Details for: PANHEMATIN
Company: RECORDATI RARE DISEASES CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02478765 | PANHEMATIN | HEMIN | 268 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
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
PANHEMATIN is a hemin for injection prescription medication used to relieve repeated attacks of acute intermittent porphyria (AIP) related to the menstrual cycle in affected women, after initial carbohydrate therapy is known or suspected to be inadequate. PANHEMATIN should not be used for preventing attacks of porphyria.
If you have an AIP attack, your doctor will determine the best course of treatment. After 1-2 days of glucose therapy, your doctor may recommend you start PANHEMATIN. PANHEMATIN should only be used by doctors experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring practices are available.
What it does
The goal of treatment with PANHEMATIN is to reduce the production and build-up of certain chemicals in your body. This chemical build-up is what causes symptoms such as severe abdominal pain
When it should not be used
- you are allergic to this drug
What the medicinal ingredient is
Medicinal ingredients: hemin
What the non-medicinal ingredients are
Non-medicinal ingredients: sodium carbonate and sorbitol. The diluent contains sterile water for injection.
What dosage form it comes in
Powder for reconstitution for injection 268 mg/vial
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PANHEMATIN. Talk about any health conditions or problems you may have, including if you:
- you are pregnant or planning to become pregnant
- you are breastfeeding, unless clearly needed
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- When taking PANHEMATIN, do not take drugs such as estrogens (e.g., oral contraceptives), barbiturates (drugs that help with sleep and used to treat epilepsy) or steroids (body hormone-like drugs), because such drugs can trigger an attack or make an attack worse.
Proper use of this medication
PANHEMATIN is given through an IV needle into a large arm vein or a central line. Small arm veins should not be used since vein inflammation has been reported.
Usual Dose
- 0.8 to 3.1 mg/kg/day for 3 to 14 days based on the clinical signs. The standard dose in clinical practice is 2.3 to 3.1 mg/kg/day.
- Repeat dose in more severe cases no earlier than every 12 hours. Do not exceed 4.6 mg/kg in any 24 hour period.
Overdose
Side effects and what to do about them
These are not all the possible side effects you may feel when taking PANHEMATIN. If you experience any side effects not listed here, contact your healthcare professional.
Most common side effects are headache, fever, infusion site reactions, and vein inflammation.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Store PANHEMATIN at room temperature (20-25°C)
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.
More information
If you want more information about PANHEMATIN:
- Talk to your healthcare professional
- 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 http://www.recordatirarediseases.ca/, or by calling Recordati Rare Diseases Canada Inc. at 905-827-1300.
This leaflet was prepared by Recordati Rare Diseases Canada Inc.
Last Revised TBD