Tarivid 200mg/100ml solution for infusion bottles

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Ofloxacin hydrochloride

Dostupno od:

Sanofi

ATC koda:

J01MA01

INN (International ime):

Ofloxacin hydrochloride

Doziranje:

2mg/1ml

Farmaceutski oblik:

Solution for infusion

Administracija rute:

Intravenous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05011200; GTIN: 5013487182645

Uputa o lijeku

536465
536465
05SAP-NR. (DMC): 536465
SCHRIFTGRÖSSE: 8,5 PUNKT
DRUCKFARBEN: PANTONE REFLEX BLUE
FORMAT 420 X 148 MM
ERSTELLT AM: 7. SEPTEMBER 2017 / VERSION: 7 / MAC
536465
PACKAGE LEAFLET:
INFORMATION FOR THE USER
TARIVID® 2MG/ML
SOLUTION FOR
INFUSION
ofloxacin
It is possible that Tarivid may trigger an attack of
porphyria (a rare illness which affects the
metabolism) in some patients.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE TARIVID
This medicine will be kept by your doctor or
pharmacist in a safe place where children cannot
see or reach it.
Store in the original carton in order to protect
from light.
Do not use Tarivid after the expiry date, which is
stated on the label. The expiry refers to the last
day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT TARIVID CONTAINS
•
Each 1ml contains 2mg of the active substance,
ofloxacin
•
The other ingredients are sodium chloride,
hydrochloric acid and water for injections
WHAT TARIVID LOOKS LIKE AND CONTENTS OF THE
PACK
Tarivid® is a clear greenish-yellow solution in glass
vials with grey chlorobutyl rubber closures and
aluminium caps containing either 50ml, 100ml or
200ml. Not all pack size may be marketed.
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1
4YS, UK
Tel: [phone]
email: [e-mail]
Manufacturer
Sanofi-Aventis Deutschland GmbH
Bruningstrasse 50, D-65926 Frankfurt am Main,
Germany
This leaflet does no

Svojstava lijeka

OBJECT 1
TARIVID IV INFUSION SOLUTION
Summary of Product Characteristics Updated 28-Nov-2017 | SANOFI
1. Name of the medicinal product
Tarivid
TM
IV Infusion Solution.
2. Qualitative and quantitative composition
Ofloxacin, 2 mg/ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Infusion.
4. Clinical particulars
4.1 Therapeutic indications
Ofloxacin is indicated in adults for the treatment of the following
bacterial infections (see sections 4.4 and
5.1):
- Pyelonephritis and complicated urinary tract infections
- Prostatitis, epididymo-orchitis
- Pelvic inflammatory disease, in combination treatment
- Sepsis due to above-mentioned genito-urinary infections
For the below-mentioned infections ofloxacin should be used only when
it is considered inappropriate to
use antibacterial agents that are commonly recommended for the initial
treatment of these infections:
- Complicated skin and soft-tissue infections
- Acute exacerbation of chronic bronchitis
- Community acquired pneumonia
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
General dosage recommendations: The dose of ofloxacin is determined by
the type and severity of the
infection. A daily dose of up to 400 mg ofloxacin may be given as a
single dose. In this case, it is
preferable to administer ofloxacin in the morning.
Daily doses of more than 400 mg must be divided into two separate
doses and be given at approximately
equal intervals
_Adults: _The usual intravenous dosages in adults are:
Acute exacerbation of chronic bronchitis, community acquired
pneumonia: 200 mg twice daily.
Complicated skin and soft tissue infections: 400 mg twice daily.
The dose may be increased to 400 mg twice daily in severe or
complicated infections.
_INDICATION_
_DAILY DOSE REGIMEN_
_(according to severity)_
_DURATION OF TREATMENT_
_(according to severity)_
Complicated UTI
200 mg twice daily (can be increased
to 400 mg twice daily)
7-21 days
Pyelonephritis
20