Teicoplanin bradex

Package leaflet: Information for the patient

Teikoplanina BRADEX, 200 mg, powder and solvent for solution for
injection/infusion
Teikoplanina BRADEX, 400 mg, powder and solvent for solution for
injection/infusion
Teicoplaninum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

1. What Teikoplanina is and what it is used for

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

• skin and subcutaneous tissue – sometimes referred to as "soft tissue";
• bones and joints;
• lungs;
• urinary tract;
• heart – sometimes referred to as "endocarditis";
• peritoneal membranes – peritonitis;
• blood, resulting from any of the above conditions.

Teicoplanin may also be used to treat certain infections caused by Clostridium difficile bacteria in the intestine. In such cases, the solution is taken orally.

2. Important information before taking Teikoplanina BRADEX

When not to take Teikoplanina:

• 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 starting treatment with Teikoplanina BRADEX, consult a doctor, pharmacist,
or nurse if:

• the patient is allergic to an antibiotic called "vancomycin";
• the patient has experienced a redness of the upper body (red man syndrome);
• the patient has a low 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 be regularly monitored to check kidney and/or liver function (see: "Teikoplanina BRADEX and other medicines").

If any of the above conditions apply to the patient (or the patient is unsure), contact a doctor, pharmacist, or nurse before taking Teikoplanina BRADEX.

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

• treatment is expected 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 affecting the nervous system, kidneys, or hearing.

In patients receiving Teikoplanina BRADEX for a prolonged period, bacteria that are not susceptible to the antibiotic may grow more than usual—your doctor will monitor this.

Teikoplanina BRADEX and other medicines
Inform 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. Teikoplanina BRADEX may affect the way some other medicines work. Some medicines may also affect how Teikoplanina BRADEX works.

In particular, inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• Aminoglycosides, because they must not be mixed with Teikoplanina BRADEX 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.
• Cyclosporine – an immunosuppressive medicine that may cause hearing and/or kidney problems.
• Cisplatin – an anticancer medicine that may cause hearing and/or kidney problems.
• Diuretics (such as furosemide) – also called water tablets, which may cause hearing and/or kidney problems.

If any of the above apply to the patient (or the patient is unsure), contact a doctor, pharmacist, or nurse before taking Teikoplanina BRADEX.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient can be given Teikoplanina BRADEX during pregnancy. Use during pregnancy may pose risks to the inner ear and kidneys.

If the patient is breastfeeding, she should inform the doctor before taking this medicine. The doctor will decide whether the patient can continue breastfeeding while taking Teikoplanina BRADEX.

Animal fertility studies have not shown any adverse effects on fertility.

Driving and operating machinery
During treatment with teicoplanin, the patient may experience headache or dizziness. In such cases, the patient should not drive or operate any tools or machinery.

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

3. How to take Teikoplanina BRADEX

The medicine is administered to the patient by a healthcare professional in a hospital.
Recommended dose:
Adults and children (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 as intravenous or intramuscular injections
• Maintenance dose: 6 mg per kilogram of body weight, administered once daily as intravenous or intramuscular injections

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 as intravenous injections
• Maintenance dose: 12 mg per kilogram of body weight, administered once daily as intravenous or intramuscular injections

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 is usually reduced after the fourth day of treatment:

• In patients with mild to moderate kidney impairment – the maintenance dose should be administered every two days, or half the maintenance dose should be given once daily.
• In patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose should be given 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, followed by:

• 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 bag left in overnight

Use in newborns and infants (from birth to 2 months of age)

• 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 of age)

• Initial dose (first three doses): 10 mg per kilogram of body weight, administered every 12 hours as an intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once daily as an intravenous injection.

How Teikoplanina BRADEX is administered
This medicine is usually administered by a doctor or nurse.

• It is given by injection into a vein (intravenous administration) or into a muscle (intramuscular administration).
• It may also be given as an intravenous infusion (by drip into a vein).

Infants from birth to 2 months of age should receive the medicine only as an infusion.
For the treatment of certain infections, the solution may be taken orally (oral administration).
If you take more Teikoplanina BRADEX than you should
It is unlikely that a doctor or nurse would administer too high a dose. However, if the patient thinks they have received too much Teikoplanina BRADEX or feel agitated, they should contact a doctor or nurse immediately.
If you miss a dose of Teikoplanina BRADEX
The doctor or nurse will have instructions on when to administer Teikoplanina BRADEX to the patient. It is unlikely they will give the medicine incorrectly. However, if the patient has any concerns, they should contact their doctor or nurse.
Stopping Teikoplanina BRADEX
Do not stop taking this medicine without first consulting your doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Serious adverse reactions
If any of the following serious adverse reactions occur, stop treatment immediately and contact a doctor or nurse straight away – the patient may need urgent medical attention.

Uncommon ( may occur in 1 out of 100 patients)

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

Rare (may occur in 1 out of 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 genital organs – these may be symptoms of a disease called “toxic epidermal necrolysis [Lyell’s syndrome]” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms” (DRESS). Initially, DRESS presents as flu-like symptoms and facial rash, followed by widespread rash with high fever, elevated liver enzymes in blood tests, increased number of certain white blood cells (eosinophilia), and swollen lymph nodes.

If any of the above adverse reactions occur, inform a doctor or nurse immediately.

If any of the following serious adverse reactions occur, contact a doctor or nurse immediately – the patient may need urgent medical attention.

Uncommon ( may occur in 1 out of 100 patients)

• Swelling and blood clots in a vein
• Shortness of breath or wheezing (bronchospasm)
• Increased susceptibility to infections – these may be signs of reduced white blood cell count

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

• Absence of white blood cells – symptoms 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 – detectable in laboratory tests. When higher doses are administered to the patient, the frequency or severity of kidney dysfunction may increase
• Seizures

If any of the above adverse reactions occur, inform a doctor or nurse immediately.

Other adverse reactions
If any of the symptoms listed below occur, contact a doctor, pharmacist or nurse.

Common (may occur in up to 1 out of 10 patients)

• Rash, redness, itching
• Pain
• Fever

Uncommon (may occur in up to 1 out of 100 patients)

• Decreased platelet count
• Increased liver enzyme levels in blood
• Increased creatinine levels in blood (monitoring kidney function)
• Hearing loss, ringing in the ears or sensation that the patient or surrounding objects are moving
• Nausea (vomiting), diarrhoea
• Dizziness or headache

Rare (may occur in up to 1 out of 1,000 patients)

• Infection (abscess)

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

• Injection site reactions – such as skin redness, pain or swelling

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, PL-02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Faks: + 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 to provide more information on the safety of the medicine.

5. How to store Teikoplanina

The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial/ampoule label after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Powder and solvent in the retail package: No special storage instructions apply.
For single use only. Discard any unused solution.

Stability of the prepared solution:
Chemical and physical in-use stability of the solution prepared according to instructions has been demonstrated for 24 hours at 2 to 8°C.

Stability of the prepared, further diluted solution:
Chemical and physical in-use stability of the solution prepared according to instructions has been demonstrated for 24 hours at 2 to 8°C, and for an additional 24 hours at 2 to 8°C after further dilution to a final concentration between 4 mg/mL and 20 mg/mL.

From a microbiological standpoint, if the method of opening/dissolving/diluting does not exclude the risk of microbial contamination, the product should be used immediately.
If not used immediately, the user is responsible for the duration of use and storage conditions.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Teikoplanina contains

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

What Teikoplanina looks like and contents of the pack
Teikoplanina is a powder and solvent for solution for injection/infusion.
The powder is white or almost white. The solvent is a clear, colourless solution.
The powder is packed in glass vials sealed with a rubber stopper and an aluminium seal with a plastic "flip-off" cap.
The solvent is packed in ampoules made of colourless glass or polypropylene (PP) ampoules with a "twist-off" closure.

Pack sizes:
Teikoplanina BRADEX, 200 mg:
Carton containing 1 vial with 200 mg teicoplanin + 1 ampoule containing 3 mL solvent.
Carton containing 10 vials with 200 mg teicoplanin + 10 ampoules each containing 3 mL solvent.

Teikoplanina BRADEX, 400 mg:
Carton containing 1 vial with 400 mg teicoplanin + 1 ampoule containing 3 mL solvent.
Carton containing 10 vials with 400 mg teicoplanin + 10 ampoules each containing 3 mL solvent.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Tel.: +30 210 8161802, Fax: +30 2108161587

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Teicoplanine DEMO 200 mg poeder en oplosmiddel voor oplossing voor injectie/infusie
Teicoplanine DEMO 400 mg poeder en oplosmiddel voor oplossing voor injectie/infusie

France: TEICOPLANINE BRADEX 200 mg, poudre et solvant pour solution injectable/pour perfusion
TEICOPLANINE BRADEX 400 mg, poudre et solvant pour solution injectable/pour perfusion

Belgium: Teicoplanin BRADEX 200 mg poudre et solvant pour solution injectable/pour perfusion – poeder en oplosmiddel voor oplossing voor injectie/infusie – Pulver und Lösungsmittel zur Herstellung einer Injektions-/Infusionslösung
Teicoplanin BRADEX 400 mg poudre et solvant pour solution injectable/pour perfusion – poeder en oplosmiddel voor oplossing voor injectie/infusie – Pulver und Lösungsmittel zur Herstellung einer Injektions-/Infusionslösung

Italy: Teicoplanina BRADEX
Teicoplanina BRADEX

Poland: Teikoplanina BRADEX
Teikoplanina BRADEX

Sweden: Teicoplanin Bradex 200 mg pulver och vätska till injektions-/infusionsvätska, lösning
Teicoplanin Bradex 400 mg pulver och vätska till injektions-/infusionsvätska, lösning

Czech Republic: Teicoplanin DEMO
Teicoplanin DEMO

Denmark: Teicoplanin Demo S.A.
Teicoplanin Demo S.A.

Finland: Teicoplanin Demo S.A. 200 mg injektio-/infuusiokuiva-aine ja liuotin, liuosta varten
Teicoplanin Demo S.A. 400 mg injektio-/infuusiokuiva-aine ja liuotin, liuosta varten

Hungary: Teicoplanin DEMO 200 mg por és oldószer oldatos injekcióhoz/infúzióhoz
Teicoplanin DEMO 400 mg por és oldószer oldatos injekcióhoz/infúzióhoz

Norway: Teicoplanin Demo S.A.
Teicoplanin Demo S.A.

Romania: Teicoplanină DEMO 200 mg pulbere şi solvent pentru soluţie injectabilă/perfuzabilă
Teicoplanină DEMO 400 mg pulbere şi solvent pentru soluţie injectabilă/perfuzabilă

Slovakia: Teicoplanin DEMO 200 mg prášok a rozpúšťadlo na injekčný/infúzny roztok
Teicoplanin DEMO 400 mg prášok a rozpúšťadlo na injekčný/infúzny roztok

Information intended exclusively for medical professionals:

Practical information for medical professionals on the preparation and handling of the medicinal product
Teikoplanina BRADEX.
This medicinal product is intended for single use only. Any unused solution should be discarded.
Route of administration
Teikoplanin should be administered intravenously or intramuscularly. The solution may be given as an intravenous injection over 3 to 5 minutes or as a 30-minute infusion.
In neonates and infants (from birth to 2 months of age), administration should be by infusion only.
The prepared solution may also be administered orally.
Preparation of solution from powder:

• Slowly inject 3.0 mL of the provided 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, 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 ready-to-use solutions are isotonic and do not require further dilution prior to administration.

Preparation of diluted solution for infusion:
Teikoplanina BRADEX can be administered in the following infusion solutions at a final concentration
ranging from 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 lactate solution
• 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 for infusion
• Sodium chloride 4.5 mg/mL (0.45%) and dextrose 50 mg/mL (5%) solution for infusion

Shelf life of the ready-to-use solution:
Chemical and physical in-use stability of the solution prepared according to recommendations has been demonstrated for 24 hours at 2 – 8°C.

Shelf life of the ready-to-use, further diluted solution:
Chemical and physical in-use stability of the solution prepared according to recommendations has been demonstrated for 24 hours at 2 – 8°C, and for an additional 24 hours at 2 – 8°C after further dilution to a final concentration between 4 mg/mL and 20 mg/mL.

From a microbiological standpoint, the prepared and/or further diluted medicinal solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user. Usually, this time should not exceed 24 hours at 2 – 8°C, provided the solution/diluted solution was prepared under controlled and validated aseptic conditions.

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