Morphine Sulfate (Biomed)

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Morphine sulfate pentahydrate 1 mg/mL;  

Предлага се от:

Biomed Limited

INN (Международно Name):

Morphine sulfate pentahydrate 1 mg/mL

дозиране:

1 mg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Morphine sulfate pentahydrate 1 mg/mL   Excipient: Sodium chloride Water for injection

Броя в опаковка:

Bag, plastic, Propyflex with polycarbonate port and rubber stopper, 100 mL

Клас:

Class B1 Controlled Drug

Вид предписание :

Class B1 Controlled Drug

Произведено от:

Siegfried Ltd

Терапевтични показания:

Morphine sulfate is indicated for the relief of moderate to severe pain not responsive to non-opioidanalgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesisia. Morphine sulphate is indicated in palliative care for the treatment of diarrhoea and intractable cough.

Каталог на резюме:

Package - Contents - Shelf Life: Bag, plastic, flexible non-PVC polypropylene IV bag with foil overwrap - 100 mL - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate or freeze. - Syringe, - 10 mL - 10 months from date of manufacture stored at or below 25°C protect from light - Syringe, - 30 mL - 10 months from date of manufacture stored at or below 25°C - Syringe, - 50 mL - 10 months from date of manufacture stored at or below 25°C

Дата Оторизация:

1997-04-14

Данни за продукта

NEW ZEALAND DATA SHEET
MORPHINE SULFATE (BIOMED) 1 MG/ML SOLUTION FOR INJECTION
Page 1 of 17
1
PRODUCT NAME
Morphine Sulfate (Biomed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Sulfate Pentahydrate 1 mg/mL Solution for Injection
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Clear, colourless or almost colourless solution for injection.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Morphine sulfate is indicated for the relief of moderate to severe
pain not responsive to
nonopioid analgesics. It may also be used as a pre-operative
medication and as an
analgesic adjunct in general anaesthesia.
Morphine sulfate is indicated in palliative care for the treatment of
diarrhoea and intractable
cough.
4.2
DOSE AND METHOD OF ADMINISTRATION
Note: Opioid antagonists and facilities for administration of oxygen
and control of respiration
should be available during, and immediately following parenteral
administration
.
SLOW INTRAVENOUS ADMINISTRATION
ADULTS: Morphine sulfate may be administered intravenously when a
rapid onset of action is
desired. The dose is usually in the range of 2.5 to 15 mg given slowly
over 4 to 5 minutes.
CHILDREN: When a rapid onset of action is desirable, in a closely
monitored environment,
morphine may be titrated intravenously with caution, in a dose of 0.05
to 0.1 mg/kg,
incrementally over 5 to 15 minutes. Repeat intravenous dosing is
unsubstantiated as a
method of analgesia in children. Morphine sulfate is not usually given
pre-operatively in
children under 1 year, and it should be given with extreme care to
neonates. It should not be
given to premature infants (see Section 4.3).
CONTINUOUS INTRAVENOUS INFUSION
The dosage of morphine should be titrated according to the patient’s
analgesic requirements
and previous opiate experience. For the management of acute pain via
intravenous infusion,
most adults with no previous history of opioid intake can be continued
on 0.5 to 2.0 mg/hour
after adequate analgesia has been established.
In children, an infusion dose