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Product name Product type Date released
Expand Vpriv PI 09 Jul 2020
 
Expand Vpriv CMI 09 Jul 2020
 
VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body. The build-up of this material causes the signs and symptoms found in Gaucher disease.
VPRIV contains a substance called velaglucerase alfa ghu which is used to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
VPRIV should not be used in children under the age of 2 years.
This medicine is not addictive.
This medicine is not expected to affect your ability to drive or use machines.
This medicine is only available on a doctor's prescription.
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Expand Vyvanse PI 09 Jul 2020
 
Expand Rixubis PI 09 Jul 2020
 
Expand Rixubis CMI 09 Jul 2020
 
RIXUBIS, nonacog gamma (rch) is a coagulation factor IX product that is produced by recombinant technology. Mammalian cells, which have the DNA for human coagulation factor IX put in them, are grown in large amounts in cell culture laboratories. These cells make recombinant human factor IX, which is released into cell culture media and then very highly purified. The recombinant factor IX does not contain any human blood, preservatives, or added animal or human components.
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Expand Vyvanse CMI 09 Jul 2020
 
VYVANSE is a central nervous system stimulant used to treat:
Attention Deficit Hyperactivity Disorder (ADHD). VYVANSE increases attention and decreases impulsiveness and hyperactivity in patients with ADHD.
Binge Eating Disorder (BED). VYVANSE may help to reduce the number of binge eating days in patients with moderate to severe BED.
VYVANSE is not for weight loss.
It is not to be taken by children with ADHD under 6 years of age or in patients with BED under 18 years of age. VYVANSE should be used as part of a comprehensive treatment program which usually includes psychological, educational and social therapy. For BED, VYVANSE should only be prescribed by a psychiatrist as part of a comprehensive treatment program.
The main ingredient in VYVANSE is lisdexamfetamine dimesilate which itself is not active (such medicines are sometimes called a pro-drug). After VYVANSE is taken, it is converted in the blood to dexamphetamine which is the active medicine.
Your doctor may have prescribed VYVANSE for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you/your child.
VYVANSE can be abused or lead to dependence. VYVANSE is a controlled substance and should be handled responsibly. It is illegal for anyone prescribed VYVANSE to sell or give it to other people.
Keep VYVANSE in a safe place to prevent misuse and abuse. Also, return any unused capsules to your pharmacy to safeguard against them being taken by anyone else (see Disposal section).
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Expand Obizur PI 09 Jul 2020
 
Expand Obizur CMI 09 Jul 2020
 
OBIZUR is a recombinant DNA derived, anti-haemophilic factor used for the treatment of bleeding episodes in adults with acquired haemophilia A.
It is possible that your doctor may give you OBIZUR for another reason.
Ask your doctor if you have any questions about why you are being given OBIZUR. 

How does OBIZUR work

Under normal physiological conditions, factor VIII is essential for blood clotting and therefore the control of bleeding.
Acquired haemophilia is a bleeding disorder that is not present at birth but develops suddenly at some point in life due to an abnormality in the immune system. In patients with acquired haemophilia A, factor VIII is not working properly because the patient has developed antibodies which neutralise this blood clotting factor, and this prevents blood from clotting.
OBIZUR belongs to a group of medicines called anti-haemophilic agents.
OBIZUR is a man-made clotting factor. It is similar to the naturally occurring protein in the body.
OBIZUR works by temporarily replacing the inhibited human clotting factor VIII, so that blood can clot normally.
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Expand Replagal CMI 09 Jul 2020
 
REPLAGAL is used to treat Fabry Disease. REPLAGAL is given as enzyme replacement therapy when the level of enzyme in the body is lower than normal as in Fabry Disease.
Agalsidase alfa is a form of the human enzyme α-galactosidase A. It is produced by switching on the gene for α-galactosidase A in cells. The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion.
Before REPLAGAL is given to you, it is mixed with 0.9% sodium chloride intravenous solution (saline). The prepared solution will be infused into a vein in your arm over a 40 minute period.
Your doctor may have prescribed REPLAGAL for another use. Ask your doctor if you have any questions about why REPLAGAL has been prescribed for you.
REPLAGAL is not addictive.
REPLAGAL is not expected to affect your ability to drive a car or operate machinery.
REPLAGAL is only available on a doctor's prescription.
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Expand Replagal PI 09 Jul 2020
 
Expand Kiovig PI 09 Jul 2020
 
Expand Kiovig CMI 09 Jul 2020
 
KIOVIG is used for:
Treatment of patients who do not have sufficient antibodies (replacement therapy):
Primary immunodeficiency disorders
Disease or medical treatment that leads to a lack of antibody production and frequent infection (secondary hypogammaglobulinaemia).
Treatment of patients with certain inflammatory disorders (immunomodulation):
Idiopathic thrombocytopenic purpura (ITP, a disease where patients do not have enough blood platelets), who are at high risk of bleeding or prior to surgery to correct the platelet count.
Guillain Barré syndrome (a disease with multiple inflammations of the nervous system of the whole body)
Kawasaki disease (a disease which results in multiple inflammations of several organs)
Multifocal motor neuropathy
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Expand Revestive PI 09 Jul 2020
 
Expand Revestive CMI 09 Jul 2020
 
Do not use if you have ever had an allergic reaction to REVESTIVE or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use REVESTIVE? in the full CMI.
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Expand Mezavant PI 09 Jul 2020
 
Expand Mezavant CMI 09 Jul 2020
 
The name of your medicine is MEZAVANT 1.2g, gastro-resistant, prolonged release tablets. It contains the active ingredient mesalazine (also called 5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug for the treatment of ulcerative colitis.
Ulcerative colitis is a disease of the large intestine (the colon and rectum), where the lining of the intestine becomes red and swollen (inflamed) and ulcers develop. This can cause symptoms of frequent and bloody stools together with stomach cramps.
When MEZAVANT is taken for a flare up of ulcerative colitis, it acts through the entire colon and rectum to treat the inflammation and reduce symptoms. MEZAVANT can also be taken to help prevent re-occurrence of ulcerative colitis.
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Expand Ajovy CMI 08 Jul 2020
 
AJOVY is used to prevent migraine in adults.
Do not give this medicine to a child or adolescent under the age of 18 years.
AJOVY is not recommended for children and adolescents below the age of 18 years because it has not been studied in this age group.

How it works

AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and binds to a specific target in the body.
Fremanezumab binds to the calcitonin gene-related peptide (CGRP) thereby blocking it from binding to the CGRP receptor. CGRP plays an important role in migraine.
AJOVY has been shown to reduce the frequency of migraine attacks and days with headache. This medicine also decreases important migraine-associated symptoms like nausea, vomiting, sensitivity to light and sound.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or operate machinery.
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Expand Firazyr CMI 08 Jul 2020
 
FIRAZYR is used for treating the symptoms of an acute attack of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older.
During attacks of HAE, levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea.

How it works

FIRAZYR contains the active ingredient icatibant. It blocks the activity of bradykinin and therefore, helps reduce the symptoms of an HAE attack.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is not addictive.
This medicine is available only with a doctor's prescription.
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Expand Hyqvia PI 08 Jul 2020
 
Expand Firazyr PI 08 Jul 2020