atients with transaminase levels in blood plasmaexceeding more than 1.5 times the upper limit of normaltren 100 side effects, or alkaline phosphatase, exceeding more than 2.5 times , the recommended . Patients with elevated bilirubin and / or increased activity in conjunction with increased levels of alkaline phosphatase more than 6 times .
At the moment, there are no data on the use of Taxotere in combination with other drugs in patients with impaired hepatic function.
The safety and efficacyin children poorly understood. There is limited experience with the use in children.
Elderly In view of the pharmacokinetic data analysis of any specific instructions on the use of Taxotere are absent in the elderly.
In combination with capecitabine in patients older than 60 years, it recommended starting dose reduction of capecitabine (see. On the use of capecitabine instructions).
Instructions for preparation of the solution
Concentrate for solution for infusion of 20 mg / 0.5 ml : the actual content in the vial of 24.4 mg / 0.61 ml to compensate for fluid loss in the preparation of a pre-mixed solution due to foaming, adhesion to the walls of the vial and the presence of ” dead space. ” Thus, an excess of drug in the vial will ensure that its contents after dilution solvent supplied minimal volume dialed be premixed solution of 2 ml containing 10 mg / ml docetaxel, corresponding to 20 mg (dose indicated on the label).
Concentrate for solution for infusion at 80 mg / mL of 2 : The actual contents of the tren 100 side effectscompensate for fluid loss in the preparation of a pre-mixed solution due to foaming, adhesion to the walls of the vial and the presence of “dead space “. Thus, the excess drug vial ensures that the amount of 8 ml containing 10 mg / ml docetaxel, which corresponds to 80 mg (dose indicated on the label) of its contents after dilution solvent supplied dialed minimum volume premixed solution.
Preparation of the solution for intravenous administration
Concentrate for infusion solution must first dissolve in the accompanying solvent.
a) Preparation of pre-mixed solution of Taxotere (docetaxel 10 mg / ml)
Before dilution vial and solvent is necessary to withstand for 5 minutes at room temperature.
The entire contents of the vial with the solvent is typed in via syringe needle (vial located slightly angled) and injected into the vial with Taxotere.
Bottle the mixture obtained is flipped over 45 seconds. (Do not shake!) And left for 5 minutes. at room temperature, after which the solution was checked for homogeneity and clarity (presence foam even after 5 min. is the norm).
The pre-mixed solution is recommended for solution for infusion immediately after its preparation. Taxotere premix solution may be stored in a refrigerator (+ 2 ° C to 8 ° C) or at room temperature for 8 hours.
b) Preparation of infusion solution
The required amount of pre-mixed solution in accordance with the desired dose is injected into infusion bag or bottle containing 250 ml of 5% dextrose or 0.9% sodium chloride solution. If the required dose exceeds 200 mg docetaxel, use a larger volume of liquid for infusions, the concentration of docetaxel was not above 0.74 mg / ml.
The contents of the bag for infusion or vial should be mixed. The resulting solution should be used within 4 h by intravenous infusion of one hour at room temperature and under normal light conditions.
Taxotere premix solution and infusion solution, tren 100 side effects as well as any other products for parenteral use, should be inspected prior to administration; when sediment availability solution should be destroyed.
From the side of hematopoiesis: the most common side effect of is reversible neutropenia, in some cases accompanied by a fever, infection joining, and sometimes sepsis and pneumonia. The number of neutrophils is reduced to a minimum in an average of 7 days (in patients previously treated with chemotherapy, this period may be shorter), the average duration of severe neutropenia (<500 cells / mm) and is 7 days. Perhaps the development of thrombocytopenia and anemia. Rarely bleeding occur, mainly due to thrombocytopenia.
Allergic reaction : usually occur within a few minutes after the start of infusion of tren 100 side effects, and are easy to moderate (flushing, rash combined with itching, chest tightness, back pain, dyspnoea and drug fever or chills). Severe reactions, characterized by a decrease in blood pressure and / or bronchospasm or generalized rash / erythema disappeared after cessation of the infusion and the appointment of adequate therapy.
Skin and skin appendages: alopecia, mild to moderate skin reactions. Less common are expressed reactions such as rash, itchy skin or limited limb erythema (including heavy defeat syndrome palms and feet) with edema followed by desquamation, and the hands, face and chest. Hypo – or hyperpigmentation of nails, heavy defeat nails (onycholysis) are rare. Also rarely develops bullous rash (Lyell’s syndrome or Stevens-Johnson syndrome). Fluid retention: described cases of peripheral edema and less frequently pleural and pericardial effusion, ascites and weight gain. The peripheral edema usually appear initially on the lower limbs, and can then be generalized, leading to an increase in body weight of 3 kg or more. The incidence and severity of fluid retention increases with repeated administration of the drug; average total dose of tren 100 side effects, in which there is fluid retention, formed during premedication 818.9 mg / m 2 , and without a pre-medication – 489.7 mg / m 2 ; In some cases, fluid retention may occur during the first course of therapy. Fluid retention is not accompanied by acute episodes of oliguria or decrease in blood pressure. In rare cases it reported the development of dehydration and pulmonary edema.
In the fall of neutrophil count trenbolone side effects was observed more than a week, or the development of febrile neutropenia, or the development of severe skin reactions or severe peripheral neuropathy during therapy with docetaxel, the dose of the drug for the following introductions should be reduced . If such complications occur when applying and docetaxel 60 mg / m 2 , the treatment should be discontinued.
In the combination therapy of breast cancer.
Patients with resectable form of breast cancer receiving adjuvant therapy, during the development of febrile neutropenia should receive in all subsequent cycles. When you save a febrile netropenii need to reduce the dose of , If is not used to Taxotere dose should be reduced . Stomatitis in patients with grade 3 or 4 necessary to decrease .
With the combination of Taxotere with capecitabine:
The first appearance of grade 2 toxicity, which persists until the time of the next cycle of treatment Taxotere / capecitabine, the next treatment cycle may be postponed to reduce toxicity to 0-1 degrees, while during the next cycle of treatment is introduced 100% initial dose of Taxotere.
Patients with recurrent developmental toxicity grade 2 toxicity, or development of the first 3 degrees at any time a treatment cycle, the treatment is delayed to reduce the degree of toxicity to 0-1, then Taxotere treatment is resumed 2 .
If any further manifestations of toxicity, or the appearance of any kind of grade 4 toxicity Taxotere administration should be discontinued.
With regard to the capecitabine dose adjustment when combined with trenbolone side effects, see the instructions for use of capecitabine.
In the combination therapy
For patients who initially receive trenbolone side effects in combination with cisplatin or carboplatin in which the platelet count in the previous cycle of treatment was reduced (with cisplatin) and up to <75,000 / ul (carboplatin), or in patients who have developed a febrile neutropenia, or in patients with severe manifestations of hematological toxicity dose of Taxotere in the next cycle to be reduced to 65 mg / m 2 . For recommendations on dose adjustment for the use of cisplatin, see the instructions of cisplatin.
With the combination of plus cisplatin and 5-fluorouracil
In developing febrile neutropenia or accession infection despite receiving , dose should be . Upon subsequent development episodes neutropenia complicated recommended to reduce . With the development of thrombocytopenia grade 4 dose of it is recommended to reduce .Subsequent cycles of docetaxel with possible when the number of neutrophilsmicroliter.When you save toxicity, treatment should be discontinued.
Kinetics docetaxel is dose-dependent and corresponds to the three-phase model with the pharmacokinetic half-life of 4 min., 36 min. and 11.4 hr., respectively. Docetaxel is more than 95% bound to plasma proteins.
Within 7 days docetaxel excreted in urine and feces after oxidation tert-butyl ester group with cytochrome; excretion in the urine and feces is respectively 6% and 75% of the dose. Approximately 80% of the drug output with the feces is detected within 48 hours of the primary inactive metabolite and three less significant active metabolites, and at very low levels, in an unmodified form. The pharmacokinetics of docetaxel does not depend on the age and sex of the patient. With mild hepatic dysfunction (levels of alanine aminotransferase parabolan steroid and aspartate transaminase standards, combined with an increase in the activity of alkaline phosphatase> 2.5 standards) total clearance is reduced by 27% compared to the average. Clearance of docetaxel does not change with mild to moderate fluid retention; information on the clearance of the drug with severe fluid retention there.
– Adjuvant therapy for operable breast cancer with a lesion of regional lymph nodes in combination with doxorubicin and cyclophosphamide;
– Locally advanced or metastatic breast cancer (in combination with doxorubicin as a primary chemotherapeutic treatment (1st line), or as a therapy second line: monotherapy after failure of prior treatments include anthracyclines or alkylating agents, and in combination with capecitabine, if previous treatment included anthracyclines);
– Metastatic breast cancer tumor with expression in combination with trastuzumab, if no prior chemotherapy;
– Unresectable, locally advanced or metastatic non-small cell lung cancer (in combination with cisplatin or carboplatin) therapy as first line monotherapy or as therapy 2nd line chemotherapy after failure based on platinum preparations;
– Metastatic ovarian cancer after failure of prior therapy first line (treatment 2nd line);
– Unresectable, locally advanced squamous cell carcinoma of the head and neck (in combination with cisplatin and 5-fluorouracil) as a therapy for first line;
– Metastatic squamous cell carcinoma of the head and neck after failure of prior treatment (therapy 2nd line)
– Metastatic, hormone-refractory prostate cancer (in combination with prednisone or prednisolone).
– Metastatic cancer of the stomach, including the cardia, (in combination with cisplatin and 5-fluorouracil) as the first treatment line.
– Expressed hypersensitivity reactions to docetaxel or other components of the drug in history;
– Initial neutrophil count parabolan steroid;
– The expressed disturbances of liver function;
– Pregnancy and lactation.
Dosing and Administration
To prevent hypersensitivity reactions, as well as to reduce fluid retention, all patients (with the exception of prostate cancer patients) prior to administration of a drug Taxotere premedication glucocorticosteroids such as dexamethasone orally at a dose of 16 mg / day. (8 mg twice a day) in, for 3 days starting 1 day prior to administration of Taxotere.
In patients with prostate cancer receiving concomitant treatment with prednisone or prednisolone, dexamethasone premedication performed at a dose of 8 mg for 12, 3 and 1 hour before the administration of Taxotere.
recommended prophylactic administration of colony-stimulating factor to reduce the risk of hematological oslozhenenija
Taxotere is administered as a one-hour intravenous infusion every 3 weeks.
When the adjuvant therapy of patients with operable breast cancer form of a recommended dose of 75 mg of Parabolan steroidover 1 hour after the administration of doxorubicin and cyclophosphamide (500 mg / m 2 ) every three weeks. A total of 6 cycles.
In combination with trastuzumab, recommended dose is 100 mg / m 2 every three weeks. Regarding trastuzumab dose and method of administration, see for trastuzumab instruction.
Non-small cell lung cancer
Taxotere is administered monotherapy in combination with a platinum drug every 3 weeks. When inefficiencies concomitant therapy with platinum drugs recommended Taxotere monotherapy . Metastatic Ovarian Cancer Taxotere is administered every 3 weeks.
Locally advanced squamous cell carcinoma of the head and neck
Taksoter administered at a dose of 75 mg / m 2 . After infusion of parabolan steroid in the day is conducted infusion of cisplatin 75 mg / m 2 over 1 hour, followed by continuous infusion of 5-fluorouracil (5-FU) in a dose of 750 mg / m 2 / day in a 24 hour infusion for 5 days. This mode is administered once every three weeks and repeated up to 4 cycles. After a course of chemotherapy radiation therapy.
Metastatic Squamous Neck Cancer Head and Taxotere administered in a dose of 100 mg / m 2 every 3 weeks.
Metastatic hormone-refractory prostate cancer
Taxotere is administered at a dose of 75 mg / m 2 1 every 3 weeks. Prednisone or prednisolone is assigned inside of 5 mg twice a day for a long time for the duration of a course of treatment.
Relationship to plasma proteins is 95%. Excretion of plasma dwuhfazno corresponding hours. Clemastine subject to significant metabolism in the liver. Metabolites in the ground (45 – 65%) excreted through the kidneys in the urine; unmodified active substance found in urine in trace amounts only. During lactation a small amount of clemastine can penetrate into breast milk.
– prevention or treatment of allergic reactions and pseudoallergic (including the introduction of contrast agents, blood transfusion, diagnostic application of histamine)
– angioedema, anaphylactic or anaphylactoid shock (as an adjunct).
Hypersensitivity, pregnancy, lactation, taking monoamine oxidase inhibitors parabolan dosage, lower respiratory diseases (including asthma), fructose intolerance, children up to 1 year.
Intra-arterial injection of the drug is not permitted!
in patients with ulcer stenosing gastric piloroduodenalnoy obstruction, with obstruction of the bladder neck and prostatic hypertrophy, accompanied by urinary retention with increased intraocular pressure, hyperthyroidism, diseases of the cardiovascular system, including hypertension.
Pregnancy and lactation
Use of the drug during pregnancy and lactation is contraindicated.
Dosage and administration
intravenously or intramuscularly. Adults: 2 mg (2 ml), that is, the contents of 1 mg, 2 times a day (morning and evening). For prophylaxis intravenously administered drug slowly (within 2-3 min or more) at a dose of 2 mg possible immediately before the occurrence of anaphylactic reactions or reactions in response to the use of histamine. The solution preparation can be further diluted with isotonic sodium chloride solution or 5% glucose solution in the ratio 1: 5. Babies: 0,025 mg / kg per day intramuscularly, dividing by 2 injection.
From the nervous system:
Common: fatigue, somnolence, sedation, weakness, fatigue, lethargy, incoordination;
Rare: headache, tremor, stimulating effect.
From the gastrointestinal tract:
Rare: dyspepsia, nausea, vomiting, gastralgia, dry mouth
Very rare: constipation.
From the senses:
Rare: violation of clarity of vision, diplopia, acute labyrinthitis, tinnitus.
On the part of the kidney and urinary tract:
Very rare: palpitations, or difficulty urinating.
rare: thickening of bronchial parabolan dosage secretions and difficulty sputum discharge, feeling of pressure in the chest, respiratory failure, nasal congestion.
Rare:. Decrease in blood pressure (often in elderly patients), extrasystoles
Very rare: tachycardia.
From the blood and blood-forming organs:
Occasionally: hemolytic anemia, thrombocytopenia, agranulocytosis.
Skin and subcutaneous tissue:
Rare: skin rash.
Uncommon: photosensitivity, shortness of breath,
rarely: anaphylactic shock.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, inform your doctor.
Overdose Symptoms. Overdose antihistamines can lead to both depressing and a stimulating effect on the central nervous system, most often seen in children. Also, the phenomenon may develop anticholinergic action: dry mouth, fixed dilated pupils, flushing to the upper half of the body, tachycardia, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting). Treatment. Symptomatic therapy.
Interaction with other drugs
Parabolan dosage increases the effects of drugs, central nervous system depressants (hypnotics, sedatives, anxiolytics), m-cholinergic antagonists, as well as alcohol. Incompatible with the simultaneous intake of MAO inhibitors.
Clemastine has a slight sedation (from mild to moderate in intensity), are advised to refrain from driving vehicles, using machinery, as well as other activities that require high concentration and speed of psychomotor reactions.
Tavanic must not be used to treat children and adolescents because of the probability of destruction of the articular cartilage.
In the treatment of elderly patients should be aware that patients in this group often have impaired renal function parabolan cycle.
for very severe pneumonia, caused by pneumococcus tavanic may not give the optimal therapeutic effect. Hospital infections caused by certain pathogens (P. aeruginosa), may require combination therapy.
During treatment may develop seizures attack in patients with previous brain damage caused by, for example, stroke or severe injury. Seizure may be increased, and while the application fenbufena similar to him or theophylline (sm. “Interactions”).
Despite the fact that the photosensitivity observed in the application of levofloxacin is very rare, in order to avoid her patients is not recommended to be subjected unnecessarily to strong sunlight or artificial ultraviolet light (eg, exposure to the sun in the highlands or the solarium).
If you suspect pseudomembranous colitis should immediately cancel tavanic and start appropriate treatment. In such cases, you can not use drugs that suppress intestinal motility.
Rarely observed when using the drug tavanic tendinitis (especially inflammation of the Achilles tendon) may lead to tendon rupture. Elderly parabolan cycle patients are more prone to tendonitis. Corticosteroid treatment ( “cortisone preparations”) are likely to increase the risk of tendon rupture. If you suspect tendonitis, stop treatment and start appropriate treatment of the affected tendon, for example, providing him rest state .
Patients with deficiency of parabolan cycle dehydrogenase (an inherited metabolic disorder) fluoroquinolones can respond to the destruction of erythrocytes (hemolysis). In this regard, the treatment of such patients with levofloxacin should be carried out with great care.
These side effects Tavanic drug like dizziness or numbness, drowsiness and visual disturbances , can impair reactivity and ability to concentrate. this can be a risk in situations where these abilities are of special importance (eg while driving, during maintenance of machines and mechanisms, when working in an unstable position). in particular as it concerns cases of drug interactions with alcohol.