SYNTHOMYCINE 3 %

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

CHLORAMPHENICOL

Disponibil de la:

TEVA ISRAEL LTD

Codul ATC:

D10AF03

Forma farmaceutică:

OINTMENT

Compoziție:

CHLORAMPHENICOL 3 %

Calea de administrare:

DERMAL

Tip de prescriptie medicala:

Required

Produs de:

TEVA ISRAEL LTD, ISRAEL

Grupul Terapeutică:

CHLORAMPHENICOL

Zonă Terapeutică:

CHLORAMPHENICOL

Indicații terapeutice:

Antibiotic.

Data de autorizare:

2021-12-31

Prospect

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s
prescription only
Synthomycine 3%
Skin ointment
Composition
Chloramphenicol 3%
For information regarding inactive ingredients and
allergens,
see
section
2
“Important
information
about some of the ingredients of the medicine” and
section 6 – “Additional information”.
Read the entire leaflet carefully before using the
medicine. This leaflet contains concise information
about
the
medicine.
If
you
have
additional
questions, refer to the doctor or the pharmacist.
This
medicine
has
been
prescribed
for
your
treatment. 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 IS THE MEDICINE INTENDED
FOR?
For treating superficial skin infections caused by
microorganisms sensitive to chloramphenicol.
Therapeutic class
Topical antibacterial.
2. BEFORE USING THE MEDICINE
Do not use this medicine if:
•
You are sensitive (allergic) to chloramphenicol
or to any of the other ingredients this medicine
contains (see below in the section “Important
information about some of the ingredients of the
medicine” and section 6 “Additional information”).
•
You or any of your family members have a
history of anemia, bleeding or other problems
in the blood system or bone marrow. These
problems may include a severe drop in the
amount of red blood cells or lower than normal
blood count.
Special
warnings
regarding
the
use
of
the
medicine
This preparation contains chloramphenicol, which
may
cause
changes
in
the
blood
profile
upon
prolonged use. Therefore, prolonged use of the
preparation should be avoided.
The preparation is not intended for use in the eyes,
do not allow the preparation to come into contact
with them. In case of contact with the eyes, wash
them immediately with water.
Drug interactions
If
you
are
taking,
or
have
recently
taken,
other
medicines,
including
non-prescription
medicines
and
nutritional
supplements,
tell

Caracteristicilor produsului

Synthomycine 3% FW Notification 12/2023
Summary of Product Characteristics
Synthomycine 3%
Dermal Ointment
1.
NAME OF THE MEDICINAL PRODUCT
Synthomycine 3%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition
Active Ingredient
Chloramphenicol
3%
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment.
Yellow ointment.
4.4
Special warnings and precautions for use
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Antibiotic.
Chloramphenicol
is
effective
against
certain
protozoa,
rickettsia
and
virus-like
infections, as well as against many Gram-positive and Gram-negative
bacteria. It is
useful in the treatment of superficial pyodermas, impetigo, acute
folliculitis, seborrhea-
like streptodermatitis, and infectious eczematoid dermatitis.
4.2
Posology and method of administration
Direction for use
Patients should be cautioned to report to their physician if no
improvement in their
condition occurs after 4-5 days of treatment.
Apply to the infected area 3-4 times daily after cleansing.
4.3
Contraindications
Known hypersensitivity to any of the active ingredients or to any of
the excipients
listed in section 6.1.
Patients who have experienced myelosuppression during previous
exposure to
chloramphenicol.
Synthomycine 3% FW Notification 12/2023
Patients with a known personal or family history of blood dyscrasias
including
aplastic anaemia.
4.4
Special warnings and precautions for use
This medicine is not intended for ophthalmic application.
Chloramphenicol toxicity has been reported following chronic exposure.
Discontinue promptly if sensitization or irritation occurs.
The use of chloramphenicol may occasionally result in overgrowth of
non-
susceptible organisms, including fungi. If any new infection appears
during
treatment, the antibiotic should be discontinued and appropriate
measures taken.
In severe infections the topical use of chloramphenicol should be
supplemented by
appropriate systemic treatment.
Prolonged or frequent intermittent use of topical chloramphenicol
should be avoided,
b