ZYVOXID 600 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

LINEZOLID

Dostopno od:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Koda artikla:

J01XX08

Farmacevtska oblika:

TABLETS

Sestava:

LINEZOLID 600 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

PFIZER INC, USA

Terapevtsko območje:

LINEZOLID

Terapevtske indikacije:

Therapy is indicated only when an organism resistant to all other antibiotics is suspected. Zyvoxid is indicated in adult and pediatric patients for the treatment of infections when known or suspected to be caused by susceptible organisms including those associated with concurrent bacteraemia such as: 1) Pneumonia - community acquired and nosocomial pneumonia including multi drug resistant streptococcus pneumonia (MDRSP). 2) Skin and soft tissue infections including diabetic foot infections. 3) Enterococcal infections. Combination therapy may be indicated if a concomitant Gram negative pathogen is documented or suspected.

Datum dovoljenje:

2021-06-30

Navodilo za uporabo

.بيبطلا ىلإ
ً
اروف هجوت - ةيلصلأا ضارعلأا تداعو
ءاودلا لوانت نع تفقوت اذإ
.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا
.يلطم هنلأ صرقلا غضم/رطش/قحس عنم
ُ
ي
ً
اروف هجوت ،ءاودلا نم أطخلاب لفط علب
اذإ وأ
ً
اطرفم
ً
ايئاود
ً
ارادقم تلوانت اذإ
.ءاودلا ةبلع كعم رضحأو ىفشتسملا يف
ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ
لاح يئاود رادقم لوانت بجيف ،ددحملا
تقولا يف ءاودلا اذه لوانت تيسن اذإ
،اذه يئاودلا رادقملا نم
ً
اءدب يلاتلا يئاودلا رادقملا دعوم باسح
بجي .كلذب كركذت
!فعاضم يئاود رادقم لوانت لاوحلأا نم
لاح يأب زوجي لا نكلو
ءاودلاب جلاعلا نع فقوتلا زوجي لا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
.ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
،بيبطلا ةراشتسإ نودب رادقملا نم دكأتلاو ءاودلا عباط صيخشت
بجي !ةمتعلا يف ةيودأ لوانت زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت ةرم لك يف يئاودلا
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
ةيبناجلا ضارعلأا .4
.نيلمعتسملا ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق ديسكوڨيز لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا
:)اهعويشو( ديسكوڨيز ـل ةريطخلا
ةيبناجلا ضارعلأا
:لاح يف بيبطلا ىلإ
ً
اروف هجوتلاو لامعتسلإا نع فقوتلا بجي
ةقطنم يف ة�

Lastnosti izdelka

Zyvoxid LPD CC 131222
Page 1 of 21
2020-0065057
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zyvoxid® I.V. 2 mg/ml Solution for Infusion
Zyvoxid® 600 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution for infusion:
1 ml contains 2 mg linezolid.
Excipients with known effect: each 1 ml also contains 45.7 mg
glucose and 0.38 mg sodium.
600 mg tablet:
Each tablet contains 600 mg linezolid.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion:
Isotonic, clear, colourless to yellow solution with pH range of
4.4-5.2.
600mg tablet:
A white to off-white coated tablet with “ZYV” debossed on one side
and “600” debossed on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Therapy is indicated only when an organism resistant to all other
antibiotics is suspected.
Zyvoxid is indicated in adult and pediatric patients for the treatment
of infections when
known or suspected to be caused by susceptible organisms including
those associated with
concurrent bacteraemia such as:
1) Pneumonia - community acquired and nosocomial pneumonia including
multi drug
resistant streptococcus pneumonia (MDRSP).
2) Skin and soft tissue infections including diabetic foot infections.
3) Enterococcal infections.
Linezolid is active against Gram–positive bacteria only. Linezolid
has no clinical activity against Gram–negative pathogens. Specific
Gram-
negative therapy is required if a concomitant Gram-negative pathogen
is documented or
suspected (see section 4.4 and 5.1).
Linezolid should only be initiated after consultation with a relevant
specialist such as a
microbiologist or infectious diseases specialist.
CONSIDERATION SHOULD BE GIVEN TO OFFICIAL GUIDANCE ON THE APPROPRIATE
USE OF
ANTIBACTERIAL AGENTS.
Zyvoxid LPD CC 131222
Page 2 of 21
2020-0065057
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Zyvoxid
®
solution for infusion and tablets may be used as initial therapy.
Patients who
commence treatment on the parenteral formulation may