LAENNEC 50X2ml

Product Features
Laennec was named after a French physician (1781-1826, who invented the stethoscope) - RTH Laennec. Placenta injections are bioactive ingredients produced using substances derived from placentas, by using unique technologies for effective extraction of a variety of growth factors, cytokines, and other physiologically active substances from the human placenta.

Intended of use
(Injection) Improvement of hepatic function in chronic hepatic disease

Active Ingredients
1ml Water-soluble substance of a product of enzymatic human placenta

How to use
The normal adult dose is a 2 ml subcutaneous or intramuscular injection once daily. According to symptoms, the dose can be increased to 2 or 3 times daily.

Composition
2ml x 50ampoules

Expiry Date
36 months from the production date.

Storage Temperature
Please keep away from direct sunlight.
Store in a cool, dry place at a temperature of 1 to 30 ℃.

General Precautions
Patients should be made aware of the following points during administration. Although they are treated with safety measures during the manufacturing process, the risk of infection may not be completely ruled out because the human placenta may not be completely excluded.
This product efficacy is an improvement of liver function in patients with chronic hepatic disease
Use during Pregnancy. Delivery or Lactation: In reproductive development toxicity experiments on animals, including teratogenicity, this product can be considered not to have such toxicity.
Pediatric use: The safety of this product in premature infants, newborns, infants, toddlers, or children has not been established due to insufficient clinical data (Insufficient clinical data).
Use in the Elderly: From clinical data and present use, no particular caution is needed in the administration of this product to the elderly. However, since elderly patients often have reduced physiological function, it should be administered with care.

Precautions for use
In order to avoid any effect on tissue or nerves, the product should be injected subcutaneously or intramuscularly taking the following precautions:
- For the injection site, to avoid nerve pathways, it should be administered with care.
- In the case of repeated injections, avoid injecting into the same site by alternating on the left and right side, etc.
- If intense pain or regurgitation of blood is observed, the needle should be removed immediately, and injected into a different site.
When opening the ampoule, it is preferable to wipe the part to be cut with an ethanol sponge before opening it.
Over-dosage of this product and the resulting efficacy or safety have not been established (Insufficient clinical data).
Treatment when overdosed: This product has been reported for high dosage use in the treatment of chronic Hepatitis. However, the advantage and safety validity for high dose is not established (Insufficient clinical data).

Contraindication
Do not use it for patients who have an allergic reaction to this medicine and the ingredients of this medicine.
The product should be administered with care in patients predisposed to allergies.

Side Effects
Shock: Shock may occur due to the proteins or amino acids in human tissues. If this occurs, stop administration and take proper treatment immediately.
Allergic reactions: Stop administration immediately if symptoms of shivering and chills, high fever, or rash occur.
Injection site: Pain, redness, and hardening may occur.
Hypersensitiveness: Skin symptoms and edema, such as urticarial, may appear.
Others: There may be breast growth development occur. If such symptoms occur, stop administration immediately.

Warning
Side effects may be caused by the shard of glass mixed into the substance during the opening of the ampoule by breaking it. Be sure extra cautious when breaking the ampoule. Moreover, keep out of the reach of children and elderly.
The main ingredient of this product is the human placenta. However, although safety measures are taken to prevent infection during the manufacturing process, it is theoretically impossible to fully eliminate the risks of infection transmission originating in a human placenta used as raw material. Therefore, a moderate dosage is recommended.

Other (Clinical revaluation results)
194 patients (95 in the experimental group and 99 in the control group) with abnormal alcoholic hepatitis and non-alcoholic fatty liver disease exceeding 1.5 times the normal value of ALT (40 U/L) were evaluated for efficacy and safety. In the results of the clinical trial of the injection for 6 weeks, the ALT value at the time of completion of treatment was compared with that before treatment. More than 20% of the improved test subject evaluation values were less effective than the control group.
In the safety evaluation results of clinical trials, the rate of side effects occurring was 20% (19 patients out of 95 patients, 21 cases), which was not related to the use of this product. Among them, there was 1 case of rash side effect that occurred due to the use of this product, that's 1.05% (1 patient out of 95 patients, 1 case).

This product is a medical device. Customs clearance may be difficult depending on each country's rules and regulations. So please check the customs clearance situation in each country before ordering.