ROVAMYCIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SPIRAMYCIN

Available from:

SANOFI ISRAEL LTD

ATC code:

J01FA02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SPIRAMYCIN 1.5 MIU

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SANOFI S.P.A., ITALY

Therapeutic area:

SPIRAMYCIN

Therapeutic indications:

Respiratory tract infections, infections caused by clamydia, cryptosporidiosis pregnancy toxoplasmosis.

Authorization date:

2020-07-31

Patient Information leaflet

ءاودلا عبﺎط صيخشت بجي !ةمتعلا يف
ةيودأ لوﺎنت زوجي لا .ءاود ﺎهيف لوﺎنتت ةرم لك يف يئاودلا
رادقملا نم دكأتلاو
.كلذ رملأا مزل اذإ ةيبطلا تارﺎظنلا عض ،ءاودلا اذه لﺎمعتسإ لوح ةيفﺎضإ ةلئسأ
كيدل ترفوت اذإ
.يلديصلا وأ بيبطلا رشتسإ
ةيبنﺎجلا ضارعلأا )4
ةيبناج
ً
اضارعأ ببسي دق نيسيماﭬور لامعتسإ نإ
،ءاود لكب امك
.ةيبناجلا ضارعلأا ةمئاق نم شهدنت لا
.نيلمعتسملا ضعب دنع
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم
:وحنلا اذه ىلع ةداع ةفنصم ةيبناجلا
ضارعلأا ةريتو
نيجلاعتم 10 نيب نم 1 نم رثكأ ىلع رثؤت :
ً
ادج ةعئاش
جلاعتم 100 نيب نم 10 ىتح 1 ىلع رثؤت :ةعئاش
جلاعتم 1
٫
000 نيب نم 10 ىتح 1 ىلع رثؤت :ةعئاش ريغ
جلاعتم 10
٫
000 نيب نم 10 ىتح 1 ىلع رثؤت :ةردان
جلاعتم 10
٫
000 نيب نم 1 نم لقأ ىلع رثؤت :
ً
ادج ةردان
)ةرفوتملا تايطعملا نم مييقتلا نكمي لا(
فورعم ريغ ترهظ اذإ بيبطلل
ً
لاﺎح هجوتلاو لﺎمعتسلإا نع فقوتلا بجي
:ةيلﺎتلا تﺎملاعلا ىدحإ
:ةعئﺎش
.يسسحت لعف درل ةملاع وه يذلا ،عقبلاب
هيبش حفط -
:فورعم ريغ
دق هذه .ةنوخسو روثب عم مسجلا ةفاك حطس
ىلع رارمحإ
-
Acute Generalized ىمسي ريطخ لعف درل تاملاع
نوكت
ً
ابلاغ ضرعلا اذه ثدحي .Exanthematous Pustulosis
لوانتت لاأ كيلع ،ضرعلا اذه نم تيساق
اذإ .جلاعلا ةيادب يف
.نيسيماريپس ىلع يوتحت ةيودأ قلاطلإا
ىلع
هيبش يدلج حفط( ىرش لمشت ةيساسحل تاملاع
.ةيساسح -
ئجافم

Summary of Product characteristics

2
ROVA-PO-1.5MIU-19.0
Rovamycin - SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
ROVAMYCIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Spiramycin 1.5 MIU for one film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1. Therapeutic indications
Respiratory tract infections, infections caused by clamydia,
cryptosporidiosis pregnancy
toxoplasmosis.
4.2. Posology and Method of Administration
Posology
Patients with normal renal function:
Usually:
-
Adults: 6 to 9 million IU/24 hours, i.e. 4 to 6 tablets per day, taken
as 2 or 3 divided doses.
-
Children: 1.5 to 3 million IU per 10 kg of body weight per day, taken
as 2 or 3 divided doses.
Sore throats should be treated for 10 days.
Prophylaxis of meningococcal meningitis
-
Adults: 3 million IU/12 hours.
-
Children: 75 000 IU/kg/12 hours.
for the duration of treatment for meningococcal meningitis is 5 days.
In patients with renal insufficiency:
No dose adjustment is necessary.
Method of Administration
The tablets should be swallowed whole with a glass of water.
4.3. Contraindications
-
Hypersensitivity to the active substance, other macrolids or to any of
the excipients listed in
section 6.1.
-
Children under 6 years of age, due to the risk of pulmonary aspiration
resulting from the tablet
form.
3
4.4. Special warnings and precautions for use
Cases of severe skin reactions including Stevens-Johnson syndrome,
toxic epidermal
necrolysis, and acute generalised exanthematous pustulosis (AGEP) have
been reported with
Rovamycine. Patients must be informed of the signs and symptoms of
these conditions and
the skin should be closely monitored.
If any signs or symptoms of Stevens-Johnson syndrome, toxic epidermal
necrolysis (e.g.
progressive skin eruption often with blisters or mucosal lesions) or
AGEP (generalised febrile
erythema associated with pustules) (see section 4.8) occur, treatment
must be discontinued
and any further administration of spira