qanastek/EMEA-V3 huggingface dataset:
It affects the lungs, sweat glands and the digestive system causing chronic respiratory and digestive problems.
Din taffettwa l- pulmuni, il- glandoli ta ’ l- għaraq u s- sistema diġestiva, u tikkawża problemi respiratorji u diġestivi kroniċi.
BEFORE YOU USE CIPROFLOXACIN HIKMA
QABEL MA TUŻA CIPROFLOXACIN HIKMA
Do NOT use Ciprofloxacin Hikma: • If you have known allergic reaction (hypersensitivity) to ciprofloxacin or any of the other ingredients of Ciprofloxacin Hikma or other medicines of the quinolone type • In children aged below 5 years • In children and growing adolescents except for the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa bacteria in children and adolescents aged 5-17 years with cystic fibrosis • In patients with a history of tendon disorder related to fluoroquinolone administration • If you are pregnant or wish to become pregnant • If you are breast-feeding. • If Ciprofloxacin Hikma and tizanidine (used to treat muscle spasms) are given at the same time.
TUŻAX Ciprofloxacin Hikma: • Jekk għandek reazzjoni allerġika magħrufa (sensittività eċċessiva) għal ciprofloxacin jew sustanzi oħra ta ’ Ciprofloxacin Hikma jew mediċini oħrajn tat- tip quinolone • Fi tfal taħt l- età ta ’ 5 snin • Fi tfal u f’ adolexxenti li qed jikbru, ħlief għall- kura ta ’ infezzjonijiet akuti tal- passaġġ respiratorju t’ isfel ikkawżati mill- batterji Pseudomonas aeruginosa fit- tfal u fl- adolexxenti li għandhom bejn 5 u 17- il sena b’ fibrożi ċistika • Jekk għandek storja medika ta ’ mard fit- tendini marbut ma ’ l- għoti ta ’ fluoroquinolone • Jekk inti tqila jew tixtieq li toħroġ tqila • Jekk qed tredda ’.
24 Take special care with Ciprofloxacin Hikma You should consult your doctor if one of the precautions and warnings mentioned below are or were applicable to you in the past.
Oqgħod attent ħafna b’ Ciprofloxacin Hikma Għandek kellem lit- tabib tiegħek jekk xi waħda mill- prekawzjonijiet u twissijiet imsemmija hawn taħt japplikaw, jew kienu japplikaw għalik fil- passat.
Before starting treatment - if you suffer or have suffered from one of the following diseases: • convulsions (seizures), epilepsy or another brain disease, for example decreased blood circulation in the brain, stroke or increased sensitivity to convulsions, since possible side effects of ciprofloxacin may cause damage to the brain. • life-threatening increase heart rate (torsade de pointes).
Qabel tibda l- kura - jekk inti tbati jew kont tbati minn waħda mill- mardiet li ġejjin: • konvulżjonijiet (puplesiji), epilessija jew mard tal- moħħ ieħor, pereżempju, nuqqas fiċ- ċirkolazzjoni tad- demm fil- moħħ, puplesija jew żieda fis- sensittività għal konvulżjonijiet, għax l- effetti sekondarji possibbli ta ’ ciprofloxacin jistgħu jikkawżaw ħsara lill- moħħ. • żieda fir- rata ta ’ taħbit tal- qalb li tkun ta ’ periklu għall- ħajja (torsade de pointes).
If you suffer from this disease, you should consult your doctor. • myastenia gravis (a particular type of muscle weakness).
Jekk tbati minn din il- marda, għandek tkellem lit- tabib tiegħek. • myastenia gravis (tip partikulari ta ’ dgħjufija fil- muskoli).
Ciprofloxacin can exacerbate the symptoms of this disease.
Ciprofloxacin jista ’ jaggrava s- sintomi ta ’ din il- marda.
In case of any symptom indicating an exacerbation of myastenia gravis, you should therefore consult your doctor. • liver impairment in the past.
F’ każ li jseħħ kwalunkwe sintomu li jindika aggravament ta ’ mijastenja gravis, għandek tkellem lit- tabib tiegħek. • indeboliment tal- fwied fil- passat.
When symptoms occur, such as yellowing of the skin or whites of the eyes, you should immediately consult your doctor. • significant renal impairment.
Meta jseħħu sintomi, bħal sfura tal- ġilda jew tal- parti l- bajda ta ’ l- għajnejn, għandek tkellem lit- tabib tiegħek immedjatament. • indeboliment sinifikanti tal- kliewi.
Your doctor will check your renal function carefully. • glucose-6-phosphate dehydrogenase defect (hereditary disease of the red blood cells based on a defect in an enzyme).
It- tabib tiegħek ser iċċekkja l- funzjoni tal- kliewi tiegħek bl- attenzjoni. • difett ta ’ glucose- 6- phosphate dehydrogenase (marda ereditarja taċ- ċelluli ħomor tad- demm ibbażata fuq difett f’ enzima).
If you or someone in your family suffers from this disease, you should consult your doctor.
Jekk inti jew xi ħadd fil- familja tiegħek ibati minn din il- marda, għandek tkellem lit- tabib tiegħek.
An extensive destruction of red blood cells (haemolytic reactions) may occur, causing anaemia.
Distruzzjoni estensiva taċ- ċelluli ħomor tad- demm (reazzjonijiet emolitiċi) tista ’ sseħħ, u tikkawża anemija.
Signs of anaemia are a feeling of weakness and in more severe cases breathlessness and pale skin.
Is- sinjali ta ’ anemija huma sensazzjoni ta ’ dgħjufija u f’ każijiet iktar severi, qtugħ ta ’ nifs u ġilda safra.
During or after treatment - if one of the following conditions occurs: • feeling depressed or confused after administration of Ciprofloxacin Hikma.
Matul jew wara l- kura - jekk isseħħ waħda minn dawn il- kundizzjonijiet li ġejjin: • tħossok dipress/ a jew konfuż/ a wara l- għoti ta ’ Ciprofloxacin Hikma.
In this case you should immediately consult your doctor. • temporary pain and inflammation of the tendons, in particular of the Achilles tendon.
F’ dan il- każ għandek tkellem lit- tabib tiegħek immedjatament. • uġigħ temporanju u infjammazzjoni tat- tendini, b’ mod partikulari tat- tendine ta ’ Achilles.
This medicine may cause these side effects, particularly if you are older or take a medicine of the so- called steroid group, such as hydrocortisone. • If you experience these symptoms you should immediately consult your doctor and rest the respective leg. • severe and continuous diarrhoea during treatment, possibly with blood and mucus.
Din il- mediċina tista ’ tikkawża dawn l- effetti sekondarji, partikularment jekk inti għandek iktar żmien jew qed tieħu mediċina ta ’ l- hekk imsejjaħ grupp ta ’ sterojdi, bħal hydrocortisone. • Jekk ikollok dawn is- sintomi, għandek tkellem lit- tabib tiegħek immedjatament u sserraħ ir- riġel rispettiv. • dijarea kontinwa u severa matul il- kura, possibbilment bid- demm u bil- mukus.
In this case you should immediately consult your doctor, since you may have a severe inflammation of the large intestine (pseudo membranous colitis).
F’ dan il- każ, għandek tkellem lit- tabib tiegħek immedjatament, għax jista ’ jkollok infjammazzjoni severa tal- musrana l- kbira (psewdo kolite membranuża).
This condition is life-threatening and may have a fatal outcome. • increased skin sensitivity to sunlight or UV light.
Din il- kundizzjoni hi ta ’ periklu għall- ħajja u jista ’ jkollha riżultat fatali. • Żieda fis- sensittività tal- ġilda għad- dawl tax- xemx jew għad- dawl UV.
You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation. • If exposure to sunlight or UV light is inevitable you should use sun cream to protect yourself. • If nevertheless complaints occur, such as fever, rash, itching, small red spots on the skin, you should consult your doctor since the treatment may need to be discontinued. • allergic reactions after the first administration of this medicine.
Għandek tevita espożizzjoni fit- tul għad- dawl tax- xemx qawwi, sunlamps jew sorsi oħrajn ta ’ radjazzjoni UV. • Jekk l- espożizzjoni għad- dawl tax- xemx jew għad- dawl UV hi inevitabbli, għandek tuża sun cream biex tipproteġi lilek innifsek. • Jekk madankollu jseħħu ċerti kundizzjonijiet, bħal deni, raxx, ħakk jew tikek żgħar ħomor fuq il- ġilda, għandek tkellem lit- tabib tiegħek għax jista ’ jkun li l- kura jkollha titwaqqaf. • reazzjonijiet allerġiċi wara l- ewwel l- għoti ta ’ din il- mediċina.
In this case you should immediately consult your doctor.
F’ dan il- każ għandek tkellem lit- tabib tiegħek immedjatament.
Signs of these reactions are: a sharp drop in blood pressure, paleness, restlessness, weak/ rapid pulse, clammy skin, dizziness.
Is- sinjali ta ’ dawn ir- reazzjonijiet huma: tnaqqis qawwi fil- pressjoni tad- demm, sfura, nuqqas ta ’ kwiet f’ ġismek, rata tal- polz bil- mod/ mgħaġġla, ġilda mdellka, sturdament.
In very rare cases these allergic reactions may lead to life-threatening shock. • local reactions after administration of this medicine.
F’ każijiet rari ħafna, dawn ir- reazzjonijiet allerġiċi jistgħu jwassal għal xokk li jkun ta ’ periklu għall- ħajja. • reazzjonijiet lokali wara l- għoti ta ’ din il- mediċina.
These reactions may occcur particularly when the infusion time is 30 minutes or less.
Dawn ir- reazzjonijiet jistgħu jseħħu partikularment meta l- ħin ta ’ l- infużjoni jkun ta ’ 30 minuta jew inqas.
They may take the form of local skin reactions, such as reddening of the skin, irritation or pain, which usually disappear quickly after termination of the infusion.
Jistgħu jieħdu s- sura ta ’ reazzjonijiet lokali tal- ġilda, bħal ħmura tal- ġilda, irritazzjoni jew uġigħ, li normalment jgħibu malajr wara li tintemm l- infużjoni.
If these reactions recur or exacerbate during a following infusion no further infusions should be administered. • crystalluria (presence of crystals in the urine with discomfort when passing urine).
26 • kristallurja (il- preżenza ta ’ kristalli fl- awrina bi skonfort meta tagħmel l- awrina).
In this case consult your doctor as your urine needs to be tested.
F’ dan il- każ kellem lit- tabib tiegħek għax l- awrina tiegħek għandha bżonn li tkun ittestjata.
Furthermore, you should drink a sufficient amount of liquid (about 1.5 – 2 litres daily). • Mycobacerium tuberculosis test.
Flimkien ma ’ dan, għandek tixrob ammont suffiċjenti l- ammont ta ’ likwidu (madwar 1. 5 – 2 litri kuljum). • Test ta ’ Mycobacerium tuberculosis.
Please inform your doctor when under treatment with Ciprofloxacin Hikma as the result of this test may be false.
Jekk jogħġbok informa lit- tabib tiegħek meta tkun qed tirċievi l- kura b’ Ciprofloxacin Hikma, għax ir- riżultat ta ’ dan it- test jista ’ jkun falz.
25 Using other medicines If Ciprofloxacin Hikma and one of the following medicines are given at the same time, special care should be taken: • theophylline (used to treat asthma), clozapine (used to treat schizophrenia), tacrine (used to treat symptoms of Alzheimer´s disease), ropinirol (used to treat Parkinson disease) and tizanidine (used to treat muscle spasms).
Meta tuża mediċini ohra Jekk Ciprofloxacin Hikma u xi waħda mill- mediċini li ġejjin jingħataw fl- istess ħin, għandha tingħata attenzjoni speċjali: • theophylline (jintuża għall- kura ta ’ l- ażżma), clozapine (jintuża għall- kura ta ’ l- iskiżofrenja), tacrine (jintuża għall- kura tas- sintomi tal- marda Alzheimer´s), ropinirol (jintuża għall- kura tal- marda ta ’ Parkinson) u tizanidine (jintuża għall- kura ta ’ spażmi tal- muskoli).
If you use one of these medicines together with ciprofloxacin you will be monitored for signs of overdose.
Jekk tuża waħda minn dawn il- mediċini flimkien ma ’ ciprofloxacin, inti ser tkun immonitorjat/ a għal sinjali ta ’ doża eċċessiva.
The above-mentioned substances are converted by a specific enzyme (CYP1A2).
Is- sustanzi msemmija hawn fuq jinbidlu minn enzima speċifika (CYP1A2).
Ciprofloxacin inhibits this enzyme.
Ciprofloxacin jinibixxi din l- enzima.
Therefore the amount of these other medicines may rise in the blood. • certain anti-inflammatory agents (e. g. ibuprofen, naproxen, but not acetylsalicylic acid), if ciprofloxacin is given in very high doses.
Għalhekk l- ammont ta ’ dawn il- mediċini l- oħrajn jista ’ jiżdied fid- demm. • ċerti mediċini kontra l- infjammazzjoni (eż. ibuprofen, naproxen, iżda mhux acetylsalicylic acid), jekk ciprofloxacin jingħata f’ dożi qawwijin ħafna.
This may cause epileptic seizures. • cyclosporine (used to prevent rejection reactions after organ transplantations).
Dan jista ’ jikkawża puplesiji epilettiċi. • cyclosporine (jintuża għall- prevenzjoni ta ’ reazzjonijiet li jseħħu meta l- ġisem jiċħad l- organu li jkunu ġie ttrapjantat).
In this case the kidney function must be frequently (twice per week) monitored. • oral anticoagulants (used to prevent blood from clotting, e. g. warfarin).
F’ dan il- każ, il- funzjoni tal- kliewi trid tkun immonitorjata frekwenti (darbtejn kull ġimgħa) • mediċini orali kontra l- koagulazzjoni tad- demm (jintużaw biex jiġi evitat it- tagħqid tad- demm, eż. warfarin).
This may lead to a prolongation of the bleeding time.
Dan jista ’ jwassal għat- titwil tal- ħin tal- ħruġ ta ’ demm.
Therefore the bleeding time should be monitored. • glibenclamide (used to treat diabetes).
Għalhekk il- ħin tal- ħruġ tad- demm għandu jkun immonitorjat. • glibenclamide (jintuża għall- kura tad- dijabete).
This may increase the effect of glibenclamide (too low blood sugar level). • probenecid (used to treat gout).
Dan jista ’ jżid l- effett ta ’ glibenclamide (livell ta ’ zokkor fid- demm baxx wisq). • probenecid (jintuża għall- kura tal- gotta).
The ciprofloxacin level in the blood can be increased. • phenytoin (used to treat epilepsy).
Il- livell ta ’ ciprofloxacin fid- demm jista ’ jiżdied. • phenytoin (jintuża għall- kura ta ’ l- epilessija).
The blood level of this medicine can be increased or reduced. • caffeine (used as a stimulant), pentoxifylline (used to treat circulatory disorders in the limbs) and mexiletine (used to treat irregular heart beat).
Il- livell fid- demm ta ’ din il- mediċina jista ’ jiżdied jew jonqos. • caffeine (użata bħala stimulant), pentoxifylline (jintuża għall- kura ta ’ mard ċirkolatorju fid- dirgħajn/ riġlejn) u mexiletine (jintuża għall- kura ta ’ taħbit irregolari tal- qalb).
The blood level of these medicines can be increased. • methotrexate (used to treat cancer or suppress the immune system).
Il- livell tad- demm ta ’ dawn il- mediċini jista ’ jiżdied. • methotrexate (jintuża għall- kura tal- kanċer jew biex irażżan is- sistema immuni).
Your doctor will monitor you for signs of methotrexate overdose. • Ciprofloxacin may inhibit the excretion of methotrexate via the kidney, causing an increased methotrexate level in the blood. • Pre-medicants (used before anaesthesia induction): it is recommended that opiate pre-medicants, (e. g. papaveretum) or opiate pre-medicants used with anticholinergic pre-medicants, (e. g. atropine or hyoscine) are not used concomitantly with ciprofloxacin, as the serum levels of ciprofloxacin are reduced.
It- tabib tiegħek ser jimmonitorjat għal sinjali ta ’ doża eċċessiva ta ’ methotrexate. • Ciprofloxacin jista ’ jinibixxi t- tneħħija ta ’ methotrexate permezz tal- kliewi, u dan jikkawża żieda fil- livell ta ’ methotrexate fid- demm. • Pre- medikanti (li jintużaw qabel l- induzzjoni tal- loppju): hu rakkomandat li l- pre- medikanti ta ’ l- opiate (eż. papaveretum) jew pre- medikanti ta ’ l- opiate li jintużaw ma ’ pre- medikanti antikolinerġiċi (eż. atropine jew hyoscine) ma jintużawx fl- istess ħin ma ’ ciprofloxacin, għax il- livelli ta ’ ciprofloxacin fis- serum jonqsu.
Co-administration of ciprofloxacin and benzodiazepine pre-medicants has been shown not to affect ciprofloxacin plasma levels.
Ma ntweriex li l- għoti flimkien ta ’ pre- medikanti ta ’ ciprofloxacin u benzodiazepine jaffettwa l- livelli ta ’ ciprofloxacin fil- plażma.
However, since decreased clearance of diazepam, with a prolonged half-life have been reported during co-administration of ciprofloxacin and diazepam, and in very rare cases with midazolam, careful monitoring of benzodiazepine therapy is recommended.
Madankollu, minħabba li kien irrappurtat tnaqqis fit- tneħħija ta ’ diazepam, b’ titwil tal- half- life matul l- għoti flimkien ta ’ ciprofloxacin u diazepam, u f’ każijiet rari ħafna ma ’ midazolam, monitoraġġ bl- attenzjoni tat- terapija b’ benzodiazepine hu rakkomandat.
If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe you another medicine or to adjust the dose of Ciprofloxacin Hikma or the other medicine.
Jekk waħda mis- sitwazzjonijiet imsemmija hawn fuq tapplika għalik, it- tabib tiegħek jista ’ jiddeċiedi li jagħtik riċetta għal mediċina oħra jew li jaġġusta d- doża ta ’ Ciprofloxacin Hikma jew tal- mediċina l - oħra.
It is advisable never to use several medicines at the same time without consulting your doctor first.
Hu rakkomandat li qatt ma tuża ħafna mediċini fl- istess ħin mingħajr ma tkellem it- tabib tiegħek l- ewwel.
Pregnancy and breast-feeding You must not be given Ciprofloxacin Hikma during pregnancy.
27 Tqala u treddigħ M’ għandekx tingħata Ciprofloxacin Hikma matul it- tqala.
You should consult your doctor if you are pregnant or wish to become pregnant.
Għandek tkellem lit- tabib tiegħek jekk inti tqila jew jekk tixiteq li toħroġ tqila.
Ciprofloxacin is passed into human breast milk.
Ciprofloxacin jgħaddi ġol- ħalib tas- sider tal- bniedem.
You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.
M’ għandekx tredda ’ lit- tarbija tiegħek matul il- kura b’ ciprofloxacin, minħabba r- riskju ta ’ malformazzjoni tal- kartilaġni tal- ġogi u effetti oħrajn li jagħmlu l- ħsara lit- tarbija li tkun titredda ’.
You should consult your doctor if you are breast-feeding your child.
Għandek tkellem lit- tabib tiegħek jekk tkun qed tredda ’ lit- tarbija tiegħek.
Driving and using machines Ciprofloxacin can reduce your attention.
Sewqan u tħaddim ta ’ magni Ciprofloxacin jista ’ jnaqqas l- attenzjoni tiegħek.
If you suffer from dizziness, do not drive or operate machines, which require your full concentration.
Jekk tbati minn sturdament, issuqx jew tħaddem magni, li huma attivitajiet li jeħtieġu l- konċentrazzjoni sħiħa tiegħek.
26 Important information about some of the ingredients of Ciprofloxacin Hikma If you are on a low-sodium diet, take into account that 100 ml of Ciprofloxacin Hikma contains 15.4 mmol (equivalent to 354 mg) sodium.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ciprofloxacin Hikma Jekk qed tieħu dieta li fiha livelli baxxi ta ’ sodium, ikkunsidra l- fatt li 100 ml ta ’ Ciprofloxacin Hikma fihom 15. 4 mmol (ekwivalenti għal 354 mg) ta ’ sodium.
HOW TO USE CIPROFLOXACIN HIKMA
KIF GĦANDEK TUŻA CIPROFLOXACIN HIKMA
Dosage The Ciprofloxacin Hikma dosage is based on the severity and type of the infection, the sensitivity of the pathogen(s), your age, weight and kidney function.
Dożaġġ Id- dożaġġ ta ’ Ciprofloxacin Hikma hu bbażat fuq is- severità u t- tip ta ’ l- infezzjoni, tas- sensittività tal- patoġenu( i), l- età, il- piż u l- funzjoni tal- kliewi tiegħek.
The usual dose in adults is 200-400 mg of ciprofloxacin twice daily.
Id- doża tas- soltu fl- adulti hi ta ’ 200- 400 mg ta ’ ciprofloxacin darbtejn kuljum.
In case of very severe infections the dose can be increased up to a maximum daily dose of 1200 mg (400 mg thrice daily).
F’ każ ta ’ infezzjonijiet severi ħafna, id- doża tista ’ tiżdied sa doża massima ta ’ kuljum ta ’ 1200 mg (400 mg tliet darbiet kuljum).
Children and adolescents For the treatment of acute pulmonary infections caused by Pseudomonas aeruginosa bacteria in children and adolescents (5-17 years) with cystic fibrosis 15 mg of ciprofloxacin per kg body weight is administered twice daily or 10 mg ciprofloxacin per kg body weight is administered three times daily (maximum 1200 mg daily).
Tfal u adolexxenti Għal kura ta ’ infezzjonijiet pulmonari akuti kkawżati mill- batterji Pseudomonas aeruginosa fit- tfal u fl- adolexxenti (minn 5 sa 17- il sena) b’ fibrożi ċistika, doża ta ’ 15 mg ta ’ ciprofloxacin għal kull kilogramm ta ’ piż tal- ġisem tingħata darbtejn kuljum jew 10 mg ta ’ ciprofloxacin kull kilogramm ta ’ piż tal- ġisem jingħataw tliet darbiet kuljum (massimu ta ’ 1200 mg kuljum).
Dosage adjustment If you are older than 65 years your doctor may prescribe you a dose based on your kidney function and severity of disease.
Aġġustament fid- dożaġġ Jekk għandek iktar minn 65 sena, it- tabib tiegħek jista ’ jagħtik riċetta għal doża bbażata fuq il- funzjoni tal- kliewi tiegħek u fuq is- severità tal- marda.
If you have kidney problems you should inform your doctor.
Jekk għandek problemi tal- kliewi, għandek tinforma lit- tabib tiegħek.
He/ she may find it necessary to adjust your dose due to a reduced kidney function.
Hu/ hi jista ’ jsib il- bżonn li jaġġusta d- doża tiegħek minħabba l- funzjoni mnaqqsa tal- kliewi.
Method and route of administration Ciprofloxacin Hikma should be administered via a short-term intravenous infusion (infusion into a vein) over 30 to 60 minutes.
Mod ta ’ kif u mnejn jingħata Ciprofloxacin Hikma għandu jingħata permezz ta ’ infużjoni ġol- vina fi żmien qasir (infużżjoni gol- vina), fuq perjodu ta ’ ħin ta ’ minn 30 sa 60 minuta.
Duration of treatment The duration of treatment with Ciprofloxacin Hikma is based on the severity of the infection, the effect of the treatment and the sensitivity of the pathogen(s).
Tul tal- kura It- tul ta ’ żmien tal- kura b’ Ciprofloxacin Hikma hu bbażat fuq is- severità ta ’ l- infezzjoni, l- effett tal- kura u tas- sensittività tal- patoġenu( i).
The treatment should be continued for at least three days after the signs of the infection have disappeared.
Il- kura għandha titkompla għal mill- inqas tliet ijiem wara li s- sinjali ta ’ l- infezzjoni jkunu għabu.
The treatment of acute pulmonary infections in children and adolescents with cystic fibrosis will take 10-14 days.
Il- kura ta ’ infezzjonijiet pulmonari akuti fit- tfal u fl- adolexxenti b’ fibrożi ċistika ser tieħu bejn 10 u 14- il jum.
Like all medicines, Ciprofloxacin Hikma can cause side effects, although not everybody gets them.
28 Bħal kull mediċina oħra, Ciprofloxacin Hikma jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects have been reported in 5-14% of patients receiving ciprofloxacin.
Effetti sekondarji kienu irrappurtati f’ 5- 14% tal- pazjenti li kienu qed jirċievu ciprofloxacin.
Most frequent side effects affect the stomach and intestine, the nervous system and the skin and connective tissue.
Il- biċċa l- kbira ta ’ l- effetti sekondarji frekwenti jaffettwaw l- istonku u l- imsaren, is- sistema nervuża u l- ġilda u t- tessut konnettiv.
For more details regarding some of the side effects please see Section 2, ‘ Take special care with Ciprofloxacin Hikma- During or after treatment’.
Għal iktar dettalji dwar xi wħud mill- effetti sekondarji, jekk jogħġbok ara Sezzjoni 2, ‘ Oqgħod attent ħafna b’ Ciprofloxacin Hikma - Matul jew wara l- kura ’.
27 The frequency of side effects is classified into the following categories:
Il- frekwenza ta ’ l- effetti sekondarji hi kklassifikata fil- kategoriji li ġejjin:
Very common Common Uncommon Rare Very rare
Komuni ħafna Komuni Mhux Komuni Rari
in more than 1 in 10 patients in more than 1 in 100 patients, but less than 1 in 10 patients in more than 1 in 1,000 patients, but less than 1 in 100 patients in more than 1 in 10,000 patients, but less than 1 in 1,000 patients in less than 1 in 10,000 patients, including isolated reports
f’ iktar minn 1 f’ kull 10 pazjenti f’ iktar minn 1 f’ kull 100 pazjent, iżda f’ inqas minn 1 f’ kull 10 pazjenti f’ iktar minn 1 f’ kull 1, 000 pazjent, iżda f’ inqas minn 1 f’ kull 100 pazjent f’ iktar minn 1 f’ kull 10, 000 pazjent, iżda f’ inqas minn 1 f’ kull 1, 000 pazjent
Common:
Rari ħafna
- distorted sensation of taste
f’ inqas minn 1 f’ kull 10, 000 pazjent, li jinkludu rapporti iżolati
(usually reversible upon discontinuation of treatment), dizziness, headache,
Komuni: sensazzjoni ta ’ togħma mibdula (normalment riversibbli mat- twaqqif tal- kura), sturdament, uġigħ
difficulty in sleeping (insomnia), restlessness (agitation), confusion
ta ’ ras, diffikultà biex torqod (nuqqas ta ’ rqad), nuqqas ta ’ kwiet f’ ġismek (aġitazzjoni), konfużjoni dardir, dijarea
- nausea, diarrhoea
raxx
- rash
-
Uncommon:
Mhux komuni: infezzjoni fungali (moniliasi)
- fungal infection (mobilises)
-
- increase in eosinophilic cells (eosinophilia), reduction in white blood cells (leucopenia) which makes
żieda fiċ- ċelluli eosinofiliċi (eosinofilja), tnaqqis fi ċelluli bojod tad- demm (lewkopenja) li jagħmel
infections more likely
-
- inflammation of a vein related to a blood clot (thrombophlebitis); the vein is often sensed as a tender
l- infezzjonijiet iktar probabbli infjammazzjoni ta ’ vina relatata ma ’ embolu tad- demm (tromboflebite); il- vina ta ’ spiss tinħass
hard strand covered with red skin
-
- vomiting, digestive disorders, gassiness (flatulence), loss of appetite, abdominal pain
iebsa u sensittiva, miksija b’ ġilda ħamra rimettar, mard diġestiv, ikollok il- gass, telf ta ’ aptit, uġigħ addominali
- itching (pruritus), spot-shaped rash (maculopapular rash), hives (urticaria)
ħakk, raxx f’ forma ta ’ tikek (raxx makulopapulari), urtikarja
- joint pain (arthralgia)
uġigħ fil- gogi (artralġja)
- general sensation of weakness, fatigue (asthenia), irritation or pain at the injection site
sensazzjoni ġenerali ta ’ dgħjufija, għeja kbira (astenja), irritazzjoni jew uġigħ fis- sit ta ’ l- injezzjoni
- increase of the creatinine or urea level in the blood, abnormal liver function test results, bile pigment in
żieda fil- livell tal- creatine jew ta ’ l- urea fid- demm, testijiet tal- funzjoni tal- fwied b’ riżultat
the blood (bilirubinaemia) and increased blood level of a certain enzyme (alkaline phosphatase)
anormali, kulur tal- bila fid- demm (bilirubinemija) u żieda fil- livell tad- demm ta ’ ċerta enzima (alkaline phosphatase) emboliżmu pulmonari, diffikultà biex tieħu n- nifs (dispnea), edema pulmonari, tinfaraġ, ittella ’
- pulmonary embolism, laboured breathing (dyspnoea), pulmonary oedema, nosebleed (epistaxis),
-
coughing up blood (haemoptysis) and hiccough.
d- demm mas- sogħla (emoptisi) u sulluzzu.
- reduction in red blood cells (anaemia), increase in white blood cells (leucocytosis), alteration of the
Rari: tnaqqis fiċ- ċelluli ħomor tad- demm (anemija), żieda fiċ- ċelluli bojod tad- demm (lewkoċitosi),
prothrombin (coagulation factor) values, reduction in blood platelets (thrombocytopenia) with bruises and tendency to bleed, increase in blood platelets (thrombocytosis)
bidla fil- valuri tal- prothrombin (fattur tal- koagulazzjoni), tnaqqis fil- plejtlits tad- demm (tromboċitopenja) bi tbenġil u tendenza għal ħruġ tad- demm, żieda fil- plejtlets tad- demm (tromboċitosi) nefħa tad- dirgħajn/ riġlejn u tal- wiċċ (edema periferali, edema tal- wiċċ), nefħa għal għarrieda
- swelling of the limbs and face (peripheral oedema, facial oedema), sudden swelling of the face or throat
-
with difficulties in breathing and/ or itching and rash, often as an allergic reaction (angioneurotic oedema), allergic reactions, fever due to the administration of the medicine, serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction)
tal- wiċċ jew tal- gerżuma b’ diffikultà biex tieħu n- nifs u/ jew ħakk u raxx, ta ’ spiss bħala reazzjoni allerġika (edema anġjonewrotika), reazzjonijiet allerġiċi, deni minħabba l- għoti tal- mediċina, reazzjoni allerġika serja li toħloq diffikultà biex tieħu n- nifs, jew sturdament (reazzjoni anafilattika) żieda fil- livell taz- zokkor fid- demm (ipergliċemija)
- increased blood sugar level (hyperglycaemia)
-
- anxieties, nightmares, severe depression, seeing things or hearing voices that do not exist
ansjetà, ħmar il- lejl, dipressjoni severa, tara affarijiet jew tisma ’ vuċijiet li ma jeżistux
(hallucinations)
-
- reduced taste, altered sensation (paraesthesia), shaking (tremor), spasms/ convulsions (seizures), severe
(alluċinazzjonijiet) tnaqqis fis- sens tat- togħma, tibdil fis- sensazzjoni (parestesija), rogħda (titriegħed), spażmi /
headache (migraine)
-
- altered vision such as double vision (diplopia) and seeing all objects in a certain colour (chromatopsia)
konvulżjonijiet (puplesiji), uġigħ ta ’ ras sever (emigranja) tibdil fil- vista bħal meta tara doppju (diplopja), u tara l- oġġetti kollha f’ ċerti kulur (kromatopsija)
- ringing in the ear (tinnitus), transient hearing loss (particularly high frequencies)
tisfir fil- widnejn (żanżin fil- widnejn), telf temporanju fis- sens tas- smigħ (partikularment ta ’
- increased heart rate (tachycardia)
frekwenzi għoljin)
- fainting (syncope), widening of blood vessel (vasodilation)
29 żieda fir- rata ta ’ taħbit tal- qalb (takikardija)
- shortness of breath (dyspnoea), swelling of the voice box (larynx) with difficulties in breathing
ħass ħażin (sinkope), tusigħ ta ’ vini jew arterji (vasodilatazzjoni)
(larynx oedema)
-
- severe and continuous diarrhoea, possibly with blood and mucus, due to a severe inflammation of the
qtugħ ta ’ nifs (dispnea), nefħa tal- larinġi b’ diffikultà biex tieħu n- nifs (edema tal- larinġi)
large intestine (pseudo membranous colitis), fungal infection in the mouth (oral moniliasis)
-
- yellowing of the skin or whites of the eyes (icterus), icterus due to a condition where the bile can not
dijarea severa u kontinwa, possibbilment bid- demm u bil- mukus, minħabba infjammazzjoni severa
flow normally from the liver (cholestatic icterus), liver cell necrosis
tal- musrana l- kbira (psewdo kolite membranuża), infezzjoni fungali fil- ħalq (moniliasi orali) sfura tal- ġilda jew tal- parti l- bajda ta ’ l- għajnejn (ikterus), ikterus minħabba kundizzjoni fejn
- increased sensitivity to light (photosensitivity), erythema multiforme and erythema nodusum
il- bila ma tkunx tista ’ tnixxi b’ mod normali mill- fwied (ikterus kolestatiku), nekrosi taċ- ċelluli tal- fwied żieda fis- sensittività għad- dawl, eritema multiforme u eritema nodusum
- muscular pain (myalgia), joint disorder (swollen joints)
uġigħ fil- muskoli (mijalġja), mard tal- ġogi (ġogi minfuħin)
- acute kidney failure, abnormal kidney function, vaginal secretion due to a fungal infection (vaginal
-
moniliasis), blood in the urine (haematuria), presence of crystals in the urine with discomfort when passing urine (crystalluria), infection of the kidney with blood in the urine, fever and pain in the side (interstitial nephritis)
kollass akut tal- kliewi, funzjoni anormali tal- kliewi, tnixxija vaġinali minħabba infezzjoni fungali
- perspiration
(moniliasi vaġinali), demm fl- awrina (ematurja), preżenza ta ’ kristalli fl- awrina bi skonfort meta tagħmel l- awrina (kristallurja), infezzjoni tal- kliewi bid- demm fl- awrina, deni u uġigħ fil- ġenb tal- ġisem (nefrite interstizjali) għaraq
Very rare:
-
- reduction in red blood cells due to extensive destruction of these cells (haemolytic anaemia), severe
Rari ħafna: tnaqqis fiċ- ċelluli ħomor tad- demm minħabba qerda estensiva ta ’ dawn iċ- ċelluli (anemija
reduction in blood cells (pancytopenia), severe reduction in white blood cells characterised by sudden high fever, very sore throat and mouth ulcers (agranulocytosis)
-
- a life-threatening condition characterised by a sharp drop in the blood pressure, paleness, restlessness,
emolitika), tnaqqis sever taċ- ċelluli tad- demm (panċitopenja), tnaqqis sever fiċ- ċelluli bojod tad - demm ikkaratterizzat minn deni qawwi li jseħħ għal għarrieda, uġigħ qawwi fil- griżmejn u ulċeri tal- ħalq (agranuloċitosi) kundizzjoni ta ’ periklu għall- ħajja kkaratterizzata minn tnaqqis qawwi fil- pressjoni tad- demm,
weak/ quick pulse, clammy skin, dizziness as a result of severe allergy to this medicine (anaphylactic shock), itching rash, fever, joint swellings, muscle pains, rash (symptoms similar to those occurring in a disease called serum sickness)
-
- disturbed control of own behaviour and actions (psychotic reactions which may progress to self-
sfura, nuqqas ta ’ kwiet f’ ġismek, rata tal- polż bil- mod/ mgħaġġla, ġilda mdellka, sturdament bħala riżultat ta ’ allerġija severa għal din il- mediċina (xokk anafilattiku), raxx bil- ħakk, deni, nefħa fil- ġogi, uġigħ fil- muskoli, raxx (sintomi simili bħal dawk li jseħħu f’ marda msejħa marda tas- serum) disturb fil- kontroll ta ’ l- imġiba l- azzjonijiet tiegħek stess reazzjonijiet psikotiċi (li jistgħu
endangering behaviour)
-
- smell disorder (parosmia), loss of smell (anosmia, the smell usually returns after termination of
jaggravaw għal imġiba li tipperikola lil dak li jkun). disturb fis- sens tax- xamm (parosmija), telf tas- sens tax- xamm (anosmija, ix- xamm normalment
treatment), convulsions (grand mal convulsion), abnormal (unstable) gait, increased pressure in the head (intracranial hypertension), lack of coordination (ataxia), increased sensitivity to stimulation (hyperaesthesia), stiffness (hypertonia)
jerġa ’ lura għan- normal wara li l- kura tintemm), konvulżjonijiet (konvulżjoni grand mal), mod anormali ta ’ kif timxi (mixi instabbli), żieda fil- pressjoni fir- ras (pressjoni tad- demm għolja intrakranjali), nuqqas ta ’ koordinazzjoni (atassja), żieda tas- sensittività għall- istimulazzjoni (iperestesija), ebusija (ipertonija) taħbit tal- qalb irregolari (arritmija ventrikulari), traċċar anormali ta ’ l- elettrokardjogramm
- irregular heart beat (ventricular arrhythmia), abnormal electrocardiogram heart tracing, life-
-
These side effects occur predominantly in patients at risk for certain heart disorders.
tal- qalb, żieda fir- rata ta ’ taħbit tal- qalb li tkun ta ’ periklu għall- ħajja (torsade de pointes).
- inflammation of blood vessels (vasculitis) characterised by: small spots caused by bleeding in the skin
Dawn l- effetti sekondarji jseħħu l- biċċa l- kbira f’ pazjenti li jkunu f’ riskju għal ċertu mard tal- qalb. infjammazzjoni ta ’ vini jew arterji (vaskulite) ikkaratterizzata minn: tikek żgħar ikkawżati minn
(petechiae), bloody blisters (haemorrhagic bullae), skin nodes (papules), formation of eschar (dead tissue that sheds (sloughs-off) from healthy skin)
-
- fungal infection in the gastrointestinal system (gastrointestinal moniliasis), pancreas inflammation
ħruġ ta ’ demm fil- ġilda (tbenġil), infafet bid- demm (infafet emorraġiċi), għoqod fil- ġilda (bżieżaq żgħar), formazzjoni ta ’ eschar (tessut mejjet li jaqa ’ minn ġilda b’ saħħitha) infezzjoni fungali fis- sistema gastrointestinali (moniliasi gastrointestinali), infjammazzjoni
(pancreatitis)
-
- liver inflammation (hepatitis), destruction of liver tissue (liver cell necrosis, very rarely resulting in life-
tal- pankreas (pankreatite) infjammazzjoni tal- fwied (epatite), il- qerda ta ’ tessut tal- fwied (nekrosi taċ- ċelluli tal- fwied, li
threatening liver failure)
-
- rash with red (moist) irregular spots (erythema (exsudativum) multiforme), tender bluish red bumps in
b’ mod rari ħafna tirriżulta f’ kollass tal- fwied li jkun ta ’ periklu għall- ħajja) raxx b’ tikek (umdi) irregolari ħomor (eritema (exsudativum) multiforme), ħotob rotob blu- ħomor
the skin (erythema nodosum), severe condition with (high) fever, red spots on the skin, joint pains and/ or eye infection (Stevens-Johnson syndrome), severe condition with fever and blisters on the skin/ peeling of the skin (Lyell syndrome), small purplish red spot (petechia)
fuq il- ġilda (eritema nodosum), kundizzjoni severa bid- deni (qawwi), tikek ħomor fuq il- ġilda, uġigħ fil- gogi u/ jew infezzjoni fl- għajnejn (sindrome ta ’ Stevens- Johnson), kundizzjoni severa bid - deni u nfafet fuq il- ġilda/ tqaxxir tal- ġilda (sindrome ta ’ Lyell), tikek żgħar vjola- ħomor (tbenġil) infjammazzjoni tat- tendini (tendinite, b’ mod partikulari tat- tendine ta ’ Achilles), ftuq parzjali jew
- inflammation of the tendons (tendinitis, in particular of the Achilles tendon), partial or total tendon
-
ruptures (in particular of the Achilles tendon), exacerbation of the symptoms of myasthenia gravis (a particular type of muscle weakness), muscular pains, inflammation of tendon sheaths (tenosynovitis)
totali tat- tendini (b’ mod partikulari tat- tendine ta ’ Achilles), aggravament tas- sintomi ta ’ mijastenja gravis (tip partikulari ta ’ dgħjufija fil- muskoli), uġigħ fil- muskoli, infjammazzjoni ta ’ l- għantijiet tat- tendini tenosinovite) żieda fil- livell ta ’ amylase fid- demm (enzima li tkisser l- istarch) u lipase (enzima li tkisser
- increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks
ix- xaħmijiet). dgħjufija (astenja), indeboliment temporanju tal- funzjoni tal- kliewi sa kollass temporanju
down fats).
-
- weakness (asthenia), a transient impairment of kidney function to transient renal failure, photosensitivy.
tal- kliewi, sensittività għad- dawl.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
30 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.
HOW TO STORE CIPROFLOXACIN HIKMA
KIF TAĦŻEN CIPROFLOXACIN HIKMA
Do not use Ciprofloxacin Hikma after the expiry date which is stated on the packaging after “ Exp”.
Tużax Ciprofloxacin Hikma wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun wara “ JIS ”.
• Do not refrigerate or freeze. • Keep the vial in the outer carton until time of use in order to protect from light.
• Tagħmlux fil- friġġ jew friża. • Żomm il- kunjett fil- kartuna ta ’ barra sakemm tiġi biex tużah sabiex tilqa ’ mid- dawl.
What Ciprofloxacin Hikma contains
X’ fih Ciprofloxacin Hikma Is- sustanza attiva hi ciprofloxacin lactate.
Each vial of 100 ml contains 200 mg of ciprofloxacin.
Kull kunjett b’ 100 ml fih 200 mg ta ’ ciprofloxacin.
The other ingredients are lactic acid (E270), sodium chloride, hydrochloric acid (E507) for pH adjustment and water for injections.
Is- sustanzi l- oħra huma lactic acid (E270), sodium chloride, hydrochloric acid (E507) għal aġġustament tal- pH u ilma għall- injezzjonijiet.
What Ciprofloxacin Hikma looks like and contents of the pack Ciprofloxacin Hikma is a sterile, clear and colourless to slightly yellow solution for infusion.
Id- dehra ta ’ Ciprofloxacin Hikma u d- daqs tal- pakkett Ciprofloxacin Hikma hu soluzzjoni sterili, ċara u bla kulur jew kemm kemm safra għall- infużjoni.
It is contained in a type I, clear, colourless glass vial containing 100 ml solution.
Ikun f’ kunjett tal- ħġieġ ta ’ tip I, ċar, bla kulur, li jkun fih 100 ml tas- soluzzjoni.
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705-906 Terrugem SNT Portugal Tel.: +351 219 608 410 Fax: +351 219 615 102 geral@hikma. pt
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugall Tel.: +351 219 608 410 Fax: +351 219 615 102 geral@ hikma. pt
For any information about this medicine, please contact the the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
This medicinal product is authorised in the Member States of EEA under the following names:
Dan il- prodott medicinali huwa awtorizzat fl- istati membri ta 'l- EEA b' dawn l- ismijiet:
Austria – Ciprofloxacin Hikma 200mg/ 100ml Infusionslösung Germany – Ciprofloxacin Hikma 200mg/ 100ml Lösung zur Intravenösen Anwendung Ireland – Ciprofloxacin Hikma 200mg/ 100ml Solution for Infusion Italy – Ciprofloxacin Hikma 200mg/ 100ml Soluzione per Infusione Endovenosa United Kingdom – Ciprofloxacin Hikma 200mg/ 100ml Solution for Infusion The Netherlands – Ciprofloxacine Hikma 200mg/ 100ml Oplossing voor Intraveneuze Infusie
Awstrija – Ciprofloxacin Hikma 200 mg/ 100 ml Infusionslösung Ġermanja – Ciprofloxacin Hikma 200 mg/ 100 ml Lösung zur Intravenösen Anwendung Irlanda – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Italja – Ciprofloxacin Hikma 200 mg/ 100 ml Soluzione per Infusione Endovenosa Renju Unit – Ciprofloxacin Hikma 200 mg/ 100 ml Solution for Infusion Olanda – Ciprofloxacine Hikma 200 mg/ 100 ml Oplossing voor Intraveneuze Infusie
This leaflet was last approved in {MM/ YYYY}.
{XX/ SSSS}.
Use only clear solutions and undamaged containers.
Użu biss soluzzjonijiet ċari u kontenituri mingħajr ħsara.
Ciprofloxacin Hikma is compatible with isotonic sodium chloride solution, Ringer’ s solution, Ringer’ s lactate solution, 50 mg/ ml (5%) or 100 mg/ ml (10%) glucose solution and 50 mg/ ml (5%) glucose solution with 2.25 mg/ ml (0.225%) or 4.5 mg/ ml (0.45%) sodium chloride solution and 10% fructose solution.
31 Ciprofloxacin Hikma hu kompatibbli ma ’ soluzzjoni isotonika ta ’ sodium chloride, soluzzjoni ta ’ Ringer, soluzzjoni ta ’ Ringer lactate, soluzzjoni ta ’ 50 mg/ ml (5%) jew 100 mg/ ml (10%) glucose u soluzzjoni ta ’ 50 mg/ ml (5%) glucose ma ’ 2. 25 mg/ ml (0. 225%) jew soluzzjoni ta ’ 4. 5 mg/ ml (0. 45%) ta ’ sodium chloride u soluzzjoni ta ’ 10% fructose.
The diluted solution should be inspected visually for particulate matter and discoloration prior to administration.
Is- soluzzjoni dilwita għandha tiġi eżaminata viżwalment għal materjal f’ sura ta ’ partikuli u tibdil fil- kulur qabel ma tingħata.
The diluted solution should be clear.
Is- soluzzjoni dilwita għandha tkun ċara.
London, 11 July 2007 EMEA/ CHMP/ 75066/ 2007
Londra, 11 ta 'Lulju 2007 EMEA/ CHMP/ 75066/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names
OPINJONI WARA RIFERIMENT GĦALL- ARTIKOLU 29( 4) 1 GĦAL Ciprofloxacin Hikma u ismijiet assoċjati.
International Non-Proprietary Name (INN):
Denominazzjoni Komuni Internazzjonali (INN):
Ciprofloxacin Hikma and associated names, 2 mg/ ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Ciprofloxacin Hikma u l- ismijiet assoċjati li jiġi bħala soluzzjoni għall- infużjoni ta '2 mg/ ml, hu antibijotiku li jagħmel parti mill- familja tal- quinolone li in vitro huwa effettiv kontra numru kbir ta' batterji aerobiċi Gram- negative aerobic bacteria kif ukoll kontra xi organiżmi Gram- positive.
Hikma Farmaceutica Lda. submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
Hikma Farmaceutica Lda. issottomettew żewġ applikazzjonijiet għal rikonoxximent reċiproku Isem Komuni Internazzjonali ta 'Ciprofloxacin Hikma u ismijiet assoċjati, f' soluzzjoni għall- injezzjoni ta' 2 mg/ ml abbażi ta 'l- awtorizzazzjoni għat- tqegħid fis- suq mogħtija lill- Olanda fit- 12 ta' April ta 'l- 2005.
The Mutual Recognition Procedure started on 28 January 2006.
Il- Proċedura ta ’ Rikonoxximent Reċiproku bdiet fit- 28 ta 'Jannar ta' l- 2006.
The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
L- Istat Membru ta 'Referenza kien l- Olanda u l - Istati Membri konċernati kienu l- Awstrija, il- Ġermanja, l- Irlanda, l- Italja, u r- Renju Unit.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma setgħux jaqblu dwar ir- Rikonoxximent Reċiproku ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq mogħti mill- Istat Membru ta' Referenza.
The Netherlands referred the reasons for disagreement to the EMEA on 7 July 2006.
L- Olanda rreferiet ir- raġunijiet għan- nuqqas ta 'qbil lill- EMEA fis- 7 ta' Lulju ta 'l- 2006.
Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Ġew identifikati differenzi sinjifikanti dwar id- doża fl- infezzjonijiet fil- pajp ta 'l- awrina u dwar id- doża massima ta' kuljum fl- adulti.
In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/ EWP/ 558/ 95 rev.1).
Barra minn hekk, ġie kkunsidrat li fis- Sommarju tal- Karatteristiċi tal- Prodott (punt 5. 1), l- applikant irid jinkludi l- organiżmi elenkati fil- breakpoints u t- tabella dwar is- suxxettibilità li tkun relevanti għall- indikazzjonijiet, kif indikat fin- Nota għall- Gwida fuq l- Evalwazzjoni tal- prodotti mediċinali indikati għat- trattament ta 'infezzjonijiet minn batterji (CPMP/ EWP/ 558/ 95 rev. 1).
The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Il- proċedura ta 'l- arbitraġġ inbdiet fis- 27 ta' Lulju ta 'l- 2006 bl- adozzjoni ta' lista ta 'mistoqsijiet.
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
Ir - Rapporteur kien Dr Ian Hudson l- ko- Rapporteur kien Dr Bengt Ljungberg.
The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Id- Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq ta spjegazzjoni bil- miktub fil- 20 ta' Ottubru ta 'l- 2006.
During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Waqt il- laqgħa tiegħu ta 'Jannar ta' l- 2007, il- CHMP, fid- dawl tat- tagħrif sottomess kollu u fid- dawl tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċji u r- riskji kien favorevoli għal Ciprofloxacin Hikma u ismijiet assoċjati, li l- objezzjonijiet imqajma ma għandhomx jimpedixxu l- għoti ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta' tagħrif ta 'l- Istat Membru ta' Referenza għandhom jiġu emendati.
A positive opinion was adopted by on 24 January 2007.
Fl- 24 ta 'Jannar ta' l- 2007 kienet adottata opinjoni pożittiva.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II, flimkien mas- Sommarju tal- Karatteristiċi tal- Prodott fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 11 July 2007.
L- opinjoni finali inqelbet f' Deċiżjoni mill- Kummissjoni Ewropea fil- 11 ta 'Lulju ta' l- 2007.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Artikolu 29( 4) tad- Directtiva 2001/ 83/ KE, kif emendata.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
Marketing Authorisation Invented name Holder
Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
Content (concentratio n)
Kontenut (konċentrazzjoni)
Bayer Austria GmbH Ciproxin Herbststraße 6-10 Ciproxin 1160 Wien Ciproxin Austria Ciproxin Ciproxin Ciproxin Ciprofloxacine « BAYER »
Bayer Austria GmbH Herbststraße 6- 10 1160 Wien L- Awstrija
film-coated tablets film-coated tablets film-coated tablets solution for infusion solution for infusion solution for infusion solution for infusion
pilloli miksija b’ rita pilloli miksija b’ rita pilloli miksija b’ rita soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use intravenous use intravenous use intravenous use intravenous use
użu orali użu orali użu orali użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini użu għal ġol- vini
solution for infusion
soluzzjoni għall- infużjoni
intravenous use
użu għal ġol- vini
oral suspension oral suspension
suspensjoni orali suspensjoni orali
oral use oral use
użu orali użu orali
solution for infusion solution for infusion film-coated tablets film-coated tablets
soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni pilloli miksija b’ rita
intravenous use intravenous use oral use oral use
użu għal ġol- vini użu għal ġol- vini użu orali
film-coated tablets film-coated tablets oral suspension solution for infusion solution for infusion
pilloli miksija b’ rita pilloli miksija b’ rita suspensjoni orali soluzzjoni għall- infużjoni soluzzjoni għall- infużjoni
oral use oral use oral use intravenous use intravenous use
użu orali użu orali użu orali użu għal ġol- vini użu għal ġol- vini
Bulgaria
Il- Bulgarija
Germany Ciprobay
Il- Ġermanja
modified release tablets
pilloli li jerħu l- mediċina b' mod modifikat
BAYER HELLAS ABEE, Greece 18-20 Sorou Street, 15125 Marousi, Athens, Greece
BAYER HELLAS ABEE, Greece 18- 20 Sorou Street, 15125 Marousi, Athens, Il - Greċja