Find Finished Products, Chishing Machine, Quilting Machine on Industry Directory, Reliable Manufacturer/Supplier/Factory from China.

Home > Products > Finished products > Finished Products of Varicella Vaccine PFS

Finished Products of Varicella Vaccine PFS

  • Finished Products of Varicella Vaccine PFS
  • Finished Products of Varicella Vaccine PFS
  • Finished Products of Varicella Vaccine PFS
  • Finished Products of Varicella Vaccine PFS

Finished Products of Varicella Vaccine PFS

    Transportation: Air
    Port: Beijing,Shanghai

Basic Info

Model No.: Pre-filled Syringe

Product Description

Finished products of Varicella Vaccine, Live, Pre-filled Syringe

Finished Products of varicella vaccine. It has three qualities,good safety of gelatin-free, long validity period by good stability, better protection with high titer and immune efficacy. These improvements enhanced the vaccine safety and quality, and established BCHT the leading position in varicella vaccine. And it has been exported to other countries, such as India, Philippines.

And in comparison with the penicillin bottle version, the pre-filled syringe is more convenient for using.

[Compositions and Form]

The vaccine is made by propagation of attenuated varicella-zoster virus (Oka strain) in human diploid cell culture (MRC-5), after cultivation and harvest, the virus suspension is lyophilized to make the vaccine after addition of a suitable stabilizer. This product is white fluey pellet in the glass vial. The reconstituted vaccine after dissolution with diluent is a clear solution without visually detectable presence of foreign particles.

Active ingredient: Live varicella-zoster virus(Oka strain): not less than 3.3 lgPFU (2000 PFU)

Inactive ingredients: Trehalose, Human Albumin, Sodium Glutamate, Sucrose, Glucose, Carbamide,

Arginine.

Diluent: Sterile Water for Injection

[Therapeutic indications]

The vaccine is indicated for the active immunization against varicella of healthy, varicella-susceptible subjects from age of 12 months.

[Function and use]

After vaccination, the body`s immuno-activity against varicella-zoster virus can be generated for preventing the person from varicella.

[Specification]

The vial contains 0.5 ml liquid by dissolution of the lyophilized vaccine with the diluent. The reconstituted vaccine contains not less than 3.3 lg PFU of live varicella-zoster virus and is used for one subject in a single dose.

[Immune procedures and dosage]

(1) One dose of basic immunization for children of 1-12 years old; two doses of basic immunization for people of 13 years old and above with 4-8 weeks of interval.

(2) Transfer the diluent with a syringe into the vial containing lyophilized vaccine. Shake well to ensure complete dissolution of the pellet for use and transfer all the liquid back to the syringe.

(3) Apply 0.5 ml suspension for subcutaneous injection at the deltoid area of the upper arm.

According to the epidemic data and clinical research literatures at home and abroad, the Health Authorities in the provincial level or above can make one-dose booster immunization for people below 12 years old based on the local epidemic surveillance if necessary.

[Undesirable side effects]

1. Domestic clinical study

(1) In a clinical trial involving 600 infants and children of 1-12 years old immunized by the product, the main systemic reactions were fever with the total occurrence rate 12%, please see table 1, while the common systemic reactions cough, diarrhea, rash, crying, somnolence and anorexia happened in 1-5 age group with the occurrence rate 1-10%; the main local reactions were pruritus, redness, swelling and pain with the total occurrence rate 5.25%, please see table 2.

Table 1 Fever in 1-12 years old

Age /years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

1~5

The product

200

16 (8.00)

10 (5.00)

1 (0.50)

27 (13.5)

Control

100

3 (3.00)

4 (4.00)

0 (0.00)

7 (7.00)

6~12

The product

200

14 (7.00)

7 (3.50)

0 (0.00)

21 (10.50)

Control

100

5 (5.00)

1 (1.00)

1 (1.00)

7 (7.00)

Total

The product

400

30 (7.50)

17 (4.25)

1 (0.25)

48 (12.00)

Control

200

8 (4.00)

5 (2.50)

1 (0.50)

14 (7.00)

Table 2 Local reactions in 1-12 years old

Age /years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

1~5

The product

200

9 (4.50)

1 (0.50)

0

10 (5.00)

Control

100

4 (4.00)

0 (0.00)

0

4 (4.00)

6~12

The product

200

11 (5.50)

0 (0.00)

0

11 (5.50)

Control

100

8 (8.00)

0 (0.00)

0

8 (8.00)

Total

The product

400

20 (5.00)

1 (0.25)

0

21 (5.25)

Control

200

12 (6.00)

0 (0.00)

0

12 (6.00)

There is no significant difference between vaccine group and control group in table 1 and 2.

(2) In a clinical trial involving 928 people of 13 years old and above immunized by the product, the total occurrence rate of systemic reactions was 28.76% which was mainly fever, please see table 3, and the total occurrence rate of local reactions was 8.24% which was mainly redness, swelling and pain, please see table 4.

Table 3 Systemic reactions in 13 years old and above

Dose

Age/ years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

First dose

13~16

The product

299

69 (23.08)

14 (4.68)

0 (0.00)

83 (27.76)

Control

149

53 (35.57)

4 (2.68)

0 (0.00)

57 (38.26)

17~50

The product

320

49 (15.31)

3 (0.94)

1 (0.31)

53 (16.56)

Control

160

21 (13.13)

6 (3.75)

0 (0.00)

27 (16.88)

Total

The product

619

118 (19.06)

17 (2.75)

1 (0.16)

136 (21.97)

Control

309

74 (23.95)

10 (3.24)

0 (0.00)

84 (27.18)

Second dose

13~16

The product

293

41 (13.99)

4 (1.37)

1 (0.34)

46 (15.70)

Control

146

19 (13.01)

4 (2.74)

0 (0.00)

23 (15.75)

17~50

The product

307

21 (6.84)

0 (0.00)

0 (0.00)

21 (6.84)

Control

154

15 (9.74)

1 (0.65)

1 (0.65)

17 (11.04)

Total

The product

600

62 (10.33)

4 (0.67)

1 (0.17)

67 (11.17)

Control

300

34 (11.33)

5 (1.67)

1 (0.33)

40 (13.33)

Total

13~50

The product

619

155 (25.04)

21 (3.39)

2 (0.32)

178 (28.76)

Control

309

88 (28.48)

14 (4.53)

1 (0.32)

103 (33.33)

Table 4 Local reactions in 13 years old and above

Dose

Age/years

Group

Cases (n)

Mild (%)

Moderate (%)

Severe (%)

Total (%)

First dose

13~16

The product

299

10 (3.34)

5 (1.67)

1 (0.33)

16 (5.35)

Control

149

10 (6.71)

4 (2.68)

0 (0.00)

14 (9.40)

17~50

The product

320

21 (6.56)

8 (2.50)

2 (0.63)

31 (9.69)

Control

160

22 (13.75)

11 (6.88)

4 (2.50)

37 (23.13)

Total

The product

619

31 (5.01)

13 (2.10)

3 (0.48)

47 (7.59)

Control

309

32 (10.36)

15 (4.85)

4 (1.29)

51 (16.50)

Second dose

13~16

The product

293

4 (1.37)

1 (0.34)

0 (0.00)

5 (1.71)

Control

146

1 (0.68)

0 (0.00)

0 (0.00)

1 (0.68)

17~50

The product

307

1 (0.33)

1(0.33)

0 (0.00)

2 (0.65)

Control

154

1 (0.65)

0 (0.00)

0 (0.00)

1 (0.65)

Total

The product

600

5 (0.83)

2 (0.33)

0 (0.00)

7 (1.17)

Control

300

2 (0.67)

0 (0.00)

0 (0.00)

2 (0.67)

Total

13~50

The product

619

35 (5.65)

13 (2.10)

3 (0.48)

51 (8.24)

Control

309

32 (10.36)

15 (4.85)

4 (1.29)

51 (16.50)

There is no significant difference between vaccine group and control group in table 3 and 4.

The undesirable side effects can be devided as follows according to the occurence rate: very common (≥10%) ; common (1% and <10%) ; occasional (0.1% and <1%) ; rare (0.01% and <0.1%) ; very rare (<0.01%).

In the clincial study of 2-dose immunization on people of 13 years old and above with 6-week interval by this product, the conclusions for local and systemic reactions observed on day 42 are as follows :

Common adverse reactions:

(1) Usually within 24 hours after vaccination, pain and haphalgesia happen in the injection location, in most cases, they will vanish automatically.

(2) Usually within 1-2 weeks after vaccination, temporal fever reaction may happen, mostly mild, and it can be relieved automatically after lasting 1-2 days without any treatment, patients need rest if necessary and more water, keeping warm in case of secondary infection; for moderate fever or fever time more than 48 hours, it can be treated by physical method or medicine.

(3) Rash: usually within 72 hours after vaccination, minor rashes may happen, in which case

symptomatic treatment can be given appropriately,and the duration will be less than 2 days.

Extremely rare adverse reactions:

(1) Allergic rash: usually within 72 hours after vaccination, urticaria happens, when the reactions occur, see a doctor timely and take anti-allergic treatment.

(2) Allergic shock: usually happen within 1 hour after vaccination. Epinephrine injection and other emergency measures shall be carried out as treatments timely.

(3) Allergic purpura: when allergic purpura reactions happen, you should see a doctor timely and cortical steroids shall be administrated as an anti-allergic treatment, if not treated appropriately or timely, purpura nephritis may erupt simultaneously.

[Contraindications]

(1) Subjects with known hypersensitivity to any constituent of this product including neomycin.

(2) Women during pregnancy.

(3) Subjects suffering from acute disease, serious chronic disease, acute episode of chronic disease , fever and any advanced immune disease.

(4)Subjects with immune deficiency, immunocompromise or receiving immunosuppression therapy.

(5) Subjects with known history of congenital immune disease or having closely touched with the family member who has a history of this disease.

(6) Subjects suffering from cerebropathy and uncontrolled epilepsy and other progressive neurological diseases

(7) Avoid the use of salicylate within 6 weeks following vaccination of this product.

[Special precautions]

(1) Patients in the following conditions should restrainedly use: person or the person`s family has convulsions history, patients suffering from chronic disease, history of epilepsy, patients with allergic constitution, women in lactation.

(2)Subjects injected with this products should be observed for at least 30 minutes on the spot. Epinephrine and other drugs should be prepared for emergency use in case of serious allergic reaction happens occasionally.

(3) Transmission of vaccinal virus only occurs in extremely rare cases. All patients who may develop varicella, especially the patients suffering from cutaneous reaction two to three weeks after vaccination, should avoid contacting with patients suffering from leukaemia or who are undergoing immune-suppressant therapy, or pregnant women especially in the first three months of pregnancy.

(4) Administrated subcutaneously, not intradermally and never, under any circumstances, intravenously.

(5) Avoid any disinfectant to contact the vaccine of this product during opening the vaccine vials and carrying the injection. Alcohol and any other disinfectants may inactivate the attenuated virus, thus the vaccination should be applied right after ensuring the complete evaporation of the disinfectant away from skin.

(6) If any abnormal appearance conditions exist, such as cracked glass vial, unclear label of glass vial or losing efficacy, turbidity occurring after dissolution, etc, the injection shall not be administrated.

(7) Vaccine of this product should be administered immediately when opening the vaccine vials; in special circumstances, the vaccine can be placed at 2-8℃, and should be used within 30 minutes, the remanent vaccine should be discarded.

(8) Women of child-bearing age can be vaccinated only if appropriately contraceptive measures have been taken for at least 3 months following vaccination.

(9) Administration of other live attenuated vaccine should keep at least one-month interval after vaccination with this vaccine of product; however, this vaccine of product can be administered simultaneously with live attenuated vaccines of measles, rubella and mumps.

(10) Freezing is forbidden.

[Storage]

Stored and transported with cold chain in dark between 2-8 ℃.

[Packaging]

The white fluey pellet of lyophilized vaccine is in one 2ml vial made of borosilicate glass.

1 vial/ human dose× 1 human dose/ box (with one vial or one prefilled syringe of Sterile Water for Injection).

[Validity period] 36 months.

[Production standard] Pharmacopoeia of The People`s Republic of China (2015 Volume III), and the product`s Registration Standard.


Pre-filled Syringe of Varicella Vaccine

Changchun BCHT Biotechnology Co.

 

BCHT was established in March 2004 by the investment of Changchun High-technology Industry Development Property (Group). The company is a high-tech enterprise engaged in research, development, production and marketing of biologics and drugs. BCHT now owns four manufacturing sites which cover 235,000 square meters in total and two R&D centers for vaccine and drug with the most equipped laboratories and pilot plants in the areas over 5000 square meters. For the last few years, the company`s R&D investment exceeds over 120 million RMB.

In 2008, BCHT successfully launched its product Varicella Vaccine, Live in China. In the following years, BCHT continuously committed to improving the product and led in 2010 removal of gelatin from adjuvant and extended the vaccine shelf-life up to 36 months which is the longest one in the world in 2011. These improvements enhanced the vaccine safety and quality, and established BCHT the leading position in varicella vaccine.

Jilin Maifeng Biopharmaceutical Co., Ltd., a subsidiary of BCHT, is devoted to mostly R&D in high density cell culture technique and its application for large scale production. Jilin Maifeng is the first company to develop and apply the self-developed microcarrier bioreactor technology to produce rabies vaccine for human use.

Company Info

  • Company Name: Changchun BCHT Biotechnology Co.
  • Product/Service: Varicella Vaccine , Rabies Vaccine for Human Use , Bulk of Varicella Vaccine , Bulk of Rabies Vaccine , PFS Varicella Vaccine , Exenatide Acetate
  • Capital (Million US $): US$0.2Million
  • Year Established: 2004
  • Total Annual Sales Volume (Million US $): US$1 Million - US$2.5 Million
  • Export Percentage: 1% - 10%
  • Total Annual Purchase Volume (Million US $): Below US$1 Million
  • No. of Production Lines: 4
  • No. of R&D Staff: 51 -60 People
  • No. of QC Staff: 91 -100 People
  • OEM Services Provided: no
  • Factory Size (Sq.meters): Above 100,000 square meters
  • Factory Location: 1260Huoju Road,Changchun High-tech Zone,Changchun,Jilin,China
  • Contact Person: Mr. Jason Jiang
  • Tel: 86-0431-87078891
Email to this supplier
  • *Subject:
  • To:

  • *Messages:
    Your message must be between 20-8000 characters