Details for: KAMRAB
Company: KAMADA LTD
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02482436 | KAMRAB | RABIES IMMUNOGLOBULIN (HUMAN) | 150 UNIT / ML | SOLUTION | INTRAMUSCULAR |
Summary Reports
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
- KamRAB is used to treat rabies infection. It is a single dose treatment used along with a full course of rabies vaccine
What it does
KamRAB contains antibodies that inactivate the rabies virus. It is administered as soon as
possible after a person is bitten by an animal suspected of being infected with rabies and is
injected directly into and around the wound as a single dose.
Any person who might have been exposed to rabies and has never been vaccinated against
rabies should receive KamRAB as well as a series of rabies vaccinations. KamRAB provides
immediate protection against the rabies virus until the person to develop antibodies of his/ her
own against the rabies virus.
When it should not be used
What the medicinal ingredient is
Medicinal ingredients: Anti-rabies immunoglobulin (human antibodies to rabies)
What the non-medicinal ingredients are
Non-medicinal ingredients: glycine, water for injection and sodium hydroxide
What dosage form it comes in
Single-use vials containing 2 mL or 10 mL of ready-to-use solution with a potency of 150 IU/mL.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you recieve KamRAB. Talk about any health conditions or problems you may have, including if you:
- Have any bleeding disorders or take medication for bleeding disorders
- Have an inflammatory condition
- Are receiving high doses of other immunoglobulins.
- Have previously received vaccinations for rabies
- Have previously had allergic reactions after being injected with other immunoglobulins
- Have any immune deficiencies which cause you to be deficient in certain antibodies
- Are pregnant or breast feeding
Other warnings you should know about:
KamRAB is made from human plasma; therefore, the potential exists that KamRAB
administration may transmit infectious disease such as viruses, both known and unknown, and
other diseases such as the Creutzfeldt-Jakob disease (CJD) agent. The risk of getting an
infectious disease from KamRAB administration is very small and is minimized by screening
human plasma donors for prior exposure to certain viruses, testing donors for certain viral
infections and by designated viral inactivation and removal certain viruses during the
manufacturing of KamRAB; however, there is the possibility that KamRAB administration could
transmit infectious diseases.
KamRAB administration may interfere with other vaccines. It is important to avoid immunization
with measles vaccines within 4 months after KamRAB administration and avoid immunization
with other live vaccines for 3 months after KamRAB administration.
KamRAB should not be mixed with the rabies vaccine or injected in the same syringe with the
rabies vaccine.
KamRAB should not be administered into the same injection site on the body where rabies
vaccine was injected.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with KamRAB:
- Administration of other vaccines
Proper use of this medication
Treatment with KamRAB:
KamRAB should be administered by a healthcare professional provider only.
KamRAB is administered following suspected exposure to a rabid animal, at the time of the first
rabies vaccine dose.
If the bite wound is visible, KamRAB should be injected into and around the bite wound, and any
remaining product should be injected intramuscularly in the arm or the thigh.
If the bite would is not visible, or if injection at the bite wound is difficult, KamRAB should be
injected intramuscularly on a part of the body that is far away from the site of any rabies
vaccinations.
Usual Dose
The recommended dose of KamRAB is 20 IU/kg body weight.
Overdose
Overdose of KamRAB is unlikely. If it does happen, your doctor will treat any symptoms that follow.
Side effects and what to do about them
The most frequent side effects occurring with KamRAB included pain at the site of injection, headache, muscle pain, and upper respiratory tract infection. Less common side effects included joint pain, dizziness, fatigue, abdominal pain, blood in the urine, nausea, feeling faint, bruising, and sunburn.
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
RARE | |||
Serious allergic reactions, with symptoms such as swelling of the face and throat, difficulty breathing, and rash | ✔ | ✔ | |
fever, chills and dark urine | ✔ | ✔ |
These are not all the possible side effects you may feel when taking KamRAB. If you experience any side effects not listed here, contact your healthcare professional.
How to store
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Reporting Suspected Side Effects
For the general public: Should you experience a side effect following immunization, please
report it to your doctor, nurse, or pharmacist.
Should you require information related to the management of the side effect, please contact
your healthcare provider. The Public Health Agency of Canada, Health Canada and Valneva
Canada Inc. cannot provide medical advice.
For healthcare professionals: If a patient experiences a side effect following immunization,
please complete the Adverse Events Following Immunization (AEFI) Form appropriate for
your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to
your local Health Unit.
More information
If you want more information about KamRAB
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.valneva.ca, or by calling 1-855-356-0831
This leaflet was prepared by Kamada Ltd.
Last Revised 2018-11-07