TEICOPLANINA 200 mg Proszek I Rozpuszczalnik Do Roztworu Do Wstrzykiwań/Infuzji

Treść ulotki

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

Teicoplanina Zentiva 200 mg powder and solvent for injectable/infusion solution or oral solution
teicoplanin

Read this leaflet carefully before taking this medicine as 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 get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Teicoplanina Zentiva is an antibiotic that contains the active substance “teicoplanin”. It works by killing the
bacteria responsible for infections in the body.
Teicoplanina Zentiva is used in adults and children (including newborns) to treat bacterial infections
of:
skin and underlying tissues (sometimes called “soft tissues”)
bones and joints
lungs
urinary tract
heart (endocarditis)
abdominal area (peritonitis)
blood, when caused by one of the above conditions.
Teicoplanina Zentiva can be used to treat some infections caused by bacteria Clostridium difficile
in the intestine. For this, the solution is taken orally.

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

Do not use Teicoplanina Zentiva if:

• you are allergic to teicoplanin or 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 Zentiva if:

• you are allergic to an antibiotic called “vancomycin”
• you have had redness of the upper part of your body (red neck syndrome)
• you have a decrease in the number of platelets (thrombocytopenia)
• you have kidney problems
• you are taking other medicines that could cause problems with your hearing and/or kidneys. You may need to have regular tests to check if your kidneys and/or liver are working properly (see “Other medicines and Teicoplanina 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 Teicoplanina Zentiva. Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of teicoplanin. If you develop a severe rash or other skin symptoms as described in section 4, stop taking Teicoplanina Zentiva and contact your doctor or seek immediate medical attention.

Tests
During treatment, you may need to have tests to check your blood, kidneys, liver 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 a day)
• you have kidney problems
• you are taking or may take other medicines that can affect the nervous system, kidneys or hearing.

In patients who are given Teicoplanina Zentiva for a long time, bacteria that are not affected
by the antibiotic may grow more than normal – your doctor will do checks to monitor this
possibility.

Other medicines and Teicoplanina Zentiva
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Teicoplanina Zentiva can affect the way other medicines work.
Also, some medicines can affect the way Teicoplanina Zentiva works.
In particular, tell your doctor, pharmacist or nurse if you are taking any of the following
medicines:

• aminoglycosides, which must not be mixed with Teicoplanina Zentiva in the same injection. They can also cause problems with your hearing and/or kidneys
• amphotericin B - a medicine to treat fungal infections that can cause problems with your hearing and/or kidneys
• cyclosporine - a medicine that affects the immune system that can cause problems with your hearing and/or kidneys
• cisplatin - a medicine to treat malignant tumors that can cause problems with your hearing and/or kidneys
• diuretic tablets (such as furosemide) which can cause problems with your hearing and/or kidneys.

If any of the above applies to you (or if you are not sure), talk to your doctor or pharmacist or nurse
before you are given Teicoplanina Zentiva.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may 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 will be
given this medicine while you are pregnant. There may be a potential risk of problems
with the inner ear and kidneys.
Tell your doctor if you are breastfeeding before you are given this
medicine. They will decide whether you can continue or stop breastfeeding while you are given Teicoplanina
Zentiva.
Studies in animals have not shown evidence of problems with fertility.

Driving and operating machinery
While you are being treated with Teicoplanina Zentiva you may have headache or feel dizzy. If this
happens, do not drive vehicles and do not use machines.

Teicoplanina 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

The recommended dose is
Adults and children (12 years of age and older) without kidney problems
Skin and subcutaneous tissue infections, lungs and urinary tract

• Initial dose (for the first 3 doses): 6 mg per each kg of body weight administered every 12 hours, with an injection into a vein or a muscle
• Maintenance dose: 6 mg per each kg of body weight administered once a day with an injection into a vein or a muscle.

Infections of the bones and joints, and the heart

• Initial dose (for the first 3-5 doses): 12 mg per each kg of body weight administered every 12 hours, with an injection into a vein.
• Maintenance dose: 12 mg per each kg of body weight administered once a day with an injection into a vein or a muscle. To treat infections caused byClostridium difficilebacteria, the recommended dose is 100-200 mg by mouth twice a day for 7 - 14 days.

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

• For people with mild and moderate kidney problems, the maintenance dose will be given every 2 days, or half the maintenance dose will be given every day.
• For people with severe kidney problems or undergoing hemodialysis: the maintenance dose will be administered every 3 days, or one third of the maintenance dose will be given every day.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per each kg of body weight, with a single injection into a vein, 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 night bag.

Newborns (from birth to 2 months)

• Initial dose (first day): 16 mg per each kg of body weight, administered as an infusion drop by drop into a vein
• Maintenance dose: 8 mg per each kg of body weight, administered as an infusion drop by drop into a vein once a day.

Children (from 2 months to 12 years)

• Initial dose (for the first three doses): 10 mg per each kg of body weight, administered every 12 hours with injection into a vein
• Maintenance dose: 6 - 10 mg per each kg of body weight, administered once a day with injection into a vein

How Teicoplanina Zentiva is given
This medicine is usually given by a doctor or nurse

• it is given by injection into a vein (intravenous) or into a muscle (intramuscular)
• it can also be given by infusion drop by drop into a vein. In children from birth to 2 years of age, it must only be administered by infusion. To treat some infections, the solution can be taken by mouth (oral use).

If you receive more Teicoplanina Zentiva than you should
It is unlikely that the doctor or nurse will give you too much medicine. However, if you think you have been
given too much Teicoplanina Zentiva or if you feel agitated, tell your doctor or nurse immediately.

If you forget to receive Teicoplanina Zentiva
The doctor or nurse will have instructions on when to give you Teicoplanina Zentiva. It is unlikely that they will not
give you the medicine as prescribed. However, if you are concerned, tell your doctor or nurse.

If you stop taking Teicoplanina Zentiva
Do not stop taking this medicine without first talking to your doctor, pharmacist or
nurse.
If you have any questions about using this medicine, ask 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 tell 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 which can be life-threatening - signs may include: difficulty breathing or wheezing, sweating, skin 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 lesions, mouth, eyes or genitals - these may be signs of a condition called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”
• widespread red and scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever - these may be symptoms of a condition called "Acute Generalized Exanthematous Pustulosis (AGEP)"
• “drug reaction with eosinophilia and systemic symptoms (DRESS)”. This reaction initially manifests with flu-like symptoms and a rash on the face followed by a widespread rash and high temperature, increased levels of liver enzymes observed in blood tests and an increase in cells belonging to the white blood cell family (eosinophilia) and enlarged lymph nodes.

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

Tell 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 - this could be a sign of a decrease in the 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)
• low levels of all types of blood cells
• problems with the kidneys or changes in the way the kidneys work - highlighted by tests. Frequency or severity of kidney problems may be increased if you receive higher doses.
• seizures Tell your doctor or nurse immediately if you notice any of the side effects listed above.

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

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 (to check the kidneys)
• hearing loss, ringing in the ears or feeling that you, or things around you, are moving
• feeling unwell or sick (vomiting), diarrhoea
• feeling dizzy 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, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 which is stated on the package 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 particular storage conditions.
Information on the storage and usage time of Teicoplanina Zentiva, after it has been
reconstituted and is ready for use, is described in “Practical information for healthcare professionals
on the preparation and handling of Teicoplanina Zentiva”

6. Contents of the pack and other information

What Teicoplanina 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 Teicoplanina Zentiva and contents of the pack
Teicoplanina Zentiva is a powder and solvent for solution for injection/infusion or oral solution. The
powder is a homogeneous, spongy mass of ivory colour. The solvent is a clear and colourless liquid.
The powder is packaged in colourless type I glass vials with a useful volume of 10 mL for 200 mg
closed with a bromobutyl rubber stopper, a yellow aluminium crimp cap and a tear-off plastic tab.
The solvent is packaged in a colourless type I glass vial.
Pack:

• 1 vial of powder with 1 vial 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 with the
following denominations:
Germany: Teicoplanin sanofi-aventis
Italy: Teicoplanina Zentiva

---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for doctors or healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of
Teicoplanina Zentiva.
This medicinal product is for single use only.
Method of administration
The reconstituted solution can be injected directly or alternatively further diluted.
The injection can be administered as a bolus over 3-5 minutes or with an infusion of 30 minutes.
In children from birth to 2 months of age, it should only be administered via infusion.
The reconstituted solution can also be given orally.
Preparation of the reconstituted solution
Slowly inject the entire contents of the solvent vial into the powder vial
Gently rotate the vial between your hands until the powder is completely
dissolved. If the solution becomes foamy, allow it to stand for about 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 range from yellowish to
dark yellow.
The final solution is isotonic with plasma and has a pH of 7.2-7.8.

Preparation of the diluted solution before infusion
Teicoplanina Zentiva can be administered in the following infusion solutions:

• sodium chloride 9 mg/mL (0.9%) solution
• Ringer's solution
• Ringer's 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 a 1.36% or 3.86% glucose solution.

Validity of the reconstituted solution
The chemical-physical stability in use 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 point of view, the product must be used immediately. If this does not
happen, the user is responsible for the period and conditions of conservation of the product which
should not normally exceed 24 hours at a temperature between 2 and 8°C, unless the
reconstitution is carried out under controlled and validated aseptic conditions.
Validity of the diluted medicinal product
The chemical-physical stability in use 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 point of view, the product must be used immediately. If this does not happen,
the user is responsible for the period and conditions of conservation of the product and should not
normally exceed 24 hours at a temperature between 2 and 8°C, unless the
reconstitution/dilution is carried out under controlled and validated aseptic conditions.
Disposal
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with
local regulations.