qanastek/EMEA-V3 huggingface dataset:
The reconstituted suspension is stable for no more than about 14 days even when stored in a refrigerator.
Is- suspensjoni rikostitwita hija stabbli għal mhux aktar minn 14- il ġurnata anki meta maħżuna fil- friġġ.
Do try to take the suspension at around the same time every day.
Ipprova ħu s- suspensjoni f’ madwar l- istess ħin kuljum.
Always use the measuring spoon provided.
Dejjem uża l- mgħarfa tal- kejl ipprovduta.
The full spoon will give you a dose of 250 mg Ciprofloxacin Bayer.
Mgħarfa mimlija tagħtik doża ta ’ 250 mg Ciprofloxacin Bayer.
A glass of water may be taken after taking the dose.
Tista ’ tittieħed tazza ilma wara li tieħu d- doża.
You can take the suspension at mealtimes or in between meals.
Tista ’ tieħu s- suspensjoni f’ ħin l- ikel jew bejn l- ikliet.
However, do not take Ciprofloxacin Bayer suspension with dairy products such as milk or yoghurt or with fortified fruit-juice (e.g. calcium-fortified orange-juice).
Madankollu, tieħux is- suspensjoni ta ’ Ciprofloxacin Bayer ma ’ prodotti tal- ħalib bħal ħalib jew jogurt jew ma ’ meraq tal- frott imsaħħaħ (e. ż. meraq tal- larinġ imsaħħaħ bil- kalċju).
If possible, take the oral suspension or the box with you to show the doctor.
Jekk possibli, ħu s- suspensjoni orali jew il- kaxxa miegħek biex turihom lit- tabib.
Common side effects (between 1 and 10 in every 100 people are likely to get these):
380 Effetti sekondarji komuni (x’ aktarx li jaffettwaw minn persuna waħda sa 10 minn kull 100):
374
ta ’ periklu għall- ħajja
Granules and solvent for oral suspension [To be completed nationally]
Grani u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
This medicinal product is authorised in the Member States of the EEA under the following names:
382 Dan il- prodott mediinali huwa awtorizzat fl- istati membri ta 'l- EEA b' dawn l- ismijiet:
5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly
5 - Wara li tispiċċa l- kura, ħu kull mediċini li ma tkunx użajt għand l- ispiżjar tiegħek biex tiżgura li jintremew b’ mod xieraq
376 PACKAGE LEAFLET:
383 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg/ mL grani u solvent għal suspensjoni orali [Ara Anness I - Biex timtela mill- pajjiż partikolari]
377 Children and adolescents
384 Tfal u adoloxxenti
378 • You may experience psychiatric reactions the first time you take Ciprofloxacin Bayer.
385 • L- ewwel darba li tieħu ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
379 • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
386 • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
As Ciprofloxacin Bayer contains 1.3 g sucrose per 5-mL measuring spoonful, this has to be taken into consideration in terms of daily intake.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ciprofloxacin Bayer Peress li Ciprofloxacin Bayer fih 1. 3 g ta ’ sucrose f ’ kull mgħarfa ta ’ kejl ta ’ 5mL, dan għandu jiġi kkunsidrat f ’ termini tad- doża ta ’ kuljum
The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.
387 Il- kura ġeneralment iddum minn 5 ijiem sa 21 ġurnata, iżda tista ’ ddum aktar għall- infezzjonijiet severi.
380 Preparing and taking the suspension
Preparazzjoni u teħid tas- suspensjoni
The full spoon will give you a dose of 500 mg Ciprofloxacin Bayer.
Mgħarfa mimlija tagħtik doża ta ’ 500 mg Ciprofloxacin Bayer.
381 Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):
Effetti sekondarji mhux komuni (x’ aktarx li jaffettwaw minn persuna waħda sa 10 minn kull 1, 000):
382
ta ’ periklu għall- ħajja
Austria:
390 L- Awstrija:
384 PACKAGE LEAFLET:
391 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Before you are given Ciprofloxacin Bayer 3.
Qabel ma tingħata Ciprofloxacin Bayer 3.
How to use Ciprofloxacin Bayer 4.
Kif għandek tuża Ciprofloxacin Bayer 4.
• respiratory tract infections • long lasting or recurring ear or sinus infections • urinary tract infections • infections of the testicles • genital organ infections in women • gastro-intestinal tract infections and intra-abdominal infections • skin and soft tissue infections • bone and joint infections • to treat infections in patients with a very low white blood cell count (neutropenia) • to prevent infections in patients with a very low white blood cell count (neutropenia) • anthrax inhalation exposure
• infezzjonijiet fl- apparat respiratorju • infezzjonijiet fil- widnejn jew fis- sinus fit- tul jew li jerġgħu jitfaċċaw • infezzjonijiet fl- apparat urinarju • infezzjonijiet fit- testikoli • infezzjonijiet fl- organi ġenitali fin- nisa • infezzjonijiet fl- apparat gastro- intestinali u intra- addominali • infezzjonijiet fil- ġilda u fit- tessut l- artab • infezzjonijiet fl- għadam u l- ġogi • biex jikkuraw infezzjonijiet f’ pazjenti b’ għadd ta ’ ċelluli bojod tad- demm baxx ħafna (newtropenija) • biex jipprevjenu infezzjonijiet f’ pazjenti b’ għadd ta ’ ċelluli bojod tad- demm baxx ħafna (newtropenija) • esponiment għal teħid man- nifs ta ’ antraċe
Children and adolescents
392 Tfal u adoloxxenti
385 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
BEFORE YOU ARE GIVEN CIPROFLOXACIN BAYER
QABEL MA TINGĦATA CIPROFLOXACIN BAYER
You must not be given Ciprofloxacin Bayer if you are:
M’ għandekx tingħata Ciprofloxacin Bayer jekk inti:
Before you are given Ciprofloxacin Bayer
Qabel ma tingħata Ciprofloxacin Bayer
While under treatment with Ciprofloxacin Bayer
Waqt li qed tiġi kkurat b’ Ciprofloxacin Bayer
Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin Bayer.
Għid lit- tabib tiegħek immedjatament jekk xi wieħed minn dawn li ġejjin iseħħu waqt il- kura b’ Ciprofloxacin Bayer.
Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.
Anki ma l - ewwel doża, hemm possibbiltà rari li jista ’ jkollok esperjenza ta ’ reazzjoni allerġika severa bis- sintomi li ġejjin: tagħfis fis- sider, tħossok sturdut, tħossok ma tiflaħx jew b’ ħass ħażin, jew ikollok esperjenza ta ’ sturdament meta tqum bilwieqfa.
If this happens, tell your doctor immediately since the administration of Ciprofloxacin Bayer will have to be stopped.
Jekk iseħħ dan, għid lit- tabib tiegħek immedjatament għax l- għoti ta ’ Ciprofloxacin Bayer ikollu jitwaqqaf.
• Pain and swelling in the joints, and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids.
• Xi kultant jistgħu jseħħu uġigħ u nefħa fil- ġogi u tendinite, speċjalment jekk inti anzjan u qed tiġi kkurat b’ kortikosterojdi wkoll.
At the first sign of any pain or inflammation Ciprofloxacin Bayer will have to be stopped, rest the painful area.
Ma l- ewwel sinjal ta ’ uġigħ jew infjammazzjoni Ciprofloxacin Bayer se jkollu jitwaqqaf, serraħ il- post fejn qed tħoss l- uġigħ.
Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
Evita kull eżerċizzju li mhux neċessarju peress li dan jista ’ jżid ir- riskju ta ’ tiċrita fit- tendon.
• You may experience psychiatric reactions after first administration of ciprofloxacin.
393 • Wara l- ewwel għoti ta ’ ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
386 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
• Jista ’ jkollok sintomi ta ’ newropatija bħal uġigħ, ħruq, tingiż, tnemnim u/ jew debbulizza.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped using them.
• Tista ’ tiżviluppa dijarea waqt li qed tieħu antibijotiċi inkluż Ciprofloxacin Bayer, jew anki diversi ġimgħat wara li tkun waqqaft l- użu tagħhom.
If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately.
Jekk din issir severa jew persistenti jew jekk tinnota li l- ippurpar tiegħek fih id- demm jew il- mukus, għid lit- tabib immedjatament.
Ciprofloxacin Bayer treatment will have to be stopped immediately, as this can be life-threatening.
Kura b’ Ciprofloxacin Bayer ikollha titwaqqaf immedjatament, għax din tista ’ tkun ta ’ periklu għall- ħajja.
Do not take medicines that stop or slow down bowel movements.
Tieħux mediċini li jwaqqfu jew inaqqsu l- movimenti tal- musrana.
If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin Bayer must be stopped immediately.
Jekk tinnota xi sintomi bħal telf t’ aptit, suffejra (il- ġilda tisfar), awrina skura, ħakk, jew tenerezza fl- istonku, Ciprofloxacin Bayer għandu jitwaqqaf immedjatament.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin Bayer.
• Waqt kura b’ Ciprofloxacin Bayer il- ġilda tiegħek issir aktar sensittiva għad- dawl tax- xemx jew ultravjola (UV).
Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
Evita esponiment għal dawl tax- xemx qawwi jew dawl UV artificjali bħal sodod tax- xemx.
"You must not be given Ciprofloxacin Bayer if you are").
Tużax Ciprofloxacin Bayer flimkien ma ’ tizanidine, għax dan jista ’ jikkawża effetti sekondarji bħal pressjoni tad- demm baxxa u ngħas (ara Sezzjoni 2: "M’ għandekx tingħata Ciprofloxacin Bayer jekk inti").
Using Ciprofloxacin Bayer together with these medicines can influence the therapeutic effect of these medicines.
L- użu ta ’ Ciprofloxacin Bayer flimkien ma ’ dawn il- mediċini jista ’ jinfluwenza l- effet terapewtiku ta ’ dawn il- mediċini.
• warfarin or other oral anti-coagulants (to thin the blood) • probenecid (for gout) • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) • theophylline (for breathing problems) • tizanidine (for muscle spasticity in multiple sclerosis) • clozapine (an antipsychotic) • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
394 • probenecid (għall- gotta) • • methotrexate (għal ċertu tipi ta ’ kanċers, psorijasi, artrite rewmatika) • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
387 • pentoxifylline (for circulatory disorders) • caffeine
• pentoxifylline (għal disturbi fiċ- ċirkulazzjoni) • kafeina
Food and drink does not affect your treatment with Ciprofloxacin Bayer.
L- ikel u x- xorb ma jaffettwax il- kura tiegħek b’ Ciprofloxacin Bayer.
Important information about some of the ingredients of Ciprofloxacin Bayer Glucose [To be completed nationally]
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ciprofloxacin Bayer Glucose [Biex timtela mill- pajjiż partikolari]
HOW TO USE CIPROFLOXACIN BAYER
KIF GĦANDEK TUŻA CIPROFLOXACIN BAYER
Your doctor will explain to you exactly how much Ciprofloxacin Bayer you will be given as well as how often and for how long.
It- tabib tiegħek se jispjegalek eżatt kemm se tingħata Ciprofloxacin Bayer kif ukoll kull meta u t- tul.
Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.
Il- kura ġeneralment iddum bejn 5 ijiem u 21 ġurnata, iżda tista ’ tkun itwal għall- infezzjonijiet severi.
Your doctor will give you each dose by slow infusion through a vein into your bloodstream.
It- tabib tiegħek ser jagħtik kull doża permezz ta ’ infużjoni bil- mod minn ġo vina għal ġewwa d- demm tiegħek.
For children, the infusion duration is 60 minutes.
Għat- tfal, it- tul ta ’ l- infużjoni hija 60 minuta.
In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin Bayer and 30 minutes for 200 mg Ciprofloxacin Bayer.
F’ pazjenti adulti, il- ħin ta ’ l- infużjoni hija 60 minuta għal 400mg Ciprofloxacin Bayer u 30 minuta għal 200mg Ciprofloxacin Bayer.
Administering the infusion slowly helps prevent immediate side effects occurring.
L- għoti ta ’ l - infużjoni bil- mod tgħin biex tipprevjeni l- okkorrenza ta ’ effetti sekondarji mmedjati.
If you stop your course of Ciprofloxacin Bayer
Jekk twaqqaf il- kors tiegħek ta ’ Ciprofloxacin Bayer
It is important that you finish the course of treatment even if you begin to feel better after a few days.
395 Huwa mportanti li tispiċċa l- kors tal- kura anki jekk tibda tħossok aħjar wara ftit ġranet.
If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse.
Jekk tieqaf tuża din il- mediċina kmieni wisq l- infezzjoni tiegħek tista ’ ma tkunx fieqet għal kollox u s- sintomi ta ’ l- infezzjoni jistgħu jerġgħu jitfaċċaw jew jiggravaw.
388 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
- nausea, diarrhoea, vomiting
- tqalligħ, dijarea, rimettar
- local reaction at the injection site, rash
- reazzjoni lokali fis- sit ta ’ l- injezzjoni, raxx
- temporary increased amounts of substances in the blood (transaminases)
- żjieda temporanja fl- ammont ta ’ sustanzi fid- demm (transaminases)
- a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts
- konċentrazzjoni għolja ta ’ esinofils, tip ta ’ ċellula bajda tad- demm, ammonti miżjuda jew
of a blood cloting factor (thrombocytes)
imnaqqsa ta ’ fattur tat- taqgħid tad- demm (tromboċiti)
- hyperactivity, agitation, confusion, disorientation, hallucinations
- iperattività, aġitazzjoni, konfużjoni, diżorjentazzjoni, alluċinazzjonijiet
- headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to
- uġigħ ta ’ ras, sturdament, problemi bl- irqad, disturbi fit- togħma, tingiż, sensittività mhux tas -
stimuli of the senses, seizures (see Section 2:
soltu għal stimuli tas- sensi, aċċessjonijiet (ara Sezzjoni 2:
Take special care with Ciprofloxacin Bayer), giddiness
Oqgħod attent ħafna b’ Ciprofloxacin Bayer), sturdament
- eyesight problems
- problemi fil- vista
- loss of hearing
- telf ta ’ smigħ
- expansion of the blood vessels (vasodilation), low blood pressure
- espansjoni tal- kanali tad- demm (vasodilatazzjoni), pressjoni baxxa, uġigħ addominali,
- abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind
problemi tad- diġestjoni bħal taqlib ta ’ stonku (indiġestjoni/ ħruq ta ’ stonku), gass
- liver disorders, increased amounts of one substance in the blood (bilirubin), jaundice
- disturbi fil- fwied, żjieda fl- ammont ta ’ sustanza fid- demm (bilirubin), suffejra (ikterus
(cholestatic icterus)
kolestatiku)
- itching, hives
- ħakk, urtikarja
- poor kidney function, kidney failure
- funzjoni tal- kliewi batuta, insuffiċjenza tal- kliewi
- pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention
- weġgħat fil- muskoli u l- għadam tiegħek, tħossok ma tiflaħx (astenja), deni, żamma ta ’ fluwidi
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see
- infjammazzjoni tal- musrana (kolite) marbuta ma ’ l- użu ta ’ antibijotiċi (f' każijiet rari tista ’ tkun
Section 2:
fatali) (ara Sezzjoni 2:
- changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the
- bidliet fl- għadd tad- demm (lewkopenija, lewkoċitosi, newtropenija, anemija), tnaqqis fin -
number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone - marrow depression which may also be fatal (see Section 2:
numru ta ’ ċelluli ħomor u bojod tad- demm u ta ’ plejtlits (panċitopenija), li tista ’ tkun fatali, depressjoni tal- mudullun ta ’ l- għadam li tista ’ tkun fatali wkoll (ara Sezzjoni 2:
- allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes
- reazzjoni allerġika, nefħa (edima) allerġika, nefħa f’ daqqa fil- ġilda u l- membrani mukużi
(angiooedema), severe allergic reaction (anaphylactic shock) which can be life -threatening (see Section 2:
(anġjoedima), reazzjoni allerġika severa (xokk anafilattiku) li tista ’ tkun ta ’ periklu għall- ħajja (ara Sezzjoni 2:
- increased blood sugar (hyperglycemia)
- żjieda fiz- zokkor fid- demm (ipergliċemija)
- anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see
- reazzjoni ta ’ ansjetà, ħolm stramb, depressjoni, disturbi mentali (reazzjonijiet psikotiċi) (ara
Section 2:
Sezzjoni 2:
- decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders)
- tnaqqis fis- sensittività tal- ġilda, tregħid, emigranja, disturb fis- sens tax- xamm (disturbi fix -
- tinnitus, impaired hearing
- żanżin fil- widnejn, smigħ imnaqqas
- fainting, inflammation of the blood vessel (vasculitis)
- ħass ħażin, infjammazzjoni tal- kanali tad- demm (vaskulite)
- shortness of breath including asthmatic symptoms
- qtugħ ta ’ nifs, inkluż sintomi ta ’ ażżma
- hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
- epatite, mewt ta ’ ċelluli tal- fwied (nekrosi tal- fwied) li rari ħafna twassal għall- insuffiċjenza
Take special care with Ciprofloxacin Bayer), small, pin-point
Oqgħod attent ħafna b’ Ciprofloxacin Bayer), fsada
bleeding under the skin (petechiae)
żgħira, daqs ras ta ’ labra taħt il- ġilda (petekje)
- muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon rupture –
- uġigħ fil- muskoli, infjammazzjoni tal- ġogi, żjieda fit- tensjoni tal- muskoli, bugħawwieġ, tiċrita
especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2:
fit- tendon – speċjalment tat- tendon il- kbira wara l- għaksa (Achilles tendon) (ara Sezzjoni 2:
- blood or crystals in the urine (see Section 2:
- demm fl- awrina, kristalli fl- awrina (ara Sezzjoni 2:
Take special care with Ciprofloxacin Bayer),
Oqgħod attent ħafna b’ Ciprofloxacin
urinary tract inflammation
Bayer), infjammazzjoni fl- apparat urinarju
- excessive sweating
- għaraq eċċessiv
- abnormal levels of a clotting factor (prothromibin) increased levels of the enzyme amylase
- livelli mhux normali ta 'fattur tat- tagħqid (prothrombin), żjieda fil- livelli ta ’ l- enżima amylase
Very rare side effects (less than 1 in every 10,000 people are likely to get these):
-
- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type
Effetti sekondarji rari ħafna (x’ aktarx li jaffettwaw inqas minn persuna waħda minn kull 10, 000):
of white blood cells (agranulocytosis)
- tip speċjali ta ’ tnaqqis ta ’ l- għadd ta ’ ċelluli ħomor tad- demm (anemija emolitika); tnaqqis
- severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can
perikoluż ta ’ tip ta ’ ċelluli bojod tad- demm (agranuloċitożi) reazzjoni allerġika severa (reazzjoni anafilattika, xokk anafilattiku, marda tas- serum) li tista ’ tkun fatali (ara Sezzjoni 2:
- disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial
- disturbi fil- koordinazzjoni, mixja mhux soda (disturb fil- mixja), pressjoni fuq il- moħħ
pressure)
(pressjoni intrakranjali)
- various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic
- diversi eruzzjonijiet jew raxx fil- ġilda (e. ż. s- sindrome Stevens- Johnson li tista ’ tkun fatali jew
epidermal necrolysis)
nekrolisi epidermali tossika)
- muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis
- indeboliment fil- muskoli, infjammazzjoni tat- tendon, irkadar tas- sintomi ta ’ myasthenia gravis
(see Section 2:
(ara Sezzjoni 2:
Do not use Ciprofloxacin Bayer after the expiry date which is stated on the carton after "EXP":
Tużax Ciprofloxacin Bayer wara d- data ta ’ skadenza li tidher fuq il- folja jew il- kartuna wara “ EXP ”:
Solution for infusion [To be completed nationally]
Soluzzjoni għall- infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
390 {Name and address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
Iceland Ireland:
L- Irlanda:
United Kingdom
Ir- Renju Unit:
3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
398 3 - Terġax tuża l- antibijotiku mingħajr preskrizzjoni medika, anki jekk trid tikkura marda simili.
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
--------------------------------------------------------------------------------------------------------------------------- It- tagħrif li ġej huwa maħsub għall- professjonisti fil- qasam mediku u tas- saħħa biss
Ciprofloxacin Bayer should be administered by intravenous infusion.
Ciprofloxacin Bayer għandu jingħata permezz ta ’ infużjoni fil- vini.
Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
Infużjoni bil- mod ġo vina kbira tnaqqas l - iskomdu għall- pazjent u r- riskju ta ’ irritazzjoni tal- vina.
The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.
Is- soluzzjoni għall- infużjoni tista ’ tiġi nfuża direttament jew wara li titħallat ma ’ soluzzjonijiet għall- infużjoni kompatibbli oħra.
391 Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately.
Sakemm ma tkunx ikkonfermata kompatibilità ma ’ soluzzjonijiet għall- infużjoni/ mediċini oħra, is - soluzzjoni għall- infużjoni għandha dejjem tingħata separatament.
The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.
Is- sinjali viżwali ta ’ inkompatibilità huma e. ż. preċipitazzjoni, is- soluzzjoni tidher imdardra jew tibdil fil- kulur.
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions:
Inkompatibilità tidher ma ’ kull soluzzjoni għall- infużjoni/ mediċini li huma fiżikament jew kimikament mhux stabbli fil- pH tas- soluzzjoni (e. ż. penicillins, soluzzjonijiet ta ’ eparina), speċjalment meta jitħaltu ma ’ soluzzjonijiet aġġustati għall- pH alkaline (pH ta ’ soluzzjonijiet għall- infużjoni ta ’ ciprofloxacin:
3.5-4.6).
3. 5 - 4. 6).
After intravenous initiation of treatment, the treatment can be continued orally as well.
Wara bidu ta ’ kura fil- vini, il- kura tista ’ titkompla b’ mod orali wkoll.
392 PACKAGE LEAFLET:
399 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Children and adolescents
400 Tfal u adoloxxenti
393 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
• You may experience psychiatric reactions after first administration of ciprofloxacin.
401 • Wara l- ewwel għoti ta ’ ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
394 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
• Jista ’ jkollok sintomi ta ’ newropatija bħal uġigħ, ħruq, tingiż, tnemnim u/ jew debbulizza.
• warfarin or other oral anti-coagulants (to thin the blood) • probenecid (for gout) • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) • theophylline (for breathing problems) • tizanidine (for muscle spasticity in multiple sclerosis) • clozapine (an antipsychotic) • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
402 • methotrexate (għal ċertu tipi ta ’ kanċers, psorijasi, artrite rewmatika) • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
395 • pentoxifylline (for circulatory disorders) • caffeine
• pentoxifylline (għal disturbi fiċ- ċirkulazzjoni) • kafeina
If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse.
Jekk tieqaf tuża din il- mediċina kmieni wisq l- infezzjoni tiegħek tista ’ ma tkunx fieqet għal kollox
396 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
6.
405 6.
398 {Name and address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
406 4 - Qatt m’ għandek tagħti l- antibijotiku tiegħek lill- persuna oħra; jista ’ jkun li ma jkunx xieraq għal marda tiegħu/ tagħha.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only
--------------------------------------------------------------------------------------------------------------------------- It- tagħrif li ġej huwa maħsub għall- professjonisti fil- qasam mediku u tas- saħħa biss
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must
Sakemm ma tkunx ikkonfermata kompatibilità ma ’ soluzzjonijiet għall- infużjoni/ mediċini oħra, is - soluzzjoni għall- infużjoni għandha dejjem tingħata separatament.
400 PACKAGE LEAFLET:
407 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/50 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 100 mg / 50 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Children and adolescents
408 Tfal u adoloxxenti
401 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
• You may experience psychiatric reactions after first administration of ciprofloxacin.
409 • Wara l- ewwel għoti ta ’ ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
402 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
• Jista ’ jkollok sintomi ta ’ newropatija bħal uġigħ, ħruq, tingiż, tnemnim u/ jew debbulizza.
• warfarin or other oral anti-coagulants (to thin the blood) • probenecid (for gout) • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) • theophylline (for breathing problems) • tizanidine (for muscle spasticity in multiple sclerosis) • clozapine (an antipsychotic) • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
410 • methotrexate (għal ċertu tipi ta ’ kanċers, psorijasi, artrite rewmatika) • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
403 Ciprofloxacin Bayer may increase the levels of the following medicines in your blood:
Ciprofloxacin Bayer jista ’ jżid il- livelli tal- mediċini li ġejjin fid- demm tiegħek:
Important information about some of the ingredients of Ciprofloxacin Bayer Sodium [To be completed nationally]
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ciprofloxacin Bayer Sodium [Biex timtela mill- pajjiż partikolari]
3 HOW TO USE CIPROFLOXACIN BAYER
KIF GĦANDEK TUŻA CIPROFLOXACIN BAYER
stimuli of the senses, seizures (see Section 2:
uġigħ ta ’ ras, sturdament, problemi bl- irqad, disturbi fit- togħma, tingiż, sensittività mhux tas - soltu għal stimuli tas- sensi, aċċessjonijiet (ara Sezzjoni 2:
405
tal- fwied ta ’ periklu għall- ħajja
Take special care with Ciprofloxacin Bayer), small, pin -point
Oqgħod attent ħafna b’ Ciprofloxacin Bayer), fsada
[To be completed nationally]
413 [Biex timtela mill- pajjiż partikolari]
406 [See Annex I - To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
Ciproxin Ciproxine Ciprobay Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin Ciproxine
Malta:
Il- Lussemburgu:
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin
Ciproxine Malta:
Ciproxin Poland:
Il- Polonja:
Ciprobay
Is- Slovakkja:
Slovak Republic:
Ciproxin Ciproxin Ciprobay Ciprobay
Ciprobay United Kingdom:
Ir- Renju Unit:
5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly
414 5 - Wara li tispiċċa l- kura, ħu kull mediċini li ma tkunx użajt għand l- ispiżjar tiegħek biex tiżgura li jintremew b’ mod xieraq
Slow infusion into a large vein will minimise patient
Infużjoni bil- mod ġo vina kbira tnaqqas l - iskomdu għall- pazjent u r- riskju ta ’ irritazzjoni tal- vina.
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately.
Sakemm ma tkunx ikkonfermata kompatibilità ma ’ soluzzjonijiet għall- infużjoni/ mediċini oħra, is - soluzzjoni għall- infużjoni għandha dejjem tingħata separatament.
Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions:
Inkompatibilità tidher ma ’ kull soluzzjoni għall- infużjoni/ mediċini li huma fiżikament jew kimikament mhux stabbli fil- pH tas- soluzzjoni (e. ż. penicillin, soluzzjonijiet ta ’ eparina), speċjalment meta jitħaltu ma ’ soluzzjonijiet aġġustati għall- pH alkaline (pH ta ’ soluzzjonijiet għall- infużjoni ta ’ ciprofloxacin:
3.9-4.5).
3. 9- 4. 5).
408 PACKAGE LEAFLET:
415 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 200 mg / 100 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Children and adolescents
416 Tfal u adoloxxenti
409 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
• You may experience psychiatric reactions after first administration of ciprofloxacin.
417 • Wara l- ewwel għoti ta ’ ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
410 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
• Jista ’ jkollok sintomi ta ’ newropatija bħal uġigħ, ħruq, tingiż, tnemnim u/ jew debbulizza.
• warfarin or other oral anti-coagulants (to thin the blood) • probenecid (for gout) • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) • theophylline (for breathing problems) • tizanidine (for muscle spasticity in multiple sclerosis) • clozapine (an antipsychotic) • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
418 • methotrexate (għal ċertu tipi ta ’ kanċers, psorijasi, artrite rewmatika) • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
411 • pentoxifylline (for circulatory disorders) • caffeine
• pentoxifylline (għal disturbi fiċ- ċirkulazzjoni) • kafeina
412 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
414 {Name and address} < {tel} > < {fax} > < {e-mail} >
{Isem u indirizz} < {tel} > < {fax} > < {e- mail} >
Germany:
Ċipru:
Ciproxin; Ciprofloxacine « BAYER » Ciproxine Ciprobay Ciproxin Ciprobay Ciflox Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin; Ciprofloxacine « BAYER » Ciproxine Ciprobay Ciproxin
Malta:
Ciproxine Malta:
Slovak Republic:
Is- Slovakkja:
Slovenia:
Is- Slovenja:
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxine Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
- schedules
422 korsijiet xierqa
415 Ciprofloxacin Bayer should be administered by intravenous infusion.
Ciprofloxacin Bayer għandu jingħata permezz ta ’ infużjoni fil- vini.
416 PACKAGE LEAFLET:
423 FULJETT TA ’ TAGĦRIF:
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally]
Ciprofloxacin Bayer u ismijiet assoċjati miegħu (ara Anness I) 400 mg / 200 mL soluzzjoni għall - infużjoni [Ara Anness I - Biex timtela mill- pajjiż partikolari]
Children and adolescents
424 Tfal u adoloxxenti
417 • lung and bronchial infections in children and adolescents suffering from cystic fibrosis • complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) • anthrax inhalation exposure
• infezzjonijiet fil- pulmun u fil- bronki fi tfal u adoloxxenti li jbatu minn fibrożi ċistika • infezzjonijiet kumplikati ta ’ l- apparat urinarju, ikluż infezzjonijiet li laħqu l- kliewi (pijelonefrite), • esponiment għal teħid man- nifs ta ’ antraċe
• You may experience psychiatric reactions after first administration of ciprofloxacin.
425 • Wara l- ewwel għoti ta ’ ciprofloxacin jista ’ jkollok esperjenza ta ’ reazzjonijiet psikjatriċi.
418 • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
• Jista ’ jkollok sintomi ta ’ newropatija bħal uġigħ, ħruq, tingiż, tnemnim u/ jew debbulizza.
• warfarin or other oral anti-coagulants (to thin the blood) • probenecid (for gout) • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis) • theophylline (for breathing problems) • tizanidine (for muscle spasticity in multiple sclerosis) • clozapine (an antipsychotic) • ropinirole (for Parkinson’s disease) • phenytoin (for epilepsy)
426 • probenecid (għall- gotta) • methotrexate (għal ċertu tipi ta ’ kanċers, psorijasi, artrite rewmatika) • theophylline (għall- problemi bin- nifs) • tizanidine (għal spastiċità tal- muskoli fi sklerosi multipla) • clozapine (kontra l- psikosi) • ropinirole (għal marda ta ’ Parkinson) • phenytoin (għall- epilessija)
419 • pentoxifylline (for circulatory disorders) • caffeine
• pentoxifylline (għal disturbi fiċ- ċirkulazzjoni) • kafeina
It is important that you finish the course of treatment even if you begin to feel better after a few days.
427 Huwa mportanti li tispiċċa l- kors tal- kura anki jekk tibda tħossok aħjar wara ftit ġranet.
- hyperactivity, agitation, confusion, disorientation, hallucinations
- perattività, aġitazzjoni, konfużjoni, diżorjentazzjoni, alluċinazzjonijiet
421
- epatite, mewt ta ’ ċelluli tal- fwied (nekrosi tal- fwied) li rari ħafna twassal għall- insuffiċjenza
- hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
tal- fwied ta ’ periklu għall- ħajja
422 [See Annex I - To be completed nationally]
[Ara Anness I - Biex timtela mill- pajjiż partikolari]
Ciproxin, Ciprofloxacine « BAYER » Ciprobay Ciprobay Ciflox Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL
Ciproxin; Ciprofloxacine « BAYER » Ciprobay
Ciproxin Ciprobay Ciproxin Ciproxin Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
Ciflox Ciprobay; Ciprofloxacin ANTIBAC; Ciprofloxacin BAYER; Ciprofloxacin VITAL Ciproxin Ciprobay Ciproxin Ciproxin Ciproxin Ciproxin Ciprobay Ciproxina Ciprobay Ciprobay Ciprobay
Consequently, to preserve the efficacy of this drug:
430 Għalhekk, biex l- effikaċja ta ’ din il- mediċina tkun preservata:
423 Ciprofloxacin Bayer should be administered by intravenous infusion.
Ciprofloxacin Bayer għandu jingħata permezz ta ’ infużjoni fil- vini.
424
431
Ref.
Londra, 7 ta ’ Ottubru 2008 Dok. ref.
EMEA/ CHMP/ 384874/ 2008
EMEA/ CHMP/ 554245/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Ciprofloxacin Bayer and associated names International Non-Proprietary Name (INN): ciprofloxacin
OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 30 GĦAL Ciprofloxacin Bayer u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): ciprofloxacin
Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens.
Ciprofloxacin Bayer u ismijiet assoċjati huwa antibijotiku, indikat għat- trattament ta ’ infezzjonijiet ikkumplikati u mhux ikkumplikati, fosthom infezzjonijiet gravi, ikkawżati minn patoġeni suxxettibbli għal ciprofloxacin.
It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets.
Huwa disponibbli f’ pilloli miksija b’ rita b’ rilaxx immedjat, pilloli miksija b’ rita b’ rilaxx modifikat, granuli u soluzzjonijiet għal sospensjoni orali, soluzzjonijiet għal infużjoni f’ boroż, soluzzjonijiet għal infużjoni fi fliexken u sachets.
On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names.
Fit- 22 ta ’ Ġunju 2007, Franza ppreżentat referenza lill- EMEA skont l- Artikolu 30 tad- Direttiva 2001/ 83/ KE, kif emendata, bil- għan li tarmonizza s- Sommarji tal- Karatteristiċi tal- Prodott (SPC), it- Tikketta u l- Fuljett ta 'Tagħrif awtorizzati fuq livell nazzjonali tal- prodott mediċinali Ciprofloxacin Bayer u ismijiet assoċjati.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use.
Ir- referenza kienet ibbażata fuq diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) ta ’ Ciprofloxacin Bayer u ismijiet assoċjati approvati fl- Istati Membri tal- UE kollha, b’ mod partikolari fir- rigward tal- indikazzjonijiet, il- pożoloġija, il- kontraindikazzjonijiet, it- twissijiet speċjali u l- prekawzjonijiet għall- użu.
This medicinal product belongs to the list of products identified in 2007 for SPC harmonisation.
Il- prodott mediċinali jagħmel parti mil- lista ta ’ prodotti li huma identifikati fl- 2007 għall- armonizzazzjoni tal- SPC.
The procedure started on 19 July 2007.
Il- proċedura ngħatat bidu fid- 19 ta ’ Lulju 2007.
The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ipprovda informazzjoni supplimentari fit- 23 ta ’ Novembru 2007 u fit- 22 ta ’ April 2008.
During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Waqt il- laqgħa tiegħu f’ Lulju 2008, is- CHMP, fid- dawl tad- dejta kumplessiva mressqa u d- diskussjoni xjentifika li saret fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif kienet aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Ciprofloxacin Bayer and associated names.
Fl- 24 ta ’ Lulju 2008, is- CHMP ta opinjoni pożittiva li fiha rrakkomanda l- armonizzazzjoni tal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif għal Ciprofloxacin Bayer u ismijiet assoċjati.
The list of product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodotti kkonċernati hija mogħtija fl- Anness I.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II flimkien mal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif kif emendati f’ Anness III.
A Decision was issued by the European Commission on 7 October 2008.
Id- Deċiżjoni nħarġet mill- Kummissjoni Ewropea fis- 7 ta ’ Ottubru 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES Member State
LISTA TA ’ L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI Stat Membru Detentur tal- MA
Applicant
Isem Ivvintat
Strength
Saħħa
Route of administration
Għamla Farmaċewtika Mnejn jingħata Kontenut
Nycomed Danmark ApS Langebjerg 1 DK-4000 Roskilde Denmark
Ir- Renju Unit Nycomed Danmark ApS Langebjerg 1 DK- 4000 Roskilde Id- Danimarka
50 ml, 100 ml, 200 ml
Taħlita likwida għall - Użu għal ġol- vini 50 ml, 100 ml, infużjoni 200 ml
Nycomed Pharma AS Drammernsveien 852 NO-1372 Asker Norway
Nycomed Pharma AS Drammernsveien 852 NO- 1372 Asker In- Norveġja
Sweden
L- Iżvezja
Nycomed AB Tegeluddvägen 17-21 S-102 53 Stockholm Sweden
Nycomed AB Tegeluddvägen 17- 21 S- 102 53 Stockholm L- Iżvezja
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE PRODUCT INFORMATION
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT IPPREŻENTAT MILL- EMEA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Ciprofloxacin Nycomed and associated names (see Annex I)
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ Ciprofloxacin Nycomed u ismijiet assoċjati (ara Anness I)
Ciprofloxacin is a quinolone effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Ciprofloxacin huwa quinolone effettiv in vitro kontra numru kbir ta ’ batterji aerobiċi Gram- negattivi kif ukoll kontra xi organiżmi Gram- pożittivi.
Ciprofloxacin exerts a rapid bactericidal effect by inhibiting DNA-gyrase, resulting in inhibition of DNA synthesis.
Ciprofloxacin jeżerċita effett batteriku rapidu billi jimpedixxi d- DNA- gyrase, li tirriżulta f’ inibizzjoni tas- sintesi tad- DNA.
Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Ciprofloxacin jiġi assorbit malajr u b’ mod effettiv wara amministrazzjoni orali.
There is a linear correlation between dose and plasma concentration.
Hemm korrelazzjoni lineari bejn id- doża u l - konċentrazzjoni fil- plażma.
Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 10-14 days based on urine culture and sensitivity.
Il- kura ta ’ pazjenti b’ infezzjonijiet ikkumplikati fis- sistema awrinarja (UTIs) attwalment tinkludi trattament empiriku b’ antibijotiku ta ’ spettru wiesa ’ (fluoroquinolone), u trattament potenzjali sussegwenti għal 10- 14- il ġurnata ibbażat fuq kultura ta ’ l- awrina u s- sensittività.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing be adequate.
Sabiex jiġi evitat li t - trattament ma jirnexxix u titfaċċa reżistenza huwa meħtieġ li l- konformità tal- pazjent u d- dożaġġ ikunu adegwati.
During the referral procedure the Applicant/ Marketing Authorisation Holder was requested to:
Matul il- proċedura ta ’ referenza l- Applikant/ Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ġie mitlub:
1. submit clinical data and discuss the risk/ benefit of the proposed dose in urinary tract infections (UTI).
1. jissottometti informazzjoni klinika u jiddiskuti r- riskju/ benefiċċju tad- doża proposta f’ infezzjonijiet tas- sistema awrinarja.
The applicant/ MAH should discuss both the 100 mg twice daily (bid) dose and the 200 – 400 mg bid dose from a safety and efficacy point of view.
L- applikant/ MAH għandu jiddiskuti kemm id- doża ta ’ 100 mg darbtejn kuljum (bid) kif ukol id- doża ta ’ 200 – 400 mg bid minn perspettiva ta ’ sigurtà u effikaċja.
In doing so the applicant/ MAH should discuss the data in relation to complicated and uncomplicated, upper and lower urinary tract infections.
Meta jagħmel dan l- applikant/ MAH għandu jiddiskuti l- informazzjoni b’ referenza għal infezzjonijiet ikikkumplikati u mhux ikikkumplikati fil- parti ta ’ fuq u ta ’ isfel tas- sistema awrinarja.
2. submit clinical data and discuss the risk/ benefit of the maximum adult daily dose, i. e. whether it should be 400 mg bid or 400 mg three times daily.
2. jissottometti informazzjoni klinika u jiddiskuti r- riskju/ benefiċċju tad- doża massima tal- ġurnata għall- adulti, jiġifieri jekk għandhiex tkun 400 mg bid jew 400 mg tliet darbiet kuljum.
The applicant/ MAH did not submit any clinical data to address the questions related to the risk/ benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″ generic″ application (reference product/ originator Ciproxin from Bayer).
L- applikant/ MAH ma ssottometta l- ebda informazzjoni klinika biex jindirizza l- kwistjonijiet marbuta mar- riskju/ benefiċċju tad- doża proposta f’ UTIs u d- doża massima tal- ġurnata għall- adulti, billi din l - applikazzjoni hija hekk imsejħa applikazzjoni ″ ġenerika ″ (prodott ta ’ referenza/ Ciproxin oriġinatur mingħand Bayer).