natgillin/translations-raw huggingface dataset:
Der er i randomiserede, kontrollerede forsøg ikke vist kardiovaskulære fordele ved kontinuerlig behandling med kombineret, konjugeret østrogen og medroxyprogesteronacetat (MPA).
Coronary artery disease (CAD) There is no evidence from randomised controlled trials of cardiovascular benefit with continuous combined conjugated oestrogens and medroxyprogesterone acetate (MPA).
To store kliniske studier (WHI og HERS, som er Heart and Estrogen/ progestin Replacement Study) har vist en mulig øget risiko for kardiovaskulær morbiditet i det første behandlingsår og ingen generel fordel.
Heart and Estrogen/progestin Replacement Study) showed a possible increased risk of cardiovascular morbidity in the first year of use and no overall benefit.
For andre HRT- produkter er der kun begrænsede data fra randomiserede, kontrollerede forsøg, der undersøger effekten ved kardiovaskulær morbiditet og mortalitet.
For other HRT products there are only limited data from randomised controlled trials examining effects in cardiovascular morbidity or mortality.
Det er derfor usikkert, om resultaterne også gælder for andre HRT- produkter.
Therefore, it is uncertain whether these findings also extend to other HRT products.
Et stort randomiseret klinisk forsøg (WHI- studiet) viste som sekundært resultat en øget risiko for iskæmisk slagtilfælde hos raske kvinder i kontinuerlig behandling med kombineret, konjugeret østrogen og MPA.
Stroke One large randomised clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischaemic stroke in healthy women during treatment with continuous combined conjugated oestrogens and MPA.
1000 kvinder i alderen 60- 69 år.
For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5 year period is about 3 per 1000 women aged 50-59 years and 11 per 1000 women aged 60-69 years.
1000 kvinder i alderen 60- 69 år.
It is estimated that for women who use conjugated oestrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate = 1) per 1000 users aged 50-59 years and between 1 and 9 (best estimate = 4) per 1000 users aged 60-69 years.
Det er uvist, om den øgede risiko også omfatter andre HRT- produkter.
It is unknown whether the increased risk also extends to other HRT products.
Langtidsbehandling (mindst 5- 10 år) af hysterektomerede kvinder med østrogen alene har i nogle epidemiologiske studier været forbundet med en øget risiko for ovariecancer.
Ovarian cancer Long-term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies.
Det er uvist om langtidsbehandling med kombinerede HRT- produkter udgør en anden risiko end for rene østrogenprodukter.
It is uncertain whether long-term use of combined HRTs confers to a different risk than oestrogen-only products.
Østrogen kan forårsage væskeophobning, og patienter med kardial eller renal dysfunktion bør derfor overvåges nøje.
Other conditions Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
16 Kvinder med tidligere hypertriglyceridæmi bør følges nøje under østrogen - eller hormonsubstitutionsbehandling, da der er set sjældne tilfælde af massiv forhøjelse af plasmatriglycerider, som har medført pankreatitis i forbindelse med østrogenbehandling.
Women with pre-existing hypertriglyceridemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Østrogener øger thyroxinbindende globulin (TBG), hvilket medfører en øget totalmængde thyreoideahormon målt ved protein- bundet jodid (PBI), T4 niveauer (ved kolonne - eller radio - immunanalyse) eller T3 niveauer (radio- immunanalyse).
Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radio- immunoassay) or T3 levels (by radio-immunoassay).
T3- resinoptagelsen er nedsat, hvilket ses i det forhøjede TBG.
T3 resin uptake is decreased, reflecting the
Andre plasma proteiner kan være forhøjede (angiotensinogen/ renin substrat, alpha- I- antitrypsin, ceruloplasmin).
Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, and ceruloplasmin).
WHI- studiet viste nogen evidens for en øget risiko for mulig demens hos kvinder, som påbegyndte behandling med kontinuerlig, kombineret CEE og MPA efter 65 års alderen.
There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65.
Det er uvist, om resultatet kan overføres til yngre postmenopausale kvinder eller andre HRT- produkter.
It is unknown whether the findings apply to younger post- menopausal women or other HRT products.
Medicinen bør ikke tages af patienter med følgende arvelige og sjældne sygdomme: galactoseintolerans, lactasemangel eller glucose/ galactosemalabsorption.
Patients with any of the following rare hereditary diseases should not take this medicine: galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Østrogen - og gestagenmetabolismen kan blive forøget ved samtidig indtagelse af stoffer, som er kendt for at påvirke lægemiddelmetaboliserende enzymer, specielt cytochrom P450 enzymer såsom antiepileptika (fx barbiturater, phenytoin, carbamazepin), eller bredspektret antibiotika (rifampicin, rifabutin, nevirapin og efavirenz).
The metabolism of oestrogens and progestagens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepin) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Naturmedicin, der indeholder perikum (Hypericum Perforatum), kan øge østrogen - og gestagenmetabolismen.
Herbal preparations containing St John’s Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestagens.
Forøget østrogen - og gestagenmetabolisme kan klinisk medføre en nedsat virkning og ændringer i blødningsprofilen.
Clinically, an increased metabolism of oestrogens and progestagens may lead to decreased effect and changes in the uterine bleeding profile.
Ved doseringer, der er højere end normalt for orale contraceptiva og HRT- produkter, er der observeret en maskulinisering af hunkønsfostre.
At doses higher than normally used in OC and HRT formulations masculinisation of female foetuses was observed.
Til dato har de fleste epidemiologiske studier ikke indiceret en teratogen eller foetotoksisk effekt ved uforvaren påvirkning af fostre med østrogen- gestagen kombinationer.
The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of oestrogens and progestagens indicate no teratogenic or foetotoxic effect.
Activelle er kontraindiceret ved amning.
Lactation Activelle is not indicated during lactation
Ved afslutningen af forsøget på 6 måneder blev der rapporteret gennembrudsblødning eller pletblødning hos 11% af kvinderne i den 1. måned, hos 15% af kvinderne i den 4. måned og hos 11% af kvinderne ved afslutningen af forsøget.
11% of women at month 1, 15% of women at month 4 and 11% of women at the end of the 6 month trial reported bleeding or spotting.
Organklasser Infektioner og parasitære sygdomme
18 System organ class Infections and infestations
Meget almindelig ≥1/ 10
Very common ≥1/10
Almindelig ≥1/ 100 til, < 1/ 10 Vaginal mykotisk infektion, se også ” Det reproduktive system og mammae ”
Common ≥1/100; < 1/10 Vulvovaginal mycotic infection, see also “Reproductive system and breast disorders
Ikke almindelig ≥1/ 1. 000 til, < 1/ 100
Uncommon ≥1/1,000; < 1/100
Sjælden ≥1/ 10. 000 til, < 1/ 1. 000
Rare ≥1/10,000; < 1/1,000
Hypersensitivitet Se også ” Hud og subkutane væv ”
Hypersensitivity, see also “Skin and subcutaneous tissue disorders
Væskeophobning Se også ” Almene symptomer og reaktioner på administrations - stedet ”
Fluid retention, see also “General disorders and administration site conditions
Depression eller forværret depression
Depression or depression aggravated Nervousness
Migræne
Headache
Mave- tarmkanalen
Migraine Dizziness
Mavesmerter
Gastrointestinal disorders Skin and subcutaneous tissue disorders
Udspilet mave
Abdominal pain Nausea
Kvalme
Abdominal distension Dyspepsia Pruritus or urticaria Alopecia Acne
Fordøjelsesbesvær
Musculoskeletal and connective
Hud og
Back pain
Pruritus eller
Leg cramps
subkutane væv
tissue disorders
Acne Knogler, led, muskler og
Neck pain Pain in extremity
Kramper i benene
Reproductive system and breast disorders
Smerter i ekstremiteterne
Vaginal haem orrhage
Det reproduktive system og Mammae
Endometrial thickening Vulvovaginal mycotic infection
Vaginal hæmorrhagi
Breast pain Breast discomfort
Fortykkelse af endometrie - slimhinden
19 System organ class General disorders and administration site conditions
Smerter i brysterne Ubehag i brysterne
Very c ommon ≥1/10
Vaginal mykotisk infektion
Common ≥1/100; < 1/10
Almene symptomer og reaktioner på administrationsste det
Uncommon ≥1/1,000; < 1/100 Oedema peripheral
Perifere ødemer
Rare ≥1/10,000; < 1/1,000
I et større antal epidemiologiske studier og et randomiseret placebokontrolleret studie, WHI (the Women’ s Health Initiative) er det evident, at den samlede risiko for brystcancer øges med stigende behandlingsvarighed hos kvinder, som er eller lige har været i HRT - behandling.
According to evidence from a large number of epidemiological studies and one randomised placebo- controlled trial, the Women’s Health Initiative (WHI), the overall risk of breast cancer increases with increasing duration of HRT use in current or recent HRT users.
1, 21 – 1, 40).
For oestrogen-only HRT, estimates of relative risk (RR) from a reanalysis of original data from 51 epidemiological studies (in which > 80% of HRT use was oestrogen-only HRT) and from the epidemiological Million Women Study (MWS) are similar at 1.35 (95%CI 1.21 – 1.49) and 1.30 (95%CI 1.21 – 1.40), respectively.
For kombineret østrogen- gestagen behandling har adskillige epidemiologiske studier vist en generelt større risiko for brystcancer end ved østrogenbehandling alene.
F or oestrogen plus progestagen combined HRT, several epidemiological studies have reported an overall higher risk for breast cancer than with oestrogens alone.
1, 01 – 1, 54) efter 5, 6 års behandling med kombineret østrogen- gestagen (CEE + MPA) sammenlignet med placebo.
The WHI trial reported a risk estimate of 1.24 (95%CI 1.01 – 1.54) after 5.6 years of use of oestrogen- progestagen combined HRT (CEE + MPA) in all users compared with placebo.
De endelige beregnede risici fra MWS - og WHI- studierne er beskrevet herunder:
The absolute risks calculated from the MWS and the WHI trial are presented below:
MWS- studiet estimerede ud fra den kendte forekomst af brystcancer i industrialiserede lande, at:
The MWS has estimated, from the known average incidence of breast cancer in developed countries, that: • For women not using HRT, about 32 in every 1000 are expected to have breast cancer diagnosed between the ages of 50 and 64 years.
19 • For hver 1000 kvinder, der bruger eller lige har brugt HRT, vil antallet af ekstra tilfælde i den tilsvarende periode være:
• For 1000 current or recent users of HRT, the number of additional cases during the corresponding period will be
For kvinder, der kun bruger østrogen HRT:
For users of oestrogen-only replacement therapy
mellem 0 og 3 (bedste skøn = 1, 5) ved brug i 5 år
Between 0 and 3 (best estimate = 1.5) for 5 years’ use
mellem 3 og 7 (bedste skøn = 5) ved brug i 10 år
Between 3 and 7 (best estimate = 5) for 10 years’ use.
For kvinder, der bruger kombineret østrogen- gestagen HRT:
For users of oestrogen plus progestagen combined HRT,
mellem 5 og 7 (bedste skøn = 6) ved brug i 5 år
Between 5 and 7 (best estimate = 6) for 5 years’ use
mellem 18 og 20 (bedste skøn = 19) ved brug i 10 år.
Between 18 and 20 (best estimate = 19) for 10 years’ use.
WHI- studiet estimerede ved opfølgning efter 5, 6 år af kvinder i alderen 50- 79 år, at yderligere 8 tilfælde af invasiv brystcancer pr.
The WHI trial estimated that after 5.6 years of follow-up of women between the ages of 50 and 79 years, an additional 8 cases of invasive breast cancer would be due to oestrogen-progestagen combined HRT (CEE + MPA) per 10,000 women years.
10. 000 kvindeår kunne skyldes kombineret østrogen- gestagen HRT (CEE + MPA).
For 1000 women in the placebo group,
Beregninger fra disse forsøgsdata giver anledning til følgende estimater:
About 16 cases of invasive breast cancer would be diagnosed in 5 years.
Ud af 1000 kvinder i placebogruppen ville ca.
1000
16 tilfælde af invasiv brystcancer kunne diagnosticeres inden for 5 år
women who used oestrogen + progestagen combined HRT (CEE + MPA), the
Ud af 1000 kvinder, som brugte kombineret østrogen- gestagen HRT (CEE + MPA), ville antallet af ekstra tilfælde over en periode på 5 år være mellem 0 og 9 (bedste skøn = 4).
Between 0 and 9 (best estimate = 4) for 5 years’ use.
4. 4).
The number of additional cases of breast cancer in women who use HRT is broadly similar for women who start HRT irrespective of age at start of use (between the ages of 45-65) (see section 4.4).
Post- marketing- erfaringer
Post marketing experience:
Udover ovennævnte uønskede bivirkninger er de bivirkninger, som er opstillet nedenfor, blevet rapporteret spontant, og efter en overordnet vurdering betragtes de som muligvis relateret til behandlingen med Activelle 1 mg/ 0, 5 mg.
In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported, and are by an overall judgement considered possibly related to Activelle 1 mg/0.5 mg treatment.
Rapporteringshyppigheden af disse uønskede bivirkninger er meget sjælden (< 1/ 10. 000 patienter pr. år).
The reporting rate of these spontaneous adverse drug reactions is very rare (< 1/10,000 patient years).
Post- marketing- erfaringer er påvirket af underrapportering specielt med hensyn til almindelige og velkendte uønskede bivirkninger.
Post-marketing experience is subject to underreporting especially with regard to trivial and well known adverse drug reactions.
• Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper):
Endometrial cancer
Endometriecancer • Psykiske forstyrrelser:
• Psychiatric disorders:
Svimmelhed
Insomnia, anxiety, libido decreased, libido increased
20
Dizziness
• • • •
• Eye disorders:
Øjne:
• Vascular disorders:
Synsforstyrrelser Vaskulære sygdomme:
Hypertension aggravated
Forværret hypertension Mave- tarmkanalen:
Dyspepsia, vomiting
Dyspepsi, opkastning Lever og galdeveje:
• Hepatobilitary disorders:
Galdeblærelidelser, galdestenssygdomme, forværret galdestenssygdom, tilbagevendende galdestenssygdom
Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis re-occurrence
Hud og subkutane væv:
• Skin and subcutaneous tissue disorder:
Seboré, udslæt, angioneurotiske ødemer Det reproduktive system og mammae:
• Reproductive system and breast disorders:
Fortykkelse af endometrieslimhinden, vaginal pruritus Undersøgelser:
Hyperplasia endometrial, vulvovaginal pruritus
Vægttab, forhøjet blodtryk
• Investigations:
Der er blevet rapporteret følgende bivirkninger i litteraturen i forbindelse med østrogen - progesteronbehandling:
21 The following adverse reactions have been reported in the literature in association with oestrogen/progestagen treatment:
Østrogenafhængige neoplasmer, godartede og maligne, fx endometriecancer Vene tromboembolisme, dvs. dyb venetrombose i underekstremitet eller bækken og lungeemboli, forekommer hyppigere blandt brugere af HRT end hos ikke- brugere, (se pkt.
Venous thromboembolism, i.e. deep leg or pelvic venous thrombosis and pulmonary embolism, is more frequent among hormone replacement therapy users than among non-users (For further information, see sections 4.3 and 4.4)
4. 3 og 4. 4 for yderligere oplysninger)
Myocardial infarction and stroke
• • • •
Gall bladder disease
Cloasma, erythema multiforme, erythema nodosum, vaskulær purpura Mulig demens (se pkt.
Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura
4. 4 for yderligere oplysninger)
Probable dementia (For further information, see section 4.4)
Ved overdosering kan der forekomme kvalme og opkastning.
Overdose may be manifested by nausea and vomiting.
Gestagen og østrogen i faste kombinationer, ATC kode:
Progestogens and estrogens, fixed combinations, ATC code:
Østradiol:
Estradiol:
Det aktive indholdsstof, syntetisk 17β- østradiol, er kemisk og biologisk identisk med det endogene humane østradiol.
The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Norethisteronacetat:
Norethisterone acetate:
Eftersom østrogener fremmer væksten af endometriet, vil ukonjugeret østrogen øge risikoen for endometriehyperplasi og cancer.
As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer.
Tilsætningen af gestagen reducerer i høj grad men eliminerer ikke fuldstændigt den østrogeninducerede risiko for endometriehyperplasi hos ikke - hysterektomerede kvinder.
The addition of a progestagen reduces, but does not completely eliminate, the oestrogen-induced risk of endometrial hyperplasia in non- hysterectomised women.
Ved 3. uge sås et fald i det gennemsnitlige antal moderate til svære hedestigninger i behandlingsgruppen med 0, 5 mg
By Week 3, the decrease in mean number of moderate to severe hot flushes for the 0.5 mg estradiol treatment group was statistically significant (p≤0.001) when compared to the placebo group.
Activelle er et kombineret HRT- produkt til kontinuerlig behandling, som indeholder 17β- østradiol og norethisteronacetat til at undgå de regelmæssige blødninger, der forekommer ved cyklisk eller sekventiel HRT.
Activelle is a continuous combined HRT product containing 17β-estradiol and norethisterone acetate with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT.
Blødning og/ eller pletblødning forekom hos 11- 15% af kvinderne i de første 6 behandlingsmåneder.
Bleeding and/or spotting appeared in 11 to 15% of the women during the first six months of treatment.
Det gennemgår omfattende first- pass metabolisme i lever og tarme og når maksimal plasmakoncentration inden for 5- 8 timer.
Following oral administration of Activelle, 17β-estradiol is absorbed from the gastrointestinal tract, undergoes a first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration within 5-8 hours.
Den maksimale gennemsnitlige plasmakoncentration var på 24 pg/ ml (CV 38%) efter administration af to Activelle tabletter.
After administration of two Activelle tablets, the average peak plasma
Halveringstiden for 17β- østradiol er ca.
22 concentration was 24 pg/ml (CV 38%).
15 timer.
The half-life of 17β-estradiol is about 15 hours.
Kun ca.
It circulates bound to SHBG (37%) and to albumin (61%), while only approximately 1-2% is unbound.
Omdannelsen af 17β- østradiol sker hovedsageligt i lever og tarmsystem, men også i effektorganer og inkluderer dannelse af mindre aktive eller inaktive metabolitter herunder estron, katekoløstrogener og adskillige østrogensulfater og glukoronider.
Metabolism of 17β-estradiol, occurs mainly in the liver and gut but also in target organs, and involves the formation of less active or inactive metabolites, including estrone, catecholestrogens and several oestrogen sulphates and glucuronides.
2, 4 ng/ ml CV 41% (efter administration af to Activelle tabletter) opnås indenfor 0, 5 - 1, 5 time.
It undergoes first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration of approximately 2.4 ng/ml CV 41% (after administration of two Activelle tablets) within 0.5 -1.5 hour.
NET’ s terminale halveringstid er 9 - 11 timer.
The terminal half-life of NET is about 9- 11 hours.
De vigtigste metabolitter er isomere af 5α- dihydro- NET og af tetrahydro- NET, som hovedsageligt udskilles med urinen som sulfat eller glukoronidkonjugater.
The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfate or glucuronide conjugates.
Den akutte østrogen- toksicitet er lav.
The acute toxicity of estrogens is low.
Dyreforsøg har vist, at østradiol eller østradiolvalerat har en dødelig effekt på embryoer, selv ved meget lave doser; der er blevet observeret misdannelser af urogenitalkanalen og feminisering af hankønsfostre.
Animal studies have shown embryo -lethal effects of estradiol or estradiol valerate even at relatively low doses; malformations of the urogenital tract and feminization of male fetuses were observed.
Ikke- kliniske data baseret på konventioenelle studier pharmakologisk sikkerhed, genotoksicitet og karcinogen potentiale udviser ingen specielle humane risici udover hvad, der allerede er diskuteret i andre dele af produktresuméet.
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazard for humans apart from those already discussed in other sections of the summary of product characteristics.
Laktosemonohydrat Majsstivelse Hydroxypropylcellulose Talkum Magnesiumstearat
Lactose monohydrate Maize starch Hydroxypropylcellulose Talc Magnesium stearate
Hypromellose Triacetin Talkum
Hypromellose Triacetin Talc
6. 3 Opbevaringstid
23 6.3 Shelf life
Må ikke opbevares koldt.
Do not refrigerate.
Opbevares i ydre karton for at beskytte mod lys.
Keep the container in the outer carton in order to protect from light.
1 x 28 tabletter eller 3 x 28 tabletter i kalenderpakning.
1 x 28 tablets or 3 x 28 tablets in calendar dial packs.
Kalenderpakningen, der indeholder 28 tabletter, består af følgende tre dele:
The calendar dial pack with 28 tablets consists of the following 3 parts:
- Bunden er fremstillet af farvet ikke- transparent polypropylen
- The base made of coloured non-transparent polypropylene
- Det ringformede låg er fremstillet af transparent polystyren
- The ring-shaped lid made of transparent polystyrene
- Midterskiven er fremstillet af ikke- transparent polystyren
- The centre-dial made of coloured non-transparent polystyrene
[Se bilag I - Udfyldes nationalt]
[See Annex I – To be completed nationally]
23 < {fax >} < {email} >
{Name and address} < {tel} > < {fax} > < {e-mail} >
Yderligere information om dette lægemiddel er tilgængeligt på hjemmesiden:
Detailed information on this medicinal product is available on the website of:{name of MS/Agency}[PIQ-QRD1]
24 ETIKETTERING
24 25 LABELLING
25 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Activelle og tilhørende navne (Se bilag I) 0, 5 mg/ 0, 1 mg filmovertrukne tabletter [Se bilag I – Udfyldes nationalt]
Activelle and associated names (see Annex I) 0.5 mg/0.1 mg film-coated tablets [See Annex I – To be completed nationally]
estradiol/ norethisteronacetat
estradiol/norethisterone acetate
Hver filmovertrukken tablet indeholder: estradiol 0, 5 mg (som estradiolhemihydrat), norethisteronacetat 0, 1 mg
Each film-coated tablet contains: estradiol 0.5 mg (as hemihydrate), norethisterone acetate 0.1 mg
Activelle indeholder lactose.
Activelle contains lactose.
Filmovertrukne tabletter 1 x 28 filmovertrukne tabletter 3 x 28 filmovertrukne tabletter
Film-coated tablet 1 x 28 film-coated tablets 3 x 28 film-coated tablets
Læs indlægssedlen inden brug Til oral anvendelse
Read the package leaflet before use Oral use
Må ikke opbevares over 25°C Må ikke opbevares i køleskab Opbevar beholderen i den ydre karton for at beskytte mod lys
Do not store above 25°C Do not refrigerate Keep the container in the outer carton, in order to protect from light
[Se bilag I – Udfyldes nationalt]
[See Annex I – To be completed nationally]
{Navn og adresse} < {tlf} > < {fax >} < {email} >
{Name and address} < {tel} > < {fax} > < {e-mail} >