Kefentech plaster plaster transdermal

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

ketoprofen

Tilgjengelig fra:

Jeil Health Science Inc

ATC-kode:

M01AE03

INN (International Name):

ketoprofen

Dosering :

30mg

Legemiddelform:

plaster transdermal

Enheter i pakken:

(7) in pack

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2019-12-24

Preparatomtale

SUMMARY OF PHARMACEUTICAL PRODUCT
1.
PRODUCT NAME
Kefentech plaster
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION Each plaster (10cm × 7cm,
1,25g) contains ;
_ Active substance_ Ketoprofen 30.0mg
_Excipient _ Mineral oil q.s
_Adhesive agent_ Alkyl acrylate/Vinyl acetate Copolymer Solution
(solid 48%) 384.0 mg
_Solubilizer _ Isopropyl Myristate 10.0mg
_Solubilizer _ Tocopherol Acetate 18.0mg
_Solubilizer_ Concentrated Glycerin 28.0mg
_Supporting fabric_ Lint Fabric q.s
_Covering agent_ Release Paper q.s
3.
PHARMACEUTICAL FORM
Plaster
4.
CHARACTERISTICS
A colorless, transparent, and adhesive agent is applied to the lint
fabric and then the
solid surface of a plaster is coated with non-woven fabric.
5.
INDICATIONS
Anti-inflammation and soothing of pain caused by following diseases
and symptoms;
1)
Degenerative arthritis(Osteoarthritis)
2)
Periarticular inflammation of shoulder
3)
Tendinitis, tenosynovitis
4)
Peritendinitis
5)
Epicondylitis of humerus(such as tennis elbow, etc)
6)
Myalgia
7)
Pain and swelling following trauma
6.
DOSAGE AND ADMINISTRATION
Remove the nonwoven fabric and then apply to the affected part twice
daily.
7.
PRECAUTIONS
_(1)_
_ _
_CONTRAINDICATION _
1)
Patients with hypersensitivity to any ingredients of this product
2)
Patients with aspirin asthma (asthmatic attack due to NSAIDs) or
patients
with a history thereof (It may cause asthmatic attack)
3)
History of hypersensitivity to the following drugs: Tiaprofenic Acid,
Fenofibrate, Bezafibrate, Ciprifibrate, Oxybenzone
(It may cause cross-hypersensitivity)
4)
Pregnant woman of the last trimester: In rat with this drug during
late
pregnancy, premature closure of the ductus arteriosus has been
reported. In oral
administration during late pregnancy (oral,injection, rectal infusion)
Persistent fetal
circulation (PFC) and fetus renal failure have been reported.
5)
Pediatrics below 15years of age
_(2)_
_ _
_THIS MEDICINE SHOULD BE ADMINISTERED WITH CARE IN THE FOLLOWING
PATIENTS. _
1)
Patients with bronchial asthma (It may cause asthmatic attack)
2)
U