Abelcet

Package Leaflet: Information for the Patient

ABELCET, 5 mg/mL, Concentrate for Solution for Infusion

Amphotericin B in Lipid Complex

Read All of This Leaflet Carefully Before You Start Using This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Pack and Other Information

• 1. What Abelcet is and what it is used for
• 2. Before you use Abelcet
• 3. How to use Abelcet
• 4. Possible side effects
• 5. How to store Abelcet
• 6. Contents of the pack and other information

1. What Abelcet is and what it is used for

Abelcet is used to treat serious invasive fungal infections such as candidiasis, aspergillosis, cryptococcal meningitis, and disseminated cryptococcosis in HIV-infected patients, fusariosis, zygomycosis, blastomycosis, and coccidioidomycosis.

2. Before you use Abelcet

Contraindications

If you are allergic (hypersensitive) to amphotericin B or any of the other ingredients of Abelcet.

Warnings and Precautions

If you are being treated with Abelcet, your doctor will monitor your kidney function and electrolyte levels, such as potassium, before and during treatment with Abelcet. This is especially important if you have pre-existing kidney damage or are taking other medications that may affect kidney function.

Interactions with Other Medicinal Products

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

Pregnancy and Breastfeeding

Before taking any medicine, consult your doctor. If you are pregnant or breastfeeding, inform your doctor. Your doctor will decide whether you can use Abelcet.

Driving and Using Machines

Do not drive or operate machinery after taking Abelcet, as some of the side effects may affect your ability to drive or operate machinery.

Abelcet Contains Sodium

The medicine contains 3.6 mg of sodium (a major component of common salt) per 1 mL, which is 72 mg of sodium per 20 mL (in one vial). This corresponds to 3.6% of the maximum recommended daily intake of sodium for adults.

3. How to use Abelcet

Method of Administration

Abelcet is given as an infusion into a vein. The infusion can last for more than 2 hours.

Dose and Frequency of Administration

Abelcet will usually be given to you by a doctor or nurse. The recommended dose is 5 mg of Abelcet per kilogram of body weight per day, given as a single infusion.

Overdose

If you think you have been given too much Abelcet, tell your doctor immediately.

Missed Dose

If you miss a dose, tell your doctor immediately, who will decide when to give the next dose of Abelcet.

Stopping Treatment

Follow your doctor's instructions and complete the full course of treatment, even if you feel better.

4. Possible Side Effects

Like all medicines, Abelcet can cause side effects, although not everybody gets them.

Very Common Side Effects

• Chills, fever
• Increased serum creatinine levels

Common Side Effects

• Increased heart rate, irregular heartbeat
• High or low blood pressure
• Low platelet count, anemia
• Shortness of breath, asthma
• Nausea, vomiting, abdominal pain
• Headache, tremors
• Abnormal kidney function tests
• Kidney disorders
• Electrolyte imbalance
• Increased bilirubin levels
• Abnormal liver function tests
• Rash

Uncommon Side Effects

• Cardiac arrest
• Shock
• Anaphylactic reactions
• Injection site reactions
• Seizures, neuropathy
• Muscle pain
• Respiratory disorders

Side Effects with Unknown Frequency

• Encephalopathy
• Bronchospasm
• Exfoliative dermatitis
• Nephrogenic diabetes insipidus

5. How to Store Abelcet

Keep this medicine out of the sight and reach of children. Do not use Abelcet after the expiry date which is stated on the carton after EXP.

6. Contents of the Pack and Other Information

What Abelcet Contains

• The active substance is amphotericin B. 1 mL of the concentrate contains 5 mg of amphotericin B in a lipid complex.
• The other ingredients are L-α-dimyristoylphosphatidylcholine (DMPC), L-α-dimyristoylphosphatidylglycerol (DMPG) (as sodium and ammonium salts), sodium chloride, water for injections.

What Abelcet Looks Like and Contents of the Pack

Abelcet is a yellow concentrate for solution for infusion. One vial of 20 mL contains 100 mg of amphotericin B.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel.: (22) 345 93 00

Manufacturer:

Merckle GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany

Date of Last Revision: September 2024

Information for Healthcare Professionals Only:

1. PRODUCT NAME

Abelcet, 5 mg/mL, Concentrate for Solution for Infusion

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 mL of the concentrate contains 5 mg of amphotericin B in a lipid complex.

3. CLINICAL PARTICULARS

3.1 Indications for Use

Abelcet is indicated for the treatment of serious invasive fungal infections.

3.2 Posology and Method of Administration

Posology

The recommended dose is 5 mg/kg body weight per day, given as a single infusion.

3.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

3.4 Special Warnings and Precautions for Use

Abelcet should be administered by a healthcare professional.

3.5 Interaction with Other Medicinal Products and Other Forms of Interaction

Amphotericin B in a lipid complex is potentially nephrotoxic.

3.6 Fertility, Pregnancy and Lactation

There are no adequate data on the use of Abelcet in pregnant women.

3.7 Effects on Ability to Drive and Use Machines

Abelcet has no or negligible influence on the ability to drive and use machines.

3.8 Undesirable Effects

The most common adverse reactions are chills, fever, increased serum creatinine levels, hypokalemia, nausea, vomiting, abdominal pain, headache, and tremors.

3.9 Overdose

In the event of an overdose, the patient should be closely monitored and supportive care should be provided.

4. PHARMACOLOGICAL PROPERTIES

Abelcet contains the antifungal agent amphotericin B in a lipid complex.

4.1 Pharmacodynamic Properties

Amphotericin B is a macrocyclic polyene antifungal antibiotic with a broad spectrum of activity.

5. PHARMACEUTICAL PARTICULARS

Abelcet should be stored in a refrigerator at 2-8°C.

6. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

PREPARATION OF THE MEDICINAL PRODUCT FOR ADMINISTRATION

Abelcet is a sterile, apyrogenic suspension, for intravenous infusion only, after reconstitution.