Teicoplanin pharmline

Package leaflet: Information for the user

Teicoplanin Pharmline, 200 mg, powder and solvent for solution for
injection / infusion or oral solution
Teicoplanin Pharmline, 400 mg, powder and solvent for solution for
injection / infusion or oral solution
Teicoplaninum
Please read all of this leaflet carefully before using 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Teicoplanin Pharmline is an antibiotic. It contains the active substance called "teicoplanin".
It acts bactericidally against bacteria causing infection in the patient's body.
Teicoplanin Pharmline is used in adults, adolescents, and children (including newborns)
for the treatment of bacterial infections of:

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

Teicoplanin Pharmline may also be used in the treatment of certain infections caused by
"Clostridioides difficile" – bacteria in the intestines. In such cases, the solution of the medicine is taken orally.

2. Information before using Teicoplanin Pharmline

When not to use Teicoplanin Pharmline

• 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 Pharmline, 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 dysfunction. The patient may undergo regular tests to monitor whether the kidneys and/or liver are functioning properly (see “Teicoplanin Pharmline and other medicines”). If any of the above conditions apply to the patient (or the patient is unsure), contact your doctor, pharmacist, or nurse before taking Teicoplanin Pharmline.

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported following administration of teicoplanin. If the patient develops a severe rash or other skin reactions described in section 4, treatment with Teicoplanin Pharmline 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 is prolonged,
• the patient is receiving high loading doses (12 mg/kg body weight twice daily),
• the patient has impaired kidney function,
• the patient is taking or may take other medicines that can damage the nervous system, kidneys, or hearing.

In patients receiving Teicoplanin Pharmline for a prolonged period, there may be an overgrowth of bacteria not affected by the antibiotic. This will be monitored by the treating physician.

Teicoplanin Pharmline and other medicines
Inform your doctor, pharmacist, or nurse about all medicines currently taken or recently used, as well as any medicines the patient plans to take. This is because Teicoplanin Pharmline may affect the action of other medicines, and some medicines may affect the action of Teicoplanin Pharmline. In particular, inform your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• aminoglycosides – these must not be mixed with Teicoplanin Pharmline in the same injection. They may also cause hearing problems and/or kidney dysfunction.
• amphotericin B – a medicine used to treat fungal infections, which may cause hearing problems and/or kidney dysfunction.
• cyclosporine – a medicine affecting the immune system, which may cause hearing problems and/or kidney dysfunction.
• cisplatin – a medicine used in the treatment of malignant tumours, which may cause hearing problems and/or kidney dysfunction.
• diuretics (such as furosemide) – also known as “water tablets”, which may cause hearing problems and/or kidney dysfunction.

If any of the above apply to the patient (or the patient is unsure), contact your doctor, pharmacist, or nurse before taking Teicoplanin Pharmline.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor, pharmacist, or nurse before using this medicine. The doctor will decide whether this medicine can be administered during pregnancy. There is a risk of damage to the inner ear and kidney dysfunction.

If the patient is breastfeeding, she should inform her doctor before taking this medicine. The doctor will decide whether she may continue breastfeeding while taking Teicoplanin Pharmline.

Animal studies on reproductive toxicity did not show evidence of impaired fertility.

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

Teicoplanin Pharmline contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. the medicine is considered “sodium-free”.

3. How to use Teicoplanin Pharmline

Recommended dose:

Adults, adolescents, and children (aged 12 years and above) with normal kidney 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 Clostridioides difficile
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 given once daily.
• In patients with severe kidney impairment or undergoing haemodialysis – the maintenance dose should be administered every three days, or one-third of the maintenance dose given once daily.

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

• Week 1: 20 mg/L in each dialysis bag
• Week 2: 20 mg/L in every second dialysis bag
• Week 3: 20 mg/L in the dialysis bag left overnight

Neonates and infants (from birth up 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 Pharmline is administered
This medicine is usually administered by a doctor or nurse.

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

Use of a higher than recommended dose of Teicoplanin Pharmline
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. However, if the patient believes they have received too high a dose of Teicoplanin Pharmline, or if the patient feels unwell, seek immediate medical advice from a doctor or nurse.

Missed dose of Teicoplanin Pharmline
The doctor or nurse will follow instructions on how to administer Teicoplanin Pharmline to the patient. It is unlikely they will administer the medicine incorrectly. However, if the patient has any concerns, contact the doctor or nurse.

Stopping Teicoplanin Pharmline treatment
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 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 and
medical advice must be sought immediately from a doctor or nurse – the patient may
require urgent medical attention.
Uncommon (may occur in no more than 1 in 100 patients)

• Sudden, life-threatening allergic reaction (anaphylactic reaction) – symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills.

Rare (may occur in no more than 1 in 1,000 patients)

• Redness of the upper part of the body.

Frequency unknown (frequency cannot be determined from available data)

• Severe drop in blood pressure caused by a sudden, life-threatening allergic reaction (anaphylactic shock);
• Blisters on the skin, mouth, eyes or genital organs – these may be symptoms of a disease called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome";
• Red, scaly, widespread rash with small lumps under the skin (including in skin folds, chest, abdomen, back and arms) and blisters, accompanied by fever – these may be symptoms of so-called "acute generalized exanthematous pustulosis (AGEP)";
• 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 with high fever, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and enlarged lymph nodes;
• Low levels of all types of blood cells;
• Swelling of the face, tongue and (or) throat and (or) difficulty swallowing, potentially with breathing difficulties (angioedema).

If the patient notices any of the following serious adverse reactions, a doctor or nurse must be
informed immediately, as the patient may require urgent medical attention.
Uncommon (may occur in no more than 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 a reduced number of white blood cells.

Frequency unknown (frequency cannot be determined 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;
• Skin reaction causing red spots or patches on the skin, which may look like a target or "bull's eye" with a dark red center surrounded by lighter red rings (erythema multiforme);
• Redness and peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis).

If any of the above adverse reactions occur, a doctor or nurse must be informed immediately.
Other adverse reactions
Consult a doctor, pharmacist or nurse if any of the following symptoms occur:
Common (may occur in no more than 1 in 10 patients)

• Rash, redness, itching;
• Pain;
• Fever.

Uncommon (may occur in no more than 1 in 100 patients)

• Decreased number of platelets;
• Increased level of white blood cells in blood (eosinophilia);
• Increased level of liver enzymes in blood;
• Increased creatinine concentration in blood (monitoring kidney function);
• Hearing loss, ringing in the ears or sensation that the patient or surrounding objects are moving;
• Nausea, vomiting, diarrhoea;
• Dizziness;
• Headache.

Rare (may occur in no more than 1 in 1,000 patients)

• Infection (abscess).

Frequency unknown (frequency cannot be determined from available data)

• Overgrowth of organisms resistant to teicoplanin;
• Rash (urticaria);
• Injection site reactions – such as redness of the skin, pain or swelling;
• Chills.

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 Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps provide more information on the safety of using the medicine.
5. How to prepare Teicoplanin Pharmline medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label following: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Information on storage conditions of reconstituted Teicoplanin Pharmline and its shelf-life after reconstitution is described in the section "Practical information for healthcare professionals on preparation and handling of Teicoplanin Pharmline".

6. Contents of the pack and other information

What Teicoplanin Pharmline contains
Teicoplanin Pharmline, 200 mg, powder and solvent for solution for injection /
for infusion or oral solution

• The active substance is 200 mg of teicoplanin per vial.
• The other components are: sodium chloride and sodium hydroxide in the powder, and water for injections in the solvent.

Teicoplanin Pharmline, 400 mg, powder and solvent for solution for injection /
for infusion or oral solution

• The active substance is 400 mg of teicoplanin per vial.
• The other components are: sodium chloride and sodium hydroxide in the powder, and water for injections in the solvent.

What Teicoplanin Pharmline looks like and contents of the pack
Teicoplanin Pharmline is a white powder and solvent for preparing a solution for
injection / infusion or oral solution. The powder is a white or off-white homogeneous
mass or powder. The solvent is a clear, colourless liquid.
Teicoplanin Pharmline, 200 mg, powder and solvent for solution for injection /
for infusion or oral solution
A colourless, transparent vial made of type I glass containing sterile powder for preparing a solution for injection/infusion or oral solution, containing 200 mg of teicoplanin, closed with a bromobutyl rubber stopper and sealed with an aluminium cap with a blue polypropylene flip-off cap.
A colourless, transparent ampoule made of type I glass with a break ring, containing 3 mL of water for injections.
The pack is enclosed in a cardboard box.
Pack sizes

• 1 vial of powder and 1 ampoule of solvent.
• 5 vials of powder (1 PVC/PET/PE tray containing 5 vials) and 5 ampoules of solvent (1 tray containing 5 ampoules).

Not all pack sizes may be marketed.
Teicoplanin Pharmline, 400 mg, powder and solvent for solution for injection /
for infusion or oral solution
A colourless, transparent vial made of type I glass containing sterile powder for preparing a solution for injection/infusion or oral solution, containing 400 mg of teicoplanin, closed with a bromobutyl rubber stopper and sealed with an aluminium cap with a white polypropylene flip-off cap.
A colourless, transparent ampoule made of type I glass with a break ring, containing 3 mL of water for injections.
The pack is enclosed in a cardboard box.
Pack sizes

• 1 vial of powder and 1 ampoule of solvent.
• 5 vials of powder (1 PVC/PET/PE tray containing 5 vials) and 5 ampoules of solvent (1 tray containing 5 ampoules).

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmline Company Sp. z o.o.
ul. Juliana Ursyna Niemcewicza 17/11
02-306 Warsaw
Poland
tel: +48 780 008 085
e-mail: [email protected]
Manufacturer
S.C. Rompharm Company S.R.L.
1A, Eroilor Street
075100 Otopeni
Romania
This medicinal product is authorised in the European Economic Area countries under the following names:
Hungary Teicoplanin Rompharm 200 mg powder and solvent for solution for injection/infusion or oral solution
Teicoplanin Rompharm 400 mg powder and solvent for solution for injection/infusion or oral solution
Romania Teicoplanină Rompharm 200 mg powder and solvent for injectable/perfusable solution or oral solution
Teicoplanină Rompharm 400 mg powder and solvent for injectable/perfusable solution or oral solution
Bulgaria Теикопланин Ромфарм 200 mg powder and solvent for injectable/infusion solution or oral solution
Теикопланин Ромфарм 400 mg powder and solvent for injectable/infusion solution or oral solution
Poland Teicoplanin PHARMLINE

Information intended exclusively for healthcare professionals:

Practical information for healthcare professionals on preparation and handling
of Teicoplanin Pharmline
This medicinal product is for single use only.
Route of administration
Teicoplanin should be administered intravenously or intramuscularly. Intravenously, the solution may be given as an injection over 3 to 5 minutes or as a 30-minute infusion.
In neonates, administration should be exclusively via the infusion method.
In cases of diarrhoea and colitis associated with Clostridioides difficile infection, oral administration should be used.
Preparation of the reconstituted solution
The solution is reconstituted by adding 3 mL of water for injections from the ampoule of solvent to the vial containing the powder. The water should be added slowly to the vial, which should be gently rotated until all the powder is dissolved, to avoid foaming. If foam appears, the solution should be left to stand for approximately 15 minutes until the foam disappears. Only clear solutions should be used. The colour of the reconstituted solution is yellowish.

The reconstituted solution may be injected directly or alternatively further diluted or administered orally.
Preparation of diluted solution for infusion
The medicinal product Teicoplanin Pharmline can 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

Shelf life of the solution after reconstitution
Chemical and physical stability of the solution prepared as recommended 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 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 of the diluted medicinal product
Chemical and physical stability of the solution prepared as recommended 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 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 material should be disposed of in accordance with local regulations.