Teicoplanin Zentiva

Package Leaflet: Information for the User

Teicoplanin Zentiva 200 mg powder and solvent for injectable/infusion solution or oral solution
teicoplanin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

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

Teicoplanin Zentiva is an antibiotic containing the active substance “teicoplanin”. It works by killing bacteria responsible for infections in the body.
Teicoplanin Zentiva 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 area (peritonitis)
bloodstream, when caused by any of the above conditions.
Teicoplanin Zentiva may be used to treat certain intestinal infections caused by Clostridium difficile bacteria. For this use, the solution is taken by mouth.

2. What you need to know before you are given Teicoplanin Zentiva

Do not use Teicoplanin Zentiva 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 Teicoplanin Zentiva 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 platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that may 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 Teicoplanin Zentiva"). 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 Teicoplanin Zentiva. Serious skin reactions have been reported with the use of teicoplanin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe skin rash or other skin symptoms as described in section 4, stop taking Teicoplanin Zentiva and contact your doctor or seek immediate medical advice.

Tests
During treatment, you may need to undergo tests to monitor your blood, kidneys, liver, and/or hearing.
This is more likely if:

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

In patients receiving long-term treatment with Teicoplanin Zentiva, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor for this possibility.

Other medicines and Teicoplanin Zentiva
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Teicoplanin Zentiva may affect how other medicines work. Some medicines may also affect how Teicoplanin Zentiva 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 Teicoplanin Zentiva 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
• ciclosporin – 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 Teicoplanin Zentiva.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor, pharmacist, or nurse for advice before you are given this medicine. They will decide whether you should be given this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems.
Inform your doctor if you are breastfeeding before you are given this medicine. Your doctor will decide whether you can continue breastfeeding while receiving Teicoplanin Zentiva.
Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines
While being treated with Teicoplanin Zentiva, you may experience headache or dizziness. If this occurs, do not drive or operate machinery.

Teicoplanin Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How to use Teicoplanina Zentiva

Recommended dose
Adults and children (12 years of age and older) with normal kidney function
Skin and soft tissue infections, lung infections, and urinary tract infections

• Initial dose (for the first 3 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 3–5 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.
  To treat infections caused by Clostridium difficile bacteria
  The recommended dose is 100–200 mg orally twice daily for 7–14 days.

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

• For patients with mild to moderate renal impairment: the maintenance dose will be given every 2 days, or half the maintenance dose will be given daily.
• For patients with severe renal impairment or undergoing hemodialysis: the maintenance dose will be given every 3 days, or one-third of the maintenance dose will be given daily.

Peritonitis in patients undergoing peritoneal dialysis
Initial dose: 6 mg per kg of body weight, administered as a single intravenous injection, followed by:

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

Neonates (from birth to 2 months of age)

• Initial dose (first day): 16 mg per kg of body weight administered as an intravenous infusion
• Maintenance dose: 8 mg per kg of body weight administered once daily as an 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 Zentiva is administered
This medicine is usually administered by a doctor or nurse.

• It is given by intravenous (IV) or intramuscular (IM) injection.
• It may also be given as an intravenous infusion. In children from birth up to 2 months of age, it must be administered only by infusion. For the treatment of certain infections, the solution may be taken orally.

If you receive more Teicoplanina Zentiva than you should
It is unlikely that a doctor or nurse would give you too much medicine. However, if you think you have been given too much Teicoplanina Zentiva, or if you feel unwell, inform your doctor or nurse immediately.

If you forget to receive Teicoplanina Zentiva
Your doctor or nurse will have specific instructions on when to administer Teicoplanina Zentiva. It is unlikely that you will miss a dose. However, if you are concerned, inform your doctor or nurse.

If you stop Teicoplanina Zentiva treatment
Do not stop taking this medicine without first discussing it with your doctor, pharmacist, or nurse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
Stop treatment and 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 patients)

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

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

• Hot flushes in 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”
• Widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including the stomach), back and arms) and blisters accompanied by fever – these may be symptoms of a condition called "acute generalised exanthematous pustulosis (AGEP)"
• “Drug reaction with eosinophilia and systemic symptoms (DRESS)” – this reaction initially presents with flu-like symptoms and facial rash, followed by widespread rash and high temperature, increased liver enzyme levels seen in blood tests, increase in 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 patients)

• Swelling and blood clotting in a vein
• Difficulty breathing or wheezing (bronchospasm)
• Increased risk of infections – this could be a sign of reduced blood cell count

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

• Rash, redness, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 patients)

• Decrease in platelet count
• Increased liver enzyme levels in the blood
• Increased creatinine levels in the blood (to monitor kidney function)
• Hearing loss, ringing in the ears or sensation that you or objects around you are moving
• Feeling unwell or nausea, vomiting, diarrhoea
• Dizziness or headache

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

• Infection (abscess)

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

• Problems at the injection site – such as redness, pain or swelling

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanina Zentiva

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 after Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Information on storage and the duration of use of Teicoplanina Zentiva after reconstitution and when ready for use are described in the “Practical information for healthcare professionals on the preparation and handling of Teicoplanina Zentiva”.

6. Package contents and other information

What Teicoplanin Zentiva contains

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin.
• The other components are sodium chloride and sodium hydroxide in the powder, and water for injections in the solvent.

Description of the appearance of Teicoplanin Zentiva and package contents
Teicoplanin Zentiva is a powder and solvent for injectable/infusion solution or oral solution. The
powder is a homogeneous, ivory-colored, spongy mass. The solvent is a clear, colourless liquid.
The powder is supplied in colourless type I glass vials with a 10 mL useful volume, containing 200 mg,
closed with a bromobutyl rubber stopper, a yellow aluminium seal, and a plastic flip-off cap.
The solvent is supplied in a colourless type I glass ampoule.
Packaging:

• 1 vial of powder with 1 ampoule of solvent.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi S.r.l. – Viale L. Bodio, 37/B – Milan
Manufacturer
Sanofi S.r.l. - Via Valcanello, 4 - 03012 Anagni (FR)
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Germany: Teicoplanin sanofi-aventis
Italy: Teicoplanin Zentiva

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare personnel on the preparation and handling of
Teicoplanin Zentiva.
This medicinal product is for single use only.
Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a 3-5 minute bolus or as a 30-minute infusion.
In neonates and infants from birth up to 2 months of age, administration must be only by infusion.
The reconstituted solution may also be administered orally (oral use).
Preparation of the reconstituted solution
Slowly inject the entire content of the solvent ampoule into the vial of powder.
Gently rotate the vial between the hands until the powder is completely dissolved. If foaming occurs, allow the solution to stand for approximately 15 minutes.
The reconstituted solution contains 200 mg of teicoplanin in 3.0 mL.
Only clear solutions should be used. The colour of the solution may vary from pale yellow to dark yellow.
The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Preparation of diluted solution prior to infusion
Teicoplanin Zentiva may be administered in the following infusion solutions:

• sodium chloride solution 9 mg/mL (0.9%)
• Ringer's solution
• Ringer's lactate solution
• 5% glucose solution
• 10% glucose solution
• solution containing 0.18% sodium chloride and 4% glucose
• solution containing 0.45% sodium chloride and 5% glucose
• peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.

Stability of the reconstituted solution
Chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the product should be used immediately. If this is not possible, the user is responsible for the storage period and conditions, which should not normally exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution is carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product
Chemical and physical in-use stability of the reconstituted solution prepared according to the recommendations has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the product should be used immediately. If this is not possible, the user is responsible for the storage period and conditions, which should not normally exceed 24 hours at a temperature between 2 and 8°C, unless reconstitution/dilution is carried out under controlled and validated aseptic conditions.

Disposal
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.