natgillin/translations-raw huggingface dataset:
Den systematiske eksponering til lopinavir/ ritonavir ved de maternelt og udviklingsmæssigt toksiske doser er lavere end den anbefalede terapeutiske eksponering hos mennesker.
The systemic exposure to lopinavir/ ritonavir at the maternal and developmental toxic dosages was lower than the intended therapeutic exposure in humans.
Langtids karcinogenicitetsforsøg af lopinavir/ ritonavir i mus viste en ikke genotoksisk, mitogen induktion af levertumorer, som generelt menes at have lille relevans for mennsker.
Long-term carcinogenicity studies of lopinavir/ ritonavir in mice revealed a nongenotoxic, mitogenic induction of liver tumours, generally considered to have little relevance to human risk.
Karcinogenicitetsforsøg i rotter viste ingen fund af tumorer.
Carcinogenicity studies in rats revealed no tumourigenic findings.
Lopinavir/ ritonavir var ikke mutagent eller klastogent i flere in vitro og in vivo tests, inklusive Ames bakterielle tilbagemutationsmåling, muselymfomtest, musemikronukleustest og måling af kromosomændringer i humane lymfocytter.
Lopinavir/ ritonavir was not found to be mutagenic or clastogenic in a battery of in vitro and in vivo assays including the Ames bacterial reverse mutation assay, the mouse lymphoma assay, the mouse micronucleus test and chromosomal aberration assays in human lymphocytes.
21 6.
20 6.
Kapslen indeholder: oleinsyre, propylenglykol, polyoxyl 35 ricinusolie, renset vand
Capsule contents: oleic acid, propylene glycol, polyoxyl 35 castor oil, purified water
Selve kapslen: gelatine, flydende sorbitol, vandfrit (blanding af sorbitol, sorbitol anhydrid og mannitol), glycerol, titandioxid (E171), sunset yellow FCF (E110), middellange triglyceridkæder lecithin
Capsule shell: gelatine, anhydrized liquid sorbitol (mixture of sorbitol, sorbitol anhydrides and mannitol), glycerol, titanium dioxide (E171), sunset yellow (E110) medium-chain triglycerides, lecithin
Sort blæk indeholdende: propylenglykol, sort jernoxid (E172), polyvinylacetatphtalat, polyethylenglycol 400, ammoniumhydroxid
Black ink containing: propylene glycol, black iron oxide (E172), polyvinyl acetate phthalate, polyethylene glycol 400, ammonium hydroxide
Opbevaring efter åbning: hvis Kaletra opbevares udenfor køleskab, bør det ikke opbevares over 25°C og smid al ubrugt indhold ud efter 42 dage (6 uger).
If kept outside of the refrigerator, do not store above 25°C and discard any unused contents after 42 days (6 weeks).
High- density polyethylen (HDPE) flasker produceret med polypropylen hætter.
High density polyethylene (HDPE) bottles closed with polypropylene caps.
Hver flaske indeholder 90 kapsler.
Each bottle contains 90 capsules.
Hver pakning indeholder 2 flasker (180 kapsler).
Each pack contains 2 bottles (180 capsules).
Blisterpakninger, der består af PVC/ fluoropolymer folie.
Blisters consisting of PVC/ fluoropolymer foil.
Hver æske indeholder 6 blisterkort hver med 6 kapsler (36 kapsler).
Each carton contains 6 foil blisters each containing 6 capsules (36 capsules).
Hver pakning indeholder 5 æsker (180 kapsler).
Each pack contains 5 cartons (180 capsules).
22 7.
21 7.
Abbott Laboratories Limited Queenborough Kent ME11 5EL England
Abbott Laboratories Limited Queenborough Kent ME11 5EL United Kingdom
20. marts 2001 Dato for sidste fornyelse:
20 March 2001 Date of last renewal:
Hver 5 ml Kaletra oral opløsning indeholder 400 mg lopinavir formuleret sammen med 100 mg ritonavir, der virker som en farmakokinetisk forstærker.
Each 5 ml of Kaletra oral solution contains 400 mg of lopinavir co-formulated with 100 mg of ritonavir as a pharmacokinetic enhancer.
Mængde pr. ml
Quantity per ml
Lopinavir Ritonavir - excipient( s)
Lopinavir Ritonavir
356, 3 mg 168, 6 mg
- excipient (s)
Propylenglykol Glycerol Polyoxyl 40 hydrogeneret ricinusolie Kaliumacesulfam
Alcohol (42% v/ v) High fructose corn syrup Propylene glycol Glycerol Polyoxyl 40 hydrogenated castor oil Acesulfame potassium
152, 7 mg 59, 6 mg 10, 2 mg 4, 1 mg
356.3 mg 168.6 mg 152.7 mg 59.6 mg 10.2 mg 4.1 mg
Der er begrænset mængde data på salvage terapi for patienter, hvor Kaletra ikke har haft terapeutiskeffekt.
There are limited data on salvage therapy on patients who have failed therapy with Kaletra.
24 4. 2 Dosering og indgivelsesmåde
4.2 Posology and method of administration
Den anbefalede dosis af Kaletra er 5 ml oral opløsning (400/ 100 mg) to gange dagligt i forbindelse med et måltid.
Adult and adolescent use: the recommended dosage of Kaletra is 5 ml of oral solution (400/ 100 mg) twice daily taken with food.
Den anbefalede dosis af Kaletra er 230/ 57, 5 mg/ m2 to gange dagligt i forbindelse med et måltid, op til en maksimal dosis på 400/ 100 mg to gange dagligt.
23 Paediatric use (2 years of age and above): the recommended dosage of Kaletra is 230/ 57.5 mg/ m2 twice daily taken with food, up to a maximum dose of 400/ 100 mg twice daily.
Doseringen på 230/ 57, 5 mg/ m2 kan være utilstrækkeligt i nolge børn, når det gives sammen med nevirpin eller efavirenz.
The 230/ 57.5 mg/ m2 dosage might be insufficient in some children when co-administered with nevirapine or efavirenz.
En øget dosis Kaletra til 300/ 75 mg/ m2 bør overvejes i disse patienter.
An increase of the dose of Kaletra to 300/ 75 mg/ m2 should be considered in these patients.
Den orale opløsning er den anbefalede mulighed til den mest præcise dosering af børn baseret på kropsoverflade.
The oral solution is the recommended option for the most accurate dosing in children based on body surface area.
Derfor kan børn, der modtager bløde kapsler have en højere eksponering (med forøget risiko for toksicitet) eller en mindre optimal eksponering (med risiko for utilstrækkelig effekt).
Therefore, children receiving soft capsules might have higher exposure (with the risk of increased toxicity) or suboptinal exposure (with the risk of insufficient efficacy).
Pædiatrisk doserings vejledning 230/ 57, 5 mg/ m2
Paediatric Dosing Guidelines for the Dose 230/ 57.5 mg/ m2
Kroppens overflade * (m2)
Body Surface Area* (m2)
Dosering to gange dagligt oral opløsning (dosis i mg)
Daily Oral Solution Dose (dose in mg)
Dosering to gange dagligt bløde kapsler (dosis i mg)
Twice Daily Soft Capsule Dose (dose in mg)
0, 7 ml (57, 5/ 14, 4 mg)
0.7 ml (57.5/ 14.4 mg)
Ikke relevant
1.2 ml (96/ 24 mg)
0, 40 0, 50 0, 75
1 soft capsule (133.3/ 33.3 mg)
1, 2 ml (96/ 24 mg) 1, 4 ml (115/ 28, 8 mg) 2, 2 ml (172, 5/ 43, 1 mg)
1.4 ml (115/ 28.8 mg)
1 blød kapsel (133, 3/ 33, 3 mg) 1 blød kapsel (133, 3/ 33, 3 mg) 1 blød kapsel (133, 3/ 33, 3 mg)
1 soft capsule (133.3/ 33.3 mg)
0, 80 1, 00 1, 25 1, 3 1, 4 1, 5 1, 75
0.75 0.80 1.00 1.25 1.3 1.4 1.5 1.7
2, 3 ml (184/ 46 mg) 2, 9 ml (230/ 57, 5 mg) 3, 6 ml (287, 5/ 71, 9 mg) 3, 7 ml (299/ 74, 8 mg) 4, 0 ml (322/ 80, 5 mg) 4, 3 ml (345/ 86, 3 mg) 5 ml (402, 5/ 100, 6 mg)
2.2 ml (172.5/ 43.1 mg) 2.3 ml (184/ 46 mg) 2.9 ml (230/ 57.5 mg) 3.6 ml (287.5/ 71.9 mg) 3.7 ml (299/ 74.8 mg) 4.0 ml (322/ 80.5 mg) 4.3 ml (345/ 86.3 mg) 5 ml (402.5/ 100.6 mg)
bløde kapsler (266, 6/ 66, 6 mg) bløde kapsler (266, 6/ 66, 6 mg) bløde kapsler (266, 6/ 66, 6 mg) bløde kapsler (266, 6/ 66, 6 mg) 3 bløde kapsler (400/ 100 mg) 3 bløde kapsler (400/ 100 mg) 3 bløde kapsler (400/ 100 mg)
1 soft capsule (133.3/ 33.3 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 2 soft capsules (266.6/ 66/ 6 mg) 3 soft capsules (400/ 100 mg) 3 soft capsules (400/ 100 mg) 3 soft capsules (400/ 100 mg)
4. 4).
Paediatric patients should switch from Kaletra oral solution to soft capsules as soon as they are able to swallow the capsule formulation (see section 4.4).
Hos HIV- inficerede patienter med mild til moderat svækket leverfunktion, er der set en stigning på omkring 30% i lopinavir eksposition, men dette forventes ikke at have nogen klinisk relevans. (se pkt.
In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance.
4. 3).
Kaletra should not be given to these patients (see section 4.3).
Det er ikke nødvendigt at justere dosis til patienter med nedsat nyrefunktion.
No dose adjustment is necessary in patients with renal impairment.
25 4. 3 Kontraindikationer
4.3 Contraindications
Disse lægemidler indbefatter astemizol, terfenadin, oral midazolam (se advarsler vedrørende parenteral administreret midazolam, se pkt.
These medicinal products include astemizole, terfenadine, oral midazolam (for
4. 5)., triazolam, cisaprid, pimozid, amiodaron, ergotalkaloider (f. eks. ergotamin, dihydroergotamin, ergonovin og methylergonovin) og vardenafil
24 caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e. g. ergotamine, dihydroergotamine and ergonovine and methylergonovine) and vardenafil.
4. 4).
Kaletra oral solution is contraindicated in children below the age of 2 years, pregnant women, patients with hepatic or renal failure and patients treated with disulfiram or metronidazole due to the potential risk of toxicity from the excipient propylene glycol (see section 4.4).
Særlig forsigtighed bør udvises overfor patienter med høje basalniveauer og med en forhistorie med
Particular caution should be paid to patients with high values at baseline and with history of lipid disorders.
Patienter med fremskredet HIV infektion kan have forøget risiko for en stigning i triglycerider og pankreatitis.
Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis.
Pankreatitis bør overvejes, hvis kliniske symptomer (kvalme, opkast, smerter i underlivet) eller unormale laboratorieværdier (såsom øget serumlipase eller amylaseværdier), der tyder på pankreatitis, forekommer.
25 Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur.
Omfordeling af fedt og metaboliske forstyrrelser
Fat redistribution & metabolic disorders
Langtidsvirkningerne af dette er ikke kendt for tiden.
Knowledge about the mechanism is incomplete.
Viden om denne mekanisme er ufuldstændig. En forbindelse mellem lipomatose i maveregionen og PI og lipoatrophy og NRTI er blevet omtalt som en teori.
A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised.
27 hjertesygdom og eksisterende overledningsforstyrrelser eller hos patienter, der får lægemidler, der er kendt for at forlænge PR- intervallet (sådan som verapamil eller atazanavir).
Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ ritonavir.
Kaletra forårsager sandsynligvis en stigning i plasmakoncentrationen af lægemidler, der fortrinsvis metaboliseres af CYP3A,.
Kaletra is likely to increase plasma concentrations of medicinal products that are primarily
Metabolismen af HMG- CoA reduktasehæmmerne simvastatin og lovastatin er stærkt afhængige af CYP3A, derfor er samtidig brug af Kaletra og simvastatin eller lovastatin ikke anbefalet på grund af en øget risiko for myopati, derunder rhabdomyolyse.
The HMG-CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A for metabolism, thus concomitant use of Kaletra with simvastatin or lovastatin is not recommended due to an increased risk of myopathy including rhabdomyolysis.
Forsigtighed skal ligeledes udvises og nedsatte doser af Kaletra bør overvejes, hvis Kaletra anvendes sammen med rosuvastatin eller med atorvastatin, der metaboliseres i mindre udstrækning af CYP3A4.
Caution must also be exercised and reduced doses should be considered if Kaletra is used concurrently with rosuvastatin or with atorvastatin, which is metabolised to a lesser extent by CYP3A4.
4. 5).
If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
Kaletra kan øge koncentrationerne af lægemidler, der anvendes samtidig, og dette kan resultere i en stigning i disses relaterede kardiale bivirkninger.
Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse events.
Samtidig administration af Kaletra og af rifampicin kan ikke anbefales. Rifampicin i kombination med Kaletra forårsager stor reduktion i lopinavir- koncentrationer, hvilket kan resultere i et signifikant fald i lopinavirs terapeutiske effekt.
Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect.
4. 3).
Patients taking the oral solution, particularly those with renal impairment or with decreased ability to metabolise propylene glycol (e. g. those of Asian origin), should be monitored for adverse reactions potentially related to propylene glycol toxicity (i. e. seizures, stupor, tachycardia, hyperosmolarity, lactic acidosis, renal toxicity, haemolysis) (see section 4.3).
Udover propylenglycol, som beskrevet ovenfor, indeholder Kaletra oral opløsning også alkohol (42% v/ v), der er potentielt skadeligt for patienter, der lider af leversygdomme, alkoholisme, epilepsi, hjerneskader eller sygdomme og ligeledes for gravide og børn.
Besides propylene glycol as described above, Kaletra oral solution contains alcohol (42% v/ v) which is potentially harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children.
Kaletra oral opløsning indeholder op til 0, 8 g fruktose per dosis, når det indtages ifølge anbefalingerne.
Kaletra oral solution contains up to 0.8 g of fructose per dose when taken according to the dosage recommendations.
Kaletra oral opløsning indeholder op til 0, 3 g glycerol per dosis.
Kaletra oral solution contains up to 0.3 g of glycerol per dose.
28 amerikansk olie og kalium i Kaletra oral opløsning forårsage gastrointestinale gener ved utilsigtet høje doser.
Furthermore, polyoxol 40 hydrogenated castor oil and potassium present in Kaletra oral solution may cause only at high inadvertent doses gastrointestinal upset.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
27 4.5 Interaction with other medicinal products and other forms of interaction
Didanosin: det anbefales, at didanosin gives på tom mave; derfor skal didanosin tages en time før eller to timer efter Kaletra (der tages i forbindelse med mad).
Didanosine: it is recommended that didanosine be administered on an empty stomach; therefore, didanosine is to be given one hour before or two hours after Kaletra (given with food).
Zidovudin og Abacavir:
Zidovudine and Abacavir:
Baseret på klinisk erfaring, kan en stigning i Kaletra dosis til 533/ 133 mg to gange dagligt (∼6, 5 ml) overvejes, når det gives sammen med nevirapin, særligt til patienter, der har en sandsynlig nedsat lopinavir følsomhed.
However, based on clinical experience, Kaletra dose increase to 533/ 133 mg twice daily (~6.5 ml) may be considered when co-administered with nevirapine, particularly for patients in whom reduced lopinavir susceptibility is likely.
29 Efavirenz: når Kaletra anvendes i kombination med efavirenz og to nukleosid revers transkriptasehæmmere i patienter, der tidligere er behandlet med flere proteasehæmmere, skal dosis af Kaletra øges med 33, 3% fra 400/ 100 mg (3 kapsler) to gange dagligt til 533/ 133 mg (4 kapsler) to gange dagligt for at opnå samme lopinavir plasmakoncentrationer som afprøvninger har vist, der opnås med Kaletra 400/ 100 mg (3 kapsler) to gange dagligt.
Efavirenz: when used in combination with efavirenz and two nucleoside reverse transcriptase inhibitors in multiple protease inhibitor-experienced patients, increasing the dose of Kaletra 33.3% from 400/ 100 mg (3 capsules) twice daily to 533/ 133 mg (4 capsules) twice daily yielded similar lopinavir plasma concentrations as compared to historical data of Kaletra 400/ 100 mg (3 capsules) twice daily.
Dosisforøgelse af Kaletra fra 400/ 100 ml (5 ml) to gange dagligt til 553/ 133 mg (∼6, 5 ml) to gange dagligt bør overvejes i forbindelse med samtidig administration af efavirenz.
Dosage increase of Kaletra from 400/ 100 mg (5 ml) twice daily to 533/ 133 mg (~6.5 ml) twice daily should be considered when co-administered with efavirenz.
Kombinationsbehandling med andre HIV- proteasehæmmere( PIs):
28 Co-administration with other HIV protease inhibitors (PIs):
Amprinavir: samtidig administration af Kaletra med amprenavir 750 mg to gange daglig medførte en øgning i amprenavir AUC på 70% og i Cmin med 4, 6- gange sammenlignet med amprenavir 1200 mg to gange med dagligt aqdministreret alene.
Amprenavir: the concomitant use of Kaletra with amprenavir 750 mg twice daily, resulted in an increase in amprenavir AUC by 70% and of Cmin by 4.6-fold, relative to amprenavir 1200 mg twice daily alone.
Samtidig administration af øgede doser af fosamprenavir 1400 mg to gange daglig med lopinavir/ ritonavir 533/ 133 mg to gange daglig til protease- hæmmer- erfarne patienter resulterede i en højere forekomst af gastrointestinale bivirkninger og øgede triglycerider med kombinationsregiment uden øgning i virologisk effekt, når der blev sammenlignet med fosamprenavir/ ritonavir standarddoser.
Co-administration of increased doses of fosamprenavir 1400 mg twice daily with lopinavir/ ritonavir 533/ 133 mg twice daily to protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ ritonavir.
30 Saquinavir: Saquinavir 800 mg to gange dagligt i kombination med Kaletra medfører en stigning i saquinavir AUC 9, 6- gange sammenlignet med saquinavir 1200 mg administreret tre gange daglig alene
Saquinavir: saquinavir 800 mg twice daily co-administered with Kaletra produces an increase of saquinavir AUC by 9.6-fold relative to saquinavir 1200 mg three times daily given alone.
Andre lægemidler:
29 Other medicinal products:
Anti- arrhythmiske midler:
Antiarrhythmics:
(bepridil, systemisk lidokain og quinidin): koncentrationerne kan blive forhøjet ved samtidig indgift af Kaletra.
(bepridil, systemic lidocaine and quinidine): concentrations may be increased when co-administered with Kaletra.
Bupropion: ved steady- state blev bupropion og dens aktive metabolit hydroxybupropions AUC og Cmax nedsat med omkring 50% hos raske frivillige ved samtidig administration med lopinavir/ ritonavir kapsler 400/ 100 mg to gange daglig.
Bupropion: in healthy volunteers, the AUC and Cmax of bupropion and of its active metabolite, hydroxybupropion, were decreased by about 50% when co-administered with lopinavir/ ritonavir capsules 400/ 100 mg twice daily at steady-state.
Det vides dog ikke om kombinationen af lopinavir/ ritonavir forårsager en lignende stigning i trazodon- eksponeringen.
However, it is unknown whether the combination of lopinavir/ ritonavir causes a similar increase in trazodone exposure.
31 Digoxin: plasmakoncentrationerne af digoxin kan stige ved samtidig administration af Kaletra.
Digoxin: plasma concentrations of digoxin may be increased when co-administered with Kaletra.
Dihydropyridin calciumkanal blokkere:
Dihydropyridine calcium channel blockers:
Kaletra oral opløsning indeholder alkohol, der kan forårsage disulfiram - lignende virkninger ved samtidig indgift med disulfiram eller andre lægemidler med samme virkning.
Kaletra oral solution contains alcohol which can produce disulfiram-like reactions when co-administered with disulfiram or other medicinal products that produce this reaction.
Lipidsænkende lægemidler:
Lipid lowering agents:
HMG- CoA reduktasehæmmere, der er stærkt afhængige af CYP3A4 metabolisme, såsom lovastatin og simvastatin forventes at have en markant stigning i plasmakoncentrationer, ved samtidig indgift med Kaletra.
Since increased concentrations of HMG-CoA
Da en stigning i koncentrationer af HMG - CoA reduktasehæmmere kan forårsage myopati, derunder rhabdomyolyse, anbefales kombination af disse produkter med Kaletra ikke.
30 reductase inhibitors may cause myopathy, including rhabdomyolysis, the combination of these medicinal products with Kaletra is not recommended.
Resultater fra et interaktionsstudie med Kaletra og pravastatin viser ingen klinisk signifikante interaktioner.
Results from an interaction study with Kaletra and pravastatin reveal no clinically significant interaction.
Ketoconazol og itraconazol: disses serumkoncentrationer kan forhøjes af Kaletra.
Ketoconazole and itraconazole: may have serum concentrations increased by Kaletra.
32 Clarithromycin: moderate stigninger i clarithromycin AUC forventes ved samtidig indgift med Kaletra.
Clarithromycin: moderate increases in clarithromycin AUC are expected when co-administered with Kaletra.
Der sås ingen klinisk signifikant interaktion ved samtidig administration af buprenorphin (doseret med 16 mg daglig) og lopinavir/ ritonavir (doseret med 400/ 100 mg to gange daglig).
Buprenorphine: buprenorphine (dosed at 16 mg daily) co-administered with lopinavir/ ritonavir (dosed at 400/ 100 mg twice daily) showed no clinically significant interaction.
Rifampicin: administration af Kaletra med rifampicin kan ikke anbefales.
31 Rifampicin: co-administration of Kaletra with rifampicin is not recommended.
Hvis man ikke kan undgå samtidig administration, kan forhøjede doser af Kaletra på 400 mg/ 400 mg to gange daglig administreres sammen med rifampicin ved nøje sikkerheds - og terapeutisk medicinsk- overvågning.
If this co-administration is judged unavoidable, increased dose of Kaletra at 400 mg/ 400 mg twice daily may be administered with rifampicin under close safety and therapeutic drug monitoring.
4. 4).
The Kaletra dose should be titrated upward only after rifampicin has been initiated (see section 4.4).
I et klinisk studie, hvor ritonavir 100 mg kapsler blev givet 2 gange daglig samtidig med 50 μg intranasal fluticasonpropionat (4 gange daglig) i 7 dage til raske personer, steg fluticasonpropionat- plasmaniveauet signifikant, mens det interne kortisolniveau faldt med cirka 86% (90% konfidensinterval 82- 89%).
Fluticasone propionate (interaction with ritonavir): in a clinical study where ritonavir 100 mg capsules twice daily were co − administered with 50 μ g intranasal fluticasone propionate (4 times daily) for seven days in healthy subjects, the fluticasone propionate plasma levels increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% confidence interval 82 − 89%).
Større påvirkning kan forventes når
Greater effects may be expected when fluticasone propionate is inhaled.
For at undgå overførelse af HIV, bør HIV- smittede kvinder ikke under nogen omstændigheder amme deres børn.
HIV-infected women must not breast-feed their infants under any circumstances to avoid transmission of HIV.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
32 4.7 Effects on ability to drive and use machines
Bivirkninger i kliniske studier for voksne Infektiøse og parasitære sygdomme
33 Undesirable effects in clinical studies in adult patients Infections and infestations
Mellemørebetændelse, bronkititis, sinitus, furunculus, bakterieinfektion, virusinfektion
Otitis media, bronchitis, sinusitis, furunculosis, bacterial infections, viral infection
Hypogonadisme, Cushings syndrom, hypothyreodisme
Hypergonadism male, Cushing syndrome, hypothyroidism
A- vitaminosis, dehydrering ødemer, øget appetit, laktose acidose, fedme, anoreksi, diabetes mellitus, hyperglykæmi, hypocholesteræmi
Avitminosis, dehydration, oedema, increased appetite, lactic acidosis, obesity, anorexia, diabetes mellitus, hyperglycaemia, hypocholesteramia