Teicoplanin Ibigen

Package Leaflet: Information for the User

Teicoplanin Ibigen 200 mg powder and solvent for injectable/infusion solution or oral solution
Teicoplanin Ibigen 400 mg powder and solvent for injectable/infusion solution or oral solution
Teicoplanin
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This medicinal product 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 given 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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

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

• skin and underlying tissues (also called "soft tissues")
• bones and joints
• lungs
• urinary tract
• heart (endocarditis)
• abdominal wall (peritonitis)
• blood, when caused by any of the conditions listed above.

Teicoplanin Ibigen may be used to treat certain infections caused by Clostridium difficile bacteria in the intestine. For this infection, the solution is taken by mouth.

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

Do not use Teicoplanin Ibigen 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 being given Teicoplanin Ibigen if:

• you are allergic to an antibiotic called “vancomycin”
• you experience redness of the upper part of the 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. You may need regular tests to check whether your blood, kidneys, and liver are functioning properly (see “Other medicines and Teicoplanin Ibigen”). If any of the above apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before receiving Teicoplanin Ibigen.

Tests
During treatment, you may need tests to monitor kidney function 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 Teicoplanin Ibigen for a prolonged period, 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 Ibigen
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Teicoplanin Ibigen may affect how other medicines work. Likewise, some medicines may affect how Teicoplanin Ibigen 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 Ibigen 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), also called “diuretics”, which may cause hearing and/or kidney problems

If any of the above apply to you (or if you are unsure), talk to your doctor, pharmacist, or nurse before being given Teicoplanin Ibigen.

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 being 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.

Tell your doctor if you are breastfeeding before being given this medicine. Your doctor will decide whether you can continue breastfeeding while receiving Teicoplanin Ibigen.

Animal reproduction studies have not shown evidence of fertility problems.

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

Teicoplanin Ibigen 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 Ibigen

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, joint, 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 injection

To treat infections caused by the bacterium Clostridium difficile
The recommended dose is 100 to 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 should be given every 2 days, or half the maintenance dose should be given daily
• For patients with severe renal impairment or undergoing hemodialysis, the maintenance dose should be given every 3 days, or one-third of the maintenance dose should be given daily.

Peritonitis in patients undergoing peritoneal dialysis
Initial dose: 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 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 Ibigen 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 by intravenous infusion.

In children from birth 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 Ibigen than you should
It is unlikely that a doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanina Ibigen or if you feel unwell, inform your doctor or nurse immediately.

If you miss a dose of Teicoplanina Ibigen
Your doctor or nurse will have specific instructions on when to administer Teicoplanina Ibigen. It is unlikely that the medicine will not be given as prescribed. However, if you are concerned, inform your doctor or nurse.

If you stop treatment with Teicoplanina Ibigen
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 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)

• 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 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” or “drug reaction with eosinophilia and systemic symptoms (DRESS)”. This reaction initially presents with flu-like symptoms and facial rash, followed by widespread skin rash and increased body temperature, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cells (eosinophils), and swollen lymph nodes. Inform your doctor or nurse immediately if you notice any of the side effects listed above.

Inform 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 blood clot in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased occurrence 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 – detected by blood tests
• seizures

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

Other side effects

Inform 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)

• reduced 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 objects 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 skin redness, pain or swelling

Reporting of side effects

If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system: http://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 Ibigen

Keep the 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
Scad/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 Ibigen after reconstitution and when ready for administration are described in the "Practical information for healthcare professionals on the preparation and handling of Teicoplanina Ibigen".
Do not dispose of any medicine via wastewater or household waste.
Disposing of medicines that you no longer use properly helps protect the environment.

6. Contents of the pack and other information

What Teicoplanina Ibigen 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 in the powder, and water for injections in the solvent.

Description of the appearance of Teicoplanina Ibigen and contents of the pack
Teicoplanina Ibigen is a powder and solvent for solution for injection/infusion or oral solution. The powder is a homogeneous, ivory-coloured, spongy mass. The solvent is a clear, colourless liquid.

The powder is supplied in:
• colourless type I glass vials with a useful volume of 6 mL containing 200 mg, closed with a bromobutyl rubber stopper, an aluminium seal and a plastic tear-off cap
• colourless type I glass vials with a useful volume of 10 mL containing 400 mg, closed with a bromobutyl rubber stopper, an aluminium seal and a plastic tear-off cap.

The solvent is supplied in colourless type I glass ampoules.

Pack sizes:
• 1 vial of powder with 1 ampoule of solvent
• 5 x 1 vials of powder and 5 ampoules of solvent

It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano, 2
04011 - Aprilia (LT)
Italy
[email protected]

Manufacturers
Powder vial
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano, 2
04011 - Aprilia (LT)
Italy

Solvent ampoule
Biologici Italia Laboratories S.r.l.
Via F. Serpero, 2
20060 - Masate (MI)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Teicoplanin Ibisqus 200 mg powder and solvent for solution for injection/infusion or oral solution
Teicoplanin Ibisqus 400 mg powder and solvent for solution for injection/infusion or oral solution

Italy: Teicoplanina Ibigen 200 mg powder and solvent for solution for injection/infusion or oral solution
Teicoplanina Ibigen 400 mg powder and solvent for solution for injection/infusion or oral solution

Malta: Teicoplanin 200 mg powder and solvent for solution for injection/infusion or oral solution
Teicoplanin 400 mg powder and solvent for solution for injection/infusion or oral solution

The following information is intended exclusively for doctors or healthcare professionals

.
This medicinal product is for single use only.
Preparation of the reconstituted solution
Reconstitute the solution by adding 3.2 ml of water for injection to the 200 mg and 400 mg vial of powder.
The water should be added slowly to the vial, which must then be gently rotated until all the powder is dissolved,
to avoid foam formation. If foam develops, allow the solution to stand for approximately 15 minutes so that the foam dissipates.
Only clear, yellowish solutions should be used.

The reconstituted solution may be injected directly or alternatively further diluted, or administered orally.

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

• sodium chloride solution 9 mg/mL (0.9%)
• Ringer's solution
• Ringer lactate solution
• 5% dextrose solution
• 10% dextrose 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
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 between 2 and 8°C.
From a microbiological standpoint, 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, unless reconstitution is carried out under controlled and validated aseptic conditions.

Stability of the diluted medicinal product
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 between 2 and 8°C.
From a microbiological standpoint, 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, unless reconstitution/dilution is carried out under controlled and validated aseptic conditions.

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