Model NO.: 5000IU
Pharmaceutical Technology: Chemical Synthesis
Origin: China
HS Code: 3004909099
Model NO.: 5000IU
Pharmaceutical Technology: Chemical Synthesis
Origin: China
HS Code: 3004909099

Chymotrypsin for  injection: For intramuscular use only
Â
Each vial contains: Chymotrypsin lyophilized powder for injection  5000IU
Each ampoule contains:Â 1ml sterile normal saline ( Sodium Chloride 0.9%)
Â
Prescription Drug
Â
INGREDIENTS:Â Active ingredient: Chymotrypsin ( a proteolytic)
enzyme extracted from bovine or porvine pancreas) inactive ingredient: dextrin , manitol , water for injection.
Â
Appearance: White Lyophilized crystalline powder
Â
Indications:
The medicament can help clearance of blood coagulation , purulent secretion and necrotic tissue ;
It can relax ciliary ligament in ophthalmic operation ;
It can reduce inflammation of traumatic irisciliary body ;Â
It can also be used in trauma or local inflammation to decrease local secretion and edema.
Â
Specification:Â Â 5000IU/800IU
Â
Recommended Usage: Dissolved with appropriate Sodium Chloride injection before use.
1. Intramuscular injection: 4000 Unite per time
2. Ophthalmic posterior chamber injection : 800 Units per time , then rinse the remaining medicament in anterior and posterior chamber with Sodium Chloride injections 3 minutes later.
Â
Adverse Effects:
1. Make sure the skin allergic test is negative before you take the intramuscular injection in case it may induce allergic shock.
2. It may bring about local injection site pain and  swelling via inducing the release of histamine.
3. It may bring about abnormal high intraocular fluid pressure in a short time in ophthalmic local application , then lead to ophthalmalgia , corneal swelling and glaucoma symptoms which may go away in a week.
4. May cause corneal thread-like opacity , vitreous hernia , iris pigment defluivrum , uveitis and wound dehiscence or wound healing over slowly.
5. Keep it from permeating the vitreous body because of strong to toxicity to retina , in case it may hurt the crystalline lens.
Â
Warnings:
1. Not suitable to severe hepatopathy or coagulation disorders.
2. Not suitable to high intraocular fluid pressure or cataract together with corneal denaturalization patients , or patients whose lens are aptto colliquate.
3. Not suitable to patients under 20 because their crystalline lens envelope is connected with vitreous body ligament and their small eyeballs and strong sclera elasticity. It may make their vitreous body out after administration.
Â
Caution:
1. Can't be administered via intravenous injection.
2. Avoid of not coagulate blood in administration site because it inactivates when meets blood.
3. Please discontinue taking it and treat with antihistamine drug when allergic reactions appear.
4. Confect just before injection because it's unstable in solvent.
Â
Effects to pregnant and breast - feeding women: Not clear.
Effects to childen: No experimental data or trustful reference.
Effects to the olds: No experimental data or trustful reference.
Â
Interaction:
1. Do not use together with penicillin or adrenalin or hydrogen peroxide.
2. For alleviating glaucoma symptoms , administered with betareceptor blocker ( for example timolol) or carbonic anhydrase inhibitor ( for example acetazolamide)
Â
Overdose:Â No experimental data or trustful reference.
Â
Pharmacology & Toxicology
It cleaves polypeptide chains of protein into small molecular peptides or cleaves small peptides into amino acids.
It can be used to eliminate the liquor puris , hematocele and necrotic tissues.
It can also cleanse wounds , reduce inflammation and swelling by effecting as lipase to hydrolyze some liqids lipids.
Furthermore , it can relax the ciliary ligament and dissolve some tissue proteins of eyes.
Â
Pharmacokineties:Â No experimental data or trustful reference.
Storage condition:Â Store in a dry and cool place , keep away freom light and preserve in a tight container.
Â
Shelf life:Â 36 months
Â
Â
                         Certificate of Drug Analysis
Â
Name of Drug |
Chymotrypsin for Injection |
Batch  No. |
160701 |
Mfg. Date |
07/2016 |
Exp. Date |
04/2019 |
Specification |
5000IU |
Quantity |
1750000Ampoules |
Standards |
 CHP2005 |
 |
 |
Â
ITEM |
STANDARDS |
RESULTS |
Characteristics |
This product is white frozen dry block. |
White jelly dry block |
Identification |
Positive reaction |
Complies |
Acidity |
5.5-6.5 |
6.4 |
Clarity and color of solution |
Meet the specification |
Complies |
Dry weight loss |
≤8.0% |
2.1% |
Visible foreign body |
Meet the specification |
Complies |
Particulate contamination |
Meet the specification |
Complies |
Filling |
Meet the specification |
Complies |
Sterile |
Meet the specification |
Complies |
Titer determination |
Meet the specification |
Complies |
Assay |
90.0%-120.0% |
104.0% |
Â
Â
CONCLUSION: The above product confirms CH.P.2005 STANDARDS.
Â

Chymotrypsin for  injection: For intramuscular use only
Â
Each vial contains: Chymotrypsin lyophilized powder for injection  5000IU
Each ampoule contains:Â 1ml sterile normal saline ( Sodium Chloride 0.9%)
Â
Prescription Drug
Â
INGREDIENTS:Â Active ingredient: Chymotrypsin ( a proteolytic)
enzyme extracted from bovine or porvine pancreas) inactive ingredient: dextrin , manitol , water for injection.
Â
Appearance: White Lyophilized crystalline powder
Â
Indications:
The medicament can help clearance of blood coagulation , purulent secretion and necrotic tissue ;
It can relax ciliary ligament in ophthalmic operation ;
It can reduce inflammation of traumatic irisciliary body ;Â
It can also be used in trauma or local inflammation to decrease local secretion and edema.
Â
Specification:Â Â 5000IU/800IU
Â
Recommended Usage: Dissolved with appropriate Sodium Chloride injection before use.
1. Intramuscular injection: 4000 Unite per time
2. Ophthalmic posterior chamber injection : 800 Units per time , then rinse the remaining medicament in anterior and posterior chamber with Sodium Chloride injections 3 minutes later.
Â
Adverse Effects:
1. Make sure the skin allergic test is negative before you take the intramuscular injection in case it may induce allergic shock.
2. It may bring about local injection site pain and  swelling via inducing the release of histamine.
3. It may bring about abnormal high intraocular fluid pressure in a short time in ophthalmic local application , then lead to ophthalmalgia , corneal swelling and glaucoma symptoms which may go away in a week.
4. May cause corneal thread-like opacity , vitreous hernia , iris pigment defluivrum , uveitis and wound dehiscence or wound healing over slowly.
5. Keep it from permeating the vitreous body because of strong to toxicity to retina , in case it may hurt the crystalline lens.
Â
Warnings:
1. Not suitable to severe hepatopathy or coagulation disorders.
2. Not suitable to high intraocular fluid pressure or cataract together with corneal denaturalization patients , or patients whose lens are aptto colliquate.
3. Not suitable to patients under 20 because their crystalline lens envelope is connected with vitreous body ligament and their small eyeballs and strong sclera elasticity. It may make their vitreous body out after administration.
Â
Caution:
1. Can't be administered via intravenous injection.
2. Avoid of not coagulate blood in administration site because it inactivates when meets blood.
3. Please discontinue taking it and treat with antihistamine drug when allergic reactions appear.
4. Confect just before injection because it's unstable in solvent.
Â
Effects to pregnant and breast - feeding women: Not clear.
Effects to childen: No experimental data or trustful reference.
Effects to the olds: No experimental data or trustful reference.
Â
Interaction:
1. Do not use together with penicillin or adrenalin or hydrogen peroxide.
2. For alleviating glaucoma symptoms , administered with betareceptor blocker ( for example timolol) or carbonic anhydrase inhibitor ( for example acetazolamide)
Â
Overdose:Â No experimental data or trustful reference.
Â
Pharmacology & Toxicology
It cleaves polypeptide chains of protein into small molecular peptides or cleaves small peptides into amino acids.
It can be used to eliminate the liquor puris , hematocele and necrotic tissues.
It can also cleanse wounds , reduce inflammation and swelling by effecting as lipase to hydrolyze some liqids lipids.
Furthermore , it can relax the ciliary ligament and dissolve some tissue proteins of eyes.
Â
Pharmacokineties:Â No experimental data or trustful reference.
Storage condition:Â Store in a dry and cool place , keep away freom light and preserve in a tight container.
Â
Shelf life:Â 36 months
Â
Â
                         Certificate of Drug Analysis
Â
Name of Drug |
Chymotrypsin for Injection |
Batch  No. |
160701 |
Mfg. Date |
07/2016 |
Exp. Date |
04/2019 |
Specification |
5000IU |
Quantity |
1750000Ampoules |
Standards |
 CHP2005 |
 |
 |
Â
ITEM |
STANDARDS |
RESULTS |
Characteristics |
This product is white frozen dry block. |
White jelly dry block |
Identification |
Positive reaction |
Complies |
Acidity |
5.5-6.5 |
6.4 |
Clarity and color of solution |
Meet the specification |
Complies |
Dry weight loss |
≤8.0% |
2.1% |
Visible foreign body |
Meet the specification |
Complies |
Particulate contamination |
Meet the specification |
Complies |
Filling |
Meet the specification |
Complies |
Sterile |
Meet the specification |
Complies |
Titer determination |
Meet the specification |
Complies |
Assay |
90.0%-120.0% |
104.0% |
Â
Â
CONCLUSION: The above product confirms CH.P.2005 STANDARDS.
Â