Wobenzym tablets gastro-resistant

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

pancreatin, trypsin, chymotrypsin, bromelain, papain, amylase, lipase, rutoside trihydrate

Available from:

Mucos Emulsionsgesellschaft mbH

ATC code:

առկա չէ (L03AX)

INN (International Name):

pancreatin, trypsin, chymotrypsin, bromelain, papain, amylase, lipase, rutoside trihydrate

Dosage:

300 prot.UA+ 360FIP-U+ 300FIP-U+ 225FIP-U+ 90FIP-U+ 50FIP-U+ 34FIP-U+ 50mg (40/2x20/) and (200/10x20/) in blister, (800) in plas

Pharmaceutical form:

tablets gastro-resistant

Units in package:

300 prot.UA+360FIP-U+300FIP-U+225FIP-U+90FIP-U+50FIP-U+34FIP-U+50mg (40/2x20/) and (200/10x20/) in blister, (800) in plastic bot

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-05-30

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Wobenzym
®
gastro-resistant tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gastro-resistant tablet contains:
Active ingredients
Pancreatin 300 Prot.-UA., Papain 90 FIP-U., Bromelain 225 FIP-U.,
Trypsin 360 FIP-U, Lipase 34
FIP-U., Amylase 50 FIP-U., Chymotrypsin 300 FIP-U., Rutoside
Trihydrate 50,00 mg
For the full list of excipients, see section 6.1.
Excipient(s) with known effect
Lactose: 0.16 g
Sucrose: 0.04 g
Yellow Orange S (E 110) and Ponceau 4R (E 124) - a total of 1.21 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant tablet
Round, biconvex film-coated tablets with a smooth surface, red-orange
color, with a characteristic
odor.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATION
ANGIOLOGY:
thrombophlebitis, postphlebitic syndrome, acute thrombophlebitis of
superficial veins,
endarteritis, vasculitis, obliterating atherosclerosis of lower
extremities, prevention of recurrent
phlebitis, lymphedema.
UROLOGY:
inflammation of urinary and genital organs, cystitis, cystopyelitis,
prostatitis, sexually
transmitted infections.
GYNECOLOGY:
chronic infections of genital organs, adnexitis, mastopathia,
gestosis. To decrease a
frequency and intensity of side effects connected to hormone
replacement therapy.
CARDIOLOGY:
stenocardia, sub-acute stage of myocardial infarction (to improve the
blood rheology).
PULMONOLOGY:
sinusitis, bronchitis, pneumonia.
GASTROENTEROLOGY:
pancreatitis, hepatitis.
NEPHROLOGY:
pyelonephritis, glomerulonephritis.
ENDOCRINOLOGY:
diabetic angiopathy, diabetic rethinopathy, autoimmune thyroiditis.
RHEUMATIC DISEASES:
rheumatoid arthritis, reactive arthritis, Bechterew’s disease.
2
DERMATOLOGY:
atopic dermatitis, acne
SURGERY:
prevention and treatment of postoperative inflammatory conditions,
thrombosis, edema,
adhesive disease, posttraumatic and lymphatic edema, plastic and
reconstructive operations.
TRAUMATOLOGY:
traumas, fractures, distorsis, traumatic injuries, soft tis