Stronger Neo-Minophagen C 53mg/20ml(40mg/20ml)+400mg/20ml+22,29mg/20ml (20mg/20ml) solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, L-cysteine hydrochloride hydrate (L-cysteine hydrochloride)

Available from:

Minophagen Pharmaceutical Co.

ATC code:

A05B

INN (International Name):

monoammonium glycyrrhizinate (glycyrrhizic acid), glycine, L-cysteine hydrochloride hydrate (L-cysteine hydrochloride)

Dosage:

53mg/20ml(40mg/20ml)+400mg/20ml+22,29mg/20ml (20mg/20ml)

Pharmaceutical form:

solution for injection

Units in package:

(30) ampoules 20ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-04-08

Patient Information leaflet

AGENT FOR LIVER DISEASE / ANTIALLERGIC AGENT
Stronger Neo-Minophagen
®
C
Storage: Store at 1-30°C
Expiration date: Specified on the outer package and label.
Caution: Use only pursuant to the prescription of a physician, etc.
CONTRAINDICATIONS
This product is contraindicated in the following patients:
(1) Patients with a history of hypersensitivity to any of the
ingredients of this product
(2) Patients with aldosteronism, myopathy and hypokalaemia [There is a
concern
about aggravation of hypokalaemia, hypertension or the like.]
DESCRIPTION
1. COMPOSITION
Ingredients per ampoule
20mL
Active ingredients
Monoammonium glycyrrhizinate
(as Glycyrrhizic acid)
53mg
(40mg)
Glycine (JP)
400mg
L-Cysteine hydrochloride hydrate (JP)
(as L-Cysteine hydrochloride)
22.29mg
(20mg)
Inactive ingredients
Dried sodium sulfite (JP)
16mg
Sodium chloride (JP)
100mg
Ammonia water (JP)
q.s
JP: Japanese Pharmacopoeia
2. DESCRIPTION
Product description
This product is a colorless, clear aqueous injection
in glass ampoules.
pH
6.0 to 7.0
Osmotic pressure ratio
1.5 to 1.7 (ratio relative to isotonic sodium chloride
solution)
INDICATIONS
Eczema or dermatitis, urticaria, pruritus, drug eruption or
toxicoderma, stomatitis, infant
strophulus, phlycten
Improvement of abnormal hepatic function in chronic liver diseases
DOSAGE AND ADMINISTRATION
The usual adult dosage for intravenous use is from 5 to 20 mL once a
day. Dose should
be adjusted according to the patient’s age and symptoms.
For chronic liver diseases, the daily dosage is from 40 to 60 mL once
a day by intrave-
nous injection or intravenous drip infusion. The dosage may be
adjusted depending on
the patient’s age and symptoms. If an increased dosage is required,
the daily dosage
should be kept within the limit of 100 mL.
PRECAUTIONS
1. CAREFUL ADMINISTRATION
This product should be administered with caution to the following
patients.
The elderly [A higher incidence of hypopotassemia or the like is
known.] (See “Use in
the Elderly”.)
2. IMPORTANT PRECAUTIONS
(1) Patients should be c

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
STRONGER NEO-MINOPHAGEN
® C
Minophagen Pharmaceutical Co., Ltd.
2
1. NAME OF THE MEDICINAL PRODUCT
Stronger Neo-Minophagen
®
C
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains the following active ingredients in 20 mL
solution:
Monoammonium Glycyrrhizinate
53 mg (40 mg as Glycyrrhizic Acid)
Glycine
400 mg
L-Cysteine Hydrochloride Hydrate
22.29 mg (20 mg as L-Cysteine Hydrochloride)
For a full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
This product is a colourless, clear aqueous injection in glass
ampoules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Improvement of abnormal hepatic function in chronic liver diseases
Eczema or dermatitis, urticaria, pruritus, drug eruption or
toxicoderma, stomatitis, infant
strophulus, phlycten
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual adult dosage for intravenous use is from 5 to 20 mL once a
day. Dose should be
adjusted according to the patient’s age and symptoms.
For chronic liver diseases, the daily dosage is from 40 to 60 mL once
a day by intravenous
injection or intravenous drip infusion. The dosage may be adjusted
depending on the patient’s
age and symptoms. If an increased dosage is required, the daily dosage
should be kept within
the limit of 100 mL.
4.3 CONTRAINDICATIONS
This product is contraindicated in the following patients:
(1) Patients with a history of hypersensitivity to any of the
ingredients of this product
(2) Patients with aldosteronism, myopathy and hypokalaemia [There is a
concern about
aggravation of hypokalaemia, hypertension or the like.]
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Careful Administration
This product should be administered with caution to the following
patients.
The elderly [A higher incidence of hypopotassemia or the like is known
] (See “Use in the
Elderly”.)
Important Precautions
(1) Patients should be carefully interviewed to assess the risk of
shock and the like.
(2) Emergency treatment should be ready for the occurrence of shock.
(3) Af