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Mycophenolate Mofetil Dispersible Tablets for The Treatment of Refractory Rejection

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Model NO.
HT221-2
Model NO.
HT221-2


Mycophenolate Mofetil Dispersible Tablets for The Treatment of Refractory Rejection
Generic name: Metecophenol ester dispersible tablet

Mycophenolate mofetil Dispersible Tablets

Chinese pinyin: MycophenolatemofetilDispersibleTablets

Ingredient < P > The main ingredient of this product is mycophenol ester.

[Properties] This product is white or quasi-white.

[Indications] It can be used for the prevention of rejection in patients with allotransplantation and the treatment of refractory rejection, and it can be used together with cyclosporine and adrenocorticosteroid.

[Usage and Dosage] The dose to prevent rejection should be taken within 72 hours after transplantation. The recommended dose for kidney transplant patients is 1 gram twice a day (2 grams a day). The safety of oral metecophenolate tablets 2 grams a day is better than oral metecophenolate tablets 3 grams a day. Dose for refractory rejection. In clinical trials, the recommended initial and maintenance dose for refractory rejection is 1.5 g twice daily (3 g/day). Special dose. If neutropenia (absolute neutropenic count <1.3x103/ μ l) occurs, it should be stopped or reduced. Severe renal impairment: In patients with severe chronic renal impairment (glomerular filtration rate <25 ml/min 1.73 m2), doses of more than 1 g twice daily should be avoided (except immediately after transplantation). These patients should be carefully observed. Patients with delayed recovery of renal function after transplantation do not need dose adjustment or doctor's advice. Pregnant and lactating women should consult their doctor in time as the safety and effectiveness of medication has not been confirmed. The safety and efficacy of the drug in children has not been established. Pharmacokinetic data in children are limited and more observation is necessary when using. The recommended dosage for elderly patients is 1g orally, twice a day. Note the increased risk of adverse events in older adults.

Adverse reactions The main adverse reactions included diarrhea, leukopenia, sepsis and vomiting, as well as frequent infections of some types.

[Contraindication] Contraindicated in patients with hypersensitivity to mycophenolate ester and mycophenolate acid. Avoid the use of azathioprine in combination.

[Precautions] Patients receiving immunosuppressive therapy often take combination drugs, and the use of Metecophenol ester tablets as combination immunosuppressive drugs may increase the risk of lymphoma and other malignant tumors (especially skin cancer). The risk is related to the intensity and duration of immunosuppression, not to a particular drug. Excessive suppression of the immune system may also increase susceptibility to infection.

[Medication for Special Groups] Precautions for children:

The safety and efficacy of the drug in children has not been established. Pharmacokinetic data in children are limited and more observation is necessary when using.



Precautions during pregnancy and lactation:

There is a possibility of fetal malformation during organogenesis in rats and rabbits during pregnancy. Although there have not been sufficient and well-controlled studies in pregnant women, the drug should be used only when the potential benefits outweigh the potential risks to the fetus. Metecocorticoid tablets should be started only after a negative pregnancy test. Effective contraceptive measures should be taken during the use of MMC tablets, and patients should consult their doctors once they become pregnant. Studies in mice have shown that MMF can be secreted through milk. It is not clear whether the tablets are secreted in human milk. In addition, MMF may have potentially serious side effects for lactating infants, and the decision should be made based on the importance of MMF to the mother: stop breastfeeding, or stop taking the medicine.



Notes for the elderly:

It's not clear.

[Drug interaction] Acyclovir: Plasma concentrations of MPAG and acyclovir were higher when MMF and acyclovir were taken together than when the two drugs were taken alone. When renal function is impaired, plasma concentrations of both MPAG and acyclovir are elevated. The competitive excretion of the two drugs through renal tubules may further increase the blood concentration of both drugs. Acid-making drugs and magnesium hydroxide and aluminum hydroxide: MMF absorption is reduced when acid-making agents are taken together. Cholestyramine: healthy people first take cholestyramine 4 grams three times a day, four days later, given a single dose of 1.5 grams of MMF, MPA area under the curve reduced by 40%. Cyclosporine A: The pharmacokinetics of Cs A were not affected by MMF. Ganciclovir: No pharmacokinetic crossover between MMF and intravenous ganciclovir was observed. Oral contraceptives: at present not found MMF and oral contraceptives, 1 mg norethindrone 35 micrograms of ethinylestradiol/interaction between the two, but this is only a single dose research institute came to the conclusion, and can't rule out long-term use it for 7 of phenol resin after change the possibility of pharmacokinetics of oral contraceptives, which may lead to the efficacy of oral contraceptives. Sulfamethoxazole: has no effect on the bioavailability of MPA. Other interactions: concomitant administration of pensulfonamide and MMF in monkeys resulted in a three-fold increase in the area under the curve of plasma MPAG, for which other drugs excreted through the renal tubules could compete with MPAG and thus increase the concentration of plasma MPAG or these drugs. Live vaccines should not be given to patients with impaired immune responses. Antibody responses to other inoculations may be eliminated.

[Pharmacological Effects] MMF is a 2-ethyl ester derivative of MPA. MPA is a highly efficient, selective, non-competitive and reversible inhibitor of hypoxanthine mononucleotide dehydrogenase (IMPDH), which can inhibit the classical synthesis pathway of guanine nucleotides. MPA has a highly selective effect on lymphocytes. It is very effective to prevent and treat refractory rejection after kidney transplantation.

[Storage] Keep sealed and in a cool place.

[Specification] 500mg

[Packing specification] 500mg*40s/ box.

[Validity] Tentatively 24 months

[Approval Number] National Drug approval word H20080380


FAQ
1.who are we?
We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.

4. why should you buy from us not from other suppliers?
We have our own manufacture factories and one professional sales team working for the clients all over the world.

5. what services can we provide?
Accepted Delivery Terms: FOB,CIF,EXW,DDP,Express Delivery;
Accepted Payment Currency:USD,EUR,CAD,AUD,GBP,CNY;
Accepted Payment Type: T/T,L/C,PayPal,Western Union;
Language Spoken:English,Chinese,Japanese

Our Ddvantage:
1. Quick delivery
2. Online payment
3. Quality assurance
4. Welcome big order
5. After-sales service 24 hours
6. Competitive advantage products
7. Our value information is "Quality is our culture"
8. Work with us to provide you with secure funds, your business is securely protected, our advantages

Our Service
a)  Free amples can be provided.
b) Guide customers through professional technology and teach them how to use our products after sale
c) Determine the lowest price of high-quality products
1. Skilled experience: Our company is a leading manufacturer of professional production in China pharmaceutical field for many years.
2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you.
3. Safe transportation: by air express (FedEx, UPS, DHL, EMS). It is recommended that you choose the most professional freight forwarder.
4. Fast delivery: We have stock, so once payment is received, we can deliver quickly.
5. Quality service: We will provide you with enthusiastic after-sales service. If you have any questions, we will reply to youwithin 24 hours.
6. Competitive price: discounts will be obtained when making large orders.

Our Manufacture Factory
Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.

At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.


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