CAFNEA ORAL SOLUTION caffeine citrate oral solution 25 mg/5 mL oral administration vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

caffeine, Quantity: 12.5 mg

Διαθέσιμο από:

Phebra Pty Ltd

INN (Διεθνής Όνομα):

Caffeine

Φαρμακοτεχνική μορφή:

Oral Liquid, solution

Σύνθεση:

Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injections

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

10 x 5 mL vials per carton

Τρόπος διάθεσης:

Not Scheduled after consideration by Committee

Θεραπευτικές ενδείξεις:

CAFNEA ORAL SOLUTION is indicated for the short-term treatment of apnoea of prematurity in infants between 28 and 33 weeks gestational age.

Περίληψη προϊόντος:

Visual Identification: Colourless liquid, free of haze, obvious turbidity and precipitate; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2010-04-09

Φύλλο οδηγιών χρήσης

Cafnea Injection and Cafnea Oral Solution
Page 1 of 3
_Version 05 _
CAFNEA
® INJECTION AND
CAFNEA
® ORAL SOLUTION
CAFFEINE CITRATE INJECTION AND ORAL SOLUTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cafnea Injection and
Cafnea Oral Solution. It does not
contain all the available information. It
does not take the place of talking to
your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
your baby being given Cafnea Injection
or Cafnea Oral Solution against the
benefits this medicine is expected to
have for your baby.
IF YOU HAVE ANY CONCERNS ABOUT
EITHER MEDICINE BEING GIVEN TO YOUR
BABY, ASK YOUR DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE
.
You may need to read it again.
WHAT
CAFNEA INJECTION
AND CAFNEA ORAL
SOLUTION
ARE USED FOR
Cafnea Injection and Cafnea Oral
Solution are used to help improve the
breathing of premature infants
suffering from apnoea of prematurity
who have been born between 28 and
less than 33 weeks gestation.
Apnoea of prematurity is a condition
where a baby stops breathing for short
periods of time.
Cafnea Injection and Cafnea Oral
Solution work by stimulating breathing
in premature babies.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CAFNEA
INJECTION OR CAFNEA ORAL SOLUTION
HAS BEEN PRESCRIBED FOR YOUR BABY.
Your doctor may have prescribed it for
another reason.
BEFORE CAFNEA INJECTION
OR CAFNEA ORAL SOLUTION
IS GIVEN
_WHEN THEY SHOULD NOT BE _
_GIVEN _
YOUR BABY SHOULD NOT BE GIVEN
CAFNEA INJECTION OR CAFNEA ORAL
SOLUTION IF THEY HAVE AN ALLERGY TO:
•
caffeine or citrate
•
any other similar medicine.
YOUR BABY SHOULD NOT BE GIVEN
CAFNEA INJECTION OR CAFNEA ORAL
SOLUTION IF
THE SOLUTION IS
DISCOLOURED, CLOUDY, TURBID, OR A
PRECIPITATE OR PARTICLES ARE PRESENT.
The solutions are normally clear, and
colourless.
YOUR BABY SHOULD NOT BE GIVEN EITHER
MEDICINE IF, WHEN MIXED WITH
ANOTHER
SOLUTION IT CAUSES THE
SOLUTION, TO BECOME DISCOLOURED,
CLOUDY, TURBID, PRECIPITATE OR FORM
PARTICLES.
T

Αρχείο Π.Χ.Π.

PRODUCT INFORMATION
Australian Product Information - Cafnea Injection and Cafnea Oral
Solution
Page 1 of 11
_Version 12 _
CAFNEA
®
CAFFEINE CITRATE
1
NAME OF THE MEDICINE
Caffeine citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cafnea Injection contains 20 mg/mL caffeine citrate (equivalent to 10
mg/mL of caffeine base).
Cafnea Oral Solution contains 5 mg/mL caffeine citrate (equivalent to
2.5 mg/mL of caffeine base).
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Both Cafnea Injection (Caffeine Citrate Injection 40 mg/2 mL) and
Cafnea Oral Solution (Caffeine Citrate Oral
Solution 25 mg/5 mL) are clear, colourless, preservative free sterile
solutions adjusted to a pH of 4.2 - 5.2.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Cafnea Injection and Cafnea Oral Solution are indicated for the
short-term treatment of apnoea of prematurity
(AOP) in infants of gestational age 28 to less than 33 weeks.
4.2
D
OSE AND METHOD OF ADMINISTRATION
CAFNEA INJECTION AND CAFNEA ORAL SOLUTION ARE INTENDED TO BE USED IN
NEONATAL SPECIALIST UNITS. THE PRODUCT
IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY RESIDUE.
NOTE:
▪
A
prior
check
should
be
made
to
ensure
that
no
other
methylxanthine
(e.g.
theophylline
and
aminophylline) is being administered.
▪
Baseline serum levels of caffeine should be measured if mothers have
consumed caffeine containing
fluids prior to delivery, since caffeine readily crosses the placenta.
▪
The dose expressed as caffeine base is half the dose when expressed as
caffeine citrate (e.g. 20 mg of
caffeine citrate is equivalent to 10 mg of caffeine base).
LOADING DOSE
Caffeine citrate 20 mg/kg body weight intravenously using a syringe
infusion pump over 30 minutes.
PRODUCT INFORMATION
CAFNEA
® INJECTION AND
CAFNEA
® ORAL SOLUTION
Australian Product Information - Cafnea Injection and Cafnea Oral
Solution
Page 2 of 11
_Version 12_
MAINTENANCE DOSE
Caffeine citrate 5 mg/kg once a day until apnoea ceases or until
treatment is considered to be no longe