INDICES> SYNVIC (2)

["Daglish,Lorraine" <Lorraine.Daglish@afrox.boc.com>]

INDICES> SYNVIC (2)
-------------------

Hi

The following is en extract from MIMS

Kind regards

Lorraine Daglish
Pharmacy Manager
Entabeni Hospital 
Ph: 27 31 2041336
fax: 27 31 2614303
email: lorraine.daglish@afrox.boc.com

[moderator: Is this MIMS South Africa? Is it available online or is it a CD? WB]

> Storage instructions: Store at room
> temperature below 30 °C. Do not freeze. Keep out of reach of children.
> 
> SYNVISC, Roche [P/S]
> Hylan G-F20.
> Indications: Osteo-arthrosis knee pain where respons.to
> conservat.non-pharmacolog.therapy & analges.fail.
> (S4) INJ. 31/3.2/0397. 8 mg/ml.
> 848816-005: 3x2 ml sngl.dos pre-fill.syr., R1995,00.
> Dosage: Admin.by intra-articul.inj.once wkly.x3 inj. Remove synovial
> fluid/effus.pres.bef.admin.
> Contra-indications: Bird prot.hypersens., ven/ lymphat.stasis., large
> intra-articul.effus., infect./ sev.inflam.joints., skin dis./infects.at
> inj.site, safety & effectiven.in locat.other than knee & condit.other than
> osteoarthros.not est., not test.in pregn./ childr.und.18 yrs., do not use
> disinfects. contain.quarternary ammon.salts for skin prep.as hyaluronan
> may precipitat.in their pres.
> Side-effects: Loc.reacts., second.infect.with sept.arthrit., gen.urticar.,
> small hives, pain on one side of body with naus.,anx.& listlessn.,
> fac.flush. with lip swell., naus.with dizzin., shiver.with headache,
> naus., resp.diffucult., body prick.
> Special precautions: Admin. und.strict.asept. condits., drs.to be exper.in
> intra-articul.proced., do not inj.intravasc./extra-articularly/into
> synovial tiss.& caps.as system.events may occur, safety of rep.treatm.not
> est., avoid stren.activ./prolong. weight-bear.activ.follow.inj.
> 
> 
> 
> Pharmacological action: Synvisc is biologically similar to hyaluronan.
> Hyaluronan is a component of synovial fluid which is responsible for its
> viscoelasticity. Hylans are degraded in the body by the same pathway as
> hyaluronan, and breakdown products are non-toxic.
> The mechanism of action has not been investigated completely. In
> osteoarthrosis of the knee, the viscoelasticity of the synovial fluid
> decreases. Clinically, the sodium hyaluronate fractions in Synvisc have a
> pain-relieving effect and may improve the function of the joint. The
> optimal effect is achieved after 3 weekly injections and may persist for
> several months.
> 
> 
> Warnings: Synvisc should only be administered under strict aseptic
> conditions, by medical practitioners experienced in performing
> intra-articular procedures.
> Do not inject intravascularly. Systemic events may occur.
> Do not concomitantly use disinfectants containing quartemary ammonium
> salts for skin preparation because hyaluronan can precipitate in their
> presence.
> Do not inject Synvisc extra-articularly or into the synovial tissues and
> capsule, as this may cause systemic side-effects.
> The safety and effectiveness of repeated treatment cycles of Synvisc have
> not been established.
> lt is recommended that the patient avoid any strenuous activities or
> prolonged weight bearing activities such as jogging or tennis following
> the intra-articular injection.
> 
> Storage instructions: Store at room temperature below 30 °C. Do not
> freeze. Keep out of reach of children.
> 
> Presentation: Synvisc is supplied in a 2,25 ml glass syringe containing 2
> ml Synvisc, packed aseptically in a blisterpack. The contents of the
> syringe are sterile and nonpyrogenic. The carton contains three single use
> syringe
> 
> Composition: Synvisc (hylan G-F 20) is an elastoviscous fluid containing
> hylan polymers produced from chicken combs. Hylans are derivatives of
> hyaluronan (sodium hyaluronate, a natural complex sugar of the
> glycosaminoglycan family, Hyaluronan is a long-chain polymer containing
> repeating disaccharide units of sodium glucuronate-N-acetylglucosamine.
> Each 1 ml contains: Hylan 8,0 mg, sodium chloride, disodium hydrogen
> phosphate, sodium dihydrogen phosphate hydrate, sterile water for
> injection.
> 
> 
> Known symptoms of overdosage and particulars of its treatment: See
> "Side-effects and special precautions". Treatment is symptomatic and
> supportive.
> 
> Dosage and directions for use: Synvisc is administered by intra-articular
> injection once a week (one week apart) for a total of 3 injections.
> Remove synovial fluid or effusion if present, before injecting Synvisc.
> 
> Side-effects: More frequent: Any of the following local symptoms may
> occur: Pain, tenderness, swelling, effusion, redness and a feeling of heat
> which may persist for several weeks.
> Less frequent: Secondary infection with septic arthritis.
> Adverse events reported occasionally include: Generalised urticaria,
> recurring small hives, pain on one side of the body with nausea, anxiety
> and listlessness, facial flush with swelling of lips, nausea with
> dizziness and shivering with headache, nausea, respiratory difficulties,
> and prickling in the body.
> Precautions:
> 1.	Synvisc contains small amounts of avian protein and should not be
> used in patients with related hypersensitivities. As the sodium
> hyaluronate in Synvisc has been highly purified, the risk of immunological
> reactions is very small. However, it cannot be excluded, as the
> preparation comes from a biological source.
> 2.	The effectiveness of a single treatment cycle of less than three
> injections of Synvisc has not been established.
> 3.	Do not use Synvisc if package is opened or damaged. Store in
> original packaging (protected from light) at room temperature below 30 °C.
> DO NOT FREEZE.
> 4.	Do not resterilize Synvisc.
> Inject at room temperature, treatment with Synvisc in the cold state may
> cause temporary swelling and pain.
> The syringe contents are for single use only. The contents of the syringe
> must be used immediately after the syringe has been removed from its
> packaging. Inject the full 2 mI in one knee only. If treatment is
> bilateral, a separate syringe must be used for each knee. Discard any
> unused Synvisc.
> Administer using aseptic procedures, taking particular care in removing
> the tip cap. Strict aseptic techniques must be used in order to minimise
> the risk of infection which exists when giving intra-articular injections.
> Use an appropriate size needle (e.g. 18 to 22 gauge).
> Do not use the same syringe for removing synovial fluid and for injecting
> Synvisc.
> Under strictly aseptic conditions, the needle used for arthrocentesis
> should be left in the knee while changing the syringe for Synvisc
> injection.
> Inject into the synovial space only.
> Do not inject anaesthetics or any other medications intra-articularly into
> the knee while administering Synvisc therapy. This may dilute Synvisc and
> affect its safety and efficacy.
> 
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