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Cisplatin Accord can be used as monotherapy, as well as in combination therapy, for the treatment of adults and children.
active substance: cisplatin, 1 vial contains 50 mg of cisplatin 1 mg / ml.
Excipients: sodium chloride, sodium hydroxide, concentrated hydrochloric acid, water for injection.
Hypersensitivity to cisplatin, other components of the drug or other preparations containing platinum, impaired renal function, dehydration, suppression of bone marrow function, hearing impairment, neuropathy caused by treatment with cisplatin, use of yellow fever vaccine and prophylactic therapy with phenytoin.
Mode of application
The concentrate must be diluted aseptically before use.
When preparing and administering the solution for infusion, do not use tools with parts that contain aluminum if they can come into contact with the drug.
The required amount of concentrate for the preparation of an infusion solution, calculated according to the following recommendations, is diluted with 1-2 l of a 0.9% sodium chloride solution or a mixture of 0.9% sodium chloride solution and 5% glucose solution in a 1: 1 ratio.
If hydration is not possible before the introduction of cisplatin, the concentrate can be diluted with a mixture of 0.9% sodium chloride solution and 5% mannitol solution in a 1: 1 ratio.
Infusion solutions with a concentration of cisplatin 0.1 mg / ml, prepared by diluting the cisplatin Accord concentrate with 0.9% sodium chloride solution, a mixture of 0.9% sodium chloride solution and 5% glucose solution in a 1: 1 ratio or 0.9 mixture % sodium chloride solution and 5% mannitol solution in a ratio of 1: 1.
From a microbiological point of view, the infusion solution must be administered immediately after preparation. If the solution is not used immediately, the user should monitor the duration and conditions of its storage.
It can cause temporary or permanent infertility, therefore, men who in the future want to become parents should consult about cryopreservation of their sperm before starting therapy.
There is not enough information on the use of cisplatin for pregnant women.
Cisplatin can have a toxic effect on the fetus and, due to its pharmacological properties, can cause serious fetal defects.
Animal studies have shown reproductive toxicity and transplacental carcinogenicity.
Therefore, cisplatin should not be used by pregnant women if there is no vital evidence for this.
It was found in breast milk, therefore breastfeeding during cisplatin therapy is contraindicated.
Studies of the impact on the ability to drive vehicles and other mechanisms have not been conducted.
However, adverse reactions can adversely affect the ability to drive vehicles and other mechanisms.
In case of an overdose, the previously mentioned toxic effects may be observed, but their intensity is higher.
Effective hydration and osmotic diuresis immediately after an overdose can reduce the toxic effects of cisplatin.
An acute overdose of cisplatin can lead to renal failure, liver failure, deafness, ophthalmotoxicity, significant inhibition of bone marrow function, nausea, can not be treated, vomiting and neuritis.
An overdose can be fatal.
- On the part of the kidneys and urinary system: slight reversible impaired renal function can occur after a single dose of cisplatin in medium doses, with the introduction of cisplatin in high doses or daily use of cisplatin, renal failure with tubular necrosis may develop, manifested by uremia or anuria, renal failure may be irreversible
- On the part of the blood: causes dose-dependent and predominantly reverse leukopenia, thrombocytopenia and anemia, isolated cases of the development of Coombs-positive hemolytic anemia have been reported, hemolysis, which may have been caused by cisplatin, has been reported.After administration of cisplatin in high doses, severe inhibition of bone marrow function is possible. Approximately 14 days after the administration of cisplatin, the number of leukocytes in most patients is significantly reduced.
- From the digestive tract: anorexia, nausea, vomiting, pain in the stomach and diarrhea are often noted, these symptoms in most patients go away within 24 hours, nausea and anorexia are less pronounced and can last up to 7 days after the drug is administered, in rare cases, inflammation develops mucous membranes of the oral cavity
- On the part of the hearing organs: hearing impairment was noted in about 30% of patients who were given cisplatin at a dose of 50 mg / m 2 of the body surface, deafness and malfunctioning of the vestibular apparatus in combination with systemic dizziness, irradiation of the skull area with cisplatin therapy, or simultaneously with it increases the risk of hearing loss
- On the part of the organs of vision: in rare cases, after combined chemotherapy with cisplatin and other drugs, vision loss was observed, isolated cases of development of optic disk edema with visual impairments were noted, however, they are reversible, and after treatment the vision is restored
- From the nervous system: it can lead to peripheral neuropathy, in rare cases, loss of taste or tactile function or retrobulbar neuritis with loss of vision and cerebral function disorders, cases of the development of Lermitt symptom, autonomic neuropathy and myelopathy of the spinal cord were reported, severe brain damage was reported
- From the hepatobiliary system: in rare cases, liver dysfunction develops with an increase in serum transaminases, however, these changes are reversible, a decrease in albumin levels is rarely observed, possibly due to treatment with cisplatin
- From the cardiovascular system. In rare cases, heart rhythm disturbances develop, in particular bradycardia, tachycardia and other arrhythmias. ECG changes are sometimes noted, cardiac arrest has been reported during treatment with cisplatin in combination with other cytostatics, severe coronary heart disease, impaired cardiac activity, myocardial infarction may occur
Serum electrolytes: in rare cases, hypomagnesemia, hypocalcemia, hyponatremia, hypophosphatemia and hypokalemia with muscle cramps and ECG changes due to damage to the renal system by cisplatin develop.
Allergic reactions: in rare cases, anaphylactic reactions develop, there have been separate reports of arterial hypotension, tachycardia, shortness of breath, bronchospasm, facial swelling and fever, in such cases treatment with antihistamines, epinephrine and steroids may be required
Other side effects: after administration of the drug, local swelling and pain, erythema, skin ulcers and phlebitis at the injection site are possible.
The appearance of metal deposits on the gums was observed.
Alopecia, impaired spermatogenesis and ovulation, as well as painful gynecomastia are possible.
Cisplatin reacts with aluminum to form a black platinum precipitate.
Therefore, when preparing and administering the solution for infusion, you cannot use tools with parts that contain aluminum, if they can come into contact with the drug.
Do not dilute with 5% glucose solution or 5% mannitol solution, but only with mixtures thereof with 0.9% sodium chloride solution.
Antioxidants, bicarbonates (sodium bicarbonate), sulfates, fluorouracil and paclitaxel can inactivate cisplatin in infusion systems.
Store in at a temperature not exceeding 25 ° C, in a dark place, out of the reach of children, do not cool and do not freeze.