Water for Injections solvent for parenteral use

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Water for injection
Available from:
CSL Behring GmbH
ATC code:
V07AB
INN (International Name):
Water for injection
Dosage:
.
Pharmaceutical form:
Solvent for parenteral use
Therapeutic area:
Solvents and diluting agents, incl. irrigating solutions
Authorization number:
PA0800/011/001
Authorization date:
2019-08-02

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Package leaflet: Information for the user

Water for Injections

solvent for parenteral use

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Water for Injections is and what it is used for

What you need to know before you use Water for Injections

How to use Water for Injections

Possible side effects

How to store Water for Injections

Contents of the pack and other information

1.

What Water for Injections is and what it is used for

Sterilised Water for Injections is used to dissolve and dilute other medicines that require mixing

with water before they can be given as an injection or an infusion (a drip) into your veins, muscles

or other tissues in the body.

2.

What you need to know before you use Water for Injections

The following sections contain information that you and your doctor should consider before you

use Water for Injections.

Do not use Water for Injections

as an injection or infusion on its own

Water for Injections must only be used to dissolve or dilute necessary drugs.

You should read the Patient Information Leaflet of your medicine or medicines that are being

mixed with Water for Injections. This will tell you whether or not you can receive the solution.

Warnings and precautions

Water for Injections should not be used on its own.

Before you use Water for Injections:

it should always be mixed with one or more medicines

Before you are given medicines mixed with Water for Injections your doctor will check that:

the medicines are stable in Water for Injections

the medicines will not interact with each other

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Other medicines and Water for Injections

Please refer to the Patient Information Leaflet of your medicine that is being mixed with Water for

Injections. Those medicinal products known to be incompatible with water for injections must not

be used.

Pregnancy, breast-feeding, and fertility

Please refer to the Patient Information Leaflet of your medicine that is being mixed with Water for

Injections.

Driving and using machines

Water for Injections has no influence on the ability to drive and use machines. Any effects on

your ability to drive or use machines will depend on which medicines you are using mixed with

Water for Injections.

3. How to use Water for Injections

Always use this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Your doctor will decide how much you need and when and how it is to be given. This will depend

on which medicine or medicines you need to take with Water for Injections.

Use only if the Water for Injections is clear, colourless, without visible particles and if the

container is undamaged.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible Side Effects

Please refer to the Patient Information Leaflet of your medicine that is being mixed with Water for

Injections.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly to:

HPRA Pharmacovigilance Section

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 676 4971

Fax: +353 1 676 2517

Website: www.hpra.ie

Email: medsafety@hpra.ie

By reporting side effects, you can help provide more information of the safety of this medicine.

5. How to store Water for Injections

Do not use Water for Injections after the expiry date, which is stated on the label and carton.

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Keep this medicine out of the sight and reach of children.

Do not freeze.

Your doctor will inform you how to dispose of unused product or waste material.

After opening, the product must be used immediately.

This medicinal product does not require any special storage conditions.

For in use shelf life, after reconstitution of the medicinal product, check the Package Information

Leaflet of the medicinal product which was reconstituted with Water for Injections.

6. Contents of the pack and other information

What Water for Injections contains

The only ingredient is sterile Water for Injections in one vial.

What Water for Injections looks like and contents of the pack

Water for Injections is a clear and colourless liquid.

Pack sizes (1 vial per pack)

Container details

2 mL, 2.5 mL, 3 mL, 4 mL, 5 mL

6 mL, 10 mL

15 mL

20 mL

In 6 mL injection vial clear glass with

chlorobutyl or bromobutyl rubber stopper

and aluminium crimp-cap with

polypropylene plastic disc.

For the filling size:

2 mL (overage 0.3 mL): Blue/ purple,

2.5 mL (overage 0.3 mL): Blue/ blue,

2.5 mL (overage 0.4 mL): Blue/ lime,

2.5 mL (overage 0.6 mL): Blue/ light blue,

3 mL (overage 0.4 ml): Blue/ orange,

4 mL (overage 0.3 mL): Blue/ grey,

5 mL (overage 0.4 mL): Blue/ green

In 10 mL injection vial clear glass with

chlorobutyl or bromobutyl

rubber stopper

and aluminium crimp-cap with

polypropylene plastic disc.

For the filling size:

6 mL (overage 0.1 mL): Blue/ lime,

10 mL (overage 0.5 mL): Blue/

blue.

In 15 mL injection vial clear glass with

chlorobutyl or bromobutyl rubber stopper

and aluminium crimp-cap with

polypropylene plastic disc.

For the filling size:

15 mL (overage 0.5 mL): Blue/ blue.

In 25 mL injection vial clear glass with

chlorobutyl or bromobutyl rubber stopper

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40 mL, 50 mL

and aluminium crimp-cap with

polypropylene plastic disc.

For the filling size:

20 mL (overage 1 mL): Blue/ blue.

In 50 mL injection vial clear glass with

chlorobutyl or bromobutyl rubber stopper

and aluminium crimp-cap with

polypropylene plastic disc.

For the filling size:

40 mL (overage 1.5 mL): Blue/ blue

50 mL (overage 2 mL): Blue/ blue.

Not all sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

CSL Behring GmbH

Tel: +49 69 30517254

This leaflet was last revised in 03/2020

Health Products Regulatory Authority

28 August 2020

CRN009PTP

Page 1 of 4

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Water for Injections solvent for parenteral use

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 vial contains 2, 2.5, 3, 4, 5, 6, 10, 15, 20, 40 or 50 mL Water for Injections

3 PHARMACEUTICAL FORM

Solvent for parenteral use

Clear, colourless liquid

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

For use as a solvent for reconstitution of suitable medicinal products for parenteral use

4.2 Posology and method of administration

Dosage and method of administration depend on the instructions given for the medicinal product to be dissolved or diluted.

4.3 Contraindications

Do not administer Water for Injections on its own

4.4 Special warnings and precautions for use

Water for Injections is hypotonic and it should not be administered alone

4.5 Interaction with other medicinal products and other forms of interactions

None

4.6 Fertility, pregnancy and lactation

None

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

None

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: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517;

website: www.hpra.ie; Email: medsafety@hpra.ie

Health Products Regulatory Authority

28 August 2020

CRN009PTP

Page 2 of 4

4.9 Overdose

None

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Solvent and diluting agent

ATC code: V07AB

Pharmacodynamics: 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

For possible interactions and incompatibilities check Summary of Product Characteristics and Package Information Leaflet of

the medicinal product which is intended to be reconstituted with Water for Injections.

Those medicinal products known to be incompatible with Water for Injections must not be used.

6.3 Shelf life

2.5, 3, 4, 5, 6, 10, 15, 20, 40, 50 mL: 5 years

2 mL: 30 months

After opening, the product must be used immediately.

For in use shelf life, after reconstitution of the medicinal product, check Summary of Product Characteristics and Package

Information Leaflet of the medicinal product which was reconstituted with Water for Injections.

6.4 Special precautions for storage

Do not freeze.

This medicinal product does not require any special storage conditions.

For storage conditions after first opening and reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Pack sizes (1 vial per pack)

Container details

2 mL, 2.5 mL, 3 mL, 4 mL, 5 mL

In 6 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and

aluminium crimp-cap with polypropylene plastic disc.

For the filling size:

2 mL (overage 0.3 mL): Blue/ purple,

2.5 mL (overage 0.3 mL): Blue/ blue,

Health Products Regulatory Authority

28 August 2020

CRN009PTP

Page 3 of 4

6 mL, 10 mL

15 mL

20 mL

40 mL, 50 mL

Not all pack sizes may be marketed.

2.5 mL (overage 0.4 mL): Blue/ lime,

2.5 mL (overage 0.6 mL): Blue/ light blue,

3 mL (overage 0.4 ml): Blue/ orange,

4 mL (overage 0.3 mL): Blue/ grey,

5 mL (overage 0.4 mL): Blue/ green

In 10 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and

aluminium crimp-cap with polypropylene plastic disc. For the filling size:

6 mL (overage 0.1 ml): Blue/ lime,

10 mL (overage 0.5 ml): Blue/ blue.

In 15 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and

aluminium crimp-cap with polypropylene plastic disc. For the filling size:

15 mL (overage 0.5 ml): Blue/ blue.

In 25 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and

aluminium crimp-cap with polypropylene plastic disc. For the filling size:

20 mL (overage 1 ml): Blue/ blue.

In 50 mL injection vial clear glass with chlorobutyl or bromobutyl rubber stopper and

aluminium crimp-cap with polypropylene plastic disc. For the filling size:

40 mL (overage 1.5 ml): Blue/ blue

50 mL (overage 2 ml): Blue/ blue.

6.6 Special precautions for disposal and other handling

- Discard after single use.

- Use only if the Water for Injections is clear, colourless, without visible particles and if the container is undamaged.

- Reconstitution and withdrawal must be carried out under aseptic conditions.

- Any unused solution should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

8 MARKETING AUTHORISATION NUMBER

PA0800/011/001

Health Products Regulatory Authority

28 August 2020

CRN009PTP

Page 4 of 4

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 2

August 2019

10 DATE OF REVISION OF THE TEXT

August 2020

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