Targocid

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Targocid
200 mg, powder and solvent for solution for injection / infusion or oral solution
Teicoplanin
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, so that it can be read again if necessary.
• If there are any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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 acts
bactericidally against bacteria causing infection in the patient's body.
Targocid is used in adults and children (including newborns) for the treatment of bacterial infections:

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

Targocid may be used in the treatment of 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 to 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 reduced number of platelets (thrombocytopenia),
• the patient has impaired kidney function,

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• the patient is taking other medicines which may cause hearing problems and (or) kidney problems. The patient may have regular tests to check whether the kidneys and (or) liver are functioning properly (see "Targocid with other medicines"). If any of the above conditions apply to the patient (or 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 after administration of teicoplanin. If the patient develops a severe rash or other skin reactions described in section 4, treatment with Targocid should be discontinued and the patient should contact a doctor immediately 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 will 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 which may damage the nervous system, kidneys, or hearing.

In patients receiving Targocid for prolonged periods, there may be an increased risk of overgrowth of bacteria not susceptible to the antibiotic. This will be monitored by the treating physician.

Targocid with other medicines
Tell 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, and 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. These medicines may also cause hearing problems and (or) kidney problems.
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and (or) kidney problems.
• cyclosporine – a medicine affecting the immune system, which may cause hearing problems and (or) kidney problems.
• cisplatin – a medicine used in the treatment of malignant tumours, which may cause hearing problems and (or) kidney problems.
• diuretics (such as furosemide) – also known as "water tablets", which may cause hearing problems and (or) kidney problems.

If any of the above points apply to the patient (or 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 have a baby, she should consult a doctor, pharmacist, or nurse before using this medicine. They will decide whether this medicine can be given during pregnancy. There is a risk of damage to the inner ear and kidney function impairment.

If the patient is breastfeeding, she should inform the doctor before taking this medicine. The doctor will decide whether she can continue breastfeeding while taking Targocid.

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Animal studies on fertility have not shown evidence of impaired fertility.

Driving and using machines

During treatment with Targocid, the patient may experience pain or dizziness. If such side 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 that the medicine is considered "sodium-free".

3. How to use Targocid

The medicine is available in the following strengths: 200 mg and 400 mg.
Recommended dose
Adults and children (aged 12 years and older) with normal kidney function
Skin and soft tissue infections, lung 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 the bacterium Clostridium difficile
The recommended dose is 100 to 200 mg orally, twice daily for 7 to 14 days.
Adults and elderly patients with impaired kidney function
If the patient has impaired kidney function, the dose usually needs to be reduced after the fourth day of treatment:

• In patients with mild to moderate kidney impairment – the maintenance dose should be administered every two days, or half the maintenance dose once daily.
• In patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose 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 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 (from 2 months to 12 years of age)
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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 (into a vein) or intramuscular (into a muscle) injection.
• It may also be given as an intravenous infusion (drip). In infants from birth to 2 months of age, only infusion administration should be used. In the treatment of certain infections, the solution may be taken orally (oral administration).

Use of a higher than recommended dose of Targocid
It is unlikely that a doctor or nurse will administer too high a dose of the 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.
Missing a dose of Targocid
Your doctor or nurse will have instructions on how to administer Targocid. It is unlikely 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 the medicine without first consulting your doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, contact your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following serious adverse reactions occur, treatment must be stopped and the doctor or nurse should be contacted immediately – the patient may require urgent medical attention.
Uncommon (may occur in not 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 not more than 1 in 1,000 patients):

• redness of the upper part of the body.

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

• blisters on the skin, mouth, eyes or genital organs – 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)". Initially, DRESS presents with flu-like symptoms and 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 adverse symptoms occur, the doctor or nurse must be informed immediately.
  If the patient notices any of the following serious adverse reactions, the doctor or nurse must be informed immediately, as the patient may require urgent medical attention.
  Uncommon (may occur in not 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 reduced white blood cell count.

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)
• low numbers of all types of blood cells
• kidney function disorders or changes in kidney function – visible in tests. When higher doses are administered to the patient, the frequency or severity of kidney function disorders may increase
• seizures. If any of the above adverse reactions occur, the doctor or nurse must be informed immediately.

Other adverse reactions
Consult a doctor, pharmacist, or nurse if any of the following symptoms occur:
Common (may occur in not more than 1 in 10 patients):

• rash, redness, itching
• pain
• fever.

Uncommon (may occur in not more than 1 in 100 patients):

• reduced platelet count
• 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 not more than 1 in 1,000 patients):

• infection (abscess).

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

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

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

5. How to store Targocid medicine

Keep this medicine out of 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 for Targocid after reconstitution of the powder and on the period of usability are described in the section "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 200 mg of teicoplanin.
• The 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, supplied with a solvent. The powder is a porous, homogeneous, ivory-coloured mass. The solvent is a clear, colourless solution.
The powder is packed in 10 ml colourless Type I glass vials, closed with a bromobutyl rubber stopper and an aluminium yellow cap with a flip-off seal;
The solvent is packed in ampoules of colourless Type I glass. The pack is contained in a cardboard box.
Pack size: 1 vial of powder and 1 ampoule of solvent.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Greece, country of export:
VIANEX S.A.
Varibobis 8, 146 71 N. Erythrea, Greece
Manufacturer:
Sanofi S.r.l.
Anagni, Italy
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
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Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Greece, country of export: 32401/13-4-2016
Parallel Import Authorisation Number: 41/26
This medicinal product is authorised for marketing in the European Economic Area member states under the following names:
Austria, Belgium, Czech Republic, Croatia, Germany, Hungary, Ireland, Luxembourg, Malta, Poland, Slovakia,
Slovenia: Targocid
Bulgaria, France, Greece, Netherlands, Romania, Spain: TARGOCID
Italy: TARGOSID
Portugal: Targosid

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 intended for single use only.
Administration method
The solution obtained after reconstitution of the powder may be administered by direct injection or further diluted if necessary.
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, only infusion should be used.
The solution obtained after dissolving the powder may also be administered orally.
Reconstitution of the powder

• Slowly inject the entire contents of the provided solvent into the vial containing the powder.
• 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 range 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
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• 5% glucose solution for injection
• 10% glucose solution for 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.

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, responsibility for storage conditions and duration prior to use lies with the user, and the time should
usually 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, responsibility for storage conditions and duration prior to use lies with the user, and the time should
usually not exceed 24 hours at a temperature of 2 to 8°C, provided reconstitution of the powder and dilution of the solution were performed
under controlled and validated aseptic conditions.

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