Teicopix

Leaflet attached to the packaging: patient information

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

Teicopix (Teicoplanin Sandoz)

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

preparing an oral solution
Teicoplaninum
Teicopix and Teicoplanina Sandoz are different trade names for the same medicine.

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

• The leaflet should be kept so that it can be read again if necessary.
• 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 Teicopix and what is it used for
• 2. Important information before using Teicopix
• 3. How to use Teicopix
• 4. Possible side effects
• 5. How to store Teicopix
• 6. Contents of the packaging and other information

1. What is Teicopix and what is it used for

Teicopix is an antibiotic. It contains the active substance teicoplanin, which kills bacteria (bactericidal action) that cause infection in the patient's body.
Teicoplanin 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);
• in the abdominal cavity (peritonitis);
• of the blood, if caused by any of the above conditions.

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

• bacteria in the intestines. In the treatment of such infections, the solution is taken orally.

2. Important information before using Teicopix

When not to use Teicopix:

is allergicto teicoplanin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using Teicopix, you should discuss it with your doctor, pharmacist, or nurse if the patient:

• is allergic to the antibiotic vancomycin,
• has a red upper body („red man syndrome”),
• has a decreased platelet count (thrombocytopenia), Page 1 8
• has kidney function disorders,
• takes other medicines that may cause hearing disorders and/or kidney function disorders. The doctor may prescribe regular tests to check the blood morphology and kidney and/or liver function (see „Teicopix and other medicines”).

If any of the above conditions apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before Teicopix is administered.

Tests

During treatment, the patient may have tests to check their blood, liver, kidney, and/or hearing function. This is more likely if:

• treatment is long-term,
• high loading doses are required (12 mg/kg twice a day)
• the patient has kidney function disorders,
• the patient is taking or may take other medicines that may affect the nervous system, kidneys, or hearing. In people receiving Teicopix for a long time, there may be a higher than usual increase in bacteria that the antibiotic does not affect. The doctor will check this.

Teicopix and other medicines

You should tell your doctor, pharmacist, or nurse about all the medicines the patient is taking or has recently taken, as well as any medicines they plan to take. Teicopix may affect the action of other medicines, and other medicines may affect the action of Teicopix.
You should especially tell your doctor, pharmacist, or nurse if the patient is taking:

• aminoglycoside antibiotics, as they should not be mixed with Teicopix in the same injection; they may also cause hearing disorders and/or kidney function disorders;
• amphotericin B (a medicine used to treat fungal infections) may cause hearing disorders and/or kidney function disorders;
• cyclosporine (a medicine that affects the immune system) may cause hearing disorders and/or kidney function disorders;
• cisplatin (a medicine used to treat cancer) may cause hearing disorders and/or kidney function disorders;
• diuretics, such as furosemide (also called „water pills”), may cause hearing disorders and/or kidney function disorders.

If the patient is taking any of these medicines (or is unsure), they should consult their doctor, pharmacist, or nurse before Teicopix is administered.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before using this medicine.
The doctor will decide whether the medicine can be given to the pregnant patient. 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 receiving this medicine.
The doctor will decide whether the patient can breastfeed while taking Teicopix.
Studies on the effect on fertility in animals have not shown any effect on fertility.

Driving and using machines

Teicopix may cause headache or dizziness. If the patient experiences these symptoms, they should not drive or use any tools or machines.
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Teicopix contains sodium

This medicine contains 9.45 mg of sodium (the main component of common salt) per vial. This is equivalent to 0.47% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Teicopix

Teicopix is available in 200 mg and 400 mg doses.

Recommended dosage

Adults and adolescents (12 years and older) with normal kidney function

Infections of the skin and subcutaneous tissue, lungs, and urinary tract

• Initial dose (first three doses): 6 mg per kilogram of body weight administered every 12 hours by intravenous injection or intramuscularly.
• Maintenance dose: 6 mg per kilogram of body weight administered once a day by intravenous injection or intramuscularly.

Infections of the bones and joints and heart infections

• Initial dose (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 injection or intramuscularly.

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

Adults and elderly patients with kidney function disorders

In patients with kidney function disorders, it is usually necessary to reduce the dose after the fourth day of treatment:

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

• Initial dose (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 Teicopix is administered

The medicine is usually administered by a doctor or nurse.

• The medicine will be administered by intravenous injection (intravenous administration) or intramuscularly.
• It can also be administered by intravenous infusion (drip).

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

Administration of a higher dose of Teicopix than recommended

It is unlikely that a doctor or nurse will administer too much Teicopix. However, if the patient thinks they have received too much Teicopix or if they are agitated, they should immediately consult a doctor or nurse.

Missing a dose of Teicopix

The doctor or nurse will know when to administer Teicopix to the patient. It is unlikely that they will administer the medicine contrary to the recommendations. However, if the patient has doubts, they should consult a doctor or nurse.

Stopping the use of Teicopix

The patient should not stop taking the medicine without first consulting their doctor, pharmacist, or nurse.
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, Teicopix 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 the treatment and immediately consult a doctor or nurse – emergency medical attention may be necessary.

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

• life-threatening allergic reactionwith symptoms such as: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

Rare(may occur in less than 1 in 1000 patients)

• redness of the upper body.

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

• blistering of the skin, mouth, eyes, or genitals - these may be symptoms of diseases called „toxic epidermal necrolysis” or „Stevens-Johnson syndrome” or „drug rash with eosinophilia and systemic symptoms (DRESS)”. Initially, DRESS occurs as flu-like symptoms and a rash on the face, then a widespread rash with high fever, increased liver enzyme activity in blood tests, and increased eosinophil count (a type of white blood cell) and lymph node enlargement.

If the patient experiences any of these side effects, they should immediately consult a doctor or nurse.

If the patient experiences any of the following severe side effects, they should stop the treatment and immediately consult a doctor or nurse – emergency medical attention may be necessary.

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

• vein swelling and blood clot in the vein
• difficulty breathing or wheezing (bronchospasm)
• increased susceptibility to infections - these may be symptoms of a decrease in white blood cell count.

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 their function - visible in tests. The frequency or severity of kidney problems may increase when using higher doses of the medicine.
• seizures.
• low levels of all types of blood cells

If the patient experiences any of these side effects, they should immediately consult a doctor or nurse.

Other side effects

The patient should consult their doctor, pharmacist, or nurse if they experience any of the following symptoms.
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)

• decreased platelet count
• increased liver enzyme activity
• increased creatinine levels in the blood (a indicator of kidney function)
• hearing loss, ringing in the ears, or feeling of spinning
• nausea or vomiting, diarrhea
• dizziness or headache

Rare(may occur in less than 1 in 1000 patients)

• infection (abscess)

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

• reaction at the injection site, e.g. 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, 02-222 Warsaw, Tel.: + 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 Teicopix

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.
Do not store above 25°C.
Information on the storage conditions of Teicopix after reconstitution and its shelf-life are described in the section „Practical information for healthcare professionals on handling and preparing Teicopix”.
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Do not store in a syringe.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Teicopix contains

The active substance of the medicine is teicoplanin.

• Each vial contains 400 mg of teicoplanin (400,000 IU). After reconstitution, the solution contains: 400 mg of teicoplanin in 3.0 mL
• Other ingredients are:
• powder: sodium chloride and, if necessary, sodium hydroxide to adjust the pH (see information on sodium at the end of section 2);
• solvent: water for injections.

What Teicopix looks like and what the pack contains

Teicopix is a powder for solution for injection/infusion or for preparing an oral solution, with a solvent attached. The powder is white to slightly yellowish.
The solvent is a clear liquid without solid particles.
The powder is packaged in vials made of colorless glass type I with a capacity of 22 mL for 400 mg, closed with a bromobutyl rubber stopper, aluminum seal, and a plastic cap (flip-off type).
The solvent is packaged in an ampoule made of colorless glass type I and contains 3 mL.
Pack sizes:

• 1 vial with powder + 1 ampoule with solvent 3 mL
• 5 vials with powder + 5 ampoules with solvent 3 mL

For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

Sandoz S.p.A., L.go U. Boccioni 1 - 21040 Origgio (VA), Italy

Manufacturer:

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, 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
Italian authorization number: 041769050
041769062

Parallel import authorization number: 191/23

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Teicoplanin Sandoz - Austria
Planitec – Bulgaria
Teicoplanina Sandoz – Italy
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Teicoplanine Sandoz – Netherlands
Teicoplanin Sandoz – Sweden
Teicoplanin – United Kingdom (Northern Ireland)
Date of approval of the leaflet: 11.09.2023
[Information on the trademark]
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Information intended exclusively for healthcare professionals

Practical information for healthcare professionals on handling and preparing Teicopix

This medicinal product is intended for single use.
Method of administration
The solution obtained after reconstitution of the powder can be injected directly or further diluted.
The solution can be administered by intravenous injection (bolus) lasting from 3 to 5 minutes or in a 30-minute infusion.
In infants from birth to 2 months, the medicine should only be administered by infusion.
The solution obtained after reconstitution of the powder can also be administered orally.
Preparation of the solution

• The entire contents of the attached solvent should be slowly injected into the vial with the powder.
• 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. Only clear and yellowish solutions should be used.

The resulting solution contains 400 mg of teicoplanin in 3.0 mL.
The final solution is isotonic with blood serum and has a pH of 7.2-7.8.

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

• 9 mg/mL (0.9%) sodium chloride solution
• Ringer's solution
• Hartmann's solution
• 5% glucose solution for injection
• 0.18% sodium chloride solution with 4% glucose solution
• peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Shelf-life of the solution obtained after reconstitution of the powder and dilution
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.
For microbiological reasons, the medicinal product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions prior to use, and the storage time should not normally exceed 24 hours at a temperature of 2 to 8°C.
Disposal

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