Metoclopramide (Lumacina)

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Metoclopramide hydrochloride monohydrate 5.27 mg/mL equivalent to metoclopramide hydrochloride 5 mg/mL

Tersedia dari:

Lumacina New Zealand

INN (Nama Internasional):

Metoclopramide hydrochloride monohydrate 5 mg/mL

Dosis:

10 mg/2mL

Bentuk farmasi:

Solution for injection

Komposisi:

Active: Metoclopramide hydrochloride monohydrate 5.27 mg/mL equivalent to metoclopramide hydrochloride 5 mg/mL Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection

Unit dalam paket:

Ampoule, plastic, 10 x 2mL, 20 mL

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Cosma SpA

Indikasi Terapi:

Adults (20 years and over) · Relief of nausea and vomiting associated with migraine, cancer therapy (chemotherapy or radiation), malignant disease, labour, infectious disease and uraemia · Control of post-operative vomiting · Assist in small bowel intubation Metoclopramide is of little benefit for the prevention or treatment of motion sickness. Young Adults and Children (over 1 year of age) Metoclopramide should be restricted to the following conditions and only used as second line therapy, when used to treat children and young adults under 20 years of age because of the risk of adverse effects. · Severe intractable vomiting of known cause · Vomiting associated with radiation therapy or intolerance to cytotoxic drugs · Assist in small bowel intubation

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, plastic, 10 x 2mL - 20 mL - 24 months from date of manufacture stored at or below 25°C - Ampoule, plastic, 50 x 2mL - 100 mL - 24 months from date of manufacture stored at or below 25°C

Tanggal Otorisasi:

1990-09-05

Selebaran informasi

Metoclopramide Injection
1
METOCLOPRAMIDE INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I GIVEN METOCLOPRAMIDE INJECTION?
Metoclopramide Injection contains the active ingredient metoclopramide
hydrochloride monohydrate.
Metoclopramide Injection is used to relieve nausea and vomiting in
migraine, cancer treatment, childbirth and infectious
diseases; control vomiting after surgery; or to help with placing
tubes into the intestine in adults over 20 years of age.
Metoclopramide Injection is used as second line therapy to treat
severe vomiting of known cause or following chemotherapy
or radiation treatment; or to help with placing tubes into the
intestine in young adults and children (over 1 year of age).
For more information, see Section 1. Why am I given Metoclopramide
Injection? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE RECEIVING METOCLOPRAMIDE INJECTION?
Do not use if you have ever had an allergic reaction to
metoclopramide, or any other similar medicines, such as procaine,
procainamide.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before
receiving Metoclopramide Injection? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metoclopramide Injection and affect
how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS METOCLOPRAMIDE INJECTION GIVEN?
Metoclopramide Injection will be given to you by a doctor or nurse as
an injection into the muscle or by slow injection into a
vein.
More information can be found in Section 4. How is Metoclopramide
Injection given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE RECEIVING METOCLOPRAMIDE INJECTION?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST

Karakteristik produk

Page 1 of 11
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
Metoclopramide Injection Ampoule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metoclopramide
Injection
contains
metoclopramide
hydrochloride
monohydrate
10.54 mg/2 mL,
e
quivalent to m
etoclopramide hydrochloride 10 mg/2 mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Metoclopramide Injection is a clear, colourless, sterile,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (20 YEARS AND OVER)
•
Relief of nausea and vomiting associated with migraine, cancer therapy
(chemotherapy or radiation),
malignant disease, labour, infectious disease and uraemia
•
Control of post-operative vomiting
•
Assist in small bowel intubation
Metoclopramide is of little benefit for the prevention or treatment of
motion sickness.
YOUNG ADULTS AND CHILDREN (OVER 1 YEAR OF AGE)
Metoclopramide should be restricted to the following conditions and
only used as second line therapy,
when used to treat children and young adults under 20 years of age
because of the risk of adverse effects:
•
Severe intractable vomiting of known cause
•
Vomiting associated with radiation therapy or intolerance to cytotoxic
drugs
•
Assist in small bowel intubation
4.2 DOSE AND METHOD OF ADMINISTRATION
The dosage recommendations should be strictly adhered to in order to
minimise the possibility of
dystonic side effects. Metoclopramide should only be used after
careful examination has excluded any
underlying disorder (such as cerebral irritation) that may have
induced nausea and vomiting.
Total daily doses of metoclopramide should not normally exceed 0.5
mg/kg bodyweight with a
maximum of 30 mg daily. This should be less (if possible) in children
and young adults, when given
by injection. Maximum recommended treatment duration is 5 days in all
age groups.
Page 2 of 11
Usual dosage is as follows and should be administered intramuscularly
or by slow intravenous injection
over 1 to 2 minutes.
_ADULTS _
_20 years a