Garant and hope in the treatment of Oncological Pathology

Quality treatment for healthy life
            
Polyplatillen® — original anti-cancer agent on the DNA-carrier

Instructions

Decision on state reregistration
of the medical product is approved
by order of the Ministry of Health of Ukraine
of 25.08.2009 No. 627.
Marketing authorization for medical product
No. UA/1774/01/01.
 

INSTRUCTION for medical use

POLYPLATILLEN®

(POLYPLATILLEN)

 

   Composition

   Active substance: polyplatillen;

   1 ml of concentrate contains: 1.47 mg of polyplatillen;

   Additive agents: sodium chloride, sodium citrate, sodium hydroxide, fluorouracil (2,4-dihydroxy-5-fluoropyrimidine), water for injections.

   Pharmaceutical form

   Concentrate for solution for infusion.

   Pharmacotherapeutic group

   Antineoplastic agents. Platinum compounds. ATC code: L 01X A05.

   Clinical characteristics

   Therapeutic indications

   Treatment of patients with widespread forms of malignant growth (ovary, liver, stomach, pancreas, large intestine, lung, brain tumors and neck, sarcomas of bone and soft tissue), including those that are accompanied by polyserositis with the expressed cancer toxemia, with carcinosis of abdominal cavity and ascites. The drug is used in chemoresistant tumors, non sensitive to treatment by the conventional chemotherapeutic schemes.

   Polyplatillen can be used in combination with other antineoplastic drugs and radiation therapy for the treatment of patients with widespread forms of malignant growth (ovary, uterus, liver, stomach, pancreas, large intestine, prostate, kidney, adrenal gland, bladder, lung, brain tumors, head and neck, oropharynx, thyroid, sarcomas of bone and soft tissue).

   Contraindications

   Hypersensitivity to platinum preparations, generalization of tumor, terminal state of a patient, severe dysfunction of liver and renal, pregnancy and lactation.

   Posology and method of administration

   Recommended single doses of the drug at intravenous and intra arterial routes of administration are 250-300 mg/m2. Administration regime is 3-6 multiple, by drop infusion, every 24-48 hours; time of infusion is 3-3.5 hours. Course dose is 650-1300 mg/m2.

   Recommended single doses of the drug when administered in the abdominal cavity are 150-300 mg/m2.

   Administration regime is 3-6 multiple, by drop infusion, every 24-72 hours, depending on the patient's condition. Time for intraperitoneal infusion is 4.5-5 hours. Course dose is 650-1300 mg/m2.

   The recommended dose of Polyplatillen according to schemes combined therapy is constituted ½ of calculated therapeutic dose. For all methods of introduction the drug must be diluted 1:1 with physiological solution of sodium chloride with adding into the dropper 4-8 mgs of Dexamethasone.

   In case of intraperitoneal introduction recommended the addition into the dropper of 1 ml (5000 Units) solution of Heparin, 10-20 ml of 2% solution of Lidocaine. The treatment can be repeated after 3-4 weeks.

   Undesirable effects

   Investigation of patients with liver cancer allows concluding that the medical product is rather safety.

   Only 10% of the patients have nausea and vomiting after 1 – 4 hours of the drug introduction, that are can be stopped with a help of antiemetic agents(tropisetron, metoclopramide). After introduction of Polyplatillen the following adverse effects may occur: allergic reactions (rise in temperature), pain in place of introduction (intraperitoneal introduction), diarrhea, rash, anaphylactic shock (frequency of occurrence is less than 1 %); on the part of heart-vascular system adverse effects in the form of embolism may occur (frequency of occurrence is less than 1 %). In case of large weight of a tumor at introduction of the medical product can observed “lysis syndrome” (rapid break-up of a tumor) manifestations of which must be corrected with the help of generally accepted methods of detoxication.

   In case of intraperitoneal introduction Polyplatillen if the time of administration is less than 4 hours, can be developed adhesive process or arise dynamic obstruction.

   Overdose

   Antidote for Polyplatillen is not known. Expected consequences of overdosage (450mg/m2 at single introduction) include cardiotoxicity with interruption of heart rate that may be eliminated with the help of symptomatic means.

   Pregnancy and lactation

   During pregnancy, the drug is not used. During treatment with Polyplatillen should stop breastfeeding.

   Children

   As experience of application of Polyplatillen at children is absent, it should not be used in this age group of patients.

   Special warnings and precautions for the use

   Polyplatillen should be used only by physicians with enough experience of chemotherapy or by physicians who passed special preparatory training.

   During therapy by Polyplatillen should be carried out an analysis of blood and urine.

   Effects on ability to drive and use machines

   Neurotoxicity is not present, but during use of Polyplatillen it is not recommended to drive a car or to work with other mechanisms.

   Interaction with other medicinal products and other forms of interaction

   In complex therapy Polyplatillen may be used after methods and means with myelodepressive and immunodepressive effect. All necessary methods of immunotherapy should be used after construction of complete course of treatment with Polyplatillen.

   Pharmacological properties

   Pharmacodynamic properties

   Polyplatillen – is high-molecular weight compound of platinum with deoxyribonucleic acid.

   Polyplatillen has antitumor properties due to ability to inhibit synthesis of nuclear DNA and irreversibly attack first of all of cells in G1-S stage of a cycle.

   Already in case of the first introduction of Polyplatillen the following is observed: high antitumor activity and reduction of a tumor weight, thus there is no damage to healthy tissue. The drug is effective in case of treatment of tumor with acquired drug resistance to other chemopreparations.

   Pharmacokinetic properties

   Polyplatillen is administered to patients in doses of 250 - 300 mg/m2 by one-time intra-arterial administration (time of administration 3 - 3.5 hours). After intraarterial infusion Polyplatillen dynamic changes in plasma concentrations of the drug characterized by two phases: an initial phase with the period semi-removal of approximately 75 hours, and a period required to remove 97% of platinum content is about 150 hours.

   After a single intraarterial infusion, the average percentage of platinum, which is excreted in the urine within 2 days with temporary intervals of   0-12, 0-24 and 0 - 48 hours is about 6% of the introduced dose of platinum that indicates on significant non-renal clearance. Polyplatillen is excreted through gastro-intestinal tract in full, and unlike other chemopreparations has no nephrotoxic effect.

   Pharmaceutical particulars

   The main physical and chemical properties:opalescent yellowish liquid.

   Incompatibilities: Never mix Polyplatillen with other drugs before introduction, as this may affect the efficacy and safety of the drug (except recommended solvents and agents that are in the “Dosage and Administration”).

   Shelf life

   2 years.

   Special precautions for storage

   Store in a dark place at temperature from +15°С to + 25°С. Sterility of unsealed medicinal product in the form of concentrate is saved for 7 days. Freezing of the preparation in the process of storage is not allowed.

   Packaging

   Concentrate for solution for infusion of 100 ml or 250 ml vials № 1.

   Legal category

   On prescription

Telephone:
+38(044)451-73-80
+38(067)460-15-48
Central Office:
st. Saksaganskogo 63/28, of.18 Kyiv