MORPHINE KALCEKS 10 MGML

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

MORPHINE HYDROCHLORIDE

Sẵn có từ:

A.L. MEDI-MARKET LTD.

Mã ATC:

N02AA01

Dạng dược phẩm:

SOLUTION FOR INJECTION

Thành phần:

MORPHINE HYDROCHLORIDE 10 MG / 1 ML

Tuyến hành chính:

S.C, I.M, I.V

Loại thuốc theo toa:

Required

Sản xuất bởi:

HBM PHARMA S.R.O., SLOVAKIA

Khu trị liệu:

MORPHINE

Chỉ dẫn điều trị:

Symptomatic relief of moderate to severe pain, especially that associated with neoplastic disease, myocardial infarction, and surgery.Pre-operatively as an adjunct to anesthesia for pain relief and to allay anxiety.Alleviation of the anxiety associated with severe pain. It is useful as a hypnotic where sleeplessness is due to pain.

Ngày ủy quyền:

2020-03-10

Đặc tính sản phẩm

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Morphine Kalceks 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule (1 ml) contains 10 mg morphine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless or yellowish liquid, pH 3-5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of moderate to severe pain,especially that
associated with neoplastic disease,
myocardial infarction, and surgery. Pre-operatively as an adjunct to
anesthesia for pain relief and to
allay anxiety. Alleviation of the anxiety associated with severe pain.
It is useful as a hypnotic where
sleeplessness is due to pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Administration and posology should be adjusted according to the nature
and severity of the pain as
well as the general condition of the patient. Individual criteria for
the dose are dependent on the
patient’s age, weight, pain severity and medical and analgesic
history.
Adults
Subcutaneous or intramuscular injection
The usual dose by subcutaneous or intramuscular injection is 5-20 mg
(0.5-2 ml) every 4 hours.
Intravenous injection
Doses of up to 15 mg (1.5 ml) have been given by slow intravenous
injection, sometimes as a loading
dose for continuous or patient controlled infusion.
_ _
Elderly
Because of the depressant effect on respiration, caution is necessary
when giving morphine to the
elderly. A reduction of dose is advisable.
_ _
Hepatic Impairment:
Morphine may precipitate coma in hepatic impairment – avoid or
reduce dose
.
Renal Impairment
2
A reduced maintenance dose may be necessary in moderate to severe
impairment.
Discontinuation of therapy
An abstinence syndrome may be precipitated if opioid administration is
suddenly discontinued.
Therefore the dose should be gradually reduced prior to
discontinuation.
Method of administration
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
adm