Teicoplanin Sandoz

Package leaflet: Information for the user

Teicoplanin Sandoz 100 mg powder and solvent for injectable or infusion or

oral solution
Teicoplanin Sandoz 200 mg powder and solvent for injectable or infusion or
oral solution
Teicoplanin Sandoz 400 mg powder and solvent for injectable or infusion or
oral solution
Equivalent medicine
Equivalent medicine
This medicine is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of 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, ask your doctor, pharmacist, or nurse.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Teicoplanina Sandoz is and what it is used for

Teicoplanina Sandoz is an antibiotic that contains an active substance called
"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:

• skin and underlying tissues, also known as "soft tissues"
• bones and joints
• lungs
• urinary tract
• heart, also known as "endocarditis"
• abdominal wall – peritonitis
• blood, when caused by one of the above-mentioned conditions.

Teicoplanina Sandoz may be used to treat certain intestinal infections caused by the bacterium Clostridium difficile. In this case, the solution must be taken orally.

2. What you need to know before being given Teicoplanin Sandoz

Do not use Teicoplanin Sandoz

• 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 receiving
Teicoplanin Sandoz if:

• you are allergic to an antibiotic called "vancomycin"
• you have redness of the upper body (red man syndrome)
• you have a low platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that may cause hearing and/or kidney problems. Regular tests may be needed to check whether your blood, kidneys and/or liver are functioning properly (see "Other medicines and Teicoplanin Sandoz"). If any of the conditions listed above apply to you (or if you are unsure), talk to your doctor, pharmacist or nurse before receiving Teicoplanin Sandoz.

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

• the treatment will last a long time
• 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 Sandoz, bacteria not affected by the antibiotic may grow more than usual – your doctor will monitor you for this.

Other medicines and Teicoplanin Sandoz
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
might take any other medicines. This is because Teicoplanin Sandoz may
affect how other medicines work. Some medicines may also affect how Teicoplanin Sandoz works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of
the following medicines:

• aminoglycosides, as they must not be mixed with Teicoplanin Sandoz in the same injection. They 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) – also called “water tablets” that may cause hearing and/or kidney problems

If any of the conditions listed above apply to you (or if you are unsure), consult your
doctor, pharmacist or nurse before receiving Teicoplanin Sandoz.
Pregnancy, breast-feeding 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 receiving this
medicine. They will decide whether or not to administer this medicine during
pregnancy. There may be a potential risk of inner ear and kidney problems.
Inform your doctor if you are breast-feeding before receiving this
medicine. Your doctor will decide whether you can continue or not to breast-feed while receiving Teicoplanin Sandoz. Reproduction studies in animals have not shown evidence of fertility problems.
Driving and using machines
While being treated with Teicoplanin Sandoz, you may experience headache or mild dizziness.
If this occurs, do not drive or operate machinery.
Teicoplanin Sandoz contains sodium
Teicoplanin Sandoz 100 mg:
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically "sodium-free".
Teicoplanin Sandoz 200 mg, 400 mg:
This medicine contains 1.0 mmol (or 24 mg) of sodium per dose. This should be taken into
consideration in patients with impaired kidney function or those on a low-sodium diet.

3. How Teicoplanin Sandoz will be administered to you

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 three doses): 400 mg (equivalent to 6 mg per kg of body weight) administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 400 mg (equivalent to 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): 800 mg (equivalent to 12 mg per kg of body weight) administered every 12 hours by intravenous or intramuscular injection
• Maintenance dose: 800 mg (equivalent to 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 100–200 mg orally twice daily for 7–14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose usually needs to be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment – the maintenance dose will be administered every 2 days, or half the maintenance dose will be given daily.
• For patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose will be administered every 3 days, or one-third of the maintenance dose will be given 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 1: 20 mg/L in each dialysis bag
• Week 2: 20 mg/L in alternate dialysis bags
• Week 3: 20 mg/L in the nighttime dialysis bag.

Neonates (from birth up 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 Teicoplanin Sandoz is administered
This medicine is usually administered to you by a doctor or nurse.

• It will be given by intravenous injection (intravenous use) or intramuscular injection (intramuscular use).
• It may also be administered by intravenous infusion. In neonates 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 (oral use).

If you are given more Teicoplanin Sandoz than you should
It is unlikely that a doctor or nurse will give you too much Teicoplanin Sandoz. However, if you think you have been given too much, or if you feel unwell, inform your doctor or nurse immediately.
If you miss a dose of Teicoplanin Sandoz
Your doctor or nurse will have clear instructions on when to administer Teicoplanin Sandoz. It is unlikely that you will miss a dose. However, if you are concerned, inform your doctor or nurse.
If you stop treatment with Teicoplanin Sandoz
Do not stop receiving this medicine without first discussing it with your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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)

• life-threatening allergic reaction – signs may include: difficulty breathing or shortness of breath, swelling, rash, itching, fever, chills

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

• 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"

Immediately contact your doctor or nurse if you notice any of the side effects listed above.

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)

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

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)
• kidney problems or changes in kidney function – shown by laboratory tests
• seizures

Immediately contact your doctor or nurse if you notice any of the side effects listed above.

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

Common (may affect up to 1 in 10 people)

• Rash, redness, itching
• Pain
• Fever

Uncommon (may affect up to 1 in 100 people)

• decrease in the number of platelets
• 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 things around you are moving
• feeling unwell (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 the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teicoplanina Sandoz

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 vial after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Information on storage and duration of use of Teicoplanina Sandoz after reconstitution and when ready for administration are described in the "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Sandoz".
Do not store in a syringe.

6. Package contents and other information

What Teicoplanin Sandoz contains

• The active substance is teicoplanin. Each vial contains 100 mg, 200 mg or 400 mg of teicoplanin, equivalent to 100,000 IU, 200,000 IU or 400,000 IU respectively. After reconstitution, the solution contains 100 mg of teicoplanin in 1.5 mL, 200 mg of teicoplanin in 3.0 mL or 400 mg of teicoplanin in 3.0 mL respectively.
• The other components are:
  Powder: sodium chloride and, if necessary, sodium hydroxide to adjust the pH (see end of section 2 for further information on sodium content).
  Solvent: water for injections.

Description of the appearance of Teicoplanin Sandoz and contents of the pack
Teicoplanin Sandoz is a powder and solvent for solution for injection, infusion or oral solution. The powder is a white to pale yellow powder. The solvent is a clear liquid, practically free from particles.
The powder is packaged:

• in a type I colourless glass vial with a useful volume of 8 ml for 100 mg, closed with a bromobutyl rubber stopper and a plastic flip-off cap sealed with a white aluminium seal;
• in a type I colourless glass vial with a useful volume of 10 ml for 200 mg, closed with a bromobutyl rubber stopper and a plastic flip-off cap sealed with a green aluminium seal;
• in a type I colourless glass vial with a useful volume of 22 ml for 400 mg, closed with a bromobutyl rubber stopper and a plastic flip-off cap sealed with a blue aluminium seal.

The solvent is packaged in a type I colourless glass ampoule containing 1.5 mL for the 100 mg strength and 3.0 mL for the 200 mg and 400 mg strengths.

Pack sizes

• 1 vial of powder with 1 ampoule of solvent
• 5 x 1 vial of powder with 5 x 1 ampoule of solvent

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

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

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

Austria
Teicoplanin Sandoz 100 mg - Powder and solvent for solution for injection/infusion or oral solution
Teicoplanin Sandoz 200 mg - Powder and solvent for solution for injection/infusion or oral solution
Teicoplanin Sandoz 400 mg - Powder and solvent for solution for injection/infusion or oral solution

Belgium
Teicoplanin Sandoz 100 mg poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing
Teicoplanin Sandoz 200 mg poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing
Teicoplanin Sandoz 400 mg poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing

Bulgaria
Planitec 400 mg powder and solvent for solution for injection/infusion or oral solution

France
Teicoplanine Sandoz 100 mg, poudre et solvant pour solution injectable/pour perfusion ou solution buvable
Teicoplanine Sandoz 200 mg, poudre et solvant pour solution injectable/pour perfusion ou solution buvable
Teicoplanine Sandoz 400 mg, poudre et solvant pour solution injectable/pour perfusion ou solution buvable

Italy
Teicoplanina Sandoz

Luxembourg
Teicoplanin Sandoz 100 mg poudre et solvant pour solution injectable/pour perfusion ou solution buvable
Teicoplanin Sandoz 200 mg poudre et solvant pour solution injectable/pour perfusion ou solution buvable
Teicoplanin Sandoz 400 mg poudre et solvant pour solution injectable/pour perfusion ou solution buvable

Netherlands
Teicoplanine Sandoz 200 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing
Teicoplanine Sandoz 400 mg, poeder en oplosmiddel voor oplossing voor injectie/infusie of orale oplossing

Poland
Teicopix

Portugal
Teicoplanina Sandoz

Romania
TEICOPLANINĂ SANDOZ 100 mg, pulbere şi solvent pentru soluţie injectabilă/perfuzabilă sau soluţie orală
TEICOPLANINĂ SANDOZ 200 mg, pulbere şi solvent pentru soluţie injectabilă/perfuzabilă sau soluţie orală
TEICOPLANINĂ SANDOZ 400 mg, pulbere şi solvent pentru soluţie injectabilă/perfuzabilă sau soluţie orală

Slovenia
Teikoplanin Lek 100 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Teikoplanin Lek 200 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino
Teikoplanin Lek 400 mg prašek in vehikel za raztopino za injiciranje ali infundiranje ali za peroralno raztopino

Spain
Teicoplanina Sandoz 200 mg polvo para inyectable y para perfusión o solución oral EFG
Teicoplanina Sandoz 400 mg polvo para inyectable y para perfusión o solución oral EFG

Sweden
Teicoplanin Sandoz

United Kingdom
Teicoplanin 100 mg Powder and Solvent for Solution for Injection or Infusion or Oral Solution
Teicoplanin 200 mg Powder and Solvent for Solution for Injection or Infusion or Oral Solution
Teicoplanin 400 mg Powder and Solvent for Solution for Injection or Infusion or Oral Solution

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare professionals on the preparation and handling of Teicoplanin Sandoz
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 bolus over 3-5 minutes or as an infusion over 30 minutes.
In children from birth up to 2 months of age, administration must be by infusion only.
The reconstituted solution may also be administered orally.

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. Only clear, slightly yellow solutions should be used.

The reconstituted solutions contain 100 mg of teicoplanin in 1.5 mL, 200 mg of teicoplanin in 3.0 mL and 400 mg in 3.0 mL.
The final solution is isotonic with plasma and has a pH of 7.2–7.8.

Preparation of the diluted solution prior to infusion
Teicoplanina Sandoz may be administered in the following infusion solutions:

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

Stability of the reconstituted solution and diluted medicinal product
The chemical and physical in-use stability of the reconstituted solution and diluted medicinal product prepared as indicated has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage period and conditions prior to use, which should normally not exceed 24 hours at a temperature between 2 and 8°C.

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