LAENNEC Injection Placental Extract Philippines

LAENNEC

Human-placental extract

Liver function improving drug/hepatic reserve-function vehicle

Specialized Biological Products/Prescription drug

1 tray of 10 ampoules

(also available: 1 box of 50 ampoules)

GUARANTEED AUTHENTIC

• retail and wholesale orders are accepted
• includes syringes
• for shipping via JRS (Monday to Saturday, except holidays), payments can be made through bank deposit
• for inquires or orders, call or text 0917 538 6088

Please do note that no website, advertising, or opinion can replace consultation with an expert physician and before making any decision on using this product, it is advisable to speak to your doctor first.

 Package leaflet says:

CONTRAINDICATION (Laennec is contraindicated in the following patients)

Patients with history of hypersensitivity to the product

COMPOSITION

Each 1 ml of this product contains 1 ml of human placenta hydrolysis (by extracting)

APPEARANCE

The product is 2ml injectable brown ampoule containing light yellow-brown or yellow-brown transaprent liquid.

INDICATION(S)

Improvement of hepatic function in chronic hepatic disease

DOSAGE AND ADMINISTRATION

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.

PRECAUTIONS FOR USE

Warning

1.) When cutting ampoules, adverse events can occur by glass fragments. Be careful to minimize contamination of glass fragment, especially to children and the elderly.

2.) 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 human placenta used as raw material.

1. Inject with care

Patients predisposed to allergies

2. General precaution

While safety measures during the manufacturing process to prevent infection, as well as confirmation of the necessity of treatment for the disease before administration are carried out, doctors should explain to patients and try to have them understand that when human placenta is used as the raw material of the product, the risk of infection cannot be fully ruled out.

3. Adverse event

1.) Shock

Since this product is a protein/amino acid preparation derived from human tissue, this product may cause a shock. If any signs of abnormality are observed, the drug should be discontinued immediately, appropriate measures should be taken and the condition should be monitored fully.

2.) Hypersensitivity

Occasionally chills, rash, fever etc. may occur

3.) Injection site:

Occasionally local reaction such as pain, redness and induration may  occur in injection site.

4.) Sometimes gynaecomastia may occur, injection should be discontinued in this case.

4. Geriatric use

Since elderly patients often have reduced physiological function, it should be administered with care.

5. Administration for pregnant or lactating women

In reproductive development toxicity experiments on animals, including teratogenicity, this product can be considered not to have such toxicity. With the previous experience, no adverse events reported in pregnant or lactating women

6. Pediatric use

The safety of this product in premature infants, newborns, infants, toddlers or children has not been established (Due to insufficient clinical data).

7. Overdose

Treatment of fulminant hepatitis has been reported in the mass treatmaent. But overdosage of this product and the resulting efficacy or safety have not been established (Due to insufficient clinical data).

8. Precaution for administration

1) In order to avoid any effect on tissue or nerves, this product should be injected subcutaneously or intramuscularly taking the following precautions.

(1) For the injection site, to avoid nerve pathways, it should be administered with care

(2) In the case of repeated injections, avoid injecting into the same site by alternating on the left and right side, etc.

(3) If intense pain or regurgitation of blood is observed, the needle should be removed immediately, and injected into a different site.

2) Opening the ampoule, it is preferable to wipe the part to be cut with an alcohol swap before opening it.

3.) When this product is directly mixed with a strong base prepraation of pH8.5 or more, attenuation of pharmacological activity has been reported.

9. Others (Clinical re-evaluation results)

1) This study was conducted for 194 subjects (test group 95, control group 99) with alcoholic hepatitis or non-alcoholic steatohepatitis whose ALT level were over 1.5 times of acceptance criteria (40U/L) in order to see the safety and efficacy.

Drug product was administered maximum for 6 weeks, and the efficay endpoint was the subject rate of improvement more than 20% of prior ALT level.

Accordingly, the efficacy showed that the efficacy was non-inferior to control group.

2) According to safety evaluation, adverse events not related to drug product were 20% (19 out of 95 subjects, 21 cases) and the adverse drug reactions related to drug product were 1.05% (1 out of 95 subjects, 1 case).

HOW SUPPLIED

2ml *10 ampoules

2ml *50 ampoules

Manufactured by

GCJBP Corp.

156-50 Naesong-ri, Geumwang-eup, Eumsung-gun, Chungbuk, Korea

(Under the technical operation between Japan Bio Products co., Ltd. and GCJBP Corp.)

Distributed by

Japan Bio Products Co., Ltd.

1-44-4, Tomigaya, Shibuya-ku, Tokyo, Japan 151-0063