Language selection

Search

Details for: KAMRAB

Company: KAMADA LTD

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02482436KAMRABRABIES IMMUNOGLOBULIN (HUMAN)150 UNIT / MLSOLUTIONINTRAMUSCULAR
Search Reported Side Effects Report a Side Effect

Summary Reports

Regulatory Decision Summary

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.

If you think you have been administered too much KamRAB, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
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.

Serious side effects and what to do about them
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

Date modified: