natgillin/translations-raw huggingface dataset:
Other common side effects are pseudofolliculitis barbae (ingrown hairs), alopecia (hair loss), stinging skin, burning skin, dry skin, pruritus (itching), erythema (redness), tingling skin, irritated skin, rash, and folliculitis (infected hair follicles).
Drugi pogosti stranski učinki so bili pseudofolikulitis barbe (vraščene dlake), alopecija (izpadanje las in dlak), zbadajoč ali pekoč občutek na koži, suha koža, pruritus (srbenje), eritema (pordelost), mravljinčavost, razdražena koža, izpuščaji ter folikulitis (vneti lasni mešički)..
For the full list of all the side effects reported with Vaniqa, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Vaniqa, najdete v Navodilih za uporabo.
Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or to any of the other ingredients.
Zdravila Vaniqa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na eflornitin ali katerokoli drugo sestavino zdravila.
Why has Vaniqa been approved?
Zakaj je bilo zdravilo Vaniqa odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that Vaniqa’ s benefits are greater than its risks for the treatment of facial hirsutism in women.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Vaniqa pri zdravljenju obraznega hirsutizma pri ženskah večje od z njim povezanih tveganj.
They recommended that Vaniqa be given marketing authorisation (made available to doctors).
Zato je za zdravilo Vaniqa priporočil podelitev dovoljenja za promet z zdravilom (pomeni, da ga zdravniki lahko uporabljajo).
Other information about Vaniqa:
Druge informacije o zdravilu Vaniqa:
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa in on 20 March 2001.
Evropska komisija je dovoljenje za promet z zdravilom Vaniqa, veljavno po vsej Evropski uniji, odobrila dne 20. marca 2001.
The marketing authorisation holder is Laboratorios Almirall, S. A.
Imetnik dovoljenja za promet z zdravilom je družba Laboratorios Almirall, S. A.
The full EPAR for Vaniqa is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Vaniqa je na voljo tukaj.
This summary was last updated in 08-2008
Ta povzetek je bil nazadnje posodobljen marca 2008.
EU-Numbers
Številka EU
Content (concentration) Package sizes
Vsebina (koncentracija)
Cream Cream Cream
Mazilo Mazilo Mazilo
Cutaneous use Cutaneous use Cutaneous use
Za zunanjo uporabo Za zunanjo uporabo Za zunanjo uporabo
SUMMARY OF PRODUCT CHARACTERISTICS
POVZETEK GLAVNIH ZNA ILNOSTI ZDRAVILA 1.
Vaniqa 11.5% cream
Vaniqa 11, 5% krema
Each gram of Vaniqa 11.5% w/ w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
1 gram kreme Vaniqa 11, 5% m/ m vsebuje 115 mg eflornitina (v obliki klorida monohidrat).
Cetostearyl alcohol Stearyl alcohol.
Cetil in stearilalkohol Stearilalkohol
White to off white cream
Bela do umazano bela krema.
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight hours apart.
Zdravilo je treba v tankem sloju nanesti dvakrat dnevno v vsaj osemurnih presledkih na isto in suho kožo prizadetih predelov.
Hands should be washed after applying this medicine.
Po vtiranju zdravila si je treba umiti roke.
For maximal efficacy, the treated area should not be cleansed within four hours of application.
Predelov, kjer ste zdravilo nanesli, zaradi boljše u inkovitosti ne istite vsaj še štiri ure po nanosu.
Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.
Preko predelov, kamor ste nanesli zdravilo, lahko nanašate kozmeti ne preparate (vklju no s kremami za son enje), vendar ne prej kot v petih minutah po nanosu zdravila.
Application should be limited to these areas.
U inkovitost je dokazana le za prizadete predele obraza in brade, zato zdravilo uporabljajte le na teh predelih.
The product should be applied such that no visual residual product remains on the treated areas after rub-in.
Zdravilo nanesite tako, da po vtiranju v kožo na prizadetih predelih ni ostankov kreme.
Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Najvišji varni odmerki v klini nih raziskavah so do 30 gramov mese no.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
Izboljšanje stanja lahko pri akujete znotraj osmih tednov zdravljenja.
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Nadaljevanje zdravljenja izboljša u inek zdravila in je nujno za vzdrževanje ugodnega u inka zdravila.
Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Osem tednov po prekinitvi zdravljenja se lahko bolezen ponovi v enaki jakosti kot pred zdravljenjem. e po štirih mesecih zdravljenja ne pride do izboljšanja stanja, zdravljenje prekinite.
Patients may need to continue to use a hair removal method (e. g. shaving or plucking) in conjunction with Vaniqa.
Pri nekaterih bolnikih je lahko potrebna, poleg zdravilaVaniqa, tudi nadaljnja uporaba metod odstranjevanja dlak (kot npr. britje ali puljenje).
In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.
V teh primerih zdravilo nanesite pet minut po odstranitvi dlak, saj se lahko na teh predelih pojavi zbadajo ali peko ob utek.
(> 65 years) no dosage adjustment is necessary.
(> 65 let) prilagajanje odmerka ni potrebno.
(< 12 years) safety and efficacy of Vaniqa have not been established.
(< 12 let) varnosti in u inkovitosti zdravila Vaniqa niso dolo ili.
2 Hepatic/ renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
Jetrna/ ledvi na okvara: varnosti in u inkovitosti zdravila Vaniqa pri ženskah z jetrno/ ledvi no okvaro niso dolo ili.
Hypersensitivity to eflornithine or to any of the excipients (see section 6.1).
Preob utljivost za eflornitin ali katerokoli pomožno snov (glejte poglavje 6. 1).
Excessive hair growth can result from serious underlying disorders (e. g. polycystic ovary syndrome, androgen secreting neoplasm) or certain medications (e. g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
Prekomerna poraš enost je lahko posledica nekaterih resnih obolenj (kot npr. sindrom policisti nih ovarijev, neoplazme, ki izlo ajo androgene) ali jemanja nekaterih zdravil (npr. ciklosporin, glukokortikoidi, minoksidil, fenobarbiton, fenitoin, kombinirana estrogenska- androgenska hormonska nadomestna terapija).
Transient stinging or burning may occur when the cream is applied to abraded or broken skin.
Izogibajte se kontaktu z o mi ali sluznicami (npr. nos ali usta). e zdravilo nanesete na poškodovano kožo, se lahko na mestu nanosa pojavi prehoden peko ob utek.
If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day.
V primeru draženja kože ali intolerance na mestu nanosa za asno zmanjšajte pogostnost nanašanja na enkrat dnevno. e draženje ne preneha, prekinite terapijo in se posvetujte z zdravnikom.
If irritation continues, treatment should be discontinued and the physician consulted.
Priporo amo, da si po uporabi umijete roke.
As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients.
Varnost uporabe zdravila Vaniqa pri hudi ledvi ni okvari ni bila ugotovljena, zato je pri teh bolnikih potrebna pazljivost pri uporabi zdravila Vaniqa.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e. g. contact dermatitis).
Zdravilo vsebuje cetil in stearilni alkohol in stearilni alkohol, ki lahko povzro ta lokalne reakcije na koži (npr. kontaktni dermatitis).
Pregnancy:
Nose nost:
Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses.
Klini ne študije z omejenim številom nose nic, izpostavljenih zdravilu Vaniqa (22), ne dajejo klini nih dokazov, da je jemanje zdravila škodljivo za mater ali plod.
Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa.
Med 22 nose nostmi med študijo je samo 19 žensk zanosilo med uporabo zdravila Vaniqa.
Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down’ s Syndrome to a 35 year old).
Od teh 19 nose nosti je bilo 9 zdravih novorojen kov, 5 elektivnih prekinitev nose nosti, 4 spontane in 1 novorojen ek z genetsko okvaro (Downov sindrom novorojen ka matere, stare 35 let).
Animal studies have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksi nost (glejte poglavje 5. 3).
Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.
Zato ženske, ki so nose e ali na rtujejo nose nost, pri prekomerni poraš enosti obraza odstranjujejo dlake na druga en na in.
Lactation: it is not known if eflornithine is excreted in human milk.
Ni znano ali se eflonitin izlo a v materino mleko.
Women should not use Vaniqa whilst breast-feeding.
Med dojenjem se zdravila Vaniqa ne sme uporabljati.
No effect is expected.
Vpliva na sposobnost vožnje in upravljanje s stroji ni pri akovati.
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment.
Ve ina s kožo povezanih neželenih u inkov je bilo milih in so izzveneli brez prekinitve uporabe zdravila Vaniqa ali uporabe zdravil.
The most frequently reported undesirable effect was acne, which was generally mild.
Najpogostejši neželeni u inek so akne, ki so ponavadi milejše oblike.
In the vehicle controlled trials (n= 594), acne was observed in 41% of patients at baseline; 7% of patients
V študijah, kontroliranih z vehiklom (n = 594), je imelo 41% bolnikov akne ob za etku študije.
3 treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition.
7% bolnikov zdravljenih z zdravilom Vaniqa in 8% bolnikov, ki so prejemali le vehikel, se je aknavost poslabšala.
Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
Pri bolnikih brez aken ob za etku študije se je aknavost pojavila v podobnem odstotku (14%) tako pri tistih, ki so uporabljali zdravilo Vaniqa ali pa le vehikel.
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Seznam pogostnosti neželenih kožnih reakcij v klini nih študijah po MedDRA konvenciji.
MedDRA conventions for frequency are very common (> 10%), common (> 1% to < 10%), uncommon (> 0.1% to< 1%), rare (> 0.01% to < 0.1%), or very rare (< 0.01%), including isolated reports.
MedDRA konvencija za pogostnost pojavljanja: zelo pogosto (> 10%), pogosto (> 1% do < 10%), ob asno (> 0, 1% do < 1%), redko (> 0, 01% do < 0, 1%), zelo redko (< 0, 01%), vklju no s posami nimi primeri.
Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
V teh študijah je bilo z zdravilom Vaniqa zdravljenih 1. 350 bolnikov 6 mesecev do 1 leta, medtem ko je le vehikel prejemalo nekaj ve kot 200 bolnikov 6 mesecev.
Most events were reported at similar rates between Vaniqa and vehicle.
V pojavnosti neželenih u inkov pri uporabi zdravila Vaniqa ali vehikla ni bilo ve jih razlik.
The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
3 zdravljenih z zdravilom Vaniqa, v primerjavi s tistimi, ki so prejemali le vehikel, kot je ozna eno z zvezdico (*).
Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Pogostnost s kožo povezanih neželenih u inkov, opaženih v klini nih študijah pri zdravilu Vaniqa (po MedDRA konvenciji za pogostnost pojavljanja).
Very common (> 10%)
Zelo pogosto (> 10%)
Common (> 1% to < 10%)
Pogosto (> 1% do < 10%)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Psevdofolikulitis barbae, alopecija, zbadanje na koži *, peko ob utek na koži *, suha koža, pruritus, eritem *, mravljin enje *, draženje kože, izpuš aj *, folikulitis
Uncommon (> 0.1% to < 1%)
Ob asno (> 0, 1 do < 1%)
Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Vraš anje dlak, obrazni edem, dermatitis, edem ust, papulozni izpuš aj, krvave a koža, herpes simplex, ekcem, heilitis, furunkuloza, kontaktni dermatitis, nenormalna sestava las, nenormalna rast las, hipopigmentacija, rde ina kože, otrplost ustnic, bole a koža
Rare (> 0.01% to < 0.1%)
Redko (> 0, 01% do < 0, 1%)
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Rozacea, seboroi ni dermatitis, kožni rak, makulopapulozni izpuš aj, kožne ciste, vezikulobulozni izpuš aj, bolezni kože, hirsuitizem, napetost kože
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Zaradi majhne penetracije eflornitina skozi kožo (glejte poglavje 5. 2) je preveliko odmerjanje malo verjetno.
However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/ kg/ day or approximately 24 g/ day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.
Vendar pa moramo biti v primeru zelo visokih odmerkov pri dermalni aplikaciji ali zaužitja zdravila po pomoti pozorni na u inke, vidne pri intravenskem dajanju zdravila v terapevtskih odmerkih (400 mg/ kg/ dan ali približno 24 g/ dan) pri zdravljenju infekcij s Trypanosoma brucei gambiense (afriška spalna bolezen): izguba las, otekanje obraza, kr i, okvara sluha, prebavne motnje, izguba apetita, glavobol, slabost, vrtoglavica, anemija, trombocitopenija in levkopenija.
D11A X.
Farmakoterapevtska skupina: druga dermatološka zdravila, oznaka ATC:
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Zdravilo Vaniqa upo asni rast las.
Vaniqa has been shown to reduce the rate of hair growth.
Varnost in u inkovitost zdravila Vaniqa je bila preizkušana v dveh dvojno slepih, randomiziranih, klini nih študijah, kontroliranih z vehiklom.
The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle- controlled clinical trials involving 594 women of skin types I-VI (393 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Zdravljenje je trajalo do 24 tednov.
Physicians assessed the change from baseline on a 4-point scale, 48 hours after women had shaved the treated areas of the affected areas of the face and under the chin, considering parameters such as hair length and density, and darkening of the
Po 48 urah zdravljenja so si ženske obrile prizadete predele obraza in brade.
4 skin associated with the presence of terminal hair.
Ocenjevali so parametre, kot je dolžina in gostota dlak, potemnitev kože povezane s prisotnostjo terminalnih dlak.
Improvement was seen as early as 8 weeks after initiation of treatment.
Izboljšanje so opazili že po 8 tednih po za etku zdravljenja.
Outcome* Clear / almost clear Marked improvement Improved No improvement / worse
Rezultat zdravljenja * isto/ skoraj isto O itno izboljšanje Izboljšanje Ni izboljšanja/ slabše
Vaniqa 11.5% cream 6% 29% 35% 30%
Vaniqa 11, 5% krema 6% 29% 35% 30%
Vehicle 0% 9% 33% 58%
Vehikel 0% 9% 33% 58%
* At end of therapy (Week 24).
* Ob koncu terapije (24 teden).
Statistically significant (p 0.001) improvement for Vaniqa versus vehicle was seen in each of these studies for women with marked improvement and clear/ almost clear responses.
4 V obeh študijah so pokazali statisti no zna ilno izboljšanje (p ≤ 0, 001) in rezultat zdravljenja isto/ skoraj isto pri uporabi zdravila Vaniqa v primerjavi z vehiklom.
Subgroup analysis revealed a difference in treatment success where 27% of non-white women and 39% of white women showed a marked or better improvement.
Pri 27% ne - belkah in 39% belkah je prišlo do o itnega izboljšanja.
Subgroup analysis also showed that 29% of obese women (BMI 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
V analizi podskupin se je pokazala tudi razlika med prekomerno prehranjenimi ženskami (BMI ≥ 30), kjer je prišlo do izboljšanja pri 29% in tistimi z normalno telesno maso (BMI < 30), kjer je prišlo do izboljšanja pri 43% žensk.
About 12% of women in the clinical trials were postmenopausal.
Približno 12% žensk je bilo postmenopauzalnih.
Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
Študije so pokazale statisti no zna ilno izboljšanje (p < 0, 001) pri postmenopavzalnih ženskah zdravljenih z zdravilom Vaniqa v primerjavi z vehiklom.
Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair.
Zdravilo Vaniqa je pomembno zmanjšala nelagoden ob utek zaradi obraznih dlak in as, ki ga bolnice porabijo za odstranjevanje in prekrivanje obraznih dlak.
Patient comfort in various social and work settings was also improved.
Izboljšalo se je tudi po utje bolnikov v razli nih družabnih in delovnih okoljih.
Patient self-assessments were found to correlate with physician observations of efficacy.
Samoocenjevanje bolnikov je bilo sorazmerno povezano z zdravnikovo oceno u inkovitosti zdravljenja.
These patient-observable differences were seen 8 weeks after initiating treatment.
Spremembe, ki so jih opazili bolniki, so se pojavile po 8 tednih zdravljenja.
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
Kožna penetracija eflornitina v stanju dinami nega ravnovesja na koži obraza žensk, ki se brijejo je 0, 8%.
The steady state plasma half-life of eflornithine was approximately 8 hours.
Razpolovni as eflornitina v plazmi v stanju dinami nega ravnovesja je približno 8 ur.
Steady state was reached within four days.
Stanje dinami nega ravnovesja se vzpostavi v štirih dneh.
The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ ml and 5 ng/ ml, respectively.
Najvišja koncentracija in najnižja koncentracija pred naslednjim odmerkom v stanju dinami nega ravnovesja sta 10 ng/ ml in 5 ng/ ml.
The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng. hr/ ml.
12 urna površina pod krivuljo plazemske koncentracije v odvisnosti od asa v stanju dinami nega ravnovesja je 92, 5 ng h/ ml.
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Eflornitin se ne presnavlja in se izlo a z urinom.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
Predklini ni podatki na osnovi obi ajnih študij farmakološke varnosti, toksi nosti pri ponavljajo ih se odmerkih, genotoksi nosti, kancerogenega potenciala, vklju no z eno študijo fotokancerogenosti v miših ne kažejo posebnega tveganja za loveka.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
V dermalnih fertilnostnih študijah pri podganah niso opazili škodljivih u inkov na fertilnost tudi pri 180- krat višjih odmerkih kot pri ljudeh.
In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively.
V dermalnih teratoloških študijah na podganah in kuncih niso opazili teratogenih u inkov pri 180- krat (podgane) in 36- krat (kunci) višjih odmerkih kot pri ljudeh.
Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Višji odmerki so povzro ili maternalno in fetusno toksi nost brez dokazov za teratogenost.
Cetostearyl alcohol; Macrogol cetostearyl ether; Dimeticone; Glyceryl stearate; Macrogol stearate; Methyl parahydroxybenzoate (E218); Liquid paraffin; Phenoxyethanol; Propyl parahydroxybenzoate (E216); Purified water Stearyl alcohol.
Cetil in stearilalkohol; Makrogol cetil stearileter; Dimetikon; Glicerilstearat; Makrogol stearat; Metilparahidroksibenzoat (E218); Teko i parafin; Mineralno olje; Fenoksietanol; Propilparahidroksibenzoat (E216); Pre iš ena voda in 5 Stearilalkohol.
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Polietilenska tuba visoke gostote s polipropilensko navojnim pokrov kom, ki vsebuje 15 g, 30 g, ali 60 g kreme.
Ronda General Mitre, 151 08022 Barcelona, Spain.
Ronda General Mitre, 151 08022 Barcelona Španija
7 ANNEX II
6 DODATEK II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN( ODGOVORNI) ZA SPROŠ ANJE SERIJE
8 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
7 A IMETNIK( I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠ ANJE SERIJE
Shire Pharmaceuticals Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom
Shire Pharmaceuticals Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, Velika Britanija
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D-21465 Reinbek Germany
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D- 21465 Reinbek Nem ija
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
V natisnjenem navodilu za uporabo zdravila mora biti navedeno ime in naslov izdelovalca, odgovornega za sproš anje zadevne serije
Not applicable
8 DODATEK III
LABELLING
10 PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI
Vaniqa 11.5% cream Eflornithine
Vaniqa 11, 5% krema eflornitin
STATEMENT OF ACTIVE SUBSTANCE
NAVEDBA ZDRAVILNE U INKOVINE
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
1 gram kreme vsebuje 115 mg eflornitina (v obliki klorid monohidrata).
Also contains: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol.
Vsebuje tudi: cetil in stearilalkohol; makrogol cetil stearileter; dimetikon; glicerilstearat; makrogol stearat; metilparahidroksibenzoat (E218); mineralno olje; fenoksietanol; propilparahidroksibenzoat (E216); teko i parafin; pre iš ena voda in stearilalkohol.
Cutaneous use Read the package leaflet before use.
za dermalno uporabo Pred uporabo preberite priloženo navodilo.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH 11 ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STI NIH OVOJNINAH
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
IME ZDRAVILA IN NA IN UPORABE