Tarivid IV 2 mg/ml Solution for Infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ofloxacin

Dostopno od:

Sanofi-Aventis Ireland Limited T/A SANOFI

Koda artikla:

J01MA; J01MA01

INN (mednarodno ime):

Ofloxacin

Odmerek:

2 milligram(s)/millilitre

Farmacevtska oblika:

Solution for infusion

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Fluoroquinolones; ofloxacin

Status dovoljenje:

Marketed

Datum dovoljenje:

1989-08-21

Navodilo za uporabo

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TARIVID IV 2 MG/ML
SOLUTION FOR INFUSION
_ofloxacin (as hydrochloride) _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Tarivid is and what it is used for
2. Before you have Tarivid
3. How Tarivid is given
4. Possible side effects
5. How to store Tarivid
6. Further information
1. WHAT TARIVID IS AND WHAT IT IS USED FOR
The name of your medicine is Tarivid IV 2 mg/ml Solution for Infusion
(called Tarivid throughout this
leaflet). Tarivid infusion contains a medicine called ofloxacin. This
belongs to a group of medicines
called antibiotics. It works by killing bacteria that cause
infections.
TARIVID IS INDICATED IN ADULTS FOR THE TREATMENT OF THE FOLLOWING
BACTERIAL INFECTIONS:
• urinary tract infections (kidney infection)
• genital tract infections in men and women including cases where
these infections spreads into
blood stream
• Chest or lungs
• Skin and soft tissue. Soft tissue is underneath the skin and
includes muscle
2. BEFORE YOU HAVE TARIVID
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to ofloxacin or any of the other
ingredients of Tarivid (listed in
Section 6 below)
• Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips,
face, throat or tongue
• You have ever had swelling of the tendons (called tendinitis)
which can affect areas such as the
wrist or the achilles tendon
• You have epilepsy or are at risk of fits
• You have a problem with your r

Lastnosti izdelka

Health Products Regulatory Authority
13 January 2020
CRN008ZRJ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tarivid IV 2 mg/ml Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 100ml contains 220mg Ofloxacin Hydrochloride equivalent
to 200mg Ofloxacin. (2mg/ml Ofloxacin).
Excipients: Contains 354mg of Sodium
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
A colourless, Type I, Ph. Eur., glass vial, sealed with a chlorobutyl
stopper, containing a clear greenish yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent.
Tarivid solution for infusion 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
The treatment of acute and chronic infections of respiratory tract due
to Gram-positive and Gram-negative micro organisms
sensitive to ofloxacin.
Skin and soft tissue infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of ofloxacin is determined by the type and severity of the
infection.
The usual recommended dosages of Tarivid IV in adults are:
Respiratory tract infection: 200mg twice daily.
Skin and soft tissue infections: 400mg twice a day.
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
200 mg twice daily (can be increased to 400 mg
twice daily)
7-10 days (can be extended to 14 days)
Acute prostatitis
200 mg twice daily (can be increased to 400 mg
twice daily)
2- 4 weeks *
Health Products Regulatory Authority