STERILE DILUENT FOR HUMATROPE SOLVENT FOR SOLUTION FOR INJECTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Sterile Diluent for Humatrope, solvent for solution for injection. (for 12mg and 24mg cartridges)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Humatrope cartridges are supplied in a combination package with an accompanying syringe containing 3.15mL of solvent solution.

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

Solvent for solution for injection.

The solvent is a clear solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

None stated.

4.2 Posology and method of administration

Route of administration: Humatrope in cartridges is administered by subcutaneous injection after reconstitution.

None stated

4.3 Contraindications

Humatrope should not be reconstituted with the supplied solvent for patients with a known sensitivity to either metacresol or glycerol.

4.4 Special warnings and precautions for use

None stated.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, Pregnancy and lactation

None stated.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

None stated.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Solvent syringes: glycerol, metacresol, water for injections, hydrochloric acid and sodium hydroxide

6.2 Incompatibilities

None stated.

6.3 Shelf life

Before reconstitution: 3 years.

After reconstitution: The product may be stored for a maximum of 28 days at 2°C to 8°C.

Daily room temperature exposure should not exceed 30 minutes.

6.4 Special precautions for storage

Store at 2°C to 8°C (in a refrigerator). Do not freeze.

6.5 Nature and contents of container

Solvent syringes are of type I glass.

Humatrope 12mg: 1 cartridge with powder and 1 syringe with 3.15ml of solvent solution. Packs of 1, 5 and 10.

Humatrope 24mg: 1 cartridge with powder and 1 syringe with 3.15ml of solvent solution. Packs of 1, 5 and 10.

Not all pack sizes are marketed.

6.6 Special precautions for disposal

Reconstitution: Each cartridge of Humatrope should be reconstituted using the accompanying solvent syringe and the solvent connector. To reconstitute, attach the solvent connector to the cartridge and then inject the entire contents of the pre-filled solvent syringe into the cartridge. The solvent connector automatically aims the stream of liquid against the glass wall of the cartridge. Following reconstitution, the cartridge should be gently rocked back and forth until the contents are completely dissolved. DO NOT SHAKE. The resulting solution should be clear, without particulate matter. If the solution is cloudy or contains particulate matter, the contents MUST NOT be injected.

Humatrope cartridges can be used in conjunction with compatible CE marked pen injection systems. The manufacturer’s in­structions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the Humatrope injection.

The solvent connector is for single use only. Discard it after use. A sterile needle should be used for each administration of Humatrope.

7 MARKETING AUTHORISATION HOLDER

Eli Lilly Nederland B.V.

Papendorpseweg 83

3528 BJ Utrecht

The Netherlands

8 MARKETING AUTHORISATION NUMBER(S)

PL 14895/0294