GMP Certified Sterile Water for Injection Ppv Vial 5ml and 10ml

January 18, 2019

Model NO.: DUORUI
Pharmaceutical Technology: Chemical Synthesis
Drug Reg./Approval No.: Yzzi20050812
Drug Ad Approval No.: Yzzi20050812
Shelf Time: 3 Years
5ml: 1000 Vials /Carton
10ml: 600vials/Carton
Trademark: UNPCHL
Transport Package: 600vials/Carton
Specification: 5ml or 10ml
Origin: China
HS Code: 3004909099
Model NO.: DUORUI
Pharmaceutical Technology: Chemical Synthesis
Drug Reg./Approval No.: Yzzi20050812
Drug Ad Approval No.: Yzzi20050812
Shelf Time: 3 Years
5ml: 1000 Vials /Carton
10ml: 600vials/Carton
Trademark: UNPCHL
Transport Package: 600vials/Carton
Specification: 5ml or 10ml
Origin: China
HS Code: 3004909099
1. Name of the medicinal product

Sterile water for injection

 

2. Qualitative and quantitative composition

Sterile Water for Injection Ph. Eur. 100% w/v.

 

3. Pharmaceutical form

Solution for injection or infusion

 

4. Clinical particulars

4.1 Therapeutic indications

To be used to reconstitute certain medicinal products.


4.2 Posology and method of administration

Intramuscular or intravenous injection.


4.3 Contraindications

Not applicable.


4.4 Special warnings and precautions for use

Not applicable.


4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.


4.6 Pregnancy and lactation

Not applicable.


4.7 Effects on ability to drive and use machines

Not applicable.


4.8 Undesirable effects

Not applicable.


4.9 Overdose

Not applicable.

 

5. Pharmacological properties

5.1 Pharmacodynamic properties

Not applicable.


5.2 Pharmacokinetic properties

Not applicable.


5.3 Preclinical safety data

Not applicable.

 

6. Pharmaceutical particulars

6.1 List of excipients

Not applicable.


6.2 Incompatibilities

Not applicable.


6.3 Shelf life

60 months.


6.4 Special precautions for storage

Discard any remaining solution after use.


6.5 Nature and contents of container

Ampoules:

Glass class I Ph. Eur., containing 1ml, 2ml, 3.2ml, 5ml or 10ml.

Vials:

Glass class I Ph. Eur., containing 4ml, 7.8ml, 10ml, 15.6ml or 31.2ml.

All rubber stoppers for the vials used comply with Ph.Eur. testing for rubber closures.


6.6 Special precautions for disposal and other handling

No special requirements.




 
GMP Certified Sterile Water for Injection Ppv Vial 5ml and 10ml
   
  1. Name of the medicinal product

Sterile water for injection

 

2. Qualitative and quantitative composition

Sterile Water for Injection Ph. Eur. 100% w/v.

 

3. Pharmaceutical form

Solution for injection or infusion

 

4. Clinical particulars

4.1 Therapeutic indications

To be used to reconstitute certain medicinal products.


4.2 Posology and method of administration

Intramuscular or intravenous injection.


4.3 Contraindications

Not applicable.


4.4 Special warnings and precautions for use

Not applicable.


4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.


4.6 Pregnancy and lactation

Not applicable.


4.7 Effects on ability to drive and use machines

Not applicable.


4.8 Undesirable effects

Not applicable.


4.9 Overdose

Not applicable.

 

5. Pharmacological properties

5.1 Pharmacodynamic properties

Not applicable.


5.2 Pharmacokinetic properties

Not applicable.


5.3 Preclinical safety data

Not applicable.

 

6. Pharmaceutical particulars

6.1 List of excipients

Not applicable.


6.2 Incompatibilities

Not applicable.


6.3 Shelf life

60 months.


6.4 Special precautions for storage

Discard any remaining solution after use.


6.5 Nature and contents of container

Ampoules:

Glass class I Ph. Eur., containing 1ml, 2ml, 3.2ml, 5ml or 10ml.

Vials:

Glass class I Ph. Eur., containing 4ml, 7.8ml, 10ml, 15.6ml or 31.2ml.

All rubber stoppers for the vials used comply with Ph.Eur. testing for rubber closures.


6.6 Special precautions for disposal and other handling

No special requirements.




 
GMP Certified Sterile Water for Injection Ppv Vial 5ml and 10ml
   
 

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