Teikoplanina Bradex

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Teicoplanin, 200 mg, powder and solvent for solution for injection/infusion or oral solution

for injection/infusion or oral solution

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

Teicoplanin

It is essential to carefully read the content of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient 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 Teicoplanin and what is it used for
• 2. Important information before taking Teicoplanin
• 3. How to take Teicoplanin
• 4. Possible side effects
• 5. How to store Teicoplanin
• 6. Package contents and other information

1. What is Teicoplanin and what is it used for

Teicoplanin is an antibiotic. It contains the active substance "teicoplanin".
It works by killing the bacteria that cause infections in the body.
Teicoplanin is used in adults and children (including newborns) to treat bacterial infections:

• of the skin and subcutaneous tissue - sometimes called "soft tissue";
• of bones and joints;
• of the lungs;
• of the urinary tract;
• of the heart - sometimes called "endocarditis";
• of the abdominal cavity lining - peritonitis;
• of the blood, as a result of any of the above conditions.

Teicoplanin can be used to treat some infections caused by the bacterium Clostridium difficilein the intestines. The solution is taken orally in this case.

2. Important information before taking Teicoplanin

When not to take Teicoplanin:

• 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 to take Teicoplanin, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient is allergic to the antibiotic "vancomycin";
• the patient has experienced a red man syndrome (upper body rash);
• the patient has a reduced platelet count (thrombocytopenia);
• the patient has kidney problems;
• the patient is taking other medicines that may cause hearing and/or kidney problems. The patient may need to have regular tests to check the functioning of their kidneys and/or liver (see "Teicoplanin 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 taking Teicoplanin.

Lab tests

During treatment, blood tests, kidney function tests, liver function tests, and/or hearing tests may be performed. This is more likely if:

• treatment is to be long-term;
• the patient will be treated with high loading doses (12 mg/kg twice daily);
• the patient has kidney problems;
• the patient is taking or may start taking other medicines that affect the nervous system, kidneys, or hearing.

In patients taking Teicoplanin for a long time, bacteria that the antibiotic does not affect may develop more intensively than usual - the doctor will check this.

Teicoplanin and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Teicoplanin may affect the way some other medicines work. Some medicines may also affect the way Teicoplanin works.
In particular, the patient should inform their doctor, pharmacist, or nurse if they are taking:

• Aminoglycosides, as they should not be mixed with Teicoplanin in the same injection. They may also cause hearing and/or kidney problems.
• Amphotericin B - an antifungal medicine that may cause hearing and/or kidney problems.
• Cyclosporin - an immunosuppressant that may cause hearing and/or kidney problems.
• Cisplatin - a cancer medicine that 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 any of the above points apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Teicoplanin.

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 or pharmacist before taking this medicine. These individuals will decide whether the patient can be given the medicine during pregnancy. This may pose a risk to the inner ear and kidneys.
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 Teicoplanin.
Studies in animals have not shown any fertility problems.

Driving and using machines

During treatment with Teicoplanin, the patient may experience headaches or dizziness. In this case, they should not drive or use any tools or machines.

Teicoplanin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is essentially "sodium-free".

3. How to take Teicoplanin

The medicine is administered to the patient by a healthcare professional in a hospital.

Recommended dose:

Adults and children (12 years and older) without kidney problems

Skin and soft tissue, lung, 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

Infections 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 kidney problems

In patients with kidney problems, the dose should usually be reduced after the fourth day of treatment:

• In patients with mild to moderate kidney problems - the maintenance dose will be administered every two days or half the maintenance dose will be administered once daily.
• In patients with severe kidney problems or those undergoing hemodialysis - the maintenance dose will be administered every three days or one-third of the maintenance dose will be administered once daily.

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:

• In the first week: 20 mg/L in each dialysis bag
• In the second week: 20 mg/L in every other dialysis bag
• In the third week: 20 mg/L in the overnight bag

Use in newborns and 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 daily as an intravenous infusion.

Use in 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 daily by intravenous injection.

Method of administration of Teicoplanin

This medicine is usually administered by a doctor or nurse.

• It is administered by injection into a vein (intravenous use) or into a muscle (intramuscular use).
• It can also be administered as an infusion into a vein.

Infants from birth to 2 months should only be given an infusion.
The solution can also be taken orally to treat certain infections.

In case of overdose of Teicoplanin

It is unlikely that a doctor or nurse will give the patient too much medicine. However, if the patient thinks they have been given too much Teicoplanin or are feeling unwell, they should immediately consult their doctor or nurse.

Missing a dose of Teicoplanin

The doctor or nurse will have instructions on when to give the patient Teicoplanin. It is unlikely that they will give the patient the medicine at the wrong time. However, if the patient has concerns, they should consult their doctor or nurse.

Stopping treatment with Teicoplanin

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

4. Possible side effects

Like all medicines, Teicoplanin 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 immediately consult their doctor or nurse – they may need urgent medical attention.

Uncommon (may affect up to 1 in 100 people)

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

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

• red man syndrome

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

• blistering of the skin, mouth, eyes, or genitals - these may be symptoms of a condition called "toxic epidermal necrolysis (Lyell's syndrome)" or "Stevens-Johnson syndrome" or "drug reaction with eosinophilia and systemic symptoms (DRESS)". DRESS initially appears as flu-like symptoms and a rash on the face, then as a widespread rash with a high temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

If the patient experiences any of the following severe side effects, they should immediately consult their doctor or nurse – they may need urgent medical attention.

Uncommon (may affect up to 1 in 100 people)

• swelling and blood clots in a vein
• shortness of breath or wheezing (bronchospasm)
• increased susceptibility to infections - these may be signs of a decrease in white blood cell count

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

• lack of white blood cells - signs may include: fever, severe chills, sore throat, or mouth ulcers (agranulocytosis)
• low levels of all types of blood cells
• kidney problems or changes in kidney function - visible in tests. When given in 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 immediately inform their doctor or nurse.

Other side effects

If the patient experiences any of the following side effects, they should consult their doctor, pharmacist, or nurse.
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 enzymes 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 (vomiting), diarrhea
• dizziness or headache

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

• infection (abscess)

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

• problems at the injection site - such as redness, pain, or swelling

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, PL-02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Teicoplanin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label of the vial/ampoule after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
For single use only. Discard any unused solution.
Shelf life of the prepared solution:
The chemical and physical stability of the prepared solution has been demonstrated for 24 hours at a temperature of 2 to 8°C.
Shelf life of the further diluted solution:
The chemical and physical stability of the solution prepared according to the instructions has been demonstrated for 24 hours at a temperature of 2 to 8°C and for an additional 24 hours at a temperature of 2 to 8°C after further dilution to a final concentration between 4 mg/mL and 20 mg/mL.
From a microbiological point of view, if the method of opening/mixing/dilution does not exclude the risk of microbial contamination, the product should be used immediately.
If not used immediately, the time and conditions of storage before use are the responsibility of the user and are usually not more than 24 hours at a temperature of 2 to 8°C, provided that the solution/diluted solution was prepared in controlled and validated aseptic conditions.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. Package contents and other information

What Teicoplanin contains

• The active substance of the medicine is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are sodium chloride, sodium hydroxide 0.1 N (to adjust pH) in the powder, and water for injections in the solvent.

What Teicoplanin looks like and contents of the pack

Teicoplanin is a powder and solvent for solution for injection/infusion or oral solution. The powder is white or almost white. The solvent is a clear and colorless solution.
The powder is packed in glass vials closed with a rubber stopper and an aluminum seal with a plastic flip-off cap.
The solvent is packed in ampoules made of colorless glass or polypropylene (PP) ampoules with a twist-off closure.
Package sizes:
Teicoplanin BRADEX, 200 mg:
A carton containing 1 vial of 200 mg teicoplanin + 1 ampoule containing 3 mL of solvent.
A carton containing 10 vials of 200 mg teicoplanin + 10 ampoules containing 3 mL of solvent each.
Teicoplanin BRADEX, 400 mg:
A carton containing 1 vial of 400 mg teicoplanin + 1 ampoule containing 3 mL of solvent.
A carton containing 10 vials of 400 mg teicoplanin + 10 ampoules containing 3 mL of solvent each.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

BRADEX S.A.
Asklipiou 27
14568 Kryoneri, Attiki
Greece

Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY
21st km National Road Athens-Lamia
14568 Krioneri, Attiki
Greece
Phone:+30 210 8161802, Fax:+30 2108161587

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Teicoplanine DEMO 200 mg & 400 mg powder and solvent for solution for injection/infusion or oral solution
France
TEICOPLANINE BRADEX 200 mg & 400 mg, powder and solvent for injectable solution/infusion or oral solution
Belgium
Teicoplanin BRADEX 200 mg & 400 mg powder and solvent for injectable solution/infusion or oral solution - powder and solvent for solution for injection/infusion or oral solution - Pulver und Lösungsmittel zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen
Italy
Teicoplanina BRADEX
Poland
Teikoplanina BRADEX
Sweden
Teicoplanin Bradex 200 mg & 400 mg powder and solvent for injection/infusion solution, solution
Date of last revision of the leaflet:08/2024.
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Information intended for healthcare professionals only:

Practical information for healthcare professionals on the preparation of the medicine and handling of Teicoplanin.

This medicinal product is for single use only. Discard any unused solution.
Method of administration
Teicoplanin should be administered intravenously or intramuscularly. The solution can be administered intravenously in an injection lasting from 3 to 5 minutes or in a 30-minute infusion.
In newborns and infants (from birth to 2 months), only an infusion should be used.
The prepared solution can also be administered orally.
Preparation of the solution from the powder:

• Slowly inject 3.0 mL of the supplied solvent into the vial of powder.
• Gently rotate the vial in the hands until the powder is completely dissolved. If the solution becomes frothy, leave it to stand for about 15 minutes. Only clear, yellowish solutions should be used.

pH: 7.2 – 7.8
Osmolality: 264 – 275 mOsm / kg (200 mg dose) and 285 – 305 mOsm / kg (400 mg dose)
Therefore, the prepared solutions are isotonic and do not require further dilution before administration.
Preparation of the diluted solution before infusion:
Teicoplanin can be administered in the following infusion solutions at a final concentration of 4 mg/mL to 20 mg/mL:
Sodium chloride 9 mg/mL (0.9%) solution for infusion
Dextrose 50 mg/mL (5%) solution for infusion
Ringer's solution with lactate
Sodium chloride 1.8 mg/mL (0.18%) and dextrose 40 mg/mL (4%) solution for infusion
Peritoneal dialysis solution containing dextrose at a concentration of 13.6 mg/mL (1.36%).
Peritoneal dialysis solution containing dextrose at a concentration of 38.6 mg/mL (3.86%).
Ringer's solution
Dextrose 100 mg/mL (10%) solution
Sodium chloride 4.5 mg/mL (0.45%) and dextrose 50 mg/mL (5%) solution for infusion
Shelf life of the prepared solution:
The chemical and physical stability of the prepared solution has been demonstrated for 24 hours at a temperature of 2 – 8°C.
Shelf life of the further diluted solution:
The chemical and physical stability of the solution prepared according to the instructions has been demonstrated for 24 hours at a temperature of 2 – 8°C and for an additional 24 hours at a temperature of 2 – 8°C after further dilution to a final concentration between 4 mg/mL and 20 mg/mL.
From a microbiological point of view, the prepared and/or further diluted solution should be used immediately. If not used immediately, the time and conditions of storage before use are the responsibility of the user and are usually not more than 24 hours at a temperature of 2 to 8°C, provided that the solution/diluted solution was prepared in controlled and validated aseptic conditions.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.