Annex III. Amendments to relevant sections of the product information

Transcription

1 Annex III Amendments t relevant sectins f the prduct infrmatin Nte: These amendments t the relevant sectins f the prduct infrmatin are the utcme f the referral prcedure. The prduct infrmatin may be subsequently updated by the Member State cmpetent authrities, in liaisn with the reference Member State, as apprpriate, in accrdance with the prcedures laid dwn in Chapter 4 f Title III f Directive 2001/83/EC. 164

2 A - Summary f prduct characteristics (SmPC) Fr quinlnes and flurquinlnes cntaining medicinal prducts, the existing prduct infrmatin shall be amended (insertin, replacement r deletin f the text as apprpriate) t reflect the agreed wrding as prvided belw (new text underlined and in bld, deleted text strike thrugh): Nte: the indicatins are gruped under headings r cver terms that encmpass the same medical entity; all changes apply t bth the cver term and sub-headings, as relevant. 1. Sectin 4.1: therapeutic indicatins In additin f the amendments recmmended belw, the fllwing sentence shuld be included in all quinlnes and flurquinlnes cntaining medicinal prducts at the end f sectin 4.1: Cnsideratin shuld be given t fficial guidance n the apprpriate use f antibacterial agents. 1.1 Deletin f indicatins Fr all quinlnes/flurquinlnes The indicatins in the table belw shuld be deleted fr all quinlnes/ flurquinlnes cntaining prducts Pharyngitis-Tnsillitis Pharyngitis Tnsillitis Laryngitis Acute brnchitis Prphylaxis f travellers diarrhea Prphylaxis f infectius gastrenteritis (traveller s diarrhea) Preventin f traveller s diarrhea Preperative preparatins fr chrnic chlesteatmatus titis and chrnic titis spreading t bne Septicaemia Selective decntaminatin f gastrintestinal tract in patients with cmprmised immune system Preventin f exacerbatins in wmen with recurring urinary tract infectins Frequent, recurrent urinary infectin prphylaxis Lng term prphylaxis f recurrent urinary infectins Prphylaxis f frequently repeating infectins f urinary tract infectins Preventin f systemic urinary tract infectins Prphylaxis f systemic urinary tract infectins 165

3 Preventin f infectin in surgical prcedures Prphylaxis after surgeries r interventins in the urgenital system prphylaxis after surgeries r interventins in the urgenital system Vaginal infectins Prphylaxis f recurrent urinary infectins fllwing trans-urethral surgery r transrectal prstatic bipsy Meningitis Infectin f cerebrspinal fluid Endcarditis Nscmial pneumnia External titis Additinal deletins f indicatin(s) fr specific quinlnes/flurquinlnes Additinally fr the active substance stated belw, the fllwing indicatins shuld als be deleted: Peflxacin Acute and chrnic prstatitis, including severe frms Acute uncmplicated pyelnephritis Malignant external titis Exacerbatins f brnch-pulmnary infectins in cystic fibrsis Shuld medicinal prducts n lnger have any authrised indicatins with a psitive benefit-risk balance then the natinal cmpetent authrities shuld take the apprpriate actin in line with the cnclusins n this prcedure under Article 31 f Directive 2001/83/EC. 1.2 Amendment f indicatins Fr all quinlnes/flurquinlnes The indicatins in the table belw shuld be restricted fr all quinlnes/ flurquinlnes cntaining prducts in rder t be used nly when it is cnsidered inapprpriate t use ther antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Therefre the fllwing text shuld be added in Sectin 4.1 as relevant: In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. 166

4 Uncmplicated cystitis Simple uncmplicated acute cystitis Acute cystitis in wmen Simple uncmplicated acute cystitis in the premenpausal adult wmen Recurrent cystitis in wmen Acute uncmplicated infectin f lwer urinary tract (simple cystitis) Acute exacerbatin f chrnic brnchitis and f chrnic bstructive pulmnary disease Acute exacerbatin f chrnic bstructive pulmnary disease including chrnic brnchitis Acute exacerbatins f chrnic brnchitis Exacerbatin f chrnic bstructive pulmnary disease Acute bacterial rhinsinusitis Acute sinusitis Acute bacterial sinusitis Otitis media acute Additinal amendments f indicatins fr specific quinlnes/flurquinlnes Additinally fr the fllwing active substances, the fllwing indicatins shuld be amended as recmmended belw: Ciprflxacin Current indicatins in prduct infrmatin f ciprflxacin cntaining prducts Urethritis and cervicitis due t bacteria susceptible t flurquinlnes Recmmended wrding Adults Gncccal urethritis and cervicitis due t susceptible Neisseria gnrrheae Bne and jint infectins Infectins f the bnes and jints Treatment f infectins in neutrpenic patients Infectin in immuncmprmised patients Urinary tract infectin Ciprflxacin may be used in the management f neutrpenic patients with fever that is suspected t be due t a bacterial infectin Uncmplicated acute cystitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute pyelnephritis Cmplicated urinary tract infectins Bacterial prstatitis Children and adlescents 167

5 Brnch-pulmnary infectins in cystic fibrsis caused by Pseudmnas aeruginsa Cmplicated urinary tract infectins and pyelnephritis Brnch-pulmnary infectins due t Pseudmnas aeruginsa in patients with cystic fibrsis Cmplicated urinary tract infectins and acute pyelnephritis Levflxacin Current categry 1 indicatins in prduct infrmatin f levflxacin Pyelnephritis and cmplicated urinary tract infectins (see sectin 4.4) Acute exacerbatin f chrnic brnchitis (last line) Recmmended wrding f categry 1 indicatins Acute pyelnephritis and cmplicated urinary tract infectins (see sectin 4.4) Acute exacerbatin f chrnic bstructive pulmnary disease including brnchitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmplicated skin and sft tissue infectins / Cmplicated skin and skin structure infectins skin and sft tissue infectins skin and sft structure infectins In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Mxiflxacin Current categry 1 indicatins in prduct infrmatin f mxiflxacin Acute exacerbatin f chrnic brnchitis (last line) Recmmended wrding f categry 1 indicatins Acute exacerbatin f chrnic bstructive pulmnary disease including brnchitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. 168

6 Oflxacin Current indicatins in prduct infrmatin f flxacin cntaining prducts Pyelnephritis and cmplicated urinary tract infectins Recmmended wrding Acute pyelnephritis and cmplicated urinary tract infectins Prstatitis, epididym-rchitis Chrnic bacterial prstatitis (cmplicated r uncmplicated) Prstatitis by E. cli Prstatitis, epididym-rchitis Prstatitis, infectin f the epididymis and the testicle severe prstatitis Bacterial prstatitis, epididymrchitis Pelvic inflammatry disease, in cmbinatin treatment Acute pelvic inflammatry disease Pelvic inflammatry disease, in cmbinatin treatment Pelvic regin infectin in wmen (in cmbinatin with ther antibitics) Inflammatry pelvic disease, in cmbinatins treatment Upper genital tract infectin in wmen (see 4.4) (cmplicated r uncmplicated) Upper gynaeclgical tract infectins, including infectins due t susceptible strains f Neisseria gnrrheae Pelvic inflammatry disease, in cmbinatin with ther antibacterial agents Sepsis due t abve-mentined genit-urinary infectins Ursepsis (nly applicable fr i.v. frmulatin) 169

7 Uncmplicated cystitis (last line) Uncmplicated cystitis Uncmplicated cystitis (shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the initial treatment f these infectins) Uncmplicated cystitis (XX shuld nly be used if antibacterial treatment cnsidered as first chice f treatment is deemed unfit/inapprpriate) Uncmplicated cystitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Urethritis (last line) Urethritis (shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the initial treatment f these infectins) Urethritis (XX shuld nly be used if antibacterial treatment cnsidered as first chice f treatment is deemed unfit/inapprpriate Urethritis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Bne and jint infectins (last line) Bne and jint infectins: such as stemyelitis r septic arthritis. (cmplicated r uncmplicated) Infectins f bnes (steitis, stemyelitis) Bne and jint infectins Gram negative infectin f bnes and jints Bne infectins (such as stemyelitis and rthpaedic material/implant infectin, especially when used in assciatin with ther antibitics like rifampicin Alternative frm f treatment fr bnes and jints infectins Bne and jint infectins In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. 170

8 Cmplicated skin and sft-tissue infectins Severe skin and sft-tissue infectins (last line) In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute bacterial sinusitis Acute sinusitis (last line) In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute exacerbatin f chrnic bstructive pulmnary disease including brnchitis Acute exacerbatin f chrnic brnchitis (last line) Cmmunity acquired pneumnia (last line) Cmmunity acquired pneumnia Cmmunity acquired pneumnia (flxacin shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the initial treatment f these infectins) Preventin f infectins due t flxacin susceptible pathgens (prphylaxis f infectins, in patients with a significant reductin in resistance t infectins (e.g., in neutrpenic states) In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmmunity acquired pneumnia In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Prphylaxis f bacterial infectin in neutrpenic patients Nn-gncccal urethritis and cervicitis Nn-gncccal urethritis and cervicitis Acute nn-gncccal urethritis and cervicitis caused by Chlamydia Nn-gncccal urethritis and cervicitis 171

9 trachmatis cmbinatin therapy fr the treatment f cervical infectins Gnrrhea Gnrrhea Gncccal and nn-gncccal urethritis and cervicitis (cmplicated r uncmplicated) Uncmplicated urethral and cervical gnrrhea. Uncmplicated acute gncccal urethritis and cervicitis Gncccal urethritis due t susceptible strains f Neisseria gnrrheae and nn-gncccal urethritis Gncccal urethritis and cervicitis due t susceptible Neisseria gnrrheae Chlamydia Tuberculsis Nn-gncccal urethritis and cervicitis Tuberculsis, in cmbinatin treatment Acute exacerbatin f chrnic sinusitis Chrnic sinusitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Superinfectin f chrnic titis (whatever its nature) and cavities after mastdectmy Bacterial gastrenteritis Bacterial gastrenteritis Bacterial enteritis Intestinal infectins bacterial diarrhea, which needs antibacterial treatment Abdminal and hepatbiliary infectin Abdminal and hepatbiliary infectin Chrnic suppurative titis media Infectins f the gastrintestinal tract (e.g. travellers diarrhea) In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmplicated intra-abdmnial infectins 172

10 intra-abdminal infectin intra-abdminal and bile-ducts infectins Infectins f abdminal cavity, including pelvic area Abdminal cavity infectins including f the pelvic bne Infectins f the abdmen and the lesser pelvis Chlangitis Pst-expsure prphylaxis and curative treatment f anthrax. Treatment f flxacin sensitive prphylaxis f bacterial infectins in patients with weakened resistance (fr example neutrpenic patients) Urinary tract infectins Urinary tract infectin Upper and lwer urinary tract infectins Upper and lwer urinary tract infectins, cmplicated r nt Infectins f the upper and lwer urinary tract Upper and lwer, acute and chrnic urinary tract infectins Cmplicated and uncmplicated urinary tract infectins (cystitis and pyelnephritis) Upper and lwer urinary tract infectins cming frm bacteria such as E. cli, K. pneumniae, Prteus, P. aeruginsa Lwer urinary tract infectins Acute and chrnic lwer urinary tract infectins Sinusitis Sinusitis Inhalatin anthrax: pst-expsure prphylaxis and curative treatment Treatment f bacterial infectins in neutrpenic patients Prphylaxis f bacterial infectins in neutrpenic patients Uncmplicated acute cystitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute pyelnephritis Cmplicated urinary tract infectins Uncmplicated acute cystitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmplicated urinary tract infectins Acute bacterial sinusitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the 173

11 treatment f these infectins. Respiratry infectins Acute, chrnic r recurrent respiratry tract infectins; superir acute titis media, titis externa, sinusitis, pharyngitis and laryngitis Acute, chrnic r recurrent respiratry tract infectins caused by Haemphilus influenzae r ther Gram-negative r multi-resistant pathgens, as well as by Staphylcccus aureus Respiratry tract infectins (with the exceptin, if infectin is f pneumcccal rigin r is suspected) Severe respiratry infectins caused by gram-negative bacilli and susceptible staphylccci Lwer respiratry tract infectins Pulmnary infectins Pulmnary infectins [such as: acute exacerbatin f chrnic brnchitis, exacerbatin f cystic fibrsis, nscmial pneumnia, pulmnary tuberculsis by resistant mycbacteria, especially in immuncmprmised patients (minr anti-tuberculsis medicine)] Pneumnia Pneumnia, especially when caused by s-called "prblematic" germs such as: E. cli, Klebsiella, Enterbacter, Prteus, Pseudmnas, Leginella r Staphylcccus Pneumnia, abve all if it s caused by bacteria such as Escherichia cli, Klebsiella, Enterbacter, Prteus, Pseudmnas, Leginella r Staphylcccus Chrnic bacterial sinusitis Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic brnchitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmmunity-acquired pneumnia In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic brnchitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Cmmunity-acquired pneumnia In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Pulmnary tuberculsis by resistant mycbacteria, especially in immuncmprmised patients (minr anti-tuberculsis medicine) Cmmunity-acquired pneumnia. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. 174

12 Brnchial suppuratins, in the absence f any parenchymal lesin In chrnic brnchitis during recurrent exacerbatins Brnchial suppuratins, in the absence f any parenchymal lesin: In subjects at risk (chrnic alchlism, smking, subjects ver 65 years) Ear, nse and thrat infectins Ear, nse and thrat infectins (with the exceptin f acute tnsillitis) Chrnic ear, nse and thrat infectins Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic brnchitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Acute bacterial sinusitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Chrnic bacterial sinusitis Acute titis media In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Chrnic suppurative titis media Severe chrnic ENT infectins caused by gram-negative bacilli and susceptible staphylccci Chrnic and recurrent infectins f the nse, thrat and ear, nly when caused by Gram-negative pathgens, including Pseudmnas, r by Staphylccci Chrnic and recurrent infectins f ears, nse and thrat, abve all if they are caused by gram-negative bacteria including Pseudmnas, r if they are caused by Staphylcccus Ear, nse and thrat (ENT) infectins (such as: chrnic sinusitis, superinfectin in chrnic titis, prphylaxis f infectins fllwing inner ear surgery) Chrnic and recurrent Chrnic bacterial sinusitis Chrnic suppurative titis media 175

13 trhinlarynglgical infectins Genital tract infectins Infectins f genital rgans Infectins f genitals Severe genital tract infectins caused by gram-negative bacilli and susceptible staphylccci Bacterial prstatitis, epididymrchitis including cases due t susceptible Neisseria gnrrheae Urethritis and cervicitis including cases due t susceptible Neisseria gnrrheae Gynaeclgical infectins Gynaeclgical infectins Skin and sft tissue infectins Urethritis and cervicitis including cases due t susceptible Neisseria gnrrheae Pelvic inflammatry disease including cases due t susceptible Neisseria gnrrheae Skin and sft tissue infectins Gram negative infectin f skin and sft tissue Skin and sft tissues infectins r infectins f traumas frm micrbes such as Ε. cli, K. pneumniae, Enterbacter, P. mirabilis and P. vulgaris, Prvidencia, Citrbacter, P. aeruginsa, S. aureus Cmplicated skin and sft tissue infectins In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther cmmnly recmmended fr the treatment f these infectins. Lmeflxacin Current indicatins in prduct infrmatin fr lmeflxacin cntaining prducts Recmmended wrding Acute prstatitis Acute bacterial prstatitis Acute pyelnephritis Uncmplicated acute pyelnephritis Uncmplicated acute pyelnephritis Simple uncmplicated cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate Urinary tract infectins t use cmmnly recmmended fr the treatment f these infectins Acute uncmplicated pyelnephritis Lwer respiratry tract infectins Acute exacerbatins f chrnic bstructive 176

14 Current indicatins in prduct infrmatin fr lmeflxacin cntaining prducts Recmmended wrding pulmnary disease including chrnic brnchitis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Nrflxacin Current indicatins included in prduct infrmatin fr nrflxacin cntaining prducts Recmmended wrding Acute urinary tract infectins in men acute urinary tract infectins in men acute infectin f lwer urinary tract infectins in men Acute urinary tract infectin in men Uncmplicated pyelnephritis uncmplicated pyelnephritis acute uncmplicated pyelnephritis in wmen Uncmplicated acute pyelnephritis Cmplicated cystitis chrnic cystitis in wmen Cmplicated acute cystitis Prstatitis prstatitis chrnic bacterial prstatitis Acute prstatitis caused by Escherichia cli Bacterial prstatitis Gnrrhea gnrrhea uncmplicated gnrrhea Gncccal urethritis, pharyngitis, prctitis r cervicitis frm Neisseria gnrrheae irrespective f the prductin f penicillinase. gncccal urethritis withut signs f pelvic disseminatin, in men cervical gnrrhea withut signs f pelvic Gncccal urethritis and cervicitis due t susceptible Neisseria gnrrheae 177

15 Current indicatins included in prduct infrmatin fr nrflxacin cntaining prducts Recmmended wrding disseminatin urethral and cervical gnrrhea Gnrrhea (urethritis and cervicitis) Gastrenteritis bacterial gastrenteritis Gastrenteritis Acute bacterial gastrenteritis bacterial enteritis Acute bacterial gastrenteritis after stl culture and labratry cnfirmatin f the susceptibility f the causative rganism t NOROCIN Infectins f the gastrintestinal tract (e.g. travellers diarrhea) Immuncmprmised patients: Infectins in neutrpenic patients (as prphylaxis). Cystitis Cystitis Acute and chrnic cystitis in wmen Prphylaxis f bacterial infectins in neutrpenic patients Uncmplicated acute cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Cmplicated acute cystitis Lwer urinary tract infectins Lwer urinary tract infectins Uncmplicated acute cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Urethritis including cases due t susceptible Neisseria gnrrheae 178

16 Current indicatins included in prduct infrmatin fr nrflxacin cntaining prducts Recmmended wrding Cmplicated acute cystitis Urinary tract infectins Urinary tract infectins Cmplicated and uncmplicated upper and lwer urinary tract infectins: cystitis, pyelitis, cystpyelitis Upper and lwer urinary tract infectins, including cystitis, pyelitis and cystpyelitis caused by nrflxacin susceptible bacteria Cmplicated and uncmplicated urinary tract infectins Acute urinary tract infectins in men Other lwer urinary tract infectins, including prstatic infectins, and upper urinary tract infectins with susceptible bacteria, in adults (i.e. ther than uncmplicated acute cystitis) Acute (except acute pyelnephritis) and chrnic (except chrnic cmplicated pyelnephritis) infectins f urinary tract caused by sensitive micrrganisms Acute and chrnic urinary tract infectins, uncmplicated (cystitis, pyelitis) and cmplicated, excluding cmplicated pyelnephritis, acute r chrnic Acute infectin f lwer urinary tract infectins in men Acute lwer urinary tract infectin in men Urinary tract and related infectins Cmplicated and uncmplicated, acute and chrnic, upper and lwer urinary tract infectins. These infectins include: cystitis, pyelitis, chrnic prstatitis and infectins related t urlgical surgical prcedures, neurgenic bladder r nephrlithiasis (except acute and chrnic cmplicated pyelnephritis) caused by bacteria sensitive t nrflxacin Upper and lwer, cmplicated and uncmplicated, acute and chrnic urinary tract infectins. These infectins include cystitis, pyelitis, chrnic prstatitis and thse urinary infectins assciated with urlgical surgery, neurgenic bladder r nephrlithiasis caused by bacteria susceptible t [name f prduct] Upper and lwer, cmplicated and uncmplicated, acute and chrnic urinary tract infectins. These infectins include cystitis, pyelitis, pyelcystitis, Uncmplicated acute cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Urethritis including cases due t susceptible Neisseria gnrrheae Cmplicated urinary tract infectins (except cmplicated pyelnephritis) Cmplicated acute cystitis Uncmplicated acute cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use ther antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Bacterial prstatitis Epididym-rchitis including cases due t susceptible Neisseria gnrrheae Urethritis including cases due t susceptible Neisseria gnrrheae Cmplicated urinary tract infectins (except cmplicated pyelnephritis) Cmplicated acute cystitis 179

17 Current indicatins included in prduct infrmatin fr nrflxacin cntaining prducts Recmmended wrding pyelnephritis, chrnic prstatitis, epididymitis and thse urinary tract infectins assciated with urlgical surgery, neurgenic bladder r nephrlithiasis caused by bacteria susceptible t [name f prduct] Medically incrrect indicatins Prphylaxis f systemic urinary tract infectins Preventin f systemic urinary tract infectins Periperative prphylaxis in invasive urlgical surgery Peflxacin Current indicatins included in prduct infrmatin fr peflxacin cntaining prducts Recmmended wrding Acute exacerbatin f chrnic bacterial sinusitis Chrnic sinusitis Gnrrhea Gncccal urethritis in humans Severe/Serius gastr-intestinal bacterial infectins Salmnella infectins (carrier) Germ carrying f salmnellsis In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins Gncccal urethritis and cervicitis due t susceptible Neisseria gnrrhea Serius gastr-intestinal bacterial infectins Salmnella infectins (carrier) Bne and jint infectins Bne and jint infectins (gram negative stemyelitis) Alternative frm f treatment fr bne and jint infectins Bne and jint infectins Infectins f bne and jints (stemyelitis caused by gram-negative micrrganisms) Respiratry tract infectins Respiratry infectins Respiratry infectin - severe Acute bacterial sinusitis. In [indicatin] [name f prduct] shuld 180

18 Current indicatins included in prduct infrmatin fr peflxacin cntaining prducts Recmmended wrding infectins caused by gramnegative bacilli and susceptible staphylccci Infectin f respiratry tract (acute exacerbatin f chrnic brnchitis, exacerbatin in cystic fibrsis, nscmial pneumnia) be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins Acute exacerbatin f chrnic bacterial sinusitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic brnchitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the treatment f these infectins. Pulmnary infectins Pulmnary infectins (acute exacerbatin f chrnic brnchitis, exacerbatin f cystic fibrsis, nscmial pneumnia) Ear, nse and thrat infectins Ear, nse and thrat infectins Ear, nse and thrat infectin - severe infectins caused by gramnegative bacilli and susceptible staphylccci Ear, nse and thrat (ENT) infectins (such as: chrnic sinusitis, external titis) Ear nse and thrat infectins (such as chrnic sinusitis, malignant titis externa) Urinary infectins Urinary tract infectins Urinary infectin - severe infectins caused by gramnegative bacilli and susceptible staphylccci Urinary tract infectins (including prstatitis) Infectins f urinary tract (inclusive f prstatitis) Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic brnchitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the treatment f these infectins. Acute bacterial sinusitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the treatment f these infectins. Acute exacerbatin f chrnic bacterial sinusitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins. Acute uncmplicated cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins 181

19 Current indicatins included in prduct infrmatin fr peflxacin cntaining prducts Urinary tract infectins (acute r recurrent cystitis, acute uncmplicated pyelnephritis) Genital tract infectins Genital infectins (chrnic prstatitis) Genital tract infectin - severe infectins caused by gramnegative bacilli and susceptible staphylccci Abdminal and hepat-biliary infectins Abdminal infectins Abdminal infectins - severe infectins caused by gramnegative bacilli and susceptible staphylccci Hepatbiliary infectins Hepatbiliary infectin - severe infectins caused by gramnegative bacilli and susceptible staphylccci Infectins f bile ducts Skin and sft tissue infectins Skin infectins Skin infectin - severe infectins caused by gram-negative bacilli and susceptible staphylccci Skin and sft tissue infectins by penicillin resistant Staphylcccus Infectins f skin and sft tissue caused by staphylcccus resistant t penicillin Recmmended wrding Gncccal urethritis and cervicitis including cases due t susceptible Neisseria gnrrheae Hepat-biliary infectins Cmplicated intra-abdminal infectins. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins Cmplicated skin and sft tissue infectins. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the treatment f these infectins Pruliflxacin Current indicatins included in prduct infrmatin fr pruliflxacin cntaining prducts Cmplicated infectins f lwer urinary tract Recmmended wrding Cmplicated urinary tract infectins Ruflxacin Current categry indicatins included in prduct infrmatin fr ruflxacin cntaining prducts Recmmended wrding Lwer respiratry tract infectins Acute exacerbatins f chrnic bstructive pulmnary disease including chrnic 182

20 Current categry indicatins included in prduct infrmatin fr ruflxacin cntaining prducts Recmmended wrding brnchitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use cmmnly recmmended fr the treatment f these infectins Urinary tract infectins Uncmplicated acute cystitis. In [indicatin] [name f prduct] shuld be used nly when it is cnsidered inapprpriate t use antibacterial agents that are cmmnly recmmended fr the treatment f these infectins 2. Sectin 4.4: special warnings and precautins fr use Fr quinlnes and flurquinlnes cntaining medicinal prducts, the existing prduct infrmatin shall be amended (insertin, replacement r deletin f the text as apprpriate) t reflect the agreed wrding as prvided belw (new text underlined and in bld, deleted text strike thrugh): The fllwing new warning shuld be included at the beginning f the warning statements n safety issues: The use f [INN] shuld be avided in patients wh have experienced serius adverse reactins in the past when using quinlne r flurquinlne cntaining prducts (see sectin 4.8). Treatment f these patients with [INN] shuld nly be initiated in the absence f alternative treatment ptins and after careful benefit/risk assessment (see als sectin 4.3). [ ] The fllwing warning shuld be included: Prlnged, disabling and ptentially irreversible serius adverse drug reactins Very rare cases f prlnged (cntinuing mnths r years), disabling and ptentially irreversible serius adverse drug reactins affecting different, smetimes multiple, bdy systems (musculskeletal, nervus, psychiatric and senses) have been reprted in patients receiving quinlnes and flurquinlnes irrespective f their age and pre-existing risk factrs. [INN] shuld be discntinued immediately at the first signs r symptms f any serius adverse reactin and patients shuld be advised t cntact their prescriber fr advice. The warning n tendinpathies / tendn disrders shuld be included/ amended as fllws: Tendinitis and tendn rupture 183

21 Tendinitis and tendn rupture (especially but nt limited t Achilles tendn), smetimes bilateral, may ccur as early as within 48 hurs f starting treatment with quinlnes and flurquinlnes and have been reprted t ccur even up t several mnths after discntinuatin f treatment. The risk f tendinitis and tendn rupture is increased in lder patients, patients with renal impairment, patients with slid rgan transplants, and thse treated cncurrently with crticsterids. Therefre, cncmitant use f crticsterids shuld be avided. At the first sign f tendinitis (e.g. painful swelling, inflammatin) the treatment with [INN] shuld be discntinued and alternative treatment shuld be cnsidered. The affected limb(s) shuld be apprpriately treated (e.g. immbilisatin). Crticsterids shuld nt be used if signs f tendinpathy ccur. Fr systemically administered levflxacin cntaining prducts the listing f risk factrs within the first abve mentined sentence shuld additinally include in patients receiving daily dses f 1000 mg levflxacin. The warning abut peripheral neurpathies shuld be included/amended as fllws: Peripheral neurpathy Cases f sensry r sensrimtr plyneurpathy resulting in paraesthesia, hypaesthesia, dysesthesia, r weakness have been reprted in patients receiving quinlnes and flurquinlnes. Patients under treatment with [INN] shuld be advised t infrm their dctr prir t cntinuing treatment if symptms f neurpathy such as pain, burning, tingling, numbness, r weakness develp in rder t prevent the develpment f ptentially irreversible cnditin. (see sectin 4.8) 3. Sectin 4.8: undesirable effects An asterisk shuld be added t the title f selected SOCs as fllws: Musculskeletal and cnnective tissue disrders* Nervus system disrders* General disrders and administrative site cnditins* Psychiatric disrders* Eye disrders* Ear and labyrinth disrders* *Very rare cases f prlnged (up t mnths r years), disabling and ptentially irreversible serius drug reactins affecting several, smetimes multiple, system rgan classes and senses (including reactins such as tendnitis, tendn rupture, arthralgia, pain in extremities, gait disturbance, neurpathies assciated with paraesthesia, depressin, fatigue, memry impairment, sleep disrders, and impairment f hearing, visin, taste and smell) have been reprted in assciatin with the use f quinlnes and flurquinlnes in sme cases irrespective f pre-existing risk factrs (see Sectin 4.4). 184

22 B. Package leaflet: Infrmatin fr the patient Fr quinlnes and flurquinlnes cntaining medicinal prducts, the existing package leaflet shall be amended (insertin, replacement r deletin f the text as apprpriate) t reflect the agreed wrding as prvided belw (new text underlined and in bld, deleted text strike thrugh): Sectin 2 Warnings and precautins The fllwing new warning shuld be included: Befre taking this medicine Yu shuld nt take flurquinlne/quinlne antibacterial medicines, including [prduct name], if yu have experienced any serius adverse reactin in the past when taking a quinlne r flurquinlne. In this situatin, yu shuld infrm yur dctr as sn as pssible. The current warning statement n tendinpathies/tendn disrders shuld be amended with regard t risk factrs, time t nset and need fr mnitring f patients and shuld include at least the fllwing infrmatin (r added as new statement if missing): When taking this medicine Pain and swelling in the jints and inflammatin r rupture f tendns may ccur rarely. Yur risk is increased if yu are elderly (abve 60 years f age), have received an rgan transplant, have kidney prblems r if yu are being treated with crticsterids. Inflammatin and ruptures f tendns may ccur within the first 48 hurs f treatment and even up t several mnths after stpping f <prduct name> therapy. At the first sign f pain r inflammatin f a tendn (fr example in yur ankle, wrist, elbw, shulder r knee), stp taking <prduct name>, cntact yur dctr and rest the painful area. Avid any unnecessary exercise as this might increase the risk f a tendn rupture. A new r current warning statement n peripheral neurpathies shuld include at least the fllwing infrmatin: Yu may rarely experience symptms f nerve damage (neurpathy) such as pain, burning, tingling, numbness and/r weakness especially in the feet and legs r hands and arms. If this happens, stp taking <prduct name> and infrm yur dctr immediately in rder t prevent the develpment f ptentially irreversible cnditin. 185

23 The fllwing new warning shuld be included: Prlnged, disabling and ptentially irreversible serius side effects Flurquinlne/quinlne antibacterial medicines, including [prduct name], have been assciated with very rare but serius side effects, sme f them being lng lasting (cntinuing mnths r years), disabling r ptentially irreversible. This includes tendn, muscle and jint pain f the upper and lwer limbs, difficulty in walking, abnrmal sensatins such as pins and needles, tingling, tickling, numbness r burning (paraesthesia), sensry disrders including impairment f visin, taste and smell, and hearing, depressin, memry impairment, severe fatigue, and severe sleep disrders. If yu experience any f these side effects after taking [Name f prduct], cntact yur dctr immediately prir t cntinuing treatment. Yu and yur dctr will decide n cntinuing the treatment cnsidering als an antibitic frm anther class. Sectin 4. Pssible side effects The fllwing new wrding shuld be included after listing f side effects: Very rare cases f lng lasting ( up t mnths r years) r permanent adverse drug reactins, such as tendn inflammatins, tendn rupture, jint pain, pain in the limbs, difficulty in walking, abnrmal sensatins such as pins and needles, tingling, tickling, burning, numbness r pain (neurpathy), depressin, fatigue, sleep disrders, memry impairment, as well as impairment f hearing, visin, and taste and smell have been assciated with administratin f quinlne and flurquinlne antibitics, in sme cases irrespective f pre-existing risk factrs. 186