qanastek/EMEA-V3 huggingface dataset:
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys (see sections 4.2 and 5.2).
Ma nafux x’ tagħmel il- kura bi Tractocile f' pazjenti jbatu bil- fwied jew bil- kliewi (ara sezzjoni 4. 2, Pożoloġija u metodu ta 'kif għandha tingħata u 5. 2, Tagħrif farmakokinetiku).
Atosiban has not been used in patients with an abnormal placental site.
Tractocile ma ntużax ma 'pazjenti bi plaċenta f' sit abnormali.
There is only limited clinical experience in the use of atosiban in multiple pregnancies or the gestational age group between 24 and 27 weeks, because of the small number of patients treated.
Ftit hemm tagħrif kliniku dwar l- użu ta 'Tractocile fi tqala b' iktar minn fetu wieħed jew bi tqala ta' bejn l- 24 u s- 27 ġimgħa, minħabba li n- numru ta 'pazjenti kkurati kien żgħir.
Re-treatment with TRACTOCILE is possible, but there is only limited clinical experience available with multiple re-treatments, up to 3 re-treatments (see section 4.2).
Għalkemm Tractocile tista ’ tarġa ’ tużah għall- kura, għad hemm ftit wisq tagħrif dwar l- effetti meta dan jintuża għal aktar minn darba sa mill- inqas tliet darbiet wara (ara sezzjoni 4. 2, Pożoloġija u metodu ta 'kif jingħata).
Monitoring of uterine contractions and fetal heart rate during administration of atosiban and in case of persistent uterine contractions should be considered.
Għandu jitqies il- monitoraġġ tal- kontrazzjonijiet ta 'l- utru u tar- rata tal- qalb tal- fetu waqt li qed jingħata Tractocile u f' każ ta ’ kontrazzjonijiet persistenti ta' l- utru.
As an antagonist of oxytocin, atosiban may theoretically facilitate uterine relaxation and postpartum bleeding therefore blood loss after delivery should be monitored.
Billi Atosiban jaħdem kontra oxytocin, teoretikament jista 'jgħin ir- rilassament ta' l- utru u d- dmija wara l- ħlas, għalhekk għandu jsir monitoraġġ tad- dmija wara l- ħlas.
10 4.5 Interaction with other medicinal products and other forms of interaction
10 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
It is unlikely that atosiban is involved in cytochrome P450 mediated drug-drug interactions as in vitro investigations have shown that atosiban is not a substrate for the cytochrome P450 system, and does not inhibit the drug metabolising cytochrome P450 enzymes.
Mhux probabbli li Atosiban hu involut f' interazzjonijiet bejn prodotti mediċinali permezz taċ - ċitokroma P450, billi investigazzjonijiet in vitro wrew li Atosiban mhux substrat għas- sistema taċ - ċitokroma P450, u ma jwaqqafx l- enzimi taċ- ċitokroma P450 li jimmetabolizzaw prodotti mediċinali.
However, the extent of labetalol bioavailability in terms of AUC did not change.
Madankollu, il - biodisponibbilta` ta 'labetalol fil- ġisem mill- aspett ta' l- AUC ma nbidilx.
The interaction observed has no clinical relevance.
L- interazzjoni li ġiet osservata ma kellhiex relevanza klinika.
No interaction study has been performed with antibiotics, ergot alkaloids, and anti-hypertensive agents other than labetalol.
Ma sarx studju dwar interazzjoni ma 'antibijotiċi, alkaloids ergot, u prodotti mediċinali li jnaqqsu l - pressjoni għolja ħlief għal labetalol.
Atosiban should only be used when pre-term labour has been diagnosed between 24 and 33 completed weeks of gestation.
It- Tractocile għandu jintuża biss meta ssir djanjosi ta 'ħlas qabel iż- żmien bein l- 24 u t- 33 ġimgħa magħluqa tat- tqala.
In atosiban clinical trials no effects were observed on lactation.
Fil- provi kliniċi ta ’ Tractocile ma ġewx osservati effetti fuq it- treddiegħ.
Small amounts of atosiban have been shown to pass from plasma into the breast milk of lactating women.
Intwera li ammonti żgħar ta 'atosiban għaddew mill- plażma għall- ħalib ta' l- omm li qed tredda '.
Embryo-fetal toxicity studies have not shown toxic effects of atosiban.
Studju dwar effetti tossiċi fuq l- embriju/ fetu ma wrewx effetti tossiċi ta 'Atosiban.
No studies were performed that covered fertility and early embryonic development (see section 5.3).
Ma sar ebda studju dwar il- fertilità u l- iżvilupp bikri ta ’ l- embriju (ara taqsima 5. 3)
For the newborn, the clinical trials did not reveal any specific undesirable effects of atosiban.
It- testijiet kliniċi ma wrew ebda effetti speċifiċi mhux mixtieqa ta 'atosiban fit- tarbija li għadha kemm twieldet.
The infant adverse events were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.
Fit- trabi d- drabi li kien hemm effetti avversi kienu fil- medda normali ta 'varjazzjoni, u setgħu jitqabblu tajjeb mad- drabi li ġraw bl- użu tal- plaċebo u tal- grupp beta- mimetiku.
11 The undesirable effects in the women were the following:
L- effetti mhux mixtieqa fuq in- nisa kienu:
Very common (> 1/ 10)
11 Komuni ħafna (> 10%)
Gastrointestinal disorders: nausea.
Mard gastro- intestinali:
Metabolism and nutrition disorders: hyperglycaemia Nervous system disorders: headache, dizziness Cardiac disorders: tachycardia, Vascular disorders: hot flush, hypotension Gastrointestinal disorders: vomiting General disorders and administration site conditions: injection site reaction
Nuqqas ta’ rqad
Uncommon (> 1/ 1,000, < 1/ 100)
Mhux komuni (0. 1- 1%)
Rare (> 1/ 10,000, < 1/ 1,000)
(< 0. 1%)
The frequency did not exceed that of the control groups in clinical trials.
Il- frekwenza ma kinitx ogħla minn tal- gruppi ta 'kontoll fi provi kliniċi.
One case of allergic reaction was reported, which was considered to be probably related to atosiban.
Każ rappurtat ta 'reazzjoni allerġika, sata ’ kien marbut ma' atosiban..
Few cases of atosiban overdosing were reported, they occurred without any specific signs or symptoms.
Kien hemm ftit każi rappurtati li seħħew ta 'doża eċċessiva ta' Tractocile, mingħajr ebda sinjal jew sintomi speċifiċi.
Treatment failures caused by
Il- biċċa l- kbira tad- drabi meta falliet il- kura f' CAP- 001 kien minħabba li l- prodott ma kienx tollerat sew.
12 insufficient efficacy were significantly (p=0.0003) more frequent in atosiban (n=48, 14.2%) than in the β -agonist-treated women (n=20, 5.8%).
Il- fallimenti tal- kura għax ma kienx effikaċi biżżejjed kienu iktar frekwenti b' mod sinifikanti (p=0. 0003) fin- nisa li ngħataw atosiban (n=48, 14. 2%) milli fin- nisa li ngħataw β- agonist (n=20, 5. 8%).
In the CAP-001 studies the probability of remaining undelivered and not requiring alternative tocolytics within 7 days of treatment initiation was similar for atosiban and beta-mimetics treated women at gestational age of 24-28 weeks.
12 Fl- istudji CAP- 001 il- probabbilita` li ma jkunx hemm ħlas u ma jkunx hemm bżonn tokolitiċi alternattivi fi żmien 7 ijiem wara l- bidu tal- tkura kien simili għan- nisa bi tqala ta 'bejn 24- 28 ġimgħa li ngħataw atosiban jew il- beta- mimetiċi.
Secondary endpoints: secondary efficacy parameters included the proportion of women remaining undelivered within 48 h of treatment initiation.
Secondary endpoints: il- parametri sekondarji ta 'l- effikaċja tal- prodott inkudew il- proporzjon ta' nisa li baqgħu ma ħelsux 48 siegha wara l- bidu tal- tkura.
Fetal and maternal outcome did apparently not differ between the atosiban and the β -agonist group, but the clinical studies were not powered enough to rule out a possible difference.
Ma kienx hemm differenza bejn il- grupp ta ’ atosiban u dak tal- β- agonist fejn kellhom x’ jaqsmu il- fetu u l- omm, imma l- istudji kliniċi ma kinux tajba biżżejjed biex jeskludu l- possibbilita ’ li hemm xi differenzi.
In a placebo-controlled study, fetal/ infant deaths were 5/ 295 (1.7%) in the placebo group and 15/ 288 (5.2%) in the atosiban group, of which two occurred at five and eight months of age.
Fi studju kkontrollat bill- plaċebo, ir- rata ta 'mwiet tal- fetu jew tat- trabi kienet ta' 5/ 295 (1. 7%) fil - grupp tal- plaċebo u 15/ 288 (5. 2%) fil- grupp ta 'Tractocile, li minnhom żewġt imwiet seħħew wara ħames u tmien xhur ta' ħajja.
Eleven out of the 15 deaths in the atosiban group occurred in pregnancies with a gestational age of 20 to 24 weeks, although in this subgroup patient distribution was unequal (19 women on atosiban, 4 on placebo).
Ħdax mill- 15- il mewt fil- grupp ta 'Tractocile seħħew fit- tqala ta' bejn l - 20 u l- 24 ġimgħa, għalkemm id- distribuzzjoni ta 'dawn il- pazjenti skond il- grupp ta' kura ma kinitx l - istess (19- il mara fuq Tractocile, 4 nisa fuq il- plaċebo).
Atosiban passes the placenta.
Atosiban jgħaddi mill- plaċenta.
The ratios of the main metabolite M1 (des-(Orn8, Gly-NH29)-[Mpa1, D-Tyr(Et)2, Thr4]-oxytocin) to atosiban concentrations 13 in plasma were 1.4 and 2.8 at the second hour and at the end of the infusion respectively.
Il- proporzjonijiet tal- metobolit prinċipali M1 (des - (Orn8, Gly- NH29) - [Mpa1, D- Tyr( Et) 2, Thr4] - oxytocin) għall- konċentrazzjonijiet ta 'atosiban fil- plażma kienu ta' 1. 4 u 2. 8 wara sagħtejn u fl- aħħar ta 'l- infużjoni rispettivament.
It is not known whether M1 accumulates in tissues.
Mhux maghruf jekk il- metabolit M1 jakkumulax fit- tessuti.
Main metabolite M1 is apparently as potent as the parent compound in inhibiting oxytocin-induced uterine contractions in vitro.
Il- metabolit prinċipali M1 in vitro milli jidher huwa b’ saħħtu biżżejjed biex iwaqqaf il- kontrazzjonijiet ta 'l- utru kaġunati minn oxytocin, daqs is- sustanza oriġinali.
It is unlikely that atosiban inhibits hepatic cytochrome P450 isoforms in humans (see section 4.5).
Ma jidhirx li atosiban iwaqqaf l- effett ta ’ l- isoforomi ta ’ cytochrome P450 tal- fwied (ara sezzjoni 4. 5).
No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the three-months toxicity studies in rats and dogs (up to 20 mg/ kg/ day s. c.).
Ma deherx li kien hemm effetti tossiċi sistemiċi waqt studji ta 'gimgħatejn dwar it- tossicita` li fihom il - prodott ingħata fil- vina (fil- firien u l- klieb) b' dożi li kienu bejn wieħed u ieħor 10 darbiet ogħla mid - doża terapewtika għall- bnedmin, kif ukoll waqt studji ta' tliet xhur dwar it- tossiċita` fil- firien u l- klieb (sa 20 mg/ kg kuljum s. c.).
Once the vial has been opened, the dilution must be performed immediately.
Ladarba jinfetaħ il- kunjett, il- prodott għandu jintuża fil- pront.
Diluted solution for intravenous administration should be used within 24 hours after preparation.
Is- soluzzjoni dilwita li tingħata fil- vina għandha tintuża fi żmien 24 siegħa minn meta tiġi ppreparata.
Store in a refrigerator (2°C - 8°C).
Aħżen f’ temperatura ta ’ bejn 2°C – 8°C.
One vial of concentrate for solution for infusion contains 5 ml solution, corresponding to 37.5 mg atosiban.
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
14 Colourless glass vials, clear borosilicated (type I) sealed with grey siliconised bromo-butyl rubber stopper, type I, and flip-off cap of polypropylene and aluminium.
Kunjett tal- ħġieġ borosilikat trasparenti bla kulur (tip I), issiġillat b' tapp tal- gomma bromo- butyl silikonat griż, tip I, u għatu li jinfetaħ minn naħa waħda tal - polypropylene and aluminium..
Preparation of the intravenous infusion solution:
Kif tipprepara l- ewwel soluzzjoni għall- infużjoni għal ġol- vina:
For intravenous infusion, following the bolus dose, TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion should be diluted in one of the following solutions: − 0.9% w/ v NaCl − Ringer's lactate solution − 5% w/ v glucose solution.
0. 9% w/ v NaCL soluzzjoni ta 'Ringer’ s lactate 5% w/ v soluzzjoni ta ’ glucose.
Withdraw 10 ml solution from a 100 ml infusion bag and discard.
Iġbed soluzzjoni ta ’ 10 ml minn borża għall- infużjoni tal- 100 ml u armi.
Replace it by 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Minflokha ixħet 10 ml Tractocile 7. 5 mg/ ml konċentrat għal soluzzjoni għall- infużjoni minn żewġ fjali ta ’ 5 ml biex ikollok konċentrazzjoni ta '75 mg ta' atosiban f' 100 ml.
The loading infusion is given by infusing 24 ml/ hour (i. e.
L- infużjoni tal- bidu tingħata billi ssir infużjoni ta '24 ml kull siegħa (i. e.
18 mg/ h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
18 mg/ h) tas- soluzzjoni li tkun ġiet preparata, fuq medda ta 'tliet sigħat taħt superviżjoni medika xierqa f' dipartiment ostetriku.
After three hours the infusion rate is reduced to 8 ml/ hour.
Wara tliet sigħat ir- rata ta 'l- infużjoni titnaqqas għal 8 ml/ siegħa.
Prepare new 100 ml bags in the same way as described to allow the infusion to be continued.
Ipprepara boroż ġodda tal- 100 ml bl- istess mod kif imfisser biex l- infużjoni tkun tista 'titkompla.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Jekk tintuża borża ta ’ l- infużjoni b’ volum differenti, għandu jsir kalkolu proporzjonat fil - preparazzjoni.
To achieve accurate dosing, a controlled infusion device is recommended to adjust the rate of flow in drops/ min.
Biex id- doża tkun eżatta, hu rakkomandat l- użu ta 'strument li jikkontrolla r- rata ta' l- infużjoni ta 'qtar fil- minuta.
An intravenous microdrip chamber can provide a convenient range of infusion rates within the recommended dose levels for TRACTOCILE.
Microdrip chamber fil- vina tista 'tipprovdi medda konvenjenti ta' rati ta 'infużjoni fil- limiti tad- dożi rakkomandati għal Tractocile.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products (see section 6.2).
Billi ma sarux studji dwar liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali ma għandux jitħallat ma ’ prodotti mediċinali oħrajn (ara sezzjoni 6. 2, Inkompatibilitajiet).
If other medicinal products need to be given intravenously at the same time, the intravenous cannula can be shared or another site of intravenous administration can be used.
Jekk hemm bżonn li jingħataw prodotti oħra mediċinali fil- vina fl- istess ħin, il- kannula fil- vina tista 'tintuża għal iktar minn prodott wieħed jew jista' jintuża post ieħor għall- għotja fil- vina.
This permits the continued independent control of the rate of infusion.
Dan jippremetti li jkun hemm kontroll indipendenti tar- rata ta 'l- infużjoni.
NUMBER IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
10.
20. 01. 2000 15 10.
FERRING AB Soldattorpsvägen 5 SE-20061 Limhamn Sweden
FERRING AB Soldattorpsvägen 5 SE - 20061 - Limhamn Svezja
Ferring GmbH Wittland 11 24109 Kiel Germany
Ferring GmbH Wittland 11 24109 Kiel Il- Ġermanja
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.
Il- fuljett stampat fil- pakkett tal- prodott mediku jrid ikun fih l- isem u l- indirizz tal- manifattur responsabbli għall- ħruġ tal- lott partikolari
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUHORISATION HOLDER
• KUNDIZZJONIJIET U RESTRIZZJONIJIET MARBUTA MAT- TQASSIM U L- UŻU, IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Summary of Product Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2)
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- detentur ta ’ din l- awtorizzazzjoni għat- tqegħid fis- suq irid/ għandu javża lill- Kummisjoni Ewropea dwar l- ippjanar tal- kummerċ ta ’ dan l- prodott mediku kif awtorizzat b’ din id- deċiżjoni.
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING.
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
TRACTOCILE 7.5 mg/ ml solution for injection atosiban
TRACTOCILE 7. 5 mg/ ml soluzzjoni għall- injezzjoni atosiban
Each vial contains 6.75 mg of atosiban
Kull kunjett fih 6. 75 mg ta 'atosiban
1 ml of solution contains:
1 ml ta ’ soluzzjoni fiha:
Mannitol 50 mg Hydrocloric acid 1M to pH 4.5 Water for injections to 1 ml
Hydrochloric acid 1M sa pH 4. 5 Ilma għall- injezzjoni sa 1 ml
Solution for injection One vial of 0.9 ml contains 6.75 mg of atosiban
Soluzzjoni għall- injezzjoni Kunjett ta '0. 9 ml fih 6. 75 mg ta' atosiban
For intravenous use only
Użu għal ġol- vini biss.
EXP {MM/ YYYY}
JIS [xahar/ sena]
Store in a refrigerator Store in the original package Once the vial has been opened, the solution must be used immediately
Aħżen fil- kontenitur oriġinali.
INSTRUCTIONS ON USE
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Read the package leaflet before use
Prodott mediċinali jingħata bir- riċetta tat- tabib.
TRACTOCILE 7.5 mg/ ml solution for injection
TRACTOCILE 7. 5 mg/ ml soluzzjoni għall- injezzjoni
EXP {MM/ YYYY}
JIS [xahar/ sena] >
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
OĦRAJN
6.75 mg in 0.9 ml
6. 75 mg in 0. 9 ml
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING.
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion atosiban
TRACTOCILE 7. 5 mg/ ml konċentrat għal soluzzjoni għall- infużjoni atosiban
Each vial contains 37.5 mg of atosiban
Kull fjala fiha 37. 5 mg ta 'atosiban
1 ml of solution contains:
1 ml tas- soluzzjoni fiha:
Concentrate for solution for infusion One vial of 5 ml contains 37.5 mg of atosiban Provides 0.75 mg/ ml when diluted as recommended
Konċentrat għal soluzzjoni għall- infużjoni Fjala ta '5 ml fiha 37. 5 mg ta' atosiban Minnha toħroġ 0. 75 mg/ ml meta dilwita kif rakkomandat
Store in a refrigerator Store in the original package The diluted solution must be used within 24 hours
Aħżen fil- kontenitur oriġinali.
Dilute before use Read the package leaflet before use
Prodott mediċinali jingħata bir- riċetta tat- tabib.
TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion
TRACTOCILE 7. 5 mg/ ml konċentrat għal soluzzjoni għall- infużjoni
37.5 mg in 5 ml
OĦRAJN
PACKAGE LEAFLET
26 FULJETT TA ’ TAGĦRIF
- This leaflet contains practical information on TRACTOCILE.
Aqra dan- il fuljett kollu qabel tibda tuża din il- mediċina. − Dan il- fuljett fih informazzjoni prattika dwar Tractocile. − Żomm dan il- fuljett.
- If you have further questions, please ask your doctor, midwife or pharmacist.
Jekk ikollok aktar mistoqsijiet, jew jekk hemm xi ħaġa li ma fhimthiex, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. − Tractocile huwa prodott mediċinali li jintuża fi sptar u għandu jingħata biss taħt superviżjoni ta 'professjonisti kwalifikati b' esperjenza.
What TRACTOCILE is and what it is used for 2.
X’ inhu Tractocile u għalxiex jintuża 2.
Before you use TRACTOCILE 3.
Qabel ma tuża Tractocile 3.
How to use TRACTOCILE 4.
Kif għandek tuża Tractocile 4.
Storing TRACTOCILE 6.
Kif taħżen Tractocile
TRACTOCILE 7.5 mg/ ml, solution for injection atosiban
Tractocile 7. 5mg/ ml, soluzzjoni għall- injezzjoni Atosiban
The active substance is atosiban.
Is- sustanza attiva hi atosiban.
The other ingredients are mannitol, hydrochloric acid and water for injections.
Sustanzi oħra huma mannitol, hydrochloric acid, u l- ilma għall- injezzjoni.
Marketing Authorisation Holder Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Denmark
Isem u Indirizz tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Ferring Pharmaceuticals A/ S Kay Fiskers Plads 11 2300 København S Danimarka
Manufacturer Ferring AB Soldattorpsvägen 5 Box 30047 SE - 20061 Limhamn Sweden
Manifattur Ferring AB Soldattorpsvägen 5 Box 30047 SE - 20061 Limhamn Svezja
Ferring GmbH Wittland 11 24109 Kiel Germany
Ferring GmbH Wittland 11 24109 Kiel Germanja
WHAT TRACTOCILE IS AND WHAT IT IS USED FOR
X’ INHU TRACTOCILE U GĦALXIEX JINTUŻA
Each vial of TRACTOCILE 7.5 mg/ ml, solution for injection, contains atosiban acetate equivalent to 6.75 mg of atosiban in 0.9 ml.
Kull kunjett ta 'Tractocile 7. 5 mg/ ml, soluzzjoni għall- injezzjoni, fih atosiban acetate ekwivalenti għal 6. 75 mg ta' Atosiban f' 0. 9 ml.
Atosiban blocks the ability of the natural hormone oxytocin to cause the uterus (womb) to contract.
Atosiban iwaqqaf il- kontrazzjonijiet fl- utru billi jtellef l- effett ta 'l- ormon tal- bniedem oxytocin.
TRACTOCILE can be used to decrease the frequency and intensity of uterine contractions in pregnant women in order to delay a premature birth.
Tractocile jista 'jintuża biex inaqqas il- frekwenza u l- intensita` tal- kontrazzjonijiet ta' l- utru f' nisa tqal biex idewwem il- ħlas qabel iż- żmien.
- if the placenta is detaching
QABEL MA ’ TUŻA TRACTOCILE
- if you or the fetus have conditions in which continuation of pregnancy are regarded undesirable
Tużax Tractocile: − Jekk it- tqala tiegħek hija inqas minn 24 ġimgħa jew iktar minn 33 ġimgħa − Jekk l- ilma jinfaqa 'qabel iż- żmien wara 30 ġimgħa ta' tqala − Jekk il- fetu mhux qed jikber biżżejjed u ma għandux taħbit normali tal- qalb − Jekk tara d- demm mill- utru u jkollok bżonn teħles minnufih − Jekk għandek pre- eklampsja qawwija (pressjoni għolja tad- demm, żamma tal- fluwidu u/ jew proteina fl- urina) jew eklampsja (konvulżjonijiet marbuta mal- pre- eklampsja) u għalhekk għandek bżonn teħles − Jekk il- fetu miet − Jekk hemm suspett ta 'infezzjoni fl- utru − Jekk il- plaċenta qed tiksi l- kanal tal- ħlas − Jekk il- plaċenta qed tinqala' − Jekk int jew il- fetu qegħdin f' kondizzjoni li t- tkomplija tat- tqala mhix mixtieqa jew titqies ta 'periklu − Jekk int allerġika għal Atosiban jew xi sustanza f’ Tractocile
- if you have a multiple pregnancy or a pregnancy between 24 and 27 weeks
Oqgħod attenta ħafna bi Tractocile: − jekk l- ilma jinfaqa ’ qabel iż- żmien ma jistax jiġi eskluż − jekk għandek problemi tal- kliewi jew tal- fwied − jekk il- plaċenta mhix f' pożizzjoni normali − jekk għandek tqala multipla jew tqala ta 'bejn l- 24 u s- 27 ġimgħa − jekk ikollok kontrazzjonijiet rikorrenti, il- kura ta' Tractocile tista 'terġa' tingħata sa tliet darbiet − jekk il- fetu huwa żgħir għaż- żmien tat- tqala − waqt il- kura ta 'Tractocile, il- kontrazzjonijiet tiegħek u r- rata tal- qalb tal- fetu jistgħu jkunu monitorjati − jekk it- tarbija twieldet, Tractocile jista' fit- teorija jnaqqas il- ħila ta 'l- utru biex ikollu l - kontrazzjonijiet.
This may cause bleeding.
Dan jista 'jwassal għal dmija.
Please tell your doctor, midwife or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk tkunx qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
HOW TO USE TRACTOCILE
KIF GĦANDEK TUŻA TRACTOCILE
TRACTOCILE is a medicine that is used only in hospital and should only be administered by qualified staff.
Tractocile hija mediċina li tintuża biss fl- isptar u għandha tiġi mogħtija biss minn professjonisti kwalifikati.
Before using TRACTOCILE, the solution should be examined to ensure it is clear and free from particles.
Qabel ma jintuża Tractocile, is- soluzzjoni trid tiġi eżaminata biex ikun assigurat li ma fihiex frak.
TRACTOCILE is given intravenously in three successive stages: • The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute. • A continuous infusion at a dose of 18 mg/ hour is given for 3 hours. • A continuous infusion at a dose of 6 mg/ hour is given for up to 45 hours, or until the contractions of the uterus have subsided.
Infużjoni kontinwa b' doża ta '6mg/ siegħa tingħata fuq medda sa 45 siegħa, jew sakemm jonqsu il - kontrazzjonijiet ta' l- utru.
The total duration of the treatment should be no more than 48 hours.
It- tul totali tal- kura m' għandux ikun iktar minn 48 siegħa.
Further treatment cycles of TRACTOCILE can be used should contractions recur.
Jekk jerġa 'jkun hemm kontrazzjonijiet jistgħu jingħataw ċikli oħra ta' Tractocile.
It is recommended that no more than three retreatments should be used during a pregnancy.
M' għandhomx jingħataw iktar minn tliet trattamenti waqt it - tqala.
Preparation of the intravenous infusion The intravenous infusion is prepared by diluting TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion in 0.9% w/ v sodium chloride solution, Ringer's lactate solution or 5% w/ v glucose solution.
Kif tipprepara l- infużjoni fil- vina Tipprepara l- infużjoni għal ġol- vina billi jiġi dilwit Tractocile 7. 5mg/ ml, konċentrat għal soluzzjoni għall- infużjoni f' 0. 9% w/ v ta 'soluzzjoni ta ’ sodium chloride, soluzzjoni ta ’ Ringer’ s lactate jew 5% w/ v ta' soluzzjoni ta ’ glukożju.
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Dan isir billi jitneħħa 10ml ta ’ soluzzjoni minn borża ta 'l- infużjoni tal - 28 100ml u minfloku jitqiegħed 10ml ta' Tractocile 7. 5mg/ ml ta 'konċentrat għal soluzzjoni għall - infużjoni minn żewġ kunjetti tal- 5ml biex ikun hemm konċentrazzjoni ta' 75 mg ta 'atosiban f' 100 ml.
If an infusion bag with a different volume is used, a proportional calculation should be made for the preparation.
Jekk tintuża borża ta ’ l- infużjoni b’ volum differenti, ikun hemm bżonn ta ’ kalkulazzjoni proporzjonali.
TRACTOCILE should not be mixed with other medicinal products in the infusion bag.
Tractocile m' għandux jitħallat ma 'prodotti mediċinali oħra fil- borża ta' l- infużjoni.
Like all medicines, TRACTOCILE can have side effects.
Bħal kull mediċina oħra, Tractocile jista ’ jkollu effetti oħra.
The observed side effects for the mother were generally of a mild severity.
L- effetti oħra osservati fl- omm ġeneralment kienu ħfief.
There are no known side effects on the fetus or new-born baby.
Mhux magħruf li hemm effetti oħra fil- fetu jew fit- tarbija li tkun għadha kemm twieldet,
For the mother the most commonly reported side effects are nausea, headache, dizziness, hot flushes, vomiting, rapid heart beat, low blood pressure, injection site reaction and high blood sugar.
Għall- omm l- effetti l- oħra li l- iktar li huma rrapurtati huma tqalligħ, uġigħ ta 'ras, sturdament, fwawar tas- sħana, remettar, taħbit mgħaġġel tal- qalb, pressjoni baxxa tad- demm, reazzjoni fil- post ta' l - injezzjoni u livell għoli ta 'zokkor fid- demm.
Uncommon side effects include fever, insomnia, itching and rash.
Effetti oħra mhux komuni jinkludu deni, nuqqas ta ’ rqad, ħakk u raxx.
Rare side effects include a reduction in the ability of the uterus to contract after your baby has been delivered, which may cause bleeding.
Effetti oħra rari jinkludu tnaqqis fil- ħila ta 'l- utru li jkollu kontrazzjonijiet wara li t- trabija tiegħek titwieled, li jista' jikkawża dmija.
Allergic reaction has been rarely reported.
Kienu rappurtati wkoll reazzjonijiet allerġiċi f’ kazijiet rari.
If you notice these or any other side effects not mentioned in this leaflet, please inform your doctor, midwife or pharmacist.
Jekk tinduna b ’ xi effetti oħrajn li mhux imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
STORING TRACTOCILE
KIF TAĦŻEN TRACTOCILE
Store in the original package.
Aħżen f’ temperatura ta ’ bejn 2°C – 8°C (fil- friġġ) Aħżen fil- kontenitur oriġinali.
Do not use after the expiry date stated on the label.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq it- tikketta.
Do not use TRACTOCILE if you notice particulate matter and discoloration prior to administration.
M’ għandekx tuża Tractocile jekk tara xi frak jew bidla fil- kulur qabel ma jingħata.
Once the vial has been opened, the product must be used immediately.
Ladarba l- fjala tinfetaħ, il- prodott għandu jintuża mal- ewwel.
FURTHER INFORMATION For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtoriżżazzjoni għall- Kummerċ.
Vā cieš a iela 13 Rī ga LV-1004 Tā lr.: + 371 7 805 140
Vācieša iela 13 Rīga LV- 1004 Tālr.: + 371 7 805 140 Lietuva MediNet International Ltd Laisvės pr.
Lietuva MediNet International Ltd Laisvė s pr.
Dan il- fuljett kien approvat l- aħħar f ’ [data]
This leaflet was last approved on {date}
FULJETT TA ’ TAGĦRIF
32 PACKAGE LEAFLET
32 FULJETT TA ’ TAGĦRIF
TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion atosiban
Atosiban
Each vial of TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion, contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml.
Kull kunjett tat- Tracticile 7. 5 mg/ ml, konċentrat tas- soluzzjoni għall- infużjoni, fih atosiban acetate ekwivalenti għal 37. 5 mg ta 'atosiban f' 5 ml.
TRACTOCILE can be used to decrease the frequency and intensity of uterine contractions in pregnant women in order to delay a premature birth.
Tractocile jista 'jintuża biex inaqqas il- frekwenza u l- intensita` tal- kontrazzjonijiet ta' l- utru f' nisa tqal biex jittardja l- ħlas qabel iż- żmien.
BEFORE YOU USE TRACTOCILE
QABEL MA ’ TUŻA TRACTOCILE
- if your pregnancy is less than 24 weeks or more than 33 weeks
Tużax Tractocile: − Jekk it- tqala tiegħek hija inqas minn 24 ġimgħa jew iktar minn 33 ġimgħa − Jekk l- ilma jinfaqa 'qabel iż- żmien wara 30 ġimgħa ta' tqala − Jekk il- fetu mhux qed jikber biżżejjed u l- qalb mhix qed tħabbat normali
urine) or eclampsia (convulsions associated with pre-eclampsia) requiring delivery
33 − Jekk tara d- demm mill- utru u jkollok bżonn teħles minnufih − Jekk għandek pre- eklampsja qawwija (pressjoni għolja tad- demm, żamma tal- fluwidu u/ jew proteina fl- urina) jew eklampsja (konvulżjonijiet marbuta mal- pre- eklampsja) u għalhekk għandek bżonn teħles − Jekk il- fetu miet − Jekk hemm suspett ta 'infezzjoni fl- utru − Jekk il- plaċenta qed tiksi l- kanal tal- ħlas − Jekk il- plaċenta qed tinqala' − Jekk int jew il- fetu qegħdin f' kondizzjoni li t- tkomplija tat- tqala mhix mixtieqa jew titqies ta 'periklu − Jekk int allerġika għal Atosiban jew xi sustanza f’ Tractocile
- if you have a multiple pregnancy or a pregnancy between 24 and 27 weeks
Oqgħod attenta ħafna bi Tractocile: − jekk l- ilma jinfaqa ’ qabel iż- żmien ma jistax jiġi eskluż − jekk għandek problemi tal- kliewi jew tal- fwied − jekk il- plaċenta mhix f' pożizzjoni normali − jekk għandek tqala multipla jew tqala ta 'bejn l- 24 u s- 27 ġimgħa − jekk ikollok kontrazzjonijiet rikkorenti, il- kura ta' Tractocile tista 'terġa' tingħata sa tliet darbiet − jekk il- fetu huwa żgħir għaż- żmien tat- tqala − waqt il- kura ta 'Tractocile, il- kontrazzjonijiet tiegħek u r- rata tal- qalb tal- fetu jistgħu jkunu monitorjati − jekk it- tarbija twieldet, Tractocile jista' fit- teorija jnaqqas il- ħila ta 'l- utru biex ikollu l - kontrazzjonijiet.
Please tell your doctor, midwife or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk tkun qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
It is recommended that no more than three re- treatments should be used during a pregnancy.
M' għandhomx jingħataw iktar minn tliet trattamenti waqt it - tqala.
Preparation of the intravenous infusion The intravenous infusion is prepared by diluting TRACTOCILE 7.5 mg/ ml, concentrate for solution for infusion in 0.9% w/ v sodium chloride solution, Ringer's lactate solution or 5% w/ v glucose solution.
Kif tipprepara l- infużjoni fil- vina L- infużjoni għal ġol- vina tiġi ppreparata billi jiġi dilwit Tractocile 7. 5mg/ ml, konċentrat għal soluzzjoni għall- infużjoni f' 0. 9% w/ v ta 'soluzzjoni ta ’ sodium chloride, soluzzjoni ta ’ Ringer’ s lactate jew 5% w/ v ta' soluzzjoni ta ’ glucose.
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml TRACTOCILE 7.5 mg/ ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml.
Dan isir billi jitneħħa 10ml ta ’ soluzzjoni minn borża ta 'l - infużjoni tal- 100ml u minfloku jitqiegħed 10ml ta' Tractocile 7. 5mg/ ml ta 'konċentrat għal soluzzjoni għall- infużjoni minn żewġ kunjetti tal- 5ml biex ikun hemm konċentrazzjoni ta' 75 mg ta 'atosiban f' 100 ml.
There are no known side effects on the fetus or newborn baby.
Mhux magħruf li hemm effetti oħra fil- fetu jew fit- tarbija li tkun għadha kemm twieldet,
For the mother the most commonly reported side effects are nausea, headache, dizziness, hot flushes, vomiting, rapid heart beat, low blood pressure, injection site reaction and high blood sugar.
Għall- omm l- effetti l- oħra li l- iktar li huma rrapurtati huma tqallih, uġiegħ ta 'ras, sturdament, fwawar ta ’ sħana, remettar, taħbit mgħaġġel tal- qalb, pressjoni baxxa tad- demm, reazzjoni fil- post ta' l - injezzjoni u livell għoli ta 'zokkor fid- demm.
Rare side effects include a reduction in the ability of the uterus to contract after your baby has been delivered, which may cause bleeding.
Effetti oħra rari jinkludu tnaqqis fil- ħila ta 'l- utru li jkollu kontrazzjonijiet wara li t- tarbija tiegħek titwieled, li jista' jikkawża dmija.
Allergic reaction has been rarely reported.
Kienu rappurtati reazzjonijiet allerġiċi f`kazijiet rari.
Do not use after the expiry date stated on the label
M’ għandekx tuża wara id- data li jiskadi li tidher fuq it- tikketta.
Dilutions for intravenous administration must be used within 24 hours after preparation.
Meta s- soluzzjoni tiġi dilwita għandha tingħata fil- vina fi żmien 24 siegħa wara li tiġi ppreparata
Do not use TRACTOCILE if you notice particulate matter and discoloration prior to administration.
Tużax Tractocile jekk tara ftrak mhux maħlul jew bidla fil- kulur qabel ma jingħata.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtoriżżazzjoni għall- Kummerċ.
Ελλάδα FERRING ΕΛΛΑΣ ΑΕ Γκύζη 3, GR-151 25, Μαρούσι Τηλ. + 30 (210) 6843449
Καποδιστρίου 42 GR- 104 32 Αθήνα Τηλ: +30 (210) 5205400
Slovenská republika Ferring Pharmaceuticals SA organizač ná zlož ka Slovakia BC Aruba, Galvaniho 7/ D SK-821 04 Bratislava tel: +421 2 5441 1847
Slovenská republika Ferring Ferring Pharmaceuticals SA organizačná zložka Slovakia BC Aruba, Galvaniho 7/ D SK- 821 04 Bratislava tel: +421 2 5441 1847
TRAVATAN 40 micrograms/ ml eye drops, solution
TRAVATAN 40 mikrogramma/ ml qtar għall- għajnejn, soluzzjoni.
1 ml of solution contains 40 micrograms of travoprost.
Ml ta ’ soluzzjoni fih 40 mikrogramma travoprost.
Excipients: benzalkonium chloride 0.15 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 5 mg (see section 4.4.)
Sustanzi mhux attivi: benzalkonium chloride 0. 15 mg, polyoxyethylene hydrogenated castor oil 40 (HCO- 40) 5 mg (ara sezzjoni 4. 4.)
Decrease of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma (see section 5.1).
Tnaqqis ta ’ pressjoni għolja fl- għajnejn f’ pazjenti bi pressjoni għolja ta ’ l- għajnejn jew bi glawkoma tat- tip open- angle (ara sezzjoni 5. 1).
Use in adults, including the elderly The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily.
Użu fl- adulti, inkluż l- anzjani Id- doża hija qatra waħda ta ’ TRAVATAN darba kuljum fil- borża konġuntivali tal- għajn( ejn) affettwata( i).
Optimal effect is obtained if the dose is administered in the evening.
L- aħjar effett jintlaħaq jekk id- doża tingħata fil- għaxija.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.
Wara l- għoti huwa rrakkomandat li jkun hemm okklużjoni nasolakrimali jew li l- kappell tal- għajn jingħalaq bil- mod.
This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Dan jista ’ jnaqqas l- assorbiment sistemiku tal- prodotti mediċinali mogħtija mill - għajn u jirriżulta fi tnaqqis tar- reazzjonijiet avversi sistemiċi.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).
Jekk ikun qed jintuża aktar minn prodott mediċinali topiku għall- għajnejn wieħed, il- prodotti mediċinali għandhom jingħataw b’ interval ta ’ mill- inqas 5 minuti minn xulxin (ara sezzjoni 4. 5).
If a dose is missed, treatment should be continued with the next dose as planned.
Jekk tintnesa doża, il- kura għandha titkompla bid- doża li jmiss kif ippjanat.
The dose should not exceed one drop in the affected eye(s) daily.
Id- doża m’ għandhiex tkun aktar minn qatra waħda kuljum fl- għajn( ejn) affettwata( i).
When substituting another ophthalmic antiglaucoma agent with TRAVATAN, the other agent should be discontinued and TRAVATAN should be started the following day.
Meta qed tiġi sostitwita sustanza oħra għall- għajnejn kontra l- glawkoma bi TRAVATAN, is- sustanza l- oħra għandha titwaqqaf u TRAVATAN għandu jinbeda l- ġurnata ta ’ wara.
Paediatric patients The efficacy and safety of TRAVATAN in patients below the age of 18 years have not been established and its use is not recommended in these patients until further data become available.
Pazjenti pedjatriċi L- effikaċja u s- sigurtà ta ’ TRAVATAN f’ pazjenti taħt 18- il sena ma ġewx stabbiliti u l- użu tiegħu mhux irrakkomandat f’ dawn il- pazjenti qabel ma jkun disponibbli aktar tagħrif.
2 Use in hepatic and renal impairment TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/ min).
2 Użu f’ indeboliment tal- fwied u tal- kliewi TRAVATAN kien studjat f’ pazjenti b’ indeboliment ħafif sa sever tal- fwied u f’ pazjenti b’ indeboliment ħafif sa sever tal- kliewi (tneħħija tal- krejatinina b’ livell baxx sa 14 ml/ min).
No dosage adjustment is necessary in these patients.
L- ebda aġġustament fid- doża ma huwa neċessarju f’ dawn il- pazjenti.
The patient should remove the protective overwrap immediately prior to initial use.
Il- pazjent għandu jneħħi il- pakkett ta ’ protezzjoni ta ’ barra, eżatt qabel ma jużaħ l- ewwel darba.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Biex tiġi evitata kontaminazzjoni tat- tarf tal- qattara u tas- soluzzjoni, għandu jkun hemm attenzjoni biex il - kappell ta ’ l- għajnejn, il- postijiet tal- madwar jew xi superfiċji oħra ma jintmissux bit- tarf tal- qattara tal- flixkun.
TRAVATAN may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes.
TRAVATAN b’ mod gradwali jista ’ jbiddel il- kulur tal- għajn billi jżid in- numru ta ’ melanosomi (grani tal- pigment) fil- melanoċiti.
The long term effects on the melanocytes and any consequences thereof are currently unknown.
L- effetti ta ’ l- użu għal zmien twil fuq il- melanoċiti u il- konsegwenzi ta ’ dan s’ issa għadhom mhux magħrufa.
The change in iris colour occurs slowly and may not be noticeable for months to years.
Il- bidla fil- kulur tal- ħabba tal- għajn iseħħ bil- mod, u jista ma jidhirx għal xhur sa snin.
The change in eye colour has predominantly been seen in patients with mixed coloured irides, i. e., blue- brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in patients with brown eyes.
Il- bidla fil- kulur tal- għajn kienet osservata l- aktar f’ pazjenti li għandhom il- ħabba ta ’ għajnejhom ta ’ kulur imħallat; i. e., blu- kannella, griż- kannella, isfar- kannella u aħdar- kannella; madankollu, dan kien osservat ukoll f’ pazjenti li għandhom għajnejhom kannella.
Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish.
Tipikament, il - pigmentazzjoni kannella ta ’ madwar il- pupilla tinfirex b’ mod konċentriku lejn in- naħa ta ’ barra fl - għajnejn affettwati, iżda l- ħabba tal- għajn kollha jew partijiet minnha jistgħu jsiru aktar kannella.
In controlled clinical trials, periorbital and/ or eyelid skin darkening in association with the use of TRAVATAN has been reported in 0.4% of patients.
Fi provi kliniċi kkontrollati, f’ 0. 4% tal- pazjenti kien irrapportat li l- ġilda ta ’ madwar l- għajnejn u/ jew tal- kappell tal- għajn skuraw fil- kulur f’ assoċjazzjoni ma ’ l- użu ta ’ TRAVATAN.
TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/ or number of lashes.
TRAVATAN b’ mod gradwali jista ’ jbiddel ix- xagħar tal- għajn( ejn) ikkurati; dawn il- bidliet kienu osservati f’ madwar nofs il- pazjenti fil- provi kliniċi u jinkludu: żjieda fit- tul, ħxuna, pigmentazzjoni u/ jew ammont ta ’ xagħar tal- għajnejn.
The mechanism of eyelash changes and their long term consequences are currently unknown.
Il- mekkaniżmu ta ’ bidla fix- xagħar tal- għajnejn u l - konsegwenzi fit- tul ta ’ din il- bidla s’ issa għandhom mhux magħrufa.
TRAVATAN has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey.
Fi studji li saru fuq xadini ntwera li TRAVATAN jikkawża tkabbir żgħir fil- fetħa tal- palpebra.
There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
M’ hemm l- ebda esperjenza ta ’ TRAVATAN f’ kundizzjonijiet ta ’ infjammazzjoni fl- għajnejn; l- anqas fi glawkoma neovaskulari, angle- closure, narrow- angle jew konġenitali, u hemm biss esperjenza limitata f’ mard tal- għajnejn ikkawżat mit- tirojde, fi glawkoma open- angle f’ pazjenti psewdoafakiċi u fi glawkoma pigmentarja jew psewdoeksfoljattiva.
Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
Hija rakkomandata attenzjoni meta TRAVATAN jintużata f’ pazjenti afakiċi, pazjenti psewdoafakiċi bil- kapsula tal- lenti posterjuri jew lentijiet tal- kompartiment anterjuri mqatta ’, jew f’ pazjenti b’ fattur ta ’ riskju magħruf għall- edima ċistojda makulari.
Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Kuntatt ta ’ TRAVATAN mal- ġilda għandu jiġi evitat peress li fil- fniek kien dimostrat assorbiment ta ’ travoprost mill- ġilda.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/ or toxic ulcerative keratopathy.
Benzalkonium chloride li jintuża b’ mod komuni bħala preservativ fi prodotti għall- għajnejn, kien irrapportat li jjikkawża keratopatija bil- ponot u/ jew keratopatija ulċerattiva tossika.
Since TRAVATAN contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Peress li TRAVATAN fih benzalkonium chloride, hija meħtieġa sorveljanza mill- viċin jekk jintuża b’ mod frekwenti jew fit- tul.
In patients with known predisposing risk factors for iritis/ uveitis, TRAVATAN can be used with caution.
3 TRAVATAN jista ’ jintuża b’ attenzjoni f’ pazjenti li għandhom fatturi ta ’ riskju magħrufa li jippredisponewhom għal irite/ uveite.
3 Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin.
Prostaglandins u analogi ta ’ prostaglandin huma materjali bijoloġikament attivi li jistgħu jiġu assorbiti mill- ġilda.
Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle.
Nisa tqal jew li qed jippruvaw joħorġu tqal għandhom jieħdu prekawzjonijiet xierqa biex jevitaw kuntat dirett mal- kontenut tal- flixkun.
In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately
F’ każ estrem ta ’ kuntatt ma ’ ammont sostanzjali tal - kontenut tal- flixkun, il- partit tal- ġisem esposta għandha tinħasel sew minnufih.
TRAVATAN contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.
TRAVATAN fih benzalkonium chloride li jista ’ jikkawża irritazzjoni u huwa magħruf li jista jbiddel il- kulur tal- lentijiet tal- kuntatt rotob.
Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait 15 minutes after instillation of the dose before reinsertion.
Il- pazjenti għandhom jiġu rrakkomandati biex ineħħu il- lentijiet tal- kuntatt qabel l- applikazzjoni ta ’ TRAVATAN u għandhom jistenew 15- il minuta wara l- applikazzjoni tad- doża qabel ma jerġgħu jilbsu l- lentijiet tal- kuntatt.
TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
TRAVATAN fih polyoxyethylene hydrogenated castor oil 40 li jista ’ jikkawża reazzjonijiet fil- ġilda.
Women of child-bearing potential/ contraception TRAVATAN must not be used in women of child bearing age/ potential unless adequate contraceptive measures are in place (see section 5.3).
Nisa li jista ’ jkollhom it- tfal/ kontraċezzjoni TRAVATAN m’ għandux jintuża f’ nisa li jistgħu joħorġu tqal sakemm ma jintużawx meżżi sikuri ta ’ kontraċezzjoni (ara sezzjoni 5. 3).
Pregnancy Travoprost has harmful pharmacological effects on pregnancy and/ or the foetus/ new-born child.
Tqala Travoprost għandu effetti farmakoloġiċi ħżiena fuq it- tqala u/ jew fuq il- fetu/ tarbija tat- twelid.
TRAVATAN should not be used during pregnancy unless clearly necessary.
TRAVATAN m’ għandux jintuża waqt it- tqala ħlief meta hemm bżonn speċifiku.
Lactation It is unknown whether travoprost from eye drops is excreted in human breast milk.
Treddigħ Mhux magħruf jekk travoprost minn qtar għall- għajnejn jitneħhiex fil- ħalib tas- sider uman.
Animal studies have shown excretion of travoprost and metabolites in breast milk.
Studji fuq il- bhejjem urew eskrezzjoni ta ’ travoprost u l- metaboliti fil- ħalib tas- sider.
The use of TRAVATAN by breast- feeding mothers is not recommended.
L- użu ta ’ TRAVATAN minn nisa li qed ireddgħu mhux irrakkomandat.
In clinical studies involving over 4200 patients, TRAVATAN was administered once daily as monotherapy or adjunctive therapy to timolol 0.5%.
Fi studji kliniċi fuq aktar minn 4200 pazjent, TRAVATAN kien mogħti darba kuljum bħala monoterapija jew flimkien ma ’ 0. 5% timolol.
No serious ophthalmic or systemic undesirable effects related to TRAVATAN were reported in any of the clinical studies.
Fl- ebda studju kliniku ma kienu rrapportati effetti mhux mixtieqa serji, fl- għajnejn jew sistemiċi, relatati ma ’ TRAVATAN.
The most frequently reported treatment-related undesirable effect with TRAVATAN monotherapy was hyperaemia of the eye (22.3%), which included ocular, conjunctival, or scleral hyperaemia.
L- effett mhux mixtieq, relatat mal - kura, rrapportat l- aktar frekwenti b’ monoterapija ta ’ TRAVATAN kien iperimija ta ’ l- għajnejn (22. 3%), li jinkludi iperimija ta ’ l- għajn, iperimija konġuntivali jew ta ’ l- isklera.
Hyperaemia was mild in 83.0% of those patients who experienced it.
L- iperimija kienet ta ’ natura ħafifa f’ 83. 0% ta ’ dawk il- pazjenti li sofrew minn din il- kundizzjoni.
Almost all patients (98%) who experienced hyperaemia did not discontinue therapy as a result of this event.
Kważi l- pazjenti kollha (98%) li kellhom esperjenza ta ’ iperimija ma waqqfux it- terapija minħabba dan l- avveniment.
In phase III clinical studies ranging from 6 to 12 months in duration, hyperaemia decreased over time.
Fi studji kliniċi ta ’ fażi III li damu minn 6 xhur sa 12 il- xahar, l- iperimija naqset maż- żmien.