.2 l/ h, respectively.
Der forefindes intet tegn på at choriogonadotropin alfa metaboliseres og udsøndres anderledes end endogent hCG.
There are no indications that choriogonadotropin alfa is metabolised and excreted differently than endogenous hCG.
40%.
5 Following subcutaneous administration, choriogonadotropin alfa is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
De ikke- kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og toksicitet i forbindelse med reproduktion. Der er ikke udført undersøgelser af det karcinogene potentiale.
Studies on carcinogenic potential were not performed.
Dette er begrundet da det aktive stof er et protein, og da resultaterne af genotoksicitets- tests var negative.
This is justified, given the proteinous nature of the active substance and the negative outcome of the genotoxicity testing.
Saccharose Fosforsyre, koncentreret Natriumhydroxid
Sucrose Phosphoric acid, concentrated Sodium hydroxide
Anvendes straks efter åbning og opløsning.
For immediate and single use following first opening and reconstitution.
Opbevares i den originale ydrepakning.
Store in the original package.
Pulveret er pakket i neutralt, farveløst (type 1, Ph. Eur.) hætteglas med en bromobutyl gummiprop.
Eur.) glass vial with a bromobutyl rubber stopper.
Solvensen er pakket i neutralt, farveløst type 1 hætteglas med en bromobutyl gummiprop eller i neutral, farveløs glas type 1 ampul.
The solvent container is a neutral, colourless glass type 1 vial with a bromobutyl rubber stopper or a neutral, colourless glass type 1 ampoule.
Produktet leveres i pakninger a 1, 2 eller 10 hætteglas med et tilsvarende antal solvensbeholdere.
The product is supplied in packs of 1, 2, 10 vials with the corresponding number of solvent containers.
6 Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Not all pack sizes may be marketed.
6. 6 Særlige forholdsregler ved bortskaffelse
6 6.6 Special precautions for disposal
Ovitrelle er udelukkende til engangsbrug.
Ovitrelle is for single use only.
Et hætteglas Ovitrelle blandes med 1 ml solvens før brug.
One vial of Ovitrelle can be reconstituted with 1 ml of the solvent before use.
Den opløste væske må ikke anvendes, hvis den indeholder partikler eller er uklar.
The reconstituted solution should not be administered if it contains particles or is not clear.
Ikke anvendt lægemiddel samt affald heraf bør bortskaffes i overensstemmelse med lokale regler.
Any unused product or waste material should be disposed of in accordance with local requirements.
Serono Europe Limited 56, Marsh Wall London E14 9TP Storbritannien
Serono Europe Limited 56, Marsh Wall London E14 9TP United Kingdom
2. februar 2001 Dato for fornyelse:
2 February 2001 Date of last renewal:
Ovitrelle 250 mikrogram/ 0, 5 ml, injektionsvæske, opløsning i en fyldt injektionssprøjte.
Ovitrelle 250 micrograms/ 0.5 ml, solution for injection in a pre-filled syringe
Choriogonadotropin alfa * 250 mikrogram per 0, 5 ml.
Choriogonadotropin alfa* 250 micrograms in 0.5 ml.
(svarer til cirka 6500 IE.) Hjælpestoffer:
(equivalent to approximately 6500 IU)
27, 3 mannitol, 0, 05 mg poloxamer 188, 0, 1 mg L- methionin
27.3 mg mannitol, 0.05 mg poloxamer 188, 0.1 mg L-methionine
* Fremstillet efter rekombinant DNA- teknologi i ovarieceller fra kinesiske hamster.
Produced by recombinant DNA technology in CHO
Injektionsvæske, opløsning i fyldt injektionssprøjte.
Solution for injection
Opløsningen har en pH på 6, 5 – 7, 5 og osmolaritet på 250- 400 mOsm/ L.
The pH of the solution is 7.0 ± 0.3, its osmolarity 250-400 mOsm/ L