natgillin/translations-raw huggingface dataset:
Der er i toksicitetsforsøg med enkeltdoser og gentagne doser på ≥ 0,3 ml/kg til rotter og aber set abnorm vejrtrækning, ændringer i hjertefrekvens samt nedsat aktivitet umiddelbart efter intravenøs injektion af Luminity.
Abnormal respiration, heart rate changes and decreased activity were observed soon after intravenous injection of Luminity at doses ≥ 0.3 ml/kg in single and repeat-dose toxicity studies in rats and monkeys.
Ikke almindelig: Svimmelhed, dysgeusia Sjælden: Paræstesier
Uncommon: Dizziness, dysgeusia
Luminity indsprøjtes derefter i en vene enten som en ”bolusinjektion” (hvor alt lægemiddel indsprøjtes på en gang) eller som en infusion (drop) efter fortynding med natriumklorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
Luminity is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion (drip solution) after being diluted with sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
- Luminity kan fortyndes med natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller glucose 50 mg/ml (5 %) opløsning til injektion.
- Luminity may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection.
Inden administration skal Luminity aktiveres i et mekanisk rysteudstyr, Vialmixeren (se pkt.
Before administering Luminity, the medicinal product must be activated by using a mechanical shaking device, the Vialmix, see section 6.6.
• bevidstløshed,
• loss of consiousness,
Hver ml indeholder maksimalt 6,4 x 109 perflutrenholdige lipidmikrosfærer med en gennemsnitlig diameter på 1,1-2,5 mikrometer (μm).
Each ml contains a maximum of 6.4 x 109 perflutren-containing lipid microspheres, with a mean diameter range of 1.1-2.5 micrometres (μm).
Anbefalet dosis er 10 mikroliter dispersion/kg ved langsom intravenøs bolusinjektion, efterfulgt af en 10 ml bolusdosis natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
The recommended dose is 10 microlitre dispersion/kg by slow bolus intravenous injection, followed by a 10 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Luminity 150 mikroliter/ml gas og solvens til injektions-/infusionsvæske, dispersion perflutren
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion perflutren
Anbefalet dosis via intravenøs infusion er 1,3 ml dispersion i tillæg til 50 ml natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion.
The recommended dose via an intravenous infusion is 1.3 ml dispersion added to 50 ml of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Ikke kendt: Respirationsstop, nedsat iltning, hypoksi Mave-tarm-kanalen sygdomme Ikke almindelig: Abdominalsmerter, diarré, kvalme, opkastning Sjælden: Dyspepsi
Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia, Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting,
Luminity 150 mikroliter/ml gas og solvens til injektions-/infusionsvæske, dispersion
Luminity 150 microlitres/ml gas and solvent for dispersion for injection/infusion
Patienter med hjerteshunt
Patients with hepatic impairment
Indholdet af hætteglasset er beregnet som enkeltdosis.
The contents of the vial are intended for single use only.
• Ledsmerter, sidestik, nakkesmerter, muskelkramper, feber, muskelstivhed og
• joint pain, pain on the side(s), neck pain, muscle cramp, fever, muscle stiffness
Hjerte sygdomme
Pulmonary disease
Inden aktivering (omrystning), opbevares i køleskab (2 ºC-8 ºC).
Do not use Luminity after the expiry date which is stated on the carton and label after EXP. Before activation (shaking), store in a refrigerator (2°C - 8°C).
Nedsat leverfunktion Farmakokinetik er ikke blevet specifikt undersøgt hos patienter med leversygdom.
Hepatic impairment Pharmacokinetics has not been specifically studied in the hepatic disease patients.
Øjne sygdomme
Eye disorders
Sjælden: Pyreksi, kulderystelser
Rare: Bradycardia, Tachycardia, Palpitations
Luminity er ikke blevet specifikt undersøgt hos patienter med nedsat nyrefunktion.
Luminity has not been specifically studied in patients with renal impairment.
Nedsat nyrefunktion Farmakokinetik er ikke blevet specifikt undersøgt hos patienter med nyresygdom.
Renal impairment Pharmacokinetics has not been specifically studied in the renal disease patients.
• Vejrtrækningsbesvær, halsirritation,
• difficulty in breathing, throat irritation,
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholin (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidsyre, mononatriumsalt (DPPA) N-(methoxypolyethylenglycol
1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC) 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA) N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE) Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate heptahydrate Sodium chloride
• Vejrtrækningsbesvær, hoste, tør hals, synkebesvær
• breathing problems, cough, dry throat, difficulty in swallowing,
• Kløe
Posology
• unormalt syn
• and abnormal vision.
5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE), natriumdihydrogenphosphat monohydrat, dinatrium hydrogenphosphatheptahydrat, natriumchlorid, propylenglycol, glycerol, vand til injektionsvæsker
Excipients: 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2-dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol, water for injections
Anbefalet dosis er gentagne injektioner på 0,1-0,4 ml dispersion, efterfulgt af en 3-5 ml bolusdosis af natriumchlorid 9 mg/ml (0,9 %) eller glucose 50 mg/ml (5 %) opløsning til injektion for at opretholde en optimal kontrastforstærkning.
Bolus intravenous injection using non-linear contrast imaging technique at rest and stress: The recommended dose is multiple injections of 0.1 to 0.4 ml of dispersion, followed by a 3 to 5 ml bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement.
5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamin, mononatriumsalt (MPEG5000 DPPE), natriumdihydrogenphosphat monohydrat, dinatrium hydrogenphosphatheptahydrat, natriumchlorid, propylenglycol, glycerol, vand til injektionsvæsker.
- The other ingredients are 1,2-dipalmitoyl-sn-glycero-3-phosphatidylcholine (DPPC), 1,2dipalmitoyl-sn-glycero-3-phosphatidic acid, monosodium salt (DPPA), N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine, monosodium salt (MPEG5000 DPPE), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, propylene glycol, glycerol and water for injections.
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
- If you have any further questions, ask your doctor, pharmacist or nurse.
Ikke almindelig: Dyspnø, halsirritation
Uncommon: Dyspnoea, Throat Irritation
Almindelig: Hovedpine
Nervous system disorders Common: Headache
(Ved suboptimalt resultat forstås i denne forbindelse at det ikke har været muligt at evaluere ventrikelvæggens afgrænsning i 2 eller flere ud af 6 segmenter i 4eller 2- kammerbilledet).
Luminity is an ultrasound contrast-enhancing agent for use in adult patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.
Liste over bivirkninger, i tabelform
Tabulated list of adverse reactions
Luminity må ikke gives ved administrationsmåder, der ikke er specificerede i pkt.
Administration and mechanical activation procedure Luminity should not be administered by methods not specified in section 4.2 (e.g. intra-arterial injection).
Indgivelse og mekanisk aktiveringsprocedure
Patients on mechanical ventilation
Ikke almindelig: Brystsmerter, træthed, varmefølelse, smerter ved injektionsstedet
Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors
Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) Hovedpine, ansigtsrødme.
Common side effects (may affect up to 1 in 10 people)
• Rygsmerter, brystsmerter
• back pain, chest pain,
• Voldsom træthed
• peripheral coldness,
Knogler, led, muskler og bindevæv sygdomme
Musculoskeletal and connective tissue disorders
Den anbefalede dosis er 500 mg én gang om måneden med en ekstra dosis på 500 mg to uger efter den første dosis.
The recommended dose is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose.
Den fuldstændige EPAR for Fulvestrant Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Fulvestrant Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dosen gives som to injektioner, en i hver af sædemusklerne over ét til to minutter.
The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fulvestrant Mylan.
This is a summary of the European public assessment report (EPAR) for Fulvestrant Mylan.
Fulvestrant Mylan er et antiøstrogent middel til behandling af fremskreden eller metastatisk brystkræft (kræft, der har spredt sig til andre dele af kroppen) hos kvinder efter overgangsalderen med en type brystkræft kaldet "østrogenreceptor-positiv kræft", der ikke tidligere har fået hormonbehandling, eller hvis kræft er vendt efter behandling med et andet antiøstrogent middel.
Fulvestrant Mylan is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in postmenopausal women with a type of breast cancer known as ‘oestrogen-receptor positive cancer' who have not previously had hormonal treatment, or whose cancer had come back after treatment with another anti-oestrogen.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Fulvestrant Mylan er sammenligneligt med Faslodex.
The European Medicines Agency concluded that, in accordance with EU requirements, Fulvestrant Mylan has been shown to be comparable to Faslodex.
De fleste typer brystkræft stimuleres til at vokse, når hormonet østrogen binder til mål (receptorer) på kræftcellerne.
Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells.
Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Fulvestrant Mylan.
As for every medicine, the company provided studies on the quality of Fulvestrant Mylan.
Det blokerer receptorerne for østrogen på cellerne og medfører et fald i antallet af østrogenreceptorer.
It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall.
Det betyder, at Fulvestrant Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Faslodex.
This means that Fulvestrant Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Faslodex.
Fulvestrant Mylan er et "generisk lægemiddel".
Fulvestrant Mylan is a ‘generic medicine'.
Agenturet anbefalede, at Fulvestrant Mylan godkendes til anvendelse i EU.
The Agency recommended that Fulvestrant Mylan be approved for use in the EU.
Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Faslodex, og det er ikke nødvendigt at gentage disse for Fulvestrant Mylan.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Faslodex, and do not need to be repeated for Fulvestrant Mylan.
Dette skyldes, at sammensætningen af Fulvestrant Mylan er den samme som referencelægemidlets, og når det indgives ved injektion i musklen, forventes det aktive stof i begge lægemidler at blive absorberet på samme måde.
This is because the composition of Fulvestrant Mylan is the same as the reference medicine and when given by injection into the muscle, the active substance in both products is expected to be absorbed in the same way.
Der var ikke behov for "bioækvivalensundersøgelser" af, om Fulvestrant Mylan absorberes på samme måde som referencelægemidlet for at producere den samme mængde af det aktive stof i blodet.
There was no need for ‘bioequivalence' studies to investigate whether Fulvestrant Mylan is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Dette medfører, at kræftcellerne ikke stimuleres af østrogen, og dermed reduceres væksten af tumoren.
As a result, the cancer cells are not stimulated to grow by oestrogen and this slows down the growth of the tumour.
Fulvestrant Mylan indeholder det aktive stof fulvestrant.
Fulvestrant Mylan contains the active substance fulvestrant.
Andre oplysninger om Fulvestrant Mylan
Other information about Fulvestrant Mylan
Det aktive stof i Fulvestrant Mylan, fulvestrant, er et antiøstrogen.
The active substance in Fulvestrant Mylan, fulvestrant, is an antioestrogen.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fulvestrant Mylan?
What measures are being taken to ensure the safe and effective use of Fulvestrant Mylan?
Hvilke fordele og risici er der forbundet med Fulvestrant Mylan?
What are the benefits and risks of Fulvestrant Mylan?
Hvis du ønsker yderligere oplysninger om behandling med Fulvestrant Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Fulvestrant Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da Fulvestrant Mylan er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Fulvestrant Mylan is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Fulvestrant Mylan udleveres kun efter recept og fås som en injektionsvæske, opløsning, i fyldte sprøjter (250 mg).
Fulvestrant Mylan can only be obtained with a prescription and is available as a solution for injection in prefilled syringes (250 mg).
Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Faslodex.
Therefore, the Agency's view was that, as for Faslodex, the benefit outweighs the identified risk.
Det er ikke en praktisk vejledning i, hvordan Fulvestrant Mylan bør anvendes.
It is not intended to provide practical advice on how to use Fulvestrant Mylan.
Hvad er Fulvestrant Mylan, og hvad anvendes det til?
What is Fulvestrant Mylan and what is it used for?
Hvis du ønsker praktisk vejledning om anvendelsen af Fulvestrant Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Fulvestrant Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor blev Fulvestrant Mylan godkendt?
Why is Fulvestrant Mylan approved?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fulvestrant Mylan.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fulvestrant Mylan have been included in the summary of product characteristics and the package leaflet.
Hvordan blev Fulvestrant Mylan undersøgt?
How has Fulvestrant Mylan been studied?
Hvordan anvendes Fulvestrant Mylan?
How is Fulvestrant Mylan used?
Hvordan virker Fulvestrant Mylan?
How does Fulvestrant Mylan work?
MF (EU)-nummer (Særnavn)
MA (EU) number (Invented) name
Fyldt injektionssprøjte 1 fyldt injektionssprøjte
Solution for injection Subcutaneous use pre-filled syringe 1 pre-filled syringe
Det absorberes også godt ad oral vej.
It is also well absorbed by the oral route.
Hyppigheden er ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The frequencies are not known (cannot be estimated from the available data).
Alternative behandlingsmuligheder bør overvejes.
Alternative treatment options should be considered.
Dato for første markedsføringstilladelse: 6 maj 2011 Dato for seneste fornyelse: 8 februar 2016
Date of first authorisation: 06 May 2011 Date of latest renewal: 08 February 2016
Om nødvendigt kan der gives endnu en dosis efter en time.
A second dose may be given after one hour if required.
Der kan være behov for lavere doser (<1 mg/kg).
Lower doses (<1 mg/kg) may be needed.
I rotter er der observeret øgede resorptionsrater.
In rats, increased resorption rates have been observed.
Case-rapporter om virkningen findes også i litteraturen.
Case reports of efficacy are also available in literature.
Hvis lægemidlet ikke anvendes omgående, er opbevaringstid- og forhold brugerens ansvar.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Disse symptomer forsvinder normalt i løbet af 2 til 12 timer efter injektionen.
These features resolve generally within 2-12 hours of the injection.
Toksicitet ved gentagen dosis i en måned hos hunde viste ingen makroskopiske toksiske virkninger.
One-month repeated dose toxicity in dogs showed no macroscopic toxic effects.
Forberedelse til intravenøs administration
Preparation for intravenous administration
Dosisjustering er ikke påkrævet.
No dose adjustment is necessary.
Misfarvningen er forventelig og vil forsvinde efter behandlingens ophør.
This discolouration is expected and will disappear after the treatment has ended
Når hyppigheden er angivet, er den baseret på en meget lille stikprøvestørrelse.
When indicated, the frequency is based on a very small sample size.
Behandlingen bør normalt ikke vare mere end en dag.
Usually, treatment should not exceed one day.
Dette lægemiddel vil hjælpe dit hæmoglobin til at vende til normalen og genoprette transporten af ilt i blodet.
This medicine will help your haemoglobin return to normal and restore the transport of oxygen in the blood.
Fototoksicitet/fotosensitivitet
Phototoxicity / Photosensitivity
Patienten bør holdes under observation, methæmoglobinniveauet bør kontrolleres, og der bør træffes passende understøttende foranstaltninger efter behov.
The patient should be maintained under observation, the methaemoglobin level should be monitored and appropriate supportive measures taken as necessary.
Farmakoterapeutisk klassifikation: Alle andre behandlingsprodukter, modgifte, ATC-kode: V03AB17
Pharmacotherapeutic group: All other therapeutic products, antidotes, ATC code: V03AB17
Behandlingen varer normalt ikke mere end en dag.
Treatment does not usually exceed one day.
Det anbefales, at de parenterale opløsninger kontrolleres før indgivelse for at sikre, at de er fri for partikler.
Before any administration, it is recommended to inspect the parenteral solutions to verify that they are free of particles.
• Overfølsomhed over for det aktive stof eller over for andre thiazinfarvestoffer
• Hypersensitivity to the active substance, or to any other thiazine dyes
Lægen eller sundhedspersonalet kontrollerer, at udløbsdatoen på mærkaten ikke er overskredet, før du får injektionen.
The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you.
Kun indberettet for spædbørn
Reported in infants only
I rotter og kaniner er der indberettet teratogene virkninger med føtal og maternel toksicitet.
In rats and rabbits, teratogenic effects have been reported, with foetal and maternal toxicity.
Risikoen er dog begrænset, da lægemidlet er beregnet til akut indgivelse i nødsituationer på hospitaler.
However, the risk is limited as the medicinal product is intended for acute administration only in emergency situations at hospital.
Lægen injicerer dette lægemiddel i en vene (intravenøst) langsomt over et tidsrum på 5 minutter.
Your doctor will inject this medicine into a vein (intravenously) slowly over a period of 5 minutes.
Der foreligger ikke tilstrækkelige data til støtte for en anbefaling om en løbende infusionsdosis.
Too limited data are available to support a continuous infusion dose recommendation.
For instruktioner om håndtering og fortynding af lægemidlet før administration, se pkt.
For instructions on handling and dilution of the medicinal product before administration, see section 6.6.
Der skal tages forholdsregler, der beskytter mod lys.
Protective measures against exposure to light should be taken.
Det må ikke indgives ved subkutan eller intratekal injektion.
It must not be administered by subcutaneous or intrathecal injection.
Ampullen opbevares i den originale yderpakning for at beskytte mod lys.
Keep the ampoule in the original package in order to protect from light.
Begge spædbørn havde komplekse medicinske lidelser, og methylthioniniumchlorid var kun delvis ansvarlig.
Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible.
Størstedelen af dosen udskilles via urinen, normalt i form af leucomethylthioniniumchlorid.
The majority of the dose is excreted in the urine, usually in the form of leucomethylthioninium chloride.
Spædbørn over 3 måneder, børn og unge: Samme dosering som for voksne.
Infants above 3 months, children and adolescents: Same posology as for adults.
Voksne, børn over 3 måneder og ældre
Adults, children above 3 months and elderly
Efter åbning eller fortynding: Fra et mikrobiologisk synspunkt skal produktet anvendes omgående, medmindre åbningsmetoden/fortyndingsmetoden udelukker risikoen for mikrobiel kontamination.
After opening or dilution: From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product must be used immediately.
Lavere doser bør derfor overvejes, og den samlede kumulative dosis bør ikke overstige 4 mg/kg.
Lower doses should therefore be considered and total cumulative dose should not exceed 4 mg/kg.
Lægemidlet skal anvendes umiddelbart efter åbning eller opløsning.
The medicine must be used immediately after opening or dilution.
Den kliniske konsekvens er ukendt.
The clinical consequence is not known.
Toksicitet ved gentagen dosis
Repeated dose toxicity
fluvoxamin, paroxetin, sertralin og zimelidin
fluvoxamine, paroxetine, sertraline and zimelidine
Ved methæmoglobinæmi indeholder dit blod for meget methæmoglobin (en unormal form af hæmoglobin, der ikke kan transportere ilt rundt i din krop effektivt).
In methaemoglobinaemia, your blood contains too much methaemoglobin (an abnormal form of haemoglobin that is not able to transport oxygen around your body effectively).
Det har også vist sig at hæmme væksten af dyrkede tocellede museembryoer og produktionen af progesteron i dyrkede luteale menneskeceller.
It has also been shown to inhibit the growth of cultured two-cell mouse embryos and the production of progesterone in cultured human luteal cells.
Kun til engangsbrug Eventuel resterende opløsning i ampullerne skal kasseres.
For single use only Any solution remaining in the opened ampoules must be discarded.
Indehaver af markedsføringstilladelsen Provepharm SAS
Marketing Authorisation Holder Provepharm SAS
Den maksimale anbefalede kumulative dosis for hele behandlingsforløbet er på 7 mg/kg.
The maximum recommended cumulative dose for the course of treatment is 7 mg/kg.