MACUGEN 0.3 mg.

What is MACUGEN and what it is used
Macugen is an ophthalmic drug, which means that it is only used to treat the eye.
Macugen is used to treat the wet form of age-related macular degeneration (AMD). This disease leads to loss of vision due to damage to the central part of the retina (called the macula) at the back of the eye. The macula enables the eye to provide the fine central vision that is needed for activities such as driving, reading fine print and other similar tasks.
In the wet form of AMD disease blood vessels grow under the retina and macula. These new blood vessels can lead to bleed and leak fluid, causing bulging or lifting of the macula, causing changes or loss of central vision. These conditions may be rapid and severe vision loss. Macugen works by inhibiting the growth of these abnormal blood vessels and by stemming the bleeding and leakage. Macugen is used to treat all types of diseased blood vessels growth in adult patients with AMD.

2. What you should know before using MACUGEN
Do not use Macugen
If you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients of this medicine (listed in section 6);
If you have an infection in or around the eye.
Warnings and Precautions
Macugen is given as an injection into the eye. Rarely following treatment with Macugen (in the next two weeks) may occur infection or bleeding in the eye. It is important that these conditions be recognized and treated as soon as possible. Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision. If for some reason you can not contact your doctor, you should immediately contact another doctor.
In some patients, immediately after the injection, the pressure inside the treated eye may increase for a short period of time. Your doctor may monitor this after each injection.

children
Macugen should not be used in children and adolescents under 18 years.

Other medicines and Macugen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, lactation and fertility
There is no experience of using Macugen in pregnant women; therefore the potential risks are unknown. If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before treatment with Macugen.
It is not known whether Macugen is excreted in human milk. Not recommended Macugen is during lactation. Ask your doctor or pharmacist for advice before treatment with Macugen.

Driving and using machines
You may experience temporary blurred vision after administration of Macugen. If you are affected, you should not drive or operate machines until this effect.

Macugen contains
This product contains less than 1 mmol sodium (23 mg) per dose of 90 microliters, i.e. contains virtually no sodium.

3. How to use MACUGEN
All injections of Macugen will be administered by your doctor.
Macugen is administered as a single injection (0,3 mg) into your eye at intervals of 6 weeks (ie 9 times per year). The injection is given into the vitreous of the eye, which is a jelly-like substance inside the eye. Your doctor will monitor your condition and recommend how long you should be treated with Macugen.
Before the treatment, your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully. Please tell your doctor if you are known to be allergic to any substance. Please follow these instructions carefully.
Before the injection, your doctor will give you some local anesthetic (local anesthesia). This will reduce or prevent any pain you might have with the injection, which is a simple and rapid procedure.
Macugen is supplied in pre-filled syringe that contains more than the recommended dose of 0,3 mg. Your doctor will follow the given below instructions to remove the excess amount of the drug before injecting the correct dose of 0,3 mg.

CAUTION: Pre-filled syringe contains amount of excess product.
1. Before you remove the air and excess drug
The syringe should be checked for bubbles with the needle pointing up. If there are bubbles, the syringe should be gently tapped with a finger until the bubbles rise to the top.
Slowly push the plunger to eliminate all bubbles and remove excess drug so that the top of the third rib of the plunger to align with printed black line strength. The plunger should be pulled back.
2. After removing the air and excess drug
In this situation, the quantity remaining in the syringe should be injected.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.

If you miss a scheduled appointment
Call the hospital or clinic as soon as possible to reschedule the visit.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some rare cases after injection have been reported serious allergic reactions. Please seek emergency medical attention if soon after the injection experience something of the following: sudden shortness of breath or wheezing, swelling of the mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting or diarrhea.
Rarely in the next two weeks after treatment with Macugen can occur infection inside the eye. Symptoms may receive are described in section 2 of this leaflet ("Take special care with Macugen"). Please read Section 2. It tells you what you should do if you get these symptoms.

The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 patient in 10);
Common (affects 1 to 10 patients in 100);
Uncommon (affects 1 to 10 patients in 1000);
rare (affects 1 to 10 users in 10,000);
very rare (affects less than 1 in 10,000).
Very common side effects are probably caused by the injection procedure rather than the drug, and include: eye irritation, eye pain, increased pressure inside the eye, small marks on the eye surface (punctate keratitis), small particles or spots in your vision (floaters or opacities in the vitreous).

Other common eye side effects possibly caused by the drug or by the injection procedure include: blurred vision, visual disturbance, eye discomfort, decreased vision, increased sensitivity to light, appearance of flashing lights, bleeding around the eye (periorbital bleeding), bloodshot eye (conjunctival haemorrhage), disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment), clouding of the lens (cataract), disorder of the surface of the eye (cornea), swelling or inflammation eyelid swelling on the inside of the eyelid or the outer surface of the eye (conjunctiva), eye inflammation, oozing, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, eye pruritus, redness of the eye or expansion of apple.

Other common non-visual, side effects possibly caused by the drug or by the injection procedure include: headache or nasal discharge.

Uncommon eye side effects possibly caused by drug or injection procedure include: inflammation of the eye or on the outer surface of the eye, bleeding in the eye, or the inner part of the eye (vitreous), eye strain, inflammation of the central part of the surface of the eye (keratitis), small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye, itching of the eyelids, disturbance of eye responses to light (broken Pupillary light reflex), small erosion on the central part of the surface of the eye (cornea), drooping eyelid, scar inside the eye (retinal scar), small lump on your eyelid due to inflammation (halatsion), decreased pressure inside the eye, injection site reaction administration bubbles at the application site, displacement or tear the layer at the back of the eye (retina), disorder of the pupil, the colored part of the eye (iris), retinal artery occlusion, eversion of the eyelid, eye movement disorder, eyelid irritation, blood in the eye, a change the color of the eye, deposit eye, inflammation of the eye (iritis), optic nerve cupping, deformation of the pupil, occlusion of the vein at the back of the eye, discharge of inner jelly of the eye.

Uncommon non-visual, side effects possibly caused by the drug or by the injection procedure include: nightmares, depression, deafness, vertigo, palpitations, high blood pressure, dilatation of the aorta (the main blood vessel), inflammation of the upper respiratory tract, vomiting , indigestion, irritation and inflammation of the skin, changes in hair color, rash, pruritus, night sweats, back pain, fatigue, chills, increased sensitivity, chest pain, sudden fever, generalized aches and pains, elevation of liver enzymes , bruise.

If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.

5. How to store MACUGEN
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C).
Do not freeze.
Macugen should be discarded if kept at room temperature for more than two weeks.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Macugen
The active substance is pegaptanib. Each pre-filled syringe with a single dose deliver a dose of 0,3 mg pegaptanib.
The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

Macugen looks like and contents of the pack
Macugen injection comes in a package with a single dose.
Each pack contains a pouch in a carton containing 1ml pre-filled syringe, Type 1 glass, sealed with an elastomeric piston and pre-assembled stem piston fixed with plastic clip. The syringe is pre-mounted polycarbonate plastic luer lock adapter and the tip is sealed with an elastomeric tip cap.
The pack is supplied without a needle. The pre-filled syringe is used only once and then discarded.