B-12 Compliance Injection

 Antiseptic

• Store at room temperature: 15º-30ºC (59º-86ºF)
• Avoid excessive heat

Sensitivity to cobalt and/or Vitamin B12 is a contraindication.

General Precautions

Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result.

Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

Information for Patients

Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration.

A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Patients following such a diet, should be advised to take oral vitamin B12 regularly. The need for vitamin B12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

Laboratory Tests

During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary.

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow.

Patients with pernicious anemia have about 3 times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.

Drug/Laboratory Test Interactions

Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and vitamin B12 diagnostic blood assays.

Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B12.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

Pregnancy: Teratogenic Effects. Pregnancy Category C:

Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

Nursing Mothers

Vitamin B12 is known to be excreted in human milk. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation.

Pediatric Use

Intake in children should be in the amount (0.5 to 3 mcg daily) recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.

Cyanocobalamin Injection, USP 1000 mcg/mL

1 mL vials are multiple dose vials, packaged 25 vials per tray.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

PROTECT THE PRODUCT FROM LIGHT.

IN0031
Rev. 4/14
MG #10565

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

NDC 49836-527-01
Rx-Only

B-12 Compliance
Injection Kit

Kit Contains:
1 Cyanocobalamin Injection, USP 1,000 mcg/mL (1 mL)
1 Sterile Isopropyl Alcohol 70% Prep Pad
1 Pair Nitrile Powder Free Sterile Gloves (Size 7.5)
1 Sterile Towel Drape
1 Sterile Adhesive Bandage

1 Dose

Needles and Syringes Not included

DISTRIBUTED BY:

SCHMIGS
HAUPPAUGE, NY 11788

MANUFACTURED BY:

Rx
Pharma
Pack
HAUPPAUGE, NY 11788

Questions/Comments 1-844-632-7898

ORG 09/2015

Directions for use: See enclosed inserts

Kit Contents:

CyanocobalaminInjection, USP 1,000 mcg/mL*
(Manufactured by American Regent)
Each mL contains: benzyl alcohol 1.5%; sodium chloride 9mg;
Water for Injection q.s. pH adjusted with hydrochloric acid or sodium hydroxide if necessary. Contains no more than 57 mcg/L of aluminum.

Sterile Alcohol Prep Pad (Dynarex)*
Gamma-Sterilized* Isopropyl Alcohol, 70% by Volume

Nitrile Powder Free Sterile Gloves (Dynarex) - Size 7.5*

Sterile Towel Drape (Dynarex)*

Sterile Adhesive Bandage (Dynarex)*

*Internal package components remain sterile as long as items are unopened and undamaged

WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

PROTECT FROM LIGHT

STORE AT CONTROLLED ROOM TEMPERATURE 20º-25ºC (68º-77ºF) [SEE USP CONTROLLED ROOM TEMPERATURE]

B-12 Compliance Injection Kit

Cyanocobalamin is a man-made form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.

How to use B-12 Compliance Kit

If you are using this medication at home, learn all preparation and usage instructions from your health care professional.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

This medication is given by injection into a muscle or under the skin as directed by your doctor.

Dosage is based on your medical condition and response to treatment. Injections may be given daily when you first start treatment. Certain medical conditions (e.g., pernicious anemia) may require you to continue receiving injections every month.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

Applies to cyanocobalamin: intramuscular solution

Other dosage forms:

• nasal gel/jelly, nasal spray

Along with its needed effects, cyanocobalamin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking cyanocobalamin:

• Abdominal or stomach pain
• bleeding from the gums or nose
• blue lips and fingernails
• chest pain
• cough
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with swallowing
• dilated neck veins
• dizziness
• extreme fatigue
• eye pain
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased sweating
• irregular breathing
• irregular heartbeat
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• ringing in the ears
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest
• unusual tiredness or weakness
• weight gain

Some side effects of cyanocobalamin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• skin rash with a general disease