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TARGOCID 200MG

Active substance: TEICOPLANIN

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• Blood - sometimes called ‘septacaemia’
• Heart - sometimes called ‘endocarditis’
• Stomach or gut - sometimes called ‘peritonitis’. This may happen if
you have kidney problems and have regular home dialysis
It can also be used before some operations, to stop an infection happening.

Teicoplanin

2. Before you have Targocid

Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start treatment with
this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 nurse.
In this leaflet:
1. What Targocid is and what it is used for
2. Before you have Targocid
3. How to have Targocid
4. Possible side effects
5. How to store Targocid
6. Further information

1. What Targocid is and what it is used for

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Targocid contains a medicine called teicoplanin. This belongs to a group
of medicines called antibiotics. It works by killing the bacteria that cause
infections in your body.
Targocid is used to treat infections which cannot be treated with other
antibiotics. This includes infections of the:
• Skin and underneath the skin, including muscle - sometimes called
‘soft tissue’
• Urinary tract - including your kidneys or bladder
• Lungs - which affect your breathing
• Joints and bones - including your hips or knees

Do not have Targocid if:
✖ You are allergic (hypersensitive) to teicoplanin or any of
the other ingredients of Targocid (see Section 6: Further
Information).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.
Do not have this medicine if any of the above apply to you. If you are
not sure, talk to you doctor or nurse before having Targocid.
Take Special Care with Targocid
Check with your doctor or nurse before having this
medicine if:
▲ You have kidney problems
▲ You are allergic to the antibiotic called vancomycin
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines. This includes medicines you buy
without a prescription, including herbal medicines. This is
because Targocid can affect the way some other medicines work. Also
some medicines can affect the way Targocid works.
In particular, check with your doctor if you are taking any of the following:
• Medicines for infections (such as the aminoglycoside antibiotics including gentamicin, streptomicin, neomycin, kanamycin, amikacin
or tobramycin) or other antibiotics (such as cephaloridine or colistin)
• Medicines for fungal infections (such as amphotericin B)
• Ciclosporin - used in transplant surgery and in painful joint and skin
diseases
• Cisplatin - used for some cancers
• Water tablets (diuretics) such as furosemide, etacrynic acid

Tests
Your doctor may want to carry out blood tests to check on the amount
of medicine in your blood. Your doctor may also do tests of your liver,
kidney or hearing during treatment with Targocid.
Pregnancy and breast-feeding
Talk to your doctor or nurse before you are given Targocid if you are
pregnant, might become pregnant or are breast-feeding. Ask your doctor
or pharmacist for advice before taking any medicine if you are pregnant
or breast-feeding.
Driving and using machines
You may have headaches or feel dizzy. If this happens, do not
drive or use any machinery.
Important information about some of the ingredients of Targocid
Targocid contains 11 mg of sodium in each 400 mg dose and is essentially
‘sodium free’.

3. How to have Targocid
How Targocid is given
• Your medicine will normally be given to you by a doctor or nurse
• It will be given by injection into a vein or muscle
• It can also be given as an infusion through a drip into a vein
How much Targocid is given
• Your doctor will decide on how much Targocid to give you
• The dose will depend on the type of infection and any other illnesses
you may have
• You may be given a different dose depending on your weight
• The length of your treatment will depend on your infection
• If you have any kidney problems you may be given a lower dose of
Targocid.
The usual dose is:
Adults (18 years and over)
Moderate infection:
• 400mg on the first day
Turn
Over
• 200mg once a day on the following days

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Teicoplanin
The following information is extracted from the SPC.
Technical information for the preparation and administration of Targocid.
1 NAME OF THE MEDICINAL PRODUCT
Targocid 200mg / Teicoplanin 200mg Powder for Injection
Targocid 400mg / Teicoplanin 400mg Powder for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Teicoplanin 200mg / 400mg
3 PHARMACEUTICAL FORM
Powder for Injection
4.2 Posology and method of administration
Administration
The reconstituted Targocid injection may be administered directly either
intravenously or intramuscularly. The intravenous injection may be administered
either as a bolus or as a 30 minute infusion. Only the infusion method must be
used in neonates.
Dosage is usually once daily but, in cases of severe infection, a second injection
should be administered on the first day in order to reach more rapidly the
required serum concentrations.
The administration of teicoplanin by the intraventricular route is not indicated.
The majority of patients with infections caused by organisms sensitive to the
antibiotic show a therapeutic response within 48-72 hours. The total duration of
therapy is determined by the type and severity of the infection and the clinical
response of the patient. In endocarditis and osteomyelitis, treatment for three
weeks or longer is recommended.
Targocid must not be administrated for more than 4 months.
Determination of teicoplanin serum concentrations may optimise therapy.
In severe infections, trough serum concentrations should not be less than
10mg/1. Peak concentrations measured one hour after a 400mg intravenous
dose are usually in the range of 20-50mg/1; peak serum concentrations of up
to 250mg/1 have been reported after intravenous doses of 25mg/kg. A relationship
between serum concentration and toxicity has not been established.

Therapeutic dosage:
Adult or elderly patients with normal renal function
Prophylaxis:
400mg intravenously as a single dose at induction
of anaesthesia
Moderate infections:
Skin and soft tissue infection, urinary tract infection,
lower respiratory tract infection
Loading dose:
One single i.v. or i.m. injection of 400mg on the first
day
Maintenance dose:
A single i.v. or i.m. injection of 200mg daily
Severe infections:
Joint and bone infection, septicaemia, endocarditis
Loading dose:
Three 400mg i.v. injections, administered 12 hours
apart
Maintenance dose:
A single i.v. or i.m. injection of 400mg daily
1. Standard doses of 200 and 400mg equate respectively to mean doses of 3 and
6mg/kg. In patients weighing more than 85kg it is recommended to adapt
the dosage to the weight following the same therapeutic schedule: moderate
infection 3mg/kg, severe infection 6mg/kg.
2. In some clinical situations, such as infected, severely burned patients or
Staphylococcus aureus endocarditis, unit maintenance doses of up to 12mg/kg
have been administered (intravenously).
In endocarditis caused by Staphylococcus aureus, satisfactory results have been
achieved with teicoplanin in polytherapy. When serum concentrations are
controlled in severe infections, the trough levels must be 10 times higher than
the MIC or, generally, at least 10 mg/l.
In the treatment of antibiotic-associated diarrhoea caused by Clostridium difficile:
one oral dose of 200 mg twice a day.
Children
Teicoplanin can be used to treat Gram-positive infections in children from the
age of 2 months. For severe infections and neutropenic patients the recommended
dose is 10mg/kg every 12 hours for the first three doses; thereafter a dose of
10mg/kg should be administered by either intravenous or intramuscular injection
as a single dose each day.
For moderate infections the recommended dose is 10mg/kg every twelve hours
for the first three doses; thereafter a dose of 6mg/kg should be administered by
either intravenous or intramuscular injection as a single dose each day.
The recommended dosage regimen for neonates is a loading dose of 16mg/kg
followed by a daily dose of 8mg/kg.
The I.V. dose must be infused over 30 minutes.

6.4 Special precautions for storage
Finished Product:
Vials of dry Targocid should not be stored above 25°C.
Reconstituted Product:
In keeping with good clinical pharmaceutical practise reconstituted
vials of Targocid should be used immediately and any unused portion discarded.
On the few occasions when changing circumstances make this impractical,
reconstituted solutions should be kept at 2 - 8°C and discarded within 24 hours.
Do not store in a syringe.
6.5 Nature and contents of container
Colourless, BP, Type I glass vials, closed with a butyl rubber plug and combination
aluminium/plastic “flip-off cap” (colour coded yellow).
Pack size: 1 vial
6.6 Special precautions for disposal
Preparation of Injection
The entire contents of the water ampoule should be slowly added to the vial of
Targocid and the vial rolled gently until the powder is completely dissolved,
taking care to avoid formation of foam. If the solution does become foamy then
allow to stand for about 15 minutes for the foam to subside.
A calculated excess is included in each vial of Targocid so that, when prepared
as described above, a full dose of 100mg, 200mg or 400mg (depending on the
strength of the vial) will be obtained if all the reconstituted solution is withdrawn
from the vial by a syringe. The concentration of teicoplanin in these injections
will be 100mg in 1.5ml (from the 100mg and 200mg vials) and 400mg in 3ml
(from the 400mg vial).
The reconstituted solution may be injected directly, or alternatively diluted with:
• 0.9% Sodium Chloride Injection
• Compound Sodium Lactate Injection (Ringer-Lactate Solution, Hartmanns
Solution)
• 5% Dextrose Injection
• 0.18% Sodium Chloride and 4% Dextrose Injection
• Peritoneal dialysis solution containing 1.36% or 3.86% Dextrose.
9 DATE OF FIRST AUTHORISATION
2 August 1989
10 DATE OF (PARTIAL) REVISION OF THE TEXT
4 April 2010
89025971



In continuous ambulatory peritoneal dialysis
After a single loading IV dose of 400mg if the patient is febrile, the recommended
dosage is 20mg/1 per bag in the first week, 20mg/1 in alternate bags in the
second week and 20mg/1 in the overnight dwell bag only during the third week,
feverish patients must also take an I.V. loading dose of 400 mg of teicoplanin.
Teicoplanin remains stable in solutions for peritoneal dialysis (1.36% or 3.86%
dextrose). These solutions must not be kept for more than 24 hours.
Combined treatment:
It is recommended that the treatment be combined with an appropriate antibacterial
agent when the infection requires a maximum antibacterial activity (e.g. staphylococcal
endocarditis) and when it cannot be ruled out that there is a mixed infection with
gram-negatives (e.g. empirical treatment of fever in a neutropenic patient).
Prophylaxis of endocarditis caused by gram-positives in dental surgery and in
patients with heart valve disease:
To induce anaesthesia, 400 mg (6 mg/kg) of I.V. teicoplanin.
Adults and elderly patients with renal insufficiency
For patients with impaired renal function, reduction of dosage is not required
until the fourth day of Targocid treatment. Measurement of the serum
concentration of teicoplanin may optimise therapy (see section ‘Administration’).
From the fourth day of treatment
In mild renal insufficiency
Creatinine clearance between 40 and 60ml/min, Targocid dose should be halved,
either by administering the initial unit dose every two days, or by administering
half of this dose once a day.
In severe renal insufficiency
Creatinine clearance less than 40ml/min and in haemodialysed patients, Targocid
dose should be one third of the normal either by administering the initial unit
dose every third day, or by administering one third of this dose once a day.
Teicoplanin is not removed by dialysis.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
6.2 Incompatibilities
Solutions of teicoplanin and aminoglycosides are incompatible when mixed
directly and should not be mixed before injection.
6.3 Shelf life
3 years unopened.
24 hours after reconstitution.

Severe infection:
• 400mg every 12 hours for the first 3 doses
• 400mg once a day on the following days
To stop infections happening:
• Single dose of 400mg before the operation
Peritoneal Dialysis:
• 400 mg into your vein on the first day, followed by:
• Week one: 20mg per litre in each dialysis bag
• Week two: 20mg per litre in every other dialysis bag
• Week three: 20mg per litre in the overnight dwell bag
Children (2 months and over)
Moderate infection:
• 10mg for every kilogram of body weight
• This is given every twelve hours for the first three doses
• Followed by 6mg for every kilogram of body weight, once a day
Severe infection or increased risk of infection:
• 10mg for every kilogram of body weight
• This is given every twelve hours for the first three doses
• Followed by 10mg for every kilogram of body weight, once a day
To stop infection:
• Single dose of 400mg before the operation
Babies (in the first month after birth)
• The usual dose of Targocid is 16mg for every kilogram of body weight
• Followed by 8mg for every kilogram of body weight each day
If you have more Targocid than you should
It is unlikely that your doctor or nurse will give you too much medicine.
Targocid is not usually given for more than 4 months. Your doctor and nurse
will be checking your progress, and checking the medicine that you are
given. Ask them if you are not sure why you are getting a dose of medicine.
If you miss a dose of Targocid
Your doctor or nurse will have instructions about when to give you your
medicine. It is unlikely that you will not be given the medicine as it has
been prescribed. If you think that you may have missed a dose, then
talk to your doctor or nurse.

If you stop having Targocid
It is important that the course of treatment your doctor has prescribed
is finished. Do not stop having Targocid just because you feel better.

4. Possible side effects
Like all medicines, Targocid can cause side effects, although not everybody
gets them. These side effects are usually mild and last for a short time.
Tell your doctor straight away if you notice any of the
following serious side effects - you may need urgent
medical treatment:
• If you have an allergic reaction. The signs may include: rash,
itching, fever, difficulty in breathing or wheezing, chills,
swelling
• Blistering of the skin, mouth, eyes or genitals. This may be something
called ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’
• Epileptic fits after the use of teicoplanin directly into the brain
(intraventricular)
Tell your doctor or nurse if any of the following side effects get
serious or lasts longer than a few days:
• You bruise more easily and get more infections than usual. This could
be because of a blood problem (called ‘leucopenia’)
• Reactions at the site of the injection including reddening of the skin,
pain or swelling
• Feeling or being sick (vomiting), diarrhoea
• Dizziness or headache
• Mild hearing loss, ringing in the ears or feeling dizzy (vertigo)
• Flushing of the upper body
• Infection
Other side effects include:
• Blood and kidney problems or changes in the way your kidney works.
These would show up in the results of blood tests
If any of the side effects gets serious or lasts longer than a few days, or
if you notice any side effects not listed in this leaflet, talk to your doctor
or nurse.

5. How to store Targocid
• Keep out of the reach and sight of children
• Do not use Targocid after the expiry date which is stated on the label
and carton. The expiry date refers to the last day of that month
• Vials of Targocid powder must not be stored above 25°C
• After being mixed with water (reconstituted) vials of Targocid should
be used immediately

6. Further Information
What Targocid contains
• The active substance is teicoplanin
• The other ingredients are sodium chloride and, if necessary, sodium
hydroxide for pH adjustment.
What Targocid looks like and contents of the pack
• Targocid is a white powder
• Each pack contains one vial of Targocid powder and one ampoule of
water for injections
• Each vial contains 200mg or 400mg of teicoplanin
• Targocid powder will be mixed with the water for injections to make
a solution which is ready for use as an injection or an infusion (a drip)
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Targocid is:
Sanofi
One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
The Manufacturer of Targocid is:
SANOFI-AVENTIS S.P.A.
Loc. Valcanello, 03012, Anagni (FR), Italy.
This leaflet was last revised in 11/2012
89025971

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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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