Osiris

* Sores in the mouth, when applied to the skin as a gel.

* Eye surgery and corneal transplant, when injected by an eye surgeon.

Osteoarthritis, when injected into the joint by a healthcare provider. Despite being approved by the FDA for treatment of osteoarthritis by injection, results vary. Some people report a moderate improvement in joint stiffness and pain decrease with Hyaluronic Acid (Osiris) treatment, but this is not always the case. Whether Hyaluronic Acid (Osiris) might delay or lessen progressive joint damage with long-term use is unknown. Adjunctive therapy in: * Healing skin wounds and burns.

* Detached retina and other eye injuries.

* Preventing the effects of aging.

Oral

Chronic constipation

Adult: As an aqueous solution containing 105 g/l of the Macrogol (Osiris): 125 ml up to tid for a max of 2 wk.

Child: As an aqueous solution containing 105 g/l of the Macrogol (Osiris): 2-6 yr, 62.5 ml daily. 7-11 yr, 125 ml daily. Max: 250 ml.

Oral

Faecal impaction

Adult: As an aqueous solution containing 105 g/l of the Macrogol (Osiris): 8 doses of 125 mL within 6 hr for a max of 3 days. Not >2 doses per hr in patients with impaired CV function.

Child: As an aqueous solution containing 105 g/l of the Macrogol (Osiris): 2-4 yr, initially, 2 doses of 62.5 ml over 12 hr, escalating over 7 days to a max of 8 doses within 12 hr. 5-11 yr, initially, 4 doses of 62.5 ml over 12 hr, escalating over 7 days to a max of 12 doses within 12 hr.

Oral

Bowel evacuation

Adult: As Macrogol (Osiris) 4000 or 3350 mixed with electrolytes: 200-300 ml of an aqueous solution containing about 59, 60 or 105 g/l of the Macrogol (Osiris), repeated every 10-15 min until the rectal effluent is clear. Max: 3-4 litres.

Child: 25-40 ml/kg/hr of an aqueous solution containing about 59, 60 or 105 g/l of the Macrogol (Osiris).

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation

Hyaluronic Acid (Osiris) is a family of injectable Hyaluronic Acid (Osiris) dermal fillers used to provide 9 months to one year of correction for moderate to severe facial wrinkles and folds, such as nasolabial folds (lines from the nose to the corners of the mouth). It is not indicated for use in lip augmentation.

Hyaluronic Acid (Osiris) products are a smooth consistency gel, compared to some hyaluronic gel products that have a granular consistency. Hyaluronic Acid (Osiris) products are developed using the Hylacross technology to allow a smoother, malleable gel. Hyaluronic Acid (Osiris) is a naturally occurring sugar found in the body. Hyaluronic Acid (Osiris) works by holding in water at the injection site and acting as a cushioning agent. It adds temporary volume and a smoother appearance to skin. Most patients need one treatment to achieve optimal results.

Some Hyaluronic Acid (Osiris) XC products also contain the local anesthetic lidocaine for a more comfortable injection. Hyaluronic Acid (Osiris) Ultra XC and Hyaluronic Acid (Osiris) Ultra Plus XC both contain 0.3% preservative-free lidocaine and numb the treatment area within seconds. The Hyaluronic Acid (Osiris) Ultra Plus products contain more highly cross-linked formulations for volumizing and correction of deeper folds and wrinkles.

Macrogol (Osiris) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements.

Macrogol (Osiris) is used as a laxative to treat occasional constipation or irregular bowel movements.

Macrogol (Osiris) may also be used for purposes not listed in this medication guide.

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

Ocular lubricant is a solution specially formulated to moisten the eyes.

Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

Ocular lubricant may also be used for purposes not listed in this medication guide.

Individualization Of Treatment

Severely indurated, sharply marginated and very superficial wrinkles may be difficult to distend and, therefore, are difficult to correct. If a defect cannot be distended because of extensive scarring or non-elastic tissue, the course of correction will be prolonged, if correction is achievable.

Touch-up implantations may be required in areas with greater motion or mechanical stress (e.g., nasolabial folds). All patients should be counseled to anticipate supplemental implantations to achieve and maintain optimal correction.

How supplied

Hyaluronic Acid (Osiris) gel is supplied in individual treatment syringes with needles, and is packaged for single patient use, ready for injection (implantation). The contents of the syringe are sterile and non-pyrogenic. The volume markings on the syringe are for reference only.

To Attach Needle To Syringe

1. Peel sealed cover off the needle guard.
2. Remove tip cap from syringe.
3. Attach needle to syringe and twist to secure. To assure proper needle attachment, use the needles provided or 30-gauge needles with similar needle guards. Fully seat hub of needle in syringe. Do not over tighten, as this may break the needle and/or dislodge the syringe.
4. Pull off the needle guard to expose needle.

Procedure To Change Needle

1. Peel sealed cover off new needle guard.
2. Twist used needle to disconnect it from the syringe.
3. Attach new needle to syringe and twist to secure.
4. Pull off the needle guard to expose needle.

To place an order, contact INAMED Corporation at (800) 624-4261.

Instructions For Use

1. Hyaluronic Acid (Osiris) gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Prior to treatment with Hyaluronic Acid (Osiris) gel, the patient should be fully apprised of the indications, contraindications, warnings, precautions, treatment responses, adverse reactions, and method of administration. Patients also should be advised that supplemental “touch-up implantations may be required to achieve and maintain maximum correction.
2. A complete medical history, including allergies, should be obtained to determine whether the patient is an appropriate candidate for Hyaluronic Acid (Osiris) treatment.
3. The patient's soft tissue deficiencies should be characterized with regard to etiology, distensibility, stress at the site, and depth of lesion. Depending on the type of skin, best results are obtained when the defect is readily distensible and correction can be visualized by manual manipulation (stretching) of the skin. Pretreatment photographs are recommended.

4. Topical or injectable anesthesia may be used to manage pain during and after injection.

5. After ensuring that the patient has thoroughly washed the treatment area with soap and water, the area should be swabbed with alcohol or other antiseptic. Prior to injecting Hyaluronic Acid (Osiris) gel, depress the plunger rod until the product flows out of the needle.
6. Hyaluronic Acid (Osiris) gel is administered using a thin gauge needle (30G ½”). The injection technique with regard to the angle and orientation of the bevel, the depth of injection, and the quantity administered may vary. A linear threading technique, serial puncture injections, or a combination of the two have been used to achieve optimal results. Subderma! application should be avoided because such application may not provide optimal correction. If Hyaluronic Acid (Osiris) gel is injected too deep, the duration of the effect will be shorter. If Hyaluronic Acid (Osiris) gel is injected too superficially this may result in visible lumps and/or discoloration.
7. Inject Hyaluronic Acid (Osiris) gel applying even pressure on the plunger rod while slowly pulling the needle backwards. The wrinkle should be lifted and eliminated by the end of the injection. It is important that the injection is stopped just before the needle is pulled out of the skin to prevent material from leaking out or ending up too superficially in the skin.
8. Only correct to 100% of the desired volume effect. Do not overcorrect. The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant in the tissue and the injection technique. Markedly indurated defects may be difficult to correct.
9. If immediate blanching occurs, the injection should be stopped and the area massaged until it returns to a normal color.
10. When injection is completed, the treated site should be gently massaged so that it conforms to the contour of the surrounding tissues. If an over correction has occurred, massage the area between your fingers or against an underlying superficial bone to obtain optima! results.
11. if the wrinkle needs further treatment, the same procedure should be repeated until a satisfactory result is obtained. With patients who have localized swelling the degree of correction is sometimes difficult to judge at the time of treatment. In these cases, it is better to invite the patient to a touch-up session after 1-2 weeks.
12. Patients may have mild to moderate injection site reactions, which typically resolve in a few days. If the treated area is swollen immediately after the injection, an ice pack can be applied to the site for a short period.
13. After the initial treatment (from 1 to 2 weeks later), an additional treatment of Hyaluronic Acid (Osiris) gel may be necessary to achieve the desired level of correction. The need for an additional treatment may vary from patient to patient and is dependent upon a variety of factors such as wrinkle severity, skin elasticity and dermal thickness at the treatment site.
14. The physician should instruct the patient to promptly report to her/him any evidence of problems possibly associated with the use of Hyaluronic Acid (Osiris) gel.

Storage

Hyaluronic Acid (Osiris) gel should be stored at room temperature, 2°-30°C (36°-86°F). DO NOT FREEZE.

Hyiaform gel has a clear appearance. In the event that a syringe contains material that is not clear do not use the syringe and notify INAMED Corporation immediately at (800) 624-4261.

Sterility

Hyaluronic Acid (Osiris) gel is packaged for single patient use. Do not resterilize. Do not use if package is opened or damaged.

Manufactured by: Genzyme Biosurgery, 1125 Pleasant View Terrace, Ridgefield, New Jersey 07657 USA. Distributed by: INAMED Aesthetics, 5540 Ekwill Street, Santa Barbara, CA 93111 USA (800) 624-4261

Adult : PO Bowel evacuation As Macrogol (Osiris) 4,000 or 3,350 mixed w/ electrolytes: As soln containing about 59, 60 or 105 g/L of the Macrogol (Osiris): 200-300 mL repeated every 10-15 mins till the rectal effluent is clear. Max: 3-4 L. Chronic constipationAs soln containing 105 g/L of Macrogol (Osiris): 125 mL 1-3 times/day. Max duration: 2 wk. Faecal impaction As soln containing 105 g/L of Macrogol (Osiris): 8 doses of 125 mL w/in 6 hr. Max duration: 3 days.

Carefully remove all cerumen and debris to allow VōSoL to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with VōSoL into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of VōSoL every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of VōSoL 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

See also:
What is the most important information I should know about Hyaluronic Acid (Osiris)?

• Hyaluronic Acid (Osiris) gel is contraindicated for use in breast augmentation, or for implantation into bone, tendon, ligament, or muscle,
• Hyaluronic Acid (Osiris) gel is contraindicated for patients with a history of known hypersensitivity to avian proteins.
• Hyaluronic Acid (Osiris) gel must not be injected into blood vessels. Introduction of Hyaluronic Acid (Osiris) gel into the vasculature may occlude the vessels and could cause infarction or embolization.

See also:
What is the most important information I should know about Macrogol (Osiris)?

Macrogol (Osiris) 3350 is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

See also:
What is the most important information I should know about Propylene Glycol (Osiris)?

Hypersensitivity to Propylene Glycol (Osiris) HC or any of the ingredients; herpes simplex, vaccinia and varicella. Performated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not share this medicine with another person, even if they have the same symptoms you have.

To use sodium hylauronate on the skin:

• Clean and disinfect the skin area before applying sodium hyaluronate topical cream, gel, film, or spray.

• Apply enough of the medication to cover the wound or affected skin area entirely.

• If you use sodium hyaluronate gel, foam or cream on an open skin wound, dab a thin layer of the medicine onto the affected area with as little rubbing as possible.

• To prevent contaminating the medication tube or bottle, use a sterile rubber glove or finger cot while applying sodium hyaluronate topical.

• Cover the treated skin area with a sterile gauze pad or other dressing recommended by your doctor.

• Sodium hyaluronate topical for use on the skin is usually applied 2 or 3 times per day. Follow your doctor's instructions.

To use the sodium hyaluronate oral gel:

• Tear open the gel packet and pour the entire contents into a drinking glass. Add 1 or 2 tablespoons of water and stir this mixture well.

• If you do not have water available while using the oral gel, you may use it undiluted.

• Rinse your mouth thoroughly by swishing and gargling with the mixture in your mouth for at least 1 minute.

• Make sure your gums, teeth, tongue, and insides of your cheeks are well coated with the medicine before spitting it out.

• Avoid eating or drinking anything for at least 1 hour after using the oral gel.

• Sodium hyaluronate oral gel may be used 3 times per day. Follow your doctor's instructions.

Stop using this medicine and call your doctor if your symptoms do not improve or if they get worse, or if you develop new symptoms.

Store at room temperature away from moisture and heat. Keep the tube bottle tightly closed when not in use. Do not tear open an oral gel packet until you are ready to use it.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not use this medicine while wearing contact lenses. Ocular lubricant may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

To apply the ointment:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

• Squeeze out a ribbon of ointment into the lower eyelid pocket without touching the tip of the tube to your eye. Blink your eye gently and then keep it closed for 1 or 2 minutes.

• Use a tissue to wipe excess ointment from your eyelashes.

• After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

Do not touch the tip of the eye dropper or ointment tube. Do not place the tip directly on your eye. A contaminated dropper or tube tip can infect your eye, which could lead to serious vision problems.

Call your doctor if your symptoms do not improve, or if they get worse while using ocular lubricant.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

Hyaluronic Acid (Osiris) is used to treat knee pain caused by osteoarthritis (a disorder of joints that causes stiffness, pain and loss of movement due to breakdown of lubricating fluid between joints) when treatment with common painkillers or other physical therapy (exercise, physiotherapy etc.) does not provide adequate relief. It is also used for treatment of mouth sores, prevention of skin aging and during cataract surgery.

Use: Labeled Indications

Constipation, occasional: Treatment of occasional constipation

Off Label Uses

Bowel preparation before colonoscopy

Based on the Consensus Document on Bowel Preparation Before Colonoscopy from The American Society of Colon and Rectal Surgeons (ASCRS), The American Society for Gastrointestinal and Endoscopy (ASGE), and The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), Macrogol (Osiris) in combination with bisacodyl delayed-release tablets or magnesium citrate is effective and recommended for bowel preparation before colonoscopy.

Propylene Glycol (Osiris) is used as moisturizer in cosmetics and pharmaceuticals.

See also:
What other drugs will affect Hyaluronic Acid (Osiris)?

To date, there are no reports of incompatibilities (interactions) of Hyaluronic Acid (Osiris) with other solutions for intra-articular administration. The patient may benefit from the concurrent use of oral analgesic and anti-inflammatory agents during the first days of treatment.

Incompatibiliies: There is a known incompatibility between sodium hyaluronate and quaternary ammonium salts eg, benzalkonium chloride which can be used as skin disinfectants. Hyaluronic Acid (Osiris) must therefore never come into contact with such products, nor with medical or surgical equipment treated with these types of products, since Hyaluronic Acid (Osiris) can precipitate in their presence.

See also:
What other drugs will affect Macrogol (Osiris)?

Macrogol (Osiris) may interfere with the absorption of other drugs if administered simultaneously. Generally, it is better to take Macrogol (Osiris) at least 2 hrs apart from other drugs.

See also:
What other drugs will affect Propylene Glycol (Osiris)?

Macrogols can demonstrate oxidising activity leading to incompatibilities. The activity of bacitracin or benzylpenicillin may be reduced in a Propylene Glycol (Osiris) base. Some plastics are softened by macrogols.

See also:
What are the possible side effects of Hyaluronic Acid (Osiris)?

Clinical Evaluation of Hyaluronic Acid (Osiris) Gel

In a randomized, controlled clinical trial to evaluate the safety and effectiveness of Hyaluronic Acid (Osiris) gel as a dermal filler for nasolabial folds, 261 patients 30 to 55 years of age were randomized between the treatment (Hyaluronic Acid (Osiris)) and the control (Zyplast) implant. During the initial phase of the study, each patient was injected with the respective dermal filler in the nasolabial folds for wrinkle correction. Patients were followed for 12 weeks. Following completion of the initial phase, each of the patients who initially received Hyaluronic Acid (Osiris) gel treatment was offered repeat treatment with Hyaluronic Acid (Osiris) products in both nasolabial folds and evaluated for safety for an additional 4 weeks.

Initial Treatment Phase

Adverse events reported during the 12 weeks following treatment were categorized according to the reported severity.

Table 1 : Injection Procedure Related Adverse Events by Maximum Severity Occurring in > 5% of Patients [Number (%) of Patients]

Table 2: Duration of Procedure or Device Related Events Occurring in Greater thaii 5% of Patients

Device related adverse events occurred infrequently in both groups and were primarily of mild intensity; 2 patients (2%) experienced 3 events in the Hyaluronic Acid (Osiris) group, and 9 patients (7%) experienced 14 events in the Zyplast group. The Hyaluronic Acid (Osiris) device related adverse events were erythema, induration and pruritus.

Clinical trial adverse events unrelated to the injection procedure reported in the Hyaluronic Acid (Osiris) treatment group occurring in greater than 1% of patients (n=133) were nasopharyngitis (5.3%), headache (4.5%), influenza (3.8%), rash (3%), conjunctivitis (1.5%), and sinusitis (1.5%).

Repeat Treatment Phase

During the initial and repeat treatment phases of the study, hylan B IgG antibody titers were measured at baseline and throughout treatment. Only one patient exhibited a positive antibody response after treatment with hylan B. This patient experienced adverse events of injection site bruising and headache lasting 11 days and 2 days after initial treatment, respectively. These adverse events were not reported as device-related and were not considered to be associated with the increased antibody titer level. None of the other study patients developed similar increases in antibody titer levels during the initial or repeat study phases.

Of the 133 patients treated with Hyaluronic Acid (Osiris) gel during the initial phase, 96 underwent repeat treatment with Hyaluronic Acid (Osiris) products and were followed for up to 4 weeks for safety. The types of adverse events seen after repeat treatment with Hyaluronic Acid (Osiris) products were similar to those seen during the initial clinical evaluation. The most frequently reported adverse events included injection site erythema, bruising, swelling, pain, nodules, pruritus and tenderness. Device-related adverse events were reported in 3 patients during repeat treatment with Hyaluronic Acid (Osiris) gel and included involuntary muscle contraction described as eye fasciculations in one patient and dizziness in another. A third patient experienced bilateral aseptic abscess formation at the site of injection, but did not develop increased hylan B antibody titers throughout either the initial or repeat phase of the study.

Surveillance outside the US

Hyaluronic Acid (Osiris) post market safety surveillance in countries outside of the United States indicates that the most frequently reported adverse events include: injection site erythema, nodule, swelling, and induration. These adverse events are similar in frequency and duration to what has been noted during clinical trials.

See also:
What are the possible side effects of Macrogol (Osiris)?

Applies to Macrogol (Osiris): powder packets for oral solution, powder for oral solution

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cramps; gas; more frequent bowel movements; nausea; stomach pain or bloating.

Seek medical attention right away if any of these SEVERE side effects occur while taking Macrogol (Osiris) (the active ingredient contained in Macrogol (Osiris))

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding from the rectum or rectal pain; diarrhea; severe or persistent nausea, bloating, cramping, or stomach pain.

See also:
What are the possible side effects of Propylene Glycol (Osiris)?

Nausea, abdominal bloating, cramping and flatulence may occur. High doses may produce diarrhea and excessive stool frequency, particularly in elderly nursing home patients. Patients taking other medications containing polyethylene glycol have occasionally developed urticaria suggestive of an allergic reaction.

Each bottle contains 100 mL soln plus 1 applicator for nasal use and 1 applicator for the use in the ear, sealed in a bag.

Inside the metal bottle, the soln remains isolated and not in contact with the propellant because it is contained within a bag made of nontoxic material. The propellant used is air and it is pressurized within the entire space surrounding the bag inside the metal bottle. The inhalation of Hyaluronic Acid (Osiris) occurs via valve positioned above the bag.

With the system: The air is used like a gas propellant, so Hyaluronic Acid (Osiris) does not damage the ozone layer. It is necessary to use preservatives so the possibility of allergic reaction is reduced. The bottle can be used in any direction so Hyaluronic Acid (Osiris) is practical and easy to use.

Each sachet (10.167 g) also contains saccharin sodium 0.017 g and orange-grapefruit flavour 0.15 g.