natgillin/translations-raw huggingface dataset:
265 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Sočasna uporaba ciprofloksacina in varfarina lahko zveča antikoagulacijski učinek varfarina.
BLISTER
Klozapin
1.
31%.
NAME OF THE MEDICINAL PRODUCT
4. 6 Nosečnost in dojenje
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Nosečnost Podatki o uporabi ciprofloksacina pri nosečnicah, ki so na voljo, ne kažejo malformacij ali feto/ neonatalne toksičnosti.
NAME OF THE MARKETING AUTHORISATION HOLDER
Dojenje Ciprofloksacin se izloča v materino mleko.
[To be completed nationally]
257 4. 8 Neželeni učinki
{Name}
Organski
3.
Pogosti
EXPIRY DATE
Občasni
EXP
Redki
BATCH NUMBER
Neznana (ni mogoče
Lot
sistem
OTHER
≥ 1/ 100 do
266 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
≥ 1/ 10. 000 do <
OUTER CARTON
oceniti iz
1.
1/ 1. 000
NAME OF THE MEDICINAL PRODUCT
razpoložljivih podatkov)
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Infekcijske
2.
glivične
STATEMENT OF ACTIVE SUBSTANCE(S)
kolitis, ki nastane
[To be completed nationally]
in parazitske bolezni
3.
okužbe
LIST OF EXCIPIENTS
eozinofilija
[To be completed nationally]
hemolitična
PHARMACEUTICAL FORM AND CONTENTS
limfatičnega
[To be completed nationally]
agranulocitoza
5.
sistema
METHOD AND ROUTE(S) OF ADMINISTRATION
trombocitopenija trombocitemija
Oral use Read the package leaflet before use.
(smrtno nevarna) depresija kostnega mozga (smrtno nevarna)
6.
sistema
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
šok (smrtno nevaren) (glejte poglavje 4. 4) reakcija, podobna serumski bolezni
Keep out of the reach and sight of children.
Presnovne in prehranske motnje
7.
anoreksija
OTHER SPECIAL WARNING(S), IF NECESSARY
hiperglikemija
EXPIRY DATE
Psihiatrične
EXP
motnje
9.
na
[To be completed nationally]
dezorientiranost
10.
reakcije
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
hiperaktivnos t / agitacija
[See Annex I – To be completed nationally]
anksiozna reakcija nočne more depresija halucinacije
{Name and Address} < {tel} > < {fax} > < {e-mail} >
(glejte poglavje 4. 4)
12.
Bolezni
MARKETING AUTHORISATION NUMBER(S)
parestezija in
[To be completed nationally]
živčevja
13.
omotica
BATCH NUMBER
disestezija
Lot
motnje
14.
258
GENERAL CLASSIFICATION FOR SUPPLY
Organski
[To be completed nationally]
Občasni
15.
Redki
INSTRUCTIONS ON USE
Zelo redki < 1/ 10. 000
16.
sistem
INFORMATION IN BRAILLE
≥ 1/ 100 do
[To be completed nationally]
≥ 1/ 1. 000 do
268 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
≥ 1/ 10. 000 do <
BLISTER
< 1/ 100
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
koordinacije motnje ravnotežja motnje vohanja zvišan intrakranialni tlak
NAME OF THE MARKETING AUTHORISATION HOLDER
motnje vida zvonjenje v ušesih oglušitev/ motnje sluha
[To be completed nationally]
motnje zaznavanja barv
{Name}
tahikardija
EXPIRY DATE
vaskulitis
EXP
Bolezni
4.
slabost
BATCH NUMBER
pankreatitis
Lot
prebavil
OTHER
driska
269 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
bolečine v trebuhu dispepsija flatulenca
OUTER CARTON
Bolezni
1.
prehodno
NAME OF THE MEDICINAL PRODUCT
jetrna okvara
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
jetrna nekroza
2.
jeter,
STATEMENT OF ACTIVE SUBSTANCE(S)
holestatski
[To be completed nationally]
žolčnika in
3.
ikterus
LIST OF EXCIPIENTS
žolčevodov
[To be completed nationally]
transaminaz
4.
smrtno
PHARMACEUTICAL FORM AND CONTENTS
zvišanje vrednosti bilirubina
[To be completed nationally]
nevarno jetrno odpoved)
5.
Bolezni
METHOD AND ROUTE(S) OF ADMINISTRATION
izpuščaji
Oral use Read the package leaflet before use.
fotosenzitivne
6.
srbenje
Keep out of the reach and sight of children.
reakcije (glejte
7.
Erythema
OTHER SPECIAL WARNING(S), IF NECESSARY
multiforme minor Erythema nodosum
8.
259
EXPIRY DATE
Organski
EXP
Pogosti
9.
Redki
SPECIAL STORAGE CONDITIONS
Zelo redki < 1/ 10. 000
10.
≥ 1/ 10. 000 do <
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 270 11.
1/ 1. 000
[See Annex I – To be completed nationally]
Stevens - Johnsonov sindrom (lahko smrtno nevaren) toksična epidermalna nekroliza (lahko smrtno nevarna)
{Name and Address} < {tel} > < {fax} > < {e-mail} >
razpoložljivih podatkov)
MARKETING AUTHORISATION NUMBER(S)
mišično -
[To be completed nationally]
mialgija
13.
mišična
BATCH NUMBER
mišično -
Lot
skeletne
14.
artritis
GENERAL CLASSIFICATION FOR SUPPLY
oslabelost
[To be completed nationally]
skeletnega
15.
bolečine
INSTRUCTIONS ON USE
zvečanje
[To be completed nationally]
tendinitis
16.
(npr.
INFORMATION IN BRAILLE
mišičnega tonusa
[To be completed nationally]
raztrganine
271 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
bolečine v
BLISTER
in krči
1.
tkiva
NAME OF THE MEDICINAL PRODUCT
hrbtu, prsnem košu) artralgija
Ciprofloxacin Bayer and associated names (see Annex I) 750 mg film-coated tablets [See Annex I - To be completed nationally] Ciprofloxacin
Ahilove tetive) (glejte poglavje 4. 4) poslabšanje miastenije gravis (glejte poglavje 4. 4)
2.
okvara
NAME OF THE MARKETING AUTHORISATION HOLDER
hematurija kristalurija (glejte poglavje 4. 4) tubulointersticijs ki nefritis
[To be completed nationally]
Splošne
{Name}
astenija
3.
edem
EXPIRY DATE
težave in
EXP
zvišana
4.
hidroza)
BATCH NUMBER
Preiskave
Lot
zvišanje
OTHER
nenormalne
272 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
vrednosti protrombina zvišanje vrednosti amilaze
OUTER CARTON
pogosti občasni
1.
redki
NAME OF THE MEDICINAL PRODUCT
4. 9 Preveliko odmerjanje
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
Bolniki morajo biti primerno hidrirani.
STATEMENT OF ACTIVE SUBSTANCE(S)
FARMAKOLOŠKE LASTNOSTI
[To be completed nationally]
5. 1 Farmakodinamične lastnosti
3.
J01MA02
LIST OF EXCIPIENTS
Mehanizem delovanja
[To be completed nationally]
Mehanizen odpornosti
PHARMACEUTICAL FORM AND CONTENTS
Spekter protibakterijske učinkovitosti
[To be completed nationally]
mikroorganizmi
5.
odporna
METHOD AND ROUTE(S) OF ADMINISTRATION
R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 1 mg/ l R > 0, 5 mg/ l R > 0, 06 mg/ l R > 0, 06 mg/ l R > 1 mg/ l
Oral use Shake before use applying slight pressure to the wall.
262 aerobni, po Gramu negativni mikroorganizmi Aeromonas spp.
Then tear the sachet open as indicated and take the contents directly.
Moraxella catarrhalis * Neisseria meningitidis Pasturella spp.
Read the package leaflet before use.
Salmonella spp. * Shigella spp. * Vibrio spp.
6.
(2):
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Meticilin- odporni S. aureus zelo pogosto izraža koodpornost na flurokinolone.
Keep out of the reach and sight of children.
5. 2 Farmakokinetične lastnosti
7.
Presnova
OTHER SPECIAL WARNING(S), IF NECESSARY
izločanje ciprofloksacina (% odmerka)
EXPIRY DATE
intravenska uporaba
EXP
seč
9.
blato
SPECIAL STORAGE CONDITIONS
ciprofloksacin presnovki (M1 – M4)
273 10.
15, 2 2, 6
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Hude okvare ledvic zvečajo razpolovni čas ciprofloksacina do 12 ur.
11.
Otroci
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Podatki o farmakokinetiki pri otrocih, so zelo omejeni.
[See Annex I – To be completed nationally]
Vrednosti AUC so bile 17, 4 mg* h/ l (med 11, 8 in 32, 0 mg * / l) oz.
{Name and Address} < {tel} > < {fax} > < {e-mail} >
5. 3 Predklinični podatki o varnosti
MARKETING AUTHORISATION NUMBER(S)
Učinek lahko primerjamo z učinkom drugih zaviralcev giraze.
[To be completed nationally]
Vplivi zdravila na sklepe:
BATCH NUMBER
FARMACEVTSKI PODATKI
Lot
6. 1 Seznam pomožnih snovi
GENERAL CLASSIFICATION FOR SUPPLY
[Izpolni država članica]
INSTRUCTIONS ON USE
6. 3 Rok uporabnosti
INFORMATION IN BRAILLE
6. 4 Posebna navodila za shranjevanje
274 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
6. 5 Vrsta ovojnine in vsebina
SINGLE DOSE SACHETS 250 MG
[Izpolni država članica]
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Ciprofloxacin Bayer and associated names (see Annex I) 250 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
Njegovo predrtje bližje roba lahko poškoduje zamašek.
METHOD OF ADMINISTRATION
IMETNIK DOVOLJENJA ZA PROMET
Shake before use applying slight pressure to the wall.
[Glejte Dodatek I – Izpolni država članica]
Then tear the sachet open as indicated and take the contents directly.
{Ime in naslov} < {tel} > < {fax} > < {e- mail} >
EXPIRY DATE
[Izpolni država članica]
BATCH NUMBER
[Izpolni država članica]
Lot
10.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
266 {MM/ LLLL}
OTHER
267 OZNAČEVANJE
275 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
268 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Shake before use applying slight pressure to the wall.
peroralna uporaba Pred uporabo preberite priloženo navodilo.
276 10.
269 10.
{Name and Address} < {tel} > < {fax} > < {e-mail} >
{Ime in naslov} < {tel} > < {fax} > < {e- mail} >
277 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
270 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
SINGLE DOSE SACHETS 500 MG
PRETISNI OMOT
Ciprofloxacin Bayer and associated names (see Annex I) 500 mg oral suspension in single-dose sachets [See Annex I - To be completed nationally] Ciprofloxacin Oral use
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Shake before use applying slight pressure to the wall.
[Izpolni država članica]
Then tear the sachet open as indicated and take the contents directly.
{Ime}
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
DRUGI PODATKI
[To be completed nationally]
271 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 250 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Only after reconstitution Shake well before use.
peroralna uporaba Pred uporabo preberite priloženo navodilo.
279 [To be completed nationally]
[Izpolni država članica]
280 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
GLASS BOTTLE 50 mg/mL
ŠTEVILKA SERIJE
NAME OF THE MEDICINAL PRODUCT
274 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 500 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Only after reconstitution Read the package leaflet before use.
peroralna uporaba Pred uporabo preberite priloženo navodilo.
281 10.
275 10.
282 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
HDPE BOTTLE 50 mg/mL
ŠTEVILKA SERIJE
NAME OF THE MEDICINAL PRODUCT
277 PODATKI NA ZUNANJI OVOJNINI
Ciprofloxacin Bayer and associated names (see Annex I) 50 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 750 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
283 10.
278 10.
[To be completed nationally]
[Glejte Dodatek I – Izpolni država članica]
284 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
279 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
OUTER CARTON 100 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 750 mg filmsko obložene tablete [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
NAME OF THE MEDICINAL PRODUCT
[Izpolni država članica]
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules and solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 250 mg peroralna suspenzija, vrečice za enkratno uporabo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Only after reconstitution Shake well before use.
Vrečico odprite kot je označeno in zaužijte vsebino.
285 [To be completed nationally]
[Izpolni država članica]
INFORMATION IN BRAILLE
IME ZDRAVILA IN POT( I) UPORABE
[To be completed nationally]
POSTOPEK UPORABE
286 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Vrečico odprite kot je označeno in zaužijte vsebino.
GLASS BOTTLE 100 mg/mL
ŠTEVILKA SERIJE
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL granules for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 500 mg peroralna suspenzija, vrečice za enkratno uporabo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Only after reconstitution.
Vrečico odprite kot je označeno in zaužijte vsebino.
287 10.
284 10.
288 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Vrečico odprite kot je označeno in zaužijte vsebino.
HDPE BOTTLE 100 mg/mL
ŠTEVILKA SERIJE
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg/mL solvent for oral suspension [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 50 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Oral use Only after reconstitution Read the package leaflet before use.
peroralna uporaba uporaba samo po rekonstituciji Pred uporabo močno pretresite.
[To be completed nationally]
287 [Izpolni država članica]
289 10.
10.
290 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
288 PODATKI NA PRIMARNI OVOJNINI
OUTER CARTON (containing wraps with bags of 100 mL solution for infusion)
STEKLENICA 50 mg/ ml
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 50 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
For intravenous use Read the package leaflet before use.
peroralna uporaba uporaba samo po rekonstituciji Pred uporabo preberite priloženo navodilo.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 291 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
292 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
290 PODATKI NA PRIMARNI OVOJNINI
OUTER WRAP (containing 1 infusion bag of 200 mg / 100 mL solution for infusion)
1.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 293 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
294 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
292 PODATKI NA ZUNANJI OVOJNINI
FLEXIBLE PO/PVC BAG (200 mg / 100 mL solution for infusion)
ŠKATLA 100 mg/ ml peroralna suspenzija (vsebuje steklenico( e) z zrnci in steklenico( e) z vehiklom)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg / 100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
For intravenous use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
[To be completed nationally]
293 [Izpolni država članica]
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 295 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
296 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
294 PODATKI NA PRIMARNI OVOJNINI
OUTER CARTON (containing wraps with bags of 200 mL solution for infusion)
STEKLENICA 100 mg/ ml
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ ml zrnca in vehikel za peroralno suspenzijo [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 297 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
298 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
296 PODATKI NA PRIMARNI OVOJNINI
OUTER WRAP (containing 1 infusion bag of 400 mg / 200 mL solution for infusion)
1.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 299 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
300 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
298 PODATKI NA ZUNANJI OVOJNINI
FLEXIBLE PO/PVC BAG (400 mg / 200 mL solution for infusion)
ŠKATLA (vsebuje omote z vrečami s 100 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg / 200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 200 mg/ 100 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
For intravenous use Read the package leaflet before use.
intravenska uporaba Pred uporabo preberite priloženo navodilo.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 301 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
302 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
300 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (containing 5 boxes with bottles of 50 mL solution for infusion)
ZUNANJI OMOT (vsebuje 1 vrečo s 100 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 200 mg/ 100 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
10.
301 10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 303 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
304 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PO/ PVC VREČE (200 mg/ 100 ml raztopine za infundiranje)
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 305 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
306 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
304 PODATKI NA ZUNANJI OVOJNINI
COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER
ŠKATLA (vsebuje omote z vrečami z 200 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 100 mg / 50 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 400 mg/ 200 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
Read the package leaflet before use.
intravenska uporaba Pred uporabo preberite priloženo navodilo.
307 10.
305 10.
308 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
306 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (containing 5 or 40 boxes with bottles of 100 mL solution for infusion)
ZUNANJI OMOT (vsebuje 1 vrečo z 200 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 400 mg/ 200 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 309 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
310 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PO/ PVC VREČE (400 mg/ 200 ml raztopine za infundiranje)
OUTER CARTON (containing 1 bottle of 200 mg / 100 mL solution for infusion)
1.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 311 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
312 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
310 PODATKI NA ZUNANJI OVOJNINI
COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER
ŠKATLA (vsebuje 5 škatel s steklenico s 50 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 200 mg/100 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ 50 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
313 10.
311 10.
314 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
312 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON (containing 5 boxes with bottles of 200 mL solution for infusion)
ŠKATLA (vsebuje 1 steklenico s 100 mg/ 50 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 100 mg/ 50 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 315 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
316 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
314 PODATKI NA PRIMARNI OVOJNINI
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 317 11.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
318 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
316 PODATKI NA ZUNANJI OVOJNINI
COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER.
ŠKATLA (vsebuje 5 škatel s steklenico s 100 ml raztopine za infundiranje)
Ciprofloxacin Bayer and associated names (see Annex I) 400 mg/200 mL solution for infusion [See Annex I - To be completed nationally] Ciprofloxacin
Ciprofloksacin Bayer in povezana imena (Glejte Dodatek I) 200 mg/ 100 ml raztopina za infundiranje [Glejte Dodatek I – Izpolni država članica] ciprofloksacin