TIMENTIN 0.8G 1.6G 3.2G

Active substance: TICARCILLIN

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K169202/02169202

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Other medicines and Timentin
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.

Package Leaflet:
Information for Healthcare Professionals

K169202
GSK-ContractMfg-Eur-Ita-Italy-Biopharma
United Kingdom-GBR
Timentin
1

Package Leaflet:
Information for the Patient

Timentin® 3.2 g

Timentin® 3.2 g

ticarcillin and clavulanic acid

ticarcillin and clavulanic acid

Dosage and Administration Information Only
Please refer to the Summary of Product
Characteristics for further information
Presentation
Powder for solution for infusion.
Timentin 3.2 g: Vials of sterile powder providing
3.0 g ticarcillin with 200 mg clavulanic acid. The
clavulanic acid is present as potassium clavulanate
BP and the ticarcillin as ticarcillin sodium.
Contraindications
Timentin contains ticarcillin, which is a penicillin, and should
not be given to patients with a history of hypersensitivity to
beta-lactam antibiotics (e.g. penicillins and cephalosporins).

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Posology and method of administration
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 be more than the maximum
recommended dose for adults.
For premature infants <2 kg in weight, the dosage is 80 mg
Timentin/kg body weight every 12 hours.
Renal impairment - Adults and children over 40 kg
An initial loading dose of 3 g should be followed by doses based
on creatinine clearance rate and type of dialysis as indicated below:
- Creatinine clearance greater than 60 ml/minute: 3 g every
4 hours OR every 6 hours
- Creatinine clearance 30 to 60 ml/minute: 2 g every 4 hours
OR 3g every 8 hours
- Creatinine clearance 10 to 30 ml/minute: 2 g every 8 hours
OR 3 g every 12 hours
- Creatinine clearance less than 10 ml/minute: 1 g i.m. every
6 hours OR 2 g every 12 hours OR 3 g every 24 hours
- Creatinine clearance less than 10 ml/minute (with hepatic
dysfunction): 1 g i.m. every 12 hours OR 2 g every 24 hours
- Patients on peritoneal dialysis: as for creatinine clearance less
than 10 ml/minute
- Patients on haemodialysis: as for creatinine clearance less
than 10 ml/minute supplemented with 3 g after each dialysis.
Renal impairment - Children under 40 kg
Similar dosage adjustment as for adults, e.g. an initial loading
dose of 75 mg/kg should be followed by doses based on
creatinine clearance and type of dialysis as indicated below:
- Greater than 30 ml/minute:
75 mg/kg every 8 hours
- 10 to 30 ml/minute:
37.5 mg/kg every 8 hours
- Less than 10 ml/minute:
37.5 mg/kg every 12 hours
NOTE: Each gram of Timentin contains approximately 11.9 mg
of potassium and 100 mg of sodium.
Preparation and administration
Administration
Timentin is for administration by intermittent IV infusion.
Timentin should be infused preferably in Water for Injections BP
or Glucose Intravenous Infusion BP (5% or less).

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.
• f you have any further questions, ask your doctor, nurse or
I
pharmacist.
• his medicine has been prescribed for you only. Do not
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pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• f you get any side effects, talk to your doctor, nurse or
I
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:
• re allergic to ticarcillin, ticarcillin sodium, clavulanic acid,
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potassium clavulanate, penicillin or cephalosporin
• ave ever had an allergic (hypersensitive) reaction to any
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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
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 important symptoms
Timentin can make some existing conditions worse, or cause
serious side effects, such as allergic reactions, bleeding and
severe diarrhoea (pseudomembranous colitis). You must look
out for certain symptoms while you are receiving Timentin, to
help reduce the risk of any problems. See section 4.
You may need regular tests
If you take Timentin for a long time, your doctor may
arrange for you to have extra tests. These are to check your
blood and to make sure your kidneys and liver are working
properly.
Blood tests
If you are having any blood tests, let the doctor or nurse know
that you are on Timentin. This is because Timentin can affect
the results of these tests.

develop if Timentin is used for a long time. If this occurs and
you have been taking Timentin for longer than recommended,
tell your doctor.

Timentin should not be taken without first discussing this with
your doctor if you are also taking:
• minoglycoside-type antibiotics such as neomycin or
a
gentamycin
• probenecid, a medicine for gout
• methotrexate, to treat cancer or rheumatic diseases.
Timentin may stop the contraceptive pill working. You will need
to use extra contraceptive precautions, such as using a condom.
If you need any advice, talk to your doctor or pharmacist.

If you have too much Timentin
It is unlikely you will be given too much, but if you think
you have been given too much Timentin, tell your doctor,
pharmacist or nurse immediately. Signs might include feeling
sick or being sick, diarrhoea or fits.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine if you think you might be pregnant, if you are
pregnant or if you are breast-feeding.
Important information about some of the ingredients of
Timentin
• imentin 3.2 g contains 320 mg of sodium per vial.
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This should be considered if you are on a controlled sodium
diet.
• Timentin 3.2 g contains 39 mg of potassium per vial.
This should be considered if you have kidney problems or are
on a controlled potassium diet.

3 How Timentin is given
You will never give yourself this medicine. A qualified person,
like a doctor or a nurse, will give you this medicine.
• he correct dose of Timentin will be decided by your doctor
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and depends on the type of infection, whether you are on
any other antibiotics and your weight and age.
• imentin will be given by a doctor or nurse into a vein by
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intravenous (IV) infusion. Timentin is made up by adding the
following amount of Water for Injections or other suitable
infusion fluid.
Vial size
3.2 g

Intravenous infusion Intravenous infusion
(+Water for Injections) (+Glucose IV infusion)
100 ml
100 to 150 ml

Further detailed instructions for the doctor or nurse are given in
the section for the Healthcare Professional.
• Each dose will be infused over a period of 30 to 40 minutes.
The usual doses are as follows.
Adults and elderly patients
3.2 g of Timentin given every 6 to 8 hours by IV infusion.
If you have a severe infection you may be prescribed 3.2 g every
4 hours.
Children (including premature babies weighing more than 2
kilograms)
80 mg of Timentin per kilogram of the childs body weight given
every 8 hours by IV infusion.
The maximum dose for children is 80 mg Timentin per kilogram
of the child’s body weight given every 6 hours. This should not
be more than the maximum recommended dose for adults.
Premature babies weighing less than 2 kilograms
80 mg of Timentin per kilogram of the childs body weight given
every 12 hours by IV infusion.
Adults, elderly patients or children and babies with kidney
problems
• ay be given a different dose to the usual dose. The doctor
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or nurse will advise how much Timentin you will need,
depending on the severity of the kidney disease
• our doctor will keep a close check on you and you may have
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more regular kidney function tests.
If you are on Timentin for a long time you should have blood
tests to check your potassium levels.
Thrush (a yeast infection of moist areas of the body) may

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The side effects below may
happen with this medicine.
Tell your doctor or nurse straight away if you notice any of the
following serious side effects - you may need urgent medical
treatment:
The following are rare (may affect up to 1 in 1,000 people)
• igh temperature (fever), chills, a sore throat or other signs
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of an infection or if you bruise more easily. These may be
signs of a problem with your blood cells
• nflammation of the large bowel (colon) with diarrhoea
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sometimes containing blood, pain and fever
The following are very rare (may affect up to 1 in 10,000 people)
• llergic reactions, the signs may include: skin itching or
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rash, swelling of the face, lips, tongue, body or breathing
difficulties. These can be serious and occasionally deaths have
occurred
• skin reaction known as ‘erythema multiforme’ where
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you may develop: itchy reddish-purple patches on the skin
especially on the palms of the hands or the soles of the feet,
‘hive-like’ raised swollen areas on the skin, tender areas of
the surfaces of the mouth, eyes and private parts. You may
have a fever and be very tired
• ash or pinpoint flat red round spots under the skin surface
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or bruising of the skin. This is due to inflammation of blood
vessel walls due to an allergic reaction. It can be associated
with joint pain (arthritis) and kidney problems
• ther severe skin reactions can include: changes in skin
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colour, bumps under the skin, blistering, pustules, peeling,
redness, pain, itch, scaling. These may be associated with
fever, headaches and body aches
• hanges to your white blood cells which might make you
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more susceptible to infections
• decrease in the number of red blood cells in your blood, a
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symptom may be tiredness
• erious liver side effects may occur. You must tell your doctor
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urgently if you get:
- severe diarrhoea with bleeding
- blisters, redness or bruising of the skin
- darker urine or paler stools
- yellowing of the skin or the whites of the eyes (jaundice). See
also anaemia below which might result in jaundice.
These can happen when having the medicine or for up to
several weeks after.
• n excessive breakdown of red blood cells causing a form of
a
anaemia. Signs include: tiredness, headaches, shortness of
breath, dizziness, looking pale and yellowing of the skin and
the whites of the eyes
If any of the above happen to you speak to your doctor or
nurse straight away as your medicine should be stopped.
Sometimes you may get less severe skin reactions such as:
• mildly itchy rash (round, pink-red patches), ‘hive-like’
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swollen areas on forearms, legs, palms, hands or feet. The
frequency is unknown.
If you have this talk to your doctor or nurse as Timentin will
need to be stopped.

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K169202
GSK-ContractMfg-Eur-Ita-Italy-Biopharma
United Kingdom-GBR
Timentin
1

The other possible side effects are:
Rare (may affect up to 1 in 1,000 people)
• a lower than average amount of potassium in the blood
• nflammation of the bladder which may cause blood in your urine
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• he blood may take longer to clot than it normally would.
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You may notice this if you have a nosebleed or cut yourself
• its (convulsions) may be experienced in patients on high
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doses or with kidney problems
Frequency not known
• ain, burning, swelling or inflammation at the site of the
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injection
• skin rashes
• itching
• diarrhoea
• feeling sick (nausea)
• vomiting
• changes in the results of blood tests for liver function
• alse positive red blood cell status tests (Coombs or rhesus test)
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Reporting of side effects
If you notice 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.

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5 How to store Timentin
Timentin is for use in hospital only and the expiry date and
storage instructions stated on the vial label and carton are
for the doctor, nurse or pharmacist’s information. The doctor,
pharmacist or nurse will make up your medicine.

6 Contents of the pack and other information
What Timentin contains
• imentin is available in one strength, 3.2 g. The active
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substance is 3 g of ticarcillin (present as ticarcillin sodium) and
200 mg of clavulanic acid (present as potassium clavulanate).
• here are no other ingredients. However, see section 2 for
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further important information about some of the ingredients
of Timentin, sodium and potassium.
What Timentin looks like and contents of the pack
Timentin 3.2 g is supplied as sterile powder in glass vials with
a rubber bung and aluminium seal. These are supplied to the
hospital in packs of 4. Your doctor, pharmacist or nurse will make
the IV infusion up with Water for Injections or a suitable infusion
fluid. When made up, Timentin becomes a pale straw colour.

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Marketing authorisation holder and manufacturer
Marketing Authorisation Holder: Beecham Group plc, Stockley
Park West, Uxbridge, Middlesex UB11 1BT
Manufacturer: Biopharma S.r.l.,Via delle Gerbere 22/30,
00134 Santa Palomba, Roma - Italy
Other formats
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Timentin 3.2 g
Reference number
00038/0329
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in September 2013
Timentin is a registered trademark of the GlaxoSmithKline
group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved

Reconstitution
Vials: The sterile powder should be dissolved in
approximately 10 ml prior to dilution into the
infusion container (e.g. mini-bag) or in-line burette.
The following approximate infusion volumes
are suggested:
Water for
Injections BP
3.2 g

100 ml

Glucose Intravenous
Infusion BP
(5% w/v)
100-150 ml

Each dose of Timentin should be infused
intravenously over a period of 30-40 minutes;
avoid continuous infusion over longer periods as
this may result in subtherapeutic concentrations.
800 mg Timentin has a displacement value of 0.55 ml.
Heat is generated when Timentin dissolves.
Reconstituted solutions are normally a pale
straw colour.
Timentin presentations are not for multi-dose use or for direct
IV or IM injection. Any residual antibiotic solution should be
discarded if less than the fully made up vial is used.
Stability and Compatibility
Timentin is stable in a range of intravenous fluids. Ideally, intravenous
solutions should be prepared at the time of administration. However,
Timentin infusions have been shown to be stable for the following
extended periods; the infusion should be prepared under appropriate
aseptic conditions and used within the times stated.
Intravenous fluids

Stability period
(hours)
5°C
25°C
Water for Injections BP
72
24
Glucose Intravenous Infusion BP (5% w/v)
72
12
Sodium Chloride (0.18% w/v) and Glucose (4% w/v)
24
Intravenous Infusion BP
Sodium Chloride Intravenous Infusion BP (0.9% w/v)
24
Dextran 40 Intravenous Infusion BP (10%) in
6
Glucose Intravenous Infusion (5%)
Dextran 40 Intravenous Infusion BP (10%) in
24
Sodium Chloride Intravenous Infusion (0.9%)
Glucose Intravenous Infusion BP (10% w/v)
6
Sorbitol Intravenous Infusion BP (30% w/v)
6
Sodium Lactate Intravenous Infusion BP (M/6)
12
Compound Sodium Lactate Intravenous Infusion
12
BP (Ringer-Lactate Solution, Hartmann’s Solution)
Incompatibilities
Timentin is not compatible with the following:
Proteinaceous fluids (e.g. protein hydrolysates); blood and
plasma; intravenous lipids; sodium bicarbonate.
Timentin solutions containing lidocaine hydrochloride should
not be used for intravenous administration.
If Timentin is prescribed concurrently with an aminoglycoside
the antibiotics should not be mixed in the syringe, intravenous
fluid container or giving set because loss of activity of the
aminoglycoside can occur under these conditions.
Storage
Timentin vials should be stored in a dry place. Do not store above 25°C.
Marketing authorisation
PL 00038/0329
This leaflet was last revised in September 2013
Timentin is a registered trademark of the GlaxoSmithKline
group of companies
© 2013 GlaxoSmithKline group of companies. All rights reserved

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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