Nepalm Vitamin A 100,000units/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Vitamin A palmitate

Available from:

Imported (France)

ATC code:

A11CA01

INN (International Name):

Vitamin A palmitate

Dosage:

50000unit/1ml

Pharmaceutical form:

Solution for injection

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060101

Summary of Product characteristics

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VITAMIN A PROVEPHARM 100,000 IU /2 ML, SOLUTION FOR INJECTION (I.M.)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Retinol palmitate (Vitamin
A)……………………………………………………………………
100,000 IU
in one ampoule
Excipient(s) with known effect: Polyoxyl 40 Hydrogenated Castor Oil
(CREMOPHOR RH 40), sodium
benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (I.M.).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Vitamin A deficiency, when the oral route is not possible;
Digestive malabsorption of vitamin A: cystic fibrosis, hepatic
cholestasis, pancreatic impairment, other
malabsorptions.
Vitamin A intake during elemental enteral feeding.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In adults: 100,000 IU per month.
_Paediatric population_
Children: 50,000 IU per month or 100,000 IU every 2 months, in cases
of hepatic cholestasis.
Method of administration
Deep intramuscular use.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to one of the excipients
mentioned in section 6.1.
•
Intestinal occlusion.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not administer the product subcutaneously (see section 4.8), or by
oesophageal catheter.
This medicine contains castor oil and can cause severe allergic
reactions.
Due to the presence of benzoic acid (or sodium benzoate), this
medicine can irritate the skin, eyes and
mucous membranes.
Paediatric population
Due to the presence of benzoic acid (or sodium benzoate), this
medicine can increase the risk of
jaundice in new-borns.
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4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Contraindicated combinations
+ CYCLINES
For intake of 10,000 IU/d or more: risk of intracranial hypertension.
+ RETINOIDS
Risk of symptoms suggestive of hypervitaminosis A.
4.6.
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
Vitamin A is teratogenic in animals on