Application Information

This drug has been submitted to the FDA under the reference 011683/001.

Names and composition

"THIOTEPA" is the commercial name of a drug composed of THIOTEPA.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
011683/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
075547/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
075698/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
075730/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075730/002 THIOTEPA THIOTEPA INJECTABLE/INJECTION 30MG per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
011683/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
020058/001 THIOPLEX THIOTEPA INJECTABLE/INJECTION 15MG per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075547/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
075698/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL
075730/001 THIOTEPA THIOTEPA INJECTABLE/INJECTION 15MG per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075730/002 THIOTEPA THIOTEPA INJECTABLE/INJECTION 30MG per VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
208264/001 TEPADINA THIOTEPA POWDER/IV (INFUSION) 15MG per VIAL
208264/002 TEPADINA THIOTEPA POWDER/IV (INFUSION) 100MG per VIAL

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Answered questions

Dosage Calculation Practice Problem. Need help checking answer /steps to problem! =]?
Ex: Order: Thiotepa 0.4 mg/kg IV q 1 week. Supply on hand: Thiotepa 15mg injection. Reconstitute 15 mg vial with 15 mL sterile water, yielding 10 mg/mL. Patients weight is 216 lbs. Give_____mL.(NOTE:DURING CALCULATION PROBLEM ROUND TO NEAREST TENTHS, AND FINAL ANSWER ROUND TO NEAREST WHOLE NUMBER)First, I... Asked by Erlinda Luber 1 year ago.

Ex: Order: Thiotepa 0.4 mg/kg IV q 1 week. Supply on hand: Thiotepa 15mg injection. Reconstitute 15 mg vial with 15 mL sterile water, yielding 10 mg/mL. Patients weight is 216 lbs. Give_____mL. (NOTE:DURING CALCULATION PROBLEM ROUND TO NEAREST TENTHS, AND FINAL ANSWER ROUND TO NEAREST WHOLE NUMBER) First, I converted 216 lbs to kg. 216/2.2=98.18 = 98 kg Next, 98 kg * 0.4mg/kg = 39.2 mg [ IS THIS THE CORRECT NEXT STEP???] Last, [totally confused here] 39.2mg/10mg * 1 mL= 3.92 = 4 mL (rounding to nearest whole #) PLEASE HELP, NOT SURE WHAT I AM DOING WRONG, IF U KNOW HOW TO WORK THIS OUT PLEASE EXPLAIN TO ME. I WOULD REALLY APPRECIATE IT. THANKS A L0T! =] Answered by Muriel Monka 1 year ago.

You are correct. You need 39.2mg for the patient. You have a 15 ml mixture that contains 10mg per ml. You have to give 4 ml. The patient needs approx 40 ml. If its 10 mg per ml you need to give 4 ml of the mix. Answered by Matt Pavelec 1 year ago.

The dose for diphenhydramine is 1.25 mg per kilogram. A child weighs 15kg. How many mg will you give this child? The med is provided is 12.5mg in 5ml. How many ml per dose/ Answered by Dale Schaudel 1 year ago.


My wife and i found out today that she has a mass on her bladder. she is 47 years old.?
anybody out their going or gone through this ? we know we have to start with uroligist for biopsy but not sure what happens next. any info would be of much help - thanks note: ignore question mark next to age -typo Asked by Zina Zambrana 1 year ago.

The majority of diagnosed bladder tumors are confined to the urothelium or the lamina propria and have not invaded the bladder muscle. It is best to always be over-informed of your health.....I am not stating it could be cancerous, but just in case, below are the stages: Table 1 -- Staging of primary bladder cancer tumors (T) Ta: Noninvasive papillary tumor (confined to urothelium) Tis: CIS carcinoma (high grade “flat tumor” confined to urothelium) T1: Tumor invades lamina propria T2: Tumor invades bladder muscle T2a: Invades superficial bladder muscle T2b: Invades deep bladder muscle T3: Tumor invades perivesical fat T3a: Microscopic perivesical fat invasion T3b: Macroscopic perivesical fat invasion (and progressing beyond bladder) T4: Tumor invades prostate, uterus, vagina, pelvic wall or abdominal wall T4a: Invades adjacent organs (uterus, ovaries, prostate) T4b: Invades pelvic wall and/or abdominal wall How is bladder cancer treated? Removing stage Ta and stage T1 tumors: Transurethral resection of the bladder (TURBT) is the usual treatment method for patients who, when examined with a cystoscope, are found to have abnormal growths on the urothelium (stage Ta) and/or in the lamina propria (stage T1). Alternative methods, such as laser therapy, compare favorably with TURBT in terms of treatment results. However, TURBT has a major advantage — it can provide tissue suitable for a pathologist to use in determining a tumor's grade and stage. The tumor structure is left too distorted for this purpose after the alternative treatment methods, so biopsies of the tumor must be taken before treatment. Intravesical chemotherapy and immunotherapy: Following removal, intravesical chemotherapy or intravesical immunotherapy may be used to try to prevent tumor recurrences. Intravesical means "within the bladder". These therapeutic agents are put directly into the bladder through a catheter in the urethra, are retained for one to two hours and are then urinated out. The chief intravesical agents currently available are thiotepa, doxorubicin, mitomycin C and bacillus Calmette-Guérin (BCG). The first three are drugs. The fourth, BCG, is a live but weakened vaccine strain of bovine tuberculosis. It was first used to immunize humans against tuberculosis. It is now one of the most effective agents for treating bladder cancer and especially for treating CIS. All four agents have some benefits and all four have risks. Among the benefits: Comparison studies have shown each of the four to be superior to TURBT alone for preventing tumor recurrences following TURBT. Studies have also shown both BCG and mitomycin C to be superior to doxorubicin or thiotepa for reducing recurrence of T1 tumors and high-grade Ta tumors. However, there is no absolute evidence that any intravesical therapy affects the rate of progression to muscle-invasive disease although some studies with BCG suggest this may be the case. Among the risks: Each of the four agents produces irritative side effects such as painful urination and the need to urinate frequently. In addition, BCG therapy carries a 24 percent risk of flu-like symptoms and a small risk (4 percent) of systemic infections. Thiotepa has a 13 percent risk of suppressing bone marrow activity — causing a reduction in white blood cells and platelets. The main side effects for each intravesical agent are shown in Table 2, along with estimated probabilities of occurrence. Table 2: Side effects of treatment and estimated probabilities of occurrence Intravesical Agent Side Effects BCG Mitomycin C Thiotepa Doxorubicin Frequent urination 63% 42% 11% 27% Painful urination 75% 35% 30% 20% Flu-like symptoms 24% 20% 11% 7% Fever or chills 27% 3% 4% 4% Systemic infections 4% Not available 0.3% Not available Skin rash 6% 13% 2% 2% Suppression of bone marrow activity 1% 2% 13% 0.8% Once the bladder has been assessed as free of disease at the first three to four month post-treatment cystoscopic inspection, many physicians consider it appropriate to apply additional treatments of these same drugs to forestall or prevent future recurrences. While recent studies demonstrate this concept of "maintenance therapy" is useful for some patients receiving BCG, it is of less certain benefit for those receiving the other three chemotherapeutic drugs. Whether additional treatments are given or not, periodic cystoscopies are required to make sure that tumors do not recur. During the first one to two years surveillance is carried out on a quarterly basis but then can gradually be reduced to twice and eventually even once per year thereafter. Cystectomy: Surgical removal of the bladder may be an option for patients with CIS or high-grade T1 cancers that have persisted or recurred after initial intravesical treatment. There is a substantial risk of progression to muscle-invasive cancer in such cases, and some patients may want to consider partial or full cystectomy as a first choice of treatment. If so, they should ask their doctor for information about both the risks of cystectomy and the methods of urinary reconstruction. An alternative is to repeat intravesical therapy. There is some evidence that patients may respond to repeat therapy. However, the evidence is too weak to draw firm conclusions about whether any amount or type of intravesical therapy, in any combination, can affect progression of high-grade disease. my prayers are with you guys! and PLEASE, do not fall victim of expensive juices, herbs ect.....they do not cure disease...... Answered by Henrietta Crittenden 1 year ago.

First as you say is the biopsy of the mass. It may be a fibroid, or benign, or it could be malignant. In the meantime focus on healthy living. Drink lots of water, avoid chemicals etc. This is stop the growth from expanding. Once the biopsy results are back then you will have choices to make. If it is benign then the removal of it is up to your wife it is causing any symptoms or not. If it is malignant then there will likely be surgery, radiation and chemo depending on what type of malignancy is found. Be sure you have a good doctor that you trust. Make sure you support her, and this is a good time to review your wills, and plans etc., not because of the threat, but because it is always good to have things in order. Best wishes to you both. Answered by Sandie Gaumer 1 year ago.

If you are interest in knowing about this natural juice I drink for myself instead of putting more chemicals in my body, I will give you more details. You can email me at rpelley5@yahoo.com Answered by Princess Alegre 1 year ago.

hummm, the problem not that u r 47; the problem is that u r 'divorced'. U have to answer the 5w questions : why, when, how, where, and what? Answered by Nydia Faubel 1 year ago.

Go to webmd.com under women's health Answered by Kimberli Deppe 1 year ago.

run for your life Answered by Kenisha Flanegan 1 year ago.


I'm looking 4 a kind of chemo that starts with the letter t?
Asked by Lucille Liedberg 1 year ago.

Probably the most commonly used ones are the taxanes, taxol and taxotere, which are given as infusions. Answered by Trish Nosek 1 year ago.

I am on Trentnoin. 8 Answered by Valentine Spyres 1 year ago.

When I had chemo for my breast cancer, I was on Taxotere. Answered by Eddy Castrellon 1 year ago.


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