Adverse Reactions

5% DEXTROSE INJECTION
Dosage Form
Isotonic injectable solution in flexible (PVC) containers with an
osmolarity of 278 mosm/L.
Composition
Anhydrous glucose
5g
Water for injection qs 100ml
Indications
-Source of water and calories: 100g of glucose yield 400 kilocalories
- hypoglycemic situations
Contraindications
Excess body water volume
Diabetic coma with excessively high blood sugar
Warnings and Precautions
I.V glucose solutions can cause fluid or solute overload resulting in
dilution of serum electrolyte concentrations, overhydration, congested
states or pulmonary edema.
Glucose injections should not be administered through the same
infusion equipment, simultaneously, before or after an administration of
blood, because of possibility of pseudo-agglutination.
This solution should be administered with great care to patients with
diabetes mellitus or renal insufficiency.
Fluid balance, electrolyte concentrations and acid - base balance
should be monitored during prolonged parenteral therapy or whenever
the patients condition warrants such evaluation.
Hyperglycemia and glycosuria may be due to the rate of administration
or metabolic insufficiency. To minimize these conditions, slow the
infusion rate, monitor blood and urine glucose and if necessary,
administer insulin. When concentrated dextrose infusion is abruptly
withdrawn, administer 5% or 10% dextrose to avoid rebound
hypoglycemia.
Administer so that extravasation does not occur. If thrombosis occurs
during administration, stop injection and correct.
The administration of intravenous injections can cause fluid and/or
solute overloading resulting in dilution of serum electrolyte
concentrations, over-hydration, congested states, or pulmonary edema.
The risk of dilution is inversely proportional to the electrolyte
concentrations of the injections. The risk of solute overload and
resultant congestive conditions with peripheral and/or pulmonary
edema is directly proportional to the electrolyte concentration
administered.
Excessive administration of potassium free solutions may result in
significant hypokalemia. Add potassium to dextrose solutions and
administer to fasting patients with good renal function, especially those
on digitalis therapy.
Vitamin B complex deficiency may occur with glucose administration.
Caution should be exercised when administering parenteral fluids to
patients receiving corticosteroids or corticotropin, especially those
containing sodium ions.

Febrile response; infection at the site of injection; tissue necrosis;

venous thrombosis or phlebitis extending from the site of injection;
extravasation; hypervolemia; dehydration; mental confusion or
unconsciousness. These may occur as a result of the solution or
administration technique. If an adverse reaction does occur discontinue
the infusion, evaluate the patient and institute appropriate therapeutic
countermeasures and save the remainder of the fluid for examination if
deemed necessary.
Dosage and administration
Dispensing without a doctors prescription is prohibited.
Do not administer unless solution is clear and seal is intact.
All injections in plastic containers are intended for intravenous
administration using sterile equipment. It is recommended that
intravenous administration apparatus be changed at least once every
24 hours.
Additives may be incompatible see updated literature.
If additives are introduced to the solution use an aseptic technique and
mix thoroughly and carefully.
Do not store solutions containing additives.
Dosage depends on patients age, weight, food intake and clinical
condition.
Directions for use
Warning: 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 administration of the fluid from the
secondary container is completed.
To open
Do not remove units from overwrap until ready for use. Use all units
promptly when pouch is opened.
The overwrap is a moisture barrier. The inner bag maintains the sterility
of the product.
Tear pouch at slit and remove the inner bag. If leaks are found, discard
the solution as sterility may be compromised. If supplemental
medication is desired, follow directions below before preparing for
administration.
Preparation of administration
1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at the bottom of
container.
3. Attach administration set. Refer to complete directions
accompanying set.
To add medication before solution administration
Warning: Additives may be incompatible.
1. Prepare injection site.
2. Using syringe with 19-22 gauge needle, puncture medication port
and inject.
3. Mix solution and medication thoroughly. For high-density
medication such as potassium chloride, squeeze ports while they
are upright and mix thoroughly.
To add medication during solution administration
1. Close clamp on set.
2. Prepare medication site.
3. Using syringe with 19-22 gauge needle, puncture resealable
medication port and inject.
4. Remove container from I.V pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in an
upright position.
6. Mix solution and medication thoroughly.
7. Return container to in use position and continue administration

Pregnancy: Category C

Presentations

Safety for use in pregnancy has not been established. Use only when
clearly needed and when the potential benefits outweigh the potential
hazard to the fetus.
Lactation: Exercise caution when administering dextrose to a nursing
woman.
Children: Use with caution in infants of diabetic mothers, except as may
be indicated in hypoglycemic neonates.

Flexible PVC containers 50 ml

Flexible PVC containers 100 ml
Flexible PVC containers 150 ml
Flexible PVC containers 250ml
Flexible PVC containers 500 ml
Flexible PVC containers 1000 ml
Manufacturer
Cure Medical
Manufacturing & Marketing Ltd.
5 Beit Harishonim st.
Emek Hefer Industrial Park
P.O.Box 12086
Israel 38800