MULTI-12K1 PEDIATRIC

MULTI-12 K

PEDIATRIC , 03/10/2018 AH

לע רשואו קדבנ הז ןולע

ךיראתב תואירבה דרשמ ידי

ילוי

2003

Physicians’ Prescribing Information

MULTI-12/K

1

PEDIATRIC

Multiple Vitamins for Infusion

Multi-12/K

1

Pediatric

is a multiple vitamin supplement containing the following vitamins:

Vial 1

Ascorbic acid

80 mg

Vitamin A

2300 IU

Vitamin D

400 IU

Thiamine (as hydrochloride)

1.2 mg

Riboflavin (as phosphate)

1.4 mg

Pyridoxine hydrochloride

1 mg

Niacinamide

17 mg

d

-Panthenol

5 mg

Vitamin E (

dl

-alpha tocopheryl acetate)

7 IU

Vitamin K

0.2 mg

Also contains: polysorbate 80, 1.25%, sodium hydroxide and/or

hydrochloric acid to adjust pH and water for injection.

Vial 2

Biotin

20 mcg

Folic Acid

140 mcg

Vitamin B

(cyanocobalamin)

1 mcg

Also contains: mannitol 7.5 %, sodium citrate and/or citric acid to

adjust pH and water for injection.

INDICATIONS

Multi-12/K

1

Pediatric

is indicated for use as a multiple vitamin supplement for infants and children up

to 11 years of age.

Its administration helps to maintain plasma vitamin levels and helps to prevent depletion of endogenous

stores of the vitamins and development of subsequent deficiency symptoms.

It is also indicated in other situations where there are increased requirements for vitamins due to stress

situations such as surgery, extensive burns, fractures and other trauma, severe infectious diseases, and

comatose states.

The physician should not await the development of clinical signs of vitamin deficiency before initiating

vitamin therapy. The use of a multivitamin product obviates the need to speculate on the status of

individual vitamin nutriture.

Multi-12/K

1

Pediatric

through

intake

these

necessary

vitamins,

contributes

towards

maintenance of the body's normal resistance and repair processes.

MULTI-12 K

PEDIATRIC , 03/10/2018 AH

CONTRAINDICATIONS

Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis.

MULTI-12 K

PEDIATRIC , 03/10/2018 AH

PRECAUTIONS

General: Unlike the adult formulation, Multi-12, and the original pediatric formulation, Multi-12

Pediatric, this product contains Vitamin K

1

.

Caution should be used when administering

Multi-12/K

1

Pediatric

to neonates undergoing concomitant

parenteral therapy with drugs containing polysorbate 80. If deemed necessary, to limit the concomitant

administration of polysorbate 80, discontinue

Multi-12/K

1

Pediatric

therapy for a few days and resume

it when the other drug therapy has been ceased.

Drug

Interactions

Multi-12/K

1

Pediatric

physically

compatible

with

acetazolamide,

aminophylline, ampicillin, or moderately alkaline solutions. It has been reported that folic acid is

unstable in the presence of calcium salts such as calcium gluconate.

Carcinogenicity

: Carcinogenicity studies have not been performed.

ADVERSE REACTIONS

There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine.

The risk, however, is negligible if thiamine is co-administered with other B vitamins. There have been no

reports of fatal anaphylactoid reactions associated with pediatric multivitamin preparations.

There have been rare reports of the following types of reactions:

Dermatologic: rash, erythema, pruritus.

CNS: headache, dizziness, agitation, anxiety.

Ophthalmic: diplopia.

Allergic: urticaria, periorbital and digital edema.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.

gov.il

SYMPTOMS AND TREATMENT OF OVERDOSAGE

The fat-soluble vitamins A, D and E can accumulate to harmful levels. Water-soluble vitamins, however,

are readily excreted in the urine. Treatment of vitamin overdosage usually consists of withdrawal of the

vitamin.

DOSAGE AND ADMINISTRATION

Multi-12/K

1

Pediatric

should not be given as a direct, undiluted intravenous injection as it may give

rise to dizziness, faintness and possible tissue irritation.

Multi-12/K

1

Pediatric must be diluted prior to

intravenous infusion.

For administration to infants and children weighing

3 kg up to 11 years of age:

Add one daily

dose [the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL)] to not less than 100 mL of 5% Dextrose

Injection or 0.9% Sodium Chloride Injection.

MULTI-12 K

PEDIATRIC , 03/10/2018 AH

For administration to infants weighing

1500 g and < 3 kg:

The daily dose is 65% of the contents of

Vial 1 and Vial 2, added to not less than 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride

Injection.

For administration to infants weighing < 1500 g:

The daily dose is 30% of the contents of Vial 1 and

Vial 2, added to not less than 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.

MULTI-12 K

PEDIATRIC , 03/10/2018 AH

After

Multi-12/K

1

Pediatric

is diluted in an intravenous infusion, the resulting solution should be

refrigerated unless it is to be administered immediately, and in any event should be administered within

24 hours. Discard any unused portions.

Some of the vitamins in this product, particularly vitamins A, D, and riboflavin, are light-sensitive.

Exposure to light should be minimized.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to

administration, whenever solution and container permit.

AVAILABILITY OF DOSAGE FORMS

Multi-12/K

1

Pediatric

is available as five single use two vial set: 5 x Vial 1 containing 4 mL and 5 x

Vial 2 containing 1 mL.

Store between 2 and 8 °C.

Protect from light.

Discard unused portion.

Latex-Free Stoppers: Stoppers contain no dry natural rubber.

Drug Registration No.:

139.34.30692.00

MANUFACTURER

SANDOZ CANADA INC.,

Quebec, Canada .

IMPORTER

Teva Medical Marketing Ltd.,

Haorgim St.

8

, Ashdod 77100.