DANALONE

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

PREDNISOLONE

Disponibil de la:

MEGAPHARM LTD

Codul ATC:

H02AB06

Forma farmaceutică:

SYRUP

Compoziție:

PREDNISOLONE 3 MG / 1 ML

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Grupul Terapeutică:

PREDNISOLONE

Zonă Terapeutică:

PREDNISOLONE

Indicații terapeutice:

For glucocorticoid respousive inflamination as: Endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states and gastrointestinal diseases.

Data de autorizare:

2020-12-31

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed with
a physician’s prescription only
DANALONE
SYRUP
Active ingredient and its concentration:
Each 1 ml contains: Prednisolone 3 mg
Inactive ingredients in this medicine - see section 6 “Additional
information”. See also “Important information about some of the
medicine’s ingredients” in section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have any further questions, consult your
physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Danalone is a glucocorticoid with an anti-inflammatory effect.
Danalone is intended to treat inflammations that respond to
glucocorticoids, for example: endocrine disorders, rheumatic
disorders, hematologic disorders, collagen diseases, ophthalmic
diseases, dermatologic diseases, respiratory diseases,
neoplastic diseases, gastrointestinal diseases, allergic and
edematous conditions.
THERAPEUTIC GROUP: Corticosteroids.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive )allergic( to the active ingredient or to
any of the additional ingredients contained in the medicine
)see section 6(. Symptoms of a severe allergic reaction
may include a red and lumpy skin rash, difficulty breathing,
swelling of the face, mouth, lips or eyelids, unexplained high
temperature, and feeling faint. IF THE SWELLING AFFECTS YOUR
THROAT AND MAKES BREATHING AND SWALLOWING DIFFICULT, GO
TO A HOSPITAL STRAIGHT AWAY.
•
You have an infection that affects your entire body )unless
you are receiving treatment for the infection(.
•
You have recently had a “live” vaccination.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE TREATMENT WITH DANALONE, TELL THE PHYSICIAN IF:
• You suffer, or h

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
DANALONE SYRUP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of syrup contains 3mg of prednisolone.
It also contains 0.86 mg of sodium, 0.36 g sucrose, 36.1 mg ethanol ,
0.23 g propylene glycol and 1 mg
benzoic acid.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup
Colourless to slightly yellowish, clear liquid, with typical
vanilla-apricot odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glucocorticoid with anti-inflammatory activity.
This medicine is intended for the treatment of glucocorticoid
responsive inflammations, such as:
endocrine disorders, rheumatic disorders, hematologic disorders,
collagen diseases, ophthalmic
diseases, dermatologic diseases, respiratory diseases, neoplastic
diseases, gastrointestinal diseases,
allergic and edematous conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest dosage that will produce an acceptable result should be
used (see section 4.4); when it is
possible to reduce the dosage, this must be accomplished by stages.
During prolonged therapy any
intercurrent illness, trauma or surgical procedure will require a
temporary increase in dosage; if
corticosteroids have been stopped following prolonged therapy they may
need to be temporarily re-
introduced.
ADULTS:
The dose used will depend upon the disease, its severity, and the
clinical response obtained.
The following regimens are for guidance only. Divided dosage is
usually employed.
SHORT-TERM TREATMENT:
20mg (6.7ml) to 30mg (10ml) daily for the first few days, subsequently
reducing the daily dosage by 2.5mg (0.8ml) or 5mg (1.67ml) every two
to five days, depending upon
the response.
RHEUMATOID ARTHRITIS:
7.5mg (2.5ml) to 10mg (3.3ml) daily. For maintenance therapy the
lowest
effective dosage is used.
MOST OTHER CONDITIONS:
10mg (3.3ml) to 100mg (33.3ml) daily for one to three weeks, then
reducing
to the minimum effective dosage.
CHILDREN:
Fractions of the adult dosage may be used (e.g. 75% at 12 years