PENTACARINAT Powder for reconstitution (2019)
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Περιεχόμενα
Name of the medicinal product
Pentacarinat 300mg Powder for Solution for Injection/Infusion.
Qualitative and quantitative composition
Pentamidine Isetionate 300 mg (Equivalent to 172.4 mg pentamidine base).
Pharmaceutical form
Powder for reconstitution. Sterile, white to almost white powder for use after reconstitution.
Therapeutic indications
Pentamidine is indicated in the treatment of: Pneumonia due to Pneumocystis carinii (PCP). Cutaneous leishmaniasis. Early phase African sleeping sickness caused by Trypanosoma gambiense. Prevention of ...
Posology and method of administration
All indications can be treated by deep intramuscular injection or intravenous injection. Pentamidine powder is reconstituted before use with Water for Injections. For intravenous use the required dose ...
Contraindications
The drug should not be administered to patients with a known hypersensitivity to pentamidine.
Special warnings and precautions for use
Pentamidine isetionate should be used with particular caution in patients with hepatic and/or renal dysfunction, hypertension or hypotension, hyperglycaemia or hypoglycaemia, leucopenia, thrombocytopenia ...
Interaction with other medicinal products and other forms of interaction
Caution is advised when pentamidine isetionate is concomitantly used with: drugs that are known to prolong the QT interval such as phenothiazines, tricyclic antidepressants, terfenadine and astemizole, ...
Pregnancy and lactation
Pregnancy There is no evidence of the safety of pentamidine isetionate in human pregnancy. A miscarriage within the first trimester of pregnancy has been reported following aerosolised prophylactic administration. ...
Effects on ability to drive and use machines
Pentamidine has no known effect on the ability to drive and use machines. Considering the risk of dizziness, one should be careful.
Undesirable effects
Adverse reactions frequency is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), ...
Overdose
Treatment is symptomatic. Cardiac rhythm disorders, including Torsades de Pointes, have been reported following overdose of pentamidine isetionate.
Pharmacodynamic properties
Pharmacotherapeutic group: Antiprotozoals, other agents against leishmaniasis and trypanosomiasis ATC Code: P01CX01 Pentamidine isetionate is an aromatic diamine. It is an antiprotozoal agent which acts ...
Pharmacokinetic properties
After intravenous infusion, plasma levels of pentamidine fall rapidly during the first two hours to one twentieth of peak levels, followed by a much slower decline thereafter. After intramuscular administration, ...
Preclinical safety data
No additional data of relevance to the prescriber.
List of excipients
Not applicable.
Incompatibilities
Pentamidine isetionate solution should not be mixed with any injection solutions other than Water for Injections BP, Glucose Intravenous Infusion BP and 0.9% (normal) Sodium Chloride Injection BP.
Shelf life
Shelf life: 5 years when unopened. After reconstitution 24 hours.
Special precautions for storage
Store the dry product below 30°C. Store the reconstituted product (for intravenous infusion) at 2-8°C. Use within 24 hours.
Nature and contents of container
Cardboard carton containing 5 10 ml glass vials each with rubber bung and aluminium ring. Each vial contains 300 mg Pentamidine Isetionate BP.
Special precautions for disposal and other handling
This product should be reconstituted in a fume cupboard. Store the dry product below 30°C. Store dilute reconstituted drug solutions between 2-8°C, and discard all unused portions within 24 hours of preparation. ...
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0572
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 June 1988 Date of latest renewal: 17 January 2003
Date of revision of the text
13 August 2019
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