Teicoplanin altan

Package leaflet: Information for the user

Teicoplanin Altan, 400 mg, powder for solution for injection/infusion
or oral solution
Teicoplaninum
Please read all of 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 further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Teicoplanin Altan is an antibiotic. It contains the active substance
teicoplanin. It works by killing bacteria causing infection in the patient's body.
Teicoplanin Altan is used in adults and children (including newborns) to treat the following bacterial infections:

• Skin and subcutaneous tissue – sometimes referred to as "soft tissue"
• Bones and joints
• Lungs
• Urinary tract
• Heart – sometimes referred to as endocarditis
• Abdomen – peritonitis
• Bloodstream infections, if caused by any of the above conditions

Teicoplanin Altan may also be used to treat certain infections caused by
Clostridium difficile – bacteria in the intestines. For this purpose, the solution is taken orally.

2. Important information before using Teicoplanin Altan

When not to use Teicoplanin Altan

• if the patient is allergic to teicoplanin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Teicoplanin Altan, discuss with your doctor, pharmacist, or
nurse if:

• the patient is allergic to an antibiotic called vancomycin
• the patient has experienced redness of the upper part of the body (red man syndrome)
• the patient has a low platelet count (thrombocytopenia)
• the patient has impaired kidney function
• the patient is taking other medicines that may cause hearing problems and/or kidney problems. The patient may have regular tests to check whether the kidneys and/or liver are functioning properly (see "Teicoplanin Altan and other medicines")

If any of the above conditions apply to the patient (or the patient is unsure),
contact a doctor, pharmacist, or nurse before taking Teicoplanin Altan.
Diagnostic tests
During treatment, the patient may undergo blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment will be long-term
• the patient is to be treated with high loading doses (12 mg/kg twice daily)
• the patient has impaired kidney function
• the patient is taking or may take other medicines that may damage the nervous system, kidneys, or hearing

In patients receiving Teicoplanin Altan for a prolonged period, there may be an overgrowth of bacteria not affected by this antibiotic—this will be monitored by the treating physician.
Teicoplanin Altan and other medicines
Tell your doctor, pharmacist, or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is because Teicoplanin Altan may affect the action of other medicines. Likewise, some medicines may affect the action of Teicoplanin Altan. In particular, inform the doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• aminoglycosides – because they must not be mixed with Teicoplanin Altan in the same injection. They may also cause hearing problems and/or kidney problems
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and/or kidney problems
• cyclosporine – an immunosuppressive medicine which may cause hearing problems and/or kidney problems
• cisplatin – a medicine used to treat malignant tumours, which may cause hearing problems and/or kidney problems
• colistin – a medicine used to treat bacterial infections, which may cause hearing problems
• diuretics (such as furosemide and ethacrynic acid) – also known as “water tablets”, which may cause hearing problems and/or kidney problems

If any of the above points apply to the patient (or the patient is unsure),
contact a doctor, pharmacist, or nurse before taking Teicoplanin Altan.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should
consult a doctor, pharmacist, or nurse before using this medicine. The healthcare provider will decide whether
this medicine can be administered during pregnancy. There is a risk of damage to the inner ear and
kidney function disorders.
If the patient is breastfeeding, she should inform the doctor before taking this medicine.
The doctor will decide whether the patient can breastfeed while taking Teicoplanin
Altan.
Animal studies on the effect on fertility did not show any adverse effect of the medicine on fertility.
Driving and operating machinery
During treatment with Teicoplanin Altan, the patient may experience pain or dizziness.
If such adverse effects occur, the patient should not drive or operate any tools or machinery.
Teicoplanin Altan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".

3. How to use Teicoplanin Altan

This medicine should always be used exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose
Adults and children (aged 12 years and older) with normal kidney function
Skin and soft tissue infections, lung infections, and urinary tract infections

• Initial dose (for the first three to five doses): 400 mg (equivalent to 6 mg per kilogram of body weight) administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 400 mg (equivalent to 6 mg per kilogram of body weight) administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first three doses): 800 mg (equivalent to 12 mg per kilogram of body weight) administered every 12 hours by intravenous injection.
• Maintenance dose: 800 mg (equivalent to 12 mg per kilogram of body weight) administered once daily by intravenous or intramuscular injection.

Infection caused by Clostridium difficile
The recommended dose is 100 to 200 mg orally, twice daily for 7 to 14 days.
Adults and elderly patients with impaired kidney function
If the patient has impaired kidney function, the dose is usually reduced after the fourth day of treatment:

• In patients with mild to moderate kidney impairment – the maintenance dose should be administered every two days, or half the maintenance dose once daily.
• In patients with severe kidney impairment or undergoing hemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose once daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kilogram of body weight, administered as a single intravenous injection, followed by:

• First week: 20 mg/l in each dialysis bag
• Second week: 20 mg/l in every other dialysis bag
• Third week: 20 mg/l in the dialysis bag left overnight.

Neonates and infants (from birth to 2 months of age)

• Initial dose (on the first day): 16 mg per kilogram of body weight administered as an intravenous infusion.
• Maintenance dose: 8 mg per kilogram of body weight administered once daily as an intravenous infusion.

Children (aged 2 months to 12 years)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once daily by intravenous injection.

How Teicoplanin Altan is administered
This medicine is usually administered by a doctor or nurse.

• The medicine may be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be administered as an intravenous infusion.

In neonates and infants from birth to 2 months of age, only intravenous infusion should be used. In the treatment of certain infections, the solution may also be taken orally (oral administration).
Use of a higher than recommended dose of Teicoplanin Altan
It is unlikely that a doctor or nurse would administer too high a dose of this medicine. However, if you believe you have received too high a dose of Teicoplanin Altan, or if you feel agitated, contact your doctor or nurse immediately.
Missing a dose of Teicoplanin Altan
Your doctor or nurse will have received instructions on how to administer Teicoplanin Altan to you. It is unlikely they will give you the medicine incorrectly. However, if you have any concerns, speak to your doctor or nurse.
Stopping treatment with Teicoplanin Altan
Do not stop treatment without first consulting your doctor, pharmacist, or nurse.
If you have any further 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 get them.

Serious side effects

If any of the following serious side effects occur, stop treatment and contact your doctor or nurse immediately – urgent medical attention may be needed.

Not common (may occur in up to 1 in 100 patients):

• sudden, life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills
• abnormal increase in the number of certain white blood cells (eosinophilia)

Rare (may occur in up to 1 in 1,000 patients):

• redness of the upper body

Frequency not known (frequency cannot be estimated from available data):

• blisters on the skin, mouth, eyes or genitals – these may be symptoms of a disease called toxic epidermal necrolysis [Lyell’s syndrome], Stevens-Johnson syndrome, or drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS presents as flu-like symptoms and a rash on the face, followed by widespread rash, high fever, increased liver enzyme activity seen in blood tests, increased number of certain white blood cells (eosinophilia), and swollen lymph nodes.
  Decrease in the number of certain white blood cells (neutropenia).
  Inflammation of a vein with formation of a blood clot in the vein (phlebitis)

If any of the above side effects occur, inform your doctor or nurse immediately.

If you notice any of the following serious side effects, inform your doctor or nurse immediately, as you may need urgent medical attention.

Not common (may occur in up to 1 in 100 patients):

• swelling and blood clots in a vein
• difficulty breathing or wheezing (bronchospasm)
• more frequent infections than usual – these may be symptoms of reduced number of blood cells

Frequency not known (frequency cannot be estimated from available data):

• absence of white blood cells – symptoms may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney function disorders or changes in kidney function – visible in laboratory tests. When higher doses are administered, the frequency or severity of kidney function disorders may increase.
• seizures
• low levels of all types of blood cells (pancytopenia)

If any of the above side effects occur, inform your doctor or nurse immediately.

Other side effects

Consult your doctor, pharmacist, or nurse if any of the following side effects occur:

Common (may occur in up to 1 in 10 patients):

• rash, redness, itching
• pain
• fever

Not common (may occur in up to 1 in 100 patients):

• reduced platelet count
• elevated liver enzyme levels in blood
• increased blood creatinine concentration (monitoring of kidney function)
• hearing loss, ringing in the ears, or sensation that you or surrounding objects are moving
• nausea or vomiting, diarrhoea
• dizziness or headache

Rare (may occur in less than 1 in 1,000 patients):

• infection (abscess)

Frequency not known (frequency cannot be estimated from available data):

• local reactions at the injection site – such as skin redness, pain or swelling

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the Marketing Authorisation Holder or its representative in Poland.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Teicoplanin Altan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage precautions are required for this medicine.
Information regarding storage conditions and duration of use of teicoplanin after reconstitution of the powder and preparation for administration is described in the section "Practical information for healthcare professionals on preparation and handling of teicoplanin".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Teicoplanin Altan contains

• The active substance is teicoplanin. Each vial contains 400 mg of teicoplanin.
• The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).

What Teicoplanin Altan looks like and contents of the pack
Teicoplanin Altan is a powder for solution for injection/infusion or for oral solution.
The powder is white to slightly yellow.
The reconstituted solution is yellowish to slightly brown.
The powder is packed in 10 ml vials made of colourless type I glass with a nominal capacity of 10 ml for a content of 400 mg, closed with a bromobutyl rubber stopper type I and an aluminium green seal, and a plastic "flip-off" cap.
Pack sizes:

• 1 vial with powder

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
Altan Pharmaceuticals S.A.
Avda. de la Constitución 198-199
Polígono Industrial Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Teicoplanin Altan, 400 mg, powder for solution for injection/infusion or for oral solution
Austria: Teicoplanin Altan 400 mg Pulver zur Herstellung einer Injektions-/Infusionslösung oder einer Lösung zum Einnehmen
France: Teicoplanine Altan 400 mg poudre pour solution injectable/pour perfusion ou solution buvable
Other sources of information
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Information intended exclusively for healthcare professionals:

Practical information for healthcare professionals on the preparation and handling of
teicoplanin
This medicinal product is for single use only.
Administration method
The reconstituted solution may be administered directly by intravenous injection or further diluted if necessary.
The solution may be given as an injection over 3 to 5 minutes or as a 30-minute infusion.
In infants from birth to 2 months of age, administration should be by infusion only.
The reconstituted solution may also be administered orally.
Preparation of the solution

• Slowly inject 3 ml of water for injections into the vial containing the powder.
• Gently rotate the vial in 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 resulting solution will contain 400 mg in 3.0 ml.
  Only clear, slightly yellow solutions should be used.
  The final solution is isotonic with serum and has a pH of 6.3–7.7.

Dilution of the solution prior to infusion
Teicoplanin Altan may be administered in the following infusion solutions:

• 9 mg/ml (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's lactate solution
• 5% glucose solution for injection
• 10% glucose solution for injection
• 0.18% sodium chloride and 4% glucose solution
• 0.45% sodium chloride and 5% glucose solution
• Peritoneal dialysis solution containing 1.36%.

Shelf life of the solution after reconstitution and dilution
Chemical and physical stability of the solution prepared according to recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage time and conditions prior to use, which should generally not exceed 24 hours at a temperature of 2 to 8°C, unless the reconstitution and dilution process was carried out under controlled and validated aseptic conditions.

Disposal
Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.