qanastek/EMEA-V3 huggingface dataset:
This is because it helps this medicine to be absorbed into the body.
Dan għaliex dan il- fatt jgħin lil din il- mediċina biex tkun assorbita ġol - ġisem.
• Are you pregnant, or do you think you might be pregnant?
• Inti tqila, jew taħseb li tista ’ tkun tqila?
Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary. • Are you breast-feeding?
Għalkemm din il- mediċina mhijiex magħrufa li tagħmel ħsara lit- tarbija mhix imwielda, ser tingħata biss lil mara tqila jekk ikun verament meħtieġ.
This medicine should not be given to women who are breastfeeding.
Din il- mediċina m’ għandhiex tingħata lil nisa li jkunu jreddgħu.
This is because small amounts of it enter the milk.
Dan hu minħabba li ammonti żgħar minnha jidħlu fil- ħalib.
41 Cefuroxime axetil tablets will not affect your ability to drive or operate machinery.
Il- pilloli Cefuroxime axetil mhux ser jaffettwaw il- ħila tiegħek li ssuq jew tħaddem il- magni.
Important information about some of the ingredients of this medicine
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ din il- mediċina
Cefuroxime axetil 125 mg coated tablets contain 0.2 mg aspartame.
Cefuroxime axetil 125 mg pilloli miksija fihom 0. 2 mg ta ’ aspartame.
If you have been told by your doctor that you have a metabolic disorder called phenylketonuria or if you are on a low-phenylalanine diet, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek marda metabolika msejħa fenilketonurja jew jekk qiegħed/ qiegħda fuq dieta ta ’ phenylalanine baxxa, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE CEFUROXIME AXETIL
KIF GĦANDEK TIEĦU CEFUROXIME AXETIL
Always take this medicine exactly as your doctor has told you.
Dejjem għandek tieħu din il- mediċina skond il- parir tat- tabib.
The dispensing label will tell you much of this medicine you should take and how often you should take.
It- tikketta tar- riċetta ser tgħidlek kemm minn din il- mediċina għandek tieħu u kemm ta ’ spiss għandek teħodha.
Please read it carefully.
Jekk jogħġbok aqraha bl- attenzjoni.
The dose your doctor prescribes depends on the type of infection and how bad the infection is.
Id- doża li għaliha t- tabib tiegħek jagħtik riċetta tiddependi fuq it- tip ta ’ infezzjoni u fuq kemm hi serja l- infezzjoni.
Your doctor will explain this to you.
It- tabib tiegħek jista ’ jispegalek dan.
Information on how many tablets and how often they should be taken will exactly be written on the dispensing label.
Informazzjoni dwar kemm għandek tieħu pilloli u kemm ta ’ spiss għandhom jittieħdu, ser tkun miktuba b’ mod preċiż fuq it- tikketta tar- riċetta.
The tablets should be taken after meals because this improves the absorption of Cefuroxime axetil into the body.
Il- pilloli għandhom jittieħdu wara l- ikel minħabba li dan itejjeb l- assorbiment ta ’ Cefuroxime axetil fil- ġisem.
The recommended doses are given below.
Id- dożi rakkomandati qed huma deskritti hawn taħt.
However, your doctor may prescribe a different dose to those below: if this applies to you, discuss it with your doctor if you have not already done so.
Madankollu, it- tabib tiegħek jista ’ jagħtik riċetta differenti minn dawn imsemmija hawn taħt: jekk dan japplika għalik, iddiskuti dan mat - tabib tiegħek jekk mhux diġà għamilt hekk.
The dose you are prescribed will depend on the type and severity of the infection.
Id- doża li għaliha ngħatajt riċetta ser tiddependi fuq it- tip u s- severità ta ’ l- infezzjoni.
The usual dose is:
Id- doża normali hi:
Adults and children above the age of 12
Adulti u tfal li għandhom aktar minn 12- il sena
For upper respiratory tract infections such as tonsillitis, otitis media, sinusitis and pharyngitis:
Għal infezzjonijiet fl- apparat respiratorju ta ’ fuq, bħal tonsillite, infjammazzjoni akuta tal- widna tan - nofs, sinusite u farinġite:
1 tablet of Cefuroximaxetil 250 or 500 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 250 jew 500 darbtejn kuljum għal 5- 10 ijiem.
For lower respiratory tract infections such as bronchitis and pneumonia:
Għal infezzjonijiet fl- apparat respiratorju t’ isfel, bħal bronkite u pnewmonja:
1 tablet of Cefuroximaxetil 500 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 500 darbtejn kuljum għal 5- 10 ijiem.
For bladder infections:
Għal infezzjonijiet tal- bużżieqa ta ’ l- awrina:
1 tablet of Cefuroximaxetil 125 or 250 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 125 jew 250 darbtejn kuljum għal 5- 10 ijiem.
For skin infections:
45 Għal infezzjonijiet tal- ġilda:
For the treatment of early Lyme disease:
Għall- kura tal- marda ta ’ Lyme fl- istadju bikri:
1 tablet of Cefuroximaxetil 500 twice a day for 20 days.
1 pillola ta ’ Cefuroximaxetil 500 darbtejn kuljum għal 20 jum.
Children between the ages of 5 and 12
Tfal ta ’ bejn l- etajiet ta ’ 5 u 12- il sena
For the conditions listed above:
Għall- kundizzjonijiet elenkati hawn fuq:
For acute otitis media:
Għal infjammazzjoni akuta tal- widna tan- nofs:
42 1 tablet of Cefuroximaxetil 250 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 250 darbtejn kuljum għal 5- 10 ijiem.
Using cefuroxim containing suspension is recommended for children under the age of 5.
L- użu ta ’ cefuroxim li jkun fih suspensjoni hu rakkomandat għal tfal taħt il- 5 snin.
There is no experience in the use of cefuroxime axetil in children under 3 months of age.
M’ hemmx esperjenza bl- użu ta ’ cefuroxime axetil fi tfal ta ’ taħt it- 3 xhur.
If you take more Cefuroxime axetil than you should
Jekk tieħu Cefuroxime axetil aktar milli suppost
If you have taken more of this medicine than you should, talk to your doctor straight away or go to the nearest hospital accident and emergency department.
Jekk tkun ħadt aktar milli suppost minn din il- mediċina, kellem lit- tabib tiegħek minnufih jew mur fl - eqreb dipartiment ta ’ l- emerġenza ta ’ l- isptar.
Take the medicine with you in the carton, so that staff will know exactly what has been taken.
Ħu l- mediċina miegħek fil- kaxxa tal- kartun, biex l- istaff ikun jaf eżattament x’ mediċina tkun ħadt.
Overdose with Cefuroximaxetil can lead to convulsions.
Doża eċċessiva ta ’ Cefuroximaxetil tista ’ twassal għal konvulżjonijiet.
If you forget to take this medicine
Jekk tinsa tieħu din il- mediċina
If you forget to take a dose of this medicine at the right time, take it as soon as you remember.
Jekk tinsa tieħu xi doża ta ’ din il- mediċina fil- ħin tagħha, ħudha hekk kif tiftakar.
If you stop taking this medicine
Jekk tieqaf tieħu din il- mediċina
It is important that you take this medicine until you finish the prescribed course.
Hu importanti li tieħu din il- mediċina sakemm tispiċċa l- kors kollu li għalih ingħatajt ir- riċetta.
You should not stop the medicine just because you feel better.
M’ għandekx tieqaf tieħu l- mediċina sempliċiment għax tħossok aħjar.
If you stop too soon, the infection may start up again.
Jekk tieqaf teħodha kmieni wisq, tista ’ terġa ’ taqbdek l- infezzjoni.
If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.
Jekk il- persuna li qed tkun ikkurata xorta jibqa ’ ma tħosshiex tajba fit- tmiem tal- kors tal- mediċina li għalih ingħatat ir- riċetta, jew tħossha agħar matul il- kura, din għandha tkellem lit- tabib tagħha.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk ikollok aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, din il- mediċina jista ’ jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Severe allergic reactions to this medicine are very rare (affecting less than 1 in 10,000 people) or rare (affecting less than 1 in 1,000 people).
Ir- reazzjonijiet allerġiċi severi għal din il- mediċina huma rari ħafna (jaffettwaw inqas minn 1 minn kull 10, 000 ruħ) jew rari (jaffettwaw inqas minn 1 minn kull 1, 000 ruħ).
These can include:
Dawn jistgħu jinkludu:
- (high) fever
- deni (qawwi)
- joint pain
- uġigħ fil- gogi
- Swelling of eyelids, face or lips
- nefħa ta ’ tebqet il- għajnejn, wiċċ jew xufftejn
- Severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals.
- Raxx sever tal- ġilda li jista ’ jkun bl- infafet u li jista ’ jinvolvi l- għajnejn, il- ħalq u l- gerżuma
- Loss of consciousness (fainting)
- Tintilef minn sensik (ħass ħażin)
- severe diarrhoea or if you see blood in your diarrhoea.
- dijarea severa jew jekk tara d- demm fid- dijarea tiegħek.
All of these reactions need urgent medical attention.
Dawn ir- reazzjonijiet kollha jeħtieġu attenzjoni medika urġenti.
If you think you are having any of these types of reaction, stop taking this medicine and contact your doctor or your nearest hospital accident and emergency department.
Jekk taħseb li qed ikollok xi waħda minn dawn it- tipi ta ’ reazzjoni, tkomplix tieħu din il- mediċina u ikkuntattja lit- tabib tiegħek jew lill- eqreb dipartiment ta ’ l- emerġenza ta ’ l- isptar.
Common side effects (affecting less than 1 in 10 people) include:
Effetti sekondarji komuni (li jaffettwaw inqas minn 1 minn kull 10 persuna) jinkludu:
Fever and a feeling of generally being unwell a short time after taking Cefuroxime axetil for the treatment of Lyme disease (Jarisch-Herxheimer reaction) Stomach problems: diarrhoea nausea and vomiting.
Deni u sensazzjoni ġenerali li ma tħossokx tajjeb/ tajba ftit wara li tieħu Cefuroxime axetil għall - kura tal- marda ta ’ Lyme (reazzjoni ta ’ Jarisch- Herxheimer) Problemi fl- istonku: dijarea, nawseja u rimettar.
Skin rash with or without severe itching and wheal formation (urticaria) Renal and urinary problems:
Raxx tal- ġilda bi jew mingħajr ħakk sever u formazzjoni ta ’ urtikarja Disturbi fil- kliewi u fis- sistema urinarja:
If you have been told that your kidneys do not work very well, changes in kidney function may occur (higher levels of creatinine and urea)
Jekk it- tabib tiegħek qallek li l- kliewi tiegħek ma tantx jaħdmu tajjeb, jista ’ jseħħ tibdil fil- funzjoni tal- kliewi (livelli ogħla ta ’ krejatinina u ta ’ urea)
Uncommon side effects (affecting less than 1 in 100 people) include:
Effetti sekondarji mhux komuni (li jaffettwaw inqas minn 1 minn kull 100 persuna) jinkludu:
Nervous system disorders: headaches, dizziness Kidneys and urinary tract: blood in the urine, fever and pain in the side (acute interstitial nephritis)
Disturbi fis- sistema nervuża: uġigħ ta ’ ras, sturdament Kliewi u apparat ta ’ l- awrina: demm fl- awrina, deni u wġigħ fil- ġenbejn (nefrite interstizjali akuta)
43 Rare side effects (affecting less than 1 in 1000 people) include:
Effetti sekondarji rari (li jaffettwaw inqas minn 1 minn kull 1000 persuna) jinkludu:
Blood and lymphatic system disorders: abnormal blood count (such as decreased haemoglobin level;, drops in the numbers of different cells in the blood (leucopenia, neutropenia), increases in some types of white blood cells (eosinophilia), decreases in the numbers of small cells that are needed for clotting of the blood.
Disturbi tad- demm u tas- sistema limfatika: għadd anormali demm (bħal tnaqqis fil- livell ta ’ l - emoglobina; tnaqqis fin- numri ta ’ ċelluli differenti fid- demm (lewkopenja, newtropenja), żidiet f’ xi tipi ta ’ ċelluli bojod tad- demm (eosinofilja), tnaqqis fin- numri ta ’ ċelluli żgħar li huma meħtieġa għat- tagħqid tad- demm.
This may result in easy bleeding or bruising.
Dan jista ’ jirriżulta fi ħruġ ta ’ demm jew tbenġil li jseħħ malajr.
Immune system disorders: allergic reactions with fever, swelling of joints, muscle pain, skin rash Liver and bile ducts: changes in blood tests that check how your liver is working (AST, ALT, LDH, bilirubin: temporary increase) General: drug fever
Disturbi fis- sistema immuni: reazzjonijiet allerġiċi bid- deni, nefħa tal- ġogi, uġigħ fil- muskoli, raxx tal- ġilda Fwied u kanali tal- bila: tibdil fit- testijiet tad- demm li jiċċekkjaw kif il- fwied tiegħek qed jaħdem (żieda temporanja fl- AST, ALT, LDH u bilirubin) Ġenerali: deni minħabba l- mediċina
Very rare side effects (affecting less than 1 in 10 000 people) include:
Effetti sekondarji rari ħafna (li jaffettwaw inqas minn 1 minn kull 1000 persuna) jinkludu:
Blood and lymphatic system disorders: anemia (a type of anaemia that is caused by red blood cells breaking up); Nervous system: restlessness, nervousness, confusion Liver and bile ducts: yellow discolouration of skin or eyes (jaundice) Skin and subcutaneous tissue: skin rash with irregular red (moist) patches (erythema multiforme);
Raxx tal- ġilda b’ irqajja ’ ħomor (umdi) irregolari (eritema multiforme);
Certain tests for determining some substances in your blood might show different results while you take cefuroxime axetil (Coombs test).
Ċerti testijiet biex ikun stabbilit jekk xi sustanzi fid- demm tiegħek jurux riżultati differenti waqt li tkun qed tieħu cefuroxime axetil (test ta ’ Coombs).
HOW TO STORE THIS MEDICINE
KIF TAĦŻEN DIN IL- MEDIĊINA
Keep Cefuroximaxetil in the original packaging..
Żomm Cefuroximaxetil fl- ippakkjar oriġinali.
Do not use this medicine after the expiry date which is stated on the label and carton.
Tużax din il- mediċina wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa tal- kartun.
Do not use the medicine after the expiry date.
Tużax il- mediċina wara d- data ta ’ skadenza.
You should not throw away any medicine through wastewater or household waste.
47 M’ għandekx tarmi kwalunkwe mediċina ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines that you no longer need.
Staqsi lill- ispiżjar tiegħek dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
This will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent.
What Cefuroxime axetil contains
X’ fih Cefuroxime axetil
- The active substance is:
- Is- sustanza attiva hi:
Cefuroximaxetil 125 contains 150.36 mg of
Cefuroximaxetil 125 fih 150. 36 mg ta ’ Cefuroximaxetil f’ kull
Cefuroximaxetil per tablet, equivalent to 125 mg of cefuroxime.
pillola, ekwivalenti għal 125 mg ta ’ cefuroxime.
croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202)and talc (E553B); in the tablet coating: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) and aspartame (E951).
Is- sustanzi l- oħrajn (sustanzi mhux attivi) huma fil- qalba tal- pillola: sodium laurylsulphate, copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202) u talc (E553B); fil- kisja tal- pillola: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) u aspartame (E951).
What Cefuroxime axetil looks like and contents of the pack
Id- dehra ta ’ Cefuroxime axetil u d- daqs tal- pakkett
44 Cefuroximaxetil tablets are coated.
Il- pilloli Cefuroximaxetil huma miksija.
Cefuroximaxetil 125 are white to slightly yellowish capsule-shaped tablets.
Il- pilloli Cefuroximaxetil 125 huma ta ’ kulur li hu minn abjad sa ftit isfar, b’ forma ta ’ kapsula.
Cefuroximaxetil 125 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14 and 24 tablets.
Il- pilloli miksija Cefuroximaxetil 125 mg huma disponibbli f’ kaxxi tal- kartun b’ folja( i) li jistgħu jinqatgħu jew strixxi li fihom 8, 10, 12, 14 u 24 pillola.
Marketing Authorisation Holder To be completed nationally.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Biex timtela mill- pajjiż partikolari.
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Awstrija
This medicinal product is authorised in the Member States of the EEA under the following names:
Dan il- prodott prodott mediċinali hu awtorizzat fl- Istati Membri ta ’ l- EEA taħt l- ismijiet li ġejjin:
Cefuroximaxetil Sandoz 125 mg – Filmtabletten
Awstrija Repubblika Ceka Estonja Ungerija Irlanda Litwanja Latvja Olanda Polonja Repubblika tas- Slovakja Spanja Renju Unit
Spain Cefuroxima Sandoz 125 mg comprimidos recubiertos con película EFG
Cefuroximaxetil Sandoz 125 mg – Filmtabletten Xorimax 125 mg potahované tablety Cefuroxim 1A Pharma 125 mg Xorimax 125 mg bevont tabletta Cefuroxime 125mg Tablets (PA 372/ 9/ 1) Xorimax 125 mg dengtos tabletės Xorimax 125 mg apvalkotās tabletes Cefuroximaxetil 125, omhulde tabletten 125 mg Xorimax 125 mg tabletki powlekane Xorimax 125 mg Cefuroxima Sandoz 125 mg comprimidos recubiertos con película EFG Cefuroxime 125mg Tablets (PL 04416/ 0626)
This leaflet is last approved in:
48 Dan il- fuljett kien approvat l- aħħar fi:
To be completed nationally
Biex timtela mill- pajjiż partikolari.
45 PACKAGE LEAFLET:
49 FULJETT TA ’ TAGĦRIF:
Not all people who are allergic to penicillins are also allergic to cephalosporins.
Mhux in- nies kollha li huma allerġiċi għal penicillins huma allerġiċi wkoll għal cephalosporins.
• Are you pregnant, or do you think you might be pregnant?
51 • Inti tqila, jew taħseb li tista ’ tkun tqila?
Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary. • Are you breast-feeding?
Għalkemm din il- mediċina mhijiex magħrufa li tagħmel ħsara lit- tarbija mhix imwielda, ser tingħata biss lil mara tqila jekk ikun verament meħtieġ. • Inti qed tredda ’?
47 Cefuroxime axetil tablets will not affect your ability to drive or operate machinery.
Il- pilloli Cefuroxime axetil mhux ser jaffettwaw il- ħila tiegħek li ssuq jew tħaddem il- magni.
1 tablet of Cefuroximaxetil 125 or 250 twice a day for 5-10 days.
52 1 pillola ta ’ Cefuroximaxetil 125 jew 250 darbtejn kuljum għal 5- 10 ijiem.
For skin infections:
Għal infezzjonijiet tal- ġilda:
48 1 tablet of Cefuroximaxetil 250 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 250 darbtejn kuljum għal 5- 10 ijiem.
49 Rare side effects (affecting less than 1 in 1000 people) include:
Effetti sekondarji rari (li jaffettwaw inqas minn 1 minn kull 1000 persuna) jinkludu:
You should not throw away any medicine through wastewater or household waste.
54 M’ għandekx tarmi kwalunkwe mediċina ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Cefuroximaxetil 250 contains 300.72 mg of Cefuroximaxetil per tablet equivalent to 250 mg of cefuroxime.
Cefuroximaxetil 250 fih 300. 72 mg ta ’ Cefuroximaxetil f’ kull pillola, ekwivalenti għal 250 mg ta ’ cefuroxime.
Cefuroximaxetil 500 contains 601.44 mg of Cefuroximaxetil per tablet (equivalent to 500 mg of cefuroxime).
Cefuroximaxetil 500 fih 601. 44 mg ta ’ Cefuroximaxetil f’ kull pillola, ekwivalenti għal 500 mg ta ’ cefuroxime.
- The other ingredients (excipients) are in the tablet core: sodium laurylsulphate, copovidone,
- Is- sustanzi l- oħrajn (sustanzi mhux attivi) huma fil- qalba tal- pillola: sodium laurylsulphate,
croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202)and talc (E553B); in the tablet coating: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) and aspartame (E951).
copovidone, croscarmellose sodium (E468), magnesium stearate (E470B), anhydrous colloidal silicon dioxide (E551), mannitol (E421), microcrystalline cellulose (E 460), crospovidone (E1202) u talc (E553B); fil- kisja tal- pillola: mannitol (E421), soluble (potato) starch, talc (E553B), titanium dioxide (E171) u aspartame (E951).
50 Cefuroximaxetil tablets are coated.
Il- pilloli Cefuroximaxetil huma miksija.
Cefuroximaxetil 250 are white to slightly yellowish capsule-shaped tablets with a break-line on both sides.
Il- pilloli Cefuroximaxetil 250 huma ta ’ kulur li hu minn abjad sa ftit isfar, b’ forma ta ’ kapsula, b’ ferq fuq iż- żewġ naħat.
Cefuroximaxetil 250 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14 and 24 tablets.
Il- pilloli miksija Cefuroximaxetil 250 mg huma disponibbli f’ kaxxi tal- kartun b’ folja( i) li jistgħu jinqatgħu jew strixxi li fihom 8, 10, 12, 14 u 24 pillola.
Cefuroximaxetil Sandoz 250 mg – Filmtabletten
Awstrija Belġju Repubblika Ceka Estonja Greċja Ungerija Irlanda
Cefuroxim Sandoz 250 mg filmomhulde tabletten
Cefuroximaxetil Sandoz 250 mg – Filmtabletten Cefuroxim Sandoz 250 mg filmomhulde tabletten Xorimax 250 mg potahované tablety Cefuroxim 1A Pharma 250 mg Cefuroxime axetil Sandoz 250 mg Xorimax 250 mg bevont tabletta Cefuroxime 250mg Tablets (PA 372/ 9/ 2)
Cefuroxim Sandoz 250 mg comprimés pelliculés
55 Litwanja Lussemburgu Latvja Olanda Polonja Portugall Repubblika tas- Slovakja Spanja Renju Unit
Spain Cefuroxima Sandoz 250 mg comprimidos recubiertos con película EFG
Xorimax 250 mg dengtos tabletės Cefuroxim Sandoz 250 mg comprimés pelliculés Xorimax 250 mg apvalkotās tabletes Cefuroximaxetil 250, omhulde tabletten 250 mg Xorimax 250 mg tabletki powlekane CEFUROXIMA Sandoz 250 mg COMPRIMIDOS Xorimax 250 mg Cefuroxima Sandoz 250 mg comprimidos recubiertos con película EFG Cefuroxime 250mg Tablets (PL 04416/ 0627)
This leaflet is last approved in:
Dan il- fuljett kien approvat l- aħħar fi:
52 PACKAGE LEAFLET:
56 FULJETT TA ’ TAGĦRIF:
However, you should not take this medicine if you have ever had a severe allergic
Mhux in- nies kollha li huma allerġiċi għal penicillins huma allerġiċi wkoll għal cephalosporins.
53 reaction to any penicillin.
57 Madankollu, m’ għandekx tieħu din il- mediċina jekk xi darba kellek reazzjoni allerġika severa għal kwalunkwe penicillin.
Ask your doctor or pharmacist for advice before taking any medicine.
58 Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
54 Cefuroxime axetil tablets will not affect your ability to drive or operate machinery.
Il- pilloli Cefuroxime axetil mhux ser jaffettwaw il- ħila tiegħek li ssuq jew tħaddem il- magni.
For the treatment of early Lyme disease:
59 Għall- kura tal- marda ta ’ Lyme fl- istadju bikri:
55 1 tablet of Cefuroximaxetil 250 twice a day for 5-10 days.
1 pillola ta ’ Cefuroximaxetil 250 darbtejn kuljum għal 5- 10 ijiem.
All of these reactions need urgent medical attention.
60 Dawn ir- reazzjonijiet kollha jeħtieġu attenzjoni medika urġenti.
56 Rare side effects (affecting less than 1 in 1000 people) include:
Effetti sekondarji rari (li jaffettwaw inqas minn 1 minn kull 1000 persuna) jinkludu:
You should not throw away any medicine through wastewater or household waste.
M’ għandekx tarmi kwalunkwe mediċina ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
18.
61 18.
57 Cefuroximaxetil tablets are coated.
Il- pilloli Cefuroximaxetil huma miksija.
Cefuroximaxetil 500 are white to slightly yellowish capsule-shaped tablets.
Il- pilloli Cefuroximaxetil 500 huma ta ’ kulur li hu minn abjad sa ftit isfar, b’ forma ta ’ kapsula.
Cefuroximaxetil 500 mg coated tablets are available in carton boxes with blister(s) tear-off or strips containing 8, 10, 12, 14, 20 and 24 tablets.
Il- pilloli miksija Cefuroximaxetil 500 mg huma disponibbli f’ kaxxi tal- kartun b’ folja( i) li jistgħu jinqatgħu jew strixxi li fihom 8, 10, 12, 14, 20 u 24 pillola.
Cefuroximaxetil Sandoz 500 mg – Filmtabletten
Awstrija Belġju Repubblika Ceka Estonja Greċja Ungerija Litwanja Lussemburgu Latvja Olanda Polonja Portugall
Cefuroxim Sandoz 500 mg filmomhulde tabletten
Cefuroximaxetil Sandoz 500 mg – Filmtabletten Cefuroxim Sandoz 500 mg filmomhulde tabletten Xorimax 500 mg potahované tablety Cefuroxim 1A Pharma 500 mg Cefuroxime axetil Sandoz 500 mg Xorimax 500 mg bevont tabletta Xorimax 500 mg dengtos tabletės Cefuroxim Sandoz 500 mg comprimés pelliculés Xorimax 500 mg apvalkotās tabletes Cefuroximaxetil 500, omhulde tabletten 500 mg Xorimax 500 mg tabletki powlekane CEFUROXIMA Sandoz 500 mg COMPRIMIDOS
Cefuroxim 1A Pharma 500 mg
62 Repubblika tas- Slovakja
Xorimax 500 mg bevont tabletta
Xorimax 500 mg
Poland
Spanja
58 To be completed nationally
Biex timtela mill- pajjiż partikolari.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
LISTA TA ’ ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, IL- QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN GĦANDHOM JINGĦATAW, ID- DETENTURI TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
1 Member
1 Stat
Marketing
Id- Detentur ta ’ l -
State
Membru
Authorisation Holder
Awtorizzazzjoni għat - Applikant Tqegħid fis- Suq
(concentration)
(konċentrazzjoni)
Hikma Farmacêutica (Portugal) Lda.
Hikma Farmacêutica (Portugal) Lda.
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705 - 906 Terrugem SNT, PORTUGAL
Ciprofloxacin Hikma 200mg/ 100ml Oplossing voor Intraveneuze Infusie
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Oplossing voor Intraveneuze Infusie
AT
Awstrija
Ciprofloxacin Hikma 200mg/ 100ml Infusionslösung
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Infusionslösung
DE
Ġermanja
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Lösung zur intravenösen Anwendung
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Lösung zur intravenösen Anwendung
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Solution for Infusion
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Solution for Infusion
IT
Italja
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Soluzione per Infusione Endovenosa
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Soluzione per Infusione Endovenosa
UK
Renju Unit
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDI FIS- SOMMARJU TAL- KARATTERISRIĊI TAL- PRODOTT, FIT- TIKKETTA U FIL- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN HIKMA AND ASSOCIATED NAMES (see Annex I)
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ CIPROFLOXACIN HIKMA U ISMIJIET ASSOĊJATI (ara l- 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 hu quinolone effettiv in vitro kontra numru kbir ta ’ batterji arobiċi Gram- negative kif ukoll kontra numru kbir ta ’ organiżmi Gram- positive.
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- ġestjoni ta ’ pazjenti b’ infezzjonijiet fil- pajp ta ’ l- awrina (UTIs) bħalissa tinkludi trattament empriku b’ antibijotiku li jaħdem kontra firxa wiesgħa ta ’ mikroorganiżmi (fluoroquinolone), u trattament potenzjali sussegwenti għal bejn 10 u 14- il jum abbażi tal- mikrobi li jkunu tkabbru fl- awrina u għal liema antibijotiku jkunu sensittivi.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing be adequate.
Biex it- trattament ma jfallix u biex tiġi evitata r- reżistenza, irid ikun hemm dożi adegwati u konformità min- naħa tal- pazjent.
The applicant/ MAH did not submit any clinical data to address the CHMP 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 tagħrif kliniku li jindirizza l- mistoqsijiet tas- CHMP dwar il - benefiċċju/ riskju tad- doża proposta għal infezzjonijiet fil- pajp ta ’ l- awrina u d- doża massima ta ’ kuljum f’ pazjenti adulti, għax din l- applikazzjoni hija “ ġenerika ” (prodott ta ’ referenza/ oriġinatur Ciproxin tal- Bayer).
The body of published literature and resistance data presented by the applicant provided adequate justification, both from an efficacy and safety (more likely to prevent bacterial resistance and no increase in adverse reactions) viewpoint, for the dosing regimen of 200-400 mg ciprofloxacin twice daily for the treatment of complicated UTI.
L- ammont ta ’ letteratura ppubblikata u ta ’ tagħrif dwar ir- reżistenza ppreżentata mill- applikant ipprovvdiet biżżejjed ġustifikazzjoni, kemm mill- aspett ta ’ l- effikaċja kif ukoll mill- aspett tas- sigurtà (probabilità ikbar li tkun prevenuta reżistenza mill- batterji u l- ebda żieda fir- reazzjonijiet sekondarji), għal trattament b’ dożi ta ’ bejn 200 u 400 mg ciprofloxacin darbtejn kuljum għat- trattament ta ’ infezzjonijiet ikkumplikati fil- pajp ta ’ l- awrina.
This product being a solution intended for intravenous infusion, should be restricted to the treatment of complicated UTI’ s.
Billi dan il- prodott hu intiż għal infużjoni ġol- vini, għandu jiġi ristrett għat- trattament ta ’ UTI’ s kumplikati.
From the published data, which have demonstrated for the proposed maximum dose 400 mg intravenous three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
Mit- tagħrif ippubblikat, li għad- doża massima ta ’ 400 mg fil- vina tliet darbiet kuljum wera prevenzjoni aqwa ta ’ reżistenza għall- antibijotiċi mingħajr żieda sinjifikanti fl- effetti sekondarji f’ infezzjonijiet f’ sistemi ta ’ organi oħra serji jew ta ’ periklu għal ħajja, ma hemm l- ebda raġuni li twassal għall- konklużjoni li dan il- profil favorevoli tar- riskju/ benefiċċju għandu jinbidel b’ mod sinjifikanti mit- trattament ta ’ UTIs komplikati.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
4 RAĠUNIJIET GĦALL- EMENDI FIS- SOMMARJU TAL- KARATTERISRIĊI TAL - PRODOTT, FIT- TIKKETTA U FIL- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL - EMEA
- The literature provided by the applicant support a dose of 200 – 400 mg twice daily in the treatment of
- Il- letteratura pprovduta mill- applikant tappoġġja doża ta ’ 200 – 400 mg darbtejn kuljum fit -
complicated urinary tract infections and a maximum adult daily dose of 400 mg three times daily.
trattament ta ’ infezzjonijiet komplikati fil- pajp ta ’ l- awrina u doża massima ta ’ 400 mg tliet darbiet kuljum u
- The requested amendments to section 5.1 of the Summary of Product Characteristics including the
- L- emendi mitluba għas- sezzjoni 5. 1 tas- Sommarju tal- Karatteristiċi tal- Prodott fosthom il -
breakpoints relevant to the indications are acceptable.
breakpoints relevanti għall- indikazzjonijiet huma aċċettabbli.
The CHMP has recommended that the indication should be complicated urinary tract infections with a recommended dose of 200 – 400 mg twice daily.
Is- CHMP irrakkomanda li l- indikazzjoni għandha tkun infezzjonijiet mhux komplikati fil- pajp ta ’ l - awrina b’ doża rakkomandata ta ’ bejn 200 u 400 mg darbtejn kuljum.
In addition the maximum daily dose for the use of ciprofloxacin should be 400 mg three times daily.
Barra minn hekk id- doża massima ta ’ kuljum għal ciprofloxacin għandha tkun ta ’ 400 mg tliet darbiet kuljum.
In addition, other amendments to the Summary of Product Characteristics, labelling and package leaflet not in relation with the outcome of the referral procedure were included in accordance with the Guideline on SPC, excipient guideline and the latest Quality Review of Documents templates.
Barra minn hekk, emendi oħra għas- Sommarju tal- Karatteristiċi tal- Prodott, it- Tikketta u l- Fuljett ta ’ Tagħrif mhux b’ rabta ma ’ l- iżvolġiment tal- proċedura ta ’ referenza kienu inklużi skond il- Linja Gwida fuq l- SPC, gwidi fuq is- sustanzi mhux attivi u l- iktar templates riċenti ta ’ l- Analiżi tal- Kwalità tad - Dokumenti.
The CHMP has therefore recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
Is- CHMP għalhekk irrakkomanda l- għoti ta ’ l- Awtorizzazzazzjoni( jiet) għat- Tqegħid fis- Suq u l - emendi għas- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif ta ’ l- Istat Membru ta ’ Referenza.
These are set out in Annex III for Ciprofloxacin and associated names (see Annex I).
Dawn huma mniżżlin fl- Anness III għal Ciprofloxacin u ismijiet assoċjati (ara l- Anness I).
5 SUMMARY OF PRODUCT CHARACTERISTICS
5 ANNESS III
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally]
Ciprofloxacin Hikma 200 mg/ 100 ml, soluzzjoni għall- infużjoni [Biex timtela nazzjonalment.]
1 ml solution for infusion contains:
1 ml soluzzjoni għall- infużjoni fiha:
Ciprofloxacin lactate equivalent to 2 mg ciprofloxacin.
Ciprofloxacin lactate ekwivalenti għal 2 mg ta ’ ciprofloxacin.
Each vial with 100 ml contains 200 mg ciprofloxacin.
Kull kunjett b’ 100 ml fih 200 mg ta ’ ciprofloxacin.
Excipient 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion For a full list of excipients, see section 6.1.
Sustanza mhux attiva 15. 4 mmol (354 mg) ta ’ sodium f’ kull 100 ml ta ’ soluzzjoni għall- infużjoni Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Solution for infusion Clear, colourless to slightly yellow solution pH of the solution:
Soluzzjoni għall- infużjoni Soluzzjoni ċara, bla kulur jew ta ’ kulur kemm kemm isfar pH tas- soluzzjoni:
3.9 – 4.5
3. 9- 4. 5
Ciprofloxacin Hikma is indicated for the treatment of serious and/ or life-threatening infections caused by ciprofloxacin-susceptible pathogens.
Ciprofloxacin Hikma hu indikat għall- kura ta ’ infezzjonijiet serji u/ jew ta ’ periklu għall- ħajja kkawżati minn patoġeni li huma suxxettibbli għal ciprofloxacin.
The following indications can be considered for treatment with Ciprofloxacin Hikma when oral therapy is not possible or not reliable:
L- indikazzjonijiet li ġejjin jistgħu jiġu kkunsidrati għall- kura b’ Ciprofloxacin Hikma meta t- terapija orali ma tkunx possibbli jew mhix affidabbli:
- complicated urinary tract infections
- infezzjonijiet kumplikati tal- passaġġ urinarju
- infections of the lower respiratory tract including pneumonia caused by aerobic gram-negative
- infezzjonijiet tal- passaġġ respiratorju t’ isfel, li jinkludu pnewmonja kkawżata minn batterji
bacteria, in case of Streptococcus pneumoniae infections ciprofloxacin is not the substance of first choice.
F’ każ ta ’ infezzjonijiet bi Streptococcus pneumoniae ciprofloxacin mhuwiex il- mediċina preferuta.
- complicated skin and soft tissue infections
- infezzjonijiet kumplikati tal- ġilda u tat- tessut artab
- osteomyelitis
- osteomjelite:
Ciprofloxacin Hikma may also be administered in the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children aged 5-17 years with cystic fibrosis.
Ciprofloxacin Hikma jista ’ wkoll jingħata fil- kura ta ’ infezzjonijiet akuti tal- passaġġ respiratorju t’ isfel ikkawżati minn Pseudomonas aeruginosa fit- tfal li jkollhom bejn 5 u 17- il sena b’ fibrożi ċistika.
In case of mixed infections with anaerobes ciprofloxacin must be combined with other antibiotics effective against anaerobes.
F’ każ ta ’ taħlita ta ’ infezzjonijiet b’ anerobi, ciprofloxacin għandu jkun ikkombinat ma ’ antibijotiċi oħrajn li huma effettivi kontra l- anerobi.
The adult dosage is 200 - 400 mg ciprofloxacin twice daily.
Id- dożaġġ fl- adulti hu ta ’ 200- 400 mg ta ’ ciprofloxacin darbtejn kuljum.
In case of very serious, life-threatening or recurrent infections the dosage can be increased to 400 mg three times daily.
F’ każ ta ’ infezzjonijiet serji ħafna li huma ta ’ periklu għall- ħajja, jew infezzjonijiet rikorrenti, id- dożaġġ jista ’ jiżdied għal 400 mg tliet darbiet kuljum.
The maximum daily dose is 1200 mg.
Id- doża massima ta ’ kuljum hi ta ’ 1200 mg.
Osteomyelitis:
Osteomjelite:
Prior to initiation of therapy, bacteriological sensitivity tests should be conducted.
Qabel il- bidu tat- terapija, testijiet tas- sensittività batterjoloġika għandhom jitwettqu.
As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section
Bħal fil- każ ta ’ l- antibijotiċi l- oħrajn kollha, il- pazjent għandu jkun immonitorjat matul it- terapija għall- iżvilupp ta ’ razez reżistenti ta ’ batterji li jkunu inizjalment sensittivi, speċjalment P. aeruginosa u S. aureus (ara 8 d- dikjarazzjonijiet rilevanti f’ sezzjoni 5. 1).
Average duration of treatment can be 4-6 weeks.
Il- medja tat- tul tal- kura tista ’ tkun ta ’ 4- 6 ġimgħat.
If a prolonged treatment is necessary, a reassessment of treatment should be done at 2 months at the latest.
Jekk tkun meħtieġa kura fit- tul, għandha ssir evalwazzjoni mill- ġdid wara mhux iktar tard minn xahrejn wara.
Impaired renal function:
Indeboliment fil- funzjoni tal- kliewi:
In patients with a creatinine clearance in the range 31 - 60 ml/ minute/ 1.73 m2 or a serum creatinine concentration in the range 124 - 174 µmol/ l, the maximum daily intravenous dose is 800 mg.
F’ pazjenti bi tneħħija tal- kreatinina fil- medda 31- 60 ml/ minuta/ 1. 73 m2 jew konċentrazzjoni tal- creatine fis- serum fil- medda ta ’ 124- 174 µmol/ l, id- doża massima ta ’ kuljum ġol- vina hi ta ’ 800 mg.
If creatinine clearance is ≤ 30 ml/ minute/ 1.73 m2 or the serum creatinine concentration is ≥ 175 µmol/ l, the maximum daily intravenous dose is 400 mg.
Jekk it- tneħħija tal- creatine hi ta ’ ≤ 30 ml/ minuta/ 1. 73 m2 jew il- konċentrazzjoni tal- creatine fis- serum hi ta ’ ≥ 175 µmol/ l, id- doża massima ta ’ kuljum ġol- vina hi ta ’ 400 mg.
In patients on haemodialysis or CAPD, the maximum daily intravenous dose is also 400 mg.
F’ pazjenti fuq l- emodijaliżi jew CAPD, id- doża massima ta ’ kuljum ġol- vina hi wkoll ta ’ 400 mg.
On the dialysis days, the dose is given after the haemodialysis session.
Fil- jiem meta jkun hemm id- dijaliżi, id- doża tingħata wara s- sessjoni ta ’ l- emodijaliżi.
Impaired hepatic function:
Indeboliment fil- funzjoni tal- fwied:
In case of impaired hepatic function it is not necessary to adjust the dosage.
F’ każ ta ’ indeboliment fil- funzjoni tal- fwied, mhux meħtieġ li taġġusta d- dożaġġ.
Impaired renal and hepatic function:
Indeboliment fil- funzjoni tal- kliewi u tal- fwied:
Dose adjustment according to renal function.
L- aġġustament tad- doża għandu jkun skond il- funzjoni tal- kliewi.
Monitoring the level of active substance in the blood provides the most reliable basis for dose adjustment.
Il- monitoraġġ tal- livell tas- sustanza attiva fid- demm jipprovdi l- iktar bażi affidabbli għall- aġġustament tad- doża.
Due to the higher plasma levels in the elderly it is advisable to administer a doses based on creatinine clearance and severity of disease.
Minħabba l- livelli ogħla fil- plażma fl- anzjani, hu rakkomandat li tagħti dożi bbażati fuq it- tneħħija tal- creatine u s- severità tal- marda.
Acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children and adolescents (5-17
Infezzjonijiet akuti tal- passaġġ respiratorju t’ isfel ikkawżati minn Pseudomonas aeruginosa fit- tfal u fl- adolexxenti (5- 17- il sena) b’ fibrożi ċistika:
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day).
Għoti darbtejn kuljum ġol- vina ta ’ 15 mg/ kg ta ’ piż tal- ġisem, jew ta ’ 10 mg/ kg piż tal- ġisem tliet darbiet kuljum (massimu ta ’ 1200 mg kuljum).
Sequential therapy can also be used.
Tista ’ tintuża wkoll it- terapija sekwenzjali.
Dosage as follows:
Id- dożaġġ hu kif ġej:
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day), then twice daily oral administration.
Għoti darbtejn kuljum ġol- vina ta ’ 15 mg/ kg ta ’ piż tal- ġisem, jew ta ’ 10 mg/ kg ta ’ piż tal- ġisem tliet darbiet kuljum (massimu ta ’ 1200 mg kuljum), imbagħad għoti mill- ħalq darbtejn kuljum.
The recommended duration of treatment is 10 - 14 days.
It- tul ta ’ żmien rakkomandat tal- kura hu ta ’ 10- 14- il jum.
The dosage in children with impaired renal and/ or hepatic function has not been investigated.
Id- dożaġġ fit- tfal b’ indeboliment tal- kliewi u/ jew tal- funzjoni tal- fwied ma kienx investigat.
The solution for infusion should be administered over an infusion period of 60 minutes.
Is- soluzzjoni għall- infużjoni għandha tingħata fuq perjodu ta ’ infużjoni ta ’ 60 minuta.
Due to the increased risk of local reactions, higher intravenous doses in particular should only be administered via a large vein or a central line.
Minħabba ż- żieda fir- riskju ta ’ reazzjonijiet lokali, dożi ogħla ġol- vina, b’ mod partikulari, għandhom jingħataw biss minn ġo vina kbira jew permezz ta ’ linja ċentrali.
For information on mixing with other solutions: see sections 6.2 and 6.6.
Għal informazzjoni dwar it- taħlit ma ’ soluzzjonijiet oħrajn: ara sezzjonijiet 6. 2 u 6. 6.
The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.
It- tul ta ’ żmien tal- kura jiddependi fuq is- severità ta ’ l- infezzjoni, ir- rispons kliniku u s- sejbiet batterjoloġiċi.
Generally, acute and chronic infections (e. g. osteomyelitis and prostatitis, etc), where the causative organism is known to be sensitive to ciprofloxacin, should be treated for at least three days after the signs and symptoms of the infection have disappeared.
Ġeneralment, infezzjonijiet akuti u kroniċi (eż. osteomjelite u prostatitis, eċċ.), fejn l- organiżmu kawżattiv hu magħruf li hu sensittiv għal ciprofloxacin, għandhom jkunu kkurati għal mill- inqas tliet ijiem wara li s- sinjali u s- sintomi ta ’ l- infezzjoni jkunu għabu.
Other specific situations such as osteomyelitis and paediatric patients are stated under Posology.
Sitwazzjonijiet speċifiċi oħrajn, bħal l- osteomjelite u pazjenti pedjatriċi, huma ddikjarati f’ din is- sezzjoni.
Ciprofloxacin Hikma is contraindicated in: • patients with a hypersensitivity to ciprofloxacin, quinoline carboxylic acid derivatives or to any of the excipients
Ciprofloxacin Hikma hu kontra- indikat f ’: • pazjenti b’ sensittività eċċessiva għal ciprofloxacin, derivattivi ta ’ quinoline carboxylic acid jew xi sustanzi mhux attivi • tfal taħt il- 5 snin.
With regard to the safety and use of ciprofloxacin in children, see also section 4.4 • children and growing adolescents except for the treatment of acute pulmonary exacerbations of cystic fibrosis in children aged 5 to 17 years. • pregnancy and lactation • patients with a history of tendon disorder related to fluoroquinolone administration • Concurrent administration of ciprofloxacin and tizanidine
9 • It- tfal u l- adolexxenti li qed jikbru, ħlief għall- kura ta ’ aggravamenti akuti pulmonari ta ’ fibrożi ċistika fit- tfal li għandhom bejn 5 u 17- il sena. • tqala u treddigħ • pazjenti bi storja medika ta ’ mard fit- tendini marbut ma ’ l- għoti ta ’ fluoroquinolone • L- għoti fl- istess ħin ta ’ ciprofloxacin u tizanidine
Renal and urinary system:
Is- sistema tal- kliewi u dik urinarja:
Crystalluria related to the use of ciprofloxacin has been reported.
Kristallurja marbuta ma ’ l- użu ta ’ ciprofloxacin kienet irrappurtata.
Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Il- pazjenti li jkunu qed jirċievu ciprofloxacin għandhom ikunu idratati tajjeb, u l- alkalinità eċċessiva fl- awrina għandha tiġi evitata.
Patients with pre-existent significant renal disorders should be carefully monitored to detect any deterioration in function.
Pazjenti b’ mard sinifikanti tal- kliewi li kien jeżisti minn qabel, għandhom ikunu mmonitorjati bl- attenzjoni biex jinstab kwalunkwe deterjorament fil- funzjoni tal- kliewi.
It should only be administered with great caution to persons with renal insufficiency, or severe dehydration.
Din il- medċina għandha tingħata biss b’ attenzjoni kbira lil persuni b’ insuffiċjenza tal- kliewi, jew b’ deidratazzjoni severa.
Blood and lymphatic system:
Is- sistema tad- demm u limfatika:
Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones, and so ciprofloxacin should be used with caution in these patients.
Pazjenti bi storja medika tal- familja jew b’ difetti attwali fl- attività ta ’ glucose- 6- phosphate dehydrogenase, huma suxxettibbli għal reazzjonijiet emolitiċi bil- quinolones, u għalhekk ciprofloxacin għandu jintuża bl- attenzjoni f’ dawn il- pazjenti.
As with other fluoroquinolones, specific undesirable effects with regard to the central nervous system must be taken into account when using Ciprofloxacin Hikma.
Is- sistema nervuża ċentrali Bħal fil- każ ta ’ fluoroquinolones oħrajn, effetti speċifiċi mhux mixtieqa fir- rigward tas- sistema nervuża ċentrali jridu jiġu kkunsidrati meta tuża Ciprofloxacin Hikma.
In patients with epilepsy or other lesions of the central nervous system (e. g. reduced convulsion threshold, a history of epileptic seizures, diminished cerebral blood flow, changes in brain structure or stroke), ciprofloxacin is only to be used after carefully weighing the benefits against the risk, because the possibility of central nervous side effects puts these patients at increased risk.
F’ pazjenti b’ epilessija jew b’ leżjonijiet oħrajn tas- sistema nervuża ċentrali (eż. limitu mnaqqas għall- konvulżjonijiet, storja medika ta ’ puplesiji epilettiċi, fluss ta ’ demm ċerebrali mnaqqas, tibdil fl- istruttura tal- moħħ jew puplesija), ciprofloxacin għandu jintuża biss wara li l- benefiċċji kontra r- riskji jintiżnu bl- attenzjoni, minħabba li l- possibbiltà ta ’ effetti sekondarji fis- sistema nervuża tpoġġi lil dawn il- pazjenti f’ riskju miżjud.
The undesirable effects sometimes occur already after the first administration of ciprofloxacin.
L- effetti mhux mixtieqa xi kultant jseħħu anki wara l- ewwel l- għoti ta ’ ciprofloxacin.
Depression or psychoses lead to self-endangering behaviour in some cases.
Id- dipressjoni jew il- psikosi jwasslu għal imġiba li tipperikola lil dak li jkun f’ xi każijiet.
If such reactions occur, treatment with ciprofloxacin must be discontinued immediately and the treating physician informed.
Jekk reazzjonijiet bħal dawn iseħħu, il- kura b’ ciprofloxacin trid titwaqqaf immedjatament, u t- tabib li jkun qed jikkura l- pazjent għandu jkun infurmat.
Since ciprofloxacin is associated with very rare cases of QT prolongation (see section 4.8) caution should be exercised when treating patients at risk for torsade de pointes arrhythmia.
Minħabba li ciprofloxacin hu assoċjat ma ’ każijiet rari ħafna ta ’ titwil tal- QT (ara sezzjoni 4. 8), għandha tingħata attenzjoni meta pazjenti li qegħdin f’ riskju għal arritmija torsade de pointes ikunu ikkurati.
As for other medicinal products in this group, ciprofloxacin has been reported to cause joint disorders in weight-bearing joints of immature animals.
Bħal fil- każ ta ’ prodotti mediċinali oħrajn f’ dan il- grupp, ciprofloxacin kien irrappurtat li jikkawża mard tal- ġogi f’ ġogi li jġorru l- piż tal- ġisem ta ’ annimali immaturi.
There are insufficient data available with regard to the use of ciprofloxacin in children and adolescents.
Hemm informazzjoni insuffiċjenti disponibbli fir- rigward ta ’ l- użu ta ’ ciprofloxacin fit- tfal u fl- adolexxenti.
Therefore, the use of ciprofloxacin in children is generally not recommended, except for cystic fibrosis patients (see section 4.1).
Għalhekk, l- użu ta ’ ciprofloxacin fit- tfal hu ġeneralment mhux rakkomandat, ħlief għal pazjenti b’ fibrożi ċistika (ara sezzjoni 4. 1).
Gastrointestinal tract:
Passaġġ gastrointestinali:
When during or after the treatment with ciprofloxacin or another fluoroquinolone severe and persistent diarrhoea occurs, pseudomembranous colitis must be taken into account (life-threatening with possibly fatal outcome).
Meta, waqt jew wara l- kura b’ ciprofloxacin jew fluoroquinolone ieħor, isseħħ dijarea severa u persistenti, trid tiġi kkunsidrata l- kolite psewdomembranuża (li hi ta ’ periklu għall- ħajja b’ riżultat possibbilment fatali).
In that case the ciprofloxacin therapy must immediately be discontinued and an appropriate treatment initiated.
F’ dak il- każ, it- terapija b’ ciprofloxacin trid titwaqqaf immedjatament, u tinbeda kura adattata.