qanastek/EMEA-V3 huggingface dataset:
Psychiatric disorders Nervous system disorders Vascular disorders Gastrointestinal disorders
Disturbi psikjatriċi Disturbi fis- sistema nervuża Disturbi vaskulari Disturbi gastro- intestinali
Anxiety Sinus headache Hypertension Diarrhoea Abdominal pain, upper Dry mouth
Ansjetà Uġigħ ta ’ ras mis- sinus Pressjoni għolja Dijarea Uġigħ fl- addome ta ’ fuq Ħalq xott
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu- skeltrali, tal- connective tissue Uġigħ ta ’ dahar u tal- għadam
ASAT increased Blood pressure increased Blood LDH increased Blood glucose increased
Żjieda f’ ASAT Żjieda fil- pressjoni tad- demm Żjieda fl- LDH fid- demm Żjieda fil- glucose fid- demm
Defined as adverse events for which the frequency on ORACEA was higher than on placebo (by at least 1%)
Iddefiniti bħala avvenimenti avversi li kellhom frekwenza ogħla b’ ORACEA milli bil- plaċebo (b’ minn ta ’ l- inqas 1%)
The following adverse reactions have been observed in patients receiving tetracyclines: -
Ir- reazzjonijiet avversi li ġejjin ġew osservati f’ pazjenti li kienu qed jirċievu tetracyclines: -
Anogenital candidiasis
Kandidajasi anoġenitali
Thrombocytopenia, neutropenia, eosinophilia Very rare:
Tromboċitopenija, newtropenija, esinofilja Rari ħafna:
Haemolytic anaemia
Anemija emolitika
Hypersensitivity reactions including anaphylaxis There have also been reports of:
Reazzjonijiet ta ’ sensittività eċċessiva inkluż anafilassi Kien hemm ukoll rapporti ta ’:
Anaphylactoid purpura
Purpura anafilattojda
Brown-black microscopic discolouration of thyroid tissue has been reported with long- term use of tetracyclines.
Bidla mikroskopika fil- kulur tat- tessut tat- tirojde għal kannela- iswed kienet irrapportata bl- użu fit- tul ta ’ tetracyclines.
Thyroid function is normal.
Funzjoni tat- tirojde hija normali.
Benign intracranial hypertension Very rare:
Pressjoni għolja intrakranjali beninna Rari ħafna:
Bulging fontanelle in infants Treatment should cease if evidence of raised intracranial pressure develops.
Fontanelle bbuzzata fit- trabi Jekk tiżviluppa evidenza ta ’ pressjoni intrakranjali għolja, l- kura għandha titwaqqaf.
These conditions disappeared rapidly when the drug was discontinued.
Dawn il - kundizzjonijiet jgħaddu malajr meta l- mediċina titwaqqaf.
13 Cardiac disorders:
Disturbi fil- qalb:
Pericarditis
Perikardite
Nausea, vomiting, diarrhoea, anorexia Very rare:
14 Rari ħafna:
Glossitis, dysphagia, enterocolitis.
Glossite, disfaġija, enterokolite.
Oesophagitis and oesophageal ulceration have been reported most often in patients administered the hyclate salt in capsule form.
Osofaġite u ulċerazzjoni ta ’ l- esofagu ġew irrapportati l - akar ta ’ spiss f’ pazjenti mogħtija l- hyclate salt f’ forma ta ’ kapsula.
Most of these patients took medication just prior to going to bed.
Il- biċċa l- kbira ta ’ dawn il- pazjenti kienu ħadu medikazzjoni eżatt qabel ma marru jorqdu.
Hepatotoxicity
Epatotossiċità
Maculopapular and erythematous rashes, skin photosensitivity, urticaria Very rare:
Raxxijiet makulopapulari u b’ eritema, fotosensittività tal- ġilda, urtikarja Rari ħafna:
Exfoliative dermatitis, angioneurotic oedema
Dermatite bil- qxur, edima anġjonewrotika
Exacerbation of systemic lupus erythematosus
Rkadar ta ’ lupus eritematosus sistemika
Increased blood urea.
Żjieda tal- urea fid- demm.
Adverse reactions typical of the tetracycline class of medicinal products are less likely to occur during medication with ORACEA, due to the reduced dosage and the relatively low plasma levels involved.
Reazzjonijiet avversa tipiċi tal- klassi ta ’ prodotti mediċinali tetracycline huma inqas probabbli li jseħħu waqt medikazzjoni b’ ORACEA, minħabba d- dożaġġ imnaqqas u l- livelli relattivament baxxi fil- plażma involuti.
However, the clinician should always be aware of the possibility of adverse events occurring and should monitor patients accordingly.
Madankollu, it- tabib għandu dejjem ikun konxju dwar il- possibbiltà li jseħħu avvenimenti avversi u għandu jissorvelja l- pazjenti kif jixraq.
To date no significant acute toxicity has been described in the case of a single oral intake of a multiple of therapeutic doses of doxycycline.
Sa issa l- ebda tossiċità akuta sinifikanti ma ġiet deskritta f’ każ ta ’ teħid orali wieħed ta ’ ħafna dożi terapewtiċi ta ’ doxycycline.
In case of overdose there is, however, a risk of parenchymatous hepatic and renal damage and of pancreatitis.
Madankollu, f’ każ ta ’ doża eċċessiva, hemm ir- riskju ta ’ ħsara parenkemali fil- fwied u fil- kliewi u r- riskju ta ’ pankreatite.
The usual dose of ORACEA is less than half the usual doses of doxycycline used for antimicrobial therapy.
Id- doża tas- soltu ta ’ ORACEA hija inqas minn nofs id- dożi tas- soltu ta ’ doxycycline wżat għal terapija kontra l- mikrobi.
Therefore clinicians should bear in mind that in many cases overdose is likely to produce blood concentrations of doxycycline within the therapeutic range for antimicrobial treatment, for which there is a large quantity of data supporting the safety of the medicinal product.
Għalhekk it- tobba għandhom jieħdu f’ kunsiderazzjoni li f’ ħafna każijiet doża eċċessiva x’ aktarx li tipproduċi konċentrazzjoniiet ta ’ doxycycline fid- demm fil- firxa terapewtiku għall- kura kontra l- mikrobi, li għaliha hemm kwantità kbira ta ’ tagħrif li jsostni is- sigurtà tal- prodott mediċinali.
In these cases observation is recommended.
F’ dawn il- każijiet osservazzjoni hija rrakkomandata.
In cases of significant overdose, doxycycline therapy should be stopped immediately and symptomatic measures undertaken as required.
F’ każijiet ta ’ doża eċċessiva sinifikanti, t- terapija b’ doxycycline għandha titwaqqaf minnufih u għandhom jittieħdu miżuri sintomatiċi skond il- ħtieġa.
Intestinal absorption of unabsorbed doxycycline should be minimised by administering magnesium or calcium salt-containing antacids to produce non-absorbable chelate complexes with doxycycline.
Assorbiment intestinali ta ’ doxycycline mhux assorbit għandu jiġi mnaqqas bl- għoti ta ’ antaċidi li fihom il- melħ ta ’ magnesium jew calcium biex dawn jipproduċu kumplessi ta ’ kelazzjoni ma ’ doxycycline li ma jiġux assorbiti.
Gastric lavage should be considered.
Ħasil gastriku għandu jiġi kkunsidrat.
Dialysis does not alter serum doxycycline half-life and thus would not be of benefit in treating cases of overdose.
Dijalisi ma tbiddilx il- half- life ta ’ doxycycline fis- serum u għalhekk ma tkunx ta ’ benefiċċju għall - kura ta ’ każijiet ta ’ doża eċċesiva.
14 5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
Antibacterials for systemic use, Tetracyclines.
Antibatteriċi għall- użu sisemiku, Tetracyclines.
J01AA02.
J01AA02
Mechanism of Action:
15 Mekkaniżmu ta ’ Azzjoni:
The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation of a neutrophil-mediated process.
Il- patofiżjoloġija tal- feriti infjammatorji ta ’ rosaċeja, hija parzjalment, manifestazzjoni ta ’ proċess medjat minn- newtrofili.
Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions including those associated with phospholipase A2, endogenous nitric oxide and interleukin-6.
Doxycycline intwera li jinibixxi l- attività tan - newtrofili u bosta mir- reazzjonijiet pro- infjammatorji inkluż dawk assoċjati ma ’ phospholipase A2, nitric oxide endoġenu u interleukin- 6.
The clinical significance of these findings is not known.
Is- sinifikat kliniku ta ’ dawn is- sejbiet mhux magħruf.
The plasma concentration of doxycycline following administration of ORACEA is well below the level required to inhibit mircoorganisms commonly associated with bacterial diseases.
Il- konċentrazzjoni fil- plażma ta ’ doxycycline wara l- għoti ta ’ ORACEA hija sew inqas mil- livell meħtieġ biex jinibixxi mikro- organiżmi assoċjati b’ mod komuni ma ’ mard ikkawżat minn mill - batterja.
In vivo microbiological studies using similar exposure to the active substance for 6 to 18 months could not demonstrate any effect on the dominating bacterial flora sampled from the oral cavity, skin, intestinal tract and vagina.
Studji mikrobijoloġiċi in vivo li wżaw esponiment simili għas- sustanza attiva għal 6 sa 18- il xahar ma setgħu juru l- ebda effett fuq kampjuni ta ’ flora ta ’ batterja dominanti meħuda mill- kavità tal- ħalq, ġilda, apparat intestinali u vaġina.
However, it can not be excluded that long-term use of Oracea can lead to emergence of resistant intestinal bacteria such as Enterobacteriaceae and enterococci, as well as to enrichment of resistance genes.
Madankollu, ma jistax jiġi eskluż li l- użu fit- tul ta ’ Oracea jista ’ jwassal għad- dehra ta ’ batteri intestinali reżistenti bħal Enterobacteriaceae u enterococci, kif ukoll li ġeni reżistenti jissaħħu.
ORACEA has been evaluated in two pivotal randomised, double-blind, placebo-controlled, 16-week studies in 537 patients with rosacea (10 to 40 papules and pustules, and two or fewer nodules).
ORACEA kien evalwat f’ żewġ studji pivitali randomised, double- blind, ikkontrollati bil- plaċebo ta ’ 16- il ġimgħa f’ 537 pazjent b’ rosaċeja (10 sa 40 ponta u nuffata, u żewġ għoqiedi jew inqas).
In both studies, the mean reduction in the total inflammatory lesion count was significantly greater in the ORACEA group than in the placebo group:
Fiż- żewġ studji, it- tnaqqis medju fl- għadd totali ta ’ feriti infjammatorji kien akbar b’ mod sinifikanti fil- grupp ta ’ ORACEA milli fil- grupp tal- plaċebo:
Mean change from baseline to Week 16 in total inflammatory lesion count:
Bidla medja mil- linja bażi sa Ġimgħa 16 fl- għadd totali ta ’ leżjonijiet infjammatorji:
Mean (SD) change from
Bidla (SD) medja mil- linja
Placebo (N = 124)
Plaċebo (N = 124)
Placebo (N = 144)
Plaċebo (N = 144)
baseline
bażi
-11.8 (9.8)
- 11. 8 (9. 8)
-5.9 (13.9)
- 5. 9 (13. 9)
-9.5 (9.6)
- 9. 5 (9. 6)
-4.3 (11.6)
- 4. 3 (11. 6)
Mean between-group difference
Differenza medja bejn il - gruppi
-5.2
- 5. 2
(95% confidence limits) a
(livelli ta ’ kunfidenza ta ’ 95%)
(-8.9, -2.9)
(- 8. 9, - 2. 9)
(-7.7, -2.7)
(- 7. 7, - 2. 7)
a
Valur pa a
p-Value for treatment difference in change from baseline (ANOVA)
Valur p għad- differenza fil- kura għal bidla mil- linja bażi (ANOVA)
Doxycycline is almost completely absorbed after oral administration.
Doxycycline huwa assorbit kważi kompletament wara għoti orali.
Following oral administration of ORACEA, mean peak plasma concentrations were 510 ng/ mL after a single dose and 600 ng/ mL at steady state (Day 7).
Wara għoti orali ta ’ ORACEA, konċentrazzjonijiet massimi medji fil- plażma kienu ta ’ 510 ng/ mL wara doża waħda u 600 ng/ mL fi stat fiss (Jum 7).
Peak plasma levels were generally achieved at 2 to 3 hours after administration.
Livelli massimi fil- plażma ġeneralment intlaħqu minn 2 sa 3 sigħat wara l- għoti.
Coadministration with a high-fat, high-protein meal that included dairy products reduced the bioavailability (AUC) of doxycycline from ORACEA by about 20% and reduced the peak plasma level by 43%.
L - għoti fl- istess waqt ma ’ ikla b’ ħafna xaħam u ħafna proteini li jinkludu prodotti mill- ħalib naqqsu l - bijodisponibiltà (AUC) ta ’ doxycycline minn ORACEA b’ madwar 20% u naqqsu l- livell massimu fil - plażma b’ 43%.
Distribution, metabolism and elimination:
Distribuzzjoni, metaboliżmu u eliminazzjoni:
Doxycycline is greater than 90% bound to plasma proteins and has an apparent volume of distribution of 50 L.
Aktar minn 90% ta ’ doxycycline huwa mwaħħal mal- proteini fil- plażma u huwa għandu volum ta ’ distribuzzjoni apparenti ta ’ 50 L.
Major metabolic pathways of doxycycline have not been identified but enzyme inducers decrease the half-life of doxycycline.
Rotot metaboliċi maġġuri ta ’ doxycycline ma ġewx identifikati iżda indutturi ta ’ l- enżimi naqqsu il- half- life ta ’ doxycycline.
15 Doxycycline is excreted in the urine and faeces as unchanged active substance.
Doxycycline jitneħħa fl- awrina u fl- ippurgar bħala sustanza attiva mhux mibdula.
Between 40% and 60% of an administered dose can be accounted for in the urine by 92 hours, and approximately 30% in the faeces.
Bejn 40% u 60% tad- doża mogħtija tista ’ tinstab fl- awrina wara 92 siegħa, u madwar 30% fl- ippurgar.
The terminal elimination half-life of doxycycline after administration of ORACEA was approximately 21 h after a single dose and approximately 23 h at steady state.
Il- half- life terminali ta ’ eliminazzjoni ta ’ doxycycline wara l- għoti ta ’ ORACEA kienet madwar 21 h wara doża waħda u madwar 23 h fi stat fiss.
Pharmacokinetics in special populations:
16 Farmakokinetika f’ popolazzjonijiet speċjali:
The half-life of doxycycline is not significantly altered in patients with severely impaired renal function.
Il- half- life ta ’ doxycycline ma tinbidilx b’ mod sinifikanti f’ pazjenti b’ funzjoni renali mdgħajjfa b’ mod sever.
Doxycycline is not eliminated to any great extent during haemodialysis.
Doxycycline mhux eliminat bi kwantità kbira waqt emodijalisi.
There is no information on the pharmacokinetics of doxycycline in patients with hepatic impairment.
M’ hemmx informazzjoni dwar il- farmakokinetika ta ’ doxycycline f’ pazjenti b’ indeboliment tal- fwied.
Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
Dawn l- effetti dehru f’ livelli ta ’ esponiment ta ’ 1. 5 darbiet sa darbtejn dawk li dehru fil- bnedmin li ngħataw ORACEA fid- doża proposta.
The clinical relevance of these findings remains unknown.
Ir- rilevanza klinika ta ’ dawn is- sejbiet għada mhix magħrufa.
Doxycycline showed no mutagenic activity and no convincing evidence of clastogenic activity.
Doxycycline ma wera l- ebda attività mutaġenika u l- ebda evidenża konvinċenti ta ’ attività klastoġenika.
In a rat carcinogenicity study increases in benign tumours of the mammary gland (fibroadenoma), uterus (polyp) and thyroid (C-cell adenoma) were noted in females.
Fi studju dwar il- karċenoġeniċità fil- firien kienu nnutati żjidiet f’ tumuri beninni tal - glandola mammarja (fibroadenoma), utru (qarnita) u tirojde (adenoma taċ- ċellula C) f’ firien femminili.
In rats, doses of 50 mg/ kg/ day doxycycline caused a decrease in the straight-line velocity of sperm but did not affect male or female fertility or sperm morphology.
Fil- firien, dożi ta ’ 50 mg/ kg/ jum ta ’ doxycycline ikkawżaw tnaqqis fil- veloċità f’ linja dritta ta ’ l - isperma iżda ma affettwawx il- fertilità maskili jew femminili jew il- morfoloġija ta ’ l- isperma.
At this dose systemic exposure experienced by rats is likely to have been approximately 4 times that seen in humans taking the recommended dose of ORACEA.
F’ din id- doża l- esponiment sistemiku li esperjenzaw il- firien x’ aktarx kien madwar 4 darbiet dak li deher fil- bnedmin li kienu qed jieħdu d- doża rrakkomandata ta ’ ORACEA.
At doses greater than 50 mg/ kg/ day fertility and reproductive performance were adversely affected in rats.
F’ dożi aktar minn 50 mg/ kg/ jum il- fertilità u l- ħila riproduttiva kienu affettwati b’ mod avvers fil- firien.
A peri/ postnatal toxicity study in rats revealed no significant effects at therapeutically relevant doses.
Studji dwar it- tossiċità waqt u wara t- twelid fil- firien ma wera l- ebda effetti sinifikanti f’ dożi terapewtikament rilevanti.
Doxycycline is known to cross the placenta and literature data indicate that tetracyclines can have toxic effects on the developing fetus.
Doxycycline huwa magħruf li jgħaddi mis- sekonda u tagħrif mil- letteratura jindika li tetracyclines jista ’ jkollhom effetti tossiċi fuq il- fetu li qed jiżviluppa.
Capsule shell Gelatin Black iron oxide Red iron oxide Yellow iron oxide Titanium dioxide
Qoxra tal- kapsula Gelatin Iron oxide iswed Iron oxide aħmar Iron oxide isfar Titanium dioxide
Printing inks Shellac Propylene glycol Black iron oxide Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C Yellow No.
Linka għall- istampar Shellac Propylene glycol Iron oxide iswed Indigo Carmine aluminium lake Allura Red AC aluminium lake Brilliant Blue FCF aluminium lake D & C Yellow No.
10 aluminium lake Opacode Black S-1-8115 Opacode Black S-1-8114
10 aluminium lake Opacode Iswed S- 1- 8115 Opacode Iswed S- 1- 8114
Capsule contents
Kontenut tal- kapsula Hypromellose Methacrylic acid- ethyl acrylate copolymer (1: 1) Triethyl citrate
16 Hypromellose Methacrylic acid-ethyl acrylate copolymer (1:1) Triethyl citrate Talc Opadry beige YS-1-17274-A (Hypromellose 3cP/ 6cP, Titanium dioxide, Macrogol 400, Yellow iron oxide, Red iron oxide, Polysorbate 80) Sugar spheres (Maize starch, Sucrose)
17 Talk Opadry kannella fl- isfar YS- 1- 17274- A (Hypromellose 3cP/ 6cP, Titanium dioxide, Macrogol 400, Iron oxide isfar, Iron oxide aħmar, Polysorbate 80) Globuli ta ’ zokkor (Maize starch, Sucrose)
Aluminium/ PVC/ Aclar blister
Folja ta ’ Aluminium/ PVC/ Aclar
56 capsules in 4 strips of 14 each
56 kapsula f’ 4 strippi ta ’ 14 kull waħda
{Name and address }< {tel }> < {fax }> < {e-mail }>
{Isem u indirizz} < {telefon} > < {fax} > < {e- mail} >
ORACEA 40 mg modified-release hard capsules doxycycline
ORACEA kapsuli iebsa ta ’ 40 mg li jerħu l- mediċina b' mod modifikat doxycycline
Each capsule contains 40 mg doxycycline (as monohydrate).
Kull kapsula fiha 40 mg ta ’ doxycycline (bħala monohydrate).
Contains also sucrose See leaflet for further information.
Fih ukoll sucrose Ara l- fuljett ta ’ tagħrif għall- aktar informazzjoni.
56 modified-release hard capsules
56 kapsula li jerħu l- mediċina b' mod modifikat
Swallow whole, do not crush or chew.
Ibla l- pilloli sħaħ, tfarrakhomx u tomgħodhomx.
Take with water.
Ħu ma ’ l- ilma.
Batch No.:
LOTT:
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
21 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
ALUMINIUM/ PVC/ AClAR BLISTER
FOLJA TA ’ ALUMINIUM/ PVC/ AClAR
Batch No..
LOTT:
22 PACKAGE LEAFLET:
22 Ċ.
ORACEA 40 mg modified release hard capsules Doxycycline
ORACEA kapsuli iebsa ta ’ 40 mg li jerħu l- mediċina b' mod modifikat Doxycycline
What ORACEA is and what it is used for 2.
X’ inhu ORACEA u għalxiex jintuża 2.
Before you take ORACEA 3.
Qabel ma tieħu ORACEA 3.
How to take ORACEA 4.
Kif għandek tieħu ORACEA 4.
How to store ORACEA 6.
Kif taħżen ORACEA 6.
WHAT ORACEA IS AND WHAT IT IS USED FOR
X’ INHU ORACEA U GĦALXIEX JINTUŻA
ORACEA is a medicine for use in adults to reduce the pimples or red bumps on the face caused by a condition called rosacea.
ORACEA huwa mediċina għall- użu fl- adulti biex inaqqas il- ponot jew l- infafet ħomor fil- wiċċ ikkawżati minn kundizzjoni msejħa rosaċeja.
BEFORE YOU TAKE ORACEA
QABEL MA TIEĦU ORACEA
Do not take ORACEA
Tieħux ORACEA
- if you are allergic (hypersensitive) to any medicinal product in the tetracycline family,
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi prodott mediċinali fil- familja ta ’
including doxycycline or minocycline, or to any of the other ingredients of ORACEA (see section 6.)
tetracyclines, inkluż doxycycline jew minocycline, jew għal xi sustanzi oħra ta ’ ORACEA (ara sezzjoni 6.)
- if you are pregnant ORACEA should not be used from the 4th month of because it may harm
- jekk inti tqila ORACEA m’ għandux jintuża mir- 4 xahar tat- tqala peress li jista ’ jagħmel ħsara lit -
the unborn child.
tarbija li għada ma twelditx.
If you suspect or learn that you are pregnant whilst taking ORACEA, contact your doctor immediately.
Jekk taħseb jew issir taf li inti tqila waqt li qed tieħu ORACEA, kellem lit- tabib tiegħek minnufih.
- if you have a condition causing absence of acid in the stomach (achlorhydria) or if you have
- Jekk inti għandek kundizzjoni li tikkawża nuqqas ta ’ aċidu fl- istonku (aklorħajdra) jew jekk
had surgery on the upper part of the gut (called the duodenum).
kellek kirurġija fil- parti ta ’ fuq tal- musrana (msejjaħ duwodenu).
ORACEA must not be taken by infants or children under the age of 12, because it may cause permanent discolouration of the teeth or problems with tooth development.
ORACEA ma jistax jittieħed minn trabi jew tfal taħt l- età ta ’ 12- il sena, minħabba li huwa jista ’ jikkawża bidla permanenti fil- kulur tas- snien jew problemi bl- iżvilupp tas- snien.
Take special care with ORACEA Inform your physician
Oqgħod attent ħafna b’ ORACEA Għarraf lit- tabib tiegħek
- if you have liver disease
- jekk għandek marda tal- fwied
- if you have a history of predisposition to candidiasis overgrowth or are currently
- jekk għandek passat ta ’ predispożizzjoni għal tkabbir żżejjed ta ’ kandidajasi jew bħalissa
experiencing an oral or vaginal yeast or fungal infection
għandek infezzjoni orali jew vaġinali kkawżata minn fungu ta ’ ċellula waħda jew mill - moffa
- if you suffer from the muscle disease called myasthenia gravis
- jekk issofri minn marda fil- muskoli msejjħa mijastenja gravis
- if you suffer from colitis
- jekk issofri minn kolite
- if you suffer from oesophageal irritation or ulceration
- jekk issofri minn irritazzjoni jew ulċerazzjoni tal- esofagu
- if you have the type of rosacea which affects the eyes
- jekk għandek tip ta ’ rosaċeja li taffettwa l- għajnejn
- if you expose your skin to strong sunlight or artificial sunlight, because more severe
- jekk inti tesponi l- ġilda tiegħek għal dawl tax- xemx qawwi jew dawl tax- xemx artifiċjali,
sunburn may occur in some people taking doxycycline.
peress li f’ ċertu persuni li qed jieħdu doxycycline jista ’ jkun hemm ħruq tax- xemx aktar sever.
You should consider using a sunscreen or sunblock to reduce the risk of sunburn and you should stop using ORACEA if your skin becomes sunburned.
Inti għandek tikkunsidra li tuża protezzjoni mix- xemx jew sunblock biex tnaqqas ir- riskju ta ’ ħruq tax- xemx u għandek twaqqaf l- użu ta ’ ORACEA jekk il- ġilda tiegħek tinħaraq bix- xemx.
23 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
ORACEA and certain other medications may not work properly when taken together.
ORACEA u ċertu medikazzjonijiet oħra jistgħu ma jaħdmux sew meta jittieħdu flimkien.
Tell your doctor about medications that you are taking or plan to take whilst you are taking ORACEA.
Għid lit - tabib tiegħek dwar medikazzjonijiet li inti qed tieħu jew qed tippjana li tieħu waqt li qed tieħu ORACEA.
- ORACEA should not be used at the same time as the medicine isotretinoin because of the risk
- ORACEA m’ għandux jintuża fl- istess waqt mal- mediċina isotretinoin minħabba r- riskju ta ’
of increased pressure in the brain.
żjieda fil- pressjoni fil- moħħ.
Isotretinoin is prescribed to patients with a severe case of acne.
Isotretinoin huwa preskritt lill- pazjenti b’ każ sever ta ’ akne.
- Do not take antacids, multi-vitamins or other products that contain calcium (such as milk and
- Tieħux antaċidi, multi- vitamini jew prodotti oħra li fihom il- calcium (bħal ħalib u prodotti mill -
dairy products and calcium-containing fruit juices), aluminium, magnesium (including quinapril tablets, which are taken for high blood pressure), iron or bismuth, or cholestyramine, activated charcoal or sucralfate until 2 to 3 hours after taking ORACEA.
ħalib u meraq tal- frott li fihom il- calcium), aluminju, manjesu (inkluż pilloli quinapril, li jittieħdu għall- pressjoni għolja tad- demm), ħadid jew bismuth, jew cholestyramine, faħam attivat jew sucralfate qabel sagħtejn sa 3 sigħat wara li tieħu ORACEA.
These medicines may reduce the effectiveness of ORACEA if taken at the same time.
Dawn il- mediċini jistgħu jnaqqsu l- effettività ta ’ ORACEA jekk jittieħdu fl- istess waqt.
- Other treatments for ulcers or heartburn may also reduce the effectiveness of ORACEA and
- Kura oħra għall- ulċeri jew ħruq ta ’ stonku wkoll jistgħu jnaqqsu l- effettività ta ’ ORACEA u
should not be taken until at least 2 hours after ORACEA.
m’ għandhomx jittieħdu qabel ta ’ l- inqas sagħtejn wara ORACEA.
- If you are taking blood thinners, your doctor may need to make changes to the dose of your
- Jekk qed tieħu sustanzi li jraqqu d- demm, it- tabib tiegħek jista ’ jkollu bżonn jagħmel tibdiliet
blood thinner.
lid- doża tas- sustanza li traqqaq id- demm tiegħek.
- If you are taking certain treatments for diabetes, your doctor may need to check whether the
- Jekk qed tieħu ċertu kura għad- dijabete, it- tabib tiegħek jista ’ jkollu bżonn jiċċekkja jekk id -
dose of the diabetes treatment has to be changed.
doża tal- kura tad- dijabete għandhiex tinbidel.
- There is a possibility that ORACEA reduces the effectiveness of oral contraceptives, resulting
- Hemm il- possibbiltà li ORACEA inaqqas l- effettività ta ’ kontraċettivi orali, li jwassal għal
in pregnancy.
tqala.
- ORACEA may make certain antibiotics, including penicillins, less effective.
- ORACEA jista ’ jnaqqas l- effettività ta ’ ċerti antibijotiċi, inkluża l- peniċillina.
- Taking barbiturates (sleeping pills or short-term pain-killers), rifampicin (tuberculosis),
- It- teħid ta ’ barbiturates (pilloli ta ’ l- irqad jew li jnaqqsu l- uġigħ għal perijodu qasir), rifampicin
carbamazepine (epilepsy), diphenylhydantoin and phenytoin (seizures of the brain), primidone (anti-convulsant) or cyclosporin (organ transplant) may reduce the time that ORACEA stays active in your system.
(tuberkulosi), carbamazepine (epilessija), diphenylhydantoin u phenytoin (attakki ta ’ puplesija fil- moħħ), primidone (anti- konvulsiv) jew cyclosporin (trapjant ta ’ organu) jistgħu jnaqqsu il - ħin li ORACEA jibqa ’ attiv fis- sistema tiegħek.
- Using ORACEA with the general anaesthetic methoxyfluorane may cause serious harm to the
- L- użu ta ’ ORACEA ma ’ l- anestetiku ġenerali methoxyfluorane jista ’ jikkawża ħsara serja lill -
kidneys.
kliewi.
Taking ORACEA with food and drink Always take ORACEA with an adequate amount of water to wash down the capsule, since this reduces the risk of irritation or ulcer in the throat or gullet.
Meta tieħu ORACEA ma ’ l- ikel u max- xorb Dejjem ħu ORACEA ma ’ ammont adegwat ta ’ ilma biex tibla l- kapsula, minħabba li dan inaqqas ir - riskju ta ’ irritazzjoni jew ulċera fil- ġriżmejn jew l- esofagu.
Do not take milk or dairy products at the same time as ORACEA since these products contain calcium which may reduce the effectiveness of ORACEA.
Tieħux ħalib jew prodotti mill- ħalib flimkien ma ’ ORACEA minħabba li dawn il- prodotti fihom il - calcium li jista ’ jnaqqas l- effettività ta ’ ORACEA.
Leave 2 to 3 hours after your daily dose of ORACEA before drinking or eating dairy products.
Ħalli sagħtejn sa 3 sigħat wara id- doża tigħek ta ’ kuljum ta ’ ORACEA qabel tixrob jew tiekol prodotti mill- ħalib.
Pregnancy and breast-feeding ORACEA must not be used during pregnancy since it may cause permanent discolouration of the teeth in the unborn child.
Tqala u Treddigħ ORACEA m’ għandux jintuża waqt it- tqala peress li jista ’ jikkawża bidla permanenti fil- kulur tas - snien tat- tarbija li għada ma twelditx.
ORACEA should not be used for long periods by breastfeeding mothers since it may cause tooth discolouration and reduced bone growth in the suckling child.
ORACEA m’ għandux jintuża għall- perijodi twal minn ommijiet li qed ireddgħu peress li jista ’ jikkawża bidla fil- kulur tas- snien u tnaqqis fit- tkabbir ta ’ l- għadam tat- tarbija li qed terda ’.
Driving and using machines ORACEA has no or negligible influence on the ability to drive and use machines.
Sewqan u tħaddim ta ’ magni ORACEA m’ għandu l- ebda effett jew influwenza żgħira ħafna fuq il- ħila biex issuq u tħaddem magni.
Important information about some of the ingredients of ORACEA ORACEA contains sugar (sucrose).
25 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ ORACEA ORACEA fih iz- zokkor (sucrose).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li inti għandek intolleranza għal ċertu zokkrijiet, kellem lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE ORACEA
KIF GĦANDEK TIEĦU ORACEA
Always take ORACEA exactly as your doctor has told you.
Dejjem għandek tieħu ORACEA skond il- parir tat- tabib.
You should take one capsule ORACEA each day in the morning.
Għandek tieħu kapusla waħda ta ’ ORACEA kuljum fil- għodu.
Swallow the capsule whole and do not chew it.
Ibla ’ l- kapsula sħiħa u tomgħodhiex.
You should take ORACEA with a full glass of water whilst sitting or standing to avoid any irritation to the throat.
Għandek tieħu ORACEA ma ’ tazza ilma mimlija waqt li bilqiegħda jew bilwieqfa biex tevita kull irritazzjoni lill- griżmejn.
If you take more ORACEA than you should If you take an overdose of ORACEA, there is a risk of damage to the liver, kidneys or pancreas.
Jekk tieħu ORACEA aktar milli suppost Jekk tieħu doża eċċessiva ta ’ ORACEA, hemm ir- riskju ta ’ ħsara lill- fwied, kliewi jew frixa.
If you take more ORACEA capsules than you should, ask your doctor immediately for advice.
Jekk tieħu aktar kapsuli ta ’ ORACEA milli suppost, saqsi lit- tabib tiegħek għall- parir immedjatament.
If you forget to take ORACEA Do not take a double dose to make up for a forgotten capsule.
Jekk tinsa tieħu ORACEA M’ għandekx tieħu doża doppja biex tpatti għal kull kapusla li tkun insejt tieħu.
If you stop taking ORACEA You should continue to take ORACEA until your doctor tells you to stop.
Jekk tieqaf tieħu ORACEA Għandek tkompli tieħu ORACEA sakemm it- tabib tiegħek jgħidlek biex tieqaf.
Like all medicines, ORACEA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, ORACEA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects The following side effects may occur commonly (affects 1 to 10 users in 100) during treatment with ORACEA:
Effetti sekondarji komuni L- effetti sekondarji li ġejjin jistgħu jseħħu b’ mod komuni (jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh) waqt kura b’ ORACEA:
• Inflammation of the nose and throat • Inflammation of the sinuses • Fungal infection • Anxiety • Sinus headache • High or increased blood pressure • Diarrhoea • Pain in the upper part of the abdomen • Dry mouth • Back pain • Pain • Changes in some blood tests (amount of glucose in blood or tests of liver function).
• Infjammazzjoni ta ’ l- imnieħer u l- griżmejn • Infjammazzjoni tas- sinuses • Infezzjoni mill- moffa • Ansjetà • Uġigħ ta ’ ras mis- sinus • Pressjoni tad- demm għolja jew miżjuda • Dijarea • Uġigħ fil- parti ta ’ fuq ta ’ l- addome • Ħalq xott • Uġigħ fid- dahar • Uġigħ • Bidliet f’ xi testijiet tad- demm (ammont ta ’ glucose fid- demm jew testijiet tal- funzjoni tal - fwied).
Rare side effects The following side effects may occur rarely (affects 1 to 10 users in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Effetti sekondarji rari L- effetti sekondarji li ġejjin jistgħu jseħħu b’ mod rari (jaffettwaw minn persuna waħda sa 10 minn kull 10, 000 li qed jużawh) waqt kura bil- klassi ta ’ mediċini li jagħmel parti minnha ORACEA (tetracyclines):
• Allergic (hypersensitivity) reaction throughout the body* • Changes in the number or type of certain blood cells • Increased pressure in the brain
• Reazzjoni allerġika (sensittività eċċessiva) mal- ġisem kollu * • Bidliet fin- numru jew tip ta ’ ċertu ċelluli tad- demm
25 • Inflammation of the membrane surrounding the heart • Nausea, vomiting, anorexia • Liver damage • Skin rashes or hives • Abnormal reaction of the skin to sunlight • Increased level of urea in the blood
26 • Żjieda fil- pressjoni fil- moħħ • Infjammazzjoni tal- membrana ta ’ madwar il- qalb • Tqalligħ, rimettar, anoressija • Ħsara fil- fwied • Raxx jew urtikarja fil- ġilda • Reazzjoni mhux normali tal- ġilda għad- dawl tax- xemx • Żjieda fil- livell ta ’ urea fid- demm
Very rare side effects The following side effects may occur very rarely (affects less than 1 user in 10,000) during treatment with the class of medicines to which ORACEA belongs (the tetracyclines):
Effetti sekondarji rari ħafna L- effetti sekondarji li ġejjin jistgħu jseħħu b’ mod rari ħafna (jaffettwaw inqas minn persuna waħda minn kull 10, 000 li qed jużawh) waqt kura bil- klassi ta ’ mediċini li jagħmel parti minnha ORACEA (tetracyclines):
• Allergic reaction causing swelling of the eyes, lips or tongue* • Yeast infection around the anus or genitals • Damage to red blood cells (haemolytic anaemia) • Inflammation of the tongue • Difficulty in swallowing • Inflammation of the intestine • Inflammation or ulceration of the gullet • Inflammation of the skin causing flakiness • Worsening of the immune system disease known as systemic lupus erythematosus (SLE)
• Reazzjoni allerġika li tikkawża nefħa ta ’ l- għajnejn, xufftejn jew ilsien * • Infezzjoni kkawżata minn fungi b’ ċellula waħda madwar l- anus jew il- ġenitali • Ħsara liċ- ċelluli ħomor tad- demm (anemija emolitika) • Infjammazzjoni ta ’ l- ilsien • Diffikultà biex tibla ’ • Infjammazzjoni tal- musrana • Infjammazzjoni jew ulċerazzjoni tal- esofagu • Infjammazzjoni tal- ġilda li tikkawża qxur • Il- marda tas- sistema mmuni magħrufa bħala lupus eritematosus sistemika (SLE) taggrava
* Tell your doctor immediately or go to casualty if you suffer side effects such as swollen face, lips, tongue and throat, difficulty in breathing, hives or itchy skin and eyes, or rapid heart beat (palpitations) and feeling faint.
* Għid lit- tabib tiegħek immedjatament jew mur l- emerġenza jekk issofri effetti sekondarji bħal nefħa fil- wiċċ, xufftejn, ilsien jew griżmejn, diffikultà biex tieħu n- nifs, urtikarja jew ħakk fil- ġilda u l - għajnejn, jew taħbit tal- qalb mgħaġġel (palpitazzjonijiet) jew tħoss ħass ħażin.
These effects may be symptoms of a severe allergic (hypersensitivity) reaction.
Dawn l- effetti jistgħu jkunu sintomi ta ’ reazzjoni allerġika (sensittività eċċessiva) severa.
HOW TO STORE ORACEA
KIF TAĦŻEN ORACEA
Do not use ORACEA after the expiry date which is stated on the outer pack and blister after Batch No.
Tużax ORACEA wara d- data ta ’ skadenza li tidher fuq il- kartuna ta ’ barra u l- folja wara JIS.
What ORACEA contains
X’ fih ORACEA:
The active substance is doxycycline.
Is- sustanza attiva hi doxycycline.
Hypromellose[piq-qrd1], methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, talc, Opadry beige YS-1-17274-A (hypromellose 3cP/ 6cP, titanium dioxide, macrogol 400, yellow iron oxide, red iron oxide, polysorbate 80), sugar spheres (maize starch, sucrose).
Is- sustanzi l- oħra huma: hypromellose, methacrylic acid- ethyl acrylate copolymer (1: 1), triethyl citrate, talk, opadry kannella fl- isfar YS- 1- 17274- A (hypromellose 3cP/ 6cP, titanium dioxide, macrogol 400, iron oxide isfar, iron oxide aħmar, polysorbate 80), globuli ta ’ zokkor (maize starch, sucrose).
Capsules: gelatin, black iron oxide, red iron oxide, yellow iron oxide, titanium dioxide
Kapsuli: gelatin, iron oxide iswed, iron oxide aħmar, iron oxide isfar, titanium dioxide
26 Printing ink: shellac, propylene glycol, black iron oxide, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no.
27 Linka għall- istampar: shellac, propylene glycol, iron oxide iswed, indigo carmine aluminium lake, allura red AC aluminium lake, brilliant blue FCF aluminium lake, D & C yellow no.
10 aluminium lake, Opacode black S-1-8115, Opacode black S-1-8114.
10 aluminium lake, Opacode iswed S- 1- 8115, Opacode iswed S- 1- 8114.
What ORACEA looks like and contents of the pack ORACEA is a modified-release hard capsule.
ORACEA hija kapsula iebsa li terħi l- mediċina b' mod modifikat.
The capsules are beige in colour and bear the marking “ CGPI 40”.
Il- kapsuli huma ta ’ kulur kannella fl- isfar u għandhom l- marka “ CGPI 40 ”.
Each pack contains 56 capsules.
Kull pakkett fih 56 kapsula.
The manufacturer responsible for batch release is:
Il- manifattur responsabbli għall- ħruġ tal- lott huwa:
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri ta ’ l- EEA taħt l- ismijiet li gejjin:
SE - ORACEA 40 mg modified release hard capsules UK - ORACEA 40 mg modified release hard capsules DE - ORACEA 40 mg modified release hard capsules IE - ORACEA 40 mg modified release hard capsules AT - ORACEA 40 mg modified release hard capsules FI - ORACEA 40 mg modified release hard capsules LU - ORACEA 40 mg modified release hard capsules NL - ORACEA 40 mg modified release hard capsules IT - ORACEA 40 mg modified release hard capsules
SE - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat UK - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat DE - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat IE - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat AT - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat FI - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat LU - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat NL - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat IT - ORACEA 40 mg kapsuli ibsin li jerħu l- mediċina b' mod modifikat
27 ANNEX IV
28 ANNESS IV
CONDITIONS OF THE MARKETING AUTHORISATION(S)
KONDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI( JIET) GĦAT- TQEGĦID FIS- SUQ
28 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
29 L- Awtoritajiet Nazzjonali Kompetenti, koordinati mill- Istat Membru ta ’ Referenza, jassiguraw li l - kondizzjonijiet li ġejjin huma ssodisfati mid- Dententuri ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
The Applicant should conduct a post-marketing microbiological study in order to further elucidate the risk for emergence of resistance in the intestinal and upper respiratory microflora associated with the long-term use of Oracea, and commit to submitting a study protocol within 3 months of approval.
L- Applikant għandu jagħmel studju mikrobijoloġiku ta ’ wara t- tqegħid fis- suq sabiex jitfa ’ iktar dawl fuq ir- riskju għal feġġa ta ’ reżistenza fil- mikroflora intestinali u respiratorja tan- naħa ta ’ fuq assoċjati ma ’ użu fit- tul ta ’ Oracea, u jintrabat li jissottometti protokoll ta ’ studju fi żmien 3 xhur mill - approvazzjoni.
The scope, design and end-points should be in line with similar trials published in the literature.
L- iskop, disinn u punti ta ’ tmiem għandhom ikunu konformi ma ’ provi simili ppubblikati fil- letteratura.
2 years) from the date of approval.
L- Applikant għandu minbarra dan jaċċetta li jkompli dan l- istudju u jippreżenta rapport fi żmien raġonevoli (per eżempju sentejn) mid- data ta ’ l- approvazzjoni.
London, 23 July 2008 EMEA/ CHMP/ 428671/ 2008
Londra, 23 ta 'Lulju 2008 EMEA/ CHMP/ 222164/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Oracea
OPINJONI WARA REFERENZA TAL- ARTIKOLU 29( 4) 1 DWAR Oracea
International Non-Proprietary Name (INN): doxycycline monohydrate
Denominazzjoni Komuni Internazzjonali (DKI): doxycycline monoidrat
Oracea, 40 mg, modified release capsules is an antibiotic (doxycycline), indicated for the reduction of papulopustular lesions in adult patients with facial rosacea.
Oracea, 40 mg, kapsuli b' rilaxx modifikat huwa antibijotiku (doxycycline) indikat sabiex inaqqas il - leżjonijiet papulopustulari f' pazjenti adulti b' rosaċea fil- wiċċ.
The applicant FGK Representative Service GmbH submitted an application for Marketing Authorisation Application of Oracea, 40 mg, modified release capsule on the basis of the marketing application to the UK on 28 February 2006.
L- applikant, FGK Representative Service GmbH ippreżenta applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq ta 'Oracea, 40 mg, kapsula b' rilaxx modifikat fuq il- bażi tal- applikazzjoni għat- tqegħid fis - suq fir- Renju Unit fit- 28 ta' Frar 2006.
The Decentralised Procedure UK/ H/ 0892/ 01/ DC started on 12 April 2006.
Il- Proċedura Deċentralizzata UK/ H/ 0892/ 01/ DC bdiet fit- 12 ta 'April 2006.
The Reference Member State was United Kingdom and the Concerned Member States were Austria, Germany, Finland, Ireland, Italy, Luxembourg, Netherlands and Sweden.
L- Istat Membru ta 'Referenza kien ir- Renju Unit u l- Istati Membri konċernati kienu l- Awstrija, il - Ġermanja, il- Finlandja, l- Irlanda, l- Italja, il- Lussemburgu, l- Olanda u l- Iżvezja.
These Member States were not able to reach an agreement and therefore the United Kingdom referred the reasons for disagreement to the CHMP on 27 July 2007.
Dawn l- Istati Membri ma setgħux jilħqu ftehim u għalhekk ir- Renju Unit irrefera r- raġunijiet għan- nuqqas ta 'qbil lis- CHMP fis- 27 ta' Lulju 2007.
Significant difference had been identified with regard to the lack of sufficient safety and efficacy evidence, the emergence of bacterial resistance caused by the use of Oracea and the insufficient demonstration of a positive benefit: risk ratio.
Ġiet identifikata differenza sostanzjali fir- rigward tan- nuqqas ta 'biżżejjed provi tas- sigurtà u l- effikaċja, il - feġġa tar- reżistenza batterjali kkawżata mill- użu ta' Oracea u l- prova mhux suffiċjenti ta 'benefiċċju pożittiv: proporzjon ta' riskju.
These issues were considered to be of serious public health concern.
Dawn il- kwistjonijiet tqiesu bħala ta 'tħassib serju għas- saħħa pubblika.
The arbitration procedure started on 20 September 2007 with the adoption of a List of Questions.
Il- proċedura ta 'arbitraġġ bdiet fl- 20 ta' Settembru 2007 bl- adozzjoni ta 'Lista ta' Mistoqsijiet.
The Rapporteur was Dr Tomas Salmonson (SE) and Co-Rapporteur was Dr Ian Hudson (UK).
Ir- Rapporteur kien Dr Tomas Salmonson (SE) u l- Ko- Rapporteur kien Dr Ian Hudson (UK).
The Applicant provided written explanations on 30 November 2007 and on 3 March 2008.
L- Applikant ipprovda spjegazzjonijiet bil- miktub fit- 30 ta 'Novembru 2007 u fit- 3 ta' Marzu 2008.
During their April 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the objections that triggered the Article 29 Referral should not prevent the granting of a Marketing Authorisation for Oracea and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Waqt il- laqgħa tiegħu ta 'April 2008, is- CHMP, fid- dawl tad- dejta globali ppreżentata u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- oġġezzjonijiet li wasslu għar- Referenza tal- Artikolu 29 m' għandhomx iċaħħdu l- għoti ta' Awtorizzazzjoni għat- Tqegħid fis- Suq għal Oracea u li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta 'tagħrif tal- Istat Membru ta' Referenza għandhom jiġu emendati.
A positive opinion was therefore adopted by consensus on 24 April 2008 and the grounds for opinion, the conditions of the Marketing Authorisation and the amended SPC, labelling and package leaflet of the relevant Member State were annexed.
Għalhekk, fl- 24 ta 'April 2008, ġiet adottata opinjoni pożittiva b' kunsens u r- raġunijiet għal opinjoni, il- kundizzjonijiet tal- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- SPC, it- Tikketta u l- Fuljett ta' Tagħrif emendati tal- Istat Membru relevanti ġew annessi.
The list of the medicinal product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodott mediċinali kkonċernati hija mogħtija fl- Anness I.
The conditions of the Marketing Authorisation are provided in Annex IV.
Il - kundizzjonijiet għall- Awtorizzazzjoni għat- Tqegħid fis- Suq huma pprovduti fl- Anness IV.
The final opinion was converted into a Decision by the European Commission on 22 July 2008.
L- opinjoni finali nbidlet f' Deċiżjoni mill- Kummissjoni Ewropea fit- 22 ta 'Lulju 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
LISTA TA ’ L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, IL- QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, U D- DETENTURI TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI U FINN- NORVEĠJA U FL- ISLANDA
Marketing Authorisation Holder
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Pharmaceutical Form
Għamla Farmaċewtika Mnejn jingħata
Pfizer Corporation Austria Gesmbh Floridsdorfer Hauptstraße 1 1210 Wien Austria
Pfizer Corporation Austria Gesmbh Floridsdorfer Hauptstraße 1 1210 Wien L- Awstrija
Gel Gel
Ġell
Parenteral use
Użu parenterali
Felden 20 Mg - Kapseln
Felden 20 Mg - Ampullen
Ratiopharm Arzneimittel Vertriebs-Gmbh Albert - Schweitzer - Gasse 3 1140 Wien Austria
Ratiopharm Arzneimittel Vertriebs- Gmbh Albert - Schweitzer - Gasse 3 1140 Wien L- Awstrija
Suppository
Suppożitorju
Rectal use
Użu għal ġor - rektum
Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien Austria
Hexal Pharma Gmbh Carlbergergasse 44 1235 Wien L- Awstrija
Ci Pharma Arzneimittel Handelsgesmbh Thimiggasse 25 1180 Wien Austria
Ci Pharma Arzneimittel Handelsgesmbh Thimiggasse 25 1180 Wien L- Awstrija
Effervescent Powder
Trab li jfexfex
Heiligenstädterstraße 52/ 2/ 8 1190 Wien Austria
Heiligenstädterstraße 52/ 2/ 8 1190 Wien L- Awstrija
Piroxistad 10 Mg Tabs - Lösbare Tabletten
Piroxistad 10 Mg Pillolas - Lösbare Tabletten
Piroxistad 20 Mg Tabs - Lösbare Tabletten
Piroxistad 20 Mg Pillolas - Lösbare Tabletten
Amat Pharma Trading Gmbh Walfischgasse 6/ 2/ 1/ 3 1010 Wien Austria
Amat Pharma Trading Gmbh Walfischgasse 6/ 2/ 1/ 3 1010 Wien L- Awstrija
Oral Suspension
Suspenjoni orali
Boehringer Ingelheim Austria Gmbh.
Boehringer InĠellheim Austria Gmbh.
Boehringer - Gasse 5-11 1121 Wien Austria
Boehringer - Gasse 5- 11 1121 Wien L- Awstrija
Topical use
Użu topiku
Gonzagagasse 16/ 16 A-1010 Wien Austria
Gonzagagasse 16/ 16 A- 1010 Wien L- Awstrija
Tablets
Pillola
Oral powder
Trab Orali
Diestersteenweg 349 B-3510 Hasselt Belgium
Diestersteenweg 349 B- 3510 Hasselt Il- Belġju
Ambachtenlaan 13e B-3001 Leuven Belgium
Ambachtenlaan 13e B- 3001 Leuven Il- Belġju
Tablet
Pilloli
Lyophilisat
Lijofilizzat
Avenue Jules Bordet 168 B-1140 Brussels Belgium
Avenue Jules Bordet 168 B- 1140 Brussels Il- Belġju
Ambachtenlaan B-3001 Heverlee Belgium
Ambachtenlaan B- 3001 Heverlee Il- Belġju
Dispersible tablet
Pillola li tinħall
Leuvensestraat 28 Bus 2 B-1800 Vilvoorde Belgium
Leuvensestraat 28 Bus 2 B- 1800 Vilvoorde Il- Belġju
Heizel Esplanade 22 B-1020 Brussels Belgium
Heizel Esplanade 22 B- 1020 Brussels Il- Belġju
Intramuscular use
Jittieħed ġol - muskolu
Intramuscular use
Użu ġol- muskolu
Astridlaan 20 B-8620 Nieuwpoort Belgium
Astridlaan 20 B- 8620 Nieuwpoort Il- Belġju
Sint Lenaartseweg 48/ 4 B-2320 Hoogstraten Belgium
Sint Lenaartseweg 48/ 4 B- 2320 Hoogstraten Il- Belġju
Rue De La Pastorale 16/ 28 B-1080 Brussels Belgium
Rue De La PastMill- ħalqe 16/ 28 B- 1080 Brussels Il- Belġju
Brusselsesteenweg 288 B-3090 Overijse Belgium
Brusselsesteenweg 288 B- 3090 Overijse Il- Belġju
Nycomed Belgium N. V.
Nycomed Il- Belġju N. V.
Gentsesteenweg 615 B-1080 Brussels Belgium
Gentsesteenweg 615 B- 1080 Brussels Il- Belġju
Granules
Granijiet
Powder
Trab
Pfizer S. A., Boulevard De La Plaine 17 B-1050 Brussels Belgium
Pfizer S. A., Boulevard De La Plaine 17 B- 1050 Brussels Il- Belġju
Rectal use
Jittieħed mir- rektum
Intramuscular use
Jittieħed ġol- muskolu
Lyophilisat
Lajofiliżejt
Pharmapartner Nv Kolonel Begaultlaan 16 B-3012 Leuven Belgium
Pharmapartner Nv Kolonel Begaultlaan 16 B- 3012 Leuven Il- Belġju
Rue Saint-Lambert 141 B-1200 Bruxelle Belgium
Rue Saint- Lambert 141 B- 1200 Bruxelle Il- Belġju
Rectal use
Jittieħed ġor- rektum
Ratiopharm Belgium S. A.
Ratiopharm Il- Belġju S. A.
9 Member State
9 Stat Membru
Telecom Ardens - Medialaan 40 B-1800 Vilvoorde Belgium
Telecom Ardens - Medialaan 40 B- 1800 Vilvoorde Il- Belġju
Luoizalaan 149 Bus 4 B-1050 Brussels Belgium
Luoizalaan 149 Bus 4 B- 1050 Brussels Il- Belġju
Laarstraat 16 B-2610 Wilrijk Belgium
Laarstraat 16 B- 2610 Wilrijk Il- Belġju
Teva Generics Belgium N. V.
Teva Generics Il- Belġju N. V.
Topgen Esv E. Demunterlaan 1/ 8 B-1090 Brussels Belgium
Topgen Esv E. Demunterlaan 1/ 8 B- 1090 Brussels Il- Belġju
10 Member State
10 Stat Membru
Kraanlei 27-29 B-900 Gent Belgium
Kraanlei 27- 29 B- 900 Gent Il- Belġju
Alkaloid Ltd 21 "Tzar Boris III" Blvd., 1000 Sofia Bulgaria
Alkaloid Ltd 21 "Tzar Boris III" Blvd., 1000 Sofia Il- Bulgarija
1220 Sofia Bulgaria
1220 Sofia Il- Bulgarija
Cutaneous use
Użu fuq il- ġilda
Boehringer Ingelheim International GmbH Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
Boehringer InĠellheim International GmbH Binger Strasse 173 D- 55216 InĠellheim am Rhein Il- Ġermanja