Ipca-Ciprofloxacin

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Ciprofloxacin hydrochloride 582mg equivalent ciprofloxacin 500 mg;  

Dostupné s:

Ipca Pharma (NZ) Pty Limited

INN (Mezinárodní Name):

Ciprofloxacin hydrochloride 582 mg (equivalent ciprofloxacin 500 mg)

Dávkování:

500 mg

Léková forma:

Film coated tablet

Složení:

Active: Ciprofloxacin hydrochloride 582mg equivalent ciprofloxacin 500 mg   Excipient: Colloidal silicon dioxide Hypromellose Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide

Jednotky v balení:

Blister pack, PVC/Al (not marketed), 7 tablets

Třída:

Prescription

Druh předpisu:

Prescription

Výrobce:

Dr Reddy's Laboratories Limited

Terapeutické indikace:

For complicated urinary tract infections or pyelonephritis due to E.coli in paediatric patients aged 1-17 years. The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate. Treatment should only be initiated after careful benefit/risk evaluation, due to possible adverse events related to joints/surrounding tissues. The use of ciprofloxacin for other indications is not recommended in children.

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 7 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizace:

2004-07-15

Charakteristika produktu

NEW ZEALAND DATA SHEET
IPCA-CIPROFLOXACIN
Page 1 of 19
1.
PRODUCT NAME
Ipca-Ciprofloxacin 250 mg, 500mg, 750 mg, film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablets
Ciprofloxacin 250:
1 tablet contains ciprofloxacin hydrochloride equivalent to 250 mg
ciprofloxacin.
Ciprofloxacin 500:
1 tablet contains ciprofloxacin hydrochloride equivalent to 500 mg
ciprofloxacin.
Ciprofloxacin 750:
1 tablet contains ciprofloxacin hydrochloride equivalent to 750 mg
ciprofloxacin.
3.
PHARMACEUTICAL FORM
Film-coated tablet:
250 mg:
White to creamish-white, round, biconvex film coated tablets with CPR
250 embossed on one side
and ‘BL’ on the other.
500 mg:
White to creamish-white caplet shaped film coated tablets with CPR 500
embossed and with
scoreline on one side and ‘BL’ on the other.
750 mg:
White to creamish-white capsule shaped film coated tablets with CPR
750 embossed on one side
and ‘BL’ on the other.
Do not halve the tablet. Dose equivalence when the tablet is divided
has not been established.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
Uncomplicated and complicated infections caused by ciprofloxacin
sensitive pathogens:
Infections of the lower respiratory tract.
In the treatment of outpatients with pneumonia due to Pneumococcus,
ciprofloxacin should not be
used as a medicine of first choice. Ciprofloxacin can be regarded as a
suitable treatment for
pneumonias caused by _Klebsiella_, _Enterobacter_, _Proteus_, _E.coli,
Pseudomonas, Haemophilus,_
_ _
_Branhamella, Legionella, and Staphylococcus_.
Infections of the kidneys and/or the efferent urinary tract.
Infections of the genital organs, including adnexitis, gonorrhoea,
prostatitis.
NEW ZEALAND DATA SHEET
IPCA-CIPROFLOXACIN
Page 2 of 19
Infections of the abdominal cavity (e.g. infections of the
gastrointestinal tract or of the biliary tract,
peritonitis).
Infections of the skin and soft tissue.
Infections of the bones and joints.
Sepsis.
Inhalational anthrax (post-exposure): To reduce the incidence or
progression