qanastek/EMEA-V3 huggingface dataset:
It is recommended that hands are washed following use.
Hu rakkomandat li l- idejn jin aslu wara l- u u.
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.
Min abba li s- sigurtà ta ’ Vaniqa ma kinitx studjata fuq pazjenti b’ indeboliment sever tal - kliewi, g andha ting ata attenzzjoni meta ting ata ri etta g al Vaniqa lil dawn il- pazjenti.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e. g. contact dermatitis).
Dan il- prodott fih cetostearyl alcohol u stearyl alcohol li jistg u jikkaw aw reazzjonijiet lokali tal - ilda (e. dermatite tal- kuntatt).
No interaction studies have been performed.
Ma sarux studji dwar l- effett ta ’ medi ini jew ta ’ affarijiet o ra fuq l- effett farma ewtiku tal - prodott.
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.
Matul provi klini i, informazzjoni minn numru limitat ta ’ tqaliet esposti (22) tindika li m’ hemm l- ebda evidenza klinika li l- kura b’ Vaniqa taffettwa b’ mod negattiv lill- ommijiet jew lill- feti.
Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa.
Fost it- 22 tqala li se ew matul il- provi, 19 biss minnhom se ew waqt li l- pazjenta kienet qed tu a 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).
Minn dawn id- 19- il tqala, kien hemm 9 trabi b’ sa ithom, 5 aborti elettivi, 4 aborti spontanji u difett wie ed tat- twelid (Sindromu ta ’ Down li se lil omm ta ’ 35 sena).
To date, no other relevant epidemiological data are available.
Sal- lum, l- ebda informazzjoni epidemjolo ika rilevanti o ra m’ hi disponibbli.
Animal studies have shown reproductive toxicity (see section 5.3).
Studji fuq l- annimali wrew tossi ità riproduttiva (ara sezzjoni 5. 3).
The potential risk to humans is unknown.
Ir- riskju potenzjali g all - bnedmin mhuwiex mag ruf.
Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.
G alhekk nisa li huma tqal jew li qed jippjanaw li jinqabdu tqal g andhom ju aw mezzi alternattivi biex jie du sieb ix- xag ar tal- wi.
Lactation: it is not known if eflornithine is excreted in human milk.
Treddig: mhux mag ruf jekk eflornithine jg addix fil - alib tal- bniedem.
Women should not use Vaniqa whilst breast-feeding.
In- nisa m’ g andhomx ju aw Vaniqa waqt li jkunu qed ireddg u.
No effect is expected.
L- ebda effett m’ hu mistenni.
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment.
Ir- reazzjonijiet avversi rrappurtati, li eneralment kienu marbuta mal - ilda, kienu primarjament fief fl- intensità u kienu fiequ bit- twaqqif ta ’ Vaniqa jew bil- bidu ta ’ kura
The most frequently reported undesirable effect was acne, which was generally mild.
L- aktar effett mhux mixtieq li kien rrappurtat b’ mod frekwenti kien l- akne, li kienet eneralment afifa.
In the vehicle controlled trials (n= 594), acne was observed in 41% of patients at baseline; 7% of patients
Fil- provi kkontrollati bil- vehicle (n= 594), l- akne kienet osservata f’ 41% tal- pazjenti fil- linja ba i; 7% tal- pazjenti kkurati b’ Vaniqa u 8% kkurati bil- vehicle kellhom sitwazzjoni fejn il- kundizzjoni tag hom marret g all- ag ar.
Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
Fost dawk ming ajr akne fil - linja ba i, per entwali simili (14%) irrappurutaw l- akne wara l- kura b’ Vaniqa jew bil- vehicle.
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Il- lista li ejja tinnota l- frekwenza tar- reazzjonijiet avversi tal - ilda li dehru fi provi klini i, skond il- konvenzjoni MedDRA.
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.
Il- konvenzjonijiet MedDRA g all- frekwenza huma: komuni afna (> 10%), komuni (> 1% sa < 10%), mhux komuni (> 0. 1% sa < 1%), rari (> 0. 01% sa < 0. 1%), jew rari afna (< 0. 01%), li jinkludu rapporti i olati.
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.
Innota li iktar minn 1, 350 pazjent kienu kkurati b’ Vaniqa f’ dawn il- provi g al minn 6 xhur sa sena, filwaqt li ftit iktar minn 200 pazjent kienu kkurati bil- vehicle g al 6 xhur.
Most events were reported at similar rates between Vaniqa and vehicle.
Il- bi a l- kbira ta ’ l- avvenimenti kienu rrappurtati f’ rati simili bejn Vaniqa u l- vehicle.
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 (*).
L- effetti fuq il - ilda tal - ruq, tingi, tnemnim, raxx u eritema kienu rrappurtati f’ livelli og la f’ pazjenti kkurati b’ Vaniqa meta mqabbla mal - vehicle, kif indikat mill- asterisk (*).
Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Frekwenza tar- reazzjonijiet avversi fuq il - ilda li dehru fi provi klini i b’ Vaniqa (skond il - konvenzjoni tal- frekwenza MedDRA).
Skin and subcutaneous tissue disorders
Disturbi fil - ilda u fit- tessuti ta ’ ta t il - ilda
Very common (> 10%)
Komuni afna (> 10%)
Common (> 1% to < 10%)
Komuni (> 1% sa < 10%)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Barbae psewdofollikulite, alope ja, tingi tal - ilda *, ruq tal - ilda *, ilda niexfa, akk, eritema *, tnemnim tal - ilda *, irritazzjoni tal - ilda, raxx *, follikulite
Uncommon (> 0.1% to < 1%)
Mhux Komuni (> 0. 1% sa < 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
Tkabbir ’ il ewwa tax- xag ar, edema fil- wi, dermatite, edema fil - alq, nuffata, ru ta ’ demm mill - ilda, herpes simplex, ek ema, cheilitis, furunkolosi, dermatite tal- kuntatt, struttura anormali tax- xag ar, tkabbir anormali tax- xag ar, ipopigmentazzjoni, mura tal - ilda, tnemnim tax - xufftejn, u ig tal - ilda.
Rare (> 0.01% to < 0.1%)
Rari (> 0. 01% sa < 0. 1%)
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Rosa ea, dermatite seborreika, neopla ma tal - ilda, raxx makulopapulari, isti tal - ilda, raxx, raxx vesikulobullu, disturbi tal - ilda, tkabbir e essiv ta ’ xag ar, ilda ssikkata.
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
Min abba l- penetrazzjoni minima fil - ilda ta ’ eflornithine (ara sezzjoni 5. 2), diffi li afna li jkun hemm do a e essiva.
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.
Madankollu, jekk ting ata do a kbira afna fuq il - ilda jew tinbela ’ a identalment, g andha ting ata attenzjoni g all- effetti murija b’ do i terapewti i ta ’ eflornithine fil- vina (400 mg/ kg/ kuljum jew madwar 24 g/ kuljum) u ati fil- kura ta ’ infezzjoni bi Trypanosoma brucei gambiense (marda Afrikana ta ’ l- irqad): telf ta ’ xag ar, nef a tal - wi, puplesiji, indeboliment tas- smig, disturbi gastrointestinali, nuqqas t’ aptit, u ig ta ’ ras, indebboliment, sturdament, anemija, trombo itopenja u lewkopenja.
Pharmacotherapeutic group: other dermatologicals, ATC code:
Kategorija farmakoterapewtika: dermatolo i i o rajn, kodi i ATC:
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Eflornithine jinibixxi b’ mod irriversibbli ornithine decarboxylase, enzima involuta fil - produzzjoni tal- ba i tax- xag ra mill- follikulu tax- xag ar.
Vaniqa has been shown to reduce the rate of hair growth.
Intwera li Vaniqa tnaqqas ir- rata tat- tkabbir tax- xag ar.
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.
4 Is- sigurtà u l- effika ja ta ’ Vaniqa kienu evalwati f ’ ew provi klini i, double- blind, randomised, ikkontrollati bil- vehicle li involvew 594 mara b ’ ilda tat- tip I VI (393 b’ Vaniqa, 201 bil- vehicle) li ew kkurati sa 24 img a.
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
It- tobba g amlu evalwazzjoni tal- bidla mil- linja ba i fuq skala ta’ 4 punti, 48 sieg a wara li n- nisa kienu qaxxru l- partijiet affettwati fuq il - wi u ta t l- il it, b’ konsiderazzjoni ta ’ parametri b at- tul u d- densità tax- xag ar, u l - oskurita` tal - ilda asso jata mal- pre enza ta ’ xag ar terminali.
Improvement was seen as early as 8 weeks after initiation of treatment.
It- titjib deher sa minn 8 img at wara l- bidu tal- kura.
The combined results of these two trials are presented below:
Ir- ri ultati kombinati ta ’ dawn i - ew provi huma ppre entati hawn ta t:
Outcome* Clear / almost clear Marked improvement Improved No improvement / worse
Ri ultat * ar / kwa i ar Titjib notevoli Titjib L- ebda titjib / ag ar
Vaniqa 11.5% cream 6% 29% 35% 30%
Vaniqa 11. 5% krema 6% 29% 35% 30%
Vehicle 0% 9% 33% 58%
Vehicle 0% 9% 33% 58%
* At end of therapy (Week 24).
* Fit- tmiem tat- terapija (img a 24).
For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
G al pazjenti li waqqfu t- terapija matul il- prova, l- a ar osservazzjonijiet kienu mg oddija g all - img a 24.
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.
Titjib statistikament sinifikanti (p 0. 001) g al Vaniqa meta mqabbel mal- vehicle deher f’ kull wie ed minn dawn l- istudji fuq in- nisa fejn kien hemm ri ultati ta ’ titjib notevoli u risponsi li kienu ari/ kwa i ari.
These improvements resulted in a corresponding reduction in the darkening appearance of the facial skin associated with the presence of terminal hair.
IIIr.
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.
Anali i tas - sotto- grupp velat differenza fis- su ess tal- kura, fejn 27% tan- nisa mhux bojod u 39% tan - nisa bojod urew titjib notevoli jew a jar.
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.
L- anali i tas- sotto- grupp uriet ukoll li 29% tan- nisa oxnin, (BMI 30) u 43% tan- nisa b’ pi normali (BMI < 30) urew titjib notevoli jew a jar.
About 12% of women in the clinical trials were postmenopausal.
Madwar 12% tan- nisa fil- provi klini i kienu nisa li di à kellhom il- menopawsa.
Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
Titjib sinifikanti (p < 0. 001) meta mqabbel mal- vehicle deher f’ nisa li di à kellhom il- menopawsa.
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Evalwazzjonijiet tal- pazjenti fuqhom infushom urew tnaqqis sinifikanti fl- iskonfort psikolo iku bil- kundizzjoni tag hom, kif imkejla mit- twe ibiet g al 6 mistoqsijiet fuq skala analoga vi wali.
Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair.
Vaniqa naqqset b’ mod sinifikanti l- livell ta ’ kemm il- pazjenti assewhom imdejqin bix- xag ar ma ’ wi hom u bil - in me tie biex jitne a, ji i kkurat, jew biex jitg atta x- xag ar tal- wi.
Patient comfort in various social and work settings was also improved.
Kien hemm titjib ukoll fil- komfort tal- pazjenti f’ diversi sitwazzjonijiet so jali u fuq ix- xog ol.
Patient self-assessments were found to correlate with physician observations of efficacy.
Instab li kien hemm korrelazzjoni bejn l - evalwazzjonijiet li l- pazjenti g amlu fuqhom infushom u l- osservazzjonijiet tat- tabib dwar l - effika ja.
These patient-observable differences were seen 8 weeks after initiating treatment.
Dawn id- differenzi li jidhru fuq il- pazjenti dehru 8 img at wara l- bidu tal- kura.
The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
Il- kundizzjoni rritornat g al- livelli ta ’ qabel il- kura fi mien tmien img at wara t- twaqqif tal- kura.
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
Il- penetrazzjoni fil - ilda fl- istat fiss ta ’ eflornithine fin- nisa minn Vaniqa fuq il - ilda tal- wi ta ’ nisa li jqaxxru x- xag ar kienet ta ’ 0. 8%.
The steady state plasma half-life of eflornithine was approximately 8 hours.
Il- half- life tal- pla ma fl- istat fiss ta ’ eflornithine kienet ta ’ madwar 8 sig at.
Steady state was reached within four days.
L- istat fiss intla aq fi mien erbat ijiem.
The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ ml and 5 ng/ ml, respectively.
Ir- rata massima ta ’ l- istat fiss u l- kon entrazzjonijiet minimi tal- pla ma ta ’ eflornithine kienu ta ’ madwar 10 ng/ ml u 5 ng/ ml, rispettivament.
The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng. hr/ ml.
L- istat fiss ta ’ 12- il sieg a fi - ona ta ’ ta t il- kon entrazzjoni tal- pla ma kontra l- kurva tal - in kienet ta ’ 92. 5 ng. sieg a/ ml.
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Eflornithine mhuwiex mag ruf li ji i metabolit, u hu eliminat primarjament fl- awrina.
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.
5 Informazzjoni mhux klinika ma velat l- ebda periklu g all- persuni bba ata fuq studji konvenzjonali dwar it- tossi ità ta ’ do i ripetuti, il - enotossi ità u l- potenzjal kar ino eniku, inklu studju dwar il- fotokar ino eni ità fil - rieden.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
Fi studju dwar il- fertilità dermali fuq il- firien, ma kienu osservati l- ebda effetti avversi fuq il - fertilità sa 180 darba aktar mid- do a umana.
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.
Fi studju dwar it- teratolo ija dermali, l- ebda effetti terato eni i ma kienu osservati fil- firien u l- fniek f’ do i sa 180 u 36 darba aktar mid - do a umana, rispettivament.
Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Do i akbar irri ultaw f’ tossi ità materna u fuq il- fetu ming ajr evidenza ta ’ terato eni ità.
Cetostearyl alcohol; Macrogol cetostearyl ether; Dimeticone; Glyceryl stearate; Macrogol stearate; Methyl parahydroxybenzoate (E218); Liquid paraffin; Phenoxyethanol; Propyl parahydroxybenzoate (E216); Purified water Stearyl alcohol.
Cetostearyl alcohol; Macrogol cetostearyl ether; Dimeticone; Glyceryl stearate; Macrogol stearate; Methyl parahydroxybenzoate (E218); Liquid paraffin; Phenoxyethanol; Propyl parahydroxybenzoate (E216); Purified water Stearyl alcohol.
Do not store above 25°C.
Ta inx f’ temperaturi ’ l fuq minn 25°C.
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Sto tal- polyethylene b’ densità g olja b’ g atu bil- kamini tal- polypropylene, li jkun fih 15 g, 30 g jew 60 g ta ’ krema.
Ronda General Mitre, 151 08022 Barcelona, Spain.
Ronda General Mitre, 151 08022 Barcelona Spanja
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TI DID TA ’ L - AWTORIZZAZZJONI
20 March 2001
20 ta ’ Marzu, 2001
DATE OF REVISION OF THE TEXT
DATA TA ’ META
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
8 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
8 A DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI G ALL - RU TAL- LOTT
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, Renju Unit
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D-21465 Reinbek Germany
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D- 21465 Reinbek ermanja
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
Fuq il- fuljett ta ’ tag rif tal- prodott medi inali g andu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli mill - ru tal- lott kon ernat.
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - U U IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT - TQEG ID FIS- SUQ
Not applicable
Ma jg oddx f’ dan il- ka.
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
11 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Vaniqa 11.5% cream Eflornithine
Vaniqa 11. 5% krema Eflornithine
Each gram of cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Kull 1 g ta ’ krema fiha 115 mg ta ’ eflornithine (b ala hydrochloride monohydrate).
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.
Fih ukoll: cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol.
Cutaneous use Read the package leaflet before use.
U u g al fuq il - ilda Aqra l- fuljett ta ’ tag rif qabel l- u u.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT - TQEG ID FIS- SUQ
Ronda General Mitre, 151 08022 Barcelona Spain.
Ronda General Mitre, 151 08022 Barcelona Spanja
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDI INALI U MNEJN G ANDU JING ATA
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS - SUQ
14 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
14 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq:
MARKETING AUTHORISATION NUMBER (S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI G AT- TQEG ID FIS- SUQ
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
17 TAG RIF LI G ANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
19 TAG RIF MINIMU LI G ANDU JIDHER FUQ IL- PAKKETTI - G AR EWLENIN
21 PACKAGE LEAFLET:
21 FULJETT TA ’ TAG RIF:
Vaniqa 11.5% cream (eflornithine)
Vaniqa 11. 5% krema (eflornithine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
AQRA DAN IL- FULJETT KOLLU QABEL TIBDA TU A DIN IL- MEDI INA. omm dan il- fuljett.
If you have any further questions, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispi jar tieg ek.
This medicine has been prescribed for you.
Din il- medi ina iet mog tija lilek.
Do not pass it on to others.
TAG TIHIEX lil persuni o ra.
It may harm them, even if their symptoms are the same as yours.
Tista ’ tag mlilhom il - sara, anki jekk ikollhom l- istess sintomi bhal tieg ek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wie ed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jog bok g id lit- tabib jew lill- ispi jar tieg ek.
What Vaniqa is and what it is used for Before you use Vaniqa How to use Vaniqa Possible side effects How to store Vaniqa Further information
X’ INHU Vaniqa U G ALXIEX JINTU A Qabel ma tu a Vaniqa Kif g andek tu a Vaniqa Effetti sekondarji li jista ’ jkollu Kif g andek tu a Vaniqa Aktar tag rif
WHAT Vaniqa IS AND WHAT IT IS USED FOR
X’ INHU Vaniqa U G ALXIEX JINTU A
Women use Vaniqa to reduce the growth of excessive hair on their faces.
In- nisa ju aw Vaniqa biex inaqqsu t- tkabbir ta ’ xag ar e essiv fuq wi hom.
How it works
Kif ja dem
Vaniqa slows down the growth of hair through its effect on an enzyme involved in the production of hair.
Vaniqa jnaqqas ir- rata tat- tkabbir tax- xag ar permezz ta ’ l- effett tieg u fuq l- enzima involuta fil- produzzjoni tax- xag ar.
It does not remove hair.
Vaniqa ma jne ix ix- xag ar.
It is not a depilatory cream so you may need to continue removing hair, for example by shaving or plucking.
Din mhix krema depilatorja u g alhekk jista ’ jkollok b onn tibqa ’ tne i x- xag ar, pere empju billi tqaxxru jew taqilg u.
Improvement may be seen as early as 2 months after start up of treatment.
It- titjib jista ’ jibda jidher sa minn xahrejn wara l- bidu tal- kura.
If you do not see any benefit after using it for 4 months contact your doctor.
Jekk ma tara l- ebda benefi ju wara li tkun u ajt il- krema g al 4 xhur, ikkuntattja lit- tabib tieg ek.
If you stop using it your original hair growth may return in 2 months.
Jekk tieqaf tu aha, it - tkabbir ori inali ta ’ xag rek jista ’ jirritorna wara xahrejn.
BEFORE YOU USE Vaniqa
QABEL MA TU A Vaniqa
Do NOT use Vaniqa:
TU AX Vaniqa
if you are allergic (hypersensitive) to eflornithine or to any of the other ingredients.
jekk int aller ika (tbati minn sensittività e essiva) g al eflornithine jew g al xi sustanzi mhux attivi.
Take special care with Vaniqa:
Oqg od attenta afna b’ Vaniqa
Before using Vaniqa, tell your doctor of any other medical problems (especially related to your kidneys or liver).
Qabel tu a Vaniqa, g id lit- tabib tieg ek b’ xi problemi medi i o ra (spe jalment dwar dawk marbuta mal- kliewi jew mal- fwied tieg ek).
If you are unsure whether or not to use this medicine contact your doctor or pharmacist for advice.
Jekk m’ intix erta jekk g andekx tu a din il- medi ina, ikkuntattja lit- tabib jew lill - ispi jar tieg ek g all- parir.
22 Excessive growth of hair may be a result of underlying diseases or certain medications.
22 X’ g andi nkun naf aktar?
Contact your doctor if you have any questions.
It- tkabbir e essiv tax- xag ar jista ’ jkun ir- ri ultat ta ’ mard li ma jidhirx jew ta ’ ertu medi ini.
Wait at least 5 minutes after shaving or plucking before using this cream.
Stenna mill- inqas 5 minuti wara t- tqaxxir jew it- tne ija tax- xag ar qabel ma tu a din il - krema.
It may sting or burn if you put this medicine on cut or irritated skin.
Jista ’ jkun hemm tingi jew ruq jekk tpo i din il- medi ina fuq ilda maqsuma jew irritata.
Do not get it in your eyes or inside your nose or mouth.
Idda alhiex f’ g ajnejk jew f’ imnie rek jew f ’ alqek.
If this happens accidentally, rinse thoroughly with water.
Jekk dan ise b’ mod a identali, la la sew bl- ilma.
Using Vaniqa with other medicines
Meta tu a Vaniqa ma ’ medi ini o ra
Speak to your doctor if you need to use other medicines on the areas of skin where you are using it.
Kellem lit- tabib tieg ek jekk g andek b onn tu a medi ini o ra fuq partijiet tal - ilda fejn qed tu aha.
Pregnancy and Breast-feeding
Tqala u treddig
Do not use Vaniqa if you are pregnant, or trying to become pregnant.
Tu ax Vaniqa jekk inti tqila jew qed tipprova to ro tqila.
You should not use this medicine while breast-feeding.
M’ g andekx tu a din il- medi ina waqt li tkun qed tredda ’.
Important information about some of the ingredients of Vaniqa
Tag rif importanti dwar xi w ud mis- sustanzi ta ’ Vaniqa
This medicine contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Dan il- prodott fih cetostearyl alcohol u stearyl alcohol li jistg u jikkaw aw reazzjonijiet lokali tal - ilda (e. dermatite tal- kuntatt).
HOW TO USE Vaniqa
KIF G ANDEK TU A Vaniqa
Always use Vaniqa exactly as your doctor has instructed you.
Dejjem g andek tu a Vaniqa skond il- parir tat- tabib tieg ek.
You should check with your doctor or pharmacist if you are unsure.
Dejjem g andek ta erta ru ek mat- tabib jew ma ’ l- ispi jar tieg ek jekk ikollok xi dubju.
If you have just shaved or used any other hair removal method, wait at least 5 minutes before using Vaniqa.
Jekk tkun g adek kif qaxxart jew u ajt xi metodu ie or tat- tne ija tax- xag ar, stenna mill- inqas 5 minuti qabel tu a Vaniqa.
Clean and dry the areas of the skin where you will be using it.
Naddaf u nixxef il- partijiet tal - ilda fejn tkun se tu aha.
Apply a thin layer of cream and rub it in thoroughly.
Idlek saff irqiq ta ’ krema u og rokha sew.
If possible, do not wash these areas of skin for 4 hours after putting it on.
Jekk ikun possibbli, ta silx dawn il- partijiet tal - ilda sa 4 sig at wara li tkun dlikt il - krema.
Wash your hands after applying it.
A sel idejk wara li tkun dliktha.
Wait at least 5 minutes before using make-up or sunscreen on the same areas.
Stenna mill- inqas 5 minuti qabel ma tu a l- make- up jew krema g all- protezzjoni kontra x- xemx fl- istess partijiet.
Use it twice a day, at least 8 hours apart.
U aha darbtejn kuljum, mill- inqas wara perjodu ta ’ 8 sig at.
Vaniqa can cause irritation (stinging, burning).
Vaniqa tista ’ tikkaw a irritazzjoni (tingi, ruq).
If irritation is caused, reduce the use of Vaniqa to once a day until the irritation has gone.
Jekk ikun hemm irritazzjoni, naqqas l- u u ta ’ Vaniqa g al darba kuljum sakemm tg addi l- irritazzjoni.
If irritation persists contact your doctor.
Jekk l- irritazzjoni tippersisti, ikkuntattja lit- tabib tieg ek.
How long should I use Vaniqa?
Kemm g andi ndum nu a Vaniqa?
It may take up to 2 months before you see results.
Jista ’ jkun hemm b onn sa xahrejn biex tibda tara r- ri ultati.
Continually using it may lead to further improvement.
It- tkomplija ta ’ l- u u tag ha jista ’ jwassal g al titjib ulterjuri.
You will need to keep using it to keep the benefit.
Se jkollok b onn tkompli tu aha biex i omm il- benefi ju.
If you do not see any benefit after using it f or 4 months contact your doctor.
Jekk ma tara l- ebda benefi ju wara li tkun u ajt il- krema g al 4 xhur, ikkuntattja lit- tabib tieg ek.
If you use more Vaniqa than you should
Jekk tu a Vaniqa aktar milli suppost
If you put too much cream on your skin, it is unlikely to harm you.
Jekk tidlek ammont ejjed ta ’ krema fuq il - ilda, din x’ aktarx li mhux se tag millek sara.
If you or anyone else accidentally swallows Vaniqa, contact your doctor.
23 Jekk int jew addie or tibilg u Vaniqa b’ mod a identali, ikkuntattja lit- tabib tieg ek.
If you forget to use Vaniqa
Jekk tinsa tu a Vaniqa
Apply straight away, but wait at least 8 hours before using it again.
U aha immedjatament, i da stenna mill- inqas 8 sig at qabel ma ter a ’ tu aha.
Like all medicines, Vaniqa can cause side effects, although not everybody gets them.
B al kull medi ina o ra, Vaniqa jista ’ jkollu effetti sekondarji, g alkemm ma jidhrux fuq kul add.
The most frequently reported side effect was acne (7-14%).
L- aktar effett sekondarju rrappurtat b’ mod frekwenti kien l- akne (7 - 14%).
Other side effects commonly (> 1%) reported were skin problems such as skin reactions from ingrowing hair, hair loss, a burning, stinging or tingling feeling, dry skin, itching, redness or rash.
Effetti sekondarji o ra rrappurtati b’ mod komuni (> 1%) kienu problemi tal - ilda b al reazzjonijiet tal - ilda minn xag ar li jikber ’ il ewwa, telf ta ’ xag ar, sensazzjoni ta ’ ruq, tingi jew tnemnim, ilda xotta, akk, mura jew raxx.
Also reported, but uncommonly (< 1%), were ingrowing hairs, swelling of the face or mouth, skin bleeding, cold sores, dry, cracked or numb lips, pale areas of the skin, sore skin, flushing of the skin, eczema, irritation of the skin, skin boils, abnormal hair texture and abnormal hair growth.
Kienu rrappurtati wkoll, i da mhux b’ mod komuni (< 1%), xag ar li jikber ’ il ewwa, nef a tal- wi jew tal - alq, ru ta ’ demm mill - ilda, ponot fuq ix- xufftejn, xufftejn niexfa, maqsuma jew imtarrxa, partijiet mill - ilda li ji arraw, u ig fil - ilda, mura tal - ilda, ek ema, irritazzjoni tal - ilda, imsiemer tal - ilda, struttura anormali tax- xag ar, tkabbir anormali tax- xag ar.
Also reported, but rarely (< 0.1%), rosacea (inflammation and flushing of the skin, and can also cause pus under the skin), a red, scaly, itchy dermatitis, abnormal skin growth, red bumpy rash, skin cysts, blistering rash, excessive hair growth, skin tightness, other skin disorders.
Kienu rrappurtati wkoll, i da b’ mod rari, (< 0. 1%), rosa ea (infjammazzjoni u mura tal - ilda, u tista ’ tikkaw a wkoll materja ta t il - ilda) dermatite amra, bil- qxur u li tqabbdek il - akk, tkabbir mhux normali tal - ilda, raxx a mar bil- ponot, isti fil - ilda, raxx bin- nuffati, tkabbir e essiv tax- xag ar, issikkar tal - ilda, disturbi o ra marbuta mal - ilda.
If you notice these or any other side effects, or if you are not sure about the effect of Vaniqa, contact your doctor or pharmacist.
Jekk tinnota dawn jew xi effetti sekondarji o ra, jew jekk m’ intix erta dwar l- effett ta ’ Vaniqa, ikkuntattja lit- tabib jew lill- ispi jar tieg ek.
HOW TO STORE Vaniqa
EN Vaniqa
Do not use the cream after its expiry date.
Tu ax il- krema wara d- data ta ’ skadenza.
There is an expiry date on the box and on the bottom of the tube of Vaniqa.
Hemm data ta ’ skadenza fuq il- kaxxa u fuq il- qieg ta ’ l- isto ta ’ Vaniqa.
Make sure the cap of the tube is tightly closed after each use.
jing alaq tajjeb wara kull u u.
Do not store above 25°C (77°F).
Ta inx f’ temperaturi ’ l fuq minn 25°C (77°F).
What Vaniqa contains
X’ fih Vaniqa
The active substance is Eflornithine.
Is- sustanza attiva hi Eflornithine.
Each gram of Vaniqa 11.5% cream contains 115 mg of eflornithine (as hydrochloride monohydrate).
Kull 1 g ta ’ Vaniqa 11. 5% w/ w krema fiha 115 mg ta ’ eflornithine (b ala hydrochloride monohydrate).
The other ingredients are Cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water and stearyl alcohol.
Cetostearyl alcohol; macrogol cetostearyl ether; dimeticone; glyceryl stearate; macrogol stearate; methyl parahydroxybenzoate (E218); liquid paraffin; phenoxyethanol; propyl parahydroxybenzoate (E216); purified water u stearyl alcohol.
What Vaniqa looks like and the contents of the pack
Id- dehra ta ’ Vaniqa u d- daqs tal- pakkett
Vaniqa is a cream which is white to off white in colour.
Vaniqa hi krema ta ’ kulur abjad sa abjad jag ti fil- gri.
It is supplied in tubes of 15 g, 30 g and 60 g but not all pack sizes may be marketed.
Ti i fornuta f’ tubi ta ’ 15 g, 30 g u 60 g, i da jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu g al skop kummer jali.
24 Manufacturer
24 Id- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq
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 Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
G al kull tag rif dwar dan il- prodott medi inali, jekk jog bok ikkuntattja lir- rappre entant lokali tad- Detentur ta ’ l- Awtorizzazzjoni g at- Tqeg id fis- Suq.
25 This leaflet was last approved on {month year}
Dan il- fuljett kien approvat l- a
What is VASOVIST?
X’ inhu VASOVIST?
VASOVIST is a solution for injection containing the active substance gadofosveset trisodium.
VASOVIST hu soluzzjoni għall- injezzjoni li fih is- sustanza attiva gadofosveset trisodium.
What is VASOVIST used for?
Għalxiex jintuża VASOVIST?
VASOVIST is for diagnostic use.
VASOVIST hu għal użu dijanjostiku.
VASOVIST is used in patients who are undergoing magnetic resonance angiography (MRA), a diagnostic method where pictures of the flow of the blood in the body are taken using a special scan called magnetic resonance imaging (MRI).
VASOVIST jintuża f’ pazjenti li jkunu sottoposti għal anġjografija b’ reżonanza manjetika (MRA), metodu dijanjostiku fejn ir- ritratti tal- fluss tad- demm fil - ġisem jittieħdu billi tintuża skan speċjali msejħa immaġni bir- reżonanza manjetika (MRI).
VASOVIST is used to obtain a clearer scan in patients who have suspected or known problems with blood vessels in the abdomen or limbs.
VASOVIST jintuża biex tinkiseb skan aktar ċara f’ pazjenti li jkollhom problemi suspettati jew magħrufa bil- kanali tad- demm fl- addome jew fid- dirgħajn u r- riġlejn.
How is VASOVIST used?
Kif jintuża VASOVIST?
As all contrast media, VASOVIST should only be used by doctors who have experience in diagnostic imaging.
VASOVIST għandu jintuża biss minn tobba li għandhom esperjenza fit- teħid ta ’ immaġni dijanjostiċi.
VASOVIST is injected at a dose of 0.12 ml per kilogram body weight as an intravenous injection (into a vein) lasting about 30 seconds.
VASOVIST jiġi injettat b’ doża ta ’ 0. 12 ml għal kull kilogram ta ’ piż tal- ġisem bħala injezzjoni fil- vini (ġo vina) li tieħu madwar 30 sekonda.
Imaging can start immediately after the injection, and VASOVIST allows to take images up to one hour.
It- teħid ta ’ l- immaġni jista ’ jibda immedjatament wara l - injezzjoni, u jista ’ jkompli sa siegħa wara l- amministrazzjoni ta ’ VASOVIST.
How does VASOVIST work?
Kif jaħdem VASOVIST?
The active substance in VASOVIST, gadofosveset trisodium, contains gadolinium, a ‘ rare earth’ metal element.
Is- sustanza attiva f’ VASOVIST, gadofosveset trisodium, fiha l- gadolinium, element ta ’ metall ‘ rari ’.
Gadolinium is used as a ‘ contrast enhancer’ to help obtain better pictures with MRI scanners.
Gadolinium jintuża bħala ‘ contrast enhancer ’ biex jgħin sabiex jinkisbu ritratti aħjar bi skanners tal - MRI.
MRI is an imaging method that relies on the tiny magnetic fields produced by water molecules in the body.
Il- MRI hu metodu ta ’ immaġni li jibbaża fuq il- kampijiet manjetiċi żgħar maħluqa mill- molekuli ta ’ l- ilma fil- ġisem.
Once injected, gadolinium interacts with the water molecules.
Ladarba jiġi injettat, gadolinium jinteraġixxi mal- molekuli ta ’ l- ilma.
As a result of this interaction, the water molecules give a stronger signal, and this helps to obtain a brighter picture.
B’ riżultat ta ’ din l- interazzjoni, il- molekuli ta ’ l- ilma jagħtu sinjal aktar b’ saħħtu, u dan jgħin sabiex tinkiseb stampa aktar luminuża.
In VASOVIST, the gadolinium is bound to another chemical in a ‘ chelate ’ (a type of chemical) so that the metal is not released in the body, and prepared so that it stays within the blood, bound to proteins in the serum.
F’ VASOVIST, il- gadolinium jeħel ma ’ kimika oħra ġo ‘ kelat ’ (tip ta ’ kimika) biex il - metall ma jmurx fil- ġisem, u mħejji b’ mod li jibqa ’ fid- demm, imwaħħal mal- proteini fis- serum.
This means that the gadolinium stays long enough in the blood for a good scan to be obtained.
Dan ifisser li l- gadolinium jibqa ’ żmien twil biżżejjed fid- demm biex tinkiseb skan tajba.
How has VASOVIST been studied?
Kif ġie studjat VASOVIST?
The effects of VASOVIST were first tested in experimental models before being studied in humans.
L- effetti ta ’ VASOVIST ġew ittestjati l- ewwel darba f’ mudelli sperimentali qabel ma ġew studjati fil - bniedem.
VASOVIST was studied in several studies involving 1065 patients altogether.
VASOVIST ġie studjat f’ erba ’ studji li kienu jinvolvu 693 pazjenti.
All patients first had a scan using the standard X-ray method 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- pazjenti kienu qegħdin jagħmlu skan minħabba problemi potenzjali bil- vini aorto- iliaċi tagħhom (li jfornu d- demm lir- riġlejn), l- arterji tal- kliewi (li jfornu d- demm lill- kliewi) u l- arterji tas- saqajn (li jfornu d- demm lis - 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 (angiography), followed by MRI scans without or with VASOVIST used as a contrast enhancer.
Il- pazjenti kollha l- ewwel kellhom skan bil- metodu standard ta ’ X- Ray (anġjografija), segwita bi skan tal- MRI bi jew mingħajr VASOVIST użat bħala contrast enhancer.
The measure of effectiveness was based on the improvement in the detection of stenoses (narrowings of blood vessel) that reduced the width of the vessel by 50% or more.
Il- livell ta ’ l- effikaċja kien ibbażat fuq it- titjib fis- sejbien ta ’ stenosi (tidjiq tal- vina jew arterja) li naqqas il- wisa ’ tal- vina jew ta ’ l- arterja b’ 50% jew aktar.
What benefit has VASOVIST shown during the studies?
X’ benefiċċju wera VASOVIST matul l- istudji?
Using VASOVIST as an enhancer in MRA improved the diagnostic performance of the scan when compared with the non-enhanced scan.
L- użu ta ’ VASOVIST bħala enhancer fil- MRA tejjeb il- prestazzjoni dijanjostika ta ’ l- iskan meta mqabbel ma ’ l- iskan mhux imtejba.
The sensitivity of the scan was improved by between 6.3% and 41.5%.
Is- sensittività ta ’ l- iskan tjiebet b’ bejn 6. 3% u 41. 5%.
This means that between 6.3 and 41.5% more stenoses were detected when VASOVIST was used than when it was not used.
Dan ifisser li nstabu bejn 6. 3% u 41. 5% aktar stenosi meta ntuża VASOVIST milli meta ma ntużax.
VASOVIST also improved the accuracy and specificity of the diagnosis.
VASOVIST tejjeb ukoll l- akkuratezza u l- ispeċifiċità tad- dijanjosi.
What is the risk associated with VASOVIST?
X’ inhu r- riskju assoċjat ma ’ VASOVIST?
Most of the side effects were mild to moderate in intensity.
L- aktar effetti sekondarji komuni (dehru f’ aktar minn 1 f’ 100 pazjent) huma uġigħ ta ’ ras, parasteżija (tniggiż), togħma ħażina (disturb tat- togħma), sensazzjoni ta ’ ħruq, twessigħ tal- vini u ta ’ l- arterji, dardir (sensazzjoni ta ’ mard), ħakk (tekil tal- ġilda) u sensazzjoni ta ’ kesħa.
For the full list of all side effects reported VASOVIST, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ VASOVIST, ara l- Fuljett ta ’ Tagħrif.
VASOVIST should not be used in people who may be hypersensitive (allergic) to gadofosveset trisodium or any of the other ingredients.
VASOVIST m’ għandux jintuża f’ persuni li għandhom sensittività eċċessiva (allerġiċi) għal gadofosveset trisodium jew għal xi sustanzi oħra.
Why has VASOVIST been approved?
Għaliex ġie approvat VASOVIST?
The Committee for Medicinal products for Human Use (CHMP) decided that VASOVIST’ s benefits are greater than its risks for contrast-enhanced MRA for visualisation of abdominal or limb vessels in patients with suspected or known vascular disease.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ VASOVIST huma akbar mir- riskju tiegħu għal MRA ta ’ kuntrast imtejjeb sabiex jidhru l- vini u l - arterji addominali jew tad- dirgħajn u tar- riġlejn f’ pazjenti b’ mard vaskulari suspettat jew magħruf.
The committee recommended that VASOVIST be given marketing authorisation.
Il - Kumitat irrakkomanda li VASOVIST jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about VASOVIST:
Informazzjoni oħra dwar VASOVIST:
The European Commission granted a marketing authorisation valid throughout the European Union for VASOVIST to Schering AG on 3 October 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal VASOVIST lil Schering AG fit- 3 ta ’ Ottubru 2005.
The full EPAR for VASOVIST can be found here.
L- EPAR sħiħ dwar VASOVIST jista ’ jinstab hawn.
This summary was last updated in 02-2007.
Dan is- sommarju kien aġġornat l- aħħar f’ 03- 2007.
2/ 2
2 / 2
Invented name
Mnjen jingħata
Pharmaceutical Form
Isem Ivvintat
Route of administration
Farmaċewtika
VASOVIST 0.25 mmol/ ml, solution for injection.
VASOVIST 0. 25 mmol/ ml soluzzjoni għall- injezzjoni.
1 ml VASOVIST solution for injection contains 244 mg (0.25 mmol) of gadofosveset trisodium as active substance.
1 ml VASOVIST soluzzjoni għall- injezzjoni fih 244 mg (0. 25 mmol) ta ’ gadofosveset trisodium bħala s- sustanza attiva.
10 ml solution contain 2.44 g, 15 ml solution contain 3.66 g and 20 ml solution contain 4.88 g of gadofosveset trisodium in a vial.
Soluzzjoni ta ’ 10 ml fiha 2. 44 g, soluzzjoni ta ’ 15 ml fiha 3. 66 g u soluzzjoni ta ’ 20 ml fiha 4. 88 g ta ’ gadofosveset trisodium f’ kunjett.
This medicinal product contains 6.3 mmol sodium (or 145 mg) per dose.
Dan il- prodott mediċinali fih 6. 3 mmol ta ’ sodium (jew 145 mg) kull doża.
Clear, colourless to pale yellow liquid.
Likwidu ċar, bla kulur għal kulur isfar ċar.
This medicinal product is for diagnostic use only. • Contrast enhancement in magnetic resonance angiography (CE-MRA) VASOVIST is indicated for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.
Dan il- prodott mediċinali huwa għall- użu dijanjostiku biss. • Titjib tal- kuntrast fl- anġjografija tar- reżonanza manjetika (CE- MRA) VASOVIST hu indikat għat- titjib tal- kuntrast fl- anġjografija tar- reżonanza manjetika għall - viżwalizzazzjoni ta ’ vini/ arterji addominali jew fir- riġlejn jew fid- dirgħajn f’ pazjenti li hu ssuspettat li għandhom jew li hu magħruf li għandhom mard vaskulari.
This medicinal product should be administered as a single intravenous bolus injection, manually, or by MR injector (i. e., magnetic resonance injector) over a period of time up to 30 seconds followed by a 25-30 ml normal saline flush.
Dan il- prodott mediċinali għandu jingħata bħala injezzjoni waħda bolus ġol- vini, manwalment, jew permezz ta ’ injettur MR (i. e. injettur tar- reżonanza manjetika) fuq perjodu ta ’ 30 sekonda, segwita minn tlaħliħa b’ 25- 30 ml ta ’ ilma bil- melħ normali.
This medicinal product should only be used by physicians experienced in the field of diagnostic imaging.
Dan il- prodott mediċinali għandu jintuża biss minn tobba li għandhom esperjenza fil- qasam ta ’ l - immaġni dijanjostika.
Dosage Adults:
Dożaġġ Adulti:
0.12 ml/ kg body weight (equivalent to 0.03 mmol/ kg)
0. 12 ml/ kg ta ’ piż tal- ġisem (ekwivalenti għal 0. 03 mmol/ kg)
Imaging time points:
Ħin meta għandha ssir l- immaġni:
Dynamic imaging begins immediately upon injection.
Immaġni dinamika tibda dritt malli ssir l- injezzjoni.
Steady state imaging can begin after the dynamic scan has been completed.
Immaġni fissa tista ’ tibda wara li l- iskann dinamiku jkun tlesta.
In clinical trials, imaging was completed up to approximately one hour following injection.
Fi provi kliniċi, l- immaġni tlestiet sa madwar siegħa wara l- injezzjoni.
Renal impairment / hepatic impairment:
Indeboliment tal- kliewi / indeboliment tal- fwied:
Dose adjustments in renal or hepatic impairment are not necessary (See Section 4.4 and Section 5.2).
Aġġustamenti tad- doża f’ każ ta ’ indeboliment tal- kliewi jew tal- fwied mhumiex meħtieġa (Ara Sezzjoni 4. 4 u Sezzjoni 5. 2).
New-borns, infants, children and adolescents:
Trabi tat- twelid, trabi, tfal u adolexxenti:
Use is not recommended in newborns, infants, children and adolescents.
L- użu mhuwiex rakkomandat fi trabi tat- twelid, trabi, tfal u adolexxenti.
No clinical experience is yet available for patients younger than 18.
Għad m’ hemm l- ebda esperjenza klinika disponibbli għal pazjenti li għandhom inqas minn 18- il sena.
No clinical information is available about repeated use of this medicinal product.
M’ hemm l- ebda tagħrif kliniku disponibbli dwar l- użu ripetut ta ’ dan il- prodott mediċinali.
Diagnostic procedures involving the use of MRI contrast agents should be carried out under the supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Proċeduri dijanjostiċi li jinvolvu l- użu ta ’ sustanzi tal- kuntrast ta ’ l- MRI għandhom jitwettqu taħt is - sorveljanza ta ’ tabib li jkollu t- taħriġ prerekwiżit u għarfien komprensiv tal- proċedura li tkun ser titwettaq.
Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of potential severe reactions to the contrast agent itself.
Faċilitajiet adattati jridu jkunu disponibbli biex jilqgħu għal kwalunkwe komplikazzjoni tal - proċedura, kif ukoll għall- kura ta ’ emerġenza ta ’ reazzjonijiet severi potenzjali għas- sustanza tal - kuntrast stess.
The usual safety precautions for magnetic resonance imaging must be observed, e. g., exclusion of cardiac pacemakers and ferromagnetic implants.
Il- prekawzjonijiet tas- sigurtà tas- soltu għall- immaġni tar- reżonanza manjetika għandhom ikunu osservati, eż. l- esklużjoni ta ’ pacemakers kardijaċi u impjanti ferromanjetiċi.
As with other contrast enhanced diagnostic procedures, post-procedure observation of the patient is recommended, in particular in patients with a history of allergy, renal insufficiency, or drug reaction.
Bħal f’ każ ta ’ proċeduri dijanjostiċi oħrajn tat- titjib tal- kuntrast, l- osservazzjoni tal- pazjent ta ’ wara l - proċedura hi rakkomandata, b’ mod partikulari f’ pazjenti bi storja medika ta ’ allerġiji, insuffiċjenza tal - kliewi, jew reazzjoni għall- mediċina.
Hypersensitivity warning The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid, or cardiovascular reactions, or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, previous reaction of contrast media, a history of asthma, or other allergic disorders.
Twissija dwar sensittività eċċessiva Il- possibbiltà ta ’ reazzjoni, li tinkludi reazzjonijiet serji, li jkunu ta ’ periklu għall- ħajja, fatali, anafilattojdi jew kardjovaskulari, jew reazzjonijiet idjosinkratiċi oħrajn, għandhom dejjem jiġu kkunsidrati, speċjalment f’ dawk il- pazjenti li hu magħruf li għandhom sensittività eċċessiva klinika, li diġà kellhom reazzjoni għas- sustanza tal- kuntrast, storja medika ta ’ ażżma, jew mard allerġiku ieħor.