HEPARIN SOD AND

9% Sodium Chloride Injection should not be given orally. 2 Recommended Dose and Dosage Adjustment  Heparin administration procedures vary and are adjusted to the requirements of the individual patient by the attending physician, but a proper heparinization schedule MUST BE initiated before and maintained throughout dialysis to prevent clotting and subsequent blood path obstruction.

 Dosage is dependent upon the age, weight and clinical conditions of the patient, in addition to the procedure being employed. 9% Sodium Chloride Injection. Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

9% Sodium Chloride Injection. It is recommended that the intravenous administration apparatus be replaced at least every 24 hours. All injections in VIAFLEX Plus plastic containers are intended for administration using sterile equipment.

Note:

Read dialyzer direction sheets and follow manufacturer’s directions for use.

DIRECTION FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER 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. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

To Open Tear overwrap downside at slit and remove solution container. Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. 9% SODIUM CHLORIDE INJECTION Template Date: September 2020 Page 6 of 24 sterility of the product.

After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found discard solution as sterility may be impaired. Do not add supplementary medication. Preparation for Administration 1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set.

5 Post-market adverse reactions)). Hematocrit testing and tests for occult blood in stools should be performed periodically during heparin administration. Heparin sodium should be used with extreme care in patients suffering from conditions in which there is increased danger of hemorrhage, for example: Cardiovascular Subacute bacterial endocarditis, arteriosclerosis, severe hypertension Surgical During and immediately following (a) spinal tap or spinal anaesthesia or (b) major surgery, especially involving the brain, spinal chord or eye.

9% SODIUM CHLORIDE INJECTION Template Date: September 2020 Page 10 of 24 purpuras and thrombocytopenia. Gastrointestinal Conditions associated with inaccessible ulcerative lesions and continuous tube drainage of stomach or small intestine.

Gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy (see

), except when this is due to disseminated intravascular coagulation.  with a known hypersensitivity to heparin sodium or porcine derivatives or to any ingredient in the formulation or component of the container (for a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).

 with a history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITT).  with severe thrombocytopenia.  when suitable blood coagulation tests cannot be performed at appropriate intervals (for full-dose heparin sodium therapy).

There is usually no need to monitor the effect of low- dose heparin in patients with normal coagulation parameters. 9% Sodium Chloride Injection should not be given orally. 2 Recommended Dose and Dosage Adjustment  Heparin administration procedures vary and are adjusted to the requirements of the individual patient by the attending physician, but a proper heparinization schedule MUST BE initiated before and maintained throughout dialysis to prevent clotting and subsequent blood path obstruction.

 Dosage is dependent upon the age, weight and clinical conditions of the patient, in addition to the procedure being employed. 9% Sodium Chloride Injection. Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions, where possible.

9% Sodium Chloride Injection. It is recommended that the intravenous administration apparatus be replaced at least every 24 hours. All injections in VIAFLEX Plus plastic containers are intended for administration using sterile equipment.

Note:

Read dialyzer direction sheets and follow manufacturer’s directions for use.

DIRECTION FOR USE OF VIAFLEX PLUS PLASTIC CONTAINER 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. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

To Open Tear overwrap downside at slit and remove solution container. Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. 9% SODIUM CHLORIDE INJECTION Template Date: September 2020 Page 6 of 24 sterility of the product.

After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found discard solution as sterility may be impaired. Do not add supplementary medication. Preparation for Administration 1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. 5 OVERDOSAGE Symptoms Bleeding is the primary sign of heparin sodium overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding.

Easy bruising or petechial formations may precede frank bleeding. Treatment Neutralization of heparin effect. If reversal of heparinization is desired or in the case of overdosage, protamine sulfate (1% solution) by slow infusion is utilized.

No more than 50 mg should be given very slowly in a 10 minute period. 0 mg of heparin). Heparins derived from various animal sources require different amounts of protamine sulfate for neutralization. This fact is of most importance during procedures of regional heparinization, including dialysis.

Decreasing amounts of protamine are required as time from the last heparin injection increases. 5 mg of protamine is sufficient to neutralize each 100 USP units of heparin. Ideally, the dose required to neutralise the action of heparin should be guided by blood coagulation tests or calculated from a protamine neutralisation test.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.

For additional information the labeling of protamine sulfate products should be consulted. Blood or plasma transfusions may be necessary; these dilute but do not neutralize heparin. For management of a suspected drug overdose, contact your regional poison control centre.

9% SODIUM CHLORIDE INJECTION Template Date: September 2020 Page 7 of 24 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products health professionals should recognise the importance of recording both the brand […]

Heparin sodium is contraindicated in patients:  with uncontrollable bleeding (see 7 WARNINGS AND PRECAUTIONS), except when this is due to disseminated intravascular coagulation.  with a known hypersensitivity to heparin sodium or porcine derivatives or to any ingredient in the formulation or component of the container (for a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).

 with a history of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia with thrombosis (HITT).  with severe thrombocytopenia.  when suitable blood coagulation tests cannot be performed at appropriate intervals (for full-dose heparin sodium therapy).

There is usually no need to monitor the effect of low- dose heparin in patients with normal coagulation parameters.