Sodium chloride 30% concentrate for solution for infusion 10ml ampoules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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资料单张 资料单张 (PIL)
05-07-2018
产品特点 产品特点 (SPC)
05-07-2018

有效成分:

Sodium chloride

可用日期:

Torbay Pharmaceuticals

ATC代码:

B05XA03

INN(国际名称):

Sodium chloride

剂量:

300mg/1ml

药物剂型:

Solution for infusion

给药途径:

Intravenous

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF:

资料单张

                                PATIENT INFORMATION LEAFLET
SODIUM CHLORIDE 30% W/V CONCENTRATE FOR SOLUTION FOR INFUSION
•
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.
•
IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR
DOCTOR OR PHARMACIST.
•
IF ANY SIDE EFFECT GETS SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS
NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
1.
WHAT SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT
IT IS USED FOR
2.
BEFORE YOU ARE GIVEN SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR
INFUSION
3.
HOW SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION IS USED
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION
6.
FURTHER INFORMATION
1. WHAT SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS
USED FOR
This medicine is a concentrated electrolyte solution for infusion into
a large vein. When
diluted and mixed thoroughly with another fluid it is used for
rehydration.
2. BEFORE YOU ARE GIVEN SODIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR
INFUSION
THIS MEDICINE SHOULD NOT BE USED IF YOU:
• Have suffered with heart disease
• Have suffered with high blood pressure
• Have suffered with diabetes mellitus
Check with your doctor if you are concerned about any of the above.
THIS MEDICINE SHOULD BE USED WITH CARE:
• If you are suffering from congestive heart failure
• If you have problems with your kidneys
• If you have suffered from pulmonary oedema (fluid on the lungs)
• If you have suffered from pre-eclampsia (high blood pressure
associated with pregnancy)
• If you have suffered from peripheral oedema (swelling of hands and
feet)
• If you have high blood pressure, swelling and protein in the urine
during the last 3 months
of pregnancy (toxaemia of pregnancy)
• In children
• In the elderly
Check with your doctor if you are concerned about any of the above.
Before giving this medicine, the do
                                
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产品特点

                                OBJECT 1
SODIUM CHLORIDE 30%W/V CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 21-Sep-2017 | Torbay &
South Devon NHS Foundation
Trust
1. Name of the medicinal product
Sodium Chloride 30% w/v Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
Sodium chloride 300mg per mL (5mmol per mL)
The product is available as:
Sodium chloride 3g/10mL ampoules
Sodium chloride 15g/50mL vials.
Sodium chloride 30g/100mL vials.
For excipients, see 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion. The product is a sterile,
clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
The product is used for rehydration only when diluted. Before
administration, the concentrate must be
diluted and thoroughly mixed with a larger volume of fluid.
4.2 Posology and method of administration
When concentrations of 3 and 5% w/v are indicated, the solution should
be administered into a large vein,
at a rate not exceeding 100mL per hour.
Adults, Children and the elderly
Concentration and sodium chloride dosage for intravenous use are
determined by several factors,
including age, weight and clinical condition of the patient. The usual
sodium and chloride requirements
for adults can be satisfied by infusion of the equivalent of 1 litre
of sodium chloride 0.9% w/v daily.
Sodium Chloride 30% w/v Concentrate for Solution for Infusion should
be diluted sufficiently to obtain
an isotonic (0.9% w/v) solution. An isotonic solution can be prepared
by diluting 30 mL Sodium Chloride
30% w/v Concentrate for Solution for Infusion to 1 litre with a
non-electrolyte solution or water for
injections.
Sodium Chloride 0.9% w/v injections are often used as diluents for the
infusion of drug additives, and
0.9% w/v solutions of sodium chloride are widely used for sterile
irrigation and dilution purposes.
4.3 Contraindications
Caution: Sodium Chloride 30% w/v Concentrate for Solution for Infusion
is a hypertonic solution, and
should be diluted before use.
4.4 Special 
                                
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