biopharmaceuticals Zistdaru Danesh 

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GLATZI

General Description

Read all Glatzi leaflet carefully before you start using this medicine because it contains important information for you. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or Medical Support Team of Zistdaru Danesh Co. This medicine has been prescribed for you only. Do not pass it on to others, even if their signs of illness are the same as yours. This medicine could be prescribed by doctor for medical condition not mentioned in this leaflet. If you get any side effects, talk to your doctor, pharmacist or nurse.

Important Things To Know

On this page you read

1- What is Glatzi?

Glatzi contains the acetate salt of glatiramer that is a mixture of synthetic polypeptides.


2- Mechanism of Action

Little chains of proteins present in Glatzi are the same as proteins making myelin and it seems that by regulating the immune system function, they positively affect and control MS (Multiple Sclerosis).


3- Indications and Usage

Glatzi is indicated forthe treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome (CIS). relapsing-remitting disease (RRMS). and active secondary progressive disease (SPMS). in adults.


4- Dosage & Administration

Glatzi is administered as a subcutaneous injection. It should not be used by intravenous (IV) route.

Glatzi 20 consists of 20 mg/ml glatiramer acetate and is administered as a subcutaneous injection daily.

Glatzi 40 consists of 40 mg/ml glatiramer acetate and is administered as a subcutaneous injection three (3) times a week with at least 48 hours apart (for instance, on Saturday, Monday and Wednesday).

Remember: Your doctor makes the right dosage for your use. Never change your dose or dosing schedule without informing your doctor. Never stop taking the medicine on your own or without talking to your doctor.


5- Dosage Form, Ingredients and Packaging

Glatzi is a sterile solution for injection in pre-filled syringes. Each pre-filled syringe consists of glatiramer acetate, mannitol and sterile water for injection. Glatzi is available in packs of six (6) pre-filled glass syringes, 6 alcohol pads and 1 package insert.


6- Warnings and Precautions

  • Immune System

May or may not occur with the immediate post-injection reaction after Glatzi use; described as a transient pain usually resolving in a few minutes.

  • Immune System

Due to glatiramer acetate effect on immune system function, changes in immune system response to the medicine are possible. To this effect anaphylactic reactions are seen in Glatiramer users and the medicine should be used with caution in patients with a history of anaphylactic shocks.

  • Post-Injection Systemic Reaction Systemic reactions

Post-injection systemic reactions may occur immediately (within seconds to minutes of injection; majority of reactions observed within 1 hour). The symptoms including anxiety, chest pain. constriction of the throat dyspnea, flushing, palpitations, tachycardia and urticaria are usually self-limited and transient. These symptoms generally occur several months after initiation of treatment. In case of severe symptoms, refer the patients to the medical centers.

  • Hepatic Injury

Cases of hepatic injury, some severe, including liver failure and hepatitis with jaundice, have been reported with Glatiramer Acetate. If signs or symptoms of liver dysfunction occur, consider discontinuation of Glatiramer Acetate.


7- Contraindications

A history of sensitivity to glatiramer acetate or mannitoL


8- Concomitant use of Galatzi with other drugs


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9- How to use Glatzi

Before injecting Glatzi, make sure to fully read the instructions. Initial injection should be supervised by experienced and expert nurse and or your doctor. Patients should learn aseptic injection procedure and be evaluated periodically. Furthermore, they should be warned against the danger of reusing the needles and syringes and their safe disposal.

Instructions for use:

Step 1: gather the materials

  • Put all of the items you need on a clean, flat surface in a well-lit place.
  • Glatzi pre-filled syringe (remove one blister pack for your single dose from the refrigerator)
  • water and soap or alcohol pad (wipe)
  • dry cotton ball

After removing the medicine carton from the refrigerator. let the medicine stand for at least 20 minutes to allow the solution to warm up to room temperature. Before injecting the medicine. wash and dry your hands. Avoid touching your hair or skin after washing to prevent infection.

Avoid expelling the air bubbles from the syringe.

Step 2: choose injection site. You should choose the injection site beforehand and inject in those sites regularly. Seven (7) suitable injection areas on your body are as follows:

–              Arms: back of right and  left upper arms

–              Thigh: front of right and  left thigh (about 5 cm above the knee and 5 cm  below the groin)

–              Hips: right and left area of upper hip

-Abdomen: within 5 cm of navel area

This figure illustrates the areas suitable for injection.  Glatzi 40 users should choose one area for injection during the week. Each of the areas are divided to smaller areas and injection should be done in one of these smaller areas. Choose the new area that has not been used recently for injecting the medicine.

Remember not to inject in the area of skin that is:

  • Painful
  • Inflamed and/or mass
  • Discolored
  • Deformed

Repeated injection in the same area can worsen the condition. Self-injecting the medicine may be hard for you (for example, back of the arm).To learn how to self-inject in those areas, you can get help from special nurse for Glatzi.

Step 3: Injection

  1. Remove the syringe from its protective blister pack and put

it on a flat clean surface.

  1. Clean the desired injection site on your body with an

alcohol wipe (let the site air dry for one minute).

  1. Pick up the syringe as you hold a pencil and remove the needle shield.
  2. Pinch about 5cm fold of skin between your thumb and index finger (as in the figure).
  3. Insert the needle at a 90 degree angle, resting your hand against your body. When the needle is all in, release the fold of skin.
  4. To inject the medicine, hold the syringe steady and push down the plunger (this should take a few seconds only).
  5. Pull the needle straight out.
  6. Press a dry cotton ball on the injection site for a few seconds.
  7. Dispose of the needle and the shield in a special plastic container (resistant to opening).

11- possible adverse effects More common adverse effects (more than%10) 

-Cardiovascular: vasodilation (%20), chest pain (% 13)

-Central nervous system: pain (%20), anxiety(% 13)

-Skin: rash (% 19), sweating (% 15)

-Gastrointestinal: vomiting (% 15)

-Injection-site reactions: inflammation (%49), blush (%43), pain (%40). pruritus (%27), mass (%27)

-Musculoskeletal: weakness (%22), back pain (% 12)

-Respiratory:dyspnea (%14)

-Others: infection (%30), flu syndrome (% 14), sweating (% 15)

Common adverse effects (% 1 to% 10)

Cardiovascular. edema (%8), palpitation (%7), tachycardia (%5). syncope (%3), hypertension (% 1)

CNS: fever (%6), migraine (%4), shivering (%3). agitation (%2). speech disorders (%2). abnormal dreams(% 1), emotional instability(% 1)

-Skin: sweating (%8), pruritus (%5), erythema (%4). rash (%3). skin nodules (%2), eczema (% 1), rash (% 1)

-Endocrine and metabolic: amenorrhea (%1), sexual incompetency (%1), dysmenorrhea (% 1)

-Gastrointestinal: vomiting (%7), gastroenteritis (%6), weight gain (%3), dysphagia (%2), dental cavity(% 1)

-Urogenital: urinary frequency (%5), vaginal candidiasis (%4)

-Injection site: bleeding (%9), hypersensitivity (%4), fibrosis (%2). lipo-atrophy (%2). abscess(%1)

-Neuro-musculoskeletal: neck pain (%8), tremor (%4)

-Ophthalmic: diplopia (%3), abnormal vision (% 1)

-Respiratory: rhinitis (%7), bronchitis (%6), cough (%6)

-Others: lymphadenopathy (%7), allergic reactions (%3)


11- Use in Specific Populations  

  • Elderly (over 65 years of age):

The use of the medicine in the elderly has not been studied.

  • Pediatric:

The safety and efficacy of the medicine in pediatric patients under 18 years of age have not been established.

  • Patients with kidney disorders:

Patients with kidney disorders must be regularly monitored for kidney function while under therapy with the medicine.


12- Pregnancy

There are no particular adverse effects reported in animal studies. However, there is little information regarding glatiramer acetate use in pregnancy. As animal studies cannot indicate adverse effects of medicines on humans, it is recommended to use the medicine only if the advantages outweigh the disadvantages. This decision is your doctor’s responsibility. (Pregnancy Category B)


13- Nursing

There is little information about excretion of glatiramer acetate in mother milk. There seems to be no particular adverse effects on the newborn. Accordingly and given the available basic information, taking glatiramer acetate while nursing seems to be fairly safe with the permission of your doctor.


14- Medicine Overdose

In case of Glatzi overdose-even if no adverse effects are observed, contact hospital emergency service or poison control center soonest possible.


15- Missed Dose

In case you forget taking your injection. immediately take it as soon as you remember. In case there is less than 48 hours to your next dose, do not take the missed dose and take your injection according to the schedule. Never take two subsequent injections of Glatzi 40 in less than 48 hours.


16- Storage and Handling

– Store the medicine between ·2c and “8C in the refrigerator, protect from light and do not freeze.

-This solution must be clear, colorless to pale yellow and free of particles, otherwise, do not use it.

-For single use only. Discard unused portion according to the local rules.

-Keep out of the sight and reach of children.

-Prescription Only Medicine.

-See package insert for more information.


D.Nurse-Patient Helpline Team

You can contact Drugs Expert Consultation Center at 0935 220 3041-4 to get answers to your inquiries and also get to know nursing support centers in your city.Expert Consultation Center is always ready to answer the questions of our valued customers.