GLYCEROL WITH SODIUM CHLORIDE MONICO

ATC: B05BC49
GLYCEROL WITH SODIUM CHLORIDE MONICO
(GLYCEROL 10% AND SODIUM CHLORIDE 0.9%)
INFUSION SOLUTION

COMPOSITION
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1000 ml contains:
Active substances:
glicerol g 100.0
sodium chloride g 9.0
Excipients:
water for injections q.s. to ml 1000
mEq/l: Na 154
Cl 154
mMol/l (C H O ) 1086
theoretical osmolarity: (mOsm/l) 1394
pH: 5.0 ÷ 7.0

PHARMACEUTICAL FORM AND CONTENT
Hypertonic intravenous infusion solution (hypertonic relative to blood).
Type II glass vial of ml 50 – 100 – 250 – 500 – 1000.

THERAPEUTIC CATEGORY
Antiedema

MARKETING AUTHORIZATION HOLDER, MANUFACTURER AND FINAL CONTROLLER
MONICO S.p.A. – Via Ponte di Pietra 7 – VENEZIA/MESTRE

THERAPEUTIC INDICATIONS
Increased intracranial and intraocular pressure. Glycerol increases plasma osmolarity; as a consequence, water shifts from extravascular spaces into the circulation by osmosis, followed by an increase in diuresis. It is metabolized by all tissues, primarily by the liver. It may also be excreted unchanged.

CONTRAINDICATIONS
Contraindicated in cases of anuria due to severe renal impairment, pulmonary congestion and pulmonary edema, active cerebral and intracranial hemorrhages, severe dehydration; in patients hypersensitive to glycerol.

PRECAUTIONS FOR USE
Use with great caution in patients with congestive heart failure, severe renal insufficiency, and clinical conditions associated with edema and hydro-saline retention; in patients receiving corticosteroid or corticotropin therapy. Do not administer simultaneously with blood transfusion through the same intravenous line due to the risk of hemolysis. Monitor renal function during administration to prevent irreversible osmotic nephrosis; monitor diuresis to avoid glycerol accumulation, which may lead to cardiac decompensation. In patients with severe renal insufficiency, administer an initial test dose followed by a second dose to assess patient tolerance.

Monitor fluid balance, electrolytes, and plasma osmolarity.

INTERACTIONS
Do not use as a vehicle for other drugs.
The prescribing physician is referred to the scientific literature.

SPECIAL WARNINGS
Use immediately after opening the container. The solution must be clear, colorless or almost colorless, and free from visible particles. Intended for single, uninterrupted administration; any residual solution must not be used.

Hypertonic intravenous solution – administer with caution and at controlled infusion rate. Do not use this concentration unless specifically prescribed.

During pregnancy
Administer only if clearly needed.

In children
Safety and efficacy have not been established.

DOSAGE, ROUTE AND DURATION OF ADMINISTRATION
For intravenous use. Dosage depends on the patient's age, weight, and clinical condition.
Administer up to 500 ml of solution (equivalent to 50 g of glycerol) every 6 hours.

UNDESIRABLE EFFECTS
Hemolytic reactions when administered at rates equal to or greater than 7 mg/kg body weight/minute, corresponding to an infusion rate approximately 6 times higher than recommended. Hemoglobinuria and acute renal failure secondary to hemolysis. Severe dehydration; in diabetics, may cause hyperosmolar non-ketotic coma. Fever episodes, infections at injection site, venous thrombosis or phlebitis, tissue necrosis. In case of adverse reactions, discontinue administration and retain the unused portion for possible testing. Patients are advised to inform their physician or pharmacist of any adverse effects not described in this leaflet.

EXPIRY DATE AND STORAGE
Check the expiry date stated on the packaging.
The expiry date refers to the product stored unopened and under proper storage conditions.
Warning: do not use the medicinal product beyond this date.
Store in a tightly closed container. Do not freeze or refrigerate.

This is a medicinal product manufactured according to Pharmacopoeial standards. For further information regarding its use (precautions, drug interactions, adverse events), the prescribing physician is referred to the scientific literature.

KEEP THIS MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN

DATE OF REVISION OF THE PACKAGE LEAFLET BY THE MINISTRY OF HEALTH
6 OCTOBER 2003