TARGOCID 400MG

Active substance: TEICOPLANIN

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Package leaflet: Information for the user
®
powder

200 mg
for solution for injection/infusion
or oral solution
®
400 mg powder
for solution for injection/infusion
or oral solution
teicoplanin

Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you are given
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,
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet.
What is in this leaflet
1. What Targocid is and what it is used for
2. What you need to know before you are given Targocid
3. How to use Targocid
4. Possible side effects
5. How to store Targocid
6. Contents of the pack and other information

1. What Targocid is and what it is used for
Targocid is an antibiotic. It contains a medicine called
‘teicoplanin’. It works by killing the bacteria that cause
infections in your body.
Targocid is used in adults and children (including newborn
babies) to treat bacterial infections of:
- the skin and underneath the skin - sometimes called
‘soft tissue’
- the bones and joints
- the lung
- the urinary tract
- the heart - sometimes called ‘endocarditis’
- the abdominal wall - peritonitis
- the blood, when caused by any of the conditions listed
above
Targocid can be used to treat some infections caused by
‘Clostridium difficile’ bacteria in the gut. For this, the solution
is taken by mouth.

2. What you need to know before you are
given Targocid
Do not use Targocid if:
• you are allergic to teicoplanin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are
given Targocid if:
• you are allergic to an antibiotic called ‘vancomycin’
• you have a flushing of your upper part of your body (red
man syndrome)

• you have a decrease in platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines which may cause hearing
problems and/or kidney problems. You may have
regular tests to check if your blood, kidneys and/or liver
are working properly (see ‘Other medicines and Targocid’).
If any of the above apply to you (or you are not sure), talk to
your doctor, pharmacist or nurse before you are given
Targocid.
Tests
During treatment you may have tests to check your kidneys
and/or your hearing. This is more likely if:
• your treatment will last for a long time
• you have a kidney problem
• you are taking or may take other medicines that may
affect your nervous system, kidneys or hearing.
In people who are given Targocid for a long time, bacteria
that are not affected by the antibiotic may grow more than
normal - your doctor will check for this.
Other medicines and Targocid
Tell your doctor, pharmacist or nurse if you are using, have
recently used or might use any other medicines. This is
because Targocid can affect the way some other medicines
work. Also, some medicines can affect the way Targocid
works.
In particular, tell your doctor, pharmacist or nurse if you are
taking the following medicines:
• Aminoglycosides as they must not be mixed together
with Targocid in the same injection. They may also cause
hearing problems and/or kidney problems.
• amphotericin B - a medicine that treats fungal infections
which may cause hearing problems and/or kidney problems

• ciclosporin - a medicine that affects the immune system
which may cause hearing problems and/or kidney
problems
• cisplatin - a medicine that treats malignant tumors
which may cause hearing problems and/or kidney
problems
• water tablets (such as furosemide) - also called ‘diuretics’
which may cause hearing problems and/or kidney
problems.
If any of the above apply to you, (or you are not sure), talk
to your doctor, pharmacist or nurse before being given
Targocid.
Pregnancy, breast-feeding and fertility
If you are pregnant, think that you might be pregnant or
are planning to have a baby, ask your doctor, pharmacist or
nurse for advice before being given this medicine. They will
decide whether or not you are given this medicine while
you are pregnant. There may be a potential risk of inner ear
and kidney problems.
Tell your doctor if you are breast-feeding, before being
given this medicine. They will decide whether or not you
can keep breast-feeding, while you are given Targocid.
Studies in animals reproduction have not shown evidence
of fertility problems.
Driving and using machines
You may have headaches or feel dizzy while being treated
with Targocid. If this happens, do not drive or use any tools
or machines.
Targocid contains sodium
This medicine contains less than 1 mmol sodium (23 mg)
per vial and is essentially ‘sodium-free’.

G. Tartini, 2 2 15 8 - M I L A N O
Tel.
CROMinFOTO s.n.c. Via 02.375787 •e-mail:0crominfoto@tiscali.it
-

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89027654
(int. version 1)

TYPE OF MATERIAL: DESCRIPTION:

LEAFLET

TARGOCID 200 MG & 400 MG

MIN. FONT SIZE: CODE:

8.7 pt.

89027654

VERSION: OLD CODE :

1 a

89026727

14 APR 2014

COUNTRY:

UK
DIMENSIONS mm:

420 x 125

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

LOGO VERSION:

A1

COLOUR 2:

XXXXXXXXX

3. How to use Targocid
The recommended dose is
Adults and children (12 years and over) with no kidney
problems
Skin and soft tissue, lung and urinary tract infections
• Starting dose (for the first three doses): 400 mg (this
equates to 6 mg for every kilogram of body weight),
given every 12 hours, by injection into a vein or muscle
• Maintenance dose: 400 mg (this equates to 6 mg for
every kilogram of body weight), given once a day, by
injection into a vein or muscle
Bone and joint infections, and heart infections
• Starting dose (for the first three to five doses): 800 mg
(this equates to 12 mg for every kilogram of body weight),
given every 12 hours, by injection into a vein or muscle
• Maintenance dose: 800 mg (this equates to 12 mg for
every kilogram of body weight), given once a day hours,
by injection into a vein or muscle
Infection caused by ‘Clostridium difficile’ bacteria
The recommended dose is 100 to 200 mg by mouth, twice
a day for 7 to 14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose will usually need to
be lowered after the fourth day of treatment:
• For people with mild and moderate kidney problems the maintenance dose will be given every two days, or
half of the maintenance dose will be given once a day.
• For people with severe kidney problems or on
haemodialysis - the maintenance dose will be given every
three days, or one-third of the maintenance dose will be
given once a day.

Peritonitis for patients on peritoneal dialysis
The starting dose is 6 mg for every kilogram of body weight,
as a single injection into a vein, followed by:
• Week one: 20 mg/L in each dialysis bag
• Week two: 20 mg/L in every other dialysis bag
• Week three: 20 mg/L in the overnight dialysis bag.
Babies (from birth to the age of 2 months)
• Starting dose (on the first day): 16 mg for every kilogram
of body weight, as an infusion through a drip into a vein.
• Maintenance dose: 8  mg for every kilogram of body
weight, given once a day, as an infusion through a drip
into a vein.
Children (from 2 months to 12 years)
• Starting dose (for the first three doses): 10 mg for every
kilogram of body weight, given every 12  hours, by
injection into a vein.
• Maintenance dose: 6 to 10  mg for every kilogram of
body weight, given once a day, by injection into a vein.
How Targocid is given
The medicine will normally be given to you by a doctor or
nurse.
• It will be given by injection into a vein (intravenous use)
or muscle (intramuscular use).
• It can also be given as a infusion through a drip into a
vein.
Only the infusion should be given in babies from birth to
the age of 2 months.
To treat certain infections, the solution may be taken by
mouth (oral use).

If you have more Targocid than you should
It is unlikely that your doctor or nurse will give you too
much medicine. However, if you think you have been given
too much Targocid or if you are agitated, talk to your
doctor or nurse straight away.
If you forget to have Targocid
Your doctor or nurse will have instructions about when to
give you Targocid. It is unlikely that they will not give you
the medicine as prescribed. However, if you are worried,
talk to your doctor or nurse.
If you stop having Targocid
Do not stop having this medicine without first talking to
your doctor, pharmacist or nurse.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects
Stop your treatment and tell your doctor or nurse
straight away, if you notice any of the following serious
side effects - you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)
• sudden life-threatening allergic reaction - the signs may
include: difficulty in breathing or wheezing, swelling,
rash, itching, fever, chills
Rare (may affect up to 1 in 1000 people)
• flushing of the upper body
Not known (frequency cannot be estimated from the available
data)
• blistering of the skin, mouth, eyes or genitals - these may
be signs of something called ‘toxic epidermal necrolysis’
or ‘Stevens-Johnson syndrome’

Tell your doctor or nurse straight away, if you notice any of
the side effects above.
Tell your doctor or nurse straight away, if you notice
any of the following serious side effects - you may need
urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)
• swelling and clotting in a vein
• difficulty in breathing or wheezing (bronchospasm)
• getting more infections than usual - these could be signs
of a decrease in your blood cell count
Not known (frequency cannot be estimated from the
available data)
• lack of white blood cells - the signs may include: fever,
severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney problems or changes in the way your kidneys
work - shown in tests
• epileptic fits
Tell your doctor or nurse straight away, if you notice any of
the side effects above.
Other side effects
Talk to your doctor, pharmacist or nurse if you get any of
these:
Common (may affect up to 1 in 10 people)
• Rash, erythema, pruritus
• Pain
• Fever
Uncommon (may affect up to 1 in 100 people)
• decrease in platelet count.
• raised blood levels of liver enzymes
• raised in blood levels of creatinine (to monitor your kidney)
• hearing loss, ringing in the ears or a feeling that you, or
things around you are moving
• feeling or being sick (vomiting), diarrhoea
• feeling dizzy or headache

Rare (may affect up to 1 in 1,000 people)
• infection (abcess).
Not known (frequency cannot be estimated from the
available data)
• problems where the injection was given - such as reddening
of the skin, pain or swelling
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any side effects not listed in this leaflet.

5. How to store Targocid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and label of the vial after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information about storage and the time to use Targocid,
after it has been reconstituted and is ready to use, are
described in the ‘Practical information for healthcare
professionals on preparation and handling of Targocid’.

6. Contents of the pack and other
information
What Targocid contains
• The active substance is teicoplanin. Each vial contains
either 200 mg or 400 mg teicoplanin.
• The other ingredients are sodium chloride and sodium
hydroxide.
What Targocid looks like and contents of the pack
Targocid is a powder for solution for injection/infusion or
oral solution.
The powder is spongy, ivory and coloured homogeneous
mass.

The powder is packaged:
• in a Type I, colourless glass vial of useful volume of 10 mL
for 200 mg closed with bromobutyl rubber stopper and
plastic flip-off top aluminium yellow overseal.
• in a Type I, colourless glass vial of useful volume of 22 mL
for 400 mg closed with bromobutyl rubber stopper and
plastic flip-off top aluminium green overseal.
Pack size:
- 1 powder vial
- 5x1 powder vials
- 10x1 powder vials
- 25x1 powder vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford, Surrey
GU1 4YS, UK
Manufacturer
SANOFI-AVENTIS S.P.A.
Loc. Valcanello
03012 Anagni (FR), Italy
This medicinal product is authorised in the Member
States of the EEA under the following names:
Denmark, Finland, Norway, Sweden, United Kingdom:
Targocid
This leaflet was last revised in 07/2013.

G. Tartini, 2 2 15 8 - M I L A N O
Tel.
CROMinFOTO s.n.c. Via 02.375787 •e-mail:0crominfoto@tiscali.it
-

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

89027654
(int. version 1)

TYPE OF MATERIAL: DESCRIPTION:

LEAFLET

TARGOCID 200 MG & 400 MG

MIN. FONT SIZE: CODE:

8.7 pt.

89027654

VERSION: OLD CODE :

1 a

89026727

14 APR 2014

COUNTRY:

UK
DIMENSIONS mm:

420 x 125

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

LOGO VERSION:

A1

COLOUR 2:

XXXXXXXXX

The following information is intended for medical or
healthcare professionals only:
Practical information for healthcare professionals on
preparation and handling of Targocid.
This medicine is for single use only.
Method of administration
The reconstituted solution may be injected directly or
alternatively further diluted.
The injection will be given either as a bolus over 3 to 5
minutes or as a 30-minutes infusion.
Only the infusion should be given in babies from birth to
the age of 2 months.
The reconstituted solution may also be given by mouth.
Preparation of reconstituted solution
• Slowly inject the entire content of the supplied solvent
into the powder vial.
• Gently roll the vial between the hands until the powder
is completely dissolved. If the solution does become
foamy, then it should be left to stand for about 15 minutes.
The reconstituted solutions will contain 200 mg of teicoplanin
in 3.0 mL and 400 mg in 3.0 mL.
Only clear and yellowish solutions should be used.
The final solution is isotonic with plasma and has a pH of
7.2-7.8.
Nominal teicoplanin content of vial 200 mg 400 mg
Volume of powder vial
10 mL 22 mL
Volume withdrawable from the
solvent ampoule for reconstitution
3.14 mL 3.14 mL
Volume containing nominal
teicoplanin dose (extracted by
5 mL syringe and 23 G needle)
3.0 mL 3.0 mL

Preparation of the diluted solution before infusion
Targocid can be administered in the following infusion
solutions:
• sodium chloride 9 mg/mL (0.9%) solution
• Ringer solution
• Ringer-lactate solution
• 5% dextrose injection
• 10% dextrose injection
• 0.18% sodium chloride and 4% glucose solution
• 0.45% sodium chloride and 5% glucose solution
• Peritoneal dialysis solution containing 1.36% or 3.86%
glucose solution.
Shelf life of reconstituted solution
Chemical and physical in-use stability of the reconstituted
solution prepared as recommended has been demonstrated
for 24 hours at 2 to 8°C.
From a microbiological point of view, the medicine should
be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the
user and would normally not be longer than 24 hours at 2 to
8°C, unless reconstitution has taken place in controlled and
validated aseptic conditions.
Shelf life of diluted medicine
Chemical and physical in-use stability of the reconstituted
solution prepared as recommended has been demonstrated
for 24 hours at 2 to 8°C.
From a microbiological point of view, the medicine should
be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of
the user and would normally not be longer than 24 hours at
2 to 8°C, unless reconstitution/dilution has taken place in
controlled and validated aseptic conditions.
Disposal
Any unused medicine or waste material should be disposed
of in accordance with local requirements.
89027654

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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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