Drug Information

Drug Interaction:

Reports not available.

Indication:

Surgical aid in various anterior segment procedures ie., intracapsular and extracapsular cataract surgery.

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

145. Sodium Hyaluronate injectable gel 03-06-08

(each 0.6ml 1ml prefilled syringe contains

Sodium Hyaluronate 20mg/ml, 22.5mg/ml

For intradermal implantation and facial soft tissue

augumentation

U.S FDA APPROVED DRUGS DURING 2006

26. Sodium Hyaluronate Cream 0.2% 16-03-2006 For leg ulcers,diabetic ulcer etc.

84. Sodium Hyaluronate Injection(1%) 26-07-2006 For OA

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Sodium Hyaluronate Aid Intraocular surgery June 1989

2. Chemically modified 11-2-2010

Sodium Hyaluronate and

Carboxymethycellulose

absorbable adhesion barrier

As an adjunct in abdominal or pelvic surgery for reducing the incidence,

extent and severity of postoperative adhesions at the site of placement

3.Sodium Hyaluronate Cream 0.5% 16-03-2006

For leg ulcer, Diabetic ulcer etc.

4.Sodium Hyaluronate Injectable gel 03-06-2008

(Each 0.6ml .1ml Prefilled syringe

contains Sodium Hyaluronate

20mg/ml,22.5mg/ml )

For Intradermal Implantation and Facial Soft tissue Augmentation

5.Sodium Hyaluronate Injectable gel 06-02-2010

14mg/ml,18mg/ml, 25mg/ml

Addl.stgth

same as approved

6.Sodium Hyaluronate Injection 1% 26-07-2006

For OA

7. Sodium Hyaluronate Sol. June 1989

Sodium Injection only

Aid Intraocular surgery

3.Sodium Hyaluronate Cream 0.5% 16-03-2006

For leg ulcer, Diabetic ulcer etc.

4.Sodium Hyaluronate Injectable gel 03-06-2008

(Each 0.6ml .1ml Prefilled syringe

contains Sodium Hyaluronate

20mg/ml,22.5mg/ml )

For Intradermal Implantation and Facial Soft tissue Augmentation

5.Sodium Hyaluronate Injectable gel 06-02-2010

14mg/ml,18mg/ml, 25mg/ml

Addl.stgth

same as approved

6.Sodium Hyaluronate Injection 1% 26-07-2006

For OA

7. Sodium Hyaluronate Sol. June 1989

Sodium Injection only

Aid Intraocular surgery

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Sodium Chondroitin sulfate 40mg+ 14-05-2008

Sodium Hyaluronate 30mg oer ml

Introcular injection

Addl .Stgth

For use as surgical aid in anterior segments procedure

including cataract extraction & intra-ocular implantation

2. Sodium chondroitin sulfate + 25-08-2008

Sodium Hyaluronate injection( 40mg +

not more than 17mg per ml)

For use as a surgical aid in anterior segments procedure

including cataractextraction & ntra-ocular lens implantation

3. Sodium Hyaluronate 30mg + 04-04-2000

Chondroitin Sulfate 40mg eack ml

ophthalmic solution

For use as surgical aid in anterior segments procedure

including cataract extraction & intra-ocular implantation

4.Sodium Hyaluronate Cream 0.5% 16-03-2006

For leg ulcer, Diabetic ulcer etc.

5.Sodium Hyaluronate Injectable gel 03-06-2008

(Each 0.6ml .1ml Prefilled syringe

contains Sodium Hyaluronate

20mg/ml,22.5mg/ml )

For Intradermal Implantation and Facial Soft tissue Augmentation

6.Sodium Hyaluronate Injectable gel 06-02-2010

14mg/ml,18mg/ml, 25mg/ml

Addl.stgth

same as approved

7.Sodium Hyaluronate Injection 1% 26-07-2006

For OA

8. Sodium Hyaluronate Sol. June 1989

Sodium Injection only

Aid Intraocular surgery

Adverse Reaction:

Hypersens.

Raised intraoccular pressure from intraoccular use.

post operative corneal edema, corneal dispensation

Contra-Indications:

Hypersensitvity - Because the preparation is extracted from avian tissues and contains minutes amounts of proteins , risk of hypersensitivity may exist.

Special precautions:

Intraocular use- use only if the solution is clear. Postoperative intraocular pressure IOP may be elevated as a result of preexisting glaucoma, compromised outflow and by operative procedures.

Carefully monitor IOP especially during the immediate post operative period

Dosages/ Overdosage Etc:

Indications:

Surgical aid in various anterior segment procedures ie., intracapsular and extracapsular cataract surgery.

Dosage:

Slowly introduce sufficient amount into anterior chamber.

Storage:

Store at 2 to 8C. Do not freeze. Use the drug at room temperature.

Sodium hyaluronate - Physical Adjuncts- (FDC- List )- (June 1989)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

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