Teicoplanin Bradex

Patient Information Leaflet

Teicoplanin BRADEX 200 mg Powder and solvent for injectable solution / for infusion, 400 mg Powder and solvent for injectable solution / for infusion

Teicoplanin
Generic Medicinal Product
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

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

Contents of this leaflet:

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

1. What Teicoplanin BRADEX is and what it is used for

Teicoplanin is an antibiotic. It contains a medicinal substance called "teicoplanin".
It works by killing the bacteria responsible for infections in the body.
Teicoplanin is used in adults and children (including newborns) to treat bacterial infections of:

• skin and underlying tissues (sometimes referred to as "soft tissues")
• bones and joints
• lungs
• urinary tract
• heart (endocarditis)
• abdominal wall (peritonitis)
• blood, when caused by one of the above-mentioned conditions

Teicoplanin may be used to treat certain intestinal infections caused by the bacterium Clostridium difficile.
For this purpose, the solution is taken orally.

2. What you need to know before you are given Teicoplanina BRADEX

Do not use Teicoplanina BRADEX:

• if you are allergic to teicoplanin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Teicoplanina BRADEX if:

• you are allergic to an antibiotic called “vancomycin”
• you have experienced redness of the upper part of the body (red man syndrome)
• you have a reduced number of platelets (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to check whether your kidneys and/or liver are functioning properly (see “Other medicines and Teicoplanina BRADEX”).

If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanina BRADEX.
Tests
During treatment, you may need to undergo tests to monitor your blood, kidneys and/or hearing. This is more likely if:

• the treatment will last a long time
• you need to be treated with high loading doses (12 mg/kg twice daily)
• you have kidney problems
• you are taking or may need to take other medicines that can affect the nervous system, kidneys or hearing

In patients receiving long-term treatment with Teicoplanina BRADEX, bacteria not affected by the antibiotic may overgrow – your doctor will carry out checks to monitor for this possibility.
Other medicines and Teicoplanina BRADEX
Tell your doctor, pharmacist or nurse if you are using, have recently used, or might use any other medicines. This is because Teicoplanina BRADEX may affect how other medicines work. In addition, some medicines may affect how Teicoplanina BRADEX works.
In particular, inform your doctor, pharmacist or nurse if you are taking any of the following medicines:

• aminoglycosides, which must not be mixed with Teicoplanina BRADEX in the same injection. These may also cause hearing and/or kidney problems
• amphotericin B – a medicine used to treat fungal infections that may cause hearing and/or kidney problems
• cyclosporine – a medicine that affects the immune system and may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumours that may cause hearing and/or kidney problems
• diuretic tablets (such as furosemide) that may cause hearing and/or kidney problems.

If any of the above applies to you (or if you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanina BRADEX.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered.
Your doctor will decide whether you should receive this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.
Inform your doctor if you are breastfeeding before this medicine is administered.
Your doctor will decide whether you can continue breastfeeding while receiving Teicoplanina BRADEX.
Animal reproduction studies have not shown evidence of fertility problems.
Driving and using machines
While being treated with Teicoplanina, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.
Teicoplanina BRADEX contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Teicoplanina BRADEX is administered

This medicine is administered in a hospital setting by healthcare professionals.
The recommended dose is:
Adults and children (age 12 years and older) with normal kidney function
Skin and soft tissue infections, lung infections, and urinary tract infections

• Initial dose (for the first three doses): 6 mg per kg of body weight administered every 12 hours, by intravenous or intramuscular injection
• Maintenance dose: 6 mg per kg of body weight administered once daily, by intravenous or intramuscular injection

Bone and joint infections, and heart infections

• Initial dose (for the first three to five doses): 12 mg per kg of body weight administered every 12 hours, by intravenous injection
• Maintenance dose: 12 mg per kg 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, taken orally, twice daily for 7–14 days.

Adults and elderly patients with kidney problems
If you have kidney problems, your dose is generally reduced after the fourth day of treatment:

• For 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.
• For 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 kg of body weight, given as a single intravenous injection, followed by:

• Week one: 20 mg/L in each dialysis bag
• Week two: 20 mg/L in alternate dialysis bags
• Week three: 20 mg/L in the nighttime dialysis bag

Neonates (from birth to 2 months of age)

• Initial dose (on the first day): 16 mg per kg of body weight, administered by intravenous infusion.
• Maintenance dose: 8 mg per kg of body weight, administered once daily by intravenous infusion.

Children (from 2 months to 12 years of age)

• Initial dose (for the first three doses): 10 mg per kg of body weight administered every 12 hours, by intravenous injection.
• Maintenance dose: 6–10 mg per kg of body weight, administered once daily by intravenous injection.

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

• It is given by intravenous injection (intravenous use) or intramuscular injection (intramuscular use).
• It may also be given by intravenous infusion.

In children from birth up to 2 months of age, it should only be administered via infusion.
For the treatment of certain infections, the solution may be taken orally (oral use).

If you receive more Teicoplanina BRADEX than you should
It is unlikely that a doctor or nurse will administer too much medicine. However, if you think that you have received too much Teicoplanina BRADEX or if you feel unwell, inform your doctor or nurse immediately.

If you forget to use Teicoplanina BRADEX
Your doctor or nurse will have specific instructions on when to administer Teicoplanina BRADEX. It is unlikely that the medicine will be omitted as prescribed. However, if you are concerned, inform your doctor or nurse.

If you stop treatment with Teicoplanina BRADEX
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

Stop treatment and immediately contact your doctor or nurse if you notice any of the following serious side effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• sudden allergic reaction that could be life-threatening – signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills

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

• redness of the upper part of the body

Not known (frequency cannot be estimated from the available data)

• skin, mouth, eye or genital lesions – these may be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome” or “drug reaction with eosinophilia and systemic symptoms” (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by more widespread rash, high temperature, increased liver enzymes found in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.

Contact your doctor or nurse immediately if you notice any of the side effects listed above.

Contact your doctor or nurse immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• swelling and clotting in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased occurrence of infections – these could be signs of a reduced number of blood cells

Not known (frequency cannot be estimated from the available data)

• absence 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 how the kidneys function – shown by blood tests. The frequency or severity of kidney problems may increase if higher doses are given
• seizures

Contact your doctor or nurse immediately if you notice any of the side effects listed above.

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• Rash, erythema, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 people)

• decreased number of platelets
• increased levels of liver enzymes in the blood
• increased levels of creatinine in the blood (used to monitor kidney function)
• hearing loss, ringing in the ears or sensation that you or things around you are moving
• feeling unwell or nausea, diarrhoea
• dizziness or headache

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

• infection (abscess)

Not known (frequency cannot be estimated from the available data)

• problems at the injection site – such as redness of the skin, pain or swelling

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via [appropriate reporting system as per country guidelines]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanin BRADEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
vial/bottle after "Exp". The expiry date refers to the last day of that month.
Powder and solvent in the retail package: this medicine requires no special storage conditions.
For single use only. Dispose of all unused solutions.
Shelf life of the reconstituted solution:
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
Shelf life of the reconstituted and further diluted solution:
The chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C and for a further 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 standpoint, the product should be used immediately, unless the method of opening / reconstitution / dilution excludes the risk of microbial contamination.
If not used immediately, the user is responsible for the duration and conditions of storage of the product.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Teicoplanin BRADEX contains

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

Description of the appearance of Teicoplanin BRADEX and contents of the pack

Teicoplanin BRADEX is a powder and solvent for injectable/infusion solution. The powder is white to off-white. The solvent is a clear, colourless liquid.

The powder is packaged in glass vials closed with a rubber stopper and sealed with an aluminium cap with a plastic tear-off strip.
The solvent is packaged in transparent glass vials or polypropylene vials with a screw cap.

Pack sizes:
Carton x 1 vial x 200 mg + 1 ampoule x 3 mL solvent
Carton x 10 vials x 200 mg + 10 ampoules x 3 mL solvent
Carton x 1 vial x 400 mg + 1 ampoule x 3 mL solvent
Carton x 10 vials x 400 mg + 10 ampoules x 3 mL solvent

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: BRADEX S.A.,
27 Asklipiou Street, GR-14568 Kryoneri, Greece
Manufacturer: DEMO S.A. PHARMACEUTICAL INDUSTRY, 14568 Krioneri, Attiki, Greece,
T: +30 210 8161802, F: +30 210 8161587.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Teicoplanine DEMO 200 mg powder and solvent for solution for injection/infusion
Teicoplanine DEMO 400 mg powder and solvent for solution for injection/infusion

France: TEICOPLANINE BRADEX 200 mg, powder and solvent for injectable solution/perfusion
TEICOPLANINE BRADEX 400 mg, powder and solvent for injectable solution/perfusion

Belgium: Teicoplanin BRADEX 200 mg powder and solvent for injectable/perfusion solution – powder and solvent for solution for injection/infusion – powder and solvent for the preparation of an injection/infusion solution
Teicoplanin BRADEX 400 mg powder and solvent for injectable/perfusion solution – powder and solvent for solution for injection/infusion – powder and solvent for the preparation of an injection/infusion solution

Italy: Teicoplanina BRADEX
Teicoplanina BRADEX

Poland: Teikoplanina BRADEX
Teikoplanina BRADEX

Sweden: Teicoplanin Bradex 200 mg powder and liquid for injection/infusion solution
Teicoplanin Bradex 400 mg powder and liquid for injection/infusion solution

Czech Republic: Teicoplanin DEMO
Teicoplanin DEMO

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

Finland: Teicoplanin Demo S.A. 200 mg injection/infusion dry substance and solvent for solution
Teicoplanin Demo S.A. 400 mg injection/infusion dry substance and solvent for solution

Hungary: Teicoplanin DEMO 200 mg powder and solvent for solution for injection/infusion
Teicoplanin DEMO 400 mg powder and solvent for solution for injection/infusion

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

Romania: Teicoplanină DEMO 200 mg powder and solvent for injectable/perfusable solution
Teicoplanină DEMO 400 mg powder and solvent for injectable/perfusable solution

Slovakia: Teicoplanin DEMO 200 mg powder and solvent for injection/infusion solution
Teicoplanin DEMO 400 mg powder and solvent for injection/infusion solution

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of Teicoplanin.
This medicinal product is for single use only. Dispose of all unused solutions.

Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a bolus over 3–5 minutes or by a 30-minute infusion.
In children from birth to 2 months of age, administration should be given by infusion only.
The reconstituted solution may also be administered orally.

Preparation of the reconstituted solution:

• Slowly inject 3.0 mL of the provided solvent into the vial of powder.
• Gently rotate the vial between 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 (for 200 mg) and 285 – 305 mOsm/kg (for 400 mg)
Therefore, the reconstituted solutions are isotonic and do not require further dilution prior to administration.

Preparation of the diluted solution prior to infusion:
Teicoplanina BRADEX may be administered in the following infusion solutions with a final concentration between 4 mg/mL and 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 13.6 mg/mL (1.36%)
• Peritoneal dialysis solution containing dextrose 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

Stability of the reconstituted solution:
The in-use chemical and physical stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.

Stability of the reconstituted and further diluted solution:
The in-use chemical and physical stability of the reconstituted solution prepared according to the recommendations 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 standpoint, the reconstituted and/or further diluted product should be used immediately. If not used immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours between 2°C and 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Disposal
Any unused medicinal product and waste materials derived from such medicinal product must be disposed of in accordance with local applicable regulations.