Timentin 3.2g powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium clavulanate; Ticarcillin sodium

Available from:

Laboratoires Delbert

ATC code:

J01CR03

INN (International Name):

Potassium clavulanate; Ticarcillin sodium

Dosage:

200mg ; 3gram

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010104; GTIN: 5010004031981

Patient Information leaflet

[GlaxoSmithKline Logo]
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIMENTIN
® 3.2 G
TICARCILLIN AND CLAVULANIC ACID
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1
What Timentin is and what it is used for
2
What you need to know before you have Timentin
3
How Timentin is given
4
Possible side effects
5
How to store Timentin
6
Contents of the pack and other information
1 WHAT TIMENTIN IS AND WHAT IT IS USED FOR
WHAT TIMENTIN IS
Timentin 3.2 g (called ‘Timentin’ in this leaflet) is a penicillin
antibiotic for
intravenous (IV) infusion. It contains two different medicines,
ticarcillin
(present as ticarcillin sodium) and clavulanic acid (present as
potassium
clavulanate).
WHAT TIMENTIN IS USED FOR
Timentin is used to treat infections in different parts of the body
caused by
bacteria. Your doctor should test the type of bacteria causing your
infection
and monitor whether the bacteria are sensitive to Timentin during your
treatment.
2 WHAT YOU NEED TO KNOW BEFORE YOU HAVE TIMENTIN
Do not have Timentin if you:

are allergic to ticarcillin, ticarcillin sodium, clavulanic acid,
potassium
clavulanate, penicillin or cephalosporin

have ever had an allergic (hypersensitive) reaction to any antibiotic.
This
can include a skin rash or swelling of the face or neck

have kidney or liver problems

are on a restricted salt diet
- 2 -
Do not have Timentin if any of the above apply. If you are not sure,
talk to
your doctor, pharmacist or nurse before having Timentin.
LOOK OUT FOR

Summary of Product characteristics

TIMENTIN 0.8 G, 1.6 G, 3.2 G
Summary of Product Characteristics Updated 03-Apr-2014 |
GlaxoSmithKline UK
1. Name of the medicinal product
Timentin® 0.8 G, 1.6 G, 3.2 G
2. Qualitative and quantitative composition
_Timentin 0.8 g: _Contains 50 mg clavulanic acid with 750 mg
ticarcillin.
_Timentin 1.6 g: _Contains 100 mg clavulanic acid with 1.5 g
ticarcillin.
_Timentin 3.2 g: _Contains 200 mg clavulanic acid with 3.0 g
ticarcillin.
The clavulanic acid is present as Potassium Clavulanate BP and the
ticarcillin as ticarcillin sodium.
3. Pharmaceutical form
Powder for solution for infusion.
Vials containing sterile powder for reconstitution.
4. Clinical particulars
4.1 Therapeutic indications
Timentin is indicated for the treatment of infections in which
susceptible organisms have been detected or
are suspected.
Severe infections in hospitalised patients and proven or suspected
infections in patients with impaired or
suppressed host defences including: septicaemia, bacteraemia,
peritonitis, intra-abdominal sepsis, post-
surgical infections, bone and joint infections, skin and soft tissue
infections, respiratory tract infections,
serious or complicated renal infections (e.g. pyelonephritis), ear,
nose and throat infections.
A comprehensive list of sensitive and resistant organisms is provided
in Section 5.1. Consideration should
be given to official guidance regarding bacterial resistance and the
appropriate use of antibacterial agents.
4.2 Posology and method of administration
The dosing below is based on the ticarcillin content.
_Adult dosage _(including elderly patients)_:_
The usual dosage is 3.2 g Timentin given six to eight hourly. The
maximum recommended dosage is 3.2 g
four hourly.
_Children's dosage _(including infants, neonates and premature infants
>2 kg in weight):
The usual dosage for children is 80 mg Timentin/kg body weight given
every eight hours. The maximum
dosage for children is 80 mg Timentin/kg body weight given every six
hours. This should not exceed the
maximum recommended adult dosage.
For prem