Teicoplanin aptapharma

Package leaflet: Information for the user

Teicoplanin AptaPharma, 200 mg,
powder and solvent for solution for injection/infusion
Teicoplanin AptaPharma, 400 mg,
powder and solvent for solution for injection/infusion
Teicoplaninum
Please read all of this leaflet carefully before using this medicine because it contains important information
for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Teicoplanin AptaPharma is and what it is used for
2. Important information before using Teicoplanin AptaPharma
3. How to use Teicoplanin AptaPharma
4. Possible side effects
5. How to store Teicoplanin AptaPharma
6. Contents of the pack and other information

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

Teicoplanin AptaPharma is an antibiotic. It contains the active substance called "teicoplanin". It works by killing bacteria that cause infection in the patient's body.
Teicoplanin AptaPharma is used in adults and children (including newborns) for the treatment of bacterial infections of:

• skin and subcutaneous tissue – sometimes referred to as "soft tissues"
• bones and joints
• lungs
• urinary tract
• heart – sometimes referred to as "endocarditis"
• subcutaneous abdominal tissue – peritonitis
• blood, if caused by any of the above conditions.

Teicoplanin AptaPharma may be used in the treatment of certain infections caused by Clostridium difficile bacteria in the intestine. For this purpose, the medicinal solution is taken orally.

2. Important information before using Teicoplanin AptaPharma

When not to use Teicoplanin AptaPharma

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

Warnings and precautions
Before starting treatment with Teicoplanin AptaPharma, discuss with a 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 (so-called "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 undergo regular tests to monitor whether the kidneys and/or liver are functioning properly (see "Teicoplanin AptaPharma and other medicines").

If any of the above conditions apply to the patient (or if the patient is unsure), contact a doctor, pharmacist, or nurse before administering Teicoplanin AptaPharma.
Severe skin reactions have been reported during treatment with teicoplanin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
If the patient develops a severe rash or other skin symptoms described in section 4, treatment with Teicoplanin AptaPharma must be discontinued immediately and the patient should contact a doctor or seek medical help without delay.

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 last for a long time
• the patient is receiving high loading doses (12 mg/kg twice daily)
• the patient has impaired kidney function
• the patient is taking or may take other medicines that can affect the nervous system, kidneys, or hearing.

In patients receiving Teicoplanin AptaPharma for prolonged periods, there may be an increased risk of overgrowth of bacteria resistant to the antibiotic. This will be monitored by the treating physician.

Teicoplanin AptaPharma and other medicines
Inform the 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 AptaPharma may affect the action of other medicines, and some medicines may also influence the effect of Teicoplanin AptaPharma.
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 AptaPharma in the same injection. These medicines may also cause hearing problems and/or kidney problems.
• amphotericin B – an antifungal medicine that may cause hearing problems and/or kidney problems.
• cyclosporine – an immunosuppressive medicine that may cause hearing problems and/or kidney problems.
• cisplatin – a medicine used in the treatment of malignant tumors that may cause hearing problems and/or kidney problems.
• diuretics (such as furosemide) – also known as "water pills," which may cause hearing problems and/or kidney problems.

If any of the above conditions apply to the patient (or if the patient is unsure), contact a doctor, pharmacist, or nurse before using Teicoplanin AptaPharma.

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. They will decide whether this medicine can be administered during pregnancy. There is a risk of damage to the inner ear and kidney function impairment.
If the patient is breastfeeding, she should inform the doctor before taking this medicine. The doctor will decide whether she can continue breastfeeding while receiving Teicoplanin AptaPharma.
Animal studies on reproductive toxicity did not show evidence of impaired fertility.

Driving and operating machinery
During treatment with Teicoplanin AptaPharma, the patient may experience pain or dizziness.
If such symptoms occur, the patient should not drive, operate tools, or machinery.

Teicoplanin AptaPharma contains sodium:
This medicine contains 10 mg of sodium (a main component of table salt) per vial. This corresponds to 0.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Teicoplanin AptaPharma

Recommended dose:
Adults and children (aged 12 years and older) with normal renal function
Skin and soft tissue infections, lung infections, and urinary tract infections

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

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

• In patients with mild to moderate renal impairment – the maintenance dose should be administered every two days, or half the maintenance dose once daily.
• In patients with severe renal 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, given 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.

Newborns and infants (from birth up to 2 months of age)

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

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 AptaPharma is administered
This medicine is usually administered by a doctor or nurse.

• The medicine will be given by intravenous injection (intravenous administration) or intramuscular injection (intramuscular administration).
• The medicine may also be administered by intravenous infusion via an intravenous drip. In infants from birth up to 2 months of age, only infusion administration should be used. In the treatment of certain infections, the solution may be taken orally (oral administration).

Use of a higher than recommended dose of Teicoplanin AptaPharma
It is unlikely that a doctor or nurse will administer too high a dose of the medicine. However, if the patient believes they have received too high a dose of Teicoplanin AptaPharma, or if the patient becomes agitated, seek immediate advice from a doctor or nurse.

Missed dose of Teicoplanin AptaPharma
The doctor or nurse will have instructions on how to administer Teicoplanin AptaPharma to the patient. It is unlikely that the medicine will be given incorrectly. However, if the patient has any concerns, they should consult a doctor or nurse.

Stopping Teicoplanin AptaPharma treatment
Do not stop using this medicine without first consulting a doctor, pharmacist, or nurse.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
If any of the following serious adverse reactions occur, treatment must be stopped immediately and the patient should contact a doctor or nurse immediately – urgent medical assistance may be required.

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

• sudden, life-threatening allergic reaction – symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills

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

• redness of the upper body

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

• blisters on the skin, mouth, eyes or genital organs – these may be symptoms of a disease called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• widespread red, peeling rash with skin lesions (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever – these may be symptoms of acute generalized exanthematous pustulosis (AGEP)
• drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents as influenza-like symptoms and facial rash, followed by widespread rash with high fever, increased liver enzyme activity observed in blood tests, increased numbers of certain white blood cells (eosinophilia), and enlarged lymph nodes.

If any of the above adverse symptoms occur, a doctor or nurse must be contacted immediately.
If the patient experiences any of the following serious adverse reactions, a doctor or nurse must be contacted immediately, as urgent medical assistance may be required.

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

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

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

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

If any of the above adverse symptoms occur, a doctor or nurse must be contacted immediately.

Other adverse reactions
Consult a doctor, pharmacist, or nurse if any of the following symptoms 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):

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

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

• infection (abscess)

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

• injection site reactions – such as skin redness, pain or swelling
• low levels of all types of blood cells

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Teicoplanin AptaPharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and vial label
after: EXP. The expiry date refers to the last day of the stated month.
This medicinal product does not require any special temperature storage conditions.
Store in the original packaging to protect from light.
Information on storage conditions and the shelf-life of Teicoplanin AptaPharma after
reconstitution and preparation for use is provided in the section "Practical information on the preparation
of Teicoplanin AptaPharma and handling instructions for healthcare professionals".

6. Contents of the pack and other information

What Teicoplanin AptaPharma contains

• The active substance is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are: sodium chloride and sodium hydroxide (for pH adjustment) in the powder; water for injections in the solvent.

What Teicoplanin AptaPharma looks like and contents of the pack
Teicoplanin AptaPharma is a powder and solvent for solution for injection/infusion.
The powder is a white or ivory-coloured, lyophilised, friable solid. The solvent is a clear, colourless liquid.
After reconstitution, Teicoplanin AptaPharma 200 mg is a slightly brownish, opalescent solution.
After reconstitution, Teicoplanin AptaPharma 400 mg is a brownish, opalescent solution.
The powder is packed in:

• a 10 mL type I glass vial closed with a grey bromobutyl rubber stopper type I and a blue flip-off seal consisting of an aluminium cap and a polypropylene button (PP disc).
• a 20 mL type I glass vial closed with a grey bromobutyl rubber stopper type I and a red flip-off seal consisting of an aluminium cap and a polypropylene button (PP disc).

The solvent is contained in a clear type I glass ampoule.
Pack sizes:

• 1 vial of powder + 1 ampoule of solvent in a cardboard box.
• 10 x (1 vial of powder + 1 ampoule of solvent) in a cardboard box.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]
Manufacturer
Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
This medicinal product is authorised in the European Economic Area member states under the following names:

Information intended exclusively for medical professionals:

Practical information on the preparation of Teicoplanin AptaPharma and handling instructions
for medical professionals.
This medicinal product is for single use only.
Administration method
After reconstitution, the solution may be administered by direct injection or after further dilution.
The medicine may be given as an intravenous bolus injection over 3-5 minutes or as a 30-minute intravenous infusion.
In infants from birth to 2 months of age, the medicine should be administered exclusively by intravenous infusion.
After reconstitution, the solution may also be administered orally.

Preparation of the solution:

• Slowly inject the entire contents of the provided solvent 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. After reconstitution, the solutions will contain 200 mg teicoplanin in 3.0 mL or 400 mg in 3.0 mL.

Only clear, slightly brownish solutions should be used.
The resulting solution is isotonic with serum and has a pH of 7.2–7.8.

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

• 9 mg/mL (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's lactate solution
• 50 mg/mL (5%) glucose solution for injection
• 100 mg/mL (10%) glucose solution for injection
• 1.8 mg/mL (0.18%) sodium chloride and 40 mg/mL (4%) glucose solution
• 4.5 mg/mL (0.45%) sodium chloride and 50 mg/mL (5%) glucose solution
• peritoneal dialysis solution containing 13.6 mg/mL (1.36%) or 38.6 mg/mL (3.86%) glucose.

Shelf life of the solution after reconstitution
Chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for
24 hours at a temperature of 2 to 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If it is not used immediately,
the user is responsible for the storage duration and conditions prior to use, and the storage time should generally not exceed
24 hours at a temperature of 2 to 8°C.
Shelf life after dilution
Chemical and physical stability of the solution prepared according to the recommendations has been demonstrated for
24 hours at a temperature of 2 to 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If it is not used immediately,
the user is responsible for the storage duration and conditions prior to use, and the storage time should generally not exceed
24 hours at a temperature of 2 to 8°C.
Disposal
Any unused medicinal product or waste materials should be disposed of in accordance with local regulations.