- Approval Id
- 238a65f9350010c5
- Drug Approval Emc Name
- Water for Injections BP, solvent for parenteral use
- Drug Name
- Water for Injections BP, solvent for parenteral use
- Company Name
- B.Braun Medical
- Company Address
- Brookdale Road, Thorncliffe Park Estate, Chapeltown, Sheffield, South Yorkshire, S35 2PW
- Company Website
- //www.bbraun.co.uk/en
- Company Telephone
- 0114 225 9000
- Company Medical Info Direct Line
- 0800 298 0299
- Company Medical Info Email
- medinfo.bbmuk@bbraun.com
- Atc Code
- V07AB
- Legal Category
- Prescription only medicine
- Authorisation Holder
- B. Braun Melsungen AG
Carl-Braun-Straße 134212 Melsungen, Germany
\*Postal address:\*
34209 Melsungen, Germany
Telephone: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567
- Authorisation Number
- PL 03551/0077
- Authorisation Date
- 18/10/2006
- Instruction Authorisation Holder
- B. Braun Melsungen AG
Carl-Braun-Straße 134212 Melsungen, Germany
\*Postal address:\*
34209 Melsungen, Germany
Telephone: +49-(0)-5661-71-0
Fax: +49-(0)-5661-71-4567
- Instruction Authorisation Number
- PL 03551/0077
- Instruction Authorisation Date
- 18/10/2006
- Instruction Composition
- 100 ml of solvent contain:
Water for injections 100 ml
- Instruction Dosage Form
- Solvent for parenteral use
Clear, colourless solution
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Preparation and dilution of parenteral preparations4.2 Posology and method of administration
\*\*Posology\*\*
Water for Injection BP is used for dilution or dissolution of parenteral medicinal products. Dosage and duration of use depend on the instructions given for the medicinal product to be dissolved or diluted.
\*Paediatric population\*
The dosage has to be considered based on the instructions given for the medicinal product to be dissolved or diluted.
\*\*Method of administration\*\*
The method of administration depends on the instructions given for the medicinal product to be dissolved/diluted. The medicinal products should be reconstituted or diluted immediately before use.4.3 Contraindications
There are no contraindications for water for injections as such.4.4 Special warnings and precautions for use
Water for Injections BP must not be used alone for intravenous administration.4.5 Interaction with other medicinal products and other forms of interaction
Interactions between water for injections and other medicinal products are not known.4.6 Fertility, pregnancy and lactation
Pregnancy
Generally, water for injections can be used during pregnancy.
Breast-feeding
Water for injections can be used during breast-feeding.
Fertility
No data available.4.7 Effects on ability to drive and use machines
Water for Injections BP has no influence on the ability to drive and use machines.4.8 Undesirable effects
None known if used according to the instructions given.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Symptoms and treatment
Not applicable because this medicinal product is only for preparation and dilution of parenteral preparations.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions
ATC code: V07AB5.2 Pharmacokinetic properties
None5.3 Preclinical safety data
Non-clinical data on water for injection reveal no special hazard for humans.
Studies of toxicity to reproduction, genotoxicity or carcinogenic potential have not been performed, but based on the chemical properties of water and the fact that water is essential to life, pure water would not be expected to generate positive mutagenic or carcinogenic data.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
None6.2 Incompatibilities
Not applicable6.3 Shelf life
\*Unopened\*
| | |
| --- | --- |
| Polyethylene containers Polyethylene ampoules: 5 ml, 10 ml, 30 ml Polypropylene ampoules: 10 ml, 20 ml | 36 months 30 months 36 months |
\*After first opening\*
Not applicable. See section 6.6.
\*After admixture of additives\*
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.6.4 Special precautions for storage
Product in plastic ampoules: Do not store above 25 °C.
Product in polyethylene containers: This medicinal product does not require any special storage conditions.
For storage conditions of ready-to-use preparations see section 6.3.6.5 Nature and contents of container
● Bottles of low-density polyethylene (LD-PE),
contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml
pack sizes: 20 x 50 ml, 10 x 100 ml, 20 x 100 ml, 10 x 250 ml, 20 x 250 ml, 10 x 500 ml, 10 x 1000 ml
● Polyethylene ampoules,
contents: 5 ml, 10 ml, 20 ml
pack sizes: 20 x 5 ml, 20 x 10 ml, 20 x 20 ml, 100 x 5 ml, 100 x 10 ml, 100 x 20 ml
● Polypropylene ampoules,
contents 10 ml, 20 ml
pack sizes: 20 x 10 ml, 20 x 20 ml, 50 x 10 ml, 50 x 20 ml, 100 x 10 ml, 100 x 20 ml
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal.
Only to be used if solution is clear, colourless and the container and its closure are undamaged.
The containers are for single use only. After use discard container and any remaining contents.
Use the liquid immediately after opening of the container.
- Instruction Content
- ## Composition
100 ml of solvent contain:
Water for injections 100 ml
## Pharmaceutical Form
Solvent for parenteral use
Clear, colourless solution
## Clinical Particulars
4.1 Therapeutic indications
Preparation and dilution of parenteral preparations4.2 Posology and method of administration
\*\*Posology\*\*
Water for Injection BP is used for dilution or dissolution of parenteral medicinal products. Dosage and duration of use depend on the instructions given for the medicinal product to be dissolved or diluted.
\*Paediatric population\*
The dosage has to be considered based on the instructions given for the medicinal product to be dissolved or diluted.
\*\*Method of administration\*\*
The method of administration depends on the instructions given for the medicinal product to be dissolved/diluted. The medicinal products should be reconstituted or diluted immediately before use.4.3 Contraindications
There are no contraindications for water for injections as such.4.4 Special warnings and precautions for use
Water for Injections BP must not be used alone for intravenous administration.4.5 Interaction with other medicinal products and other forms of interaction
Interactions between water for injections and other medicinal products are not known.4.6 Fertility, pregnancy and lactation
Pregnancy
Generally, water for injections can be used during pregnancy.
Breast-feeding
Water for injections can be used during breast-feeding.
Fertility
No data available.4.7 Effects on ability to drive and use machines
Water for Injections BP has no influence on the ability to drive and use machines.4.8 Undesirable effects
None known if used according to the instructions given.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Symptoms and treatment
Not applicable because this medicinal product is only for preparation and dilution of parenteral preparations.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions
ATC code: V07AB5.2 Pharmacokinetic properties
None5.3 Preclinical safety data
Non-clinical data on water for injection reveal no special hazard for humans.
Studies of toxicity to reproduction, genotoxicity or carcinogenic potential have not been performed, but based on the chemical properties of water and the fact that water is essential to life, pure water would not be expected to generate positive mutagenic or carcinogenic data.
## Pharmaceutical Particulars
6.1 List of excipients
None6.2 Incompatibilities
Not applicable6.3 Shelf life
\*Unopened\*
| | |
| --- | --- |
| Polyethylene containers Polyethylene ampoules: 5 ml, 10 ml, 30 ml Polypropylene ampoules: 10 ml, 20 ml | 36 months 30 months 36 months |
\*After first opening\*
Not applicable. See section 6.6.
\*After admixture of additives\*
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.6.4 Special precautions for storage
Product in plastic ampoules: Do not store above 25 °C.
Product in polyethylene containers: This medicinal product does not require any special storage conditions.
For storage conditions of ready-to-use preparations see section 6.3.6.5 Nature and contents of container
● Bottles of low-density polyethylene (LD-PE),
contents: 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml
pack sizes: 20 x 50 ml, 10 x 100 ml, 20 x 100 ml, 10 x 250 ml, 20 x 250 ml, 10 x 500 ml, 10 x 1000 ml
● Polyethylene ampoules,
contents: 5 ml, 10 ml, 20 ml
pack sizes: 20 x 5 ml, 20 x 10 ml, 20 x 20 ml, 100 x 5 ml, 100 x 10 ml, 100 x 20 ml
● Polypropylene ampoules,
contents 10 ml, 20 ml
pack sizes: 20 x 10 ml, 20 x 20 ml, 50 x 10 ml, 50 x 20 ml, 100 x 10 ml, 100 x 20 ml
Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling
No special requirements for disposal.
Only to be used if solution is clear, colourless and the container and its closure are undamaged.
The containers are for single use only. After use discard container and any remaining contents.
Use the liquid immediately after opening of the container.
