Package inserts

Labeling. Labeling, controUed by FDA regulations, includes not only the affixed labels, but also the package inserts that provide mote detailed information. Trade, generic, or common name, dose, number of dose units present, and name and address of manufacturer and distributor ate requited. For nonptescription products, adequate directions for use ate requited. Prescription products must beat the phrase, "Caution Federal law prohibits use without a prescription" on theit labels. 

Diphtheria and Tetanus Toxoids and Pertussis Waccine Mdsorbed, USP Package Insert, Coimaught Laboratodes, Surftuster, Pa., revised 1994. 

Cholera Vaccine USP Package Insert, Wyeth Laboratories, Marietta, Pa., 1994. 

Wording of the package insert according to the Standard Licence ... 

Some parenteral dragp are available as a crystal or a powder. Because these dru have a short life in liquid form, they are available in ampules or vials in dry form and must be made a liquid (reconstituted) before they are removed and administered. Some of these products have directions for reconstitution on the label or on the enclosed package insert. The manufacturer may give... 

PARENTERAL ADMINISTRATION. The nurse should read the manufacturer s package insert for each drug for instructions regarding reconstitution of powder for injection, storage of unused portions, life of the drug after it is reconstituted, methods of IV administration, and precautions to be taken when the drug is administered. 

Additional adverse reactions seen with administration of the aminoglycosides may include nausea, vomiting, anorexia, rash, and urticaria When these drugs are given, individual drug references, such as the package insert, should be consulted for more specific adverse reactions. 

PI LOCARPIN E OCULAR SYSTEM. If tlie pilocarpine ocular system is prescribed, the primary health care provider must evaluate the patient s ability to insert and remove tlie system. A package insert is provided with tlie system... 

When using urokinase to clear an occluded IV catheter, the nurse follows the manufacturer s instructions in the packaged insert. The nurse avoids using excessive pressure when the drug is injected into the catheter. Excessive force could rupture the catheter or expel the clot into the circulation. It is important to remember that if the catheter is occluded by substances other than blood fibrin clots, such as drug precipitates, urokinase is not effective. 

Patient package insert and instructions are available with the product. The primary health care provider should be notified if any of the following occurs abnormal or excessive bleeding, severe cramping, abnormal or odorous vaginal discharge, fever or flu-like symptoms, pain, genital lesions, or missed periods. 

Before insertion, provide the patient with the patient package insert. 

A patient package insert is available widi die drug. Read the information carefully. If tiiere are any questions about this information, discuss diem widi the primary health care provider. 

Use the applicator correcHy. Refer to Hie package insert for correct procedure The applicator is marked wiHi Hie correct dosage and accompanies the drug when purchased. 

Administered IM dosage varies with product. Sse package insert for specific dosages. 

Administered IM in single-dose vial and single-dose prefilled syringes, fee package insert for recommended dose. Children 1-12 years one dose 0.5 mL9C Adults 0.5 mL 9C two doses... 

Diphtheria and tetanus Diphtheria and Immunization against Sfee adverse reactions for See package inserts... 

The nurse must read thoroughly the package insert supplied with the drug before the drag is prepared and administered. The manufacturer s recommendations may include information such as storage of the drag, reconstitution procedures, stability of the drag after reconstitution, the rate of administration, and the technique of administration. 

Title V Labelling and package insert Tide V Labelling and package leaflet... 

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