Targocid

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Targocid

400 mg, powder and solvent for solution for injection/infusion or oral solution
Teicoplanin

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. See section 4.

Table of contents of the leaflet:

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

1. What Targocid is and what it is 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 taking Targocid

When not to take 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, the doctor, pharmacist, or nurse should be consulted 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 reduced 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 unsure), the doctor, pharmacist, or nurse should be consulted 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 taking teicoplanin. If the patient experiences a severe rash or other skin reactions, as described in section 4, treatment with Targocid should be discontinued and medical help should be sought 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 affect. The attending doctor will check this.

Targocid and other medicines

The doctor, pharmacist, or nurse should be informed 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. Also, some medicines may affect the action of Targocid.
In particular, the doctor, pharmacist, or nurse should be informed about the use of the following medicines:

• 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 malignant tumors, can cause hearing or kidney function disorders.
• diuretics (such as furosemide) - also called "diuretics", can cause hearing or kidney function disorders.

If any of the above points apply to the patient (or the patient is unsure), the doctor, pharmacist, or nurse should be consulted before taking Targocid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult a doctor, pharmacist, or nurse before taking this medicine.
They will decide whether the medicine can be given to the patient during pregnancy. There is a risk of damage to the inner ear and kidney function disorders.
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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Studies on the effect on fertility conducted in animals did not show any evidence of fertility disorders.

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 vehicles or operate any tools or machines.

Targocid contains sodium

1 vial of the medicine contains less than 1 mmol of sodium (23 mg), which means that the medicine is considered "sodium-free".

3. How to take Targocid

The medicine is available in the following doses: 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, administered as 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, administered as an intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight, administered once a day as 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 Targocid is administered

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 by intravenous infusion. In infants from birth to 2 months, only infusion should be used. In the treatment of some infections, the solution may be taken orally (oral administration).

Taking a higher dose of Targocid than recommended

It is unlikely that the doctor or nurse will administer too much of the medicine.
If the patient thinks they have received too much Targocid or if the patient is agitated, they should immediately consult a doctor or nurse.

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 a doctor or nurse.

Stopping treatment with Targocid

Treatment with Targocid should not be stopped without prior consultation with a doctor, pharmacist, or nurse.
In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

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

Severe side effects

If any of the following severe side effects occur, treatment should be discontinued and a doctor or nurse should be consulted immediately – the patient may need urgent medical attention.

Uncommon(may occur in less than 1 in 100 patients):

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

Rare(may occur in less 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 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 any of the above side effects occur, the doctor or nurse should be informed immediately.

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

  Uncommon(may occur in less 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 white blood cell count.

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

  • lack of white blood cells - symptoms may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
  • low count of all types of blood cells
  • kidney function disorders or changes in kidney function - visible in tests. In the case of administering higher doses to the patient, there may be an increased frequency or severity of kidney function disorders
  • seizures. If any of the above side effects occur, the doctor or nurse should be informed immediately.

  Other side effects

  The doctor, pharmacist, or nurse should be consulted if the patient experiences any of the following side effects:
  Common(may occur in less than 1 in 10 patients)

  • rash, redness, itching
  • pain
  • fever.

  Uncommon(may occur in less than 1 in 100 patients):

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

  Rare(may occur in less than 1 in 1,000 patients)

  • infection (abscess).

  Frequency not known(frequency 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 any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed.
  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, 02-222 Warsaw
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  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 collected on the safety of the medicine.

  5. How to store Targocid

  The medicine should be stored out of sight and reach of children.
  The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 the medicine 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 packaging 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 made of colorless glass type I with a usable 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 made 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 Romania, the country of export:

  Sanofi Romania SRL
  Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, sector 2, Bucharest, Romania

  Manufacturer:

  Sanofi S.p.A.
  Via Valcanello, 4, 03012 Anagni, Italy

  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
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  Marketing authorization number in Romania, the country of export: 7869/2015/01

  Parallel import authorization number: 446/22 Date of approval of the leaflet: 28.12.2022

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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.
  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 by 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.
  Preparing the solution by dissolving the powder

  • 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.

  Diluting 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
  • 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 powder was dissolved and the solution was diluted in controlled and validated aseptic conditions.
  Disposal

  Nominal content of teicoplanin 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

  Disposal of the medicinal product and its waste should be carried out in accordance with local regulations.
  [Information about the trademark]
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