TEICOPLANINA 200 mg Порошок И Раствор Для Инъекционного/Инфузионного Раствора

Содержание инструкции

1. Teicoplanina Altan 200 mg Powder for injectable or infusion solution, 400 mg Powder for injectable or infusion solution
   1. What is Teicoplanina Altan and what is it used for
   2. What you need to know before you are given Teicoplanina Altan
   3. How to use Teicoplanina Altan
   4. Possible side effects
   5. How to store Teicoplanina Altan
   6. Package Contents and Other Information

Teicoplanina Altan 200 mg Powder for injectable or infusion solution, 400 mg Powder for injectable or infusion solution

Generic medicine

Read this leaflet carefully before you start to receive 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.
• This medicine has been prescribed for you. Do not pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• 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 Altan is and what it is used for
• 2. What you need to know before you are given Teicoplanina Altan
• 3. How to use Teicoplanina Altan
• 4. Possible side effects
• 5. How to store Teicoplanina Altan
• 6. Contents of the pack and other information

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

Teicoplanina Altan is an antibiotic that contains the active substance “teicoplanina”. It works
by killing the bacteria responsible for infections in the body.
Teicoplanina Altan 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 (sometimes called “endocarditis”)
• abdominal area (peritonitis)
• blood, when caused by one of the above conditions.

Teicoplanina Altan can be used to treat some infections caused by bacteria Clostridium

difficilein the intestine. For this, the solution is taken by mouth.

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

Do not use Teicoplanina Altan 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 Altan if:

• you are allergic to an antibiotic called “vancomycin”
• you have a reddening of the upper part of your body (red man 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 blood, kidneys and/or liver are working properly (see “Other medicines and Teicoplanina Altan”).

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

Tests
During treatment you may need to have tests to check 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 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 Altan for a long time, bacteria that are not
affected by the antibiotic may grow more than normal – your doctor will carry out checks to
monitor this possibility.

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

• aminoglycosides, which should not be mixed with Teicoplanina Altan 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) that can cause problems with your hearing and/or kidneys

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

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect 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 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 with breast milk, before you are given this
medicine. They will decide whether you can continue or not to breastfeed while you are given
Teicoplanina Altan.
Studies in animals have not shown evidence of fertility problems.

Driving and using machines
While you are being treated with Teicoplanina Altan you may experience headache or dizziness. If
this happens, do not drive vehicles or use machines.

Teicoplanina Altan 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 Altan

Use this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

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

• 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.

Bone and joint, and heart infections

• Initial dose (for the first 3 doses): 12 mg per each kg of body weight, administered every 12 hours, with an injection into a vein or a muscle.
• 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 by Clostridium 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 reduced 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 (on the first day): 16 mg per each kg of body weight, administered in an intravenous drip.
• Maintenance dose: 8 mg per each kg of body weight, administered in an intravenous drip 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.

The method of preparation of the reconstituted solution (to be diluted or administered orally
or by injection) and of the diluted solutions is indicated in paragraph 6.

How Teicoplanina Altan 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 with a drip into a vein.

Children from birth to 2 months of age should only be administered via infusion.
To treat some infections, the solution can be taken by mouth (oral use).

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

If you forget to receive Teicoplanina Altan
The doctor or nurse will have instructions on when to give you Teicoplanina Altan. It is unlikely
that you will not be given the medicine as prescribed. However, if you are concerned, inform the doctor or
nurse.

If you stop taking Teicoplanina Altan
Do not stop taking this medicine without first talking to your doctor, pharmacist or
nurse.
If you have any doubts about the use of 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, swelling, rash, itching, fever, chills Rare(may affect up to 1 in 1,000 people)
• flushing in the upper body

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

• skin, mouth, eyes 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)”.

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 blood clot in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased occurrence of infections - these could be signs 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)
• problems with the kidneys or changes in the way they work - highlighted by tests. Frequency or severity of kidney problems may be increased if you receive higher doses.
• seizures
• low levels of all types of blood cells

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)

• decrease in the number of platelets
• increase in liver enzyme levels in the blood
• increase in creatinine levels in the blood (to check the kidneys)
• hearing loss, ringing in the ears or feeling that you, or things around you are spinning
• 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Teicoplanina Altan

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 box and on the
vial label 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 time of use of Teicoplanina Altan, after it
has been reconstituted and is ready for use, are described in “Practical information for
healthcare professionals on the preparation and handling of Teicoplanina Altan”.
Do not dispose of any medicine in waste water 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 Teicoplanina Altan Contains
Powder vial:

• The active ingredient is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are sodium chloride, hydrochloric acid and sodium hydroxide.

Description of the appearance of Teicoplanina Altan and contents of the pack
Powder vial:
Teicoplanin is a powder for solution for injection/infusion. The powder is a white or
off-white mass. The reconstituted solution is a clear and colorless or slightly
yellowish liquid.
The powder is packaged:

• in colorless type I glass vials with a useful volume of 10 mL for 200 mg closed with a bromobutyl rubber stopper and a yellow aluminum crimp cap with a plastic tear-off tab.
• in colorless type I glass vials with a useful volume of 10 mL for 400 mg closed with a bromobutyl rubber stopper and a green aluminum crimp cap with a plastic tear-off tab.

Packs:

• 1 powder vial

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals S.A.
Pol. Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain
or
Altan Pharmaceuticals S.A.
Avda. Constitución 198-199. Pol. Industrial Monte Boyal
45950 Casarrubios del Monte (Toledo)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Spain:
Teicoplanina Altan 200 mg Polvo para solución inyectable y para perfusión EFG
Teicoplanina Altan 400 mg Polvo para solución inyectable y para perfusión EFG

United Kingdom:
Teicoplanin Altan 200 mg Powder for solution for injection and infusion
Teicoplanin Altan 400 mg Powder for solution for injection and infusion

Germany:
Teicoplanin Ethypharm 200 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder
einer Lösung zum Einnehmen
Teicoplanin Ethypharm 400 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder
einer Lösung zum Einnehmen

Portugal:
Teicoplanina Altan 200 mg Pó para solução injectável ou para perfusão
Teicoplanina Altan 400 mg Pó para solução injectável ou para perfusão

Belgium:
Teicoplanine Altan Pharma 200 mg poudre pour solution injectable/pour perfusion ou solution
buvable
Teicoplanine Altan Pharma 400 mg poudre pour solution injectable/pour perfusion ou solution
buvable

Netherlands:
Teicoplanine Altan Pharma 200 mg poeder voor oplossing voor injectie/infusie
Teicoplanine Altan Pharma 400 mg poeder voor oplossing voor injectie/infusie

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency:
http://www.agenziafarmaco.gov.it/

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The following information is intended exclusively for physicians or healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of
Teicoplanina Altan.
This medicinal product is for single use only.
Route 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 be administered only by infusion.
The reconstituted solution can also be given orally (oral use).
Preparation of the reconstituted solution

• Slowly inject 3.2 mL of water for injection into the powder vial. Gently rotate the vial in your hands until the powder is completely dissolved. If the solution becomes foamy, let it stand for about 15 minutes. The reconstituted solutions contain 200 mg of teicoplanin in 3.0 mL and 400 mg in 3.0 mL. Only transparent and slightly yellowish solutions should be used. The final solution is isotonic with plasma and has a pH of 7.2-7.8.

Preparation of the diluted solution before infusion
Teicoplanina Altan 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.

Stability of the reconstituted and diluted 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 storage of the
product which should not normally exceed 24 hours at a temperature between 2 and 8°C.
Disposal
Unused medicinal product and waste derived from such medicinal product must be disposed of in
accordance with local regulations.