Targocid

Leaflet accompanying the packaging: information for the user

Warning! Keep the 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Targocid and what is it used for
• 2. Important information before using Targocid
• 3. How to use Targocid
• 4. Possible side effects
• 5. How to store Targocid
• 6. Contents of the packaging and other information

1. What is Targocid and what is it used for

Targocid is an antibiotic. It contains the active substance teicoplanin. It works bactericidally on bacteria that cause infection in the patient's body.
Targocid is used in adults and children (including newborns) to treat bacterial infections:

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

Targocid can be used to treat some infections caused by Clostridium difficile

• bacteria in the intestines. In this case, the 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, you should discuss it with your doctor, pharmacist or nurse if:

• the patient is allergic to the antibiotic vancomycin,
• the patient has experienced redness of the upper body (red man syndrome),
• the patient has a decreased platelet count (thrombocytopenia),
• the patient has kidney function disorders,

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• the patient is taking other medicines that may cause hearing or kidney function disorders. The patient may have regular tests to check if the kidneys and/or liver are working properly (see "Targocid and other medicines"). If any of the above conditions apply to the patient (or the patient is not sure), they should consult their doctor, pharmacist or nurse before taking Targocid.

There have been reports of 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) after teicoplanin use. If the patient experiences a severe rash or other skin reactions, as described in section 4, they should stop taking Targocid and seek medical attention immediately.

Diagnostic tests

During treatment, the patient may have 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 a day),
• the patient has kidney function disorders,
• the patient is taking or may take other medicines that can damage the nervous system, kidneys or hearing.

In patients taking Targocid for a long time, there may be a greater than usual increase in bacteria that the antibiotic does not work against. The doctor will check this.

Targocid and other medicines

The patient should tell their doctor, pharmacist or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is because Targocid may affect the action of other medicines. Also, some medicines may affect the action of Targocid.
In particular, the patient should tell their doctor, pharmacist or nurse if they are taking:

• aminoglycosides - because they should not be mixed with Targocid in the same injection. They can also cause hearing or kidney function disorders.
• amphotericin B - a medicine used to treat fungal infections, can cause hearing or kidney function disorders.
• cyclosporin - a medicine that affects the immune system, can cause hearing or kidney function disorders.
• cisplatin - a medicine used to treat cancer, can cause hearing or kidney function disorders.
• diuretics (such as furosemide) - also known as "water pills", can cause hearing or kidney function disorders.

If any of the above points apply to the patient (or the patient is not sure), they should consult their doctor, pharmacist or nurse before taking Targocid.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, thinks they may be pregnant or plans to have a baby, they should consult their doctor, pharmacist or nurse before using this medicine. They will decide whether the patient can take Targocid during pregnancy. There is a risk of damage to the inner ear and kidney function disorders.
If the patient is breastfeeding, they should tell their doctor before taking this medicine. The doctor will decide whether the patient can breastfeed while taking Targocid.
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Studies on fertility in animals have not shown any effects on fertility.

Driving and using machines

During treatment with Targocid, the patient may experience pain or dizziness. If the patient experiences such side effects, they should not drive or operate any tools or machines.

Targocid contains sodium

1 vial of Targocid contains less than 1 mmol of sodium (23 mg), which means 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 (12 years and older) without kidney function disorders

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 a day 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 a day by intravenous or intramuscular injection.

Infection caused by Clostridium difficile
The recommended dose is 100 to 200 mg orally, twice a day for 7 to 14 days.

Adults and elderly patients with kidney function disorders

If the patient has kidney function disorders, the dose should usually be reduced after the fourth day of treatment:

• In patients with mild and moderate kidney function disorders - the maintenance dose will be administered every two days or half of the maintenance dose will be administered once a day.
• In patients with severe kidney function disorders or undergoing hemodialysis - the maintenance dose will be administered every three days or one-third of the maintenance dose will be administered once a day.

Peritonitis in patients undergoing peritoneal dialysis

The initial dose is 6 mg per kilogram of body weight, in a single intravenous injection, and then:

• First week: 20 mg/l in each dialysis bag
• Second week: 20 mg/l in every other dialysis bag
• Third week: 20 mg/l in the dialysis bag left overnight.

Infants (from birth to 2 months)

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

Children (from 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 a day by intravenous injection.

How to administer Targocid

This medicine is usually administered by a doctor or nurse.

• The medicine will be administered by intravenous injection (intravenous administration) or into a muscle (intramuscularly).
• It can also be administered in an intravenous infusion. In infants from birth to 2 months, only infusion should be used. In the treatment of some infections, the solution can be taken orally (oral administration).

Using a higher dose of Targocid than recommended

It is unlikely that the doctor or nurse will administer too much of the medicine. However, if the patient thinks they have received too much Targocid or if they are agitated, they should seek medical attention immediately.

Missing a dose of Targocid

The doctor or nurse will have instructions on how to administer Targocid to the patient. It is unlikely that they will administer the medicine contrary to the recommendations. However, if the patient has concerns, they should consult their doctor or nurse.

Stopping treatment with Targocid

The patient should not stop taking Targocid without consulting their doctor, pharmacist or nurse first.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Targocid can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should stop treatment and seek medical attention immediately - they may need urgent medical attention.

Uncommon(may affect up to 1 in 100 people):

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

Rare(may affect up to 1 in 1,000 people)

• redness of the upper body.

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

• blisters on the skin, mouth, eyes or genitals - these may be symptoms of a condition called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• red, scaly, widespread rash with bumps under the skin [including on skin folds, chest, abdomen (including stomach), back and arms] and blisters, accompanied by fever - these may be symptoms of "acute generalized exanthematous pustulosis (AGEP)".
• "drug reaction with eosinophilia and systemic symptoms (DRESS)". Initially, DRESS occurs as flu-like symptoms and a rash on the face, then as a widespread rash with high temperature, increased liver enzyme activity in blood tests and an increased number of a certain type of white blood cell (eosinophilia) and swollen lymph nodes.
  If the patient experiences any of the above side effects, they should inform their doctor or nurse immediately.

  If the patient notices any of the following severe side effects, they should inform their doctor or nurse immediately, as they may need urgent medical attention.

  Uncommon(may affect up to 1 in 100 people):

  • swelling and blood clots in a vein
  • difficulty breathing or wheezing (bronchospasm)
  • more infections than usual - these may be symptoms of a decrease in white blood cells.

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

  • lack 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 tests. If the patient is given higher doses, there may be an increased frequency or severity of kidney function disorders
  • seizures. If the patient experiences any of the above side effects, they should inform their doctor or nurse immediately.

  Other side effects

  The patient should consult their doctor, pharmacist or nurse if they experience any of the following side effects:
  Common(may affect up to 1 in 10 people)

  • rash, redness, itching
  • pain
  • fever.

  Uncommon(may affect up to 1 in 100 people):

  • decreased platelet count
  • increased liver enzyme activity in the blood
  • increased creatinine levels in the blood (kidney function monitoring)
  • hearing loss, ringing in the ears or feeling that the patient or objects around them are moving
  • nausea or vomiting, diarrhea
  • dizziness or headache.

  Rare(may affect up to 1 in 1,000 people)

  • infection (abscess).

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

  • disorders at the injection site - such as redness of the skin, pain or swelling.

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist or nurse.
  Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  Al. Jerozolimskie 181C
  Page 5 8
  02-222 Warsaw
  Phone: + 48 22 49 21 301
  Fax: + 48 22 49 21 309
  Website: https://smz.ezdrowie.gov.pl
  By reporting side effects, more information can be gathered on the safety of the medicine.

  5. How to store Targocid

  The medicine should be stored 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 month.
  There are no special precautions for storage.
  Information on the storage conditions of Targocid after dissolution of the powder and the shelf life of the solution is described in the section "Practical information for healthcare professionals for the preparation and handling of Targocid".

  6. Contents of the packaging and other information

  What Targocid contains

  • The active substance of Targocid is teicoplanin. Each vial contains 400 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 what the pack contains

  Targocid is a powder for solution for injection/infusion or oral solution with a solvent attached. The powder is a porous, homogeneous mass of ivory color. The solvent is a clear and colorless solution.
  The powder is packed in vials of colorless glass type I with a volume of 22 ml, closed with a bromobutyl rubber stopper and an aluminum green cap with a flip-off top made of plastic;
  The solvent is packed in an ampoule of colorless glass type I.
  Pack size: 1 vial with powder and 1 ampoule with solvent
  For more detailed information, please contact the marketing authorization holder or the parallel importer.

  Marketing authorization 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
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  Germany

  Parallel importer:

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

  Repackaged by:

  Delfarma Sp. z o.o.
  ul. Św. Teresy od Dzieciątka Jezus 111
  91-222 Łódź
  Marketing authorization number in the Czech Republic, the country of export: 15/216/93-B/C

  Parallel import authorization number: 153/17 Date of approval of the leaflet: 05.05.2022

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  The following information is intended for healthcare professionals only:

  Practical information for healthcare professionals for the preparation and handling of Targocid

  This medicinal product is intended for single use only.
  Administration method
  The solution obtained after dissolving the powder can be injected directly or further diluted.
  The solution can be administered by injection lasting from 3 to 5 minutes or in a 30-minute infusion.
  In infants from birth to 2 months, only infusion should be used. The solution obtained after dissolving the powder can also be administered orally.

  • The entire contents of the attached solvent should be slowly injected into the vial with the powder.
  • Then, the vial should be gently rotated in the hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to stand for about 15 minutes. The resulting solution will contain 400 mg in 3.0 ml. Only clear solutions should be used. The solution may have a color from yellow to dark yellow. The final solution is isotonic with plasma and has a pH of 7.2-7.8.

  Dilution of the solution before infusion
  Targocid can be administered in the following infusion solutions:

  • 9 mg/ml (0.9%) sodium chloride solution
  • Ringer's solution
  • Ringer's solution with lactate
  • 5% glucose solution for injection
  • 10% glucose solution for injection
  • 0.18% sodium chloride solution and 4% glucose solution

  Nominal teicoplanin content in the vial	400 mg
  Volume of the vial with powder	22 ml
  Volume that can be withdrawn from the ampoule with solvent	3.14 ml
  Volume containing the nominal dose of teicoplanin (withdrawn with a 5 ml syringe and a 23 G needle)	3.0 ml

  • 0.45% sodium chloride solution and 5% glucose solution
  • Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

  Shelf life of the solution after dissolving the powder
  The chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
  From a microbiological point of view, the medicine should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions before use, and the storage time should not normally exceed 24 hours at a temperature of 2 to 8°C, provided that the solution was prepared in controlled and validated aseptic conditions.
  Shelf life of the diluted solution
  The chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
  From a microbiological point of view, the medicine should be used immediately. If it is not used immediately, the user is responsible for the storage time and conditions before use, and the storage time should not normally exceed 24 hours at a temperature of 2 to 8°C, provided that the dissolution of the powder and dilution of the solution took place in controlled and validated aseptic conditions.
  Disposal
  Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
  [Information about the trademark]
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