Pharmacokinetics methenolone enanthate buy dnp online; dependent on dose and duration of administration.Repeated administration (intravenous or subcutaneous) maximum plasma concentration of the drug is proportional to the administered dose. Repeated twice administration of the drug is not revealed its accumulation.At recommended doses, the absolute bioavailability methenolone enanthate; is 30%.The average residence time in the body when administered subcutaneously for 7 hours.The half-life period methenolone enanthate; subcutaneous administration is approximately 3-4 hours after intravenous – 1 -1.5 hours.Methenolone enanthate mainly metabolized to peptides and only slightly excreted in the urine in unchanged form (less than 1% of the administered dose).There is a direct correlation between dose and plasma concentration methenolone enanthate; and between the neutrophil response and the concentration of methenolone enanthate; in plasma.
- Shorten the period of neutropenia and its associated complications (patients with tumors nemieloproliferativnymi) who underwent myelosuppressive chemotherapy followed by bone marrow transplantation (BMT) and are at increased risk of prolonged severe neutropenia.
- Reducing the duration of severe neutropenia and its associated complications after standard myelosuppressive chemotherapy.
- Mobilisation of peripheral cells – hematopoietic progenitors.
Dosing and dosing regimen
GRANOTsITom® Treatment should be under the supervision of oncologist. When a bone marrow transplant, the standard chemotherapy and cytotoxic agents to mobilize hematopoietic progenitor cells in the peripheral blood after administration of cytotoxic drugs recommended dose is 150 micrograms methenolone enanthate; (19.2 million. ME) on 1 m 2 of body surface per day, which is equivalent to 5 g (0.64 million. ME) per 1 kg of body weight per day. The introduction of the drug begin on the day following bone marrow transplantation, or the end of chemotherapy. The drug is administered daily subcutaneously (in bone marrow transplantation can be administered as a 30 minute intravenous infusion) until, until after the expected decrease in white blood cell count, the number is restored to the normal value at which the drug can be canceled. The maximum length of daily administration is 28 days. For the mobilization of hematopoietic progenitor cells in the peripheral blood without the use of cytostatics recommended dose is 10 mg (1.28 mln.ME) per kg body weight per day, subcutaneously daily for 4-6 days . leukopheresis should be performed after recovery, or the number of leukocytes in blood after determining CD34 cells using generally recognized techniques. In patients who have not previously received chemotherapy solid, quite often one of leukopheresis to obtain a minimum required number of cells (≥2,0 × 10 6 CD34 + cells per kg of body weight). In healthy donors use of the drug subcutaneously for 5-6 days at a dose of 10 mg (1.28 million. ME) per kg of body weight allowed to receive CD34 ≥3,0 × 10 cells per kilogram body weight as a result of one leukopheresis in 83% of cases and as a result two leukopheresis in 97% of cases. Elderly patients Advanced studies in the elderly have been conducted. In this regard, any particular dose recommendations for elderly patients not given. Children established safety and efficacy methenolone enanthate; bone marrow transplantation in children over 2 years.
Instructions for preparation of the solution
- The contents of one vial with a solvent (1 ml water for injection) should be added to the vial with GRANOTsITom®.
- Mix gently until dissolved (about 5 seconds). Strongly do not shake.
- Dial in the required amount of solution syringe and enter subcutaneously. For intravenous use, the resulting solution should be diluted to 0.9% concentration of sodium chloride or 5% dextrose solution Sodium not less than 0.32 Mill. IU / ml (2,5mkg / ml), but not more than 100 ml of the above solutions. Injected intravenously over 30 minutes.
- The prepared solution should be used as soon as possible.
When using methenolone enanthate; in healthy subjects most frequently occurring adverse events were headache in 30%, bone pain in 23%, lower back pain in 17.5%, asthenia in 11% and abdominal pain in 6% of individuals. Also reported in the development of pharyngitis and laryngitis 7% 6%. The risk of pain was higher in individuals with high values of the white blood cell count, particularly when the number of leukocytes greater than 50 × 10%. Leukocytosis ≥50 × 10 9 / L was observed in 24% of donors and thrombocytopenia associated with apheresis (platelet count less than 100 × 10 9 / L) was observed in 42% of donors.
Transient increase in ACT levels and / or ALT was observed in 12%, and transient increase in serum alkaline phosphatase -. 16% of the donor
bone marrow transplantation experience side effects such as infections, inflammation of the mouth, fever, diarrhea, rash, abdominal pain, vomiting, alopecia, sepsis and infection, they have been linked to regimes c, and not with the reception methenolone enanthate;.
Effect methenolone enanthate; on frequency of occurrence and severity of “graft versus host” reaction acute and chronic reliably undefined. Particular attention in bone marrow transplant should be given to control the amount of platelets in the peripheral blood, as their level in the application methenolone enanthate; may be lower than usual. When using methenolone enanthate; neutropenia caused by chemotherapy usually have side effects that are typical for receiving cytotoxic drugs. Several more common bone pain and injection site reactions (redness, swelling). It has been reported about the appearance of infiltrates in the lungs, which in some cases have led to the development of pulmonary disease or pulmonary distress syndrome adults. When symptoms such as cough, fever, shortness of breath or in combination with radiological changes and impaired respiratory function should be assigned to the appropriate therapy and consider discontinuing administration methenolone enanthate;.
- Hypersensitivity to the main active substance or other components of the preparation.
- pregnancy and lactation.
- myeloid neoplasms (except initially diagnosed acute myeloid leukemia in patients older than 55 years with unfavorable cytogenetic prognostic factors).
Precautions and special instructions
- Methenolone enanthate colony stimulating factor can enhance the growth of myeloid cells in vitro, such as in vitro effect may occur on some cells and not myeloid series.
- Do not set methenolone enanthate; efficacy and safety in myelodysplastic syndrome, secondary acute myeloid leukemia or chronic myeloid leukemia. Therefore, patients with the above pathology should not be given GRANOTSIT®. Particular attention is required in the diagnosis of acute myeloid leukemia. This diagnosis should be clearly differentiated from the blast crisis of chronic myeloid leukemia.
- Influence methenolone enanthate; the progression of myelodysplastic syndrome and its transformation into myeloid leukemia has not been established. GRANOTSIT® should be used with extreme caution in all precancerous lesions myeloid bone marrow. As some tumors may, as an exception, to carry KG-CSF receptor, caution should be exercised in the event of unexpected tumor recurrence after treatment with G-CSF.
- None of the 174 patients treated with 5 mg / kg / day (0,640,000. IU / kg / day) on the bone marrow transplantation, the number of leukocytes × 50 does not exceed 10%. Less than 5% GRANOTSIT® receiving a dose of 5 mg / kg / day (0.64 mln.ME / kg / day) after cytotoxic chemotherapy leukocyte count is equal to or greater than 70 × 10 / l. However, no adverse events directly attributable to leukocytosis, was not observed.
- Due to the potential risk associated with the emergence of pronounced leukocytosis, during treatment GRANOTsITom® should regularly monitor the number of leukocytes in the blood. If the number of white blood cells is 50 × 10 7 l methenolone enanthate; application should be stopped immediately.
- During application methenolone enanthate; to mobilize hematopoietic progenitor cells into the peripheral blood, the drug should not be administered in the case of increasing the number of white blood cells above 70 × 10 / l.
- GRANOTSIT® should not be used to reduce the set of intervals between courses of chemotherapy and / or to increase the doses of chemotherapy because only GRANOTSIT® reduced myelotoxicity and does not affect the other side effects of cytostatics.
- Due to the increased sensitivity of rapidly dividing myeloid cells to cytotoxic himiotrapii, methenolone enanthate; use not recommended 1 day before and no earlier than 24 hours after the end of chemotherapy.
- Mobilization of hematopoietic progenitor cells in peripheral blood using methenolone enanthate; after chemotherapy as compared to using only one methenolone enanthate; above. However, the choice between the two methods of mobilization must be determined individually for each patient based on treatment all purposes.
- In patients who underwent massive myelosuppressive therapy, may be observed for a sufficient minimum number mobilize progenitor hematopoietic cells in the peripheral blood and, therefore, adequate recovery of hematopoiesis.
- Patients with a significant reduction in the number of stem cells in bone marrow (due to prior intensive chemotherapy or radiotherapy), neutrophil response can sometimes be reduced by applying methenolone enanthate; safety in such cases has not been established.
- Program transplantation hematopoietic progenitor cells should be planned early in the course of treatment, and special attention should be paid to the number of mobilized hematopoietic precursor cells in the peripheral blood prior to application of chemotherapy in high doses. If the number of received cells is small, transplantation hematopoietic progenitor cells must be replaced by other treatments.
- Since the results of analyzes to determine the CD34 cells by flow cytometry performed in various laboratories differ, particular attention should be paid to methods for the quantitative determination of the obtained progenitor cells.
- Recommendation on the minimum required amount of cells ≥2,0 × 10 of CD34 + cells per kilogram of body weight based on the published data on the experience of achieving adequate recovery of hematopoiesis. Introduction of large amounts of CD34 cells leads to a more rapid recovery of blood, including the number of platelets.
- Since absolute safety cell mobilization – hematopoiesis precursors from healthy donors has not been proved, it shall be carried out in accordance with the rules established by the legislation.
- The efficacy and safety of methenolone enanthate; group of donors older than 60 years has not been evaluated. In this regard, this age group donor GRANOTSIT® not recommended for collecting hematopoietic progenitor cells. Also, do not carry out the procedure to mobilize hematopoietic progenitor cells in adolescents.
- The procedure to mobilize progenitor cells only from donors should be hematopoiesis, in which the results of clinical and laboratory studies are suitable for bone marrow donation.
- Leukopheresis should not hold donors who take anticoagulants or have impaired hemostasis. If you want to conduct more than one leukopheresis, particular attention should be paid to those donors who have platelet counts prior to leukopheresis was 100 × 10 / l.
- Overall leukopheresis should not be performed for the index number of platelets 75 × 10 / L. If possible, avoid installation of a central venous catheter.
- According to the long-term follow-up (duration up to 6 years), liver damage was observed. Despite this, there is a risk of stimulation of malignant myeloid cells clones. In this connection, it is recommended to conduct systematic monitoring of these individuals with the knowledge of the relevant documentation for the leukopheresis centers.
- Transplanting allogeneic hematopoietic progenitor cells mobilized GRANOTsITom®, patients may be associated with an increased risk of chronic reaction of “graft versus host”. These long-term monitoring of the functioning of the few transplant.
- So far not studied the efficacy and safety of methenolone enanthate; in patients with severely impaired liver and kidney function.
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