NIPENT Powder for solution for injection/infusion (2017)
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Περιεχόμενα
Name of the medicinal product
NIPENT 10 mg powder for solution for injection, powder for solution for infusion.
Qualitative and quantitative composition
One vial contains 10 mg Pentostatin. When reconstituted (see Section 6.6), the resulting solution contains pentostatin 2 mg/ml. For a full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection, powder for solution for infusion. The vials contain a solid white to off-white cake or powder. The pH of reconstituted solution is 7.0–8.2.
Therapeutic indications
Pentostatin is indicated as single agent therapy in the treatment of adult patients with hairy cell leukaemia.
Posology and method of administration
Pentostatin is indicated for adult patients. Administration to Patient It is recommended that patients receive hydration with 500 to 1,000 ml of 5% glucose only or 5% glucose in 0.18% or 0.9% saline or ...
Contraindications
Pentostatin is contraindicated in patients who have demonstrated hypersensitivity to the active ingredient or to any of the excipients. Pentostatin is contraindicated in patients with impaired renal function ...
Special warnings and precautions for use
Warnings Pentostatin should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of doses higher than those specified (see ...
Interaction with other medicinal products and other forms of interaction
Allopurinol Allopurinol and pentostatin are both associated with skin rashes. Based on clinical studies in 25 refractory patients who received both pentostatin and allopurinol, the combined use of pentostatin ...
Pregnancy and lactation
Women of childbearing potential receiving pentostatin should be advised not to become pregnant. No fertility studies have been conducted in animals. Incompletely reversible seminiferous tubular atrophy ...
Effects on ability to drive and use machines
Pentostatin has a minor or moderate influence on the ability to drive and use machines. Patients should be advised to use caution in driving or using machinery following drug administration.
Undesirable effects
Pentostatin is lymphotoxic. Aside from myelosuppression, pentostatin is immunosuppressive in particular by suppression of the CD4+ lymphocyte subset. CD4+ counts smaller than 200 per µl are usually seen ...
Overdose
No specific antidote for pentostatin overdose is known. Pentostatin administered at higher doses (20-50 mg/m²/course) than recommended was associated with deaths due to severe renal, hepatic, pulmonary, ...
Pharmacodynamic properties
LO1XX08 Pharmacotherapeutic Group: Pentostatin is an adenosine deaminase (ADA) inhibitor. Mechanism of Action Pentostatin is a potent transition state inhibitor of the enzyme adenosine deaminase. The greatest ...
Pharmacokinetic properties
In man, pentostatin pharmacokinetics are linear with plasma concentrations increasing proportionately with dose. Following a single dose of 4 mg/m² of pentostatin infused over 5 minutes, the distribution ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: Acute Toxicity ...
List of excipients
Mannitol Sodium hydroxide or Hydrochloric acid (for pH adjustment)
Incompatibilities
Acidic solutions should be avoided (the pH of the reconstituted powder is 7.0 to 8.2).
Shelf life
Shelf life: 3 years. The reconstituted solution for injection or reconstituted and further diluted solution for infusion should be used within 8 hours and should not be stored above 25°C. Immediate administration ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). For storage conditions of the reconstituted medicinal product, see Section 6.3.
Nature and contents of container
NIPENT is supplied in single-dose, 10-mg vials packaged in individual cartons (packs of 1 vial). Vials are made from Type I glass and siliconised stoppers.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements. Prescribers should refer to national or recognised guidelines on handling cytotoxic agents. Procedures ...
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Marketing authorization number(s)
PL 04515/0222
Date of first authorization / renewal of the authorization
30<sup>th</sup> January 2009
Date of revision of the text
11/ 2017
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