DESCRIPTION

REFINEX (Botulinum Toxin type A for Therapy) is a sterile, lyophilized form of purified botulinum toxin type A produced from the crude toxin Iff the culture of the Hall strain of Clostridium botulinum grown in a medium containing trypticase and yeast extract A series of purifying procedure were taken toTbrm a crystalline complex. After re-dissolved and dialyzed the crystalline toxin, an accurate amount of the sterile filtered (0.2microns) toxin were added to a solution containing gelatin-dextran-sucrose, then lyophilized.

Each vial of REFINES contains 100 or 50 or 35 units LDof Clostridium botulinum toxin type A, 0,5 mg human albumin, 30 mg dextran dflti 30 mg mannitol. Dilute with non-pyrogen and sterile normal saline according to different needs before using. The while loose product turns to be colorless or yellowish transparent solution after the reconstitution.

One unit (U) of REFINEX corresponds to 1 LDso of Botulinum Toxin Type A while being intraperitoneally injected into mouse.

Reeuld block neuromuscular conduction by inhibiting the release of acetylcholine and therefore causes local muscle flaccid paralysis.

INDICATIONS

REFINEX is indicated for

1. Treatment of blepharospasm, hemifacial spasm in adults some type of strabismus, especially for acute paralytic

2. Hyperhidrosis

3. Cosmetic use

USAGE AND DOSAGE

1. Position for injection

1) For blepharospasm injection shouldbe taken intramuscular at several points of upper and lower lids, i.e., taking 4 to 5 points of injection into orbicularis couli of medical and lateral or lateral oanthus temporal.

2) For hemifacial spasm: besides the points mentioned above, three other points on middle, lower face and cheek should be given intramuscular. May be given at the points of two sides of eyebrow, upper-lip or the lower jaw according to the diseases.

3) For strabismus: is injected using a coaxial electrode needle with etectromyogrhphio guidance or amplifier under topicak anesthesia of 0,5 .% Decarine.

4) For hyper hidrosis is injected in multiple points in the affected areas.

5) For cosmetic use is infiltrated into the muscles.

2. Dosage

1) For bW barospasm and hemifagal spasm: the injection could be given following above instructions. Themitial does of each point is 2.5 U/0.05ml or 2.5U/0.1 ml If the initial treatment is considered insufficient one week later. A supplementary injection may be given. Double does of 5U/0.1 ml could be given toftorudescent patients. But the limitation of total does of 55U for one injection and 200 U for one month should not be exceeded.

2) vertical and horizontal muscle strabismus for less than 20 prism diopters, the initial dose into each musole is 1.23-2.5U: for horizontal strabismus of 20-40 prism diopters, the initial does into each muscle is 2.5U; for horizontal strabismus of 40-50 prism dioters, the Initial dose into each muscle is 2.5U and can be increased (to 5.0U each time) depending on the response: for persistent VI nerve psralysis lasted for more than one mounth, 1.25-2.5

The injecting volume into each muscle should not axceed 0.1 ml.

To patients, having insufficient response, supplementary injection could be given. To recrudescent patients, the dose can be repeated or increased irregularly. But for each muscle the maximum dose should be less than 5U/inj.

3. The Dilution of "R"

The dilution of "R" with sterile normal saline should be done carefully on the basis of real needs. Following U/vial

50 100

U/O.lml the volume of diluent(ml)

10.0 0,5 1.0

5.0 1.0 2r0

2.5 2.0 4.0

1.25 , 4.0 8.0

Shaking the vial gently after adding sterile normal saline to the complete dissolving. The reconstituted "R" should be used at once or stored in a refrigerator at 2 to 8 ℃ to be used within 4 hours. The container and syringe used with the drag as well as the residual "R" solution should be disposed after sterilization.

SIDE EFFECTS

1. Temporary ptosis of the eyelid, drawback of the lower eyelid, reduced blinking, eyelid close incompletely, weakness of fecial muscles, etc. may occur to a few patients who received "R" therapy for blepharospasm and hemifacial spasm. However, all the symptoms will disappear without any therapy within 3 to 8 weeks.

2. Temporary and different degree of ptosis of the eyelid, vertical deviation and rarely mydriasis, which related to the diffusion of the toxin to muscles adjacent, may occur to some patients who received "R" therapy for strabismus. symptoms will disappear without any therapy within a few weeks.

CONRAINDICATIONS

"R" is contraindicated in individuals with anaphylactic, constitution and known hupersensitivify to preparation

PRECAUTIONS

1. "R" must be kept, issued and registered by special person and administered only to patients with abofre indications. Physicians administering especially during treatment of strabismus, have to be trained prior, know extraocular and facial muscles anatomy and be good at electomyographic amplifier technique.

2. injection procedure should to takhn later to patients who have fever, acute infections diseases and carefully to fgje patients with heart, liyer, lung diseases, active tubercqlosis, blood diseases, pregnant women and children below 12 years of age.

3. During treatment of blepharospasm & facial spasm, a few people may be temporarily ptosis, lower-eyelid fallback, winking decrease, imperfect closure of palpebral fissure,and decrease of fecial -muscle dynamic etc. All side effects will be recovered naturally within 3-8 weeks.

4. During treatment parts of patients may be temporarily & different-degree ptosis, vertical strabismus and most individual mydriasis, which is related to reason that Botulinum is diffused to neighbored muscles. It will be recovered naturally within several weeks.

HOW SUPPLIED: lOOU/vial, 50 U/Vial, 35 U/Vial

SHELF LIFE: 3 years from date of lyophilization.

STORAGE: Store at a temperatute of-5 to -20 ℃

Official site www.refinex-jp.com