AMIJECT NOVO 250 Injection 2ml

Introduction About AMIJECT NOVO 250 INJECTION

AMIJECT NOVO 250 INJECTION contains Amikacin which belongs to a group of
medicines called Aminoglycoside Antibiotic. It is used in the management of
serious infections caused by the bacteria that are sensitive to amikacin such as
respiratory tract and lung infections, gastrointestinal infections, inflammation
of the inner lining of the heart, infected burns, or bacterial infections of the
blood.

Prior to or during the management with AMIJECT NOVO 250 INJECTION, your doctor
might ask you take some diagnostic tests to check your kidney function, hearing
and levels of AMIJECT NOVO 250 INJECTION in your blood.

AMIJECT NOVO 250 INJECTION is not recommended for use in patients with
myasthenia gravis (severe weakness of body muscles). Before receiving AMIJECT
NOVO 250 INJECTION inform your doctor if you have kidney problems, hearing
difficulty or tinnitus (ringing or buzzing in the ears), an antibiotic-related
hearing loss or a mitochondrial mutation disease (a condition caused by
variations in the mitochondrial genome).

AMIJECT NOVO 250 INJECTION should be used with caution in pregnant and
breast-feeding women only if considered necessary. Contact your doctor before
receiving it. Caution must be exercised while using AMIJECT NOVO 250 INJECTION
in premature or new-born infants.

AMIJECT NOVO 250 INJECTION should be used with caution in elderly patients above
the age of 60 years. Consult your doctor before receiving it. The most common
side effects of receiving AMIJECT NOVO 250 INJECTION are tinnitus (ringing in
the ears), hearing problem, inner ear damage, decrease in excretion of urine.
Consult your doctor if the symptoms do not resolve or worsen.

Uses Of AMIJECT NOVO 250 INJECTION

• it is used in the management of serious infections caused by the bacteria that are sensitive to amikacin

How AMIJECT NOVO 250 INJECTION Works

AMIJECT NOVO 250 INJECTION acts on the bacteria and disrupt the important life
functions of the bacteria. It interferes with the present bacteria and disrupts
the cell membrane along with hampering its various cellular function which leads
to bacterial death. It also stops the further spread of the infection this way.

How to use AMIJECT NOVO 250 INJECTION

AMIJECT NOVO 250 INJECTION will be given to you only by a doctor or a nurse into
a vein or muscle as an intramuscular or intravenous injection or as infusion
(drip). Your doctor will determine the correct dose and duration for you based
upon your body weight, age and severity of disease condition.

Side Effects Of AMIJECT NOVO 250 INJECTION

Common

• tinnitus (ringing sensation in the ears)
• hearing problem, inner ear damage
• kidney function problems (nausea, vomiting, loss of appetite, changes in urination, sleep problems)
• decrease in excretion of urine

Uncommon

• infections caused by resistant yeast or bacteria
• nausea
• vomiting
• rash

Rare

• changes in level of blood cells such as reduced platelets and red blood cells, reduced or increased white blood cells (fatigue, weight loss, feeling of being unwell, paleness)
• low levels of magnesium in the blood (fatigues, muscle weakness or cramps, numbness)
• tremors
• sensory disturbances
• headache
• dizziness or vertigo (spinning feeling)
• balance disorders
• abnormal tingling or ‘pins and needles’ feeling
• blindness or other vision disturbances
• retinopathy (changes in the retina of your eye)
• low blood pressure
• phlebitis (inflammation of vein walls)
• itching, hives, joint pain
• muscle twitching
• fever
• liver function changes (dark urine, pale stool, fever, abdominal pain, jaundice)
• increase in heart rate
• heart muscle inflammation

Stop receiving AMIJECT NOVO 250 INJECTION and inform your doctor immediately if
you experience any of the following side effects:

• persisting ringing in your ears
• decrease in the amount of urine you produce
• severe allergic reaction characterised by sudden itchy rash (hives), swelling of the feet, ankles, hands, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), feeling of faintness
• paralysis
• deafness or loss of hearing
• sudden loss of breathing
• severe kidney failure

How To Manage Side Effects

Nausea:

Stick to simple meals while receiving AMIJECT NOVO 250 INJECTION. Avoid eating
rich or spicy food. Do not take any medication by yourself. Ask for your
doctor’s advice if nausea doesn’t improve or worsens.

Vomiting:

Eat light, bland foods and avoid oily, deep fried or sweet foods. Avoid
carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve or
worsens.

Headache:

Rest and relax. Consume plenty of electrolytes and water. If necessary, apply a
balm to the head to relieve the pain. Do not consume alcohol. Consult your
doctor if the headache did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. If you feel dizzy, avoid from driving
or operating machinery. Avoid alcohol consum
Contact your doctor if dizziness worsens.

Rash:

Hot water may irritate your skin, so avoid taking hot showers. Do not scratch
the affected area. Contact your doctor if rash worsens.

Warning & Precautions

!### Pregnancy

AMIJECT NOVO 250 INJECTION should be used with caution in pregnant women only if
considered necessary. Contact your doctor before receiving AMIJECT NOVO 250
INJECTION.

!### Breastfeeding

AMIJECT NOVO 250 INJECTION should be used with caution in breast feeding women
only if considered necessary as it is not known if it is excreted into breast
milk. Contact your doctor before receiving AMIJECT NOVO 250 INJECTION.

!### Driving and Using Machines

Do not drive or operate machines, if you feel dizzy after receiving AMIJECT NOVO
250 INJECTION.

!### Kidney

AMIJECT NOVO 250 INJECTION should be used with caution in patients with kidney
problems. Your doctor might monitor your kidney function. Consult your doctor
before receiving AMIJECT NOVO 250 INJECTION.

!### Allergy

Do not receive AMIJECT NOVO 250 INJECTION if you are allergic (hypersensitive)
to amikacin or any other aminoglycoside or allergic to sulphites or to other
ingredients of this medicine.

Others

AMIJECT NOVO 250 INJECTION is not recommended for use if you:

• suffer from myasthenia gravis (severe weakness of body muscles)

Before receiving AMIJECT NOVO 250 INJECTION, inform your doctor if you:

• have tinnitus or difficulty hearing (ringing or buzzing in the ears)
• or any member of your family suffers from an antibiotic-related hearing loss
• or any member of your family have mitochondrial mutation disease (a condition caused by variations in the mitochondrial genome, the components of your cells that help make energy)

Use in paediatrics:

AMIJECT NOVO 250 INJECTION should be used with caution in premature and new-born
infants. Ask your child’s doctor for advice.

Use in geriatrics:

AMIJECT NOVO 250 INJECTION should be used with caution in elderly patients. Your
doctor might adjust your dose depending on your kidney function. Consult your
doctor before receiving AMIJECT NOVO 250 INJECTION.

Interactions

A. Drug-Drug interactions:

Before receiving AMIJECT NOVO 250 INJECTION, inform your doctor if you are
taking any of the following medicines:

• diuretics (water tablets) such as furosemide and ethacrynic acid (used to get rid of fluid build-up in the body)
• indomethacin (used to reduce inflammation)
• other antibiotics such as penicillin, cephalosporins, gentamycin, tobramycin (used to manage certain infections)
• bisphosphonates such as alendronate (medicine used to manage bone mass loss)
• vitamin B1 (thiamine) (medicine used to metabolize carbohydrates, proteins, and fats)
• platinum compounds (metals used in chemotherapy) such as cisplatin, carboplatin, oxaliplatin
• muscle relaxants such as atracurium, rocuronium, vecuronium (used to relax muscles)
• anaesthetics such as methoxyflurane (used before surgery)

Overdosage:

AMIJECT NOVO 250 INJECTION will be administered to you only by a doctor or a
nurse in a hospital, and so it is unlikely to receive an overdose. However,
inform your doctor immediately if you experience any unusual symptoms.

Synopsis

Drug	:	Amikacin
Pharmacological Category	:	Aminoglycoside Antibiotics
Therapeutic Indication	:	Serious bacterial infections
Dosage Forms	:	Eye drops, Injection, Infusion

More Information

• Keep AMIJECT NOVO 250 INJECTION out of the sight and reach of children.
• Store AMIJECT NOVO 250 INJECTION below 25°C

FAQs About AMIJECT NOVO 250 INJECTION

What is AMIJECT NOVO 250 INJECTION and why is it prescribed?

AMIJECT NOVO 250 INJECTION contains Amikacin which belongs to a group of
medicines called Aminoglycoside Antibiotic. It is used in the management of
serious infections caused by the bacteria that are sensitive to amikacin

How much time does it take to administer AMIJECT NOVO 250 INJECTION?

AMIJECT NOVO 250 INJECTION will be given to you only by a doctor or a nurse into
a vein or muscle as an intramuscular or intravenous injection or as infusion
(drip). If given as an infusion, it may take from 30-60 minutes and 1-2 hours
for infants. Your doctor will determine the correct dose and duration of AMIJECT
NOVO 250 INJECTION for you based upon your body weight, age and severity of
disease condition.

Is it safe to use AMIJECT NOVO 250 INJECTION in children?

AMIJECT NOVO 250 INJECTION should be used with caution in premature and neonatal
infants and kidney function should be monitored. Consult your doctor before
receiving AMIJECT NOVO 250 INJECTION

Can I receive AMIJECT NOVO 250 INJECTION while breast feeding?

AMIJECT NOVO 250 INJECTION should be used in breastfeeding women only if
considered necessary as it is not known whether AMIJECT NOVO 250 INJECTION
passes through into breast milk. Contact your doctor before receiving AMIJECT
NOVO 250 INJECTION.

Do I need to undergo any tests prior to, or while being managed with AMIJECT
NOVO 250 INJECTION?

Prior to or during the management with AMIJECT NOVO 250 INJECTION, your doctor
might ask you take some diagnostic tests to check your kidney function, hearing
and levels of AMIJECT NOVO 250 INJECTION in your blood. You doctor will also
make sure that you are well hydrated.

Useful Diagnostic Tests

• Complete blood count
• Peripheral Smear Examination
• Kidney Function Test
• Hearing Function Test