Teicopix

Package leaflet: Information for the patient

Teicopix, 200 mg
powder and solvent for solution for injection/infusion or for oral solution
Teicopix, 400 mg
powder and solvent for solution for injection/infusion or for oral solution
Teicoplanin
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.

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

Table of contents

1. What Teicopix is and what it is used for
2. What you need to know before using Teicopix
3. How to use Teicopix
4. Possible side effects
5. How to store Teicopix
6. Contents of the pack and other information

1. What Teicopix is and what it is used for

Teicopix is an antibiotic. It contains the active substance called teicoplanin, which kills bacteria
(bactericidal action) causing infection in the patient's body.
Teicoplanin is used in adults and children (including newborns) for the treatment of 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);
abdominal cavity (peritonitis);
bloodstream, if caused by any of the above conditions.
Teicopix may be used in the treatment of certain infections caused by Clostridium difficile –
bacteria present in the intestines. In such infections, the medicinal solution is administered orally.

2. Important information before using Teicopix

When not to use Teicopix:
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 using Teicopix, discuss with your doctor, pharmacist, or nurse if the patient:
is allergic to an antibiotic called vancomycin,
experiences redness of the upper body („red man syndrome”),
has a low platelet count (thrombocytopenia),
has impaired kidney function,
is taking other medicines that may cause hearing problems and/or kidney problems.

The doctor may order regular tests to monitor blood counts and/or kidney and (or) liver function (see “Teicopix and other medicines”).

If any of the above conditions apply to the patient (or if the patient is unsure), consult a doctor, pharmacist, or nurse before administering Teicopix.

Monitoring tests
During treatment, the patient may undergo tests to monitor blood, liver function, kidney function, and/or hearing. This is more likely if:
treatment is prolonged,
high loading doses (12 mg/kg twice daily) are required,
the patient has impaired kidney function,
the patient is taking or may take other medicines affecting the nervous system, kidneys, or hearing.

In patients receiving Teicopix for a long time, there may be an increased risk of overgrowth of bacteria not susceptible to the antibiotic. The doctor will monitor for this.

Teicopix and 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. Teicopix may affect the action of other medicines, and other medicines may affect the action of Teicopix.

Especially inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:
aminoglycoside antibiotics, as they must not be mixed with Teicopix in the same injection; they may also cause hearing and/or kidney problems;
amphotericin B (a medicine used to treat fungal infections), which may cause hearing and/or kidney problems;
cyclosporine (a medicine affecting the immune system), which may cause hearing and/or kidney problems;
cisplatin (a medicine used to treat malignant tumours), which may cause hearing and/or kidney problems;
diuretics such as furosemide (also known as “water tablets”), which may cause hearing and/or kidney problems.

If the patient is receiving any of these medicines (or is unsure), consult a doctor, pharmacist, or nurse before administering Teicopix.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, pharmacist, or nurse before using this medicine.

The doctor will decide whether the medicine can be given 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 receiving this medicine. The doctor will decide whether she can continue breastfeeding during treatment with Teicopix.

Animal studies on reproductive toxicity did not show effects on fertility.

Driving and operating machinery
Teicopix may cause headache or dizziness. If the patient experiences these symptoms, he or she should not drive or operate tools or machinery.

Teicopix contains sodium
Teicopix, 200 mg, 400 mg
This medicine contains 9.45 mg of sodium (the main component of table salt) per vial. This corresponds to 0.47% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Teicopix

Recommended dosage

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

Skin and soft tissue infections, lung infections, and urinary tract infections
Initial dose (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 (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 bacteria
Recommended dose: 100 to 200 mg administered orally twice daily for 7 to 14 days.

Adults and elderly patients with impaired kidney function
In patients with impaired kidney function, dose reduction is usually required after the fourth day of treatment:
patients with mild to moderate kidney impairment will receive the maintenance dose every two days or half the maintenance dose once daily;
patients with severe kidney impairment or undergoing hemodialysis will receive the maintenance dose every three days or one-third of the maintenance dose once daily.

Peritonitis in patients undergoing peritoneal dialysis
Initial dose: 6 mg per kilogram of body weight as a single intravenous injection, followed by:
first week: 20 mg/L in each dialysis bag
second week: 20 mg/L in every second dialysis bag
third week: 20 mg/L 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 by intravenous infusion.
Maintenance dose: 8 mg per kilogram of body weight administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)
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 daily by intravenous injection.

How Teicopix is administered
The medicine is usually administered by a doctor or nurse.
Teicopix is given by intravenous injection or intramuscular injection.
It may also be given by intravenous infusion (drip infusion).
In infants from birth to 2 months of age, the medicine must be administered only by infusion.
For the treatment of certain infections, the solution may be taken orally (oral administration).

Overdose of Teicopix
It is unlikely that a doctor or nurse would administer too high a dose. However, if the patient feels that too much Teicopix has been given, or if the patient feels agitated, seek immediate medical advice from a doctor or nurse.

Missed dose of Teicopix
The doctor or nurse will know when to administer Teicopix to the patient. It is unlikely they would administer it incorrectly. However, if the patient has any doubts, consult the doctor or nurse.

Stopping Teicopix treatment
Do not stop taking Teicopix without first consulting your doctor, pharmacist, or nurse.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If the patient experiences any of the serious adverse reactions described below, treatment must be
discontinued and medical advice must be sought immediately from a doctor or nurse – urgent medical
assistance may be required.
Uncommon (may occur in fewer than 1 in 100 patients):
sudden life-threatening allergic reaction with symptoms such as: difficulty breathing or
wheezing, swelling, rash, itching, fever, chills.
Rare (may occur in fewer than 1 in 1000 patients):
redness of the upper body.
Frequency not known (cannot be estimated from available data):
formation of blisters on the skin, inside the mouth, eyes or genital organs – these may be
symptoms of diseases called "toxic epidermal necrolysis", "Stevens-Johnson syndrome", or
"drug reaction with eosinophilia and systemic symptoms (DRESS)". Initially, DRESS presents
with flu-like symptoms and a rash on the face, followed by widespread rash, high fever, increased
liver enzyme activity detected in blood tests, increased eosinophil count (a type of white blood cell),
and enlarged lymph nodes.
If any of these adverse reactions occur, medical advice must be sought immediately from a
doctor or nurse.
If the patient experiences any of the following serious adverse reactions, treatment must be
discontinued and medical advice must be sought immediately from a doctor or nurse – urgent
medical assistance may be required.
Uncommon (may occur in fewer than 1 in 100 patients):
vein swelling and blood clot in a vein
difficulty breathing or wheezing (bronchospasm)
increased susceptibility to infections – these may be symptoms of decreased white blood cell count.
Frequency not known (cannot be estimated from available data):
absence of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
kidney dysfunction or changes in kidney function – detectable in tests. The frequency or severity of kidney problems may increase when higher doses of the medicine are used.
seizures
low levels of all types of blood cells
If any of these adverse reactions occur, medical advice must be sought immediately from a
doctor or nurse.
Other adverse reactions
Consult a doctor, pharmacist, or nurse if any of the following symptoms occur.
Common (may occur in fewer than 1 in 10 patients):
rash, redness, itching
pain
fever
Uncommon (may occur in fewer than 1 in 100 patients):
decreased platelet count
increased liver enzyme activity
increased blood creatinine levels (a marker of kidney function)
hearing loss, ringing in the ears or sensation of spinning
nausea or vomiting, diarrhoea
dizziness or headache
Rare (may occur in fewer than 1 in 1000 patients):
infection (abscess)
Frequency not known (frequency cannot be estimated from available data):
reaction at the injection site, e.g. redness, pain or swelling of the skin
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Teicopix
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Information on storage conditions for Teicopix after reconstitution and the period of use are described in the section "Practical information for healthcare professionals on preparation and handling of Teicopix".
Do not store in a syringe.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Teicopix contains
The active substance is teicoplanin.
Each vial contains 200 mg of teicoplanin (200,000 IU). After reconstitution, the solution contains
respectively: 200 mg teicoplanin in 3.0 mL.
Each vial contains 400 mg of teicoplanin (400,000 IU). After reconstitution, the solution contains
respectively: 400 mg in 3.0 mL.
The other components are:
powder: sodium chloride and, if necessary, sodium hydroxide for pH adjustment (see the information on sodium at the end of section 2);
solvent: water for injections.

What Teicopix looks like and contents of the pack
Teicopix is a powder for solution for injection/infusion or for oral solution, supplied with a solvent. The powder is white to slightly yellowish in colour. The solvent is a clear liquid free from solid particles.
The powder is packed in:
vials made of colourless type I glass with a nominal capacity of 10 mL for the 200 mg strength, closed with a bromobutyl rubber stopper, aluminium seal and green flip-off plastic cap, packed in a cardboard box;
vials made of colourless type I glass with a nominal capacity of 22 mL for the 400 mg strength, closed with a bromobutyl rubber stopper, aluminium seal and blue flip-off plastic cap, packed in a cardboard box.
The solvent is packed in ampoules made of colourless type I glass and contains 3 mL (for both 200 mg and 400 mg strengths).

Pack sizes:

• 1 vial of powder + 1 ampoule of solvent
• 5 vials of powder + 5 ampoules of solvent
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

For further information about this medicine, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Teicoplanin Sandoz – Austria
Planitec – Bulgaria
Teicoplanina Sandoz – Italy
Teicoplanine Sandoz – Netherlands
Teicoplanin Sandoz – Sweden
Teicoplanin – United Kingdom (Northern Ireland)

(Responsible entity logo)

Information intended exclusively for healthcare professionals

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

• Slowly inject the entire contents of the supplied 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. Only clear, slightly yellow solutions should be used.

The resulting solution contains either 200 mg of teicoplanin in 3.0 mL or 400 mg of teicoplanin in 3.0 mL.
The final solution is isotonic with serum and has a pH of 7.2–7.8.

Dilution of the solution prior to infusion
Teicopix may 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 with 4% glucose solution
• peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Shelf life of the solution after reconstitution and dilution
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 it is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and storage should generally not exceed 24 hours at a temperature of 2 to 8°C.

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