PACKAGE LEAFLET VIALS

WATER FOR INJECTION PREPARATIONS MONICO

PHARMACOTHERAPEUTIC CATEGORY
Solvents and diluents, including cleansing solutions.
THERAPEUTIC INDICATIONS
Preparation of injectable formulations.
CONTRAINDICATIONS
Water for injection is a vehicle for various drugs; therefore, for contraindications, refer to the "Undesirable effects" section of the package leaflet of the drug to be administered.
PRECAUTIONS FOR USE
Use immediately after opening the container. The solution must be clear, colourless and free from visible particles. Any unused residue must not be reused.
Continuous administration may cause fluid overload, congestive state and decreased electrolyte concentrations; continuous administration without potassium supplementation may lead to hypokalaemia (decreased blood potassium concentration).
INTERACTIONS
Water for injection is a vehicle for various drugs; therefore, for interactions with other medicinal products, refer to the "Interactions" section of the package leaflet of the drug to be administered.
SPECIAL WARNINGS
Pregnancy and lactation
Water for injection is a vehicle for various drugs; therefore, for precautions to be taken during pregnancy and lactation, refer to the package leaflet of the drug to be administered.
Effects on ability to drive and use machines
Water for injection is a vehicle for various drugs; therefore, for effects on the ability to drive and use machines, refer to the package leaflet of the drug to be administered.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Use for solutions, dilutions or extemporaneous suspensions of injectable medicines or other sterile preparations.
Select the volume to be used according to the dilution requirements of the injectable preparation.
Water for injection is a vehicle for various drugs; therefore, for incompatibilities, refer to the package leaflet of the drug to be administered.
OVERDOSE
Water for injection is a vehicle for various drugs; therefore, for overdose, refer to the package leaflet of the drug to be administered.
UNDESIRABLE EFFECTS
Disorders of metabolism and nutrition
Continuous administration may cause fluid overload, congestive state and decreased electrolyte concentrations.
Water for injection is a vehicle for various drugs; therefore, for undesirable effects, refer to the package leaflet of the drug to be administered.
EXPIRY DATE AND STORAGE
Expiry date: see date on the packaging.
The expiry date refers to the product in its original unopened packaging, correctly stored.
Caution: do not use after this date.
For storage conditions after dilution with the drug to be administered, refer to the package leaflet of the drug to be administered.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
Sterile, pyrogen-free water for injection preparations.
When examined under optimal visibility conditions, it is clear, colourless and free from suspended particles.
Must not contain antimicrobial agents or other additives.
PHARMACEUTICAL FORM AND CONTENT
Solvent for parenteral use.
Glass vial of 2 – 5 – 10 – 20 ml.
MARKETING AUTHORISATION HOLDER
MONICO SPA, via Ponte di Pietra 7, VENEZIA/MESTRE.
MANUFACTURER
MONICO SPA, via Ponte di Pietra 7, VENEZIA/MESTRE.
04 January 2011.

INSTRUCTIONS FOR USE BOTTLES/BAGS

WATER FOR INJECTION PREPARATIONS MONICO

PHARMACOTHERAPEUTIC CATEGORY
Solvents and diluents, including cleansing solutions.

THERAPEUTIC INDICATIONS
Preparation of injectable formulations.

CONTRAINDICATIONS
Water for injection preparations is a vehicle for various drugs; therefore, for contraindications, refer to the "Contraindications" section of the package leaflet of the drug to be administered.

PRECAUTIONS FOR USE
Use immediately after opening the container. The solution must be clear, colourless, and free from visible particles. Any unused residue must not be retained. Continuous administration may cause fluid overload, congestive state, and decreased electrolyte concentrations; continuous administration without potassium supplementation may lead to hypokalaemia (reduction in blood potassium concentration).

INTERACTIONS
Water for injection preparations serves as a vehicle for various drugs; therefore, for interactions with other medicinal products, refer to the "Interactions" section of the package leaflet of the drug to be administered.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Water for injection preparations is a vehicle for various drugs; therefore, for precautions during pregnancy and breastfeeding, refer to the package leaflet of the drug to be administered.

Effects on ability to drive and use of machinery
Water for injection preparations is a vehicle for various drugs; therefore, for effects on the ability to drive and use machinery, refer to the package leaflet of the drug to be administered.

DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
Use for preparing solutions, dilutions, or extemporaneous suspensions of injectable medications or other sterile preparations.
Select the volume to be used based on the dilution requirements of the injectable preparation.
Water for injection preparations serves as a vehicle for various drugs; therefore, for incompatibilities, refer to the package leaflet of the drug to be administered.

OVERDOSE
Water for injection preparations serves as a vehicle for various drugs; therefore, for overdose information, refer to the package leaflet of the drug to be administered.

UNDESIRABLE EFFECTS
Disorders of metabolism and nutrition
Continuous administration may cause fluid overload, congestive state, and reduced electrolyte concentrations.
Water for injection preparations serves as a vehicle for various drugs; therefore, for adverse effects, refer to the package leaflet of the drug to be administered.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicinal product after the expiry date stated on the packaging.
For storage conditions after dilution with the drug to be administered, refer to the package leaflet of the drug to be administered.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicinal product out of the reach and sight of children.

COMPOSITION
Sterile, pyrogen-free water for injection preparations.
When examined under optimal visibility conditions, it is clear, colourless, and free from suspended particles.
It must not contain antimicrobial agents or other additives.

PHARMACEUTICAL FORM AND CONTENT
Solvent for parenteral use.
Type II glass vial containing 50 – 100 – 250 – 500 – 1000 ml of solution.
Polypropylene bag containing 50 – 100 – 250 – 500 – 1000 – 2000 – 3000 – 4000 – 5000 ml of solution.

MARKETING AUTHORISATION HOLDER
MONICO S.p.A.
Via Ponte di Pietra 7 – VENEZIA/MESTRE.

MANUFACTURER
MONICO S.p.A.
Via Ponte di Pietra 7 – VENEZIA/MESTRE.
22 August 2011.