SALCO 100 IU

Israel - English - Ministry of Health

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Active ingredient:
CALCITONIN SALMON; CALCITONIN SALMON
Available from:
GENMEDIX , ISRAEL
ATC code:
H05BA01
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
CALCITONIN SALMON 100 IU/ML; CALCITONIN SALMON 100 IU/ML
Administration route:
I.M, I.V, S.C, I.M, I.V, S.C
Prescription type:
Required
Manufactured by:
LABORATORIO ITALIANO BIOCHIMICO FARMACEUTICO LISAPHARMA S.P.A, ITALY
Therapeutic group:
CALCITONIN (SALMON SYNTHETIC)
Therapeutic area:
CALCITONIN (SALMON SYNTHETIC)
Therapeutic indications:
Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.• For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.• Treatment of hypercalcemia of malignancy. Calcitonin is indicated for:• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.• For the treatment of Paget's disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment.• Treatment of hypercalcemia of malignancy.
Authorization number:
103 06 28025 00
Authorization date:
2011-11-30

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

SALCO 100 IU

, solution for injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

SALCO 100 IU/ml solution for injection – 1 ampoule contains:

Active principle:

Salmon calcitonin

100 IU/ML

SALCO is essentially sodium-free, see section 4.4.

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Solution for intramuscular, intravenous and subcutaneous injection.

Salco is a clear, colourless aqueous solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Calcitonin is indicated for:

Prevention of acute bone loss due to sudden immobilisation such as in

patients with recent osteoporotic fractures.

For the treatment of Paget's disease, only in patients who do not respond to

alternative treatments or for whom such treatments are not suitable, for

example those with severe renal impairment.

Treatment of hypercalcemia of malignancy.

4.2

Posology and method of administration

Salmon calcitonin may be administered at bedtime to reduce the incidence of

nausea or vomiting which may occur, especially at the initiation of therapy.

evidence

increased

risk

malignancies

long

term

calcitonin use (see section 4.4), the treatment duration in all indications

should be limited to the shortest period of time possible and using the

minimum effective dose.

Prevention of acute bone loss due to sudden immobilisation such as in patients

with recent osteoporotic fractures

The recommended dosage is 100 IU daily or 50 IU twice daily, administered

subcutaneously or intramuscularly. The dose may be reduced to 50 IU daily at

the start of remobilisation. The recommended treatment duration is 2 weeks

and should not exceed 4 weeks in any case due to the association of the

increased risk of malignancies and long term calcitonin use.

Paget’s disease:

The recommended dosage is 100 IU per day administered subcutaneously or

intramuscularly, however, a minimum dosage regimen of 50 IU three times a

week has achieved clinical and biochemical improvement. Dosage is to be

adjusted to the individual patient’s needs. Treatment should be discontinued

once the patient has responded and symptoms have resolved. Duration of

treatment should not normally exceed 3 months due to evidence of an increased

risk of malignancies with long term calcitonin use. Under exceptional

circumstances, e.g. in patients with impending pathologic fracture, treatment

duration may be extended up to a recommended maximum of 6 months.

Periodic re-treatment may be considered in these patients, and should take into

account the potential benefits and evidence of an increased risk of malignancies

and long term calcitonin use (see section 4.4).

The effect of calcitonin may be monitored by measurement of suitable markers

of bone remodeling, such as serum alkaline phosphatase or urinary

hydroxyproline or deoxypyridinoline.

The dose may be reduced after the condition of the patient has improved.

Hypercalcemia of malignancy:

The recommended starting dose is 100 IU every 6 to 8 hours by

subcutaneous or intramuscular injection. In addition, salmon calcitonin

could be administered by intravenous injection after previous rehydration.

If the response is not satisfactory after one or two days, the dose may be

increased to a maximum of 400 IU every 6 to 8 hours. In severe or emergency

cases, intravenous infusion with up to 10 IU/kg body weight in 500 ml 0.9%

w/v sodium chloride solution may be administered over a period of at least 6

hours.

The treatment duration is limited to the shortest possible time using the

minimum effective dose.

As salmon calcitonin is a peptide, adsorption onto the plastic of the infusion set

may occur. This has the potential to reduce the total dose delivered to the

patient. Frequent monitoring of the clinical and laboratory response including

the measurement of serum calcium is recommended especially in the early

phases of treatment. The dosing of SALCO should be individualized to the

patient’s specific requirements.

Older people

Experience with the use of calcitonin in the elderly has shown no evidence of

reduced tolerability or altered dosage requirements.

Patients with hepatic impairment

Experience with the use of calcitonin in patients with altered hepatic function has

shown no evidence of reduced tolerability or altered dosage requirements.

Patients with renal impairment

The metabolic clearance is much lower in patients with end-stage renal failure

than in healthy subjects. However, the clinical relevance of this finding is not

known (see section 5.2).

Paediatric population

There is insufficient evidence to support the use of salmon calcitonin in

conditions associated with paediatric osteoporosis. Use of salmon calcitonin in

children 0 to 18 years is therefore not recommended.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in

section 6.1.

Calcitonin is also contraindicated in patients with hypocalcaemia.

4.4

Special warnings and precautions for use

Because calcitonin is a peptide, the possibility of systemic allergic reactions

exists and allergic-type reactions including isolated cases of anaphylactic shock

have been reported in patients receiving calcitonin. Such reactions should be

differentiated from generalised or local flushing, which are common non-allergic

effects of calcitonin (see section 4.8). Skin testing should be conducted in

patients with suspected sensitivity to calcitonin prior to their treatment with

calcitonin.

Analyses of randomised controlled trials conducted in patients with

osteoarthritis and osteoporosis have shown that calcitonin is associated with a

statistically significant increase in the risk of cancer compared to patients treated

with placebo. These trials demonstrated an increase in the absolute risk of cancer

occurrence for patients treated with calcitonin compared to placebo which varied

between 0.7% and 2.4% with long term therapy. Patients in these trials were

treated with oral or intra-nasal formulations however it is likely that an increased

risk also applies when calcitonin is administered subcutaneously,

intramuscularly or intravenously especially for long-term use, as systemic

exposure to calcitonin in such patients is expected to be higher than for other

formulations.

SALCO contains less than 23 mg sodium per 1 ml and can be considered

"sodium-free".

4.5

Interaction with other medicinal products and other forms of interaction

Serum calcium levels may be transiently decreased to below normal levels

following administration of calcitonin, notably upon initiation of therapy in

patients with abnormally high rates of bone turnover. This effect is diminished as

osteoclastic activity is reduced. However, care should be exercised in patients

receiving concurrent treatment with cardiac glycosides or calcium channel

blocking agents. Dosages of these drugs may require adjustment in view of

the fact that their effects may be modified by changes in cellular electrolyte

concentrations.

The use of calcitonin in combination with bisphosphonates may result in an

additive calcium-lowering effect.

Concomitant use of calcitonin and lithium may lead to a reduction in plasma

lithium concentrations. The dose of lithium may need to be adjusted.

4.6

Fertility, pregnancy and lactation

Pregnancy

Calcitonin has not been studied in pregnant women. Calcitonin should be used

during pregnancy only if treatment is considered absolutely essential by the

physician.

Breast-feeding

It is not known if the substance is excreted in human milk. In animals, salmon

calcitonin has been shown to decrease lactation and to be excreted in milk (see

section 5.3). Therefore, breast-feeding is not recommended during treatment.

Fertility

There are no data regarding a potential influence of SALCO on human fertility.

4.7

Effects on ability to drive and use machines

No studies exist on the effects of SALCO on the ability to drive and use

machines. SALCO may cause fatigue, dizziness and visual disturbances (see

section 4.8) which may impair the patient’s reactions. Patients must therefore

be warned that these effects may occur, in which case they should not drive or

use machines.

4.8

Undesirable effects

The most frequently observed undesirable effects are nausea, vomiting and

flushing. They are dose dependent and more frequent after i.v. than after i.m.

or s.c. administration.

Adverse drug reactions from multiple sources including clinical trials and

post- marketing experience are listed by MedDRA system organ class. Within

each system organ class, the adverse drug reactions are ranked by frequency,

with the most frequent reactions first. Within each frequency grouping,

adverse drug reactions are presented in order of decreasing seriousness.

Adverse reactions have been ranked under headings of frequency using the

following convention: Very common (≥1/10); common (≥1/100 to <1/10);

uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare

(<1/10,000), not known (cannot be estimated from the available data).

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Common

Malignancy (with long term use)

Immune system disorders

Uncommon:

Hypersensitivity.

Very rare:

Serious allergic-type reactions such as

bronchospasm, swelling of the tongue and

throat, anaphylactic shock.

Metabolism and nutrition disorders

Rare:

Transient decrease of calcemia

Not known:

Hypocalcaemia

Nervous system disorders

Common:

Dizziness, headache, dysgeusia.

Not known:

Tremor

Eye disorders

Uncommon:

Visual impairment.

Vascular disorders

Very Common:

Flushing (facial or upper body)

Uncommon:

Hypertension.

Gastrointestinal disorders

Very Common:

Nausea with or without vomiting

Common:

Diarrhoea, abdominal pain.

Skin and subcutaneous tissue disorders

Uncommon:

Rash generalised, pruritus.

Not known:

Urticaria.

Musculoskeletal and connective tissue disorders

Common:

Musculoskeletal pain including arthralgia.

Renal and urinary disorders

Uncommon:

Polyuria.

General disorders and administration site conditions

Common:

Fatigue.

Uncommon:

Influenza-like illness, oedema (facial, peripheral

and generalised), injection site reaction

generalised), injection site reaction

Investigations

Rare:

Development

neutralising

antibodies

calcitonin

The frequencies of the above listed undesirable effects are partly based on

results from clinical trials with Miacalcic (calcitonin salmon) Nasal Spray.

Development of neutralising antibodies to calcitonin. The development of

these antibodies is not usually related to loss of clinical efficacy, although their

presence in a small percentage of patients following long-term therapy with

calcitonin may result in a reduced response to the product. The presence of

antibodies appears to bear no relationship to allergic reactions, which are rare.

Calcitonin receptor down-regulation may also result in a reduced clinical

response in a small percentage of patients following long-term therapy.

Nausea with or without vomiting is noted in approximately 10% of patients

treated with calcitonin. The effect is more evident on initiation of therapy and

tends to decrease or disappear with continued administration or a reduction in

dose. An antiemetic may be administered, if required. Nausea/vomiting are

less frequent when the injection is done in the evening and after meals.

In case of patients with high bone remodelling (Paget’s disease and young

patients) a transient decrease of calcemia may occur between the 4

and the

hour after administration, usually asymptomatic.

Flushing (facial or upper body) is not an allergic reaction but is due to a

pharmacological effect and is usually observed 10 to 20 minutes after

administration.

Reporting of suspected adverse reactions

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

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM

edic@moh.gov.il

and e-mailed to the Registration Holder’s Patient Safety Unit at:

drugsafety@neopharmgroup.com

4.9

Overdose

Nausea, vomiting, flushing and dizziness are known to be dose dependent when

calcitonin is administered parenterally. Single doses (up to 10,000 IU) of

injectable salmon calcitonin have been administered without adverse reactions,

other than nausea and vomiting, and exacerbation of pharmacological effects.

Should symptoms of overdose appear, treatment should be symptomatic.

5.

PHARMACOLOGICAL PROPERTIES

The pharmacological properties of the synthetic and recombinant peptides have

been demonstrated to be qualitatively and quantitatively equivalent.

5.1

Pharmacodynamic properties

Pharmacotherapeutic

group:

antiparathyroid

hormone,

code:

H05BA01

(calcitonin, salmon).

Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct

action on osteoclasts. By inhibiting osteoclast activity via its specific receptors,

salmon

calcitonin

decreases

bone

resorption.

pharmacological

studies,

calcitonin has been shown to have analgesic activity in animal models.

Calcitonin markedly reduces bone turnover in conditions with an increased rate

of bone resorption such as Paget’s disease and acute bone loss due to sudden

immobilisation.

The absence of mineralisation defect with calcitonin has been demonstrated by

bone histomorphometric studies both in man and in animals.

Decreases in bone resorption as judged by a reduction in urinary

hydroxyproline

deoxypyridinoline

observed

following

calcitonin

treatment in both normal volunteers and patients with bone-related disorders,

including Paget’s disease and osteoporosis.

The calcium-lowering effect of calcitonin is caused both by a decrease in the

efflux of calcium from the bone to the ECF and inhibition of renal tubular

reabsorption of calcium.

5.2

Pharmacokinetic properties

General characteristics of the active substance

Salmon calcitonin is rapidly absorbed and eliminated.

Peak plasma concentrations are attained within the first hour of administration.

After subcutaneous administration, peak plasma levels are reached in about

23 minutes.

Animal

studies

have

shown

that

calcitonin

primarily

metabolised

proteolysis in the kidney following parenteral administration. The metabolites

lack the specific biological activity of calcitonin.

Bioavailability following subcutaneous and intramuscular injection in humans is

high

similar

routes

administration

(71%

66%,

respectively).

Calcitonin has a short absorption half-life of 10-15 minutes. The elimination

half-life is about 1 hour for intramuscular administration and 1 to 1.5 hours for

subcutaneous

administration.

Salmon

calcitonin

primarily

almost

exclusively

degraded

kidneys,

forming

pharmacologically

inactive

fragments of the molecule. Therefore, the metabolic clearance is much lower

in patients with end-stage renal failure than in healthy subjects. However, the

clinical relevance of this finding is not known.

Plasma protein binding is 30 to 40%.

Characteristics in patients

There is a relationship between the subcutaneous dose of calcitonin and peak

plasma

concentrations. Following parenteral administration of 100 IU

calcitonin, peak plasma concentration lies between about 200 and 400 pg/ml.

Higher blood levels may be associated with increased incidence of nausea and

vomiting.

5.3

Preclinical safety data

Conventional long term toxicity, reproduction, mutagenicity and

carcinogenicity studies have been performed in laboratory animals.

Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic

potential.

An increased incidence of pituitary adenomas has been reported in rats

given synthetic salmon calcitonin for 1 year. This is considered a species-

specific effect and of no clinical relevance. It is not known whether salmon

calcitonin crosses the placental barrier.

In lactating animals given calcitonin, suppression of milk production has

been observed. Calcitonin is secreted into the milk.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Glacial acetic acid

Sodium acetate trihydrate

Sodium chloride

Water for injection

6.2

Incompatibilities

Glass or hard plastic i.v. containers should not be used.

6.3

Shelf life

The expiry date is indicated on the packaging materials.

6.4

Special precautions for storage

Store in a refrigerator (between 2°C and 8°C). Store product in its original

package to protect it from light.

Use immediately after opening.

6.5

Nature and contents of container

Type I, transparent glass ampoules containing 1 ml of solution. SALCO

ampoules 100 IU/ml are supplied as packs containing 1,2,3,4 and 5 ampoules.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal

SALCO ampoule 100 IU/ml should be inspected visually. If the liquid is not

clear and colourless, or contains any particles, or the ampoule is damaged, do

not use the medicine.

Solutions for infusion should be prepared immediately before use in soft plastic

PVC infusion bags. Glass or hard plastic i.v. containers should not be used.

The ampoules are for single use only. Remaining contents should be discarded.

Allow to reach room temperature before intramuscular or subcutaneous use.

7.

MANUFACTURER

Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.

Via Licinio, 11 – 22036 ERBA (CO)

Italy

8.

REGISTRATION HOLDER

Genmedix

12 Beit Harishonim St., Emek Heffer

9.

REGISTRAION NUMBER

103-06-28025

The format of this leaflet was determined by the Ministry of Health and its content was checked

and approved in August 2017.

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