Amikin 100mg/2ml solution for injection vials

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Amikacin sulfate

Tilgjengelig fra:

Vianex S.A.

ATC-kode:

J01GB06

INN (International Name):

Amikacin sulfate

Dosering :

50mg/1ml

Legemiddelform:

Solution for injection

Administreringsrute:

Intravenous; Intramuscular

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05010400; GTIN: 5012712005001

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMIKIN INJECTION
100 MG/2ML
(AMIKACIN SULFATE)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION 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 AMIKIN is and what it is used for
2. What you need to know before you are given AMIKIN
3. How AMIKIN is given
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
1. WHAT AMIKIN IS AND WHAT IT IS USED FOR
The name of this medicine is AMIKIN. Each 2 mL vial contains 100 mg
amikacin sulfate as the
active ingredient.
Amikacin is an antibiotic and belongs to the group of medicines called
aminoglycosides.
AMIKIN is used to treat serious infections caused by certain bacteria.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMIKIN
Do not use AMIKIN if:
• You are allergic (hypersensitive) to any of the ingredients in
AMIKIN 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 AMIKIN
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 AMI

Preparatomtale

OBJECT 1
AMIKIN INJECTION 100 MG / 2 ML (AMIKACIN
SULPHATE)
Summary of Product Characteristics Updated 08-Feb-2018 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
AMIKIN INJECTION 100MG/2ML
2. Qualitative and quantitative composition
Each vial contains in 2 mL amikacin sulfate equivalent to amikacin
activity 100 mg (100,000
international units).
Excipient with known effect: Each vial contains 2.64 mg (0.13 mmol)
sodium metabisulfite (E223).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for administration to human beings by injection.
4. Clinical particulars
4.1 Therapeutic indications
Amikacin sulphate 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 certain strains of _Streptococcus_
_pyogenes_, Enterococci and
_Diplococcus pneumoniae_.
Amikin is indicated in the short-term treatment of serious infections
due to susceptible strains of Gram-
negative bacteria. It may also be indicated for the treatment of known
or suspected staphylococcal
disease.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
For most infections the intramuscular route is preferred, but in
life-threatening infections, or in patients in
whom intramuscular injection is not feasible the intravenous route,
either slow bolus (2 to 3 minutes) or
infusion (0.25% over 30 minutes) may be used