Model: KEFENTECH Plaster Pain Relief Patches
Size: 2.7 x 3.9 inch
Made in Korea South, JEIL Pharmaceutical Co., Ltd. Foundation 1959
Expire date: 2019-10-23 or Better
Kefentech the sophisticated therapeutics for arthritis was developed By JEIL Pharmaceutical Co., Ltd. in Korea.
Kefentech is an effective and safe therapeutic plaster for arthritis without systemic side effects like G.I. troubles, hepatotoxicity or nephrotoxicity, and prolonged effect by constant drug delivery is another uniqueness of Kefentech. The excellence of ketoprofen is already well known worldwide, Its effect and safety were innovated by new delivery system of Kefentech, the plaster for muscular pain, osteoarthritis and rheumatoid arthritis.
1. ACTIVE INGREDIENT : Ketoprofen 30mg / 1 sheet (7cm X 10cm ; 2.4g)
* MW: 254.29
2. DIRECTIONS / DOSE : Twice daily, Apply to the sites of pain
(PK Data is shown 1’s patch per day)
3. INDICATIONS :
* Arthritis deformans
* Rheumatoid arthritis
* Periarthritis humelo-scapularis
* Tennis elbow
* Muscular pain
* Contusion, Distorsion
(1) Comparison between Ketoprofen TDS plaster and Ketoprofen orally administration
— Ketoprofen TDS plaster can reduce systemic side effects such as gastric irritation or nephrotoxicity in every kind of orally administered NSAID.
— Ketoprofen TDS plaster can attain constant drug delivery through skin which can reduce fluctuations in local drug concentrations, therefore can rapidly achieved effective tissue levels, as well as can attain higher drug concentration at local tissues such as muscle and joint with less systemic exposure to the drug.
(2) Comparison between Ketoprofen TDS plaster and Ketoprofen gel
— Compared with Ketoprofen plaster, it is difficult in controlling the applied area and the amount of drug on the skin when using Ketoprofen gel-type. This can cause serious fluctuation in drug concentration in the tissue.
— Photosensitization Study of Kefentech plaster/Ketoprofen gel in Hartley guinea pigs showed: Kefentech plaster have no photosensitization potential in Guinea pigs. But Ketoprofen gel had a skin photosensitization potential in guinea pigs under the study conditions. The photosensitization potential of the test article was classified as grade III.
COMPOSITION OF KEFENTECH PLASTER
① Backing Layer ( Non-Woven fabric )
– No Allergy
– Air pathway
② Ketoprofen Containing Layer For Prolonged and skin-protecting effect
– Air flow system : Helping skin’s respiration
– IPM (Isopropyl Myristate) : Skin absorption enhancement of drug
– Tocopherol : The ingredient protecting skin and improving blood circulation
– Glycerine : Good for skin moisturizing
③ Film Coated Thin Paper, Protective Effect of Drug
< Precautions >
1.This product should not be administered to the following patients.
1) Patients who ever showed hypersensitivity to this product or any ingredient of this product.
2) Patients with aspirin asthma (asthmatic attack by non-steroidal analgesic or anti-inflammatory drug) or the history of the disease. (They may have asthmatic attack.)
2.This product should be carefully administered to the following patients.
1) Patients with bronchial asthma. (They may have asthmatic attack.)
2) Patients under medical treatment.
1) In rare cases, anaphylactic symptoms (hives, dyspnea, facial edema, etc.) may occur. Therefore, if such symptoms occur, stop use of this product.
2) Asthmatic attack may occur. If early symptoms, such as rhonchus, stridulous, or dyspnea, occur, immediately stop use of this product. Such asthmatic attack may occur in a few hours after administration of this product.
3) Skin: Pigmentation, xeroderma, and contact dermatitis, such as flare, eruptive, itch, bleb, maceration, irritation, and swelling, may occur. In addition, the direct ray of light (ultraviolet ray) may cause photosensitization disease and the whole body may have rashes. Stop use of this product, if such symptoms are severe.
1) Use of analgesic anti-inflammatory drug is not a causal treatment, but a symptomatic therapy.
2) This product may cause inapparent skin infection. Therefore, if used for treatment of inflammation caused by infection, be sure to use appropriate antibiotics or anti-fungal agents at the same time and to observe carefully if there are any adverse reactions.
3) If this product is used for treatment of chronic diseases (such as degenerative arthritis (osteoarthritis), consider other treatment method rather than drug therapy. In addition, be sure to observe carefully the patients if there are any adverse reactions.
4) If there is no improvement when used for about 1 week, stop use of this product and consult the doctor or pharmacist.
5.Pregnant or nursing women
1) When this product was orally administered to rats at the late stage of pregnancy, contraction of fetal arterial blood vessel was reported.
2) Administration of this product at the late stage of pregnancy (oral, injection, or rectal infusion) was reported to result in continuous fetal circulation and fetal renal insufficiency.
3) Safety in pregnant and nursing women has not been established. So, massive or broad use of this product for long-term period should be avoided for pregnant, gestational, and nursing women.
Safety in premature babies, newborn babies, infants, and young children has not been established (only a few clinical cases).
1) Do not use this product to eyes or mucous membrane.
2) Administration of this product to damaged skin, mucous membrane, eczema, or eruption may result in temporary irritation or numbing.
3) Do not use this product for treatment of athlete’s foot or tinea.
4) Do not use this product in the occlusive dressing manner.