GLATZI

Glatiramer Acetate (GA): 20mg/ml and 40mg/ml

(Sterile Prefilled Syringes)

This leaflet includes important information for you, therefore, read it carefully before taking GLATZI.

In case you need further information, please contact your doctor, pharmacist or Patient Support and Nursing Unit at Zistdaru Danesh Company (ZDD Co.)

This medication is prescribed for your current condition only, so you must avoid using it in similar conditions or recommending it to others.

As with all medication, Glatzi can cause adverse effects though all these may not be seen in one individual. In case you observe any of the side effects mentioned in this leaflet or any others, consult your doctor, pharmacist or healthcare centers.

In this leaflet you will learn:

1. What is Glatzi?
Glatzi Mechanism of Action
Glatzi Indications and Usage
Glatzi Dosage and Administration
Dosage Form, Ingredients and Packaging
Warnings and Precautions
How to Use Glatzi?
Adverse Effects
Use in Specific Populations
Medicine Overdose
Missed Dose
Glatzi Storage and Handling

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

Glatzi 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).

Indications and Usage
Glatzi is indicated for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS).

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

Dosage
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.

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, 12 alcohol pad and 1 package insert.

Warnings and Precautions
Cardiovascular:
There may be immediate reactions after Glatzi injection in some patients. These may include flushes, chest pain, palpitations, anxiety, dyspnea and/or rash.

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 Glatzi users and the medicine should be used with caution in patients with a history of anaphylactic shocks. In case of anaphylactic shock; the incidence rate is 1 in 1000, epinephrine or other therapies may be needed to recover patient condition.

Contraindications
A history of sensitivity to glatiramer acetate or mannitol.

In case you observe any problems including the following, make sure to inform your medical team: (your doctor, pharmacist or Patient Support and Nursing Unit at Zistdaru Danesh Company)

History of heart problems; some patients taking the product may experience chest pain
History of severe allergic reactions
Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Renal problems
Pregnancy or decision to become pregnant while taking the medicine
Nursing
Under 18 years of age
In case you take supplements, vitamins and herbal medicines while using Glatzi, inform your doctor of your medicine list.

Each Glatzi pre-filled syringe should be:

Used once only.
Administered by subcutaneous route only.

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 blew 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 ZDD Co. special nurse for Glatzi.

Step 3: Injection

Remove the syringe from its protective blister pack and put in on a flat, clean surface.
Clean the desired injection site on your body with an alcohol wipe (let the site air dry for one minute).
Pick up the syringe as you would a pencil and remove the needle shield.
Pinch about 5cm fold of skin between your thumb and index finger (as in the figure).


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.

 

 

 

 

 

 

To inject the medicine, hold the syringe steady and push down the plunger (this should take a few seconds only).
Pull the needle straight out.
Press a dry cotton ball on the injection site for a few seconds.
Dispose of the needle and the shield in a special plastic container.

What are the possible adverse effects of Glatzi?
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%)

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. Though there is no evidence of glomerular sedimentation of this medicine, the possibility of such side effect should be considered.

–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.


–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.


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

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 in less than 48 hours.

Storage and Handling
Store Glatzi in refrigerator (2˚-۸˚C) and do not freeze it. Glatzi is stable at room temperature (15-30˚C) for up to a month. It is, however, recommended to store Glatzi in refrigerator.

Remember: Glatzi is light sensitive. To this effect, protect it from light when not injecting.

Glatzi contains no preservatives. Avoid using the medicine if solution contains particles or is cloudy.

Each pre-filled syringe should be used for one injection only.

Keep the medicine out of reach and sight of children.

For more information about Glatzi, visit Zistdaru Danesh Co. website at www.zistdaru.ir

Patient Support and Nursing:

02142318100 & 09352203041-42

Zistdaru Danesh Co.

Tehran, Iran.This figure illustrates 

Edited: Oct.2017

Email: nursing@zistdaru.ir

گروه صنعتی پما