natgillin/translations-raw huggingface dataset:
In addition, the test used in the study to investigate the potential for the medicine to trigger an immunological response (when the body makes special proteins, called antibodies, against the medicine) had not been sufficiently validated.
Poleg tega test, ki so ga v okviru raziskave uporabljali za preučitev tveganja, ali lahko zdravilo sproži imunski odziv (pri čemer telo proizvaja posebne beljakovine, imenovane protitelesa, proti zdravilu samemu), ni bil zadostno potrjen.
At this point in time, the CHMP was of the opinion that Alpheon could not be considered as a biosimilar medicine of Roferon-A, the reference medicinal product.
V tem času je bil CHMP mnenja, da zdravilo Alpheon ne more veljati kot zdravilo, ki je biološko podobno referenčnemu zdravilu Roferon- A.
Hence, the CHMP recommended that Alpheon be refused marketing authorisation.
Iz tega razloga je CHMP priporočil zavrnitev dovoljenja za promet z zdravilom Alpheon.
What are the consequences of the refusal for patients undergoing clinical trials/ compassionate use programmes with Alpheon?
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih/ programih sočutne uporabe zdravila Alpheon?
There are no ongoing clinical trials or compassionate use programmes with Alpheon in the European Union.
V Evropski uniji ne poteka nobeno klinično preskušanje kakor tudi ne program sočutne uporabe zdravila Alpheon.
Altargo can be used in patients from the age of nine months, but in patients under 18 years of age, the area to be treated should not be more than 2% of the body’ s surface.
Zdravilo Altargo se lahko uporablja pri bolnikih, starejših od devetih mesecev, vendar pa pri bolnikih, mlajših od 18 let, prizadeto območje ne sme presegati 2% telesne površine.
The active substance in Altargo, retapamulin, is an antibiotic belonging to the ‘ pleuromutilin’ class.
Zdravilna učinkovina zdravila Altargo, retapamulin, je antibiotik iz skupine „ pleuromutilinov “.
It works by blocking the bacteria’ s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Deluje tako, da zavira ribosome bakterij (dele celice, na katerih poteka sinteza proteinov) in tako preprečuje rast bakterij.
Altargo has been studied in five main studies involving over 3,000 patients aged from 9 months upwards.
Zdravilo Altargo so preučevali v petih glavnih študijah, ki so zajele več kot 3. 000 bolnikov, starih od 9 mesecev dalje.
The other three studies 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
V prvi so učinke petdnevnega 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged compared the effects of five days’ treatment with Altargo to those of cefalexin (an oral antibiotic medicine): two studies were carried out in a total of 1,918 patients with infected skin wounds, and the final study was carried out in 545 patients with infected dermatitis (skin inflammation).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged zdravljenja z zdravilom Altargo primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 213 bolnikih, v drugi pa so učinke zdravila Altargo primerjali z učinki fusidinske kisline (drugega antibiotičnega mazila) pri 519 bolnikih.
In patients with impetigo, Altargo was more effective than placebo, with 119 (85.6%) of the 139 patients using Altargo and 37 (52.1%) of the 71 using placebo responding to treatment.
Pri bolnikih z impetigom je bilo zdravilo Altargo učinkovitejše od placeba, saj se je na zdravljenje odzvalo 119 (85, 6%) od 139 bolnikov, ki so jemali zdravilo Altargo, in 37 (52, 1%) od 71 bolnikov, ki so jemali placebo.
Altargo was at least as effective as fusidic acid, with 314 (99.1%) of 317 and 141 (94.0%) of 150 patients, respectively, responding to treatment.
Zdravilo Altargo je bilo vsaj tako učinkovito kot fusidinska kislina, saj se je na zdravljenje odzvalo 314 (99, 1%) od 317 bolnikov, pri fusidinski kislini pa 141 (94, 0%) od 150 bolnikov.
For the treatment of infected skin wounds, Altargo and cefalexin had similar response rates: when the results of both skin wound studies were taken together, around 90% of both groups of patients responded to treatment.
Pri zdravljenju okuženih kožnih ran sta bili stopnji odziva na zdravilo Altargo in cefaleksin podobni: ocena kombiniranih rezultatov obeh študij kožnih ran je pokazala, da se je na zdravljenje odzvalo približno 90% bolnikov iz obeh skupin.
The Committee for Medicinal Products for Human Use (CHMP) decided that Altargo’ s benefits are greater than its risks for the short term treatment of the following superficial skin infections: • impetigo, • infected small lacerations, abrasions or sutured wounds.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Altargo večje od z njim povezanih tveganj pri kratkotrajnem zdravljenju naslednjih povrhnjih okužb kože: • impetigo, • okužene manjše raztrganine, odrgnine ali zašite rane.
This summary was last updated in 07-2007.
Povzetek je bil nazadnje posodobljen 07- 2007.
EMEA Procedure number
Jakost
Invented name
Pakiranje
Pharmaceutical Form
Številka postopka EMEA
Route of administration Packaging
Farmacevtska oblika
Content
Pot uporabe
Ointment Ointment Ointment Ointment
mazilo mazilo mazilo mazilo
Cutaneous use Sachet (alu) Cutaneous use Tube (alu) Cutaneous use Tube (alu) Cutaneous use Tube (alu)
Vrečica (alu) Tuba (alu) Tuba (alu) Tuba (alu)
0.5g 5g 10g 15g
0. 5 g 5g 10 g 15 g
12 sachets 1 tube 1 tube 1 tube
12 vrečic 1 tuba 1 tuba 1 tuba
Altargo 1% ointment
Altargo 1% mazilo
1 g contains 10 mg retapamulin (1% w/ w).
1 g vsebuje 10 mg retapamulina (1% w/ w).
Short term treatment of the following superficial skin infections:
Kratkotrajno zdravljenje naslednjih povrhnjih okužb kože:
Infected small lacerations, abrasions, or sutured wounds.
Okužene manjše raztrganine, odrgnine ali zašite rane.
See sections 4.4 and 5.1 for important information regarding the clinical activity of retapamulin against different types of Staphylococcus aureus.
Za pomembne informacije o klinični učinkovitosti retapamulina proti različnim tipom Staphylococcus aureusa glejte poglavji 4. 4 in 5. 1.
Retapamulin is for cutaneous use only.
Retapamulin je namenjen izključno za dermalno uporabo.
A thin layer of ointment should be applied to the affected area twice daily for five days.
Zdravljenje traja pet dni.
• Impetiginous lesions > 10 in number and exceeding 100 cm2 in total surface area.
impetiginizirane spremembe, katerih število je večje od 10, in skupaj presegajo 100 cm2 • površine.
• Infected lesions that exceed 10 cm in length or a total surface area > 100 cm2.
okužene spremembe, daljše od 10 cm ali s skupno površino > 100 cm2. •
In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
Pri bolnikih, ki so mlajši od 18 let, celotna zdravljena površina ne sme preseči 2% telesne površine.
2 Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
2 Dojenčki mlajši od devetih mesecev
The safety and efficacy of retapamulin ointment has not been established in paediatric patients less than nine months of age.
Pri pediatričnih bolnikih, mlajših od devet mesecev, varnosti in učinkovitosti retapamulina v obliki mazila niso dokazali.
Elderly (aged 65 and older)
Starostniki (stari 65 let in starejši)
See section 5.3.
Glejte poglavje 5. 3.
Known or suspected hypersensitivity to retapamulin or to the excipient.
Znana preobčutljivost za retapamulin ali katerokoli pomožno snov ali sum nanjo.
Care must be taken to avoid ingestion.
Skrbeti je treba tudi, da ne pride do zaužitja.
Retapamulin should not be used to treat infections known or thought likely to be due to MRSA (see section 5.1).
Retapamulin se ne sme uporabljati za zdravljenje okužb, ki so ali bi lahko bile posledica okužbe z MRSA (glejte poglavje 5. 1).
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by methicillin-resistant Staphylococcus aureus (MRSA).
V kliničnih študijah sekundarno okuženih odprtih ran pri bolnikih z okužbami, povzročenimi s proti meticilinu odpornimi sevi Staphylococcus aureusa (MRSA), učinkovitost retapamulina ni bila zadostna.
Retapamulin should not be used to treat abscesses.
Retapamulin se ne sme uporabljati za zdravljenje abscesov.
Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin reaction (e. g. contact dermatitis), or irritation to the eyes and mucous membranes.
Mazilo z retapamulinom vsebuje butilhidroksitoluen, ki lahko povzroči lokalne kožne reakcije (npr. kontaktni dermatitis) ali draženje oči in sluznic.
As with other antibacterial agents, prolonged use of retapamulin may result in overgrowth of non-susceptible micro-organisms, including fungi.
Kot druga protibakterijska zdravila lahko tudi retapamulin pri dolgotrajni uporabi povzroči prekomerno rast neobčutljivih mikroorganizmov, vključno z glivami.
The effect of concurrent application of retapamulin and other topical products to the same area of skin has not been studied, and is not recommended.
Sočasna uporaba ni priporočljiva.
3 In human liver microsomes, retapamulin was a strong inhibitor of CYP3A4.
V človeških jetrnih mikrosomih je retapamulin močno zaviral CYP3A4.
Based on the low plasma concentration achieved in humans after topical application to abraded skin or infected superficial wounds, a clinically relevant inhibition is not expected in vivo (see section 5.2)
Na osnovi majhnih plazemskih koncentracij, doseženih pri človeku po lokalni uporabi na poškodovani koži ali okuženih povrhnjih ranah, klinično pomembnega zaviranja in vivo ne pričakujemo (glejte poglavje 5. 2).
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin AUC(0-24) and Cmax by 81% after topical application of retapamulin 1% ointment on the abraded skin of healthy adult males.
3 retapamulina v obliki 1% mazila na poškodovani koži sta se pri zdravih odraslih moških srednji vrednosti AUC( 0- 24) in Cmax retapamulina povečali za 81%.
Due to low systemic exposure following topical application in patients, dosage adjustments are considered to be unnecessary when topical retapamulin is applied during systemic treatment with CYP3A4 inhibitors.
Zaradi majhne sistemske izpostavljenosti pri lokalni uporabi menimo, da med sistemskim zdravljenjem z zaviralci CYP3A4 odmerka retapamulina pri lokalni uporabi ni treba prilagoditi.
Pregnancy No clinical data on exposed pregnancies are available.
Nosečnost Klinični podatki o izpostavljenosti med nosečnostjo niso na voljo.
Animal studies have shown reproductive toxicity after oral administration and are insufficient with respect to effects on parturition and fetal/ postnatal development (see Section 5.3).
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja po peroralni uporabi in niso zadostne za oceno vplivov na porod in razvoj zarodka ali postnatalni razvoj (glejte poglavje 5. 3).
Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial agent.
Mazilo z retapamulinom se sme med nosečnostjo uporabljati le, če je lokalno zdravljenje s protibakterijskim zdravilom nujno potrebno in uporaba retapamulina primernejša od sistemskega zdravljenja s protibakterijskim zdravilom.
Lactation It is unknown whether retapamulin is excreted in human breast milk.
Dojenje Ni znano, če se retapamulin izloča z materinim mlekom.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the woman.
Pri odločanju o nadaljevanju/ prekinitvi dojenja ali nadaljevanju/ prekinitvi zdravljenja z zdravilom Altargo je treba upoštevati tako korist dojenja za otroka kot korist zdravljenja z zdravilom Altargo za mater.
Altargo is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Zaradi lokalne uporabe zdravila Altargo je verjetnost vpliva na sposobnost vožnje in upravljanja s stroji majhna.
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the most commonly reported adverse reaction was application site irritation, which affected approximately 1% of patients.
Najpogosteje so poročali o draženju na mestu nanosa, ki se je pojavilo približno pri 1% bolnikov.
Common Uncommon
Pogosti Občasni
> 1/ 100 to< 1/10 > 1/1000 to< 1/100
≥ 1/ 100 do < 1/ 10 ≥ 1/ 1. 000 do < 1/ 100
4 Organ systems
Organski sistem
Uncommon
Občasni
General disorders and administration site conditions
Splošne težave in
Application site reactions
Reakcije na mestu
Application site reactions
spremembe na mestu aplikacije
Irritation
nanosa
Pain Pruritus Erythema
nanosa
Contact dermatitis
Bolečina Srbenje Rdečina Kontaktni dermatitis
Any signs or symptoms of overdose, either topically or by accidental ingestion, should be treated symptomatically.
Katerikoli znak ali simptom prevelikega odmerjanja, bodisi pri lokalni uporabi bodisi pri zaužitju, je treba zdraviti simptomatsko.
ATC code:
Zdravila za bolezni kože in podkožnega tkiva, oznaka ATC:
Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non- pleuromutilin antibacterial agents that interact with the ribosome.
Retapamulin selektivno zavira sintezo bakterijskih proteinov z učinkovanjem na edinstveno mesto 50S podenote bakterijskega ribosoma, ki se razlikuje od vezavnih mest drugih nepleuromutilinskih protibakterijskih učinkovin, ki učinkujejo na ribosome.
By virtue of binding to this site, pleuromutilins inhibit peptidyl transfer, partially block P-site interactions, and prevent normal formation of active 50S ribosomal subunits.
Z vezavo na to mesto pleuromutilini zavirajo prenos peptidila, deloma ovirajo interakcije P- mesta in preprečijo normalno formiranje aktivnih 50S ribosomskih podenot.
Mechanism of Resistance
Mehanizem odpornosti
Due to its distinct mechanism of action, retapamulin does not demonstrate target specific cross-resistance with other classes of antibacterial agents.
Zaradi drugačnega mehanizma delovanja retapamulin ne kaže ciljno specifične navzkrižne odpornosti s protibakterijskimi učinkovinami iz drugih skupin.
In vitro, two mechanisms have been identified which reduce susceptibility to retapamulin.
In vitro sta bila ugotovljena dva mehanizma, ki zmanjšata občutljivost za retapamulin.
One involves mutations in ribosomal protein L3, the other is a non- specific efflux mechanism (ABC transporter vgaAv).
Eden vključuje mutacije ribosomskega proteina L3, drugi pa nespecifični mehanizem prenosa (ABC- prenašalec vgaAv).
5 No development of resistance was observed during treatment with retapamulin in the clinical study programme and all clinical isolates were inhibited by retapamulin concentrations of < 2µg/ ml.
Pri vseh kliničnih izolatih je bila inhibicija dosežena pri koncentraciji retapamulina ≤ 2 μg/ ml.
Commonly susceptible species
5 Običajno občutljive vrste
$In vitro, retapamulin was equally active against methicillin-susceptible and methicillin- resistant strains of S. aureus.
Enterococcus faecalis $In vitro je bila učinkovitost retapamulina proti meticilinu občutljivim in proti meticilinu odpornim sevom S. aureus enaka.
However, see section 4.4 and below regarding clinical efficacy against MRSA.
O klinični učinkovitosti proti MRSA glejte poglavje 4. 4 in podatke v nadaljevanju.
Information from clinical trials
Podatki iz kliničnih preskušanj
Very few MRSA were isolated in studies in impetigo and all were clinical successes (100%:
Zdravljenje vseh okužb je bilo klinično uspešno (100%:
In studies in impetigo and in two studies of secondarily infected open wounds (SIOW), clinical success rates were high for retapamulin in patients with mupirocin-resistant S. aureus (100%:
V študijah uporabe pri impetigu in v dveh študijah uporabe pri sekundarnih okužbah odprtih ran so bili deleži klinične uspešnosti retapamulina visoki, tako pri bolnikih s proti mupiricinu odpornimi sevi S. aureusa (100%:
11/ 11) or fusidic acid-resistant S. aureus (96.7%:
11/ 11), kot pri bolnikih s proti fusidinski kislini odpornimi sevi S. aureusa (96, 7%:
However, in the two studies that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was inadequate (75.7%).
V dveh študijah, ki sta vključevali bolnike s sekundarnimi okužbami odprtih ran, pa je bila učinkovitost retapamulina pri okužbah z MRSA nezadostna (75, 7%).
No differences were observed in the in vitro activity of retapamulin versus S. aureus whether the isolates were susceptible or resistant to methicillin.
Pri in vitro ugotavljanju učinkovitosti retapamulina proti meticilinu občutljivim in proti meticilinu odpornim sevom S. aureus niso opazili razlik.
In the case of treatment failure associated with S. aureus, the presence of strains possessing additional virulence factors (such as Panton-Valentine Leukocidin) should be considered.
V primeru neuspešnega zdravljenja okužbe s S. aureus je treba presoditi o prisotnosti sevov z dodatnimi virulenčnimi faktorji (kot je Panton - Valentine Leukocidin).
6 Clinical Success Rates at Follow up for SIOW patients with S. aureus
Deleži klinične uspešnosti pri spremljanju bolnikov s sekundarnimi okužbami odprtih ran s S. aureus
Phenotype/ PFGE
Fenotip/ PFGE tip
n/ N Success 95% Exact n/ N
n/ N Delež 95% n/ N
Success
Delež
Rate (%)
uspešnosti (%)
CI
natančen IZ
S. aureus (all) MRSA $MSSA
S. aureus (vsi) MRSA $MSSA
(85.3,91.9) (58.8,88.2) (86.7,93.3)
(85, 3; 91, 9) (58, 8; 88, 2) (86, 7; 93, 3)
Exact CI is calculated using the F-distribution method. $: the response rate for MRSA due to PVL+ MRSA was 8/ 13 (62%)
Natančen IZ je izračunan z metodo F- porazdelitve. $: delež odziva za MRSA zaradi PVL+ MRSA je bil 8/ 13 (62%)
5.2 Pharmacokinetic properties
6 5. 2 Farmakokinetične lastnosti
In a study of healthy adult subjects, 1% retapamulin ointment was applied daily to intact and to abraded skin under occlusion for up to 7 days.
Zdravljenje je trajalo do 7 dni.
The geometric mean Cmax value in plasma after application to 200 cm2 of abraded skin was 9.75 ng/ ml on day 1 and 8.79 ng/ ml on day 7 and the maximum individual systemic exposure (Cmax) recorded was 22.1 ng/ ml.
Največja zabeležena posamezna sistemska izpostavljenost (Cmax) je bila 22, 1 ng/ ml.
Single plasma samples were obtained from 516 adult and paediatric patients who received topical treatment with retapamulin 1% ointment twice daily for 5 days for the treatment of secondarily infected traumatic lesions.
Pri 516 odraslih in pediatričnih bolnikih, ki so za zdravljenje sekundarno okuženih travmatskih sprememb 5 dni dvakrat dnevno lokalno uporabljali retapamulin v obliki 1% mazila so bili enkrat odvzeti vzorci plazme.
The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ ml).
Večina vzorcev (89%) je bila pod mejo dokazljivosti (0, 5 ng/ ml).
Of the samples that had measurable concentrations 90% had retapamulin concentrations less than 2.5 ng/ ml.
V 90% vzorcev z merljivo koncentracijo je bila koncentracija retapamulina manjšo od 2, 5 ng/ ml.
The maximum measured plasma concentration of retapamulin was 10.7 ng/ ml in adults and 18.5 ng/ ml in paediatric patients.
Pri odraslih je bila največja izmerjena koncentracija retapamulina v plazmi 10, 7 ng/ ml, pri otrocih pa 18, 5 ng/ ml.
In vitro, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
In vitro je bilo dokazano, da je retapamulin substrat za P- glikoprotein (Pgp) in njegov zaviralec.
However, the maximum individual systemic exposure in humans following topical application of 1% ointment on 200 cm2 of abraded skin (Cmax= 22 ng/ ml; AUC(0-24) = 238 ng. h/ ml) was 660-fold lower than the retapamulin IC50 for Pgp inhibition.
Vendar pa je bila največja posamezna sistemska izpostavljensot pri človeku po lokalni uporabi 1% mazila na 200 cm2 velikem predelu poškodovane kože (Cmax = 22 ng/ ml; AUC( 0- 24) = 238 ng. h/ ml) 660- krat manjša od IC50 vrednosti retapamulina za zaviranje Pgp.
Retapamulin is approximately 94% bound to human plasma proteins.
Vezava retapamulina na plazemske proteine je približno 94- odstotna.
The in vitro oxidative metabolism of retapamulin in human liver microsomes was primarily mediated by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).
Oksidativna presnova retapamulina v človeških jetrnih mikrosomih je bila in vitro v glavnem povezana s CYP3A4 in le v manjši meri s CYP2C8 in CYP2D6 (glejte poglavje 4. 5).
7 Special Patient Populations
Posebne skupine bolnikov
No pharmacokinetic data are available in children aged less than 2 years, or in patients with renal or hepatic impairment.
Pri otrocih, mlajših od 2 let, in bolnikih z okvaro ledvic ali jeter, farmakokinetični podatki niso na voljo.
In 14-day (50, 150 or 450 mg/ kg) oral toxicity studies in rats there was evidence of adaptive hepatic and thyroid changes.
Pri podganah so pri 14- dnevnih študijah toksičnosti pri peroralni uporabi (50, 150 ali 450 mg/ kg) opazili adaptivne spremembe v jetrih in ščitnici.
In monkeys dosed orally (50, 150 or 450 mg/ kg) for 14 days there was dose-related emesis.
Pri opicah so pri 14- dnevnem peroralnem dajanju (50, 150 ali 450 mg/ kg) opazili od odmerka odvisen pojav bruhanja.
Carcinogenesis, mutagenesis, reproductive toxicity
7 Kancerogenost, mutagenost in vpliv na sposobnost razmnoževanja
There was no evidence of genotoxicity when evaluated in vitro for gene mutation and/ or chromosomal effects in the mouse lymphoma cell assay, in cultured human peripheral blood lymphocytes, or when evaluated in vivo for chromosomal effects in a rat micronucleus test.
Pri in vitro vrednotenju genske mutacije in/ ali vplivov na kromosome pri testih na celicah mišjega limfoma, kulturi človeških limfocitov iz periferne krvi in pri in vivo vrednotenju vplivov na kromosome pri mikronukleus testih na podganah niso opazili znakov genotoksičnosti.
There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or 450 mg/ kg/ day, resulting in exposure margins of up to 5-times the highest human estimated exposure (topical application to 200 cm2 abraded skin:
Pri samcih in samicah podgan, ki so peroralno prejemali odmerke 50, 150 ali 450 mg/ kg/ dan, kar predstavlja do 5- krat večjo mejno izpostavljenost od največje pričakovane izpostavljenosti človeka (lokalna uporaba na površini 200 cm2 poškodovane kože:
AUC 238 ng. h/ ml).
AUC 238 ng. h/ ml), niso opazili škodljivih vplivov na plodnost.
In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150 mg/ kg/ day (corresponding to ≥ 3 times the human estimated exposure (see above).
Pri študijah embriotoksičnoti na podganah so pri peroralnih odmerkih ≥ 150 mg/ kg/ dan (kar ustreza ≥ 3- kratni pričakovani izpostavljenosti človeka (glejte zgoraj)) opazili škodljiv vpliv na razvoj (manjša telesna masa plodov in zakasnela osifikacija skeleta) in škodljiv vpliv na matere.
There were no treatment-related malformations in rats.
Pri podganah niso opazili malformacij, ki bi bile posledice uporabe zdravila.
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to day 19 of gestation.
Breje kunčje samice so prejemale retapamulin v obliki kontinuirane intravenske infuzije od 7. do 19. dneva gestacije.