Chorionic Gonadotrophin for injection |
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Source |
Pregnant woman urine | ||
Definition |
This product is a freeze-dried sterile product with chorionic gonadotrophin plus suitable excipients. Its titer should be 80%~125% of the labeled amount | Chorionic Gonadotrophin for Injection is a sterile material consisting of Chorionic Gonadotrophin with or without excipients. It is supplied in a sealedcontainer | |
Pharmacopoeia standard |
CP |
BP |
|
Character |
This product is a white lyophilized block or powder. | A white or almost white, amorphous powder | |
Identification |
_______ | Causes an increase in the weight of the seminal vesicles or the prostate glands of immature male rats when administered as directed under the Assay. | |
Test |
Loss on drying | ≤5.0% | _______ |
Abnormal toxicity | Conform with regulation | ||
Bacterial endotoxin | <0.01EU/IU | The endotoxin limit concentration of solution A is 15 IU of endotoxin per mL | |
Acidity or alkalinity | _______ | pH of a 1% w/v solution, 6.0 to 8.0 | |
Clarity and colour of solution | _______ | Solution is clear and colourless | |
Content uniformity | ±15% | _______ | |
Visible foreign matter | Conform with regulation | _______ | |
Sterile | Conform with regulation | _______ | |
Potency |
80%~125% of the stated potency | 80%~125% of the stated potency | |
Storage |
Sealed and kept in a cool dark place. | The sealed container should be protected from light and stored at a temperature not exceeding 20℃. | |
Category |
Gonadotropin drugs | ||
Specification |
1000 units 5000units |
1000 units 5000units
Patients suspected of having pituitary hyperplasia or swelling and pain, prostate cancer or other androgen-related swelling and pain tumors are contraindicated (with promoting effect). Patients with precocious puberty, vaginal bleeding with an undiagnosed diagnosis, subordinate fibroids, ovarian cysts or ovarian enlargement, thrombophlebitis, and patients with a history of allergy to gonadal stimulating hormones are contraindicated.
1. It should be used with caution in the following conditions: enlarged prostate, asthma, epilepsy, heart disease, migraine, renal impairment, etc.
2. If ovarian hyperstimulation syndrome and ovarian enlargement, pleural effusion, ascites and other comorbidities are found, the drug should be discontinued or seek medical advice.
3. The possibility of multiple pregnancies should be communicated to the patient before use. Ask about adverse reactions during use and conduct relevant clinical examinations regularly.
4. Pregnancy tests can be falsely positive and should be tested 10 days after administration.
5. Use with caution in patients with hypertension.
6. This product is temporarily formulated before application.