natgillin/translations-raw huggingface dataset:
Den passende mængde rekonstituerede pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0, 9% - natriumchloridinjektionsvæske, uden konserveringsmiddel, og indgives som langsom intravenøs infusion over 10 minutter.
The appropriate volume of reconstituted pemetrexed solution should be further diluted to 100 ml with 9 mg/ ml (0.9%) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Forsigtighedsregler i forbindelse med forberedelse og indgivelse:
Preparation and administration precautions:
Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af kræft skal der udvises forsigtighed ved hånd - tering og forberedelse af infusionsopløsninger af pemetrexed.
As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Alli er et lægemiddel, som indeholder det aktive stof orlistat.
Alli is a medicine that contains the active substance orlistat.
Det leveres som turkise kapsler (60 mg).
It is available as turquoise capsules (60 mg).
Alli anvendes til at hjælpe patienter med vægttab. Det anvendes til overvægtige voksne med et kropsmasseindeks (BMI) større end eller lig med 28 kg pr. kvadratmeter sammen med en lavkaloriediæt med reduceret fedtindhold.
It is used in adults who are overweight with a body mass index (BMI) greater than or equal to 28 kg per square metre, in combination with a low-calorie diet with reduced fat levels.
Alli tages som en kapsel med vand umiddelbart før, under eller op til en time efter hvert hovedmåltid tre gange dagligt.
Alli is taken as one capsule with water just before, during, or up to one hour after each main meal, three times a day.
30% af kalorierne kommer fra fedt.
The patient should be on a diet in which about 30% of the calories come from fat.
Patienter, der tager Alli skal påbegynde en diæt kombineret med motion, inden de begynder behandlingen.
Patients taking Alli should start a diet and exercise regime before beginning treatment.
Når disse enzymer blokeres, kan de ikke nedbryde al fedt i kosten, hvilket medfører, at ca. en fjerdel af måltidets fedt passerer igennem tarmen uden at blive nedbrudt.
When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about a quarter of the fat eaten in the meal to pass through the gut undigested.
Da Alli er baseret på et andet lægemiddel, der indeholder det samme aktive stof, som allerede er godkendt i EU (Xenical 120 mg kapsler), omfattede visse af undersøgelserne patienter, der tager Xenical.
Because Alli is based on another medicine containing the same active substance already authorised in the EU (Xenical 120 mg capsules), some of the studies involved patients who took Xenical.
1 Tidligere kendt som Orlistat GSK 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Alli er blevet undersøgt i tre hovedundersøgelser.
Alli has been studied in three main studies.
Undersøgelserne varede fra et til to år og sammenlignede tre forskellige doser af Alli med placebo (en virkningsløs behandling) i kombination med en diæt.
Two of the studies involving a total of 1,353 overweight or obese patients with a BMI of 28 kg/ m2 or more and lasted from one to two years, comparing Alli given at different doses with placebo (a dummy treatment), in combination with dieting.
Den tredje hovedundersøgelse sammenlignede Alli med placebo hos 391 overvægtige patienter med en BMI på mellem 25 og 28 kg/ m2.
The third study compared Alli with placebo in 391 overweight patients with a BMI between 25 and 28 kg/ m2.
Alli var mere effektivt end placebo med henblik på at fremkalde vægttab hos patienter med en BMI på 28 kg/ m2 eller mere.
Alli was more effective than placebo in producing a reduction in weight in patients with a BMI of 28 kg/ m2 or more.
I to af undersøgelserne havde patienter med en BMI på 28 kg/ m2 eller mere, som fik Alli 60 mg, tabt 4, 8 kg efter et år sammenlignet med 2, 3 kg hos patienter, der fik placebo.
In the two studies of patients with a BMI of 28 kg/ m2 or more, patients taking Alli 60 mg had lost an average of 4.8 kg after a year, compared with 2.3 kg in those taking placebo.
Undersøgelsen af Alli hos patienter med en BMI på mellem 25 og 28 kg/ m2 kunne dog ikke påvise et relevant vægttab for patienterne.
The study of Alli in patients with a BMI between 25 and 28 kg/ m2 failed to show a degree of weight loss that would be relevant for patients.
De hyppigste bivirkninger ved Alli (som ses hos flere end 1 ud af 10 patienter) er olielignende pletter fra endetarmen, flatus (tarmluft) med udflåd, bydende defæktationstrang (pludselig, tvingende afføringstrang), fedtlignende eller olielignende afføring, flatulens (tarmluft) og flydende afføring.
The most common side effects with Alli (seen in more than 1 patient in 10) are oily spotting, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty oily stool, oily evacuation (faeces), flatulence (gas) and soft stools.
Den fuldstændige liste over alle de indberettede bivirkninger ved Alli fremgår af indlægssedlen.
For the full list of all side effects reported with Alli, see the Package Leaflet.
Alli må ikke anvendes til personer, som kan være overfølsomme over for orlistat eller andre af af indholdsstofferne.
Alli should not be used in people who may be hypersensitive (allergic) to orlistat or any of the other ingredients.
Det må heller ikke anvendes af personer, der har en langvarig malabsorptionssygdom (nedsat optagelse af næringsstoffer under fordøjelsen) eller som har cholestatis (en leversygdom), eller hos kvinder, som er gravide eller ammer.
It must also not be used in people with a long-term malabsorption disease (where nutrients from food are not easily absorbed during digestion) or cholestasis (a liver disorder), or in women who are pregnant or breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Alli er større end risiciene ved behandling af vægttab hos voksne, der er overvægtige (BMI ≥ 28 kg/ m2), når det tages i kombination med en mild lavkaloriediæt med lavt fedtindhold.
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Alli are greater than its risks for weight loss in adults who are overweight (BMI ≥ 28 kg/ m2), taken in conjunction with a mildly hypocalorific, lower-fat diet.
Udvalget anbefalede udstedelse af en markedsføringstilladelse for Alli.
The Committee recommended that Alli be given marketing authorisation.
Andre oplysninger om Alli:
Other information about Alli:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orlistat GSK til Glaxo Group Limited den 23. juli 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Orlistat GSK to Glaxo Group Limited on 23 July 2007.
Denne tilladelse er baseret på den tilladelse, der allerede blev udstedt i 1998 for Xenical- kapsler.
This authorisation was based on the authorisation already granted in 1998 to Xenical capsules.
Navnet på lægemidlet blev ændret til Alli den 12. september 2008.
The name of the medicine was changed to Alli on 12 September 2008.
Den fuldstændige EPAR for Alli findes her.
The full EPAR for Alli can be found here.
Dette sammendrag blev sidst ajourført i 04- 2009.
This summary was last updated in 04-2009.
EU- nummer EU/ 1/ 07/ 401/ 007 EU/ 1/ 07/ 401/ 008 EU/ 1/ 07/ 401/ 009 EU/ 1/ 07/ 401/ 0010
EU number EU/ 1/ 07/ 401/ 007 EU/ 1/ 07/ 401/ 008 EU/ 1/ 07/ 401/ 009 EU/ 1/ 07/ 401/ 0010
Særnavn alli alli alli alli
Invented name alli alli alli alli
Styrke 60 mg 60 mg 60 mg 60 mg
Strength 60 mg 60 mg 60 mg 60 mg
Lægemiddelform Kapsler, hårde Kapsler, hårde Kapsler, hårde Kapsler, hårde
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use Oral use Oral use
Emballage Beholder (HDPE) Beholder (HDPE) Beholder (HDPE) Beholder (HDPE)
Packaging Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Bottle (HDPE)
Pakningsstørrelse 42 60 84 90
Package size 42 60 84 90
Kapslen har et mørkeblåt bånd på midten og turkis hætte og krop påtrykt "alli".
The capsule has a dark blue centre band, and a turquoise cap and body bearing the imprint of “ alli”.
alli er indiceret til vægttab hos overvægtige voksne med body mass index (BMI) ≥28 kg/ m2 og skal kombineres med en let diæt med lavt kalorie - og fedtindhold.
alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/ m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
Kapslen bør tages med vand umiddelbart før, under eller op til 1 time efter hvert hovedmåltid.
The capsule should be taken with water immediately before, during or up to 1 hour after each main meal.
Det anbefales at starte et kost - og motions - program før indledning af behandling med alli.
It is recommended that a diet and exercise programme is started before beginning treatment with alli.
30% af kalorierne stammer fra fedtstoffer (svarende til < 67 g fedt, hvis kosten indeholder 2000 kcal/ døgn).
While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e. g. in a 2,000 kcal/ day diet, this equates to < 67 g of fat).
Efter endt behandling med alli bør patienten fortsat følge kost - og motionsprogrammet.
The diet and exercise programme should continue to be followed when treatment with alli is stopped.
På grund af utilstrækkelig dokumentation for sikkerhed og virkning bør alli ikke anvendes til børn under 18 år.
alli should not be used in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Effekten af orlistat er ikke undersøgt hos patienter med nedsat lever - og/ eller nyrefunktion.
The effect of orlistat in individuals with hepatic and/ or renal impairment has not been studied.
2 Eftersom orlistat kun optages i et mindre omfang, er det ikke nødvendigt at justere dosis hos ældre eller hos patienter med nedsat lever - og/ eller nyrefunktion.
2 However, as orlistat is minimally absorbed, no dosage adjustment is necessary in elderly and in individuals with hepatic and/ or renal impairment.
4. 5 og 4. 8)
• Hypersensitivity to the active substance or to any of the excipients • Concurrent treatment with ciclosporin (see section 4.5) • Chronic malabsorption syndrome • Cholestasis • Pregnancy (see section 4.6) • Breast-feeding (see section 4.6) • Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8)
4. 2).
Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
4. 8).
The possibility of experiencing gastrointestinal symptoms (see section 4.8) may increase when orlistat is taken with an individual meal or a diet high in fat.
4. 5).
Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K) (see section 4.5).
Derfor skal diabetikere i medicinsk behandling konsultere en læge eller apoteket inden behandlingen med alli for at få undersøgt, om de skal have justeret doseringen af antidiabetika.
As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor or pharmacist before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product.
4. 5).
Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli (see section 4.5).
4. 5).
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
Ciclosporin
Ciclosporin
4. 3).
Concurrent use of alli and ciclosporin is contraindicated (see section 4.3).
4. 8).
When warfarin or other oral anticoagulants are given in combination with orlistat, international normalised ratio (INR) values could be affected (see section 4.8).
4. 3).
Concurrent use of alli and warfarin or other oral anticoagulants is contraindicated (see section 4.3).
3 Fravær af interaktion mellem orale kontraceptiva og orlistat er påvist i specifikke interaktionsstudier.
3 The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
4. 4.)
An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Hovedparten af personer, som i kliniske undersøgelser fik behandling med orlistat i op til 4 år, havde A -, D -, E - og K - og betakarotenniveauer, som forblev inden for normalområdet.
The vast majority of subjects receiving up to 4 full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
4. 4).
However, patients should be advised to use a multivitamin supplement at bedtime to help ensure adequate vitamin intake (see section 4.4).
Acarbose
Acarbose
Patienter, som tager amiodaron, bør konsultere en læge eller apoteket inden opstart af behandling med alli.
Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli.
4. 3).
alli is contraindicated in pregnancy (see section 4.3).
4. 3).
As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast- feeding (see section 4.3).
alli påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
Orlistat has no influence on the ability to drive and use machines.
4. 4).
Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal reactions (see section 4.4).
Hyppighed defineres som meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100),
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100), rare (≥ 1/ 10,000 to < 1/ 1,000) and very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Hyppigheden af de bivirkninger, der blev påvist efter markedsføring af orlistat, er ikke kendt, da disse reaktioner er baseret på frivillige indberetninger fra en population af ukendt størrelse.
4 The frequencies of adverse reactions identified during post-marketing use of orlistat are not known as these reactions were reported voluntarily from a population of uncertain size.
Inden for hver hyppighedsgruppering er uønskede bivirkninger ordnet efter alvorlighed med den alvorligste øverst.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Systemorganklasse og hyppighed og lymfesystem
System Organ Class and Frequency Blood and the lymphatic system disorders
Bivirkning/ hændelse
Adverse Reaction/ Event
4. 3 og 4. 5)
Decreased prothrombin and increased INR (see sections 4.3 and 4.5)
Mave- tarm- kanalen
Gastrointestinal disorders
Uro †
Anxiety†
Olielignende pletter fra rektum Flatus med udflåd Imperiøs defækationstrang Fedt - / olieholdig afføring Olieagtige udtømninger Flatulens Løs afføring
Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation Flatulence Soft stools
4. 4)
Diverticulitis Mild rectal bleeding (see section 4.4)
Hepatitis Galdestenssygdom Forhøjede værdier for transaminer og alkalisk fosfatase
Hepatitis Cholelithiasis Increase in transaminases and in alkaline phosphatase
† Det er sandsynligt, at behandling med orlistat kan føre til uro enten i forventning om eller som følge af gastrointestinale reaktioner.
† It is plausible that treatment with orlistat can lead to anxiety in anticipation of or secondary to gastrointestinal adverse reactions.
Derudover er doser på 240 mg 3 gange daglig blevet administreret til adipøse
In addition, doses of 240 mg three times daily have been administered to obese patients for 6 months.
I tilfælde af overdosering skal patienten rådføre sig med en læge.
5 In the event of an overdose, medical advice should be sought.
Farmakoterapeutisk gruppe:
Pharmaco-therapeutic group:
Perifert virkende antiobesitasmiddel, ATC- kode A08AB01.
Peripherally acting anti obesity products, ATC code A08AB01.
Orlistats terapeutiske virkninger udøves i ventriklens og tyndtarmens lumina, hvor der dannes kovalente bindinger på det aktive serinbindingssted af gastro - og pankreaslipaser.
It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases.
25% af fedtet i kosten.
From clinical studies, it has been estimated that orlistat 60 mg taken three times daily blocks the absorption of approximately 25% of dietary fat.
To dobbeltblinde, randomiserede, placebokontrollerede studier hos voksne med BMI ≥28 kg/ m2 understøtter virkningen af orlistat 60 mg, når det tages 3 gange daglig og kombineres med kalorie - og fedtfattig kost.
Two double-blind, randomised, placebo-controlled studies in adults with a BMI ≥ 28 kg/ m2 support the efficacy of orlistat 60 mg taken three times daily in conjunction with a hypocaloric, lower-fat diet.
Den primære parameter, vægtændring fra baseline (tidspunktet for randomisering), blev vurderet for kropsvægt over tid (tabel 1) og som procentdel af forsøgspersoner, der opnåede vægttab på ≥5% eller ≥10% af legemsvægten (tabel 2).
The primary parameter, change in body weight from baseline (time of randomisation), was assessed for body weight over time (Table 1) and the percentage of subjects who lost ≥ 5% or ≥ 10% of body weight (Table 2).
Virkning af 6 måneders behandling på legemsvægten målt ved baseline
Effect of 6 months treatment on body weight measured at baseline
Beha
Treatment group
ndlingsgruppe n
N
Relativ
Relative
Middeldifference
mean change (%)
middeldifference (%)
Mean
(kg)
change (kg)
- 3, 24
-3.24
- 3, 11
-3.11
216
216
- 5, 55
-5.55
- 5, 20 a
-5.20 a
- 1, 17 - 3, 66
-1.17 -3.66
- 1, 05 - 3, 59 a
-1.05 -3.59 a
Poolede data a
Pooled data
- 2, 20 - 4, 60
-2.20
- 2, 09 - 4, 40 a
-2.09
Tabel 2:
a
Tab ≥5% af udgangsvægt (%) Placebo Orlistat 60 mg a
Orlistat 60 mg
Tab ≥10% af udgangsvægt (%) Placebo Orlistat 60 mg
407
Forsøg 1 Forsøg 2
-4.60
30, 9 54, 6 21, 3 37, 7 a a
-4.40 a
10, 3 21, 3 b 2, 2 10, 5 b
p < 0.001 versus placebo
Poolede data
Study 1 Study 2 Pooled data
26, 4 46, 7 a b
30.9 54.6 21.3 37.7 a 26.4 46.7 a
6, 5 16, 2 a
10.3 21.3 b 2.2 10.5 b 6.5 16.2 a
Sammenligning med placebo: p < 0, 001; p < 0, 01
Comparison versus placebo: a p < 0.001; b p < 0.01
Den relative middelændring i totalkolesterol var - 2, 4% for orlistat 60 mg (baseline 5, 20 mmol/ l) og +2, 8% for placebo (baseline 5, 26 mmol/ l).
The mean relative change in total cholesterol was -2.4% for orlistat 60 mg (baseline 5.20 mmol/ l) and +2.8% for placebo (baseline 5.26 mmol/ l).
Den relative middelændring i LDL- kolesterol var - 3, 5% for orlistat 60 mg (baseline 3, 30 mmol/ l) og +3, 8% for placebo (baseline 3, 41 mmol/ l).
The mean relative change in LDL cholesterol was -3.5% for orlistat 60 mg (baseline 3.30 mmol/ l) and +3.8% for
6 60 mg (baseline 103, 7 cm) og - 3, 6 cm for placebo (baseline 103, 5 cm).
For waist circumference, the mean change was -4.5 cm for orlistat 60 mg (baseline 103.7 cm) and -3.6 cm for placebo (baseline 103.5 cm).
Absorption
Absorption
8 timer efter oral indgift af 360 mg orlistat kune der ikke måles plasmakoncentrationer (< 5 ng/ ml) af intakt orlistat.
Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ ml) 8 hours following oral administration of orlistat 360 mg.
Ved terapeutiske doser kunne der generelt kun måles sporadiske og yderst lave koncentrationer af intakt orlistat i plasma (< 10 ng/ ml eller 0, 02 mikromol) uden tegn på akkumulering, hvilket er i overensstemmelse med en minimal absorption.
In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
In vitro er > 99% af orlistat bundet til plasmaproteiner (hovedsageligt lipoproteiner og albumin).
In vitro, orlistat is > 99% bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Dyreforsøg viser, at det er sandsynligt, at orlistats metabolisme hovedsageligt finder sted i mave - tarmkanalens vægge.
Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
42% af den totale plasmakoncentration.
Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42% of the total plasma concentration.
M1 og M3 har en åben beta- laktonring med en yderst svag lipasehæmmende aktivitet (1000 henholdsvis 2500 gange mindre end orlistat).
M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1,000- and 2,500-fold less than orlistat, respectively).
På grund af den lave lipasehæmmende aktivitet og de lave plasmaniveauer ved terapeutiske doser (i gennemsnit henholdsvis 26 ng/ ml og 108 ng/ ml) anses disse metabolitter for at være uden farmakologisk betydning.
In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ ml and 108 ng/ ml, respectively), these metabolites are considered to be pharmacologically inconsequential.
Ca.
Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed active substance was the major route of elimination.
97% af den indgivne dosis blev udskilt i fæces, og heraf var 83% uomdannet orlistat.
Approximately 97% of the administered dose was excreted in faeces and 83% of that as unchanged orlistat.
Den kumulative renale udskillelse af totalt orlistatrelateret materiale var < 2% af den indgivne dosis.
The cumulative renal excretion of total orlistat-related materials was < 2% of the given dose.
Tiden til fuldstændig udskillelse (fækal plus renal) var 3- 5 dage.
The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle under - søgelser af farmakologisk sikkerhed, toksicitet ved gentagne doseringer, genotoksicitet, karcinogent potentiale og reproduktionstoksicitet.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
7 Natriumstivelsesglycolat Povidon (E1201) Natriumlaurilsulfat Talcum
Capsule filling Microcrystalline cellulose (E460) Sodium starch glycolate Povidone (E1201) Sodium laurilsulfate Talc
Kapselskal Gelatine Indigotin I (E132) Titandioxid (E171) Natriumlaurilsulfat Sorbitanmonolaurat
Capsule shell Gelatin Indigo carmine (E132) Titanium dioxide (E171) Sodium laurilsulfate Sorbitan monolaurate
Kapsel trykfarve Shellac Sort jernoxid (E172) Propylenglycol
Capsule printing ink Shellac Iron oxide black (E172) Propylene glycol
Kapselbånd Gelatine Polysorbat 80 Indigotin I (E132)
Band Gelatin Polysorbate 80 Indigo carmine (E132)
Kapsler, der har ligget i etuiet i over 1 måned, må ikke anvendes.
Discard any capsules stored in the carry case for more than one month.
HDPE- beholder med børnesikret låg, der indeholder 42, 60, 84 eller 90 hårde kapsler.
HDPE bottle with child resistant closure containing 42, 60, 84 or 90 hard capsules.
Et etui af polystyrenresin/ polyurethan (Shuttle), der kan indeholde 3 kapsler, er inkluderet i hver pakning.
A polystyrene resin / polyurethane carry case (Shuttle) which holds 3 capsules is included in each pack.
6. 6 Særlige opbevaringsforhold
6.6 Special precautions for disposal
23. juli 2007 Dato for sidste fornyelse:
23 July 2007 Renewal of the authorisation: