DIPROSPAN INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BETAMETHASONE AS DIPROPIONATE; BETAMETHASONE SODIUM PHOSPHATE

Available from:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC code:

H02AB01

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

BETAMETHASONE SODIUM PHOSPHATE 2 MG/ML; BETAMETHASONE AS DIPROPIONATE 5 MG/ML

Administration route:

I.M, INTRADERMAL, INTRA-ARTICULAR, INTRABURSAL, PERIARTICULAR, SOFT TISSUE INJECTION, INTRALESIONAL

Prescription type:

Required

Manufactured by:

ORGANON LLC, USA

Therapeutic group:

BETAMETHASONE

Therapeutic area:

BETAMETHASONE

Therapeutic indications:

Produces anti-inflammatory, anti rheumatic and anti-allergic action and is indicated for systemic and local therapy of acute and chronic corticosteroid-responsive disorders.

Authorization date:

2020-08-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon physician’s prescription only
DIPROSPAN
® INJECTION
SUSPENSION FOR INJECTION
Each ml of DIPROSPAN INJECTION contains:
Betamethasone dipropionate equivalent to 5 mg Betamethasone.
Betamethasone sodium phosphate equivalent to 2 mg Betamethasone.
For a list of inactive ingredients see section 6 "Further
information". See also section 2.8 “Important
information about some of the ingredients of the medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about the medicine. If you
have any further questions, refer to the
doctor 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.
1. WHAT DIPROSPAN IS INTENDED FOR?
Produces anti-inflammatory, anti-rheumatic and anti-allergic action
and is indicated for systemic and local
therapy of acute and chronic corticosteroid-responsive disorders.
THERAPEUTIC GROUP: DIPROSPAN belongs to a group of medicines called
‘corticosteroids’. These
medicines help relieve parts of the body affected by inflammation.
They work by reducing swelling, redness,
itching, and allergic reactions. They are used to treat a number of
problems.
2.
BEFORE USING DIPROSPAN
2.1 DO NOT USE DIPROSPAN IF:
•
You are sensitive (allergic) to betamethasone dipropionate or
betamethasone sodium phosphate or
any of the other ingredients that this medicine contains. For a list
of inactive ingredients, see section 6
"Further information".
•
You are allergic to other corticosteroids.
•
You have a fungal infection - please tell your doctor before using
DIPROSPAN
. Your doctor may want
to treat the infection before you use DIPROSPAN.
2.2 SPECIAL WARNINGS REGARDING USE OF DIPROSPAN
BEFORE STARTING TREATMENT WITH DIPROSPAN, TELL YOUR DOCTOR IF YOU:
•
are diabetic
•
have thyroid problems
•
have

Summary of Product characteristics

DIPROSPAN
® INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Diprospan
®
Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone dipropionate 6.43 mg/ml (equivalent to 5 mg of
betamethasone) and betamethasone
sodium phosphate 2.63 mg/ml (equivalent to 2 mg of betamethasone).
Excipients with known effect:
This medicinal product contains 9 mg of benzyl alcohol per mL.
Diprospan contains (methyl parahydroxybenzoate) and Diprospan contains
(propyl
parahydroxybenzoate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection
Diprospan suspension for injection is a clear, colourless, slightly
viscous liquid containing easily re-
suspendable white to off-white particles, free from foreign matter.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DIPROSPAN Sterile Aqueous Suspension is indicated for the treatment of
acute and chronic
corticosteroid-responsive disorders such as the following conditions:
MUSCULOSKELETAL AND SOFT TISSUE CONDITIONS:
Rheumatoid
arthritis,
osteoarthritis,
bursitis,
ankylosing
spondylitis,
epicondylitis,
radiculitis,
coccydynia, torticollis, sciatica, lumbago, ganglion cyst, exostosis,
fasciitis.
ALLERGIC CONDITIONS:
Chronic bronchial asthma (including adjunctive therapy for status
asthmaticus), hay fever, angioneurotic
edema, allergic bronchitis, seasonal or perennial allergic rhinitis,
drug reactions, serum sickness, insect
bites.
DERMATOLOGIC CONDITIONS:
Atopic dermatitis (nummular eczema), neurodermatitis (circumscribed
lichen simplex), necrobiosis
lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus,
psoriasis, keloids, pemphigus,
dermatitis herpetiformis, urticaria, hypertrophic lichen planus,
contact dermatitis, severe solar
dermatitis, cystic acne.
COLLAGEN DISEASES:
Disseminated lupus erythematosus, scleroderma, dermatomyositis,
polyarteritis nodosa.
NEOPLASTIC DISEASES:
For palliative management of leukemias and lymphomas in adults; acute
leukemia of childhood.
OTHER CONDITIONS:
Adrenogenital syndrome, ulcerative colit