Orlobin solution for injection/infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

amikacin (amikacin sulfate)

Available from:

Help S.A.

ATC code:

J01GB06

INN (International Name):

amikacin (amikacin sulfate)

Dosage:

250mg/ml

Pharmaceutical form:

solution for injection/infusion

Units in package:

(1) glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-10-23

Patient Information leaflet

PLEASE READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING YOUR MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMA
-
TION FOR YOU.
-
Please keep this leaflet. You may need to
read it again.
-
If you have any further questions, ask your
doctor.
-
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
-
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What ORLOBIN is and what it is used for
2. What you need to know before you are given
ORLOBIN
3. How ORLOBIN is given
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT ORLOBIN IS AND WHAT IT IS USED FOR
The name of this medicine is ORLOBIN.
Amikacin is an antibiotic and belongs to the
group of medicines called aminoglycosides.
ORLOBIN is used to treat serious infections
caused by certain bacteria.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN ORLOBIN
DO NOT USE ORLOBIN IF:
• You are allergic (hypersensitive) to any of the
ingredients in ORLOBIN or other antibiotics.
• You suffer from myasthenia gravis (a
disease that causes muscle weakness).
If any of the above affects you, or you are
unsure if they do, tell your doctor who will be
able to advise you.
YOU MUST TELL YOUR DOCTOR IF:
• You have any kidney problems.
• You have any hearing problems or other
problems with your ears.
• You have any muscular disorders such as
Parkinson’s Disease.
Take caution if you are elderly.
Take caution if you are dehydrated (ensure you
are well hydrated during treatment).
OTHER MEDICINES AND ORLOBIN
Always tell your doctor or pharmacist about
any other medicines you may be taking or have
recently taken including those obtained without
a prescription before you are given ORLOBIN.
Some medicines can have an affect on the ac
-
tion of other medicines. It is especially important
that you tell your doctor if you are ta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
ORLOBIN
®
(amikacinsulfate)
1. NAME OF THE MEDICINAL PRODUCT
ORLOBIN 100 MG/2MLSOLUTION FOR INJECTION/INFUSION
ORLOBIN 250 MG/2ML SOLUTION FOR INJECTION/INFUSION
ORLOBIN500 MG/2MLSOLUTION FOR INJECTION/INFUSION
ORLOBIN 1000 MG/4MLSOLUTION FOR INJECTION/INFUSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Orlobin100 mg/2mlsolution for injection/infusion:Each vial contains in
2 mL amikacin
sulfate equivalent to amikacin activity 100 mg. Excipient with known
effect: Each vial
contains2.6 mg sodium bisulphite (E223).
Orlobin250 mg/2mlsolution for injection/infusion:Each vial contains in
2 mL amikacin
sulfate equivalent to amikacin activity 250 mg. Excipient with known
effect: Each vial
contains6.5 mg sodium bisulphite (E223).
Orlobin500 mg/2mlsolution for injection/infusion: Each vial contains
in 2 mL amikacin
sulfate equivalent to amikacin activity 500 mg. Excipient with known
effect: Each vial
contains13.2mg sodium bisulphite (E223).
Orlobin1000 mg/4mlsolution for injection/infusion:Each vial contains
in 4 mL amikacin
sulfate equivalent to amikacin activity 1000 mg. Excipient with known
effect: Each
vial contains 26.4 mg sodium bisulphite (E223).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection/infusion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amikacin sulfate is an aminoglycoside antibiotic which is active
against a broad
spectrum of Gram-negative organisms, including _Pseudomonas_ spp,
_Escherichia _
_coli_, indole-positive and indole-negative _Proteus_ spp,
_Klebsiella-Enterobacter-_
_Serratia_ spp, _Salmonella, Shigella_, _Minea-Herellae, Citrobacter _
_freundii_ and _Providencia_ spp.
Many strains of these gram-negative organisms resistant to gentamicin
and
tobramycin may show sensitivity to amikacin _in vitro_. The principal
Gram-positive
organism sensitive to amikacin is _Staphylococcus aureus_, including
methicillin-
resistant strains. Amikacin has some activity against other
Gram-positive organisms
including cert