Company Information

1. Name

SK chemical Life Science Biz.

2. Website Address

http://www.skchemicals.com/en/main.asp

3. Location

310 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea [13494]

4. Contacts

skpharma@sk.com

5. References

+82-80-021-3131

Pharmaceutical Product Information

1. Brand Name

SKYCellflu Quadrivalent prefilled syringe (influenza vaccine, surface antigen, inactivated, prepared in cell cultures)

2. Active Ingredient

SKYCellflu Quadrivalent prefilled syringe is standardized according to Ministry of Food and Drug Safety of Republic of Korea requirements for the Guideline on the Cell Culture Inactivated Influenza and is formulated to contain a total of 60 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following four influenza strains: A/Christchurch/16/2010, NIB-74xp(H1N1) (an A/California/7/2009(H1N1)pdm09-like virus); A/Hong Kong/4801/2014, NYMC X-263(H3N2) (an A/Hong Kong/4801/2014(H3N2)-like virus);

B/Brisbane/60/2008, NYMC BX-35) (a B/Brisbane/60/2008-like virus); B/Phuket/3073/2013 (a B/Phuket/3073/2013-like virus).

3. Indication

SKYCellflu Quadrivalent prefilled syringe is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine in persons 3 years of age and older.

4. Information

SKYCellflu Quadrivalent prefilled syringe (Influenza Vaccine), the first cell culture-based quadrivalent influenza vaccine in the world, a vaccine for intramuscular injection, is a subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line.

A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. The cells used to manufacture SKYCellflu Quadrivalent prefilled syringe are kept frozen and “banked.” Cell banking assures an adequate supply of cells is readily available for vaccine production. Growing the influenza viruses in cell culture for the manufacture of SKYCellflu Quadrivalent prefilled syringe is not dependent on an egg supply.

SKYCellflu Quadrivalent prefilled syringe contains no preservative or antibiotics.

5. Images

Pharmaceutical Product Information

1. Barnd Name

SKYCellflu prefilled syringe (influenza vaccine, surface antigen, inactivated, prepared in cell cultures)

2. Active Ingredient

SKYCellflu prefilled syringe is standardized according to Ministry of Food and Drug Safety of Republic of Korea requirements for the Guideline on the Cell Culture Inactivated Influenza and is formulated to contain a total of 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA of each of the following four influenza strains: A/Christchurch/16/2010, NIB-74xp(H1N1) (an A/California/7/2009(H1N1)pdm09-like virus); A/Hong Kong/4801/2014, NYMC X-263(H3N2) (an A/Hong Kong/4801/2014(H3N2)-like virus);

B/Brisbane/60/2008, NYMC BX-35) (a B/Brisbane/60/2008-like virus).

3. Indication

SKYCellflu prefilled syringe is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine in persons 6 months of age and older.

4. Information

SKYCellflu prefilled syringe (Influenza Vaccine), the first cell culture-based influenza vaccine in republic of Korea, a vaccine for intramuscular injection, is a subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line.

A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. The cells used to manufacture SKYCellflu prefilled syringe are kept frozen and “banked.” Cell banking assures an adequate supply of cells is readily available for vaccine production. Growing the influenza viruses in cell culture for the manufacture of SKYCellflu prefilled syringe is not dependent on an egg supply.

SKYCellflu prefilled syringe contains no preservative or antibiotics.

5. Images

Pharmaceutical Product Information

1. Barnd Name

Hepamune®

2. Active Ingredient

Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on aluminum as aluminum hydroxide.

Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on aluminum as aluminum hydroxide.

3. Indication

Hepamune® is a vaccine indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

4. Information

Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

Hepamune [Hepatitis B Vaccine (Recombinant)] is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae AB110 cells, which carry the surface antigen gene of the hepatitis B virus.

5. Images

Pharmaceutical Product Information

1. Barnd Name

SK Td®

2. Active Ingredient

1 dose of vaccine (0.5 ml suspension) contains each of the following toxoid: tetanus toxoid, adsorbed at least 20 IU; diphtheria toxoid, adsorbed at least 2 IU; aluminium hydroxide as adsorbent 1.5 mg; formaldehyde, salts, water for injection.

3. Indication

SK Td® is an inactivated vaccine indicated for active immunisation against tetanus and diphtheria in persons 7 years of age and older.

4. Information

The national vaccination recommendations are to be followed.

Individuals of 7 years old and over receive an identical dose.

1. Primary immunisation (for non-immunised persons or for those with no known record of vaccination).

A total of 3 vaccinations with 1 dose (0.5 ml) each time:

- Initial injection (from 7 years of age) 0.5 ml

- 4 - 6 weeks later 0.5 ml

- 6 - 12 months after the 2nd injection 0.5 ml

2. Booster vaccinations

It is recommended that, during adulthood, individuals who have received the complete primary immunisation course should have routine booster vaccinations against diphtheria and tetanus at 10 year intervals. When combination vaccines are used for booster vaccinations the indications and vaccination intervals of the other antigens in the vaccine should be taken into account in compliance with the current recommendations of the Centers for Disease Control and Prevention.

Following complete primary immunisation, if there is a risk of diphtheria or tetanus infection, a booster vaccination with the diphtheria adsorbate vaccine in keeping with the age or with appropriate combination vaccines should be undertaken if the last vaccination was more than 5 years ago.

Controls of serum antibodies in cases of unclear vaccination status are not indicated.

Primary immunisation discontinued for many years need not be re-done but can be supplemented at any time with at least three vaccinations against diphtheria and tetanus (irrespective of the kind of vaccines previously used). In general there are no maximum intervals between vaccinations. Every vaccination recorded counts.

3. Immunisation after injury

a) Individuals completely protected against tetanus, whose last vaccinations were:

up to 5 years ago: no immediate vaccination necessary

5-10 years: 0.5 ml SK Td® vaccine

more than 10 years ago: simultaneously 0.5 ml SK Td® + 250 IU tetanus immunoglobulin.

If the wounds are clean and minor, tetanus immunoglobulin need not be given.

b) When vaccinating a person with a known immune deficiency or on immunosuppressive treatment (an individual with congenital or acquired impairment of the body's defences), the success of the vaccination may be uncertain. In the event of injury, it is necessary to administer a simultaneous dose of tetanus immunoglobulin to these individuals.

5. Images