COLCHICIN

Origin	Vietnam

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Supplier : TRAPHACO JOINT STOCK COMPANY

Lane 15, Ngoc Hoi - Giai Phong - Lane 15, Ngoc Hoi - Giai Phong - Hoang Mai - Hanoi

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Content:

PRESENTATION: Box of 1 blister of 20 tablets.

COMPOSITION: Each tablet contains:
Colchicin..........................................................................................1 mg Excipients (Sucrose, Lactose, Starch, PVP, Talc, Magnesium stearat, Sunset yellow lake).............................................................................q.s.

PHARMACOLOGY:
- The principal pharmacologic effect of colchicine is its antigout activity. Colchicine diminishes the leucocyte mobility, inhibits the phagocytosis of urate microcrystals and then inhibits the production of lactic acid by maintaining normal pH (acidity facilitates the precipitation of urate crystals which is the primary factor of gout).
The drug has no effect on blood concentration of uric acid or on the excretion of uric acid.
- The anti inflammatory activity of colchicines is weak, non specific effects: Colchicine decrease the migration of leukocytes, inhibits chemotaxis, metabolism and function of polynuclear leukocytes, thus decreases the inflammatory response.

PHARMACOKINETICS:
- Colchicine is absorbed by the oral route undergoes enterohepatic cycle and reaches peak concentration in the plasma within 2 hours. The drug is distributed into various tissues: intestinal mucosa, liver, kidneys, spleen, but appear to be absent in myocardium, skeletal muscles and lungs.
- Most of the drug is excreted in the feces but 10 to 20% is excreted in the urine.
The fixation of colchicine leads to tissue accumulation and when the daily dosage reaches 1 mg, toxic effects may be precipitated.

INDICATIONS:
- Acute attack of gout.
- Prophylaxis of recurrent gout and to prevent acute attacks during the first few months of treatment with Allopurinol or Uricosurics (hypouricemic treatment).
- Other acute microcrystallinic attacks: chondrocalcinosis, sarcoid arthritis, arthritis associated with erythema nodosum.
- Periodic fever.

DOSAGE AND ADMINISTRATION: As physician's prescription.
The suggested dose is:
* Acute attack of gout
- First day: take 3 tablets daily (1 in the morning, 1 at noon and 1 in the evening).
- 2nd, 3rd day: take 3 tablets daily (1 in the morning and 1 in the evening).
- 4th day and following days: take one tablet in the evening.
The total dose do not exceed 10 tablets. Treatment doses should not be repeated for at least 3 days.
* Prevention of attacks during initial treatment of allopurinol or uricosuric drugs: take one tablet in the evening.
* Acute microcrystallinic attacks, periodic fever: 1 tab in the evening.
For patients with renal failure, with serum creatinine concentration greater than or equal to 1.6 mg/100ml, or creatinine clearance ratio less than or equal 50ml/minutes: ½ tablet/day, the total dose do not exceed 4 tablets. Treatment doses should not be repeated for at least 3 days.

CONTRAINDICATIONS:
- Hypersentivity to any ingredients of this drug.
- Severe renal insufficiency.
- Severe hepatic insufficiency.
- Pregnancy.
- Patients with risk of narrow angle glaucoma.

PRECAUTIONS:
Colchicine should be used with caution in following cases:
- Treatment of acute attack of gout in patients with renal or hepatic insufficiency.
- Patients with cardiac, hepatic, renal or gastro intestinal disease. Old and debilitated patients may be particularly susceptible to cumulative toxicity.
- Monitor blood counts during prolonged treatment.
- Colchicine is distributed into breast milk, so it should be used with caution in nursing women.

ADVERSE REACTIONS:
- The most common adverse effects of oral colchicine are the gastrointestinal disturbances, including nausea, vomiting, diarrhoea, abdominal pain. There are often the first signs of toxicity and are usually an indication that Colchicine therapy should be stopped until these symptoms disappear which is usually within 24 - 48 hours.
- Morbilliform eruption and urticaria.
- Hematologic troubles: leucopenia, neutropenia, thrombopenia may rarely occur with prolonged administration.
- Reversible neuromyopathic troubles, reversible oligospermia, alopecia.
Colchicine should be withdrawn or the dose reduced if adverse gastrointestinal effects occur.
Inform your physician of any unusual reactions while using the drug.

DRUG - DRUG INTERACTIONS:
- Ciclosporin toxicity can be enhanced by Colchicine.
- Colchicine induces reversible malabsorption of Vitamin B12 apparently by altering the function of ileal mucosa.

OVERDOSAGE:
Toxic dose: about 10mg, lethal dose: > 40mg.
Symptoms:
Latent: 1 - 8 hrs, moderately: 3 hrs.
Diffused abdominal pain, vomiting, profused diarrhea (sometimes bloody), dehydration (metabolic acidosis) and circulatory troubles (hypotension). Stomatitis, arthralgia, hypocalcemia, fever, rashes. Renal damage as evidenced by oliguria and hematuria. Extreme vascular damage may result in shock and cardiovascular collapse. Hematologic troubles: leucophilia, then leucopenia and thrombocytopenia due to medullar damage. Frequent polypnea, alopecia on the 10th day of treatment. Muscular weakness, an ascending paralysis of the CNS may develop although the patient usually remains conscious. Death, generally on 2nd or 3rd day by hydroelectrolytic disequilibrium, septic shock or respiratory depression or cardiovascular collapse, bacteremia.
Treatment:
There is no specific antidote for colchicine.
Hospitalize the patient and constantly supervise the clinical and biological symptoms. Toxic elimination may be carried out by gastric lavage, then by duodenal aspiration and activated charcoal. Symptomatic treatment: correction of water and electrolyte imbalance, administration of atropine or morphine for the relief of abdominal pain, general and massive antibiotic therapy and respiratory assistance.

STORAGE: In a dry place, temperature below 300C, protect from light.

SHELF - LIFE: 36 months from manufacturing date.

INVESTMENT AND DEVELOPMENT

From 2000 to present

2017

2016

Traphaco holds General Meeting of Shareholders term of 2016-2020
Traphaco receives National Quality Gold Awards 2015
Traphaco among the top 40 valuable company brands and top 50 listed companies in Vietnam
Traphaco among Top 10 Prestigious Pharmaceutical Company of Vietnam 2016
Traphaco builds company strategy for 2017-2020
Traphaco continues to be selected as National Brand - Vietnam Value

2015

Traphaco was named among the Top 15 Brands of Vietnam 2014

Traphaco won the title “Star of Vietnamese medicine”

Traphaco was rated among Top 50 enterprises in Vietnam

Traphaco won the Top 10 well-known brands in Vietnam

2014

Traphaco CEO was honored as one of the Top 50 business leaders in 2013

Traphaco received the Certificate of Merit for the enterprise producing high quality goods 2014 (under the framework of the Vietnam High Quality Goods program)

Traphaco was named among the "Top 15 Famous Brands 2013"

2013

Traphaco won the prizes for the best international enterprise and the excellent manager of the European Business Association and other awards as follows:

Asia - Pacific International Quality Award 2013

ASEAN famous brand

Top 10 typical enterprises for social responsibility (Vietnam Gold Star Award)

Top 10 brands in Vietnam

2012

On October 29^th 2012, TRAPHACO became a major shareholder of the Quang Tri Pharmaceutical - Medical Supplies JSC, holding 42.91% of charter capital.

On May 11^th 2012, TRAPHACO officially became a major shareholder of the Dak Lak Pharmaceutical - Medical Supplies JSC with 24.5% of the charter capital. On October 10^th 2012 TRAPHACO successful bought more shares of the Dak Lak Pharmaceutical - Medical Supplies JSC to increase its ownership ratio from 24.5% to 51%.

Traphaco founded 2 more branches in Quang Ninh, Gia Lai, bringing the total branches to 14 (2 branches of level 1, 12 branches of level 2)

In April 2012, TRAPHACO received the "International Quality Award" in Germany. In May 2012, TRAPHACO received the award for TOP 10 typical enterprises for the community. On June 19^th 2012, TRAPHACO was presented the certification of "TOP 50 companies of the most efficient business in Vietnam." On October 4^th2012, TRAPHACO received the Vietnamese President’s decision on the grant of the First Labour Medal to Traphaco.

2011

In November 2011 TRAPHACO successfully bought more shares of TRAPHACO Hi-tech JSC, raising its percentage of ownership in TRAPHACO CNC from 12.83% to 50.96%.

Traphaco founded 5 branches in Binh Thuan, Dong Nai, Quang Ngai, Can Tho, and Khanh Hoa.

TRAPHACO received the TOP 100 Vietnam Gold Star Award, especially the "TOP 10 typical enterprises for social responsibility" title.

TRAPHACO attended "The Annual Report 2010" poll and was awarded the "Best Annual Report". Along with this award, TRAPHACO was rated AAA for the 'Annual Report of Vietnam confidence index" for businesses operating efficiently, demonstrating transparency, financial strength, long-term growth prospects, control of capital and risk at the lowest level.

In June 2011, the program "building standards to identify Dioscorea hamiltonii as medicinal plant,” under the GreenPlan Project (Project to research and develop medicinal plants of TRAPHACO) received funding from the World Bank presented through the program "Vietnam Innovation Day 2011".

In April 2011 the project entitled "Research and produce Boganic liver tonic and detoxification medicine from medicinal plants of Vietnam" won the first prize of the Vietnam Fund for Technological Innovation (VIFOTEC).

2010

TRAPHACO was the only unit in Vietnam to receive the WIPO Award of the World Intellectual Property Organization. The company also won the third Prize for Social Responsibility in the Field of Environment (CSR), TOP 100 Vietnam Gold Star Award. Particularly, on December 10, TRAPHACO received the title of Labour Hero for its achievement in the 2000-2009 period.

2009

TRAPHACO was recognized as the most famous brand of the Vietnam pharmaceutical industry

Traphaco launched Traphaco Sapa Co., Ltd. in Lao Cai, holding 100% of capital.

2008

On November 26^th 2008, Traphaco’s shares (code: TRA) were officially traded on the HCM City Stock Exchange (HOSE).

Traphaco won the Vietnam Gold Cup for Kindness.

2007

On November 27^th TRAPHACO JSC celebrated its 35th anniversary and received the second-class Labor Medal presented by the President of the Socialist Republic of Vietnam. The President also presented the third-class Labor Medal for the company’s trade union. Experiencing 35 years of construction and development, TRAPHACO JSC really grew up and made great contributions to the protection of people’s health as well as the development of the pharmaceutical industry in Vietnam.

2000

In January 2000, the Transportation Pharmaceutical and Medical Equipment Company officially operated under the model of a joint stock company. On July 5^th2001 the company changed its named into TRAPHACO, for the purpose of trading in multiple industries in line with the new economic trends. Its main business sectors include: Pharmaceuticals, medical materials, chemical, medical supplies and equipment, food, wine, beer, beverage, cosmetics, consulting service, scientific and technical services, transfer of technology in the field of pharmacy and export-import activities.

The period before equitization (1972 – 1999)

PHASEPERFORMANCE EQUITIZED

since 1972 to date

1999

The decision to equitize the Transportation Pharmaceutical and Medical Equipment Company was issued on September 27^th 1999, with 45% of capital held by the state. The decision was made under the State policy of renewal, reform of State-owned enterprises to improve their business and operation. This was the most important moment. The company’s leaders and workers positively prepared all legal conditions for the meeting of the founding shareholders on November 15^th 1999.

1994

The Transportation Pharmaceutical and Medical Equipment Company was founded on May 16^th, 1994 (TRAPHACO) with functions of production and trading of pharmaceuticals, medical supplies and equipment. The company opened stores at 18A Le Duan Street, No. 9 Lang Ha, No. 31 Lang Ha Street, and set up a warehouse at No. 108 Thanh Cong Street, Hanoi to facilitate its business. By directly involving in the circulation and distribution of drugs, medical supplies and equipment, Traphaco could well grasp the needs of the market. The company later hired 6,000 m2 of land in Phuc Xa, Xuan La 1, Xuan La 2 and Phu Thuong in Hanoi to expand its operation.

1993

The Railway Pharmaceutical Enterprise was founded on June 1^st 1993 (trade name RAPHACO) with the functions of manufacturing and trading medicines. The company had 80 employees, capital of VND150 million, rudimentary equipment, and narrow space (only 340 m2). The newly-established company faced a lot of difficulties, but with its courage and determination, the company overcame difficulties to step by step develop.

1981

The Railway Pharmaceutical Factory was established on May 28^th 1981 by being upgraded from the Railway Medicine Production Group.

1977

For a period of time, as required by the situation, the railway medicine production group only distributed medicines. On August 31^st 1977 its functions and tasks of producing medicines and distributing medicines to the entire railway sector was resumed. At that time the group has 37 members.

1972

The medicine production group of the Railway Health Department was founded on November 28^th 1972, with 15 employees and the main task of making drugs under prescription. The group produced serum, fluids, distilled water serving hospitals of the railway sector during the war. The group was based at No. 75 Yen Ninh Street, Hanoi, the same place with the Railways Health Department.

VISION

Vision 2020 to become No. 1 Enterprise Vietnam Pharmaceutical industry in terms of revenue, profit and market capitalization.

MISSION

Our mission is to pioneer in the development of green pharmaceuticals to protect human health.

TRAPHACO SAPA SINGLE MEMBER LIMITED LIABILITIES COMPANY

Headquarter: Section 9, Sapa Town, Sapa District, Lao Cao Province
Chartered Capital: VND16,800,000,000
TRAPHACO’s ownership: 100%

Main functions:

TRAPHACO Sapa specializes in the processing of ingredients and input

herbal ingredients as well as the researching of GACP for TRAPHACO.

At the same time, it serves as the center for developing farming areas

for herbal ingredients for TRAPHACO. The TRAPHACO SAPA factory

started in 1998 with an extraction assembly line, processing the input

herbal ingredients and with more than 4 ha of land for the test-farming

of medicinal herbs.

TRAPHACO HUNG YEN LIMITED LIABILITIES COMPANY

Headquarter: Tan Quang Commune, Van Lam district, Hung Yen Province
Chartered Capital: VND150,000,000,000
TRAPHACO’s ownership: 100%

Main functions:

Manufactures medicines, pharmaceutical ingredients

and inputs.

DAK LAK PHARMACEUTICALS AND MEDICAL EQUIPMENTS JOINT STOCK COMPANY (BAMEPHARM)

Headquarter: 9A Hung Vuong, Buon Ma Thuot City, Dak Lak province
Chartered capital: VND19,415,880,000
TRAPHACO’s ownership: 58%

Main functions:

Dak Lak Pharmaceutical and Medical Equipment joint stock company

has over 35 years of history, specializing in distributing pharmaceutical

products and medical equipment in the two provinces Dak Lak and Dak

Nong. In addition, the company has a sales network of 400 retail points

and 20 branches, locating in many townships and mountainous

communes in the region. Dak Lak Pharmaceuticals and Medical

Equipment joint stock company is a reputable brand to the people of

the Central Highland region. In line with the general trend of

development and integration, the company has opened a GPP-certified

pharmacy chain in the two provinces Dak Lak and Dak Nong to meet

the requirements of the Ministry of Health and the growing demand

of customers.

TRAPHACO HIGH-TECHNOLOGY JOINT STOCK COMPANY (TRAPHACO CNC)

Headquarter: Tan Quang Commune, Van Lam district, Hung Yen Province
Chartered Capital: VND94,703,570,000
TRAPHACO’s ownership: 51%

Main functions:

TRAPHACO specializes in processing and manufacturing of

TRAPHACO’s products.The factory of TRAPHACO CNC, which is

located at Van Lam, Hung Yen, was first constructed in October

2004 and put into operation in January 2007. With over 10.000m2

of facilities and warehouses, the factory is comprised of 01 facility

producing compressed pills for traditional medicines, 01 facility

for preliminary processing, 01 tea processing facility, 01 facility

for tubed medicines and another one for powdered medicines.

The Van Lam Factory specializes in traditional medicines and

has been certified with GPs-WHO standards in 2008. It is the first,

largest and most technologically-advanced traditional medicine

manufacturing facility in Vietnam.

CORPORATE CULTURE

»» The message of the final year of the term, 2015 “Develop corporate culture”, focus on the theme: “Cooperate in work – Share benefits – Commit to targets – Honor all commitments” with the objective all individuals and departments in the entire Traphaco network understand the activities of the Company, united for an objective, cooperated to create synergized power, which will be the catapult to launch Traphaco into a strong growth trajectory in the coming term.

»» The emulation campaign attracted 100% of employees to participate: with 200 signed projects, 20 winners, total prize value of over VND1 billion. Many projects develivered great results for the Company. Among which, the first prize belong to the project “Apply KPI in the management of the enterprise”.

»» Activities in rallying the Company’s tradition day: Selected 20 most outstanding individual to be acknowledged and given a prize, which is a trip to visit Bali – Indonesia and Singapore; Organized many activities, sports and art shows with the intention to build corporate culture, enhance the cooperation between departments/individuals within the Company for example:

The contest “bonding to show talents”, the soccer tournament, the tennis championship to improve the morale of the employees and motivate them at work.