Hyperhep B S/D: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

HyperHEP B® S/D may be used to prevent you from getting sick if you have been exposed to blood from a hepatitis B-positive patient, sexual contact and newborns infant of mothers with hepatitis B infection.

What it does:

HyperHEP B® S/D provides antibodies to help prevent or lessen the severity of hepatitis B infections.

When it should not be used:

You should not use HyperHEP B® S/D if you are allergic to this drug or to any ingredient in the formulation or component of the container.

You should not be given HyperHEP B® S/D if you have any bleeding disorder that would make it unsafe for you to be given an injection into the muscles.

See also SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

What the medicinal ingredient is:

The medicinal ingredient of HyperHEP B® S/D is human Hepatitis B Immune Globulin (at a concentration of ≥220 IU/mL).

What the nonmedicinal ingredients are:

HyperHEP B® S/D also contains the amino acid glycine (at a concentration of 0.21-0.32 M), which acts as a stabilizer.

What dosage forms it comes in:

HyperHEP B® S/D comes in 0.5 mL (neonatal) and 1mL syringes and 5 mL vials.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• HyperHEP B® S/D must be injected into muscles only. It should not be injected directly into blood vessels.
• HyperHEP B® S/D like other products made from human plasma, part of our blood, may contain viruses or other agents that can cause infection and illness. However, the processes used to make HyperHEP B® S/D are specifically designed with the ability to destroy or remove these agents if they are present. You should discuss the risks and benefits of this product with your healthcare provider.

BEFORE you use HyperHEP B® S/D talk to your doctor or pharmacist if:

• you are pregnant or breastfeeding

• you have any bleeding disorder
• you have had an allergic reaction to immune globulin or any of the other ingredients in the medicine

INTERACTIONS WITH THIS MEDICATION

HyperHEP B® S/D may interfere with some vaccines. However, measles and hepatitis B vaccinations do not interact with HyperHEP B® S/D.Talk with your healthcare professional if you will receive any type of vaccine within 3 months of HyperHEP B® S/D treatment.

See also ABOUT THIS MEDICATION: When it should not be used, and SIDE EFFECTS AND WHAT TO DO ABOUT THEM.

PROPER USE OF THIS MEDICATION

Usual dose

Your doctor will determine the amount of HyperHEP B® S/D that is right for you and when your shots should be given. An intramuscular or IM injection is a shot given into a muscle, usually in the buttocks. A doctor, nurse or other caregiver trained to give injections will give your treatment.

Overdose

Although there is no information on the effects of HyperHEP B® S/D overdose, experience with similar medicines suggests that the only effect would be pain and tenderness at the needle injection site.

Missed Dose

It is important that you receive HyperHEP B® S/D as instructed by your healthcare professional. If your doctor tells you that more than one treatment is required, you should consult him/her if a treatment appointment is missed.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Pain may occur where the injection is given. Talk with your doctor if the pain is severe.

You should talk with your healthcare professional if you experience rash or hives (swelling, redness, intense itching, and burning)., or if you develop swelling of the lips, other parts of the parts of the mouth and throat, eyelids, genitals, hands or feet.

Allergic reactions, although rare, have been reported following the injection of human immune globulin preparations. Talk with your doctor immediately if you experience any of these side effects:

• wheezing or trouble breathing
• chest tightness
• severe abdominal cramps
• severe vomiting
• severe diarrhea

This is not a complete list of side effects. For any unexpected effects while taking HyperHEP B® S/D, contact your doctor or pharmacist.

HOW TO STORE IT

HyperHEP B® S/D should be stored at 2-8°C (36-46°F). It should not be frozen or used past the expiration date.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Grifols Canada Ltd., at 1-866-482-5226.

Grifols Therapeutics Inc. (Manufacturer) 8368 US 70 Bus. Hwy West Clayton, NC 27520

Grifols Canada Ltd. (Importer and Distributor)

5060 Spectrum Way, Suite 405

Mississauga, Ontario

L4W 5N5

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