Material Creation Shanghai Baijiayi Pharmaceutical Co., Ltd. Tel: 021-66861001.
Function description usage and dosage
Adults, once 25mg, once a week, were injected into the knee joint cavity or shoulder joint (shoulder joint cavity, acromion descending sac or tendon sheath of biceps brachii long head) for 5 times in a row, and the times of administration were appropriately increased or decreased according to the severity of symptoms.
Store in the dark and sealed at 2 ~ 8℃ (antifreeze).
The validity period is tentatively set at two years.
Unified retail price 230 yuan/branch
Product advantage
1) medical insurance class b
2)GMP certification
3) National medicine quasi-characters
4) Germany imported packaging equipment, and the aseptic quality is guaranteed.
5) Biological extraction has good biocompatibility with human body, and its quality is superior to that of bacterial fermentation technology.
6) High polymer, high viscoelasticity and no pyrogen.
7) Patented inner packaging design with exclusive specifications is more suitable for clinical trials.
8) Baiyi brand
Common name: sodium hyaluronate injection (Archie)
Manufacturer: Biochemical Industry Co., Ltd.
Approval number: import registration certificate number. H20060 133
Specification: 2.5ml[ 150] dosage form: injection.
Drug Name: Archie (Sodium Hyaluronate Injection) Drug Type: Branch
Time: 2007-11-5 09: 53: 01wholesale sales: (Tel: 03 19-5978207 or consult online customer service)
Drug name
Generic name: sodium hyaluronate injection
Trade name: Archie? show
English name: sodium hyaluronate injection
Artz? show
The main components and chemical names of this product are as follows:
sodium hyaluronate
[→3]-2- acetamido -2- deoxy -β-D- glucopyranosyl -( 1→4)-β-D- glucopyranosuronate -( 1→)n
Molecular formula: (c14h20nnao11) n
Molecular weight: the weight average molecular weight is 800,000 ~ 6,543.8+200,000.
Character; Role; letter
Colorless transparent viscous water injection, odorless.
PH value: 6.8~7.8
Osmotic pressure ratio: 1.0 ~ 1.2 (compared with normal saline)
Pharmacology and toxicology
Pharmacological action:
This product can cover and protect joint tissue, improve lubrication function, inhibit cartilage degeneration, and improve cartilage metabolism in denatured cartilage by infiltrating denatured cartilage; In addition, the product shows the effect of relieving pain by inhibiting the action of pain medium on synovium. Therefore, the product can relieve pain and improve patients' daily activities and joint range of motion.
Effect of 1. on articular cartilage
(1) has affinity with articular cartilage and can cover and protect the cartilage surface (rabbit).
(2) Inhibition of cartilage degeneration (in vitro rabbits and mice).
(3) This product can inhibit the exudation of cartilage matrix proteoglycan and improve cartilage metabolism (isolated rabbit).
2. Effect on synovium
It acts on synovial cells to promote the synthesis of high molecular hyaluronic acid.
3. Effect on joint fluid
Increase the concentration and molecular weight of hyaluronic acid in diseased joint fluid and improve spinnability.
4. Improve joint contracture.
(1) acts as a physical barrier between tendon and tendon sheath to prevent tendon adhesion (rats).
(2) Improve the range of motion of experimental joint contracture model (rabbit).
Step 5: Suppress the pain
It can inhibit the experimental joint pain caused by bradykinin alone and by bradykinin combined with PGE2. Its mechanism of action is that this product covers and permeates the tissue surface to inhibit the pain caused by pain-causing substances (rats).
pharmacokinetics
1. No pharmacokinetic data is available.
2. Absorption, distribution, metabolism and excretion of animals
1% 14C- sodium hyaluronate 0. 1ml/kg was injected into the rabbit knee joint cavity at one time, and the results were as follows.
Concentration in joint fluid
It disappears from joint fluid about 3 days after administration, and its half-life in joint fluid is about 20 hours.
blood concentration
It reached the highest value about 48 hours after administration, and then gradually decreased.
Intra-articular concentration
The high concentration is distributed in ligament and synovial tissue, followed by meniscus and articular cartilage. High concentration distribution was also observed in liver and spleen, but no accumulation was found.
Dexamphetamine tablets
It is hardly metabolized in joint fluid, but absorbed into synovial tissue. This part is low molecular weight, which enters the blood and controls liver metabolism.
Drain
One part is excreted by breathing, and the other part is excreted by urine and feces.
indicate
Deformable knee joint disease, scapulohumeral periarthritis.
Clinical effect:
In the hospital of Japan 109, a total of 557 cases of knee arthropathy and scapulohumeral periarthritis were compared between groups and the clinical trials were summarized as follows.
1. Deformed knee pain
Taking 442 cases as the research object, taking pain during exercise, pain at rest, tenderness and animals in daily life as indicators, the results of comparative test and general clinical test show that the effective rate is 66.65438 0% (279/422). In addition, the comparative test also confirmed the effectiveness of this product.
2. Periarthritis of shoulder joint
Taking 10 1 as an example, and taking night pain, tenderness in daily life and animals as indicators, the results of comparative tests and general clinical trials show that the effective rate (moderate improvement or above) is 70.3% (711). In addition, the comparative test also confirmed the effectiveness of this product.
dosage
Generally, 1 time, 1 time (25mg in terms of sodium hyaluronate) and 1 time are injected into the knee joint cavity or shoulder joint (shoulder joint, acromion descending sac or tendon sheath of biceps brachii long head) five times in a row, and the number of times of administration is appropriately increased or decreased according to the severity of symptoms.
This product is for intra-articular injection and requires strict aseptic operation.
counteraction
According to the investigation of clinical trials and after-sales use of this product before it was approved in Japan, among 9,574 cases, 50 cases (0.52%) and 73 times (0.76%) reported adverse reactions. In addition, there is no abnormal change in clinical trial values.
Among 7845 cases of knee joint deformity, 45 cases (0.57%) and 68 cases (0.87%) had adverse reactions, mainly local pain in 37 cases (0.47%), swelling in 65438 04 cases (0.65438 08%) and joint edema in 3 cases (0.04%). For scapulohumeral periarthritis, 1, there were 5 cases (0.29%) and 5 times (0.29%) in 729 cases, mainly local pain 4 times (0.23%).
(Refer to "Listing Application Materials" and "Re-examination Application Materials" in Japan. )
1. Serious adverse reactions
shock
Symptoms of shock may occur (unknown incidence). Therefore, attention should be paid to observation, and if there is any abnormality, the drug should be stopped and appropriate treatment should be carried out.
2. Other adverse reactions
incidence rate
classify
0. 1~5%
No more than 0. 1%
The incidence is unknown.
Allergy (Note 2)
Rash and itching such as urticaria.
Edema (face, eyelids, etc. ), the face is red.
Drug delivery connector
Sometimes there will be painful (mainly temporary pain after administration) swelling.
Edema, redness, heat sensation, local pressure sensation
other
Nausea, vomiting, fever
Note 1) Because the factory received the report, there is no statistical significance, so the incidence rate is unknown.
Note 2) If such symptoms occur, please stop taking the medicine and take appropriate treatment.
taboo
Patients with a history of allergies to any of the ingredients in this product.
Matters needing attention
1. Use drugs with caution (for the following patients)
(1) Patients with previous allergic history to other drugs.
(2) Patients with abnormal liver function or past history. [ast (aspartate aminotransferase) and ALT(GPT) values are abnormal in patients with a history of abnormal liver function. ]
(3) Patients with dermatosis or infection at the administration site. [Because this product is intra-articular injection]
2. General attention
(1) Deformable knee joint disease. When there is serious inflammation in joints, injection of this product will sometimes aggravate local inflammatory reaction, so it is advisable to use this product after eliminating inflammation.
(2) Injection of this product may sometimes cause local pain, and the local area should be quiet after medication.
(3) The leakage of liquid medicine outside the joint cavity will cause pain, and it must be injected into the joint cavity accurately.
(4) If there are any adverse events and/or reactions during the use of this product, please consult a doctor.
(5) Please inform the doctor when taking other drugs at the same time.
(6) Please keep it out of the reach of children.
3. Instructions for medication
(1) Note
1) This product is an injection in the knee joint or shoulder joint, which requires strict aseptic operation.
2) If the symptoms are not improved, the number of injections should be limited to 5 times.
3) When joint effusion occurs, puncture and drain the fluid as appropriate.
(2) Instructions for use
1) This product is sealed, please open it immediately before use.
2) If it is found that the sealed package has been opened or damaged, please do not use it.
(3) Others
1) shall not be injected into blood vessels.
2) Do not use in ophthalmology.
3) Because this product is sticky, it is advisable to inject it with a 22 ~ 23g needle.
4) This product is a disposable drug. Please use it immediately after opening and discard it after use.
Medication for pregnant and lactating women
1. For pregnant women or women who may become pregnant, if it is judged that the benefits of treatment outweigh the risks, drugs can be used as appropriate.
【 Animal experiments (rabbits) have no teratogenic effect, but the safety of medication for pregnant women has not been established. ]
2. Breastfeeding should be avoided during the use of this product. 【 Animal experiment (rat) Sodium hyaluronate was transferred into milk. ]
Children's medication
The safety of children's medication has not been determined.
Medication for elderly patients
Usually, the physiological function of the elderly declines, so we should pay more attention to it when using it.
Pharmacological interaction
When this product meets quaternary ammonium salts such as benzalkonium chloride and chlorhexidine, it sometimes produces precipitation, which should be paid full attention to.
excessive
It is not clear that in the event of overdose, symptomatic and supportive treatment should be given.
standard
Each tablet (2.5ml) contains 25mg of sodium hyaluronate, 10 tablet/box (with needle tube), 1 tablet/box (with needle tube).
store
When the temperature is lower than 25℃, avoid freezing.
parcel
Pre-installed glass needle tubes, 10 PCs/box, 1 PCs/box.