- Approval Id
- 3db1eb9e5e02fb37
- Drug Approval Emc Name
- Sterile water for injection
- Drug Name
- Sterile water for injection
- Company Address
- Ramsgate Road, Sandwich, Kent, CT13 9NJ
- Company Telephone
- +44 (0)1304 616 161
- Company Medical Info Direct Line
- +44 (0)1304 616161
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Pfizer LimitedRamsgate RoadSandwichKentCT13 9NJ
- Authorisation Number
- PL 00057/1436
- Authorisation Date
- 13 February 1990/19 May 1995
- Instruction Authorisation Holder
- Pfizer LimitedRamsgate RoadSandwichKentCT13 9NJ
- Instruction Authorisation Number
- PL 00057/1436
- Instruction Authorisation Date
- 13 February 1990/19 May 1995
- Instruction Composition
- Sterile Water for Injection Ph. Eur. 100% w/v.
- Instruction Dosage Form
- Solution for injection or infusion
- Instruction 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Not applicable.5.2 Pharmacokinetic properties
Not applicable.5.3 Preclinical safety data
Not applicable.
- Instruction 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.
- Instruction Content
- ## Composition
Sterile Water for Injection Ph. Eur. 100% w/v.
## Pharmaceutical Form
Solution for injection or infusion
## 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Not applicable.5.2 Pharmacokinetic properties
Not applicable.5.3 Preclinical safety data
Not applicable.
## 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.
- Company Detail Path
- /organization/pfizer-limited
