Targocid

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Targocid
400 mg, powder and solvent for solution for injection/infusion or oral solution
Teicoplanin
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Targocid is and what it is used for
2. What you need to know before using 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 the active substance called teicoplanin. It works by killing bacteria that cause infection in the patient's body.
Targocid is used in adults and children (including newborns) to treat bacterial infections of:

• skin and subcutaneous tissue – sometimes referred to as soft tissue infections,
• joints and bones,
• lungs,
• urinary tract,
• heart – sometimes referred to as endocarditis,
• abdomen – peritonitis,
• blood, if caused by any of the above conditions.

Targocid may be used to treat certain infections caused by Clostridium difficile

• bacteria in the intestines. In this case, the medicinal solution is taken orally.

2. Important information before using Targocid

When not to use Targocid

• if the patient is allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Targocid, discuss with your doctor, pharmacist or
nurse if:

• the patient is allergic to an antibiotic called vancomycin,
• the patient has experienced redness of the upper part of the body (Red Man Syndrome),
• the patient has a low platelet count (thrombocytopenia),
• the patient has impaired kidney function,

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• the patient is taking other medicines that may cause hearing problems and (or) kidney dysfunction. The patient may undergo regular tests to monitor whether the kidneys and (or) liver are functioning properly (see "Targocid and other medicines"). If any of the above conditions apply to the patient (or if the patient is unsure), contact a doctor, pharmacist or nurse before taking Targocid.

Severe skin reactions, such as Stevens-Johnson syndrome,
toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS),
and acute generalized exanthematous pustulosis (AGEP), have been reported following
teicoplanin administration. If the patient develops severe rash or other skin reactions
described in section 4, treatment with Targocid should be discontinued and the patient should
immediately contact a doctor or seek medical help.
Diagnostic tests
During treatment, the patient may undergo blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment will last for a long time,
• the patient is to be treated with high loading doses (12 mg/kg twice daily),
• the patient has impaired kidney function,
• the patient is taking or may take other medicines that may damage the nervous system, kidneys or hearing.

In patients receiving Targocid for a prolonged period, there may be an increased overgrowth
of bacteria not susceptible to the antibiotic. This will be monitored by the treating physician.
Targocid and other medicines
Inform your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is because Targocid may affect the action of other medicines. Likewise, some medicines may affect the action of Targocid.
In particular, inform your doctor, pharmacist or nurse if the patient is taking any of the following medicines:

• aminoglycosides – because they must not be mixed with Targocid in the same injection. They may also cause hearing problems and (or) kidney dysfunction.
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and (or) kidney dysfunction.
• cyclosporine – an immunosuppressive medicine, which may cause hearing problems and (or) kidney dysfunction.
• cisplatin – a medicine used in the treatment of malignant tumours, which may cause hearing problems and (or) kidney dysfunction.
• diuretics (such as furosemide) – also known as "water tablets", which may cause hearing problems and (or) kidney dysfunction.

If any of the above points apply to the patient (or if the patient is unsure),
contact a doctor, pharmacist or nurse before taking Targocid.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should
consult a doctor, pharmacist or nurse before using this medicine. They will decide whether
this medicine can be administered during pregnancy. There is a risk of damage to the inner ear and
kidney dysfunction.
If the patient is breastfeeding, she should inform the doctor before taking this medicine.
The doctor will decide whether the patient can breastfeed while taking Targocid.
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Animal studies on reproductive toxicity did not show evidence of impaired fertility.
Driving and operating machinery
During treatment with Targocid, the patient may experience headache or dizziness. If such
adverse effects occur, the patient should not drive or operate any tools or machinery.
Targocid contains sodium
One vial of this medicine contains less than 1 mmol of sodium (23 mg), meaning the medicine is considered "sodium-free".

3. How to use Targocid

Targocid is available in the following strengths: 200 mg and 400 mg.
Recommended dose
Adults and children (aged 12 years and older) without renal impairment
Skin and soft tissue infections, lung infections and urinary tract infections

• Initial dose (for the first three doses): 6 mg per kilogram of body weight administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 6 mg per kilogram of body weight administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first three to five doses): 12 mg per kilogram of body weight administered every 12 hours by intravenous injection.
• Maintenance dose: 12 mg per kilogram of body weight administered once daily by intravenous or intramuscular injection.

Infection caused by Clostridium difficile
The recommended dose is 100 to 200 mg orally, twice daily for 7 to 14 days.
Adults and elderly patients with renal impairment
If the patient has renal impairment, the dose is usually reduced after the fourth day of treatment:

• In patients with mild to moderate renal impairment – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• In patients with severe renal impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given once daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight given as a single intravenous injection, followed by:

• Week 1: 20 mg/liter in each dialysis bag
• Week 2: 20 mg/liter in every other dialysis bag
• Week 3: 20 mg/liter in the dialysis bag left in overnight.

Infants (from birth to 2 months of age)

• Initial dose (on the first day): 16 mg per kilogram of body weight administered as an intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight administered once daily as an intravenous infusion.

Children (aged 2 months to 12 years)
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• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once daily by intravenous injection.

How Targocid is administered
This medicine is usually administered by a doctor or nurse.

• The medicine will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be given as an intravenous infusion. In infants from birth to 2 months of age, only intravenous infusion should be used. For the treatment of certain infections, the solution may be taken orally.

Use of a higher than recommended dose of Targocid
It is unlikely that a doctor or nurse will administer too high a dose of this medicine. However, if you think you have received too high a dose of Targocid, or if you feel agitated, contact your doctor or nurse immediately.
Missed dose of Targocid
Your doctor or nurse will have instructions on how to administer Targocid. It is unlikely that they will give you the medicine incorrectly. However, if you have any concerns, contact your doctor or nurse.
Stopping Targocid treatment
Do not stop taking this medicine without first consulting your doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects
If any of the following serious side effects occur, stop treatment and contact your doctor or nurse immediately – the patient may require urgent medical attention.
Not common (may occur in no more than 1 in 100 patients):

• sudden, life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

Rare (may occur in no more than 1 in 1,000 patients):

• redness of the upper body.

Frequency not known (frequency cannot be estimated from the available data):

• blisters on the skin, mouth, eyes or genitals – these may be symptoms of a disease called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”.

• red, scaly, widespread rash with small lumps under the skin [including in skin folds, chest, abdomen (including stomach), back and arms] and blisters, accompanied by fever – these may be symptoms of so-called “acute generalized exanthematous pustulosis (AGEP)”.

• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. DRESS initially presents as flu-like symptoms and a rash on the face, followed by widespread rash with high fever, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes.
  If any of the above side effects occur, inform your doctor or nurse immediately.
  If the patient experiences any of the following serious side effects, contact the doctor or nurse immediately, as the patient may require urgent medical attention.
  Not common (may occur in no more than 1 in 100 patients):

• swelling and blood clots in a vein

• difficulty breathing or wheezing (bronchospasm)

• more infections than usual – these may be symptoms of a reduced number of white blood cells.

Frequency not known (cannot be estimated from the available data):

• absence of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney function disorders or changes in kidney function – visible in laboratory tests. When higher doses are administered, the frequency or severity of kidney function disorders may increase.
• seizures. If any of the above side effects occur, inform your doctor or nurse immediately.

Other side effects
Talk to your doctor, pharmacist or nurse if you experience any of the following:
Common (may occur in no more than 1 in 10 patients):

• rash, redness, itching
• pain
• fever.

Not common (may occur in no more than 1 in 100 patients):

• decreased number of platelets
• increased liver enzyme activity in blood
• increased blood creatinine levels (monitoring kidney function)
• hearing loss, ringing in the ears or sensation that the patient or surrounding objects are moving
• nausea or vomiting, diarrhoea
• dizziness or headache.

Rare (may occur in no more than 1 in 1,000 patients):

• infection (abscess).

Frequency not known (cannot be estimated from the available data):

• injection site reactions – such as skin redness, pain or swelling.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Targocid medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Information on storage conditions of Targocid after reconstitution of the powder and on the time during which it is suitable for use is described in the section "Practical information for healthcare professionals on preparation and handling of Targocid".

6. Contents of the package and other information

What Targocid contains

• The active substance is teicoplanin. Each vial contains 400 mg of teicoplanin.
• Other ingredients are: sodium chloride and sodium hydroxide (for pH adjustment) in the powder, and water for injections in the solvent.

What Targocid looks like and contents of the pack
Targocid is a powder for solution for injection/infusion or oral solution with solvent supplied. The powder is a porous, homogeneous ivory-coloured mass. The solvent is a clear, colourless solution.
The powder is contained in 22 ml colourless Type I glass vials, closed with a bromobutyl rubber stopper and an aluminium green flip-off cap made of synthetic material.
The solvent is contained in ampoules made of colourless Type I glass.
Pack size: 1 vial of powder and 1 ampoule of solvent.
For further information, contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
sanofi-aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic

Manufacturer:
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni (FR), Italy
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 15/216/93-B/C
Parallel Import Authorisation Number: 153/17

The following information is intended exclusively for healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of
Targocid
This medicinal product is for single use only.
Administration method
The solution obtained after dissolving the powder may be administered directly or further diluted.
The solution may be given as an injection lasting from 3 to 5 minutes or as a 30-minute infusion.
In infants from birth to 2 months of age, infusion should be used only.
The solution obtained after dissolving the powder may also be administered orally.
Preparation of solution by dissolving the powder

• Slowly inject the entire contents of the supplied solvent into the vial containing the powder.
• Then gently rotate the vial in the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes. The resulting solution will contain 400 mg in 3.0 ml. Only clear solutions should be used. The solution may vary in color from yellowish to dark yellow. The final solution is isotonic with serum and has a pH of 7.2–7.8.

Dilution of the solution prior to infusion
Targocid may be administered in the following infusion solutions:

• 9 mg/ml (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's lactate solution
• 5% glucose solution for injection
• 10% glucose solution for injection
• 0.18% sodium chloride and 4% glucose solution Page 7 of 8
• 0.45% sodium chloride and 5% glucose solution
• Peritoneal dialysis solution containing 1.36% or 3.86% glucose.

Shelf life of the solution after reconstitution
Chemical and physical stability of the solution prepared according to recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use, and the time should generally not exceed 24 hours at a temperature of 2 to 8°C, provided the solution was prepared under controlled and validated aseptic conditions.

Shelf life of the diluted solution
Chemical and physical stability of the solution prepared according to recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use, and the time should generally not exceed 24 hours at a temperature of 2 to 8°C, provided reconstitution of the powder and dilution of the solution were carried out under controlled and validated aseptic conditions.

Disposal
Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.
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