Copaxone I Multiple Sclerosis
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`Multiple Sclerosis
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`AllAboutMS
`Posted by: Thixia I Aprilll, 2008
`
`Copaxone
`
`Brand Name
`
`Glatiramer Acetate (Subcutaneous Route)
`
`Common Name
`
`Copaxone
`
`Description
`
`Glatiramer acetate is used in the treatment of the relapsing-remitting form of
`multiple sclerosis (MS). This medicine will not cure MS, but may extend the time
`between relapses.
`
`This medicine is available only with your doctor's prescription.
`
`This product is available in the following dosage forms:
`
`Pre-filled syringes.
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` EXHIBIT NO. 1062 Page 1
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`How does this medication work? What will it do for me?
`
`Glatiramer belongs to a group of medications known as immunomodulators.
`Immunomodulators modify the way our body's defense system works. Glatiramer
`is used to treat the relapsing-remitting form of multiple sclerosis (MS). MS is a
`disease that affects the way the nerves in our body work. It is an autoimmune
`disease (the immune system attacks the body), and cannot be spread from person
`to person.
`
`In MS, damage occurs to the myelin sheath, a protective layer that wraps around
`a nerve, like insulation around electrical wiring. Normally, this sheath allows
`electrical messages to be sent down the nerve quickly and efficiently. If this
`insulation is injured, electrical signals in the central nervous system will not be
`sent properly. For unknown reasons, in MS, the immune system sees the myelin
`as foreign and attacks it.
`
`Glatiramer is thought to help treat multiple sclerosis by altering the immune
`system in such a way that its harmful effects on the myelin sheath are reduced. It
`does not cure MS, but it may increase the time between relapses of the disease.
`
`Your doctor may have suggested this medication for conditions other than the
`ones listed in these drug information articles. If you have not discussed this with
`your doctor or are not sure why you are taking this medication, speak to your
`doctor. Do not stop taking this medication without consulting your doctor.
`
`Do not give this medication to anyone else, even if they have the same symptoms
`as you do. It can be harmful for people to take this medication if their doctor has
`not prescribed it.
`
`Before Using
`
`https :// scamparoo. word press .com/2008/04111/ms-therapies-copaxone/
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` EXHIBIT NO. 1062 Page 2
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`Copaxone I Multiple Sclerosis
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`In deciding to use a medicine, the risks of taking the medicine must be weighed
`against the good it will do. This is a decision you and your doctor will make. For
`this medicine, the following should be considered:
`
`Allergies
`
`Tell your doctor if you have ever had any unusual or allergic reaction to this
`medicine or any other medicines. Also tell your health care professional if you
`have any other types of allergies, such as to foods, dyes, preservatives, or
`animals. For non-prescription products, read the label or package ingredients
`carefully.
`
`How should I use this medication?
`
`The recommended dose of glatiramer is 20 mg injected under the skin once a day.
`Glatiramer is available as an injection only. It comes in vials and pre-filled
`syringes.
`
`There are special directions enclosed in the package with the injection. Read these
`directions carefully before using the medication and follow them closely. If you fail
`to follow the instructions closely, you may accidentally contaminate the medication
`or needle and give yourself an infection, or you may damage the equipment or
`lose the medication.
`
`Many things can affect the dose of a medication that a person needs, such as body
`weight, other medical conditions, and other medications. If your doctor has
`recommended a dose different from the ones listed here, do not change the way
`that you are taking the medication without consulting your doctor.
`
`It is important that this medication be taken exactly as prescribed by your doctor.
`If you miss a dose, take it as soon as yo'u remember. If you do not remember until
`the following· day, skip the missed dose and continue with your regular dosing
`schedule. Do not take a double dose to make up for a missed one.
`
`Store the vials and prefilled syringes in the fridge and protect them from light. The
`vials contain a powder form of the medication, and come with a separate vial of
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` EXHIBIT NO. 1062 Page 3
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`Copaxone I Multiple Sclerosis
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`sterile water to mix with the powder to form the solution for injection. Store the
`sterile water vials at room temperature. The vials may also be stored at room
`temperature for up to 2 weeks, and the prefilled syringes at room temperature for
`up to one week. Each prefilled syringe is for single use only.
`
`Keep this medication out of the reach of children.
`
`What form(s) does this medication come in?
`
`Each prefilled syringe contains a sterile solution equivalent with the glatiramer
`acetate reconstituted solution i.e., 20 mg/ml glatiramer acetate and mannitol
`40 mg in Sterile Water for Injection.
`
`Some medications may have other generic brands available. Always ask your
`doctor or pharmacist about the safety of switching between brands of the same
`medication.
`Who should NOT take this medication?
`
`Glatiramer should not be taken by anyone who is allergic to any of the ingredients
`of the medication.
`What side effects are possible with this medication?
`
`Many medications can cause side effects. A side effect is an unwanted response to
`a medication when it is taken in normal doses. Side effects can be mild or severe,
`temporary or permanent. The side effects listed below are not experienced by
`everyone who takes this medication. If you are concerned about side effects,
`discuss the risks and benefits of this medication with your doctor.
`
`The following side effects have been reported by at least 1% of people taking this
`medication. Many of these side effects can be managed, and some may go away
`on their own over time.
`
`Contact your doctor if you experience these side effects and they are severe or
`bothersome. Your pharmacist may be able to advise you on managing side effects.
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` EXHIBIT NO. 1062 Page 4
`2/5/2015
`https://scamparoo.wordpress.com/2008/04/11/ms-therapies-copaxone/
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`The most common side effects of glatiramer occur at the site of injection and may
`include:
`
`redness
`
`pain
`
`swelling
`
`itching
`
`a lump
`
`Some people have a rare reaction that starts immediately after the injection and
`consists of flushing, chest tightness with racing or pounding heartbeat, anxiety,
`and difficulty breathing. The symptoms of this reaction usually last about 15
`minutes and go away without further problems. Nevertheless, if you experience
`any dizziness, hives and itching, sweating, chest pain, or difficulty breathing, you
`should contact a doctor right away.
`
`The following side effects may go away as your body becomes used to the
`medicine; check with your doctor if they continue or become bothersome.
`
`More common:
`
`increased sweating
`
`nausea
`
`trembling
`
`unusual tiredness or weakness
`
`vomiting
`
`Less common:
`
`runny nose
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` EXHIBIT NO. 1062 Page 5
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`2/5/2015
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`weight gain
`
`Although most of the side effects listed below don't happen very often, they could
`lead to serious problems if you do not seek medical attention.
`
`Check with your doctor as soon as possible if any of the following side effects
`occur:
`
`More common:
`
`anxiety
`
`bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the place
`of injection
`
`chest pain
`
`excessive muscle tone
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`flushing
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`irregular or pounding heartbeat
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`joint pain
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`neck pain
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`swelling or puffiness of face
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`swollen lymph glands
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`troubled breathing
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`vaginal yeast infection
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`Less common:
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`agitation
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`bloating or swelling
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`chills
`
`confusion
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` EXHIBIT NO. 1062 Page 6
`https :/I scamparoo. word press .com/2008/04111 /ms-therapies-copaxone/
`2/5/2015
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`Page 7 of 11
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`fainting
`
`fever
`
`infections
`
`migraine
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`muscle aches
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`pain
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`purple spots under the skin
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`skin rash
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`small lumps under the skin
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`spasm of throat
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`strong urge to urinate
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`swelling of fingers, arms, feet, or legs
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`tightness in chest or wheezing
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`Rare:
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`back pain
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`blood in urine
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`continuous uncontrolled back-and-forth or rolling eye movements
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`decreased sexual ability
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`diarrhea
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`ear pain
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`fast breathing
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`fast or racing heartbeat
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`high blood pressure
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` EXHIBIT NO. 1062 Page 7
`https :/I scamparoo. wordpress.com/2008/04111 /ms-therapies-copaxone/
`2/5/2015
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`irritation of mouth and tongue (thrush)
`
`loss of appetite
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`menstrual pain or changes
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`sensation of motion, usually whirling, either of oneself or of one's surroundings
`
`speech problems
`
`vision problems
`
`Some people may experience side effects other than those listed. Check with your
`doctor if you notice any symptom that worries you while you are taking this
`medication.
`
`Are there any other precautions or warnings for this medication?
`
`Before you begin using a medication, be sure to inform your doctor of any medical
`conditions or allergies you may have, any medications you are taking, whether
`you are pregnant or breast-feeding, and any other significant facts about your
`health. These factors may affect how you should use this medication.
`
`Reduced kidney function: Glatiramer has not been studied for use by people with
`reduced kidney function.
`
`Vaccination: Glatiramer can modify the immune response and could interfere with
`useful immune function. People taking this medication should be cautious when
`receiving a vaccination.
`
`Immunosuppression (weak immune system): Glatiramer can modify the immune
`response and could interfere with useful immune function. People with a
`suppressed or reduced immune system should use caution when taking this
`medication.
`
`Pregnancy
`
` EXHIBIT NO. 1062 Page 8
`2/5/2015
`https://scamparoo.wordpress.com/2008/04/11/ms-therapies-copaxone/
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` AMNEAL
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`Copaxone I Multiple Sclerosis
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`About these ads
`
`Pregnancy
`Category
`
`Explanation
`
`Animal studies have revealed no evidence of harm to the fetus,
`however, there are no adequate studies in pregnant women OR
`animal studies have shown an adverse effect, but adequate
`studies in pregnant women have failed to demonstrate a risk to
`the fetus.
`
`All
`Trimesters
`
`B
`
`Breastfeeding
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`There are no adequate studies in women for determining infant risk when using
`this medication during breastfeeding. Weigh the potential benefits against the
`potential risks before taking this medication while breastfeeding.
`
`Children and adolescents:
`
`The safety and effectiveness of using this medication have not been established
`for children and adolescents under 18 years old.
`
`Studies on this medicine have been done only in adult patients, and there is no
`specific information comparing use of glatiramer acetate in children with use in
`other age groups.
`
`Geriatric
`
`Many medicines have not been studied specifically in older people. Therefore, it
`may not be known whether they work exactly the same way they do in younger
`adults or if they cause different side effects or problems in older people. There is
`no specific information comparing the use of glatiramer acetate in the elderly with
`use in other age groups.
`
` EXHIBIT NO. 1062 Page 9
`2/5/2015
`https ://scamparoo. word press .com/2008/04/11/ms-therapies-copaxone/
`
` AMNEAL
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`Copaxone I Multiple Sclerosis
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`Page 10 ofll
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`About these ads
`
`Posted in Copaxone I Tags: Copaxone, glatiramer acetate, immune sytem, medication, MS,
`multiple sclerosis, relapses
`
`Responses
`
`I did feel embarrased before but I need to get rid of it, and I did. I feel much confident now.
`
`By: Common Yeast Infection Symptoms on October 29,2009
`at 1:40am
`
`Categories
`
`o Bonnie
`o Children's MS
`o Complimentary Alternatives for MS
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`0
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` EXHIBIT NO. 1062 Page 10
`2/5/2015
`https ://scamparoo. wordpress .com/2008/04/11/ms-therapies-copaxone/
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`Copaxone I Multiple Sclerosis
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`Page 11 of 11
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