Abelcet
Ask a doctor about a prescription for Abelcet
How to use 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.
- Country of registration
- Active substance
- Prescription requiredNo
- ImporterMerckle GmbH
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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