ZANOSAR Powder for concentrate for solution (2018)
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Περιεχόμενα
Name of the medicinal product
Zanosar 1 g, powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each Zanosar vial contains 1 g of the active ingredient streptozocin. The concentration of the reconstituted solution before dilution is 100 mg/mL. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for concentrate for solution for infusion. Zanosar is a freeze-dried preparation available as a sterile, white to pale yellow powder.
Therapeutic indications
Zanosar is indicated for the systemic treatment of adult patients with inoperable, advanced or metastatic, progressive and/or symptomatic, well-differentiated, G1 or G2 neuroendocrine tumours of pancreatic ...
Posology and method of administration
Zanosar should only be administered under the supervision of a physician experienced in the use of anti-cancer chemotherapeutic agents. The patient should have access to a facility with a laboratory and ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Renal failure (GFR <30 ml/min) (see section 4.4) Live and live-attenuated vaccines Breastfeeding
Special warnings and precautions for use
Renal Toxicity Many patients treated with Zanosar have experienced some degree of renal toxicity, as evidenced by an increase in plasma creatinine and proteinuria. The mechanisms of renal toxicity are ...
Interaction with other medicinal products and other forms of interaction
Live and live-attenuated vaccines: Concomitant use may induce fatal generalized vaccinal disease and is contraindicated (see section 4.3). Immunosuppressive drugs: increased immunosuppression with a risk ...
Fertility, pregnancy and lactation
Contraception Zanosar is not recommended in women of childbearing potential not using contraception. An effective method of contraception should be used during treatment. A period of contraception post-treatment ...
Effects on ability to drive and use machines
Streptozocin may cause confusion, lethargy or depression. Patients should be advised not to drive or use machines if they experience any adverse reaction that may affect their ability to perform these ...
Undesirable effects
The most common adverse reactions reported with Zanosar are gastrointestinal and renal disorders. The former are not life threatening but can be disturbing for the patient and may result in treatment discontinuation ...
Overdose
There is no specific antidote for overdose with Zanosar and treatment of overdose should consist of supportive measures. Overdose should be avoided by carefully calculating the dose to be administered. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic alkylating agent-Nitrosoureas ATC code: L01AD04 Mechanism of action The antineoplastic activity of streptozocin was assessed in vitro, and in vivo, using mice ...
Pharmacokinetic properties
After i.v. administration of radiolabeled streptozocin, the unchanged drug was cleared from the plasma within a few minutes (initial half-life: 5 minutes and terminal half-life: 35 minutes). The metabolites ...
Preclinical safety data
Conventional studies with streptozocin, including short term toxicology studies, genotoxicity and reproductive toxicity studies were conducted in mice, rats, rabbits, dogs and monkeys. Repeated dose studies ...
List of excipients
Citric acid anhydrous Sodium hydroxide for pH adjustment
Incompatibilities
This medicinal product must not be mixed with other medicinal products, especially other cytotoxic drugs, except those mentioned in section 6.6.
Shelf life
Before opening: 36 months After opening, reconstitution and dilution: The reconstituted solution should be immediately diluted. The chemical and physical in-use stability of the resulting solution has ...
Special precautions for storage
Store the vial in a refrigerator (2°C to 8°C); Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal product, see section ...
Nature and contents of container
Powder in a 20 mL type I glass vial with a bromobutyl rubber stopper and sealed with an aluminium / plastic flip-off cap. 1 vial.
Special precautions for disposal and other handling
General precautions Streptozocin is a cytotoxic agent. Therefore, caution should be used during handling and preparation of Zanosar. Use of gloves and other protective clothing to prevent skin contact ...
Marketing authorization holder
KEOCYT, Immeuble Cap Sud, 106 avenue Marx Dormoy, 92120 Montrouge, FRANCE
Marketing authorization number(s)
PL 40308/0001
Date of first authorization / renewal of the authorization
03/04/2018
Date of revision of the text
27/08/2018
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