Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation



Colours Used
Pregnancy


Process Black
There are no adequate data on the use of plerixafor in pregnant women.
1. NAME OF THE MEDICINAL PRODUCT
Based on the pharmacodynamic mechanism of action, plerixafor is suggested Mozobil.                                                                                   to cause congenital malformations when administered during pregnancy. Studies 2. QUALITATIVE AND QUANTITATIVE COMPOSITION                                                in animals have shown teratogenicity (see section 5.3). Mozobil should not be used during pregnancy unless the clinical condition of the woman requires treatment with 1 ml solution contains 20 mg plerixafor.
plerixafor.
Each vial contains 24 mg plerixafor in 1.2 ml solution.
Women of childbearing potential
Excipients



50 gsm
Women of childbearing potential have to use effective contraception during 


N/A
Each ml contains approximately 5 mg (0.2 mmol) of sodium.
treatment.
For the full list of excipients, see section 6.1.
Breastfeeding



(Description for old jobs only when descriptor does not fill in)


Pharma
3. PHARMACEUTICAL FORM



Folded: 100x26mm
It is not known whether plerixafor is excreted in human milk. A risk to the suckling 


Code
Solution for injection.                                                                    child cannot be excluded. Breast-feeding should be discontinued during treatment Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality          with Mozobil.



MOZOBIL 20MG/ML (1.2ML) Leaflet of 260 - 320 mOsm/kg.
Fertility
4. CLINICAL PARTICULARS                                                                    The effects of plerixafor on male and female fertility are not known (see section 5.3).



Measure bar should be 150mm at 100% scale
4.1 Therapeutic indications


MOZOBIL 20MG/ML Leaflet