Reconstitution of intravenous medications, diluting intravenous medications, moistening of dressings.

Posology

The dosage administered will be dictated by the nature of the additive used. The administration rate will be dependent upon the dose regimen of the prescribed drug.

Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

Method of administration

The solution is for dilution and delivery of the therapeutic additives. The directions for use related to the added medicinal product will dictate the appropriate volumes as well as the administration route

Water for Injections should not be administered alone. The contraindications related to the added medicinal product should be considered.

 

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

Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute.

When Water for Injections is used as diluent of hypertonic solutions, appropriate dilution should be applied to bring the solution close to isotonicity.

Haemolysis may occur following infusion of Sterile Water for Injections. Haemoglobin induced renal failure has been reported following haemolysis.

When administering large volumes, the ionic balance should be regularly monitored.

The large volume presentations (500 and 1000ml) are for use as a bulk source of diluent in pharmacy compounding. They are not for direct intravenous administration

No interaction studies have been performed. The possible clinical interactions between the different medicinal products to be dissolved should be considered.

The risks during use in pregnancy and in lactating women are determined by the nature of the added medicinal products

Not available.

The following adverse reactions have been reported in post-marketing experience. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data.

 

System Organ Class (SOC)	MedDRA Preferred Term	Frequency
Blood and lymphatic system disorders	- haemolysis	Not known

 

The nature of the additive will determine the likelihood of any other undesirable effects.

Reporting of suspected adverse reactions

The National Pharmacovigilance and Drug Safety Centre (NPC)

§  Fax: +966-11-205-7662

§  Call NPC at: +966-11-2038222, Ext.: 2317-2356-2353-2354-2334-2340.

§  Reporting hotline: 19999

§  E-mail:npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

Haemolysis may occur following over-infusion of hypotonic solutions using sterile water for injections as diluent (see 4.4 Warnings and Precautions).

The signs and symptoms of overdose will also be related to the nature of the medicinal product being added. In the event of accidental overdose, the treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the medicinal product administered.

Pharmacotherapeutic group: Solvents and Diluting Agents.

ATC code: VO7AB.

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacodynamics will depend on the nature of the drug added.

Water for Injections being only the vehicle for the administration of the added medicinal product, the pharmacokinetics will depend on the nature of the drug added.

Water for Injections being only the vehicle for the administration of the added medicinal product, the preclinical safety data for the solutions in use will depend on the nature of the drug added.

NA

Additives may be incompatible. Those additives known to be incompatible should not be used. Before adding drugs, verify:

- They are soluble and stable in water at the pH of Water for Injections.

- They are compatible with each other.

Shelf life as packaged: 5 years from the manufacturing date. The expiry date refers to the last day of the month. In-use shelf life: Additives. From a microbiological point of view, the diluted product must be used immediately unless dilution has taken place in controlled and validated aseptic conditions. If not used immediately, in-use storage times and conditions are the responsibility of the user

·      Keep in a safe place, out of the reach and sight of children.

·      Store below 25º C.

Bottle size: 500 ml × 10 Bottles

Sterile, pyrogen free.

 

Polyethylene granules:

White colored, round to oblong shaped granules, which are used for the production of containers for intravenous solutions.

Discard after single use.

Discard any unused portion.

Do not reconnect partially used bottle.

Use only if the solution is clear without visible particles and container undamaged. In case an infusion set has been inserted, administer immediately.

Thorough and careful aseptic mixing of any additive is mandatory.

Make the infusion isotonic prior to parenteral administration.

 

Additives may be introduced before administration or during administration through the resealable medication port.

Solutions containing additives should be used immediately after preparation unless preparation has taken place in controlled and validated aseptic conditions.

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

To open

If leaks are found, discard solution, as sterility may be impaired.

Preparation for administration after rendering isotonic

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Use an aseptic method to set up the infusion.

4. Attach administration set. Refer to complete directions accompanying set.

Warning: Additives may be incompatible

To add medicinal products before administration

1. Disinfect medication site.

2. Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.

3. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix.

To add medicinal products during administration

1. Close clamp on the set.

2. Disinfect medication site;

3. Using syringe with 19 gauge (1.10 mm) to 22 gauge (0.70 mm) needle, puncture resealable medication port and inject.

4. Remove container from IV pole and/or turn to an upright position.

5. Evacuate both ports by tapping gently while the container is in an upright position.

6. Mix solution and medication thoroughly.

7. Return container to in use position, re-open the clamp and continue administration.