Details for: HYPERHEP B S/D
Company: GRIFOLS THERAPEUTICS LLC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02230738 | HYPERHEP B S/D | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML | SOLUTION | INTRAMUSCULAR |
| 02379465 | HYPERHEP B S/D | HEPATITIS B IMMUNOGLOBULIN (HUMAN) | 220 UNIT / ML | SOLUTION | INTRAMUSCULAR |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 non-medicinal 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 form 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
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 side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
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.
This leaflet was prepared by:
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
Last revised: